CN116617319B

CN116617319B - A Chinese medicine composition for improving clinical symptoms of HIV infected persons, and its preparation and application

Info

Publication number: CN116617319B
Application number: CN202310623925.0A
Authority: CN
Inventors: 刘宇清; 刘豫; 卢雪怡
Original assignee: Individual
Current assignee: Individual
Priority date: 2023-05-30
Filing date: 2023-05-30
Publication date: 2025-02-25
Anticipated expiration: 2043-05-30
Also published as: CN116617319A

Abstract

The present invention discloses a Chinese medicine composition for improving clinical symptoms of HIV-infected patients, and its preparation and application. The Chinese medicine composition for improving clinical symptoms of HIV-infected patients is composed of pearl powder, cycad leaves and poplar flower seeds in a weight ratio of 1:3 to 10:2 to 10. The present invention only uses three medicines, pearl powder, cycad leaves and poplar flower seeds, to formulate a prescription, and the raw materials synergize with each other, and have a very significant effect of improving the clinical symptoms of HIV-infected patients. The applicant found in clinical experiments that compared with traditional Western medicine treatment alone, the number of CD4 ⁺ T cells was significantly restored after taking the Chinese medicine composition of the present invention on the basis of traditional Western medicine treatment (P<0.05), and the clinical symptoms were also significantly alleviated (P<0.05). Later follow-up also found that its clinical efficacy score was better.

Description

Traditional Chinese medicine composition for improving clinical symptoms of HIV infected person, preparation and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicine pharmacy, in particular to a traditional Chinese medicine composition for improving clinical symptoms of HIV infected patients, and a preparation and application thereof.

Background

AIDS (acquired immunodeficiency syndrome, AIDS) is a very dangerous infectious disease caused by infection with the Human Immunodeficiency Virus (HIV). HIV is a virus that attacks the immune system of the human body and it targets the most important CD4 ⁺ T cells in the immune system of the human body as the primary target for attack, destroying the cells in large amounts, causing the human body to lose immune function. The latency of HIV in human body is 8-9 years on average, and the infected person can not have any clinical manifestation in the latency of HIV. Once aids develops, patients develop various clinical manifestations. Common initial symptoms like common cold and influenza can be general fatigue weakness, anorexia, fever and the like, and with the aggravation of the illness, the symptoms are increased day by day, such as the infection of skin and mucous membrane with candida albicans, herpes simplex, herpes zoster, purpura, bleb, blood stasis and the like, and then the symptoms gradually invade internal organs, and the persistent fever with unknown causes can last for 3-4 months, and cough, shortness of breath, dyspnea, persistent diarrhea, hematochezia, hepatosplenomegaly, and malignant tumor and the like can also appear. Clinical symptoms are complex and variable, but not all of the symptoms described above appear in every patient. Dyspnea, chest pain, cough, etc. often occur when the lung is violated, persistent diarrhea, abdominal pain, emaciation, weakness, etc. may occur when the stomach and intestine is violated, and the nervous system and cardiovascular system may also be violated.

At present, cocktail therapy and high-efficiency antiretroviral therapy of western medicine have achieved certain effects in terms of relieving pain of patients, prolonging service life of patients and the like, but western medicine is expensive in price, and on the other hand, toxic and side effects of medicines may make part of patients unable to bear. A group of HIV studies in swiss showed that 45% of patients receiving antiretroviral therapy (ART) had clinical adverse events and 27% had laboratory adverse events. Drug-related events may occur early (weeks or months prior to treatment) including rash and liver dysfunction due to non-nucleoside drugs, and late (6 months or longer) including mitochondrial toxicity due to chronic administration of nucleoside drugs, such as severe lactic acidosis, myopathy, cardiomyopathy, pancreatitis, peripheral neuritis, and the like.

The traditional Chinese medicine treatment aims at symptomatic medication of patients with different physical conditions, achieves the aim of regulating the overall dialectical condition of the organism, and can provide a new way for western medicine anti-HIV treatment, improving the immune function of the organism, improving the life quality of the patients and relieving the toxic and side effects of virus resistance. Through searching, the traditional Chinese medicine has more formulas for treating AIDS, such as:

The invention discloses a Chinese medicinal preparation for treating AIDS, which is prepared from, by weight, 6-12 parts of pearl, 10-20 parts of Sichuan seven, 5-10 parts of radix curcumae, 5-10 parts of artificial bezoar, 8-15 parts of radix trichosanthis kernel, 5-10 parts of radix scutellariae, 1-2 parts of bulbus fritilariae, 5-10 parts of costustoot, 5-10 parts of rheum officinale and 0.5-1 part of borneol. Researches show that the formula can inhibit HIV to 97.7%, can obviously enhance the immune function of organisms and has no toxic reaction.

The invention discloses a Chinese medicinal preparation for treating AIDS, which comprises 20-30 parts of starwort root, 20-30 parts of cortex lycii radicis, 20-30 parts of safflower, 15-20 parts of ligusticum wallichii, 30-50 parts of red paeony root, 20-30 parts of ground beetle, 15-30 parts of rhizoma sparganii, 10-20 parts of dens draconis, 20-50 parts of dragon bone, 20-30 parts of radix cynanchi wilfordii, 20-35 parts of raspberry, 20-30 parts of mantis egg-case, 20-50 parts of pomegranate rind, 10-20 parts of crinis Carbonisatus, 20-50 parts of gentiana macrophylla, 20-50 parts of lygodium japonicum, 10-20 parts of clove, 10-20 parts of borneol, 1-2 parts of musk, 12 parts of scorpion, 10-20 parts of peach kernel, 25-60 parts of myrrh, 10-20 parts of lithospermum, 20-50 parts of cattail pollen, 10-20 parts of earthworm, 10-20 parts of fennel, 10-6 parts of calyx seu fructus physalis, 10-20 parts of pollen pini, 10-50 parts of ginseng, 10-200 parts of dried body of Chinese angelica, 20-50 parts of ginseng, and 200-50 parts of dried beard-400 parts of ginseng, and 20-50 parts of herb.

The invention patent with publication number of CN105031463A discloses an anti-AIDS traditional Chinese medicine composition, which comprises the following raw materials: 9-11 g of red sage root, 10-14 g of astragalus root, 9-11 g of ginseng, 7-9 g of cimicifuga rhizome, 8-10 g of Indian iphigenia bulb, 5-7 g of common selfheal fruit-spike, 9-11 g of giant knotweed rhizome, 5-7 g of polygonum aviculare, 7-9 g of Chinese lobelia, 9-11 g of viola philippica, 9-11 g of spanishneedles herb, 7-9 g of common sage herb, 9-11 g of Indian mockstrawberry herb, 9-11 g of manyleaf paris rhizome, 5-7 g of Chinese rose, 7-9 g of chinaroot greenbrier rhizome, 9-11 g of epimedium herb, 14-16 g of glabrous greenbrier rhizome, and 7-9 g of subprostrate sophora, 5-7 g of airpotato yam, 9-11 g of honeysuckle, 7-9 g of black nightshade, 9-11 g of bupleurum, 9-11 g of common stonecrop herb, 7-9 g of lithospermum, 2-4 g of toad venom, 9-11 g of oldenlandia diffusa, 7-9 g of fiveleaf akebia fruit, 8-10 g of raspberry, 9-11 g of herba lycopodii, 5-7 g of climbing groundsel herb, 5-7 g of coptis chinensis, 9-11 g of common andrographis herb, 9-11 g of Chinese gooseberry root, 8-10 g of tomb, 5-7 g of cyrtomium rhizome, and 5-7 g of fried swimming bladder, 9-11 g of tribulus terrestris, 18-22 g of gynostemma pentaphylla, 9-11 g of rheum officinale, 9-11 g of unique general, 9-11 g of aristolochia cinnabarina, 9-11 g of paniculate swallowwort root, 9-11 g of erigeron breviscapus, 9-11 g of centipede on the fly, 18-22 g of liquorice, 9-11 g of garden balsam, 9-11 g of spring common sage, 2-4 g of pearl, 7-9 g of gelsemium elegans, 10-14 g of lion, 8-10 g of lamiophlomis rotata, 14-16 g of armillary bulb, liu Zi-11 g of meretrix, 5-7 g of processed beetle, 14-16 g of fructus alpiniae, 16-20 g of cuttlebone, 11-13 g of Chinese starwort, 9-11 g of fibraurea stem, 9-11 g of wild jujube, 14-16 g of cat claw, 11-13 g of kiwi fruit root, 14-16 g of pyrola, 7-9 g of flos pyrolae, 7-10 g of Korean ginseng, 7-8 g of white atractylodes rhizome, 7-8 g of Chinese lobelia, 7-6 g of Japanese gecko and 3-6 g of Japanese gecko. The Chinese medicinal composition can reduce the disease course of an infected person, relieve symptoms of an AIDS patient, finally achieve the aim of curing the AIDS, and provide an economic and effective supplementary means for treating the AIDS.

The traditional Chinese medicine has certain treatment effect, but the formula is too complex.

Disclosure of Invention

The invention aims to solve the technical problem of providing a traditional Chinese medicine composition with simple formula and obvious effect for improving clinical symptoms of HIV infected patients, and a preparation and application thereof.

The traditional Chinese medicine composition for improving clinical symptoms of HIV infected persons is prepared from pearl powder, iron leaves and poplar flower seeds according to the weight ratio of 1:3-10:2-10.

The invention is characterized in that the formula is improved from secret formula uploaded by the ancestors of the inventor, the inventor performs acute and chronic toxicity tests on secret formula uploaded by the ancestors in the earlier stage, no toxic or side effect is found in clinical practice, the medicine is safe, and the secret formula has good effect on improving the immunity of organisms in the further clinical application, so the inventor improves the secret formula on the basis of secret formula, and the traditional formula formed by 3 medicines is obtained. The poplar flower seed involved in the formula is granular seed in female inflorescence of the poplar. The flowering period of the poplar is usually 3-4 months, the poplar flower seeds related in the invention are obtained by picking or collecting female inflorescences falling on the ground in the flowering period, drying (sun-drying or low-temperature drying), and stripping granular seeds from the dried female inflorescences of the poplar. The dried female aspen inflorescence is shown in figure 1, and the aspen flower seed stripped from the dried female aspen inflorescence is shown in figure 2.

Preferably, the weight ratio of the pearl powder to the iron leaves to the poplar flower seeds is 1:4-7:3-6, more preferably, the weight ratio of the pearl powder to the iron leaves to the poplar flower seeds is 1:4-5:3-4, and still more preferably, the weight ratio of the pearl powder to the iron leaves to the poplar flower seeds is 1:5:4.

The invention also provides a traditional Chinese medicine composition preparation for improving clinical symptoms of HIV infected patients, which contains the traditional Chinese medicine composition for improving clinical symptoms of HIV infected patients.

The traditional Chinese medicine composition preparation for improving the clinical symptoms of the HIV infected person can be a conventional dosage form in the prior art, such as powder, granules, tablets, capsules, decoction, oral liquid or pills and the like.

The preparation method of the traditional Chinese medicine composition preparation for improving the clinical symptoms of HIV infected patients comprises the steps of weighing pearl powder, iron tree leaves and poplar flower seeds according to a proportion, adding water for decoction or extraction, collecting decoction or extract, and preparing the preparation according to the conventional processing method. In the specific preparation method, the parameters such as the water dosage, the times of decoction or extraction and the like are the same as those of the prior art. Preferably, the Chinese medicine is soaked for a period of time after being added with water and then decocted or extracted, so that the dissolution of active ingredients in the Chinese medicine is facilitated.

In general, the traditional Chinese medicine composition for improving clinical symptoms of HIV infected patients is prepared into decoction for administration according to the following method:

Weighing the raw materials according to the proportion, soaking in a container, adding water for decoction, filtering after the decoction is finished, and concentrating the obtained decoction until the crude drug content in each milliliter of liquid is 0.5-1 gram, thus obtaining the water decoction.

In the preparation method, the soaking time of each raw material medicine in the extraction tank is usually 1-3 hours, the decoction time can be 1-3 times, the decoction time is usually 0.5-3 hours, and the water adding amount in each decoction is 4-10 times of the total weight of the raw material medicines.

The administration dosage of the traditional Chinese medicine composition is 120-200 g of crude drug per day, preferably 130-160 g/day, calculated by adults.

The invention also comprises the application of the traditional Chinese medicine composition for improving the clinical symptoms of HIV infected patients in preparing medicines for treating AIDS or medicines for improving the clinical symptoms of HIV infected patients.

Compared with the prior art, the invention only uses pearl powder, iron leaves and 3 medicines of poplar flower seeds for composing, and the raw medicines are synergistic, thus having extremely obvious effect of improving clinical symptoms of HIV infected patients. The applicant finds that compared with single-row traditional western medicine treatment, the CD4 ⁺ T cell number is obviously recovered (P < 0.05) after the traditional western medicine treatment is combined with the traditional Chinese medicine composition, clinical symptoms are obviously relieved (P < 0.05), and later follow-up visit also finds that the clinical curative effect score is better.

Drawings

FIG. 1 is a photograph of female inflorescences of a dried poplar.

FIG. 2 is a photograph of aspen flower seeds stripped from dried aspen female inflorescences.

Detailed Description

In order to better explain the technical scheme of the present invention, the present invention will be described in further detail with reference to examples, but the embodiments of the present invention are not limited thereto.

Example 1

Weighing pearl powder, folium cortex Acanthopancis and poplar flower seed according to the weight ratio of 1:5:4, placing into a ceramic container, adding water which is 8 times of the total weight of the raw materials, soaking for 1 hour, decocting for 1 hour (counting by liquid boiling), filtering, collecting decoction, adding water which is 5 times of the total weight of the raw materials into residues, decocting for 1 hour (counting by liquid boiling), filtering, collecting decoction, mixing decoctions, and concentrating to obtain water decoction with 1g of crude drug per ml.

Example 2

Weighing pearl powder, folium cortex Acanthopancis and poplar flower seed according to the weight ratio of 1:6:3, placing in an extraction tank, adding water for extraction for 3 times (the water consumption is 10 times of the total weight of the raw materials in the 1 st extraction, the extraction time is 2h (counted by boiling liquid), the water consumption is 5 times of the total weight of the raw materials in the 2 nd and 3 rd extraction, the extraction time is 1h (counted by boiling liquid)), collecting and mixing the extracts, concentrating under reduced pressure to extract, drying, pulverizing, adding adjuvants, and granulating by wet method to obtain granule.

Example 3

Weighing pearl powder, folium Cudraniae and poplar flower seed according to the weight ratio of 1:10:2, placing into an extraction tank, adding water for extraction for 2 times (the water consumption is 10 times of the total weight of the raw materials in each extraction, the extraction time is 2 hours (when the liquid boiling starts), collecting and mixing the extracting solutions, concentrating under reduced pressure to extract, drying, pulverizing, adding auxiliary materials, and making into tablet according to conventional process.

Example 4

Weighing pearl powder, folium Tieguae and poplar flower seed at a weight ratio of 1:4:6, pulverizing folium Tieguae and poplar flower seed to 200 mesh, mixing with pearl powder, packaging, and sterilizing to obtain powder.

Experimental example clinical test of the Chinese medicinal composition for treating AIDS

1. Subjects and methods

The 1.1 experimental object is 62 cases of AIDS middle-aged and elderly patients who receive and treat admission from 6 in 2010 to 4 in 2020 in the hospitals of people in Guangxi Qin (hereinafter referred to as Qinzhou, for short), 34 cases of men and 28 cases of women, and the average age of 42-71 years (51.8+/-9.7). The study group was divided into 28 cases, 34 cases, and the two groups were composed of sexes with no obvious difference in age.

1.2 Inclusion and exclusion criteria

The standard is included, and HIV positive patients are confirmed by an enzyme-linked immunosorbent assay (ELISA) of Qinzhou institute and an immunoblotting assay (WB) of Guangxi disease prevention control center, and the CD4 ⁺ T cell count is less than 350/ml.

Exclusion criteria were severe heart, liver, kidney dysfunction and other important organ disorders, severe neurological and psychiatric disorders, active opportunistic infections, pre-opportunistic anti-infective treatments, recent application or use of drugs during treatment which may be contradictory to this study.

1.3 Methods of treatment

The control group was treated with 28 cases of high-potency antiretroviral therapy, 250mg of Ganoderma lucidum, 2 times daily, 300mg of lamivudine, 1 time daily, 300mg of zidovudine, 2 times daily, and the treatment of opportunistic infections. The treatment time is half a year.

Study group 34 cases on the basis of the Western medicine treatment, 1 bag of the traditional Chinese medicine composition decoction (prepared according to the method of the invention in the embodiment 1 and packaged according to 160 ml/bag) is added and taken orally for 1 time a day for 3 months for stopping taking medicine observation. Patients all signed informed consent.

1.4 Treatment judgment criteria, clinical symptoms and efficacy

Reference is made to the syndrome and physical sign grading and scoring criteria in the clinical technical scheme (trial) of the item 1 for treating AIDS in 5 provinces of Chinese medicine administration. The Chinese medicine symptoms and signs are quantified and counted, and recorded once in 2, 4 and 6 months after treatment. CD4 ⁺ T lymphocyte count an MR23 bench centrifuge manufactured by the company Jouan, france, was used to manufacture XL flow cytometer matching reagent by beckman, usa. All patients were counted for CD4+ T lymphocytes before and after treatment, and the increase and decrease in CD4 ⁺ T cell counts were recorded by testing at 2, 4, and 6 months after treatment, respectively.

1.5 Statistical methods SPSS13.0 software was used, and the mean was expressed as X.+ -. S. X2 test and analysis of variance were performed.

2. Results

2.1 Analysis of improvement of clinical symptoms between two groups

After 2 months of treatment, the statistical significance of the two groups of comparison differences of the symptoms of weakness (P < 0.05), the statistical significance of the two groups of comparison differences of the symptoms of fever (P < 0.05) after 4 months of treatment, and the statistical significance of the two groups of comparison differences of weakness, diarrhea, fever, rash and the like (P < 0.05) after 6 months of treatment. The results are shown in Table 1.

TABLE 1 analysis of clinical symptoms improvement after two groups of treatments (n)

2.2 Analysis of CD4 ⁺ T cell detection conditions between two groups

CD4 ⁺ T cells were statistically significant (P > 0.05) before and after 2 months of treatment, and after 4 and 6 months of treatment, the differences between the two groups were statistically significant (P < 0.05), and the results are shown in table 2.

TABLE 2 detection of CD4+ T lymphocytes from two groups

Time of	Research group (n=34)	Control group (n=28)	T value	P value
					Before taking medicine	98.88±83.87	102.61±28.24	0.24	0.809
Treatment for 2 months	190.53±103.76	176.82±82.23	0.58	0.564
					Treatment for 4 months	315.09±161.03	194.46±79.19	3.84	0.000
Treatment for 6 months	471.97±165.62	265.29±119.62	5.69	0.000
					F value	49.96	17.77
P value	0.000	0.000

2.3 Analysis of clinical efficacy between two groups

The traditional Chinese medicine judgment standard shows that the difference before taking medicine and 2 months of treatment has no statistical significance, and the difference between 4 months and 6 months of treatment has statistical significance. Study group integration was significantly lower than control group (P < 0.05) over treatment time. The results are shown in Table 3

TABLE 3 integral comparison of clinical efficacy of two sets of Chinese medicinal judgment criteria

Time of	Research group (n=34)	Control group (n=28)	T value	P value
					Before taking medicine	17.88±3.68	17.54±3.29	3.87	0.700
Treatment for 2 months	13.71±3.43	15.11±4.43	1.40	0.166
					Treatment for 4 months	8.97±3.92	12.82±4.33	3.67	0.001
Treatment for 6 months	2.35±3.41	8.57±3.39	7.16	0.000
					F value	115.43	26.80
P value	0.000	0.000

3. Discussion of the invention

In the treatment observation of AIDS patients, the study group treated by the traditional Chinese medicine composition combined with western medicines is compared with the control group treated by single-row western medicines, and the difference between the study group and the control group is found to be obvious. The patient was seen with light from CD4 ⁺ T cells and quality of life. The CD4 ⁺ T cells of the study group are obviously higher than those of the control group, and have statistical significance on relieving clinical symptoms and improving the comparison difference of the two groups of weakness, diarrhea, fever, eruption and the like.

The analysis of clinical curative effect between two groups shows that before and after taking the traditional Chinese medicine composition, the integral of a research group is obviously lower than that of a control group along with the extension of treatment time, so that the traditional Chinese medicine composition has the function of resisting HIV virus and can inhibit the reproduction of the HIV virus. CD4 ⁺ T cells are not destroyed, and the CD4 ⁺ T cells can survive and improve the immunity, prevent opportunistic infection and resist malignant tumor.

The treatment observation of the 1 st AIDS patient shows that the Chinese medicinal composition can safely and healthily survive for 16 years, and other treated AIDS patients can live normally and survive for a long time except a few patients in the middle of the treatment without adherence to the matched treatment. Opens up a new treatment method for the AIDS patients.

Claims

1. A Chinese medicine composition for improving clinical symptoms of HIV-infected patients, characterized in that it is composed of pearl powder, cycad leaves and poplar flower seeds in a weight ratio of 1:3-10:2-10.

2. The Chinese medicine composition according to claim 1, characterized in that the weight ratio of the pearl powder, cycad leaves and poplar flower seeds is 1:4~7:3~6.

3. The Chinese medicine composition according to claim 1, characterized in that the weight ratio of the pearl powder, cycad leaves and poplar flower seeds is 1:5:4.

4. A Chinese medicine composition preparation for improving clinical symptoms of HIV-infected patients, characterized in that it contains the Chinese medicine composition for improving clinical symptoms of HIV-infected patients according to claim 1.

5. The Chinese medicine composition preparation for improving clinical symptoms of HIV-infected patients according to claim 4, characterized in that the preparation is in the form of powder, granules, tablets, capsules, decoctions, oral liquids or pills.

6. The method for preparing the Chinese medicine composition preparation for improving clinical symptoms of HIV-infected patients as claimed in claim 4 is characterized in that pearl powder, cycad leaves and poplar flower seeds are weighed according to the ratio, decocted or extracted with water, the decoction or extract is collected, and further prepared into a preparation.

7. The preparation method according to claim 6 is characterized in that after adding water, soaking is first performed and then decocting or extracting is performed.

8. Use of the Chinese medicine composition according to claim 1 in the preparation of a medicament for improving clinical symptoms of HIV-infected patients.