CN101073602B - Medicinal composition for treating or improving liver function, its production and use - Google Patents

Medicinal composition for treating or improving liver function, its production and use Download PDF

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CN101073602B
CN101073602B CN2007100895539A CN200710089553A CN101073602B CN 101073602 B CN101073602 B CN 101073602B CN 2007100895539 A CN2007100895539 A CN 2007100895539A CN 200710089553 A CN200710089553 A CN 200710089553A CN 101073602 B CN101073602 B CN 101073602B
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fructus schisandrae
schisandrae chinensis
monas cuspurpureus
cuspurpureus went
pharmaceutical composition
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CN101073602A (en
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邹文俊
白红艳
何民
谢娜
刘忠荣
及元乔
王若竹
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CHENGDU DIAO JIUHONG PHARMACEUTICAL FACTORY
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Abstract

The invention is concerned with the method of preparation of the compound medicine for fatty liver and chemistry damage liver therapy that made of red cube and fructus schizandrae.

Description

A kind of pharmaceutical composition for the treatment of or improving liver function and its production and use
Technical field
The present invention relates to a kind of pharmaceutical composition, Preparation Method And The Use specifically, is in preparation fatty liver, chemical liver injury to be had treatment or the medicine of improvement effect or the purposes in the health food, belongs to technical field of Chinese medicines.
Background technology
Chemical liver injury is the hepatic injury that is caused by the chemical Hepatoxic substance, and according to toxic power, these hepatotropic poisons can be divided three classes: 1, hypertoxic class: comprise phosphorus, trinitrotoluene, carbon tetrachloride etc.; 2, hypertoxic type: arsenic, hydrargyrum, chloroform etc.; 3, lower toxicity: acetaldehyde, organophosphor, lead etc.These chemical substances also comprise ethanol and some chemicals, and alcoholic liver injury also is modal at present.These poisonous substances are general susceptible in the crowd, can cause in various degree hepatic necrosis of liver, steatosis, liver cirrhosis etc.At present domestic to chemical liver injury, comprise that fatty liver, alcoholic liver, medicine liver etc. still do not have ideal medicine.
Monas cuspurpureus Went is clinical blood lipid-lowering medicine commonly used, energy is cholesterol reducing and triglyceride significantly, and the antioxidant Dimerumic acid that extraction and separation obtain from Monas cuspurpureus Went, can alleviate hepatocellular peroxidating by excessive free radical in the removing body, suppress the generation of lipid peroxide (LPO), thereby to CCl 4Inductive experimental hepatic injury has the better protect effect; Statins is global at present the most effective fat-reducing medicament of generally acknowledging, but statins is transformed by liver metabolism fully, there is the only a few crowd hepatic injury such as the transaminase raises may occur, Monas cuspurpureus Went is a rice fermented product, wherein contain natural his spit of fland material, his spit of fland of the molecular structure in natural his spit of fland and chemosynthesis is different, is active open loop structure, and his spit of fland of chemistry is little to load of liver pressure; In addition, Monas cuspurpureus Went deposits inhibitory action to lipid at liver.
Fructus Schisandrae Chinensis is the tcm clinical practice common drug, also is one of raw material commonly used in the health food product, and safety is very high.Chinese Magnoliavine Fruit alcohol extract and the serum transaminase rising effect that isolated deoxyschizandrin, second element, third element, pure first, pure second, ester first and ester second all have reduction in various degree to cause because of chemical substance from Fructus Schisandrae Chinensis; The hepatic injury of the mice that carbon tetrachloride is caused has significant protective effect, outside the function of detoxification of obvious inducing mouse of multiple composition decapacitation in the Fructus Schisandrae Chinensis and rat liver microsomes cytochrome P-450 activity, enhancing liver, the resistivity of body can also be improved, and the biosynthesis of hepatic protein and glycogen can be promoted oxygen free radical injury; The Fructus Schisandrae Chinensis crude polysaccharides can make CCl 4Hepatic injury Mouse Liver glycogen content significantly raises, and improves the energy conservation of body, helps resisting the infringement of external harmful substance to liver.Through the domestic and foreign literature retrieval, up to the present, still no-trump Monas cuspurpureus Went, Fructus Schisandrae Chinensis compatibility are used for the treatment of or improve the relevant report of liver function.
Summary of the invention
One of technical scheme to be solved by this invention provides a kind of pharmaceutical composition for the treatment of or improving liver function, and another technical scheme of the present invention provides this preparation of drug combination method and purposes.
The invention provides a kind of pharmaceutical composition, it is the medicament that is prepared from by the following weight proportion raw material: 10~50 parts in Monas cuspurpureus Went, 10~50 parts of Fructus Schisandrae Chinensis.
Further preferably, it is the medicament that is prepared from by the following weight proportion raw material: Monas cuspurpureus Went is 25~40 parts, and Fructus Schisandrae Chinensis is 25~40 parts.
Still more preferably, it is the medicament that is prepared from by the following weight proportion raw material: Monas cuspurpureus Went is 30 parts, and Fructus Schisandrae Chinensis is 30 parts.
Wherein, the fungus that produces Monas cuspurpureus Went in the described pharmaceutical composition is Mauve aspergillar Monacus purpureus, also can be Monascus ruber M.anka, Monascus ruber M.albidus turns white, Bark Monascus ruber M.barker, dark brown Monascus ruber M.fuliginosus, red Monascus ruber M.ruber, rust Monascus ruber M.rubiginosis, any one among the monascus M.serorubescens that reddens.
Wherein, described Fructus Schisandrae Chinensis is the extract of crude drug, water or the organic solvent of Fructus Schisandrae Chinensis.
Pharmaceutical composition of the present invention is to be used by Monas cuspurpureus Went, Fructus Schisandrae Chinensis compatibility, is active component with the extract of wherein crude drug, water or organic solvent, adds the medicament that acceptable accessories or complementary composition are prepared from.
Wherein, described preparation is: pharmaceutically acceptable dosage forms such as tablet, capsule, dispersible tablet, oral liquid, injection.
The present invention also provides this preparation of drug combination method, comprises the following steps:
A) take by weighing: 10~50 parts in Monas cuspurpureus Went, 10~50 parts of Fructus Schisandrae Chinensis, Monas cuspurpureus Went is beaten powder;
B) Fructus Schisandrae Chinensis is directly beaten powder; Or decoct with water; Or with 10%~85% alcohol reflux three times, extract obtained, concentrate, drying is beaten powder;
C) Hongqu powder (red colouring agent) of abundant mixing a step and the Chinese Magnolivine Fruit or the extract of b step add acceptable accessories or complementary composition and are prepared from.
Further, the present invention also provides this pharmaceutical composition in preparation fatty liver, chemical liver injury to be had treatment or the medicine of improvement effect or the purposes in the health food.
The present invention discovers that Fructus Schisandrae Chinensis and Monas cuspurpureus Went compatibility use, and the improvement effect of the acute chemical hepatic injury of tetrachloro-methane induction is had obvious role in synergism; Simultaneously in the inductive fatty liver model of high fat diet, Fructus Schisandrae Chinensis can significantly strengthen the effect for reducing fat of Monas cuspurpureus Went, when strengthening the cholesterol reducing effect, significantly strengthen the effect of triglyceride reducing, Fructus Schisandrae Chinensis can also be eliminated the burden that natural his spit of fland may be brought liver in the Monas cuspurpureus Went.
The specific embodiment
The invention will be further described below in conjunction with specific embodiment, but should not be construed as is limitation of the invention further, according to foregoing of the present invention, ordinary skill knowledge and customary means according to this area, under the prerequisite that does not break away from the above-mentioned basic fundamental thought of the present invention, the technology that modification, replacement or change realized of making other various ways all belongs to scope of the present invention.
The preparation of embodiment 1 pharmaceutical composition 1 of the present invention (ZHW-1)
Prescription is formed: Monas cuspurpureus Went 250g
Fructus Schisandrae Chinensis 250g
Method for making: Monas cuspurpureus Went 250g, pulverize the back and cross 100 mesh sieves; Fructus Schisandrae Chinensis 250g, with 5 times of amount alcohol reflux of 80% 2 times, each 2.5h, merge extractive liquid, reclaims ethanol, concentrate extractum, cross 100 mesh sieves after extract dry beaten powder; With Hongqu powder (red colouring agent) and the abundant mixing of Fructus Schisandrae Chinensis extrat, promptly get pharmaceutical composition 1 of the present invention.
The preparation of embodiment 2 pharmaceutical compositions 2 of the present invention (ZHW-2)
Prescription is formed: Monas cuspurpureus Went 500g
Fructus Schisandrae Chinensis 250g
Method for making: Monas cuspurpureus Went 500g, pulverize the back and cross 100 mesh sieves; Fructus Schisandrae Chinensis 250g, with 5 times of amount alcohol reflux of 60% 2 times, each 2.5h, merge extractive liquid, reclaims ethanol, concentrate extractum, cross 100 mesh sieves after extract dry beaten powder; With Hongqu powder (red colouring agent) and the abundant mixing of Fructus Schisandrae Chinensis extrat, promptly get pharmaceutical composition 2 of the present invention.
The preparation of embodiment 3 pharmaceutical compositions 3 of the present invention (ZHW-3)
Prescription is formed: Monas cuspurpureus Went 200g
Fructus Schisandrae Chinensis 300g
Method for making: Monas cuspurpureus Went 200g, pulverize the back and cross 100 mesh sieves; Fructus Schisandrae Chinensis 300g, with 5 times of amount alcohol reflux of 20% 2 times, each 2.5h, merge extractive liquid, reclaims ethanol, concentrate extractum, cross 100 mesh sieves after extract dry beaten powder; With Hongqu powder (red colouring agent) and the abundant mixing of Fructus Schisandrae Chinensis extrat, promptly get pharmaceutical composition 3 of the present invention.
The preparation of embodiment 4 pharmaceutical compositions 4 of the present invention
Prescription is formed: Monas cuspurpureus Went 100g
Fructus Schisandrae Chinensis 500g
Method for making is the same.
The preparation of embodiment 5 pharmaceutical compositions 5 of the present invention
Prescription is formed: Monas cuspurpureus Went 500g
Fructus Schisandrae Chinensis 100g
Method for making is the same.
The preparation of embodiment 6 pharmaceutical compositions 6 of the present invention
Prescription is formed: Monas cuspurpureus Went 500g
Fructus Schisandrae Chinensis 300g
Method for making is the same.
Below prove beneficial effect of the present invention by concrete pharmacodynamics test.
Test example 1 pharmaceutical composition of the present invention is to the experimentation of carbon tetrachloride induced mice hepatic injury
Male Kunming strain mice, 96, body weight 18~22g, be divided into 8 groups at random: normal control group, model group, ZHW-1 height of the present invention (200mg/kgd), low (100mg/kgd) dosage group, ZHW-2 (200mg/kgd) group, ZHW-3 (200mg/kgd) group, Fructus Schisandrae Chinensis extrat group (200mg/kgd) and Monas cuspurpureus Went group (200mg/kgd), 12 every group.Continuous irrigation stomach 30 days, in testing the 30th day with each treated animal fasting overnight 16 hours, model group and each administration group give carbon tetrachloride by the disposable filling stomach of the dosage of 80mg/kgBW, the normal control group gives vegetable oil, after 4 hours, last gastric infusion was put to death mice in second day.Get blood system from serum, measure glutamate pyruvate transaminase (ALT), glutamic oxaloacetic transaminase, GOT (AST), and get liver and carry out histopathology and detect, the results are shown in Table 1 and table 2.
Table 1 pharmaceutical composition of the present invention to the influence of ALT and AST (X ± s, n=12)
Figure G200710089553920070411D000051
Annotate: compare with the normal control group *P<0.05, *P<0.01, * *P<0.001; Compare with model group #P<0.05, ##P<0.01, ###P<0.001; Compare with the Fructus Schisandrae Chinensis extrat group P<0.05, ▲ ▲P<0.01; Compare with the Monas cuspurpureus Went group P<0.05, △ △P<0.01 (as follows)
Table 2 pharmaceutical composition of the present invention to the influence of mouse liver pathological change (X ± s, n=12)
Figure G200710089553920070411D000052
Table 1, table 2 result show, compare with model group, and pharmaceutical composition ZHW-1 high and low dose group of the present invention, ZHW-2, ZHW-3 and Fructus Schisandrae Chinensis extrat group all have significant reduction effect to mice ALT, the AST rising of tetrachloro-methane induction; Pharmaceutical composition ZHW-1 high and low dose group of the present invention, ZHW-2, ZHW-3 group all have the improvement effect to the change of liver balloon sample, fat-like degeneration, inflammatory cell, necrocytosis, show that pharmaceutical composition of the present invention has significant improvement effect to chemical liver injury.Simultaneously as can be seen from table 1, table 2 result, pharmaceutical composition 1 effect of the present invention obviously is better than Fructus Schisandrae Chinensis extrat group or Monas cuspurpureus Went group, especially high dose group has significant significant difference, shows in the pharmaceutical composition of the present invention that Monas cuspurpureus Went and Fructus Schisandrae Chinensis compatibility use and have synergistic function.
Test example 2 pharmaceutical compositions of the present invention are to the experimentation of the inductive hyperlipidemia fatty liver of high fat diet
90 rats are divided into general group (12) and the high fat modeling group (78) of raising, and give normal diet and fed with high respectively, continuous 4 weeks.Fasting in evening on the 28th, cut tail and get blood next day, and separation of serum is measured T-CHOL (TC), triglyceride (TG) value.The rat of 70 high fat modeling groups is by TC level divide into groups (rejecting that does not meet the requirements), be divided into model group, ZHW-1 height (200mg/kgd), low (100mg/kgd) dosage group, ZHW-2 (200mg/kgd) group, ZHW-3 (200mg/kgd) group, Fructus Schisandrae Chinensis extrat group (200mg/kgd) and Monas cuspurpureus Went group (200mg/kgd), every group 10, gastric infusion.During administration, except that blank group (the general group of raising), continue to give high lipid food, after administration, get blood the 7th week and survey TC, TG, the results are shown in Table 3.Next day, the execution animal is got fritter liver formaldehyde fixed and does histopathologic examination.
Table 3 pharmaceutical composition of the present invention to the influence of hyperlipidemia fatty liver Serum TC, TG (X ± s, n=10)
Figure G200710089553920070411D000061
Table 3 is the result show, compare with model group, pharmaceutical composition ZHW-1 high and low dose group of the present invention, ZHW-2, ZHW-3 and Monas cuspurpureus Went group have the obvious suppression effect to the rising of the inductive Serum TC of high fat diet, TG, especially pharmaceutical composition 1 high dose group of the present invention is the most remarkable to the reduction effect of TC, TG, P<0.01; Compare with the Monas cuspurpureus Went group with the Fructus Schisandrae Chinensis extrat group, the reduction effect of pharmaceutical composition of the present invention 1 couple of TC, TG is better than independent Fructus Schisandrae Chinensis extrat group and Monas cuspurpureus Went group, especially the high dose group effect is the most remarkable, P<0.01 and P<0.05 illustrates in the pharmaceutical composition of the present invention that Monas cuspurpureus Went and Fructus Schisandrae Chinensis compatibility use and have synergistic function.
The hepatic pathology check result shows, in the model group rats'liver lobule lamellar distribution hepatocyte light~degeneration of moderate intracellular edema, do not see liver cell proliferation, fibrosis.With model group relatively, the situation of each administration treated animal liver all takes a turn for the better to some extent, curative effect the best of pharmaceutical composition 1 high dose group wherein of the present invention.

Claims (9)

1. pharmaceutical composition, it is characterized in that: it is the medicament that is prepared from by the following weight proportion raw material: 10~50 parts in Monas cuspurpureus Went, 10~50 parts of Fructus Schisandrae Chinensis;
Wherein, Monas cuspurpureus Went is beaten powder; Fructus Schisandrae Chinensis is with 10%~85% alcohol reflux three times, and is extract obtained, concentrates, and drying is beaten powder; Fully mixing Hongqu powder (red colouring agent) and Fructus Schisandrae Chinensis extrat add pharmaceutically acceptable complementary composition and are prepared from.
2. pharmaceutical composition according to claim 1 is characterized in that: it is the medicament that is prepared from by the following weight proportion raw material: Monas cuspurpureus Went is that 25~40 parts, Fructus Schisandrae Chinensis are 25~40 parts.
3. pharmaceutical composition according to claim 2 is characterized in that: it is the medicament that is prepared from by the following weight proportion raw material: Monas cuspurpureus Went is that 30 parts, Fructus Schisandrae Chinensis are 30 parts.
4. according to claim 1,2 or 3 described pharmaceutical compositions, it is characterized in that: the fungus that produces Monas cuspurpureus Went is Mauve aspergillar Monacus purpureus.
5. according to claim 1,2 or 3 described pharmaceutical compositions, it is characterized in that: the fungus that produces Monas cuspurpureus Went is monascus M.anka, among the monascus M.albidus that turns white, Bark monascus M.barker, dark brown monascus M.fuliginosus, red monascus M.ruber, rust monascus M.rubiginosis, the monascus M.serorubescens that reddens any one.
6. pharmaceutical composition according to claim 5 is characterized in that: described medicine composition dosage form is tablet, capsule, pill, granule, oral liquid, injection.
7. one kind prepares the described preparation of drug combination method of claim 1, comprises the following steps:
A, take by weighing: 10~50 parts in Monas cuspurpureus Went, 10~50 parts of Fructus Schisandrae Chinensis, Monas cuspurpureus Went is beaten powder;
B, Fructus Schisandrae Chinensis are with 10%~85% alcohol reflux three times, and be extract obtained, concentrates, and drying is beaten powder;
The Hongqu powder (red colouring agent) of c, abundant mixing a step and the Fructus Schisandrae Chinensis extrat of b step add pharmaceutically acceptable complementary composition and are prepared from.
8. each described pharmaceutical composition of claim 1-3 has treatment or the medicine of improvement effect or the purposes in the health food in preparation to chemical liver injury.
9. each described pharmaceutical composition of claim 1-3 has treatment or the medicine of improvement effect or the purposes in the health food in preparation to fatty liver.
CN2007100895539A 2006-05-15 2007-03-29 Medicinal composition for treating or improving liver function, its production and use Active CN101073602B (en)

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CN117448178B (en) * 2023-10-31 2024-04-26 湖北嫦娥生物股份有限公司 Monascus purpureus CEWL and application thereof in preparation of liver protection products

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CN101549039B (en) * 2008-04-02 2012-12-19 潘思源 Application of schisandra fruit or related monomeric compound thereof for preventing or curing fatty liver
CN110170027B (en) * 2019-04-23 2021-06-29 广东健信制药股份有限公司 Hawthorn and monascus powder pills and preparation method thereof

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CN117448178B (en) * 2023-10-31 2024-04-26 湖北嫦娥生物股份有限公司 Monascus purpureus CEWL and application thereof in preparation of liver protection products

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