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CN112386635B - Application of Jingfang preparation in the preparation of drugs for treating sequelae of new coronary pneumonia and its preparation method - Google Patents

Application of Jingfang preparation in the preparation of drugs for treating sequelae of new coronary pneumonia and its preparation method

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Publication number
CN112386635B
CN112386635B CN202011011605.2A CN202011011605A CN112386635B CN 112386635 B CN112386635 B CN 112386635B CN 202011011605 A CN202011011605 A CN 202011011605A CN 112386635 B CN112386635 B CN 112386635B
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extract
preparation
fructus aurantii
weight
jingfang
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CN112386635A (en
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张贵民
关永霞
程国良
李冰冰
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Lunan Pharmaceutical Group Corp
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Lunan Pharmaceutical Group Corp
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Priority to CN202011011605.2A priority Critical patent/CN112386635B/en
Priority to CN202510605432.3A priority patent/CN120324510A/en
Priority to CN202510605433.8A priority patent/CN120361102A/en
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236—Ligusticum (licorice-root)
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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Abstract

The invention discloses application of Jingfeng preparation in preparing medicament for treating new crown sequela and a preparation method thereof, belonging to the field of medicine. The Jingfeng preparation is prepared from eleven raw medicinal materials including fineleaf schizonepeta herb, divaricate saposhnikovia root, incised notopterygium rhizome, pubescent angelica root, chinese thorowax root, whiteflower hogfennel root, szechuan lovage rhizome, bitter orange, indian buead, platycodon root, liquoric root and the like, and has the effects of inducing sweat, relieving exterior syndrome, dispelling wind and eliminating dampness. The Jingfeng preparation is an effective prescription for treating the sequelae of the new crown, can effectively treat viral myocarditis of a patient with the new crown in the recovery period, reduces serum concentrations of liver function markers ALT and AST and kidney function markers Cre and BUN, thereby effectively protecting liver and kidney functions, effectively inhibiting inflammatory reaction of acute respiratory distress syndrome, simultaneously effectively treating diarrhea, treating both principal and secondary aspect of disease and having definite treatment effect on the sequelae of the new crown.

Description

Application of Jingfeng preparation in preparing medicament for treating new crown sequela and preparation method thereof
Technical Field
The invention relates to application of an anti-vitiligo preparation and a preparation method thereof, in particular to application of the anti-vitiligo preparation in preparing a medicament for treating new crown sequelae and a preparation method thereof, and belongs to the field of medicines.
Background
Novel coronavirus pneumonia (Corona Virus Disease, 2019, covd-19), abbreviated as "novel coronavirus pneumonia", refers to acute infectious pneumonia caused by 2019 novel coronavirus infection. The most common clinical symptoms of infected patients are fever, weakness and dry cough, and a few patients are accompanied by symptoms of upper respiratory tract and digestive tract such as nasal obstruction, nasal discharge, diarrhea and the like. In severe cases, dyspnea occurs after 1 week, and severe cases further develop into acute respiratory distress syndrome, septic shock, metabolic acidosis and coagulation dysfunction which are difficult to correct, etc. New coronatine pneumonia is a multi-system disease, and the affected area of the disease on a patient is not limited to the lung, but also causes damage to the kidney, liver, heart, brain, nerve and other systems of the patient to different extents. Most of critically ill patients are reported to be accompanied by organ dysfunction, including heart injury, acute kidney injury, liver dysfunction, pneumothorax, and the like. Up to now, there is no effective medicine for treating new coronary pneumonia, mainly isolating treatment and symptomatic support treatment.
Along with the enhancement of epidemic prevention and control force, a large number of patients are cured and discharged. However, although some patients who are discharged from the hospital have negative nucleic acid detection, reduced or obvious absorption of pneumonia and normal body temperature, symptoms such as hypodynamia, shortness of breath, appetite reduction, diarrhea, anxiety and the like may exist, and some patients also have pulmonary fibrosis caused by poor absorption of pulmonary inflammation to influence the quality of life, especially the elderly and the patients with chronic basic diseases have poor prognosis. In addition, the cured patient can suffer from various organ injury sequelae caused by new coronaries, such as heart injury, acute kidney injury, liver dysfunction, nervous system injury, digestive system injury and the like. According to a recent study published by the university of frankfurt hospital, it has been shown that most human hearts recovered from new crowns are damaged, and that even if the new crown test is negative, 78% of the participants have heart problems, with the most common long-term damage factor being myocarditis. Therefore, the treatment of the new crown sequela needs to draw more attention and importance.
The traditional Chinese medicine plays an important role in epidemic diagnosis and treatment at this time, wherein the traditional Chinese medicine preparation Jingfu particles are recommended to be used for treating cold-dampness depressed lung syndrome type new coronaries pneumonia in the scheme of preventing new coronaries from multiple provinces. The Jingfang preparation is derived from palace-chastetree plant toxin-vanquishing powder, is prepared from eleven raw medicinal materials including fineleaf schizonepeta herb, divaricate saposhnikovia root, incised notopterygium rhizome, pubescent angelica root, chinese thorowax root, whiteflower hogfennel root, szechuan lovage rhizome, bitter orange, indian buead, platycodon root, liquoric root and the like, has the effects of inducing sweat to relieve exterior syndrome, dispelling wind and eliminating dampness, and is clinically used for treating symptoms such as wind-cold common cold, headache body pain, aversion to cold without sweat, nasal obstruction with nasal discharge, cough with white phlegm and the like. The monarch drugs of schizonepeta and divaricate saposhnikovia root Xin Wenbiao in the recipe can induce sweat to relieve exterior syndrome and dispel wind evil, dispel the first time of hundred diseases, ministerial drugs of notopterygium root and pubescent angelica root are pungent and warm to dispel wind-cold and dampness evil on the upper and lower sides of the recipe are cleared, the ligusticum wallichii is used for promoting blood circulation and dispelling wind, the radix bupleuri is pungent and dispel muscles, the notopterygium root and pubescent angelica root are helped to dispel exogenous evil, and pain is relieved. Fructus Aurantii reduces qi, radix Platycodi opens lung, front Hu Qutan, poria and Poria excrete dampness, and is used as adjuvant drug, and Glycyrrhrizae radix is blended with other drugs to be used as guiding drug. The medicines are combined together, sweat and heat are removed, blood is moved and wind is removed to stop pain, lung qi is facilitated, phlegm dampness is removed, cough is stopped, and symptoms of cold are removed to cure the disease. In recent years, with the deep development of traditional Chinese medicine preparation researches, more and more of the efficacy of the Jingfeng preparation is discovered.
The inventor finds that the Jingfeng preparation has obvious effect on treating the sequelae of the new crown in the process of carrying out process upgrading on the Jingfeng preparation. The pharmacodynamic test shows that the Jingfeng preparation is an effective composition for treating the sequelae of the new coronary pneumonia, can effectively treat viral myocarditis, reduce serum concentrations of liver function markers ALT and AST and kidney function markers Cre and BUN, thereby effectively protecting liver and kidney functions, effectively inhibiting inflammatory reaction of acute respiratory distress syndrome, simultaneously effectively treating diarrhea, treating both symptoms and root causes, and has definite and obvious treatment effect on the sequelae of the new coronary pneumonia.
Disclosure of Invention
The invention aims to provide an application of a Jingfeng preparation in preparing a medicament for treating new crown sequela. The Jingfang preparation of the invention is derived from ancient fructus Jingfang antiphlogistic powder, and series Jingfang preparations such as Jingfang granules, jingfang tablets and the like are prepared by the prior art. The application of the invention is found in the clinical application process of company medicines, and the application is verified by related pharmacodynamic tests, so that the invention has great commercial value.
The application of the Jingfeng preparation in preparing the medicine for treating the new crown sequela is that the Jingfeng preparation is prepared from the following traditional Chinese medicine components:
Preferably, it is:
The test result shows that the Jingfeng preparation can effectively treat viral myocarditis, reduce serum concentrations of liver function markers ALT and AST and kidney function markers Cre and BUN, thereby effectively protecting liver and kidney functions, effectively inhibiting inflammatory reaction of acute respiratory distress syndrome, effectively treating diarrhea, treating both symptoms and root causes, and having definite and obvious treatment effect on new crown sequela.
The invention also aims to provide a traditional Chinese medicine oral preparation containing the traditional Chinese medicine composition and a preparation method thereof, wherein the traditional Chinese medicine oral preparation is one of granules, tablets, capsules and microcapsules.
The preparation method of the traditional Chinese medicine oral preparation comprises the following steps:
A. Extracting volatile oil from 7 medicinal materials including herba schizonepetae, radix sileris, notopterygium root, radix angelicae pubescentis, radix peucedani, ligusticum wallichii and fructus aurantii respectively to obtain volatile oil of 7 medicinal materials respectively, and distilling the residues and the water solution of the ligusticum wallichii and the fructus aurantii for later use;
B. B, adding beta-cyclodextrin into the volatile oil obtained in the step A to prepare inclusion compounds;
C. B, preparing an ethanol solution with concentration of 20-30% from the water solution obtained by distilling the ligusticum wallichii and the fructus aurantii in the step A, and percolating the dregs of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain percolate for later use;
D. Decocting residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani obtained in step A, and the rest three materials of bupleuri radix, radix Platycodi and Glycyrrhrizae radix in water for 2-3 times, each time for 1.5-2.5 hr, mixing decoctions, filtering, concentrating filtrate to obtain extract with relative density of 1.18-1.25 at 60-70deg.C;
E. Mixing the percolate obtained in step C and the extract obtained in step D, standing, filtering, concentrating the filtrate to obtain extract with relative density of 1.22-1.28 at 50-60deg.C;
F. And E, taking the extract obtained in the step E and the beta-cyclodextrin inclusion compound obtained in the step B, and directly preparing an oral pharmaceutical preparation by using a conventional procedure or adding pharmaceutically acceptable excipients.
The preferred dosage form of the present invention is a granule, the method of preparing the granule comprising the steps of:
A. Extracting volatile oil from 7 medicinal materials including herba schizonepetae, radix sileris, notopterygium root, radix angelicae pubescentis, radix peucedani, ligusticum wallichii and fructus aurantii respectively to obtain volatile oil of 7 medicinal materials respectively, and distilling the residues and the water solution of the ligusticum wallichii and the fructus aurantii for later use;
B. B, adding beta-cyclodextrin into the volatile oil obtained in the step A to prepare inclusion compounds;
C. B, preparing an aqueous solution obtained after distillation of the ligusticum wallichii and the fructus aurantii in the step A into a 25% ethanol solution as a solvent, and percolating the dregs of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain percolate for later use;
D. decocting the residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani obtained in step A, and the rest three materials of bupleuri radix, radix Platycodi and Glycyrrhrizae radix in water for 3 times, each time for 2 hours, mixing decoctions, filtering, concentrating the filtrate to extract with relative density of 1.23 at 60-70deg.C;
E. Mixing the percolate obtained in step C and the extract obtained in step D, standing, filtering, and concentrating the filtrate to obtain extract with relative density of 1.26 at 50-60deg.C;
F. And E, taking the extract obtained in the step E, carrying out belt vacuum drying under the conditions of vacuum degree of-0.08 MPa to 0.10MPa and drying temperature of 63 ℃, crushing into fine powder, sieving, adding the beta-cyclodextrin inclusion compound obtained in the step B, uniformly mixing to obtain the fine powder of the Jingfang extract, adding the excipient with the formula weight ratio of sucrose powder to hydroxypropyl starch to mannitol=3:2:0.5, uniformly mixing, granulating, drying, and finishing to obtain the finished product.
Another preferred dosage form of the present invention is a pellet formulation, the method of preparing said microcapsule formulation comprising the steps of:
A. Extracting volatile oil from 7 medicinal materials including herba schizonepetae, radix sileris, notopterygium root, radix angelicae pubescentis, radix peucedani, ligusticum wallichii and fructus aurantii respectively to obtain volatile oil of 7 medicinal materials respectively, and distilling the residues and the water solution of the ligusticum wallichii and the fructus aurantii for later use;
B. B, adding beta-cyclodextrin into the volatile oil obtained in the step A to prepare inclusion compounds;
C. Preparing 28% ethanol solution from the water solution obtained by distilling the ligusticum wallichii and the fructus aurantii in the step A as a solvent, and percolating the dregs of the ligusticum wallichii and the fructus aurantii obtained in the step A with poria cocos to obtain percolate for later use;
D. decocting residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani obtained in step A, and the rest three materials of bupleuri radix, radix Platycodi and Glycyrrhrizae radix with water for 2 times, each time for 2.5 hr, mixing decoctions, filtering, concentrating filtrate to extract with relative density of 1.22 at 60-70deg.C;
E. mixing the percolate obtained in step C and the extract obtained in step D, standing, filtering, and concentrating the filtrate to obtain extract with relative density of 1.25 at 50-60deg.C;
F. adding the cyclodextrin inclusion compound obtained in the step (E) into the extract obtained in the step (B), uniformly mixing, granulating, carrying out belt vacuum drying, and crushing to obtain fine powder of the Jingfeng extract for later use;
G. Weighing fine powder of the Jingfeng extract, the capsule wall material, the anti-adhesion agent and the plasticizer according to the formula amount, adding the capsule wall material, the anti-adhesion agent and the plasticizer into purified water, heating and stirring at 54 ℃ to dissolve the materials, preparing a capsule wall material solution with the mass fraction of 33%, cooling to room temperature, adding the fine powder of the Jingfeng extract and the emulsifier under stirring, homogenizing and emulsifying to obtain an emulsion for later use;
H. and G, spray-drying the emulsion at the air inlet temperature of 165 ℃, the spray pressure of 0.40MPa and the feeding speed of 21.5ml/min, collecting the microcapsules, and cooling to obtain the product.
Preferably, the condition of the band vacuum drying in the step F is that the vacuum degree is between-0.08 MPa and-0.10 MPa, and the drying temperature is 56 ℃.
Preferably, in the step G, the capsule wall material is sodium laurocapram, maltodextrin=3:2, the anti-adhesion agent is stearyl alcohol, titanium dioxide=3:1, and the plasticizer is polyethylene glycol, citric acid=3:1.
Preferably, the emulsifier in the step C is sucrose fatty acid ester, and the amount of the compound emulsifier of soybean phospholipid=8:5 is 1.18% of the total amount of the preparation formula in terms of mass fraction.
In order to verify the effect of the Jingfeng preparation of the invention on treating the sequelae of the new crown, the inventor develops corresponding animal test research. It should be noted that, the animal test research is selected from the samples obtained by the representative formulation and the preparation method of the present invention, and the tests and results related to the other formulations and the products obtained by the preparation method of the present invention are not exhaustive due to the space limitation.
Experimental example 1 Effect of Jingfeng preparation on mouse myocarditis
1 Material
1.1 Laboratory animals and feed SPF grade Balb/c Male mice, 6-8 weeks old, 60 animals, weighing 16-18g, offered by Lunan pharmaceutical Co., ltd., laboratory animal license number SYXK (Lun) 2018 0008. The mice are adaptively fed for 1 week in a clean-class animal laboratory before experiments, the male and female are separated, the room temperature is 20-25 ℃, the relative humidity is 40-60%, natural illumination is carried out, and the mice can eat and drink water freely.
1.2 Instruments, reagent and medicine AG285 type electronic analytical balance (Mettler-Toledo Co., switzerland), SE-LECTRA-E type full-automatic biochemical analyzer (Holland Wilmg's sciences), thermo Scientific Medifuge small-sized desk-top centrifuge (Siemens Fed. Co., ltd.), eagle culture solution (Weissent Biotechnology Co., ltd.), mouse TNF-alpha, cTnI ELISA test kit (Nanj built BioInd.), test medicine is the JingFang Feng granule (Lunan Torpedo pharmaceutical Co., ltd.), and positive control medicine is ribavirin granule (lot No. 20190701, chenxin pharmaceutical Co., ltd.).
2 Method
The number of the healthy Balb/c male mice is 60 in groups and is randomly divided into 6 groups, and 10 in each group are a normal control group, a model control group, a ribavirin Lin Yangxing control group (short for positive control group), a Jingfu granule high-dose group (short for test high-dose group), a Jingfu granule medium-dose group (short for test medium-dose group) and a Jingfu granule low-dose group (short for test low-dose group). CVB 3 virus was cultured using Eagle medium, and each group of mice was intraperitoneally injected with 0.2ml of 1X 10 4/ml CVB3 dilution, except for the normal control group, which was intraperitoneally injected with 0.2ml of Eagle medium.
2.2 Administration of the virus after 2 hours inoculation, each group was subjected to gastric lavage administration, the dose was converted according to the dose conversion coefficient of different animals in the annex of the "guidelines for clinical study of New traditional Chinese medicine", the positive control group was filled with ribavirin 0.10g/kg, the test high dose group, the test medium dose group and the test low dose group were filled with jingfang particles 9g/kg, 4.5g/kg and 2.25g/kg respectively, equivalent doses for 2 times, 1 time and 0.5 time persons were obtained, the administration volume was 10ml/kg, and the normal control group and the model control group were filled with normal saline with equal volume 1 time daily, and the administration was continued for 7 days.
2.3 Detection index and method after 7 days of administration, mice were taken from eyeballs and blood was collected, centrifuged at 4000r/min for 10min, serum was separated, and cTnI (cardiac troponin I) and TNF-alpha (tumor necrosis factor alpha) levels in the serum were determined using ELISA kit.
2.4 Statistical treatments were analyzed using SPSS19.0 statistical software and experimental data were expressed as "mean.+ -. Standard deviation"Is in the form of. The comparison between the groups adopts single-factor analysis of variance, and the difference represented by P <0.05 has statistical significance.
3 Results
Compared with the normal control group, the levels of cTnI and TNF-alpha in the serum of the mice in the model control group are obviously increased, and the differences have statistical significance (P < 0.05), which proves that the modeling of the experiment is successful. Compared with the model control group, the positive control group and the serum of the mice in the high, medium and low dose groups are obviously reduced in cTnI and TNF-alpha, and the difference is statistically significant (P < 0.05). The results indicate that the Jingfeng particles can effectively treat viral myocarditis. The results are shown in Table 1.
TABLE 1 influence of Jingfang particles on mouse toxic myocarditisn=10)
Note that P <0.05 is indicated by "Δ" compared to the normal control group and P <0.05 is indicated by "×" compared to the model control group.
Experimental example 2 Effect of Jingfeng preparation on acute liver injury of mice
1 Material
1.1 Experimental animals and feed healthy KM mice, male and female halves, 60 animals, body weight (20+ -2) g, provided by Lunan pharmaceutical Co., ltd., experimental animal license number: SYXK (Lun) 2018 0008. Before the experiment, the animals are adaptively fed in a clean-level animal laboratory for 1 week, the male and female are separated, the room temperature is 20-25 ℃, the relative humidity is 40-60%, and the animals are subjected to natural illumination and free ingestion and drinking.
1.2 Instruments, reagents and medicines Thermo Scientific Medifuge Small desk-top centrifuges (Simer flying Co., USA), AG285 electronic analytical balance (Mettler-Toledo Co., switzerland), mouse ALT, AST enzyme-linked immunosorbent assay kit (Sigma Co., USA), carbon tetrachloride (Shanghai Ala Biochemical technologies Co., ltd.), the test drug was the anti-particle of example 5 (manufactured by Lunan Santopharmaco pharmaceutical Co., ltd.), and the positive control drug was diphenyl diester (lot number: 19058003, shandong health pharmaceutical Co., ltd.).
2 Method
The number of the healthy KM mice is 60, and the healthy KM mice are randomly divided into 6 groups, namely a normal control group, a model control group, a bifendate positive control group (short for positive control group), a high-dose group of Jingfeng particles (short for test high-dose group), a medium-dose group of Jingfeng particles (short for test medium-dose group) and a low-dose group of Jingfeng particles (short for test low-dose group), wherein each group comprises 10 groups, namely, a male group and a female group. Except for the normal control group, 0.1ml/10g of 0.2% carbon tetrachloride is injected into the abdominal cavity of each group of mice, an acute liver injury model is formed after 24 hours, and the normal control group is injected into the abdominal cavity by administering the peanut oil with the same dosage. Blood samples of 0.5mL (5 mice are randomly taken from each group and blood is taken from the eyeorbit) are collected, ALT (glutamic pyruvic transaminase) and AST (glutamic oxaloacetic transaminase) in serum are measured, and each molding module is obviously increased compared with a normal control group, so that the molding success is indicated.
2.2, After successful administration and modeling, each group is subjected to gastric administration, the dosage is converted according to the dosage conversion coefficient of different animals in the annex in the guidelines of clinical research on new traditional Chinese medicines, the positive control group is infused with 0.15g/kg of bifendate, the test high-dose group, the test medium-dose group and the test low-dose group are respectively infused with 9g/kg, 4.5g/kg and 2.25g/kg of Jingfeng particles, equivalent doses for 2 times, 1 time and 0.5 time of people, the administration volume is 10ml/kg, the model control group is infused with normal saline with equal capacity for 1 time per day, and the continuous administration is carried out for 8 days.
2.3 Detection index and method 1 hour after 8 th day of dosing, mice were bled via the orbit, sampled 1.5mL in a centrifuge tube, left for 30min, centrifuged at 10000r/min for 20min, and serum was isolated. ALT and AST levels were determined as required by ELISA kit instructions.
2.4 Statistical treatments were analyzed using SPSS19.0 statistical software and experimental data were expressed as "mean.+ -. Standard deviation"Is in the form of. The comparison between the groups adopts single-factor analysis of variance, and the difference represented by P <0.05 has statistical significance.
3 Results
Compared with the normal control group, the ALT and AST levels in the serum of the mice of the model control group are obviously increased, and the difference has statistical significance (P < 0.05), which proves that the modeling of the experiment is successful. Compared with the model control group, the positive control group and the serum of the mice in the high, medium and low dose groups have obviously reduced ALT and AST levels, and the difference has statistical significance (P < 0.05). The results suggest that the Jingfang particles have a protective effect on liver injury induced by CCl 4. The results are shown in Table 2.
TABLE 2 influence of Jingfang particles on liver injury in micen=10)
Note that P <0.05 is indicated by "Δ" compared to the normal control group and P <0.05 is indicated by "×" compared to the model control group.
Experimental example 3 Effect of drug on acute kidney injury in mice
1 Material
1.1 Experimental animals and feed healthy KM mice, male and female halves, 60 animals, body weight (20+ -2) g, provided by Lunan pharmaceutical Co., ltd., experimental animal license number: SYXK (Lun) 2018 0008. Before the experiment, the animals are adaptively fed in a clean-level animal laboratory for 1 week, the male and female are separated, the room temperature is 20-25 ℃, the relative humidity is 40-60%, and the animals are subjected to natural illumination and free ingestion and drinking.
1.2 Instruments, reagents and medicines AG285 type electronic analytical balance (Mettler-Toledo, switzerland), SE-LECTRA-E type full-automatic biochemical analyzer (Holland Wired diagram sciences), thermo Scientific Medifuge small-sized bench centrifuge (Simer femto Co., ltd.), cisplatin (Sigma Co., USA), sodium pentobarbital (Jinan Hongbo chemical Co., ltd.), creatinine assay kit (Sigma Co., USA), urea nitrogen kit (Kingshi Biotech Co., ltd.), test medicine was the JINGFANG granule (Runan Torpedo pharmaceutical Co., ltd.), and the positive control medicine was resveratrol (lot number 19067002, guangdong Bide Biotech Co., ltd.).
2 Method
The number of the healthy KM mice is 60, namely, a normal control group, a model control group, a resveratrol positive control group (called positive control group for short), a high-dose group of Jingfeng particles (called high-dose group for short), a medium-dose group of Jingfeng particles (called medium-dose group for short) and a low-dose group of Jingfeng particles (called low-dose group for short), wherein each group comprises 10 groups, namely, a male group and a female group. Except for a normal control group, 20mg/kg cisplatin was injected into the abdominal cavity of each group of mice on the 1 st day of the experiment, so as to form an acute kidney injury model of the mice, and the normal control group was injected with an equivalent amount of physiological saline into the abdominal cavity. Blood samples of 0.5mL (5 mice were randomly taken from each group and blood was taken from the orbit) were collected, and Cre (creatinine) and BUN (urea nitrogen) in serum were measured, and each molding group was significantly elevated compared with the normal control group, indicating successful molding.
2.2 The 2 nd day after the successful administration modeling, each group is subjected to gastric administration, the dosage conversion is carried out according to the dosage conversion coefficient of different animals in the annex in the "new traditional Chinese medicine clinical research guidelines", the positive control group is filled with resveratrol 0.20g/kg, the test high-dose group, the test medium-dose group and the test low-dose group are respectively filled with the equivalent dosages of the Jingfeng particles 9g/kg, 4.5g/kg and 2.25g/kg, which are equivalent to 2 times, 1 time and 0.5 time, the administration volume is 10ml/kg, the model control group is filled with normal saline with equal volume, and the administration is carried out 1 time per day for 7 days continuously.
2.3 Detection index and method mice of each group were fasted for 12 hours before last gastric lavage administration, and 1 hour after last gastric lavage, were anesthetized by intraperitoneal injection of sodium pentobarbital (60 mg/kg), collected from the eyeballs, centrifuged for 10min at 3000r/min, serum was separated, and serum creatinine (Cre) and urea nitrogen (BUN) contents were measured by a full-automatic biochemical analyzer.
2.4 Statistical treatments were analyzed using SPSS19.0 statistical software and experimental data were expressed as "mean.+ -. Standard deviation"Is in the form of. The comparison between the groups adopts single-factor analysis of variance, and the difference represented by P <0.05 has statistical significance.
3 Results
Compared with the normal control group, the serum levels of Cre and BUN in the mice of the model control group are obviously increased, and the differences have statistical significance (P < 0.05), which indicates that the modeling of the experiment is successful. Compared with the model control group, the serum levels of Cre and BUN in the positive control group and the mice in the high, medium and low dose groups are obviously reduced, and the difference is statistically significant (P < 0.05). The results suggest that the Jingfang particles have a protective effect on cisplatin-induced kidney injury. The results are shown in Table 3.
TABLE 3 influence of Jingfang particles on kidney injury in micen=10)
Note that P <0.05 is indicated by "Δ" compared to the normal control group and P <0.05 is indicated by "×" compared to the model control group.
Experimental example 4 Effect of drug on Acute Respiratory Distress Syndrome (ARDS) in rats
1 Material
1.1 Laboratory animals and feed healthy Male SD rats, 60 animals, body weight (200+ -20) g, offered by Lunan pharmaceutical Co., ltd., laboratory animal license number SYXK (Lun) 2018 0008. Before the experiment, the animals are adaptively fed in a clean-level animal laboratory for 1 week, the male and female are separated, the room temperature is 20-25 ℃, the relative humidity is 40-60%, and the animals are subjected to natural illumination and free ingestion and drinking.
1.2 Instruments, reagents and medicines Thermo Scientific Medifuge Small desk-top centrifuge (Simer femto Co., ltd.), -80℃low temperature refrigerator (Qingdao sea specialty appliances Co., ltd.), AG285 type electronic analytical balance (Mettler-Toledo Co., switzerland) rat TNF-alpha and IL-1β ELISA kit (R & D Co., USA), lipopolysaccharide LPS (Sigma Co., USA), sodium pentobarbital (Jinan Hongbo chemical Co., ltd.), test drug was the Jingfang granule (Lunan Korea Co., ltd.), and the positive control drug was ambroxol hydrochloride (lot number: 19049001, shanghai Boringer Yinhe pharmaceutical Co., ltd.).
2 Method
The number of the SD rats is 60 in groups and in modeling healthy male SD rats, and each group is divided into 6 groups at random, and 10 groups are a normal control group, a model control group, an ambroxol hydrochloride positive control group (short for positive control group), a high-dose group of Jingfeng particles (short for test high-dose group), a medium-dose group of Jingfeng particles (short for test medium-dose group) and a low-dose group of Jingfeng particles (short for test low-dose group). Except for the normal control group, 7.5mg/kg LPS (prepared by using sterile physiological saline) is instilled into the trachea of each group of rats, and then the rats are overturned, so that the liquid medicine is uniformly distributed in two lungs of the rats, an ARDS model is constructed, and the normal control group rats instilled with the same amount of sterile physiological saline into the trachea. The modeling is successful if the rat has symptoms of listlessness, hypokinesia, anorexia, shortness of breath, diarrhea and the like.
2.2 After molding for 6 hours, the dosage is calculated according to the dosage conversion coefficient of different animals in annex in the clinical study guidelines of new traditional Chinese medicine, the positive control group rats are intraperitoneally injected with ambroxol hydrochloride injection 0.04g/kg, the test high-dose group, the test medium-dose group and the test low-dose group rats are respectively infused with 9g/kg, 4.5g/kg and 2.25g/kg of Jingfang particles, equivalent doses for 2 times, 1 time and 0.5 time of human use are equivalent doses, the administration volume is 10ml/kg, and the normal control group and the model control group are infused with normal saline with equal capacity for 1 time per day for 21 days.
2.3 Detection index and method after last administration of rats, sodium pentobarbital was injected intraperitoneally at 30mg/kg. The rat was anesthetized, then passed through tracheotomy, inserted into a hollow catheter, ligated to the right bronchus, and left lung lavaged with 5ml of cold physiological saline to the left bronchus, and repeated 3 times, with a recovery rate of more than 90%. The collected BALF (bronchoalveolar lavage) was centrifuged at 3000r/min at 4℃for 10min, and the supernatant was stored in an-80℃ultra-low temperature refrigerator. The content of TNF-alpha and IL-1 beta is detected by adopting an ELISA kit of TNF-alpha and IL-1 beta, and the operation is strictly carried out according to the instruction of the kit.
2.4 Statistical treatments were analyzed using SPSS19.0 statistical software and experimental data were expressed as "mean.+ -. Standard deviation"Is in the form of. The comparison between the groups adopts single-factor analysis of variance, and the difference represented by P <0.05 has statistical significance.
3 Results
Compared with the normal control group, the levels of TNF-alpha and IL-1 beta in the BALF of the model control group are obviously increased, and the differences have statistical significance (P < 0.05), which proves that the modeling of the experiment is successful. Compared with the model control group, the levels of TNF-alpha and IL-1 beta in the serum of rats in the high, medium and low dose groups are obviously reduced, and the difference is statistically significant (P < 0.05). The results suggest that the Jingfang particles have certain inhibition effect on ARDS inflammatory response. The results are shown in Table 4.
TABLE 4 Effect of Jingfang particles on acute respiratory distress syndrome in ratsn=10)
Note that P <0.05 is indicated by "Δ" compared to the normal control group and P <0.05 is indicated by "×" compared to the model control group.
Experimental example 5 Effect of drug on diarrhea in mice
1 Material
1.1 Laboratory animals and feed SPF grade KM mice, male and female halves, 60, body weight (20+ -2) g, provided by Lunan pharmaceutical group Co., ltd., laboratory animal license number SYXK (Lun) 2018 0008. Before the experiment, the animals are adaptively fed in a clean-level animal laboratory for 1 week, the male and female are separated, the room temperature is 20-25 ℃, the relative humidity is 40-60%, and the animals are subjected to natural illumination and free ingestion and drinking.
1.2 Instruments, reagents and drugs full automatic colony counter (Shanghai Heng Jiech instruments Co., ltd.), AG285 type electronic analytical balance (Mettler-Toledo Co., switzerland, mannheim, switzerland), thermo Scientific Medifuge type small-sized table centrifuge (Seiemerer Feddo Co., ltd.), 80℃low temperature refrigerator (Qingdao Heterol specialty instruments Co., ltd.), bacteria incubator (Shanghai Seilman laboratory equipment Co., ltd.), anaerobic incubator (Shanghai Semter Instrument instruments Co., ltd.), selective medium (Qingdao Haibo biological Co., ltd.), mouse diamine oxidase (DAO) ELISA kit (Siemens Biotechnology Co., ltd.), D-lactic acid detection analytical kit (colorimetric method) (Siga, national institute of atomic energy science, isotope research, ikayaku, inc.), PBS (Mirabi pharmaceutical Co., ltd.), test drug (manufactured by Mitsu Co., ltd.), test drug in example 5, JINGFAX (Lu., ltd.), positive control drug in the form of Bifiducing tablet (trade name: 19075002, shanno Karsk Co., ltd.).
2 Method
2.1 Grouping and molding 60 SPF-grade KM mice, wherein 50 mice are given with lincomycin hydrochloride 0.4 mL/time 2 times a day for 4 days continuously, the mice are observed to be listless, reduced in activity, reduced in physical quality, anus Zhou Weigong and diarrhea, meanwhile, the defecation condition of the mice is observed, yellow brown, thin and rotten, non-formed feces are observed, and the quantity of fresh feces for culturing bifidobacterium and lactobacillus is reduced, which indicates that the molding is successful. The 50 mice with successful modeling are randomly divided into a model control group, a bifidobacterium triple viable bacteria tablet control group (short for positive control group), a Jingfeng particle high-dose group (short for test high-dose group), a Jingfeng particle medium-dose group (short for test medium-dose group) and a Jingfeng particle low-dose group (short for test low-dose group), wherein each group comprises 10 mice and each half of the mice and the male. The other 10 mice were perfused with an equivalent amount of physiological saline, and set as a normal control group.
2.2 Administration starts on day 5, each group is subjected to gastric administration, the dosage is converted according to the dosage conversion coefficient of different animals in annex in the clinical study guidelines of new traditional Chinese medicines, the positive control group is infused with 0.2g/kg of bifidobacterium triple viable bacteria tablet, the test high-dose group, the test medium-dose group and the test low-dose group are respectively infused with 9g/kg, 4.5g/kg and 2.25g/kg of Jingfeng particles, equivalent doses for 2 times, 1 time and 0.5 time of human, the administration volume is 10ml/kg, and the normal control group and the model control group are infused with normal saline with equal volume for 1 time per day for 14 days.
2.3 Detection index and method
2.3.1 Intestinal flora detection after 14 days of continuous administration, mice were sacrificed by cervical dislocation, 100. Mu.g of cecal content of each group of mice was aseptically collected, 800. Mu.L of diluent was added, thoroughly mixed, diluted again, 1X 10 -3-1×10-8 dilution suspension was selected and inoculated into selective medium, and cultured in 37℃incubator and anaerobic incubator for 24 hours, respectively, and enterobacteria, enterococci, bifidobacteria and lactobacilli were identified by colony morphology, biochemical reaction and gram staining. The identified bacteria were counted and the number of dominant bacteria (lgCFU/g) was used as a representation of the number of viable bacteria.
2.3.2 Measurement of diamine oxidase and D-lactic acid content after 14 days of continuous administration, mice were sacrificed by cervical dislocation, hearts were bled 5mL, serum was obtained after centrifugation at 3000r/min for 10min, and the serum diamine oxidase (DAO) and D-lactic acid content was measured.
2.3.3 Intestinal mucosa SIgA (secretory immunoglobulin A) is detected from a 15cm section of intestine from a position 10cm below the pylorus towards the back blind, the section is laid on filter paper, the section is cut along a longitudinal section, the intestinal mucosa surface material is washed clean by sterile PBS buffer solution, finally, a glass slide is used for slightly scraping part of mucus on the intestinal mucosa surface, and the section is put into a 1.5mL sterile EP tube for frozen storage to be detected. The level of SIgA in the intestinal mucosa was analyzed by enzyme-linked immunosorbent assay using biotin-avidin label according to the kit instructions.
2.4 Statistical treatments were analyzed using SPSS19.0 statistical software and experimental data were expressed as "mean.+ -. Standard deviation"Is in the form of. The comparison between the groups adopts single-factor analysis of variance, and the difference represented by P <0.05 has statistical significance.
3 Results
3.1 Comparison of intestinal flora compared with the normal control group, the model control group has reduced lactobacillus and bifidobacterium, increased intestinal bacillus and enterococcus, and the difference has statistical significance (P < 0.05). Compared with the model control group, the positive control group and the high, medium and low dose groups tested have increased lactobacillus number and bifidobacterium number, decreased intestinal bacillus number and enterococcus number, and the difference has statistical significance (P < 0.05). The results are shown in Table 5. The results indicate that the Jingfang particles have the protection and repair effects on the bacterial membrane barrier of the intestinal mucosa of the mice with the antibiotic-associated diarrhea.
3.2 Serum DAO and D-lactic acid content determination compared with the normal control group, the serum DAO and D-lactic acid content of the model control group mice are obviously increased, and the difference has statistical significance (P < 0.05). Compared with the model control group, the positive control group and the high, medium and low dose mice tested have obviously reduced serum DAO and D-lactic acid content, and the difference has statistical significance (P < 0.05). The results suggest that the Jingfang particles can effectively improve the intestinal barrier function of the mice with antibiotic-associated diarrhea.
3.3 Intestinal mucosa SIgA content assay compared with the normal control group, intestinal mucosa SIgA content of the model control group mice is obviously reduced, and the difference has statistical significance (P < 0.05). Compared with the model control group, the intestinal mucosa SIgA content of the positive control group and the mice in the high, medium and low dose groups is obviously increased, and the difference is statistically significant (P < 0.05). The results indicate that the Jingfang particles have positive promotion effect on improving the intestinal tract immunity of the mice with the antibiotic-associated diarrhea. The results are shown in Table 6.
In conclusion, the Jingfang granules can effectively treat the diarrhea related to antibiotics.
TABLE 5 influence of Jingfang particles on the number of intestinal flora in micen=10)
Note that P <0.05 is indicated by "Δ" compared to the normal control group and P <0.05 is indicated by "×" compared to the model control group.
TABLE 6 influence of Jingfang particles on the content of DAO, D-lactic acid and intestinal mucosa SIgA in mice serumn=10)
Note that P <0.05 is indicated by "Δ" compared to the normal control group and P <0.05 is indicated by "×" compared to the model control group.
The experimental results show that the Jingfeng granule can effectively treat viral myocarditis, reduce serum concentrations of liver function markers ALT and AST and kidney function markers Cre and BUN, thereby effectively protecting liver and kidney functions, effectively inhibiting inflammatory reaction of acute respiratory distress syndrome, effectively treating diarrhea, treating both symptoms and root causes, and having definite and obvious treatment effect on new crown sequela.
Detailed Description
The invention is further illustrated by the following specific examples, which are not intended to limit the invention in any way, as will be appreciated by those skilled in the art.
Example 1 preparation of Jingfang particles
A. Extracting volatile oil from 7 medicinal materials including herba schizonepetae, radix sileris, notopterygium root, radix angelicae pubescentis, radix peucedani, ligusticum wallichii and fructus aurantii respectively to obtain volatile oil of 7 medicinal materials respectively, and distilling the residues and the water solution of the ligusticum wallichii and the fructus aurantii for later use;
B. B, adding beta-cyclodextrin into the volatile oil obtained in the step A to prepare inclusion compounds;
C. b, preparing an aqueous solution obtained after distillation of the ligusticum wallichii and the fructus aurantii in the step A into a 27% ethanol solution as a solvent, and percolating the dregs of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain percolate for later use;
D. decocting residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani obtained in step A, and the rest three materials of bupleuri radix, radix Platycodi and Glycyrrhrizae radix with water for 3 times, each time for 2 hours, mixing decoctions, filtering, concentrating filtrate to extract with relative density of 1.24 at 60-70deg.C;
E. Mixing the percolate obtained in step C and the extract obtained in step D, standing, filtering, concentrating the filtrate to obtain extract with relative density of 1.24 at 50-60deg.C;
F. And E, taking the extract obtained in the step E, carrying out belt vacuum drying under the conditions of vacuum degree of-0.08 MPa to 0.10MPa and drying temperature of 63 ℃, crushing into fine powder, sieving, adding the beta-cyclodextrin inclusion compound obtained in the step B, uniformly mixing to obtain fine powder of the Jingfang extract, adding cane sugar powder, hydroxypropyl starch and mannitol (weight ratio of 4:2:1) in a formula amount, uniformly mixing, granulating, drying, granulating, and preparing 10 kg.
Example 2 preparation of Jingfeng tablet
A. Extracting volatile oil from 7 medicinal materials including herba schizonepetae, radix sileris, notopterygium root, radix angelicae pubescentis, radix peucedani, ligusticum wallichii and fructus aurantii respectively to obtain volatile oil of 7 medicinal materials respectively, and distilling the residues and the water solution of the ligusticum wallichii and the fructus aurantii for later use;
B. B, adding beta-cyclodextrin into the volatile oil obtained in the step A to prepare inclusion compounds;
C. b, preparing an aqueous solution obtained after distillation of the ligusticum wallichii and the fructus aurantii in the step A into a 24% ethanol solution as a solvent, and percolating the dregs of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain percolate for later use;
D. decocting residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani obtained in step A, and the rest three materials of bupleuri radix, radix Platycodi and Glycyrrhrizae radix with water for 2 times each for 1.5 hr, mixing decoctions, filtering, concentrating filtrate to obtain extract with relative density of 1.25 at 60-70deg.C;
E. Mixing the percolate obtained in step C and the extract obtained in step D, standing, filtering, and concentrating the filtrate to obtain extract with relative density of 1.28 at 50-60deg.C;
F. And E, taking the extract obtained in the step E, carrying out belt vacuum drying at the vacuum degree of-0.08 MPa to 0.10MPa and the drying temperature of 63 ℃, crushing into fine powder, sieving, adding the beta-cyclodextrin inclusion compound obtained in the step B, uniformly mixing to obtain the fine powder of the Jingfang extract, adding microcrystalline cellulose, low-substituted hydroxypropyl cellulose and mannitol (weight ratio of 4:3:1) in the formula amount, uniformly mixing, preparing coarse particles, drying, crushing, sieving, granulating, drying at low temperature, finishing, adding 0.2% magnesium stearate and 0.1% talcum powder, uniformly mixing, and pressing into 10000 tablets to obtain the finished product.
EXAMPLE 3 preparation of Jingfeng micro-capsules
A. Extracting volatile oil from 7 medicinal materials including herba schizonepetae, radix sileris, notopterygium root, radix angelicae pubescentis, radix peucedani, ligusticum wallichii and fructus aurantii respectively to obtain volatile oil of 7 medicinal materials respectively, and distilling the residues and the water solution of the ligusticum wallichii and the fructus aurantii for later use;
B. B, adding beta-cyclodextrin into the volatile oil obtained in the step A to prepare inclusion compounds;
C. B, preparing an aqueous solution obtained after distillation of the ligusticum wallichii and the fructus aurantii in the step A into a 29% ethanol solution as a solvent, and percolating the dregs of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain percolate for later use;
D. Decocting residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani obtained in step A, and the rest three materials of bupleuri radix, radix Platycodi and Glycyrrhrizae radix with water for 2 times, each time for 2.5 hr, mixing decoctions, filtering, concentrating filtrate to extract with relative density of 1.23 at 60-70deg.C;
E. mixing the percolate obtained in step C and the extract obtained in step D, standing, filtering, and concentrating the filtrate to obtain extract with relative density of 1.27 at 50-60deg.C;
F. Adding the cyclodextrin inclusion compound obtained in the step E into the extract obtained in the step B, uniformly mixing, granulating, carrying out belt vacuum drying under the conditions of vacuum degree of-0.08 MPa to-0.10 MPa and drying temperature of 55 ℃, and crushing to obtain fine powder of the Jingfeng extract for later use;
G. Weighing fine powder of the Jingfeng extract in the step F according to the formula amount, taking a mixture of sodium complexing protein acid and maltodextrin=5:3 as a capsule material, taking octadecyl alcohol and titanium dioxide=2:1 as an anti-adhesion agent, taking polyethylene glycol and citric acid=4:1 as plasticizers, adding the capsule material, the anti-adhesion agent and the plasticizers into purified water, heating and stirring at 52 ℃ to dissolve the capsule material, preparing a capsule material solution with the mass fraction of 33.5%, cooling to room temperature, adding the fine powder of the Jingfeng extract in a stirring state, adding a compound emulsifier with the total amount of the preparation formula of 1.17% sucrose fatty acid ester and soybean phospholipid=8:5, homogenizing and emulsifying to obtain an emulsion for later use;
H. and G, spray-drying the emulsion at the air inlet temperature of 166 ℃, the spray pressure of 0.40MPa and the feeding speed of 22.5ml/min, collecting the microcapsules, and cooling to obtain the product.
Example 4 preparation of Jingfang Capsule
A. Extracting volatile oil from 7 medicinal materials including herba schizonepetae, radix sileris, notopterygium root, radix angelicae pubescentis, radix peucedani, ligusticum wallichii and fructus aurantii respectively to obtain volatile oil of 7 medicinal materials respectively, and distilling the residues and the water solution of the ligusticum wallichii and the fructus aurantii for later use;
B. B, adding beta-cyclodextrin into the volatile oil obtained in the step A to prepare inclusion compounds;
C. b, preparing an aqueous solution obtained after distillation of the ligusticum wallichii and the fructus aurantii in the step A into a 29% ethanol solution as a solvent, and percolating the dregs of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain percolate for later use;
D. Decocting residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani obtained in step A, and the rest three materials of bupleuri radix, radix Platycodi and Glycyrrhrizae radix with water for 3 times, each time for 1.5 hr, mixing decoctions, filtering, concentrating filtrate to extract with relative density of 1.20 at 60-70deg.C;
E. Mixing the percolate obtained in step C and the extract obtained in step D, standing, filtering, concentrating the filtrate to obtain extract with relative density of 1.24 at 50-60deg.C;
F. And E, taking the extract obtained in the step E, carrying out belt vacuum drying under the conditions of vacuum degree of-0.08 MPa to 0.10MPa and drying temperature of 63 ℃, crushing into fine powder, sieving, adding the beta-cyclodextrin inclusion compound obtained in the step B, uniformly mixing to obtain the fine powder of the Jingzheng extract, adding the starch and the microcrystalline cellulose (weight ratio of 6:1) in the formula amount, uniformly mixing, granulating, drying, finishing, filling, polishing in a polishing machine, and removing damaged capsules to obtain the Jingqiangqi extract.
Example 5 preparation of Jingfang particles
A. Extracting volatile oil from 7 medicinal materials including herba schizonepetae, radix sileris, notopterygium root, radix angelicae pubescentis, radix peucedani, ligusticum wallichii and fructus aurantii respectively to obtain volatile oil of 7 medicinal materials respectively, and distilling the residues and the water solution of the ligusticum wallichii and the fructus aurantii for later use;
B. B, adding beta-cyclodextrin into the volatile oil obtained in the step A to prepare inclusion compounds;
C. B, preparing an aqueous solution obtained after distillation of the ligusticum wallichii and the fructus aurantii in the step A into a 25% ethanol solution as a solvent, and percolating the dregs of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain percolate for later use;
D. Decocting residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani obtained in step A, and the rest three materials of bupleuri radix, radix Platycodi and Glycyrrhrizae radix with water for 3 times, each time for 2 hours, mixing decoctions, filtering, concentrating filtrate to extract with relative density of 1.23 at 60-70deg.C;
E. Mixing the percolate obtained in step C and the extract obtained in step D, standing, filtering, and concentrating the filtrate to obtain extract with relative density of 1.26 at 50-60deg.C;
F. And E, taking the extract obtained in the step E, carrying out belt vacuum drying under the conditions of vacuum degree of-0.08 MPa to 0.10MPa and drying temperature of 63 ℃, crushing into fine powder, sieving, adding the beta-cyclodextrin inclusion compound obtained in the step B, uniformly mixing to obtain the fine powder of the Jingfang extract, adding the excipient with the formula weight ratio of sucrose powder to hydroxypropyl starch to mannitol=3:1:0.5, uniformly mixing, granulating, drying, and finishing to obtain the finished product.
Example 6 preparation of Jingfang Capsule
A. Extracting volatile oil from 7 medicinal materials including herba schizonepetae, radix sileris, notopterygium root, radix angelicae pubescentis, radix peucedani, ligusticum wallichii and fructus aurantii respectively to obtain volatile oil of 7 medicinal materials respectively, and distilling the residues and the water solution of the ligusticum wallichii and the fructus aurantii for later use;
B. B, adding beta-cyclodextrin into the volatile oil obtained in the step A to prepare inclusion compounds;
C. b, preparing an aqueous solution obtained after distillation of the ligusticum wallichii and the fructus aurantii in the step A into a 26% ethanol solution as a solvent, and percolating the dregs of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain percolate for later use;
D. Decocting residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani obtained in step A, and the rest three materials of bupleuri radix, radix Platycodi and Glycyrrhrizae radix with water for 2 times, each time for 2 hours, mixing decoctions, filtering, concentrating filtrate to extract with relative density of 1.19 at 60-70deg.C;
E. Mixing the percolate obtained in step C and the extract obtained in step D, standing, filtering, and concentrating the filtrate to obtain extract with relative density of 1.23 at 50-60deg.C;
F. And E, taking the extract obtained in the step E, carrying out belt vacuum drying under the conditions of vacuum degree of-0.08 MPa to 0.10MPa and drying temperature of 63 ℃, crushing into fine powder, sieving, adding the beta-cyclodextrin inclusion compound obtained in the step B, uniformly mixing to obtain the fine powder of the Jingfang extract, adding the starch, the superfine silica gel powder and the low-substituted hydroxypropyl cellulose (weight ratio of 5:2:2) in the formula amount, uniformly mixing, granulating, drying, granulating, filling, polishing in a polishing machine, and removing damaged capsules to obtain the finished product.
Example 7 preparation of Jingfang Capsule
A. Extracting volatile oil from 7 medicinal materials including herba schizonepetae, radix sileris, notopterygium root, radix angelicae pubescentis, radix peucedani, ligusticum wallichii and fructus aurantii respectively to obtain volatile oil of 7 medicinal materials respectively, and distilling the residues and the water solution of the ligusticum wallichii and the fructus aurantii for later use;
B. B, adding beta-cyclodextrin into the volatile oil obtained in the step A to prepare inclusion compounds;
C. B, preparing an aqueous solution obtained after distillation of the ligusticum wallichii and the fructus aurantii in the step A into a 30% ethanol solution as a solvent, and percolating the dregs of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain percolate for later use;
D. decocting residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani obtained in step A, and the rest three materials of bupleuri radix, radix Platycodi and Glycyrrhrizae radix with water for 2 times each for 1.5 hr, mixing decoctions, filtering, concentrating filtrate to obtain extract with relative density of 1.19 at 60-70deg.C;
E. mixing the percolate obtained in step C and the extract obtained in step D, standing, filtering, and concentrating the filtrate to obtain extract with relative density of 1.25 at 50-60deg.C;
F. And E, taking the extract obtained in the step E, carrying out belt vacuum drying under the conditions of vacuum degree of-0.08 MPa to 0.10MPa and drying temperature of 63 ℃, crushing into fine powder, sieving, adding the beta-cyclodextrin inclusion compound obtained in the step B, uniformly mixing to obtain the fine powder of the Jingfang extract, adding the starch and the superfine silica gel powder (weight ratio of 4:1) in the formula amount, uniformly mixing, granulating, drying, finishing, filling, polishing in a polishing machine, and removing damaged capsules to obtain the finished product.
Example 8 preparation of Jingfeng tablet
A. Extracting volatile oil from 7 medicinal materials including herba schizonepetae, radix sileris, notopterygium root, radix angelicae pubescentis, radix peucedani, ligusticum wallichii and fructus aurantii respectively to obtain volatile oil of 7 medicinal materials respectively, and distilling the residues and the water solution of the ligusticum wallichii and the fructus aurantii for later use;
B. B, adding beta-cyclodextrin into the volatile oil obtained in the step A to prepare inclusion compounds;
C. b, preparing an aqueous solution obtained after distillation of the ligusticum wallichii and the fructus aurantii in the step A into a 22% ethanol solution as a solvent, and percolating the dregs of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain percolate for later use;
D. decocting residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani obtained in step A, and the rest three materials of bupleuri radix, radix Platycodi and Glycyrrhrizae radix with water for 2 times, each time for 2.5 hr, mixing decoctions, filtering, concentrating filtrate to extract with relative density of 1.24 at 60-70deg.C;
E. mixing the percolate obtained in step C and the extract obtained in step D, standing, filtering, and concentrating the filtrate to obtain extract with relative density of 1.22 at 50-60deg.C;
F. and E, taking the extract obtained in the step E, carrying out belt vacuum drying at the vacuum degree of-0.08 MPa to 0.10MPa and the drying temperature of 63 ℃, crushing into fine powder, sieving, adding the beta-cyclodextrin inclusion compound obtained in the step B, uniformly mixing to obtain the fine powder of the Jingfang extract, adding starch, dextrin and sucrose (the weight ratio of 3:2:1) in the formula amount, uniformly mixing, preparing coarse particles, drying, crushing, sieving, granulating, drying at a low temperature, granulating, adding 0.3% magnesium stearate, uniformly mixing, and pressing into 10000 tablets to obtain the finished product.
Example 9 preparation of Jingfang particles
A. Extracting volatile oil from 7 medicinal materials including herba schizonepetae, radix sileris, notopterygium root, radix angelicae pubescentis, radix peucedani, ligusticum wallichii and fructus aurantii respectively to obtain volatile oil of 7 medicinal materials respectively, and distilling the residues and the water solution of the ligusticum wallichii and the fructus aurantii for later use;
B. B, adding beta-cyclodextrin into the volatile oil obtained in the step A to prepare inclusion compounds;
C. b, preparing an aqueous solution obtained after distillation of the ligusticum wallichii and the fructus aurantii in the step A into a 20% ethanol solution as a solvent, and percolating the dregs of the ligusticum wallichii and the fructus aurantii obtained in the step A and the poria cocos to obtain percolate for later use;
D. Decocting the residues of herba Schizonepetae, radix Saposhnikoviae, notopterygii rhizoma, radix Angelicae Pubescentis and radix Peucedani obtained in step A, and the rest three materials of bupleuri radix, radix Platycodi and Glycyrrhrizae radix with water for 3 times, each time for 1.5 hr, mixing decoctions, filtering, concentrating the filtrate to extract with relative density of 1.18 at 60-70deg.C;
E. Mixing the percolate obtained in step C and the extract obtained in step D, standing, filtering, and concentrating the filtrate to obtain extract with relative density of 1.26 at 50-60deg.C;
F. And E, taking the extract obtained in the step E, carrying out belt vacuum drying under the conditions of vacuum degree of-0.08 MPa to 0.10MPa and drying temperature of 63 ℃, crushing into fine powder, sieving, adding the beta-cyclodextrin inclusion compound obtained in the step B, uniformly mixing to obtain the fine powder of the Jingfang extract, adding cane sugar powder and dextrin (weight ratio of 5:2) in a formula amount, uniformly mixing, granulating, drying, finishing, and preparing 10 kg.

Claims (8)

1.荆防制剂在制备治疗新冠后遗症药物中的应用，其特征在于，所述新冠后遗症为急性呼吸窘迫综合征；所述荆防制剂由下列中药组分制成：1. Use of a Jingfang preparation in the preparation of a drug for treating COVID-19 sequelae, wherein the COVID-19 sequelae is acute respiratory distress syndrome; the Jingfang preparation is made from the following traditional Chinese medicine components: 荆芥97重量份 防风97重量份 羌活97重量份97 parts by weight of Schizonepeta tenuifolia, 97 parts by weight of Saposhnikovia divaricata, and 97 parts by weight of Notopterygium wilfordii. 独活97重量份 柴胡97重量份 前胡97重量份97 parts by weight of Angelica dahurica, 97 parts by weight of Bupleurum chinense, and 97 parts by weight of Peucedanum chinense. 川芎97重量份 枳壳97重量份 茯苓97重量份97 parts by weight of Chuanxiong, 97 parts by weight of Citrus aurantium, and 97 parts by weight of Poria cocos 桔梗97重量份 甘草32.4重量份。97 parts by weight of Platycodon grandiflorum and 32.4 parts by weight of Licorice. 2.根据权利要求1所述的应用，其特征在于，所述荆防制剂为颗粒剂、片剂、胶囊剂和微囊中的一种。2. The use according to claim 1, characterized in that the Jingfang preparation is one of granules, tablets, capsules and microcapsules. 3.根据权利要求1或2所述的应用，其特征在于，所述荆防制剂的制备方法包括下列步骤：3. The use according to claim 1 or 2, characterized in that the preparation method of the Jingfang preparation comprises the following steps: A.荆芥、防风、羌活、独活、前胡、川芎和枳壳7味药材分别提取挥发油，分别得7种药材挥发油，蒸馏后的药渣、川芎和枳壳蒸馏后的水溶液备用；A. Extract volatile oils from seven medicinal herbs: Schizonepeta tenuifolia, Saposhnikovia divaricata, Notopterygium wilfordii, Angelica dahurica, Peucedanum chinense, Chuanxiong rhizome, and Fructus Aurantii Immaturus. The volatile oils from these seven herbs are then distilled, followed by the distilled residues and the aqueous solutions of Chuanxiong rhizome and Fructus Aurantii Immaturus for later use. B.取步骤A所得挥发油，分别加β-环糊精制成包合物；B. Take the volatile oil obtained in step A and add β-cyclodextrin to prepare inclusion complexes; C.将步骤A所得川芎和枳壳蒸馏后的水溶液配成20-30%的乙醇溶液作溶剂，对步骤A所得川芎、枳壳的药渣与茯苓进行渗漉，得渗漉液，备用；C. The aqueous solution of the distilled Chuanxiong and Fructus Aurantii obtained in step A is prepared into a 20-30% ethanol solution as a solvent, and the residue of the Chuanxiong and Fructus Aurantii obtained in step A and Poria cocos are percolated to obtain a percolate for later use; D.将步骤A所得荆芥、防风、羌活、独活和前胡的药渣与其余柴胡、桔梗、甘草三味加水煎煮2-3次，每次1.5-2.5小时，合并煎液，滤过，滤液浓缩至60-70℃时相对密度为1.18-1.25的浸膏；D. decoct the residues of Schizonepeta tenuifolia, Saposhnikovia divaricata, Notopterygium incisum, Angelica pubescens, and Peucedanum chinense obtained in step A with the remaining three herbs: Bupleurum chinense, Platycodon grandiflorum, and Licorice root 2-3 times for 1.5-2.5 hours each time, combine the decoctions, filter, and concentrate the filtrate to an extract having a relative density of 1.18-1.25 at 60-70°C; E.合并步骤C所得漉液和步骤D所得浸膏，混匀，静置，滤过，滤液浓缩至50-60℃时相对密度为1.22-1.28的浸膏；E. Combine the filtrate obtained in step C and the extract obtained in step D, mix well, let stand, filter, and concentrate the filtrate to an extract with a relative density of 1.22-1.28 at 50-60°C; F.取步骤E所得浸膏及步骤B所得β-环糊精包合物，经常规工序直接或加入药学上可接受的赋形剂制成颗粒剂、片剂、胶囊剂或微囊。F. The extract obtained in step E and the β-cyclodextrin inclusion compound obtained in step B are prepared into granules, tablets, capsules or microcapsules directly or by adding pharmaceutically acceptable excipients through conventional procedures. 4.根据权利要求3所述的应用，其特征在于，所述颗粒剂的制备方法包括下列步骤：4. The use according to claim 3, characterized in that the preparation method of the granules comprises the following steps: A.荆芥、防风、羌活、独活、前胡、川芎和枳壳7味药材分别提取挥发油，分别得7种药材挥发油，蒸馏后的药渣、川芎和枳壳蒸馏后的水溶液备用；A. Extract volatile oils from seven medicinal herbs: Schizonepeta tenuifolia, Saposhnikovia divaricata, Notopterygium wilfordii, Angelica dahurica, Peucedanum chinense, Chuanxiong rhizome, and Fructus Aurantii Immaturus. The volatile oils from these seven herbs are then distilled, followed by the distilled residues and the aqueous solutions of Chuanxiong rhizome and Fructus Aurantii Immaturus for later use. B.取步骤A所得挥发油，分别加β-环糊精制成包合物；B. Take the volatile oil obtained in step A and add β-cyclodextrin to prepare inclusion complexes; C.将步骤A所得川芎和枳壳蒸馏后的水溶液配成25%的乙醇溶液作溶剂，对步骤A所得川芎、枳壳的药渣与茯苓进行渗漉，得渗漉液，备用；C. The distilled aqueous solution of Chuanxiong and Fructus Aurantii obtained in step A is prepared into a 25% ethanol solution as a solvent, and the residues of Chuanxiong and Fructus Aurantii obtained in step A and Poria cocos are percolated to obtain a percolate for later use; D.将步骤A所得荆芥、防风、羌活、独活和前胡的药渣与其余柴胡、桔梗、甘草三味加水煎煮3次，每次2小时，合并煎液，滤过，滤液浓缩至60-70℃时相对密度为1.23的浸膏；D. decoct the residues of Schizonepeta tenuifolia, Saposhnikovia divaricata, Notopterygium incisum, Angelica pubescens, and Peucedanum chinense obtained in step A with the remaining three herbs: Bupleurum chinense, Platycodon grandiflorum, and Licorice root in water three times for 2 hours each time. Combine the decoctions, filter, and concentrate the filtrate to an extract having a relative density of 1.23 at 60-70°C. E.合并步骤C所得漉液和步骤D所得浸膏，混匀，静置，滤过，滤液浓缩至50-60℃时相对密度为1.26的浸膏；E. Combine the filtrate obtained in step C and the extract obtained in step D, mix well, let stand, filter, and concentrate the filtrate to an extract with a relative density of 1.26 at 50-60°C; F.取步骤E所得浸膏，真空度-0.08MPa--0.10Mpa、干燥温度63℃条件下带式真空干燥，粉碎成细粉，过筛，加入步骤B所得β-环糊精包合物，混匀，即得荆防提取物细粉，加入配方量的重量比为蔗糖粉：羟丙基淀粉：甘露醇=3：2：0.5的赋形剂，混匀，制成颗粒，干燥，整粒，即得。F. Take the extract obtained in step E, dry it in a belt vacuum dryer under vacuum conditions of -0.08MPa--0.10MPa and drying temperature of 63°C, grind it into fine powder, sieve it, add the β-cyclodextrin inclusion compound obtained in step B, mix well to obtain fine powder of the schisandra chinensis extract, add excipients in a weight ratio of sucrose powder: hydroxypropyl starch: mannitol = 3:2:0.5, mix well, make into granules, dry, and granulate to obtain the product. 5.根据权利要求3所述的应用，其特征在于，所述微囊的制备方法包括下列步骤：5. The use according to claim 3, characterized in that the preparation method of the microcapsule comprises the following steps: A.荆芥、防风、羌活、独活、前胡、川芎和枳壳7味药材分别提取挥发油，分别得7种药材挥发油，蒸馏后的药渣、川芎和枳壳蒸馏后的水溶液备用；A. Extract volatile oils from seven medicinal herbs: Schizonepeta tenuifolia, Saposhnikovia divaricata, Notopterygium wilfordii, Angelica dahurica, Peucedanum chinense, Chuanxiong rhizome, and Fructus Aurantii Immaturus. The volatile oils from these seven herbs are then distilled, followed by the distilled residues and the aqueous solutions of Chuanxiong rhizome and Fructus Aurantii Immaturus for later use. B.取步骤A所得挥发油，分别加β-环糊精制成包合物；B. Take the volatile oil obtained in step A and add β-cyclodextrin to prepare inclusion complexes; C.将步骤A所得川芎及枳壳蒸馏后的水溶液配成28%的乙醇溶液作溶剂，对步骤A所得川芎、枳壳的药渣与茯苓进行渗漉，得渗漉液，备用；C. The distilled aqueous solution of Chuanxiong and Fructus Aurantii obtained in step A is prepared into a 28% ethanol solution as a solvent, and the residues of Chuanxiong and Fructus Aurantii obtained in step A and Poria cocos are percolated to obtain a percolate for later use; D.将步骤A所得荆芥、防风、羌活、独活和前胡的药渣与其余柴胡、桔梗、甘草等三味加水煎煮2次，每次2.5小时，合并煎液，滤过，滤液浓缩至60-70℃时相对密度为1.22的浸膏；D. decoct the residues of Schizonepeta tenuifolia, Saposhnikovia divaricata, Notopterygium wilfordii, Angelica pubescens, and Peucedanum chinense obtained in step A with the remaining three herbs, namely, Bupleurum chinense, Platycodon grandiflorum, and Licorice root, twice in water for 2.5 hours each time. Combine the decoctions, filter, and concentrate the filtrate to an extract having a relative density of 1.22 at 60-70°C. E.合并步骤C所得漉液和步骤D所得浸膏，混匀，静置，滤过，滤液浓缩至50-60℃时相对密度为1.25的浸膏；E. Combine the filtrate obtained in step C and the extract obtained in step D, mix well, let stand, filter, and concentrate the filtrate to an extract with a relative density of 1.25 at 50-60°C; F.取步骤E所得浸膏，加入步骤B所得环糊精包合物，混匀，制成颗粒，带式真空干燥，粉碎，得荆防提取物细粉，备用；F. Take the extract obtained in step E, add the cyclodextrin inclusion compound obtained in step B, mix well, make granules, belt vacuum dry, and grind to obtain a fine powder of the Jingfang extract for later use; G.按配方量称取步骤F荆防提取物细粉、囊材、抗粘剂和增塑剂，将囊材、抗粘剂和增塑剂加入纯化水，54℃条件下加热搅拌使溶解，配置成质量分数为33%的囊材溶液，冷却至室温，搅拌状态下加入荆防提取物细粉和乳化剂，均质乳化，得乳化液，备用；G. Weigh the fine powder of the schisandra extract from step F, the capsule material, the anti-adherent agent, and the plasticizer according to the formula, add the capsule material, the anti-adherent agent, and the plasticizer to purified water, heat and stir at 54°C to dissolve, and prepare a 33% by mass capsule material solution. Cool to room temperature, add the fine powder of the schisandra extract and the emulsifier while stirring, homogenize and emulsify to obtain an emulsion, and set aside; H.步骤G乳化液在进风温度165℃、喷雾压力0.40MPa、进料速度21.5ml/min条件下进行喷雾干燥，收集微囊，冷却，即得。H. The emulsion in step G is spray-dried under the conditions of an inlet air temperature of 165° C., a spray pressure of 0.40 MPa, and a feed rate of 21.5 ml/min, and the microcapsules are collected and cooled to obtain the microcapsules. 6.根据权利要求5所述的应用，其特征在于，步骤F中带式真空干燥的条件为真空度-0.08MPa--0.10Mpa，干燥温度56℃。6. The use according to claim 5, characterized in that the belt vacuum drying conditions in step F are a vacuum degree of -0.08 MPa to 0.10 MPa and a drying temperature of 56°C. 7.根据权利要求5所述的应用，其特征在于，步骤G所述囊材为络蛋白酸钠：麦芽糊精=3:2，抗粘剂为十八醇：二氧化钛=3：1，增塑剂为聚乙二醇：柠檬酸=3：1。7. The use according to claim 5, characterized in that in step G, the capsule material is sodium chorate:maltodextrin = 3:2, the anti-adhesive agent is octadecyl alcohol:titanium dioxide = 3:1, and the plasticizer is polyethylene glycol:citric acid = 3:1. 8.根据权利要求5所述的应用，其特征在于，步骤G所述乳化剂按重量计为蔗糖脂肪酸酯：大豆磷脂=8∶5的复合乳化剂，用量按质量分数计为制剂配方总量的1.18%。8. The use according to claim 5, characterized in that the emulsifier in step G is a composite emulsifier of sucrose fatty acid ester: soybean lecithin = 8:5 by weight, and the amount used is 1.18% by mass of the total formulation.
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