CN102389496B - Chinese medical composition for treating hepatitis and preparation method thereof - Google Patents
Chinese medical composition for treating hepatitis and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a Chinese medical composition for treating hepatitis and a preparation method thereof. The composition is prepared by traditional Chinese medicines according to the following parts by weight: 30-70 parts of fructus schisandrae, 20-50 parts of radix bupleuri, 8-20 parts of mahonia, 6-20 parts of medlar, 5-20 parts of angelica sinensis, 5-15 parts of salvia miltiorrhiza, 5-10 parts of liquorice and 5-10 parts of radix paeoniae alba. The Chinese medical composition is used for treating and preventing hepatitis for patients, and is reasonable in formula by adopting characteristic ethnomedicine formula theories and treatment principles, and safe and effective by using pure Chinese medicines for treating the hepatitis.
Description
Technical field
The present invention relates to field of medicaments, be specifically related to a kind of Chinese medicine composition for the treatment of hepatitis and preparation method thereof.
Background technology
China is hepatopathy country occurred frequently, and viral hepatitis, hepatic fibrosis, fatty liver, alcoholic liver pathological changes and hepatocarcinoma etc. more and more become the principal disease that threatens compatriots' health in recent years.From the data that Ministry of Public Health is announced, the incidence of hepatitis rate still keeps occupying the impetus high and that increase, and 1.2 hundred million hepatitis are suffered from colony and supported huge liver medicine market capacity.
Increase along with number of patients, hepatinica market is also in sustainable growth, annual growth rate surpasses 15% between 1999 to 2004, marketing scale had reached 28.7 hundred million yuan in 2004, estimate according to the expert, present domestic hepatinica market capacity is about 10,000,000,000 yuan, and wherein Chinese patent medicine preparation accounts for more than 20 hundred million yuan.
Yet the chemicals toxic and side effects is big, easily causes the overweight detoxifcation of liver burden, forms serious drug-induced liver disease, and Chinese medicine with many active component, safe and effective be characteristic, treating, prevent and nursing one's health ill physiological function is characteristics, and can supply to take for a long time.Therefore, develop the Chinese medicine traditional advantage, particularly national medicine is developed to preparation stabilization to it, and is quality controllable, and Chinese medicine preparation has great importance safely and effectively.
Compound Chinese medicinal preparation treatment hepatitis has following special advantages:
1, hepatoprotective, modern study prove, the effective ingredient in the Chinese medicine compound the protection hepatocyte, improve aspects such as liver function, transaminase lowering and have significant effect.
2, blood circulation promoting and blood stasis dispelling, Chinese medicine think fatty liver be by stop in the phlegm-damp, obstruction of collaterals by blood stasis, liver lose that bar reaches, lipidosis is fallen ill in liver, studies have shown that the Chinese medicine liver-care preparations can obviously improve hemorheology, has the effect of certain blood circulation promoting and blood stasis dispelling.
3, antiviral, the research of Chinese medicine antiviral receives the concern of traditional Chinese medical science educational circles always and obtains certain achievement, proves that after deliberation the Chinese medicine antiviral can not produce drug resistance, can reduce viral load gradually through taking medicine for a long time, to reach antiviral effect.
201010171271.5 1 kinds of medicines for the treatment of hepatopathy of Chinese patent application are made up of following medicaments in part by weight: 1 part of Radix Bupleuri, 4 parts of Herba Murdanniae Divergentis, 1.25 parts of Mahonia fortunei (Lindl.) Fedde, 2.25 parts of Fructus Lyciis, 1.75 parts of Fructus Schisandrae Chinensis, 1.25 parts of Radix Salviae Miltiorrhizaes, 3.5 parts of Fructus Crataegis, 2.5 parts of Semen Arecaes, 0.5 part in Radix Glycyrrhizae; Through experiment confirm, this medicine is to hepatitis B total effective rate 89%, and the hepatitis A total effective rate is 91.8%, the drug induced hepatic injury total effective rate is 86.2%, the alcoholic liver damage total effective rate is 88.6%, the spleen invigorating soothing liver-QI is arranged, promoting blood circulation and stopping pain, the function of hepatic cholagogic, wherein the antivirus action that plays of Semen Arecae is relevant with contained tannin, but a large amount of tannin can cause hypogeusia, and appetite is promoted, tooth shakes etc., and contained arecoline may cause sialorrhea, vomiting, diuresis, lethargy and convulsions etc.; Its major function of Fructus Crataegi has blood vessel dilating, heart tonifying, increase coronary flow, improves effects such as heart vigor for preventing and treating cardiovascular disease; The Herba Murdanniae Divergentis rareness of then originating.
Chinese patent application 201010159231.9 discloses a kind of Chinese medicine composition and preparation method thereof, and this Chinese medicine composition is by comprising that following components by part by weight makes: Radix Bupleuri 100-400 part, Ganoderma 50-300 part, Radix Salviae Miltiorrhizae 50-400 part, Fructus Schisandrae Chinensis 100-450 part.Chinese medicine composition of the present invention has heat-clearing and toxic substances removing, diuresis toxin expelling, the liver protecting and ALT lowering, activating blood circulation to dissipate blood stasis, invigorating spleen to remove dampness; Can recover normal liver function, thoroughly remove curative effects such as virus.Wherein Ganoderma is the medicine of price comparison costliness, has increased the cost for the treatment of hepatitis virtually.
Therefore, need provide a kind of source wide, moderate cost, and the medicine of the anti-hepatitis of determined curative effect.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine of effective treatment hepatitis, this medical instrument has the curative effect of hepatic cholagogic, the liver and the kidney tonifying, removing liver heat and toxic substances, blood circulation promoting and blood stasis dispelling, can prevent to greatest extent and the hepatic injury for the treatment of due to first, hepatitis B and other reasons, thereby improve the quality of life of hepatitis and prolong life.
Another object of the present invention is to provide a kind of preparation technology of new Chinese medicine preparation, for better active constituent-enriched, reduce dosage, after carrying, separates with macroporous resin again in this process using water, thereby more remove invalid components, active constituent-enriched, make the active constituent content of dosage form higher, reach the purpose that reduces drug dose.
A kind of Chinese medicine composition for the treatment of hepatitis provided by the invention, this Chinese medicine composition is made by following parts by weight of Chinese traditional medicine: Fructus Schisandrae Chinensis 30-70 part, Radix Bupleuri 20-50 part, Mahonia fortunei (Lindl.) Fedde 8-20 part, Fructus Lycii 6-20 part, Radix Angelicae Sinensis 5-20 part, Radix Salviae Miltiorrhizae 5-15 part, Radix Glycyrrhizae 5-10 part, Radix Paeoniae Alba 5-10 part.
Preferably, this Chinese medicine composition is made by following row parts by weight of Chinese traditional medicine: Fructus Schisandrae Chinensis 40-60 part, Radix Bupleuri 25-35 part, Mahonia fortunei (Lindl.) Fedde 8-15 part, Fructus Lycii 10-18 part, Radix Angelicae Sinensis 10-18 part, Radix Salviae Miltiorrhizae 5-10 part, Radix Glycyrrhizae 5-8 part, Radix Paeoniae Alba 5-8 part.
Further preferably, this Chinese medicine composition is made by following row parts by weight of Chinese traditional medicine: 40 parts of Fructus Schisandrae Chinensis, 30 parts of Radix Bupleuri, 10 parts of Mahonia fortunei (Lindl.) Fedde, 10 parts of Fructus Lyciis, 10 parts of Radix Angelicae Sinensis, 8 parts of Radix Salviae Miltiorrhizaes, 5 parts in Radix Glycyrrhizae, 5 parts of the Radix Paeoniae Albas.
The Chinese medicine composition for the treatment of hepatitis provided by the invention is solid or liquid preparation, and described solid preparation is sheet, capsule, granule or pill; Described liquid preparation is oral liquid or injection, and described injection is injection, injection freeze-dried powder or injectable sterile powder.
Of the present inventionly also provide a kind of method for preparing the Chinese medicine composition for the treatment of hepatitis, this method may further comprise the steps:
Get above-mentioned 8 flavor crude drug, decoct with water three times, filter medicinal liquid, upper prop absorption is left standstill the back and is carried out eluting with ethanol, collects eluent, filters and concentrates, and obtains concentrated extract, adds pharmaceutically acceptable carrier or diluent again, makes various dosage forms.
In the said method:
In decocting with water, consumption and the decocting time of water are respectively: add water 10-15 for the first time and doubly measure, add water 8-15 for the second time and doubly measure, add water 5-10 for the third time and doubly measure, decocted 1-3 hour at every turn.
Macroporous resin column in the used upper prop absorption is AB-8 or D-101 or the LSA-4 type macroporous resin of middle low pole.
The speed of described upper prop absorption is 0.5-1.5ml/min.
The concentration of alcohol of described eluting resin column is 10%-50%, and flow velocity is 0.5-1.5mL/min, and consumption of ethanol is equivalent to 3-5 times of column volume.
Concrete, preparation method provided by the invention may further comprise the steps:
1) takes by weighing medical material according to proportioning, decoct with water three times, add water 10-15 for the first time and doubly measure, decocted 2 hours; For the second time add water 8-15 and doubly measure, decocted 1.5 hours; Add water 5-10 for the third time and doubly measure, decocted 1 hour at every turn; Decoct the back three times and filter merging filtrate;
2) pre-treatment of macroporous resin: the alcoholic solution with 95% soaks macroporous resin respectively, wait to soak the dress post that abundant swelling is carried out macroporous resin later on, then still with the washing of 95% alcoholic solution, to the cleaning mixture dilute with water during no muddy phenomenon till, wash to alcohol-free flavor with sterilized water at last, standby;
3) filtrate that step 1) is obtained enters macroporous resin with the flow velocity of 0.5-1.5ml/min, left standstill then 2-5 hour, make effective ingredient fully be adsorbed onto on the macroporous resin, carry out eluting with the ethanol of 10-50% with the elution speed of 0.5-1.5mL/min then, consumption of ethanol is equivalent to 3-5 times of column volume, collects eluent, filters also to concentrate, obtain concentrated extract, and control extractum relative density is within the 1.25-1.30 scope.
4) concentrated extract is added purified water and be heated to 70-85 ℃, even with pharmaceutically acceptable carrier or mixing diluents then, make various dosage forms.
In the said method:
Described pharmaceutically acceptable carrier or diluent refer to the pharmaceutical carrier of pharmaceutical field routine, are selected from filler, binding agent, disintegrating agent, lubricant, surfactant or the correctives one or more.
Wherein:
Described filler is selected from starch, sucrose, lactose, mannitol, sorbitol, xylitol, microcrystalline Cellulose or glucose etc.;
Described binding agent is selected from cellulose derivative, alginate, starch, gelatin or polyvinylpyrrolidone etc.;
Described disintegrating agent is selected from microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose or cross-linking sodium carboxymethyl cellulose;
Described lubricant is selected from stearic acid, Polyethylene Glycol, calcium carbonate, sodium bicarbonate, micropowder silica gel, Pulvis Talci or magnesium stearate;
Described surfactant is selected from dodecylbenzene sodium sulfonate, stearic acid, polyoxyethylene-polyoxypropylene copolymer, the fatty acid Pyrusussuriensis is smooth or Polysorbate (tween) etc.;
Described correctives is selected from aspartame, Sucralose or saccharin sodium.
The present invention also provides the application of above-mentioned Chinese medicine composition in the medicine of preparation treatment hepatitis, preferably, is used for the hepatic injury due to hepatitis A, hepatitis B and other reasons.
Chinese medicine composition provided by the invention has the following advantages:
1, Fructus Schisandrae Chinensis is perennial fallen leaves liana, belongs to Magnoliacea plant, main product in Shanxi, ground such as Shaanxi, Yunnan, Sichuan.Its effective ingredient lignanoids such as schizandrin, schisantherin A has antiinflammation, can prevent hepar damnification, activates anabolic process to promote impaired hepatocellular reparation, and can strengthen the activity of DNA (DNA) synthetic and ornithine decarboxylase, the regeneration liver cell.Studies have shown that, due to illness the malicious chronic hepatitis person's (comprising A type, Type B, C type, D type and E type) who is caused is especially effective for suffering from for Fructus Schisandrae Chinensis, and a clinical experiment report of China shows that it is aspect the treatment hepatitis patient 76% success rate being arranged, without any side effect.
Radix Bupleuri is herbaceos perennial, main product in China northeast, North China, northwest, various places, East China, mainly contain saikoside, sterol, volatile oil, fatty acid and polysaccharide etc.Have multiple efficacies such as analgesic, antiinflammatory, promotion immunologic function, anti-liver injury.
Mahonia fortunei (Lindl.) Fedde is the Berberidaceae plant, and two kinds of broad-leaved and narrow leaf Mahonia fortunei (Lindl.) Fedde are arranged, and main substep is in various places, China south.Mainly contain berberine, palmatine, jateorhizine, magnoline.Effect with heat-clearing and toxic substances removing, relieving cough and resolving phlegm cures mainly diseases such as bacillary dysentery, gastroenteritis, infectious hepatitis, bronchitis, laryngopharynx swelling and pain, conjunctivitis, burn, scald.
Fructus Lycii is nutritious tonifying good merchantable brand commonly used, it contains carotene, betanin, vitamin A, vitamin B1, vitamin B2, vitamin C and calcium, phosphorus, ferrum etc., have the pharmacological action that increases the leukocyte activity, promotes hepatocyte new life, but also blood pressure lowering, blood sugar lowering, blood fat.
When being classified as herbaceos perennial, be distributed in ground such as Gansu, Yunnan, Sichuan in China, its root can be used as medicine, and is one of the most frequently used Chinese medicine, and it contains water miscible angelicin, has obvious effect at analgesia, analgesic, antiinflammatory, hepatoprotective etc.
Radix Salviae Miltiorrhizae, Radix Glycyrrhizae, the Radix Paeoniae Alba be at invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, promotes reparation and the regeneration of hepatic tissue, improves aspect such as liver microcirculation and all have significant effect.
Above-mentioned all medicines share, and utilize original prescription theory and the Therapeutic Principle of name family's medicine, and reasonable formula is with the hepatic injury due to pure oral preparation of Chinese traditional medicinal treatment first, hepatitis B and other reasons, safety, effective.
2, compared with prior art, the used prescription of the present invention forms under the Dai nationality's uniqueness " sickly separate earlier, first solution then control " theoretical direction, and medical material tunnel, technology are easy, determined curative effect, have no side effect, and has national tradition medicine characteristic simultaneously.
In addition, the present invention has increased the macroporous resin extraction technology on the basis of common extraction process by water, it is more to solve in the prior art invalid components content, need escalated dose just can have the problem of curative effect, and invalid components may have side effects to human body.This technology is active constituent-enriched greatly, and technology is simple, workable.
3, compositions pharmacological research premenstruum provided by the invention proves: cause in complex factors and have the liver protecting and ALT lowering, effect of anti hepatic fibrosis in the rat liver fibrosis model, composition effect provided by the invention is better than similar positive control drug; The immunity acute liver damage experimental results show that it also has therapeutical effect preferably to immunologic liver injury.
So 4, the present invention's extraction process is to be based upon on the basis of effective ingredient physicochemical property, the principle of employing similar compatibility is extracted concentrated, can be farthest active constituent-enriched, and the extraction ratio height.
The specific embodiment
Following examples are used for explanation the present invention, but are not used for limiting the scope of the invention.
Embodiment 1: the capsule for the treatment of hepatitis
1, gets material by following prescription: Fructus Schisandrae Chinensis 400g, Radix Bupleuri 300g, Mahonia fortunei (Lindl.) Fedde 100g, Fructus Lycii 100g, Radix Angelicae Sinensis 100g, Radix Salviae Miltiorrhizae 80g, Radix Glycyrrhizae 50g and Radix Paeoniae Alba 50g.
2, preparation technology:
1) above-mentioned 8 medical materials are cleaned after, clean up with drinking water, standby;
2) above-mentioned clean medical material is decocted with water three times, add 12L water for the first time, decocted 2 hours; For the second time add 10L water, decocted 1.5 hours; Add 8L water for the third time, decocted 1 hour; Filter the back merging filtrate;
3) pre-treatment of macroporous resin: the alcoholic solution with 95% soaks AB-8 type macroporous resin respectively, wait to soak the dress post that abundant swelling is carried out macroporous resin later on, then still with the washing of 95% alcoholic solution, to the cleaning mixture dilute with water during no muddy phenomenon till, wash to alcohol-free flavor with sterilized water at last, standby.
4) step 2) gained filtrate enters AB-8 type macroporous resin with the flow velocity of 0.8ml/min, left standstill then 3 hours, make effective ingredient fully be adsorbed onto on the macroporous resin, carry out eluting with 30% ethanol of 3 times of column volumes with the elution speed of 0.75mL/min then, collect effluent, filter and concentrate, obtain concentrated extract, and control extractum relative density is standby in the 1.25-1.30 scope.
5) concentrated extract of step 4) gained is added purified water and be heated to 70 ℃-85 ℃, add an amount of supplementary product starch then and put in the spray-drying pelleting machine, carry out wet granulation; the granule pulverizing of sieving with system; magnesium stearate is added crushing rear material, insert capsule after fully mixing, namely get capsule.
Embodiment 2: tablet or the granule for the treatment of hepatitis
1, gets material by following prescription: Fructus Schisandrae Chinensis 600g, Radix Bupleuri 350g, Mahonia fortunei (Lindl.) Fedde 150g, Fructus Lycii 150g, Radix Angelicae Sinensis 150g, Radix Salviae Miltiorrhizae 100g, Radix Glycyrrhizae 80g, Radix Paeoniae Alba 80g.
2, preparation technology:
1) above-mentioned 8 medical materials are cleaned after, clean up with drinking water, standby.
2) above-mentioned clean medical material is decocted with water three times, add 14L water for the first time, decocted 2 hours; For the second time add 12L water, decocted 1.5 hours; Add 8L water for the third time, decocted 1 hour; Filter the back merging filtrate.
3) pre-treatment of macroporous resin: the alcoholic solution with 95% soaks AB-8 type macroporous resin respectively, wait to soak the dress post that abundant swelling is carried out macroporous resin later on, then still with the washing of 95% alcoholic solution, to the cleaning mixture dilute with water during no muddy phenomenon till, wash to alcohol-free flavor with sterilized water at last, standby.
4) with step 2) gained filtrate enters AB-8 type macroporous resin with the flow velocity of 1ml/min, left standstill then 4 hours, make effective ingredient fully be adsorbed onto on the macroporous resin, carry out eluting with 5 times 40% ethanol that is equivalent to column volume with the elution speed of 1mL/min then, collect effluent, filter and concentrate, obtain concentrated extract, and control extractum relative density is standby in the 1.25-1.30 scope.
5) concentrated extract of step 4) gained is added purified water and be heated to 70 ℃-85 ℃; in spray-drying pelleting machine, add an amount of supplementary product starch, carboxymethyl starch sodium then; carry out wet granulation; the sieve pulverizing, drying, granulate of the granule of system sieved; then magnesium stearate is added the back material that sieves; namely get granule after fully mixing, perhaps carry out tabletting, coating again and namely get tablet.
Embodiment 3: the Chinese medicine oral liquid for the treatment of hepatitis
1, gets material by following prescription: Fructus Schisandrae Chinensis 500g, Radix Bupleuri 300g, Mahonia fortunei (Lindl.) Fedde 120g, Fructus Lycii 120g, Radix Angelicae Sinensis 120g, Radix Salviae Miltiorrhizae 80g, Radix Glycyrrhizae 60g, Radix Paeoniae Alba 60g.
2, preparation technology:
1) above-mentioned 8 medical materials are cleaned after, clean up with drinking water, standby.
2) above-mentioned clean medical material is decocted with water three times, add 12L water for the first time, decocted 2 hours; For the second time add 10L water, decocted 1.5 hours; Add 8L water for the third time, decocted 1 hour; Filter the back merging filtrate.
3) pre-treatment of macroporous resin: the alcoholic solution with 95% soaks AB-8 type macroporous resin respectively, wait to soak the dress post that abundant swelling is carried out macroporous resin later on, then still with the washing of 95% alcoholic solution, to the cleaning mixture dilute with water during no muddy phenomenon till, wash to alcohol-free flavor with sterilized water at last, standby.
4) with step 2) gained filtrate enters AB-8 type macroporous resin with the flow velocity of 0.8ml/min, left standstill then 3.5 hours, make effective ingredient fully be adsorbed onto on the macroporous resin, carry out eluting with the ethanol of 750ml30% with the elution speed of 0.8mL/min then, collect effluent, filter and concentrate, obtain concentrated extract, and control extractum relative density is standby in the 1.25-1.30 scope.
(5) extractum with the step 4) gained adds an amount of sucrose, sodium benzoate, stirs then, filters, and adds water to ormal weight, namely gets oral liquid.
Embodiment 4: the Chinese medicine pellet agent for the treatment of hepatitis
1, gets material by following prescription: Fructus Schisandrae Chinensis 300g, Radix Bupleuri 200g, Mahonia fortunei (Lindl.) Fedde 80g, Fructus Lycii 60g, Radix Angelicae Sinensis 50g, Radix Salviae Miltiorrhizae 50g, Radix Glycyrrhizae 50g, Radix Paeoniae Alba 50g.
2, preparation technology:
1) above-mentioned 8 medical materials are cleaned after, clean up with drinking water, standby.
2) above-mentioned clean medical material is decocted with water three times, add 12L water for the first time, decocted 2 hours; For the second time add 10L water, decocted 1.5 hours; Add 8L water for the third time, decocted 1 hour; Filter the back merging filtrate.
3) pre-treatment of macroporous resin: the alcoholic solution with 95% soaks AB-8 type macroporous resin respectively, wait to soak the dress post that abundant swelling is carried out macroporous resin later on, then still with the washing of 95% alcoholic solution, to the cleaning mixture dilute with water during no muddy phenomenon till, wash to alcohol-free flavor with sterilized water at last, standby.
4) with step 2) gained filtrate enters AB-8 type macroporous resin with the flow velocity of 0.8ml/min, left standstill then 3.5 hours, make effective ingredient fully be adsorbed onto on the macroporous resin, carry out eluting with the ethanol of 750ml30% with the elution speed of 0.8mL/min then, collect effluent, filter and concentrate, obtain concentrated extract, and control extractum relative density is standby in the 1.25-1.30 scope.
5) with the extract dry of step 4) gained, pulverizing and cross 60 mesh sieves, add an amount of starch, with 60% polyvinylpyrrolidone soft material processed, the soft material of making micropill mechanism ball, wet feed pushed the 0.8mm sieve aperture, and the wet grain of strip cuts off round as a ball, 50 ℃ of drying and mouldings, cross 20 mesh sieves, select ball, namely get pellet.
The present invention's all adjuvants in the process of the process for preparing and patent medicine are pharmaceutic adjuvant, be filler commonly used as starch, magnesium stearate is lubricant commonly used, polyvinylpyrrolidone is common binding agent, and the present invention is prepared in strict accordance with the rule of operation of Chinese medicine production, so the Chinese medicine preparation of the present invention's preparation has certain medical value.
In order to prove the present invention in the curative effect aspect the treatment hepatitis disease, by following zoopery report explanation.
Experimental example: effect experiment
1, experiment material
1.1 laboratory animal: healthy Wistar rat, male and female half and half.
1.2 experimental drug and reagent
The medicines of embodiment of the invention 1-4 and positive controls 1,2 preparations, drugmaker provides by rich former Tushan, Bangbu;
Test used test kit from Shanghai Vaccine and Serum Institute, other reagent are homemade analytical reagent.
2, experimental technique
2.1 experiment grouping: get 100 healthy rats, male and female half and half, after adaptability fed for 1 week, be divided into normal group, the modeling group, embodiment 1 low dosage administration group, dosed administration group among the embodiment 1, embodiment 1 high dose administration group, 2 groups of embodiment, 3 groups of embodiment, 4 groups of embodiment, 1 group of (prescription Radix Bupleuri 1 of 201010171271.5 of positive control, Herba Murdanniae Divergentis 4, Mahonia fortunei (Lindl.) Fedde 1.25, Fructus Lycii 2.25, Fructus Schisandrae Chinensis 1.75, Radix Salviae Miltiorrhizae 1.25, Fructus Crataegi 3.5, Semen Arecae 2.5, Radix Glycyrrhizae 0.5), 2 groups of positive controls (201010159231.9 optimizing prescriptions, namely Radix Bupleuri is 300 parts, 152 parts of Ganodermas, 300 parts of Radix Salviae Miltiorrhizaes, 300 parts of Fructus Schisandrae Chinensis), 10 every group.
Prepared capsule, with its with adult 5,10,30 times of recommended dose be mixed with low (20mg/kg), in (40mg/kg), high (100mg/kg) dosage group, the medicine of embodiment 2-4 is according to the gastric infusion of 40mg/kg, and positive control 1,2 groups are also according to the 40mg/kg administration.
2.2 modeling:
This test adds lipopolysaccharide (LPS) to the immunologic liver injury model with rat intravenous injection bacillus calmette-guerin vaccine (BCG), its pathological change is similar to hepatitis B with hepatic injury mechanism, because BCG at first activates sensitized T lymphocyte, especially Kupffer cell and macrophage in the sensitization liver, be gathered in liver in a large number, inject the macrophage of the laggard one-step activation sensitization of LPS again, impel it to discharge a large amount of cytokines, cause hepatocellular damage as carbon monoxide, tumor necrosis factor etc.
According to above principle, after the rat adaptability is raised several days, the BCG of tail vein injection various dose, the LPS of tail vein injection various dose after 12 days, set up rat immunity liver damage model, got tissues such as blood, liver spleen after the modeling in 10-16 hour, with indexs such as rat liver function and hepatopathy inspections of science as judge index, foundation can tentatively be judged BCG 1 * 10 near the sick pathogenetic liver damage animal model of clinical hepatitis according to the survival condition of organ index, enzyme work and rat
7Individual viable count, 5 * 10
6The dosage of the dosage of individual viable count and LPS 10 μ g be set up this model than suitable dose.
3.3 test method
In the time of modeling, model group is irritated a certain amount of normal saline of stomach every day.All the other each dosage groups are by the dosage gastric infusion of setting, administration every day 1 time, continuous 2 months.Weigh behind the last administration 24h, win the biochemical indicator amount that the eye socket blood sampling detects total serum protein (TP), albumin (A1b), alanine aminotransferase (ALT), aspartate transaminase (AST).
Simultaneously, the liver of rat is cut into slices, and show the result by HE dyeing.
3, statistical procedures: all experimental datas adopt SPSS 16.0 statistical softwares to handle, with
Carry out the t significance test.
4, result:
4.1 the influence to the rats'liver function the results are shown in Table 1
Table 1: to the influence of test rat blood serum index (
N=12)
| Group | TP(g/L) | A1b(g/L) | ALT(U/L) | AST(U/L) |
| Normal group | 69.49±2.45 | 44.73±3.01 | 32.11±5.68 | 60.75±7.34 |
| The modeling group | 60.43±3.12 * | 39.56±2.58 * | 54.25±4.37 * | 100.13±7.75 * |
| Embodiment 1 low dose group | 64.45±2.23 | 42.46±2.45 | 38.54±4.85 #※☆ | 80.81±7.75 #※☆ |
| Dosage group among the embodiment 1 | 68.22±1.34 #※☆ | 43.53±2.40 #※☆ | 35.25±3.96 #※☆ | 65.62±8.08 #※☆ |
| Embodiment 1 high dose group | 69.32±2.01 #※☆ | 44.58±2.87 #※☆ | 32.33±3.72 #※☆ | 61.34±5.32 #※☆ |
| 2 groups of embodiment | 66.97±1.98 #※☆ | 44.38±1.89 #※☆ | 34.11±4.03 #※☆ | 64.59±8.05 #※☆ |
| 3 groups of embodiment | 67.35±2.01 #※☆ | 44.05±1.98 #※☆ | 34.59±2.89 #※☆ | 66.43±7.64 #※☆ |
| 4 groups of embodiment | 68.57±2.98 #※☆ | 43.46±2.32 #※☆ | 35.57±2.86 #※☆ | 65.34±4.73 #※☆ |
| Positive controls 1 | 62.47±1.87 | 39.86±2.97 | 39.10±3.98 | 81.74±6.99 |
| Positive controls 2 | 61.32±1.91 | 39.97±2.65 | 40.01±3.43 | 82.03±6.58 |
Annotate: compare with normal group,
*P＜0.05; Compare with model group
#P＜0.05,
##P＜0.01,
###P＜0.001; Compare for 1 group with positive control,
※P＜0.05; Compare for 2 groups with positive control,
☆P＜0.05.
Table 1 result shows:
Compare with matched group: serum index testing result shows that modeling group rats'liver damage is impaired, shows as obviously descend (P＜0.05), ALT, AST content of serum T P, A1b content and obviously raises (P＜0.05), illustrate that modeling successfully.
Compare with model group: serum T P, the A1b content of dosage group among the embodiment 1, high dose group, embodiment 2-4 group obviously raise (P＜0.05), ALT, AST content obviously descend (P＜0.05);
Compare for 2 groups with 1 group of positive control and positive control respectively, embodiment 1 low dose group is to the repair similar (p＞0.05) of rats'liver damage, but middle and high dosage group to the repair of rats'liver damage apparently higher than positive drug group (P＜0.05).
4.2 the present invention is the pathological section of rat after deliberation, confirms that compositions provided by the invention causes in complex factors and has the liver protecting and ALT lowering, effect of anti hepatic fibrosis in the rat liver fibrosis model.
5, discuss: hepatic injury is the complex process that is caused by several factors, bacillus calmette-guerin vaccine (BCG) adds lipopolysaccharide (LPS) to the immunologic liver injury model, its pathological change is similar to hepatitis B with hepatic injury mechanism, can cause proliferation of fibrous tissue, cause hepatic fibrosis, cell interior ALT, AST are overflowed, thereby the content of ALT, AST increase in the blood.
Serological index shows and the present invention to make the Chinese medicine preparation agent of anti-hepatitis damage has the certain protection effect to rats'liver, and along with the increasing of dosage, ALT, AST, TP, A1b almost return to normal level in the cell, and effect obviously is better than similar positive drug.
In addition, by the pathological section result demonstration of rat, the hepatic injury that positive drug group and test group are treated due to various hepatitis and other reasons has certain curative effect, but the effect of the pathological section of test group treatment hepatic injury obviously is better than positive drug again.
6, conclusion: Chinese medicine composition provided by the invention, the effect with treatment hepatitis B.
In addition, hepatitis such as general hepatitis A, hepatitis B all are because a variety of causes is encroached on liver as virus, chemical toxicant etc., hepatocyte is suffered damage, cause hepatic fibrosis or hepatocellular degeneration, necrosis etc., above-mentioned pharmacodynamics test is verified, and this Chinese medicine preparation has good effect at aspects such as anti-hepatic fibrosis and the liver protecting and ALT lowering, illustrates also that therefore this Chinese medicine preparation has certain effect in the various types of hepatitis for the treatment of.
Though, above used general explanation, the specific embodiment and test, the present invention is described in detail, on basis of the present invention, can make some modifications or improvement to it, and this will be apparent to those skilled in the art.Therefore, these modifications or improvements all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (10)
1. a Chinese medicine composition for the treatment of hepatitis is characterized in that, said composition is made by following parts by weight of Chinese traditional medicine: Fructus Schisandrae Chinensis 30-70 part, Radix Bupleuri 20-50 part, Mahonia fortunei (Lindl.) Fedde 8-20 part, Fructus Lycii 6-20 part, Radix Angelicae Sinensis 5-20 part, Radix Salviae Miltiorrhizae 5-15 part, Radix Glycyrrhizae 5-10 part, Radix Paeoniae Alba 5-10 part.
2. Chinese medicine composition according to claim 1 is characterized in that, said composition is made by following parts by weight of Chinese traditional medicine: Fructus Schisandrae Chinensis 40-60 part, Radix Bupleuri 25-35 part, Mahonia fortunei (Lindl.) Fedde 8-15 part, Fructus Lycii 10-18 part, Radix Angelicae Sinensis 10-18 part, Radix Salviae Miltiorrhizae 5-10 part, Radix Glycyrrhizae 5-8 part and Radix Paeoniae Alba 5-8 part.
3. Chinese medicine composition according to claim 1 is characterized in that, this Chinese medicine composition is made by following parts by weight of Chinese traditional medicine: 40 parts of Fructus Schisandrae Chinensis, 30 parts of Radix Bupleuri, 10 parts of Mahonia fortunei (Lindl.) Fedde, 10 parts of Fructus Lyciis, 10 parts of Radix Angelicae Sinensis, 8 parts of Radix Salviae Miltiorrhizaes, 5 parts in Radix Glycyrrhizae, 5 parts of the Radix Paeoniae Albas.
4. each described Chinese medicine composition of claim 1-3 is characterized in that, this Chinese medicine composition is solid preparation or liquid preparation, and described solid preparation is sheet, capsule, granule or pill; Described liquid preparation is oral liquid or injection, and described injection is injection.
5. method for preparing each described Chinese medicine composition of claim 1-4, it is characterized in that this method may further comprise the steps: get above-mentioned 8 flavor crude drug, decoct with water three times, filter medicinal liquid, upper prop absorption is left standstill the back and is carried out eluting with ethanol, collects eluent, filter and concentrate, obtain concentrated extract, add pharmaceutically acceptable carrier or diluent again, make various dosage forms.
6. method according to claim 5 is characterized in that, decocts with water in three times, adds water 10-15 for the first time and doubly measures, and adds water 8-15 for the second time and doubly measures, and adds water 5-10 for the third time and doubly measures, and decocts 1-3 hour at every turn.
7. method according to claim 5 is characterized in that, the macroporous resin that uses in the described upper prop absorption is AB-8 or the D-101 type macroporous resin of middle low pole.
8. method according to claim 5 is characterized in that, the speed of described medicinal liquid upper prop is 0.5-1.5ml/min.
9. method according to claim 5 is characterized in that, described concentration of alcohol is 10%-50%, and flow velocity is 0.5-1.5mL/min, and consumption of ethanol is equivalent to 3-5 times of column volume.
10. the application of each described Chinese medicine composition of claim 1-4 in the medicine of preparation treatment hepatitis.
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| CN104435710A (en) * | 2014-11-26 | 2015-03-25 | 黑龙江省智诚医药科技有限公司 | Traditional Chinese medicine dispersible tablet capable of soothing liver and strengthening spleen, and preparation method of dispersible tablet |
| CN104996862A (en) * | 2015-06-17 | 2015-10-28 | 蚌埠市天星树脂有限责任公司 | Resin for active compound extraction for hepatitis alleviating medicine and preparation method of resin |
| CN113398209B (en) * | 2021-06-28 | 2022-04-12 | 宁夏医科大学 | Compound traditional Chinese medicine for intervening hepatic fibrosis as well as preparation method and application thereof |
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| CN101829274A (en) * | 2010-05-13 | 2010-09-15 | 西双版纳傣族自治州民族医药研究所 | Medicament for treating liver disease |
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