CN101843684A - Medicinal composition - Google Patents
Medicinal composition Download PDFInfo
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- CN101843684A CN101843684A CN 201010108724 CN201010108724A CN101843684A CN 101843684 A CN101843684 A CN 101843684A CN 201010108724 CN201010108724 CN 201010108724 CN 201010108724 A CN201010108724 A CN 201010108724A CN 101843684 A CN101843684 A CN 101843684A
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Abstract
The invention discloses a medicinal composition for assisting in treating hepatitis and application thereof in preparation of medicaments for assisting in treating the hepatitis. The medicinal composition contains dichloroacetic acid diisopropylamine and Chinese medicament extracts. By combining western medicaments and Chinese medicaments, the medicinal composition has synergistic functions, and can bring the gospel to hepatopath.
Description
Invention field
The present invention relates to a kind of Pharmaceutical composition, be specifically related to the Pharmaceutical composition formed by diisopropylamine dichloroacetate and a kind of Chinese medicine extract, and the purposes of said composition in the medicine of preparation adjuvant treating hepatitis, medical technical field belonged to.
Background technology
Hepatitis (formal name used at school: Hepatitis) be the inflammation of liver.The reason of hepatitis has a variety of, and modal is that virus causes, and also has autoimmune to cause in addition.Excessive drinking also can cause hepatitis.Medically hepatitis can be divided into first, second, third, fourth, penta, oneself, seven types of heptan, and wherein hepatitis B is the most extensive popular, a kind of infectious hepatitis that harm is the most serious.Hepatitis B (abbreviation hepatitis B) is the liver inflammatory damage that is caused by hepatitis B virus (abbreviation hepatitis B virus), the primary disease extend over the entire globe, clinical manifestation is weak, loss of appetite, feels sick, vomits, detests oil, diarrhoea and abdominal distention, some cases has heating, jaundice, the concealment of half patient onset is arranged approximately, in inspection, find.China is the most popular country of hepatitis B, reaches more than 35% some local crowd infection rate, is that the most serious of current harm people ' s health specially catches an illness.According to investigations, China's hepatitis B patient is about 2,700 ten thousand, and annual New Development patient about 9,000,000.The hepatitis B clinical manifestation is various, easily develops into chronic hepatitis and liver cirrhosis, and a few peoples finally develop into hepatocarcinoma.Hepatic fibrosis is the total pathological change of many chronic hepatopathy evolutions, and give birth to slowly, the persistence damage is the prerequisite that hepatic fibrosis forms.
Cause the factor of hepatic injury a lot,, hepatitis B, liver cirrhosis, take some drugs for a long time and all can cause acute and chronic hepatic injury generally because of factors such as medicine, a large amount of ethanol, allergy cause acute liver damage.By reducing detrimental effect to liver function, can adjuvant treating hepatitis.
The medicine that is used for the treatment of acute and chronic hepatic injury at present, commonly used have diisopropylamine dichloroacetate, tiopronin, a diammonium glycyrrhizinate etc.These chemicalses generally have certain side effect, and cause that therapeutic effect at a specified future date is poor, problem such as Strain produces after drug resistance phenomenon, the drug withdrawal relapse rate height.
The curative effect of Chinese medicine hepatitis B is proved by a large amount of clinical trials.Chinese medicine all can be brought into play curative effect preferably at aspects such as antiviral, adjusting immunity of organisms, protection hepatocyte.But Chinese medicine preparation ubiquity onset at present is slow, needs problems such as life-time service.Therefore, Western medicine and Chinese Medicine and Clavicular need be got up, i.e. synergism is played in Chinese medicine and western medicine combination, solves the problem that above-mentioned Western medicine and Chinese medicine exist in auxiliary treatment all kinds hepatitis separately, produces synergistic therapeutic effect simultaneously.
Summary of the invention
The object of the present invention is to provide the Pharmaceutical composition of being made up of diisopropylamine dichloroacetate and a kind of Chinese medicine extract, the weight ratio of the two is 1: 112.Wherein Chinese medicine extract is prepared as follows according to the method for claim 4 among the Chinese patent CN1193766C: after Fructus Gardeniae is pulverized, the water extraction 1～3 time that adds 5～8 times of amounts respectively, merge extractive liquid,, filter, the concentrated hydrochloric acid that adds medical material amount 0.1～2% (M/V), stir slightly, leave standstill, after waiting to separate out gelatinous precipitate, the centrifugal supernatant of telling, cross the macroporous adsorptive resins of having handled well, after upper prop finishes, water fully be eluted to effluent clarification and color light after, add 50～95% ethanol elutions, collect eluent, cross the neutral alumina post that is equivalent to 0.2～0.5 times of amount of medical material, 50～100% ethanol elutions are collected eluent, concentrate as for, promptly get light yellow to the off-white color Fructus Gardeniae extract.
Another object of the present invention is to provide the purposes of above-mentioned Pharmaceutical composition in the preparation accessory drug for treating hepatitis.
Compositions of the present invention and mixing acceptable accessories are made acceptable forms clinically, as tablet, capsule, granule, soft capsule, drop etc.
For ease of understanding the useful medical value of Pharmaceutical composition of the present invention, provide the pharmacological experiments of the present composition below in the adjuvant treating hepatitis disease.
Experimental example: the main pharmacodynamics of Pharmaceutical composition of the present invention studies confirm that it has strong transaminase lowering effect, i.e. function for protecting liver and reducing enzyme activity." modern pharmacology test method " (volume two) with reference to the Zhang Juntian chief editor, combined publication society of China Concord Medical Science University of Beijing Medical University, the 1397th～1398 page, disclosed method in " first segment chmice acute chemical liver injury model ", set up the acute chemical liver injury model of mouse carbon tetrachloride, carry out the pharmacodynamics test of Pharmaceutical composition anti-liver injury of the present invention.
The test grouping:
1, normal control group: animal does not do any processing, and normal physiological saline is irritated stomach;
2, model control group: after the animal model modeling success, normal physiological saline is irritated stomach;
3, pure Chinese drug-treated group: Chinese medicine extract 1.12g/kg body weight as indicated above is irritated stomach;
4, diisopropylamine dichloroacetate group: the 10mg/kg body weight is irritated stomach;
5, compositions group: 10mg/kg body weight diisopropylamine dichloroacetate+Chinese medicine extract 1.12g/kg body weight mentioned above is irritated stomach.
Following table has shown the influence of each group to Mouse Liver function leading indicator GOT, GPT:
Table one
| Group | Number of animals | GOT (active unit) | GPT (active unit) |
| The normal control group | ??10 | ??21.78±16.55 | ??48.61±15.35 |
| Model control group | ??10 | ??248.76±74.58 | ??312.25±60.47 |
| Pure Chinese drug-treated group | ??10 | ??182.43±63.42 | ??238.63±52.01 |
| The diisopropylamine dichloroacetate group | ??10 | ??110.74±39.24 | ??198.78±29.80 |
| The compositions group | ??10 | ??86.41±24.79 | ??110.12±49.24 |
This table shows that all there is significant difference (P＜0.05) in each group (pure Chinese drug-treated group, diisopropylamine dichloroacetate group, compositions group) of treatment with model control group, and all there are significant difference (P＜0.05) in compositions group and pure Chinese drug-treated group, compositions group and diisopropylamine dichloroacetate group, show that there is cooperative effect in diisopropylamine dichloroacetate and the described Chinese medicinal components in the compositions group.
Specific embodiment
The specific embodiment of form is described in further detail foregoing of the present invention by the following examples, but this should be interpreted as that the scope of above-mentioned theme of the present invention only limits to following embodiment.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.The adjuvant of each dosage form can substitute with acceptable accessories in following examples, perhaps reduces, increases.
The pharmaceutics test: the weight ratio of diisopropylamine dichloroacetate and Chinese medicine extract is 1: 112 in the Pharmaceutical composition.
Embodiment 1: the preparation of Pharmaceutical composition tablet of the present invention
Prescription 1:
Pharmaceutical composition 40g
Starch 120g
Microcrystalline Cellulose 40g
The 2%HPMC aqueous solution is an amount of
Magnesium stearate 2g
Carboxymethylstach sodium 4g
?????????????????????????????????????????????
Prepare 1000 altogether
Prescription 2:
Pharmaceutical composition 60g
Starch 120g
Microcrystalline Cellulose 40g
The 2%HPMC aqueous solution is an amount of
Magnesium stearate 2g
Carboxymethylstach sodium 4g
?????????????????????????????????????????????
Prepare 1000 altogether
Prescription 3:
Pharmaceutical composition 80g
Starch 120g
Microcrystalline Cellulose 40g
The 2%HPMC aqueous solution is an amount of
Magnesium stearate 2g
Carboxymethylstach sodium 4g
?????????????????????????????????????????????
Prepare 1000 altogether
Prescription 4:
Pharmaceutical composition 100g
Starch 120g
Microcrystalline Cellulose 40g
The 2%HPMC aqueous solution is an amount of
Magnesium stearate 2g
Carboxymethylstach sodium 4g
????????????????????????????????????????????????
Prepare 1000 altogether
Prescription 5:
Pharmaceutical composition 120g
Starch 120g
Microcrystalline Cellulose 40g
The 2%HPMC aqueous solution is an amount of
Magnesium stearate 2g
Carboxymethylstach sodium 4g
?????????????????????????????????????????????????
Prepare 1000 altogether
Preparation technology:
(1), takes by weighing supplementary material according to recipe quantity.Hypromellose 2% the aqueous solution made soluble in water is standby.
(2), with Pharmaceutical composition, starch, microcrystalline Cellulose mix homogeneously, it is an amount of to add the 2%HPMC aqueous solution, stirs, and makes suitable soft material.
(3), cross 20 mesh sieve system granules.
(4), granule is dried under 60 ℃ condition.
(5), dry good granule adds magnesium stearate and carboxymethylstach sodium, mistake 18 mesh sieve granulate, mix homogeneously.
(6), take a sample the semi-finished product chemical examination.
(7), the sheet weight sheet of determining according to chemical examination.
(8), finished product is examined the packing warehouse-in entirely.
Embodiment 2: the preparation of Pharmaceutical composition capsule of the present invention
Prescription 1:
Pharmaceutical composition 40g
Starch 120g
Microcrystalline Cellulose 40g
The 2%HPMC aqueous solution is an amount of
Magnesium stearate 2g
Carboxymethylstach sodium 4g
??????????????????????????????????????????
Prepare 1000 altogether
Prescription 2:
Pharmaceutical composition 60g
Starch 120g
Microcrystalline Cellulose 40g
The 2%HPMC aqueous solution is an amount of
Magnesium stearate 2g
Carboxymethylstach sodium 4g
????????????????????????????????????????
Prepare 1000 altogether
Prescription 3:
Pharmaceutical composition 80g
Starch 120g
Microcrystalline Cellulose 40g
The 2%HPMC aqueous solution is an amount of
Magnesium stearate 2g
Carboxymethylstach sodium 4g
???????????????????????????????????????????
Prepare 1000 altogether
Prescription 4:
Pharmaceutical composition 100g
Starch 120g
Microcrystalline Cellulose 40g
The 2%HPMC aqueous solution is an amount of
Magnesium stearate 2g
Carboxymethylstach sodium 4g
???????????????????????????????????????????
Prepare 1000 altogether
Prescription 5:
Pharmaceutical composition 120g
Starch 120g
Microcrystalline Cellulose 40g
The 2%HPMC aqueous solution is an amount of
Magnesium stearate 2g
Carboxymethylstach sodium 4g
?????????????????????????????????????????
Prepare 1000 altogether
Preparation technology:
(1), takes by weighing supplementary material according to recipe quantity.Hypromellose 2% the aqueous solution made soluble in water is standby.
(2), with Pharmaceutical composition, starch, microcrystalline Cellulose mix homogeneously, it is an amount of to add the 2%HPMC aqueous solution, stirs, and makes suitable soft material.
(3), cross 20 mesh sieve system granules.
(4), granule is dried under 60 ℃ condition.
(5), dry good granule adds magnesium stearate, mistake 18 mesh sieve granulate, mix homogeneously.
(6), take a sample the semi-finished product chemical examination.
(7), the loading amount of determining according to chemical examination incapsulates.
(8), finished product is examined the packing warehouse-in entirely.
The preparation of embodiment 3 Pharmaceutical composition granules of the present invention
Prescription 1:
Pharmaceutical composition 40g
Sucrose 1800g
The 2%HPMC50% alcoholic solution is an amount of
????????????????????????????????????????
Prepare 1000 bags altogether
Prescription 2:
Pharmaceutical composition 60g
Sucrose 1800g
The 2%HPMC50% alcoholic solution is an amount of
??????????????????????????????????????????
Prepare 1000 bags altogether
Prescription 3:
Pharmaceutical composition 80g
Sucrose 1800g
The 2%HPMC50% alcoholic solution is an amount of
???????????????????????????????????????????
Prepare 1000 bags altogether
Prescription 4:
Pharmaceutical composition 100g
Sucrose 1800g
The 2%HPMC50% alcoholic solution is an amount of
????????????????????????????????????????????????
Prepare 1000 bags altogether
Prescription 5:
Pharmaceutical composition 120g
Sucrose 1800g
The 2%HPMC50% alcoholic solution is an amount of
????????????????????????????????????????????????
Prepare 1000 bags altogether
Preparation technology:
(1), it is standby sucrose to be pulverized 100 mesh sieves.
(2), take by weighing supplementary material according to recipe quantity.
(3), with the method mix homogeneously that Pharmaceutical composition and sucrose progressively increase with equivalent, it is an amount of to add the 2%HPMC50% alcoholic solution, stirs, and makes suitable soft material,
(4), cross 20 mesh sieve system granules.
(5), granule is dried under 60 ℃ condition.
(6), dried granule is crossed 18 mesh sieve granulate.
(7), sampling, the content of principal agent is determined loading amount in the semi-finished product chemical examinations granule.
(8), packing, finished product is examined entirely, packing warehouse-in.
Embodiment 4: the preparation of Pharmaceutical composition flexible glue of the present invention agent
Prescription 1:
Pharmaceutical composition 40g
Soybean oil 400g
Soybean phospholipid 20g
Cera Flava 12g
?????????????????????????????????????????????
Prepare 1000 altogether
Prescription 2:
Pharmaceutical composition 60g
Soybean oil 400g
Soybean phospholipid 20g
Cera Flava 12g
????????????????????????????????????????????????
Prepare 1000 altogether
Prescription 3:
Pharmaceutical composition 80g
Soybean oil 400g
Soybean phospholipid 20g
Cera Flava 12g
?????????????????????????????????????????????
Prepare 1000 altogether
Prescription 4:
Pharmaceutical composition 100g
Soybean oil 400g
Soybean phospholipid 20g
Cera Flava 12g
????????????????????????????????????????????????
Prepare 1000 altogether
Prescription 5:
Pharmaceutical composition 120g
Soybean oil 400g
Soybean phospholipid 20g
Cera Flava 12g
?????????????????????????????????????????????
Prepare 1000 altogether
Preparation technology: with the soybean oil of recipe quantity and soybean phospholipid, Cera Flava heating and melting, mixing is put coldly, adds Pharmaceutical composition and grinds well, and is pressed into soft capsule and gets final product.
Embodiment 5: the preparation of Pharmaceutical composition drop pill of the present invention
Prescription 1:
Pharmaceutical composition 40g
Polyethylene glycol 6000 600g
Prescription 2:
Pharmaceutical composition 60g
Polyethylene glycol 6000 600g
Prescription 3:
Pharmaceutical composition 80g
Polyethylene glycol 6000 600g
Prescription 4:
Pharmaceutical composition 100g
Polyethylene glycol 6000 600g
Prescription 5:
Pharmaceutical composition 120g
Polyethylene glycol 6000 600g
Preparation technology: with polyethylene glycol 6000 heating and melting in water-bath, treat to add Pharmaceutical composition after whole fusions, stirring and dissolving, 60 mesh sieves filter, and keep 60 ℃ to splash in the liquid paraffin that is chilled to below 10 ℃ and make ball.
Claims (2)
1. Pharmaceutical composition, it is characterized in that it is made up of with weight ratio diisopropylamine dichloroacetate and Chinese medicine extract at 1: 112, described Chinese medicine extract prepares by following method: after Fructus Gardeniae is pulverized, the water extraction 1～3 time that adds 5～8 times of amounts respectively, merge extractive liquid, filters, and adds the concentrated hydrochloric acid of medical material amount 0.1～2% (M/V), stir slightly, leave standstill, after waiting to separate out gelatinous precipitate, the centrifugal supernatant of telling, cross the macroporous adsorptive resins of having handled well, after upper prop finishes, water fully be eluted to effluent clarification and color light after, add 50～95% ethanol elutions, collect eluent, cross the neutral alumina post that is equivalent to 0.2～0.5 times of amount of medical material, 50～100% ethanol elutions are collected eluent, be concentrated into driedly, promptly get light yellow to the off-white color Fructus Gardeniae extract.
2. the purposes of compositions as claimed in claim 1 in the medicine of preparation adjuvant treating hepatitis.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010108724 CN101843684A (en) | 2010-02-10 | 2010-02-10 | Medicinal composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010108724 CN101843684A (en) | 2010-02-10 | 2010-02-10 | Medicinal composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101843684A true CN101843684A (en) | 2010-09-29 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 201010108724 Pending CN101843684A (en) | 2010-02-10 | 2010-02-10 | Medicinal composition |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1899432A (en) * | 2006-07-06 | 2007-01-24 | 张砚 | Synergistic medicinal composition for treating hepatitis |
| CN101461798A (en) * | 2007-12-19 | 2009-06-24 | 北京德众万全药物技术开发有限公司 | Medicinal composition for oral use containing diisopropylamine dichloroacetate |
-
2010
- 2010-02-10 CN CN 201010108724 patent/CN101843684A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1899432A (en) * | 2006-07-06 | 2007-01-24 | 张砚 | Synergistic medicinal composition for treating hepatitis |
| CN101461798A (en) * | 2007-12-19 | 2009-06-24 | 北京德众万全药物技术开发有限公司 | Medicinal composition for oral use containing diisopropylamine dichloroacetate |
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| PB01 | Publication | ||
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Open date: 20100929 |