CN106692086A - Compound glycyrrhizin tablets and preparation method thereof - Google Patents
Compound glycyrrhizin tablets and preparation method thereof Download PDFInfo
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- CN106692086A CN106692086A CN201611140488.3A CN201611140488A CN106692086A CN 106692086 A CN106692086 A CN 106692086A CN 201611140488 A CN201611140488 A CN 201611140488A CN 106692086 A CN106692086 A CN 106692086A
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- glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- General Health & Medical Sciences (AREA)
- Public Health (AREA)
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- Molecular Biology (AREA)
- Biophysics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses compound glycyrrhizin tablets. The compound glycyrrhizin tablets are prepared from a main drug raw material comprising glycyrrhizic acid ammonium salt, glycine and DL-methionine and an auxiliary material comprising a filling agent and a disintegrating agent. The mass ratio of the main drug raw material to the auxiliary material is 1:(1.7-2.8). The filling agent is prepared by evenly mixing mannitol and starch in a mass ratio of 2:1, and the disintegrating agent is xanthan gum. The invention further discloses a preparation method of the compound glycyrrhizin tablets. The method sequentially comprises the steps of grinding, screening, mixing and tabletting, and then the compound glycyrrhizin tablets are prepared. Due to mannitol in the auxiliary material, the situation that the drug quality is unqualified caused by moisture absorption of glycyrrhizic glycoside can be avoided, and the sweetness of mannitol can mask the bitterness of the tablets; by matching with the starch and xanthan gum in a certain ratio, the raw materials of the tablets are good in fluidity and pressing-ability; the technology is simple, energy conservation and environment protection are achieved, and the production cost is low.
Description
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of compound tablet of glycyrrhizin agent and preparation method thereof.
Background technology
Compound glycyrrbizic acid glycosides formulation（Trade name：U.S. energy）Developed by Minophagen Pharmaceutical Co L, earliest
Appeared on the market in Japan's production in 1948, be used primarily for treating skin disease, there are two kinds of formulations of injection and solid pharmaceutical preparation.1958
Attempt that with U.S. hepatopathy can be treated, late 1970s formally report the formulation application as treatment chronic hepatitis in clinic.Day
This demonstrates the definite curative effect of its treatment chronic hepatitis from hepatic histopathology, and the retrospective study for treating hepatitis shows, can
Substantially reduce the incidence of cirrhosis；The late result observation of 22 years finds that medication can reduce within more than 15 years liver cancer incidence
More than 50%.
At present, it is beautiful can Japan as chronic hepatitis standard care medicine it is long-term, be widely used in clinic.China 1985
Start in year to treat chronic viral hepatitis using said preparation, said preparation can significantly improve the liver function of chronic hepatitis patient, drop enzyme
Effective percentage with reduction bilirubin is 80% or so and good to the improvement of serum of cirrhosis patients biochemical indicator.Experienced half
The studies and clinical application in individual many centuries, has lot of documents to report the extensive clinical practice of U.S. energy and its significantly treat both at home and abroad
Effect：In hepatopathy field, for various virus hepatitis, toxic hepatitis, DILD, cirrhosis, liver cancer, hepatic arteriochemotherapy
Deng treatment；Reacted for therapeutic in non-hepatic disorder field（Such as fash, nettle rash, drug eruption）, it is children's atopic dermatitis, flat
Liver moss, systemic loupus erythematosus, HFRS and severe acute respiratory syndrome etc..
Compound glycyrrbizic acid glycosides formulation contains three kinds of active ingredients：Glycyrrhizin, glycine, DL- METHIONINE, wherein glycyrrhizic acid
Glycosides is identified with the pharmacological action such as protection liver plasma membrane, anti-inflammatory, antiviral, immunological regulation and steroids sample, can also induce γ-
Interferon, strengthens natural killer cell activity, mitigates degeneration of liver cells necrosis, reduces glutamic-pyruvic transaminase, suppresses liver collagenous fibres
Hyperplasia, prevents liver fibrosis from being formed, and promotes the pharmacological actions such as bilirubin metabolism；Glycine can directly protect liver cell and make liver
The inflammation and degree of necrosis of cell substantially mitigate, and significantly improve liver function, with liver protection, drop enzyme, jaundice, while can be with
Adjustable renal function, prevents pseudo- aldosterone symptom.DL- METHIONINE can improve liver detoxification ability, allergic reaction be reduced, for liver
Cytothesis, differentiation and regulation liver cell are all very important for the sensitivity of various damages.
At present, it is injection and tablet, the feelings of long-term prescription that in the market is available for the compound glycyrrbizic acid glycosides formulation that patient selects
Injection is using very inconvenient under condition, and patient compliance is poor；And tablet is sugar coated tablet, formulation and technology is more complicated, and
When ensure that the intensity of tablet, the stability and dissolution rate of tablet medicine are often influenced whether.
The content of the invention
In order on the premise of tablet strength and dissolution rate is ensured, increase the stability of medicine, shorten technological process, this hair
It is bright there is provided a kind of compound tablet of glycyrrhizin agent and preparation method thereof.
To achieve these goals, the technical solution adopted by the present invention is：
A kind of compound tablet of glycyrrhizin agent, be by with mono-ammonium glycyrrhizinate, glycine and DL- METHIONINE be main ingredient raw material, to fill out
The tablet that agent and disintegrant are made for auxiliary material is filled, main ingredient raw material is 1 with the mass ratio of auxiliary material：1.7~2.8；It is sweet in main ingredient raw material
In terms of glycyrrhizin, the mass ratio of glycyrrhizin, glycine and DL- METHIONINE is 1 to the quality of oxalic acid mono-ammonium：1：1；Auxiliary material
In, filler is 20 with the mass ratio of disintegrant：1, the filler is by mannitol and starch according to mass ratio 2：1 mix and
Into the disintegrant is xanthans.
Preferably, every compound tablet of glycyrrhizin agent contains 25 milligrams of glycyrrhizin.
The preparation method of above-mentioned compound tablet of glycyrrhizin agent, comprises the following steps：
（1）Each bulk drug is ground respectively, is sieved, main ingredient raw material and filler cross 80 mesh sieves, and xanthans crosses 200 mesh sieves；
（2）Each raw material is weighed by quality proportioning, first main ingredient raw material and filler is placed in three-dimensional mixer and is well mixed, then added
Enter xanthans, mix 30 ~ 50 minutes；
（3）By step（2）Products therefrom compressing tablet, obtains final product.
Preferably, step（3）The compressing tablet includes pre- compressing tablet and secondary compressing tablet, the kN/cm of pressure 7 ~ 10 of pre- compressing tablet2, two
The kN/cm of pressure 11 ~ 14 of secondary compressing tablet2。
Because of glycyrrhizin（C42H62O16）Property is unstable, when compound tablet of glycyrrhizin agent is prepared, with mono-ammonium glycyrrhizinate
（C42H62O16·NH3·xH2O, CAS：53956-04-0）As raw material.
Mannitol, mannitol is selected not only to be avoided that medicine matter caused by the hygroscopicity because of glycyrrhizin in auxiliary material of the present invention
Amount is unqualified, and the sweet taste of itself can cover the bitter taste of tablet, obtained compound tablet of glycyrrhizin agent without sugar coating or
Person's film-coating just has preferable mouthfeel, additionally, diabetic also can be safe to use；Coordinate a certain proportion of starch again, with
And the xanthans of certain proportioning makes tablet material have good mobility and compressibility as disintegrant, it is not necessary to using having
Machine solvent, and without granulation and drying steps, so that it may direct tablet compressing, present invention process is simple, energy-conserving and environment-protective, the friability of product
Degree meets regulation, and dissolution rate and stability are preferable, and production cost is relatively low.
Specific embodiment
In order that technical purpose of the invention, technical scheme and beneficial effect are clearer, with reference to specific embodiment
Technical scheme is further illustrated, but the embodiment is intended to explain the present invention, and it is not intended that right
Limitation of the invention, in the examples where no specific technique or condition is specified, according to the technology described by document in the art or
Condition is carried out according to product description.
Mono-ammonium glycyrrhizinate, glycine, DL- METHIONINE, mannitol, starch and xanthans are commonly in following embodiments
Commercially available prod, wherein, mono-ammonium glycyrrhizinate is purchased from TCI, and every 35 mg mono-ammonium glycyrrhizinates contain 25 mg glycyrrhizins；Mannitol is
Granular pattern, the granularity of xanthans is 200 mesh.
Embodiment 1-4
A kind of compound tablet of glycyrrhizin agent, be by with mono-ammonium glycyrrhizinate, glycine and DL- METHIONINE be main ingredient raw material, to fill out
Fill the tablet that agent and disintegrant are made for auxiliary material；The consumption of each raw material is as shown in table 1 in every compound tablet of glycyrrhizin agent：
The consumption of each raw material in the every tablet of the embodiment of table 1
Embodiment 1 and the preparation method of compound tablet of glycyrrhizin agent described in embodiment 3, comprise the following steps：
（1）Each bulk drug is ground respectively, is sieved, main ingredient raw material and filler cross 80 mesh sieves, and xanthans crosses 200 mesh sieves；
（2）Each raw material is weighed by quality proportioning, first main ingredient raw material and filler is well mixed, xanthans, mixing 45 is added
Minute；
（3）By step（2）Products therefrom compressing tablet, obtains final product.
Wherein, step（3）The compressing tablet includes pre- compressing tablet and secondary compressing tablet, the kN/cm of pressure 6 of pre- compressing tablet2, secondary pressure
The kN/cm of pressure 12 of piece2。
Embodiment 2 and the preparation method of compound tablet of glycyrrhizin agent described in embodiment 4, comprise the following steps：
（1）Each bulk drug is ground respectively, is sieved, main ingredient raw material and filler cross 80 mesh sieves, and xanthans crosses 200 mesh sieves；
（2）Each raw material is weighed by quality proportioning, first main ingredient raw material and filler is well mixed, xanthans, mixing 50 is added
Minute；
（3）By step（2）Products therefrom compressing tablet, obtains final product.
Wherein, step（3）The compressing tablet includes pre- compressing tablet and secondary compressing tablet, the kN/cm of pressure 8 of pre- compressing tablet2, secondary pressure
The kN/cm of pressure 13 of piece2。
Comparative example 1,2
A kind of compound tablet of glycyrrhizin agent, be by with mono-ammonium glycyrrhizinate, glycine and DL- METHIONINE be main ingredient raw material, to fill out
Fill the tablet that agent and disintegrant are made for auxiliary material；The consumption of each raw material is as shown in table 2 in every compound tablet of glycyrrhizin agent：
The consumption of each raw material in the every tablet of the comparative example of table 2
Comparative example 1 and the preparation method of compound tablet of glycyrrhizin agent described in comparative example 2, comprise the following steps：
（1）Each bulk drug is ground respectively, is sieved, main ingredient raw material and filler cross 80 mesh sieves, and xanthans crosses 200 mesh sieves；
（2）Each raw material is weighed by quality proportioning, first main ingredient raw material and filler is well mixed, xanthans, mixing 45 is added
Minute；
（3）By step（2）Products therefrom compressing tablet, obtains final product.
Wherein, step（3）The compressing tablet includes pre- compressing tablet and secondary compressing tablet, the kN/cm of pressure 6 of pre- compressing tablet2, secondary pressure
The kN/cm of pressure 12 of piece2。
Comparative example 1 changes the consumption of xanthans compared with Example 1, only；Comparative example 2 only changes compared with Example 3
The consumption of starch and xanthans.
Result of the test：With reference to《Chinese Pharmacopoeia》2015 editions relevant regulations are carried out
By embodiment 1 ~ 4 and compound tablet of glycyrrhizin agent obtained in comparative example 1,2, and the common commercially available compound glycyrrbizic acid bought
Glycosides tablet carries out product quality detection, as a result as shown in table 3：
The testing result of the embodiment of table 3, comparative example and commercial products
From table 3 it can be seen that the dissolution results of compound tablet of glycyrrhizin agent obtained in the embodiment of the present invention 1 ~ 4 be above it is purchased in market
Product.Although comparative example 1 and comparative example 2 have only carried out less adjustment, the He of comparative example 1 to inventive formulation supplementary product consumption
Product prepared by comparative example 2 does not meet《Chinese Pharmacopoeia》The regulation of 2015 editions is no longer right in the case that friability is against regulation
Its every dissolution rate is detected.Testing result is confirmed：The consumption of filler and disintegrant is being that the present invention realizes technique effect
Key.
《Chinese Pharmacopoeia》2015 editions relevant regulations are carried out to embodiment 1 and compound tablet of glycyrrhizin agent obtained in embodiment 2
Stability test is carried out with commercial products, as shown in table 4 and table 5, total miscellaneous content, glycyrrhizin are molten in table 4 and table 5 for result of the test
The list of out-degree, glycine dissolution rate, DL- METHIONINE dissolution rate, glycyrrhizin content, Glycine Levels and DL- METHIONINE content
Position is %.
The accelerated stability test result of table 4（40 DEG C ± 2 DEG C, relative humidity 75% ± 5%）
The long-term stable experiment result of table 5（25 DEG C ± 2 DEG C, relative humidity 60% ± 10%）
Commercial products because the date of manufacture cannot control, therefore only determine product closely imitate the phase（The term of validity 30 months）Data, as a result
As shown in table 6.
The stability result of the commercial products of table 6
Understood according to table 4, table 5 and the stability data contrast of table 6：Obtained compound tablet of glycyrrhizin of the invention is in acceleration for stabilization
Property experiment in, total impurities content is up to 0.51%, and total in two years miscellaneous only up to 0.45% is deposited in long-term stable experiment, is contained
Amount and dissolution rate have almost no change in stability test, and these numerical value are superior to commercial products, and data above proves this hair
Bright obtained compound tablet of glycyrrhizin has more preferable product stability.
Claims (4)
1. a kind of compound tablet of glycyrrhizin agent, it is characterised in that：It is to be by with mono-ammonium glycyrrhizinate, glycine and DL- METHIONINE
Main ingredient raw material, with the tablet that filler and disintegrant are made as auxiliary material, main ingredient raw material is 1 with the mass ratio of auxiliary material：1.7~2.8；
In main ingredient raw material, the quality of mono-ammonium glycyrrhizinate in terms of glycyrrhizin, the mass ratio of glycyrrhizin, glycine and DL- METHIONINE
It is 1：1：1；In auxiliary material, filler is 20 with the mass ratio of disintegrant：1, the filler is by mannitol and starch according to quality
Than 2：1 mixing is formed, and the disintegrant is xanthans.
2. compound tablet of glycyrrhizin agent according to claim 1, it is characterised in that：Every compound tablet of glycyrrhizin agent is containing sweet
25 milligrams of oxalic acid glycosides.
3. the preparation method of compound tablet of glycyrrhizin agent described in a kind of claim 1, it is characterised in that comprise the following steps：
（1）Each bulk drug is ground respectively, is sieved, main ingredient raw material and filler cross 80 mesh sieves, and disintegrant crosses 200 mesh sieves；
（2）Each raw material is weighed by quality proportioning, first main ingredient raw material and filler is well mixed, disintegrant is added, mixing 30 ~
50 minutes；
（3）By step（2）Products therefrom compressing tablet, obtains final product.
4. the preparation method of compound tablet of glycyrrhizin agent according to claim 3, it is characterised in that：Step（3）The compressing tablet
Including pre- compressing tablet and secondary compressing tablet, the kN/cm of pressure 7 ~ 10 of pre- compressing tablet2, the kN/cm of pressure 11 ~ 14 of secondary compressing tablet2。
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611140488.3A CN106692086B (en) | 2016-12-12 | 2016-12-12 | A kind of compound tablet of glycyrrhizin agent and preparation method thereof |
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| CN201611140488.3A CN106692086B (en) | 2016-12-12 | 2016-12-12 | A kind of compound tablet of glycyrrhizin agent and preparation method thereof |
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| CN106692086B CN106692086B (en) | 2019-07-09 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007000967A1 (en) * | 2005-06-28 | 2007-01-04 | Minophagen Pharmaceutical Co., Ltd. | Remedy for cerebral infarction |
| CN1919185A (en) * | 2006-09-18 | 2007-02-28 | 黄本东 | Compound ammonium glycyrrhizinato S dispersed tablet and its preparing process |
| CN101288651A (en) * | 2008-06-20 | 2008-10-22 | 孙向阳 | Compound glycyrrhizin dispersible tablet and preparation method thereof |
| CN103845350A (en) * | 2012-11-30 | 2014-06-11 | 北京因科瑞斯医药科技有限公司 | Compound glycyrrhizin tablet and preparation method thereof |
-
2016
- 2016-12-12 CN CN201611140488.3A patent/CN106692086B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007000967A1 (en) * | 2005-06-28 | 2007-01-04 | Minophagen Pharmaceutical Co., Ltd. | Remedy for cerebral infarction |
| CN1919185A (en) * | 2006-09-18 | 2007-02-28 | 黄本东 | Compound ammonium glycyrrhizinato S dispersed tablet and its preparing process |
| CN101288651A (en) * | 2008-06-20 | 2008-10-22 | 孙向阳 | Compound glycyrrhizin dispersible tablet and preparation method thereof |
| CN103845350A (en) * | 2012-11-30 | 2014-06-11 | 北京因科瑞斯医药科技有限公司 | Compound glycyrrhizin tablet and preparation method thereof |
Non-Patent Citations (3)
| Title |
|---|
| 尹宗美: "用于直接压片的甘露醇-淀粉复合辅料制备技术及性能评价", 《中国药学杂志》 * |
| 朱盛山主编: "《药物制剂工程》", 31 August 2002, 化学工业出版社 * |
| 郑俊民主编: "《药用高分子材料学》", 31 August 2004, 中国医药科技出版社 * |
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