CN1899415A - Chinese medicine compound preparation for treating chronic hepatic disease and its preparing method - Google Patents
Chinese medicine compound preparation for treating chronic hepatic disease and its preparing method Download PDFInfo
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Abstract
The present invention relates to belongs to the field of Chinese medicine technology, relates to compound Chinese medicine preparation for treating chronic hepatosis, and is especially compound Chinese medicine preparation for treating hepatitis and hepatic fibrosis and its preparation process. The compound Chinese medicine preparation is prepared with red sage, fermented aweto powder, peach kernel, pine pollen, gynostemma pentaphylla, schisandra extract and medicinal supplementary material, and may be in different orally taken preparation forms. The compound Chinese medicine preparation has high effect of preventing and treating hepatic fibrosis and treating hepatitis and no obvious toxic side effect.
Description
Technical field
The invention belongs to field of traditional Chinese medicine pharmacy.Relate to a kind of compound Chinese medicinal preparation for the treatment of chronic hepatopathy and preparation method thereof.Relate in particular to a kind of compound Chinese medicinal preparation for the treatment of hepatitis and hepatic fibrosis and preparation method thereof.
Background technology
Hepatic fibrosis be various chronic hepatopathys as: chronic hepatitis B, alcoholic liver disease, fatty liver etc. must be through approach to the liver cirrhosis development, it forms with development is to influence the key that chronic hepatopathy is healed the back, lapsed to, and also is one of two hang-ups (etiological treatment and anti-hepatic fibrosis) the most thorny in the chronic hepatopathy clinical treatment.Show that according to the relevent statistics China chronic HBV infection person reaches 1.5 hundred million people, wherein the chronic viral hepatitis B patient is about 3,000 ten thousand people.The harm of chronic hepatitis is known by everybody, and the one, infect other people, the 2nd, can the secondary hepatic fibrosis.According to observations, hepatic fibrosis accounts for 65% in the slight hepatitis B patient, in, severe patient then 100% has hepatic fibrosis, wherein the chronic hepatitis patient more than 30% finally can develop into liver cirrhosis.In addition, China's Patients with Fatty Liver has accounted for 10% of population, and wherein the overweight people accounts for 50%, and alcoholic accounts for 57.5%; Along with growth in the living standard, the alcoholic liver sickness rate has the trend of rising.No matter alcoholic liver or fatty liver, the hepatic fibrosis incidence rate is up to 25%, and wherein 1.5%～8% patient can develop into liver cirrhosis.
Hepatic fibrosis is a body to the initiative reparation reaction of chronic injury, with the liver cell epimatrix (extracellular matrix, ECM) hypertrophy be deposited as feature, show as fibrosis in sinus hepaticus blood capillaryization and the lobules of liver on the form.Nearly all chronic hepatopathy, comprise that chronic type b/hepatitis C virus, chronic schistosomiasis, chronic ethanol and drug induced injury, autoimmune liver disease etc. all have this pathological change, further developing of hepatic fibrosis, promptly form liver cirrhosis, hypofunction of liver and portal hypertension etc. occur, have a strong impact on patient health and life.Modern medicine study shows, and hepatic stellate cell (hepatic stellate cell, HSC) activation is the cytology basis that hepatic fibrosis forms, liver ECM metabolic imbalances such as collagen, to generate greater than degraded be its biochemical basis.Think that hepatic fibrosis is reversible, liver cirrhosis to a certain degree also is reversible.Therefore, anti-hepatic fibrosis is not only very important, also is practicable.
Prior art (Chinese patent: 99113887.2), adopt the capsule preparations of salviamiltiorrhizabung, Semen Persicae, Cordyceps mycelium etc. that chronic hepatitis Bhepatic fibrosis is had good effect of anti hepatic fibrosis, but described capsule, remain in shortcomings and deficiencies, as: dosage form is single, moisture absorption easily, the capsule material has certain zest etc. to gastrointestinal, has influenced the stable and performance of drug effect.
Summary of the invention
The objective of the invention is shortcomings and deficiencies, a kind of compound Chinese medicinal preparation for the treatment of chronic hepatopathy is provided at prior art.Provide specifically that a kind of what treat chronic hepatitis and/or hepatic fibrosis is the compound preparation that component is made by the Chinese crude drug extract.
Another object of the present invention provides the preparation method of described compound preparation.
Compound preparation of the present invention is an effective ingredient by the Chinese medicine extract of following weight percentage ratio proportioning, adds adjuvant and makes various dosage forms:
Radix Salviae Miltiorrhizae extract 25～55%, Herb Gynostemmae Pentaphylli extract 12～40%, schisandrol extract 5-12%,
Cordyceps mycelium extract 12～30%, Pollen Pini extract 6-12%, Semen Persicae extract 5-30%,
Surplus is adjuvant.
Preferred weight percent is:
Radix Salviae Miltiorrhizae extract 38% Herb Gynostemmae Pentaphylli total glycosides 25% Chinese Magnoliavine Fruit alcohol extract 6%
Cordyceps mycelium 19% Pollen Pini extract 6% Semen Persicae extract 6%.
Compound preparation of the present invention prepares by following method: take by weighing Radix Salviae Miltiorrhizae, Semen Persicae, Herb Gynostemmae Pentaphylli by the set of dispense ratio and decoct with water, collecting decoction is got supernatant, be condensed into extractum, cooling adds ethanol (make contain alcohol amount reach 70%), sufficient standing filters, and gets filtrate and concentrates also dry; Other takes by weighing fermented Cordyceps powder, and Fructus Schisandrae Chinensis adds alcohol heat reflux, and cooling merges ethanol liquid, filters the filtrate concentrate drying; Other takes by weighing Pollen Pini and adds the ethanol warm macerating, merges leachate, and concentrate drying becomes dried cream, gets above-mentioned three kinds of dried cream, mixes and pulverizes, and adds starch, mixing, preparation compound preparation.
Compound preparation of the present invention is made tablet, capsule, granule, dispersible tablet, slow releasing tablet, drop pill and/or oral liquid.
Said medicine compound preparation wherein each active component prepares by following method:
1. Radix Salviae Miltiorrhizae extract
Get red rooted salvia, be ground into graininess, add 12 times of water gagings, 95 ℃ ± 2 extract secondary, merge extractive liquid, concentrates standby, after testing: the water-soluble composition of Radix Salviae Miltiorrhizae is received based on salvianolic acid B, danshensu, and medicinal residues add 70% alcohol heat reflux secondary, each 1 hour, merge extractive liquid, concentrates standby, after testing, fat soluble ingredient of red sage root merges the concentrated solution drying for standby based on TANSHINONES.
Radix Salviae Miltiorrhizae extract is a monarch drug in this pharmaceutical formulation.
2. Herb Gynostemmae Pentaphylli extract
After the Herb Gynostemmae Pentaphylli medical material adopted 75% soak with ethanol, high frequency ultrasound was extracted 3 times and is got Herb Gynostemmae Pentaphylli extract, and after testing, wherein main component is a total saponins.Herb Gynostemmae Pentaphylli extract is the main centralizing function that rises in this pharmaceutical formulation.
3. Chinese Magnoliavine Fruit alcohol extract
Get schisandra raw material and add 80% alcohol reflux secondary, extracting solution is pulverized through reclaiming the ethanol after drying, gets fine powder, and after testing, lignanoid's composition in the Fructus Schisandrae Chinensis belongs to cyclohexyl biphenyl octene type lignanoid composition, based on schisandrin.The present invention adopts the extraction rate reached 0.3%～2.0% of 80% alcohol reflux schisandrin.And adopt general preparation process to be difficult for proposing, thereby influence the quality and the clinical efficacy of medicine.
4. Cordyceps mycelium extract
Get the Cordyceps mycelium raw material and add 75% ethanol Wen Tisan time, merge extractive liquid, reclaims ethanol, the extracting solution drying for standby, and wherein main component is an adenosine, is one of quality control standard composition of the present invention.
5. Pollen Pini lipid extract
Adopt 70% alcohol reflux heat to extract Pollen Pini, extracting solution reclaims ethanol, and extract dry is standby, and wherein main component is the lipid flavone component, and this compounds has bigger dissolubility in ethanol.
6. Semen Persicae extract
Its effective ingredient of Chinese medicine Semen Persicae is a water soluble ingredient, and the present invention adopts the decocting method, Semen Persicae is added 10 times of water gagings decoct secondary, and extracting solution is concentrated into extractum, and extract dry is standby.
The above-mentioned extractum that respectively extracts adopts methods such as drying under reduced pressure, spray drying to carry out drying.
Adopt the HPLC method to measure, contain salvianolic acid B in the above-mentioned Radix Salviae Miltiorrhizae extract, reach 2.5～10%; Fructus Schisandrae Chinensis extrat contains schisandrin, reaches 0.3～2.0%; The Cordyceps mycelium extract contains adenosine, reaches 0.1～5.0%; Adopt colorimetric method for determining, Herb Gynostemmae Pentaphylli extract contains total saponins, reaches 0.5～8.0%.
Each component of said ratio is extracted extract dry product, pulverize separately, mix homogeneously adds an amount of adjuvant, and mix homogeneously is granulated, drying, tabletting, coating is made tablet.
Each component of said ratio is extracted extract dry product, pulverize separately, mix homogeneously adds an amount of adjuvant, and mix homogeneously incapsulates.Make capsule.
Each component of said ratio is extracted extract dry product, add an amount of adjuvant, drying is granulated.Make granule.
Each component of said ratio is extracted extract dry product, pulverize separately, proportionally mix homogeneously adds an amount of adjuvant, granulates drying, tabletting.Make dispersible tablet.
Each component of said ratio is extracted extract dry product, pulverize separately, proportionally mix homogeneously adds an amount of adjuvant, granulates drying, tabletting.Make slow releasing tablet.
Each component of said ratio is extracted extract dry product, pulverize separately, proportionally mix homogeneously adds proper amount of solvent and adjuvant, and heating makes and is molten condition, adopts dropping preparation method to make into drop pill.
Each component of said ratio is extracted extract dry product, add the dissolving of 1/3 water gaging, add appropriate amount of auxiliary materials, add water to capacity, filter packing.Make oral liquid.
The used quality of medicinal material of the present invention meets Pharmacopoeia of the People's Republic of China version pertinent regulations in 2005.Wherein: 1, Semen Persicae is the dry mature seed of rosaceous plant [Prunus Persica (L.) Batsch] or mountain peach [Prunus davidiana (Carr.) Franch].
2, Radix Salviae Miltiorrhizae is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae [Salvia miltiorrhiza Bge.].
3, Fructus Schisandrae Chinensis is Magnoliacea plant [Schisandra chinensis (Turcz.) Baill] or yellow angledtwig magnoliavine fruit [Schisandra Sphenanthera Rehd.et Wits] dry mature fruit.
4, Herb Gynostemmae Pentaphylli is the dry aerial parts of cucurbitaceous plant [Gynostemma Pentaphyllam (Thunb) mak.].
5, fermented Cordyceps powder, system produces Cordyceps-peacilomyce hepiahi element [Paccilomyces hepiali Chen] Cs-4 separating obtained the fresh Cordyceps [Cordyceps Sinensis (Berk Sacc)] and cultivates through submerged fermentation, the tunning filtration drying is made from Qinghai.Jiangxi Traditional Chinese Medicine Factory produces.
6, Pollen Pini belongs to the dry pollens of several plants together for pinaceae plant Pinus massoniana Lamb [Pinus massoniana Lamb.] Pinus tabuliformis [Pinus tabulaeformisCarr].
The present invention adopts the Chinese medicine drug extract to substitute crude drug, and adopting preparation technique to make tablet or other dosage forms, the present invention (claims: supporting vital QI and dispersing blood stasis square preparation I group) (claim: the effect efficacy trial that supporting vital QI and dispersing blood stasis square preparation II group) has carried out anti-hepatic fibrosis drug effect and anti-hepatic tissue peroxide injury thereof with the prior art capsule preparations.The result shows that drug effect further improves.The present invention is that the compound preparation that component is made has blood circulation promoting and blood stasis dispelling by the Chinese crude drug extract, beneficial intensive culture liver function, and treatment hepatitis B and hepatic fibrosis effect obviously improve.
Description of drawings:
1. Fig. 1, CCl
4Hepatic fibrosis rats model hepatic tissue HE dyeing is respectively normal group, model control group, supporting vital QI and dispersing blood stasis square preparation I group, supporting vital QI and dispersing blood stasis square preparation II group and vitamin E group,
Hepatic tissue HE dyeing among the figure, normal group lobules of liver clear in structure, hepatocyte does not have degeneration necrosis;
Model group hepatic tissue hepatic necrosis and a large amount of cloudy swelling degeneration, portal area broadening, inflammatory cells such as the visible mononuclear cell in portal area and necrotic area are invaded profit, the lobules of liver structure disturbance;
Be clearly better after supporting vital QI and dispersing blood stasis square preparation and the vitamin E intervention.Fig. 2, CCl
4The scarlet collagen staining of hepatic fibrosis rats model hepatic tissue sky wolf is respectively normal group, model control group, supporting vital QI and dispersing blood stasis square preparation I group, supporting vital QI and dispersing blood stasis square preparation II group and vitamin E group.
A small amount of collagen fiber are seen in the scarlet dyeing of hepatic tissue sky wolf among the figure, normal group hepatic tissue only portal area and central vein;
Model group hepatic tissue collagen hypertrophy is obvious, along hepatocellular degeneration punishment cloth, forms the fibrous septum;
Be clearly better after supporting vital QI and dispersing blood stasis square preparation and the vitamin E intervention.
Fig. 3, CCl
4Hepatic fibrosis rats model hepatic tissue HE dyeing is respectively normal group, model control group, supporting vital QI and dispersing blood stasis square preparation I group, supporting vital QI and dispersing blood stasis square preparation II group and vitamin E group.
Fig. 4, CCl
4The scarlet collagen staining of hepatic fibrosis rats model hepatic tissue sky wolf is respectively normal group, model control group, supporting vital QI and dispersing blood stasis square preparation I group, supporting vital QI and dispersing blood stasis square preparation II group and vitamin E group,
A small amount of collagen fiber are seen in the scarlet dyeing of hepatic tissue sky wolf among the figure, normal group hepatic tissue only portal area and central vein;
Model group hepatic tissue collagen hypertrophy is obvious, along hepatocellular degeneration punishment cloth, forms the fibrous septum;
Be clearly better after supporting vital QI and dispersing blood stasis square preparation and the vitamin E intervention.
The specific embodiment
Embodiment 1
Each is extracted extract dry product, and pulverize separately according to the formula proportion mix homogeneously, adds the adjuvant mix homogeneously, granulates drying, tabletting, coating according to a conventional method.Described principal agent, adjuvant are according to following proportioning: mix extract powder 60.0%～80.0%, amylum pregelatinisatum 15.0%～20.0%, microcrystalline Cellulose 3.0%～10.0%, carboxymethyl starch sodium 2.0%～10.0%, magnesium stearate 0.1%～0.4%.
Embodiment 2
Each is extracted extract dry product, and pulverize separately according to the formula proportion mix homogeneously, adds the adjuvant mix homogeneously, prepares capsule according to a conventional method.Described principal agent, adjuvant are according to following proportioning: mix extract powder 65%～85%, and microcrystalline Cellulose 0%～35%, calcium carbonate 0%～5%, mix homogeneously incapsulates.
Each is extracted extract dry product, pulverize separately, the proportionally mixed back that contains adds the granulation of adjuvant dextrin.Described principal agent, adjuvant are according to following proportioning: mix extract powder 60%～90%, dextrin 40%～10% is granulated behind the mix homogeneously according to a conventional method, 60～65 ℃ of dryings, and granulate, promptly.
Embodiment 4
Each is extracted extractum, and pulverize separately according to the formula proportion mix homogeneously, adds the adjuvant disintegrating agent and granulates or direct compression.Described principal agent and disintegrating agent are according to following proportioning: mix extract powder 10%～25%, and carboxymethyl starch sodium 5%～80%, guar gum 0%～20%, Herba Xanthii glue 0%～25%, sodium alginate 0%～20% is granulated or direct compression.
Embodiment 5
Each is extracted extractum, and pulverize separately according to the formula proportion mix homogeneously, adds the adjuvant film-making.Described principal agent and adjuvant are according to following proportioning: mix extract powder 30%～50%, citric acid 2%～10%, hydroxypropyl emthylcellulose 50%～60%, magnesium stearate 0.3%～1.0% will be mixed extract powder and hydroxypropyl emthylcellulose mixing, citric acid is dissolved in makes soft material in the ethanol, granulate drying, granulate, add the magnesium stearate mixing, tabletting promptly.
Embodiment 6
Each is extracted extractum, and pulverize separately according to the formula proportion mix homogeneously, adds adjuvant and makes drop pill according to a conventional method.Described principal agent and adjuvant are according to following proportioning: mix extract powder 8% ~ 15%, polyethylene glycol 6000 accounts for 11% ~ 85%, and Polysorbate 0.0 ~ 1.0%, above material are heated to about 150 ℃ and are fused into solution in oil bath.Drip about 85 ℃ of system temperature, about 20 ~ 35 ball of speed/minute, do condensed fluid with dimethicone.
Embodiment 7
Each is extracted extract dry product, add the dissolving of 1/3 water gaging, add appropriate amount of auxiliary materials, prepare oral liquid according to a conventional method.Described adjuvant is selected from correctives stevioside 0.2～1.0%, the solubilizing agent Tween 80, and addition is 0.5～2.0%, adds water to capacity, filters packing.
Embodiment 8 pharmacological actions experiment
(1) to the preventive effect of hepatic fibrosis
Pharmacological model: adopt CCl
4Subcutaneous injection and the inductive rat liver fibrosis model of high fat low protein diet complex factors model.First with 100%CCl
4Solution 1ml/kg body weight, thereafter with 40%CCl
4Olive oil solution 3ml/kg body weight subcutaneous injection, 2 times weekly, totally 2 weeks.Give high fat low albumen feedstuff (79.5% Semen Maydis powder, 20% Adeps Sus domestica, 0.5% cholesterol) in 1-2 week, then give pure Semen Maydis powder, totally 6 weeks.
Model grouping and administration: be divided into normal group, model control group, supporting vital QI and dispersing blood stasis square preparation I group, supporting vital QI and dispersing blood stasis square preparation II group and totally 5 groups of vitamin E groups.Supporting vital QI and dispersing blood stasis square preparation I group and II group from the modeling with supporting vital QI and dispersing blood stasis side's gastric infusion of 4.6g/kg rat body weight dosage, the vitamin E group is given from the modeling and the dosage gastric infusion of 50mg/kg rat body weight (be equivalent to 65kg body weight adult etc. 10 times of amounts of body weight), all every day 1 time.
Drug action: the hepatic tissue pathology inspection shows, after the prevention of supporting vital QI and dispersing blood stasis square preparation I, II group, can obviously alleviate the rat model liver tissues inflammatory, alleviates the hepatic tissue collagen deposition.Carry out fibrosis according to the known references method and judge and statistical analysis by stages, the result shows that supporting vital QI and dispersing blood stasis square preparation I, II group obviously alleviates liver tissue fibrosis by stages with the vitamin E group, and wherein the effect of supporting vital QI and dispersing blood stasis square preparation I group is better.Table 1 is that the different preparation prophylactics in supporting vital QI and dispersing blood stasis side are to CCl
4The influence by stages of hepatic fibrosis rats hepatic fibrosis.
Serum and hepatic tissue biochemical analysis show, supporting vital QI and dispersing blood stasis square preparation I, II all obviously improve rat model serum liver function, significantly alleviate rat model hepatic tissue collagen (hydroxyproline) content, and significantly reduce the rat model hepatic tissue and reduce triacylglycerol and mda content, improve superoxide dismutase (superoxidedismutase, SOD) activity, compare no significant difference with vitamin E, have good anti-liver tissue fibrosis and lipid peroxidation.Wherein preparation I group reduces the effect of Serum ALT levels, reduction hepatic tissue collagen (hydroxyproline) content, reduction hepatic tissue triacylglycerol and mda content, obviously is better than the Formulation II group, and table 2 is that the different preparation prophylactics in supporting vital QI and dispersing blood stasis side are to CCl
4The influence of hepatic fibrosis rats liver function (x ± s).Table 3 is that the different preparation prophylactics in supporting vital QI and dispersing blood stasis side are to CCl
4The influence of hepatic fibrosis rats hepatic tissue hydroxyproline, triacylglycerol and mda content, SOD activity level (x ± s).
The different preparation prophylactics in table 1. supporting vital QI and dispersing blood stasis side are to CCl
4The influence (gauge outfit preferably has) by stages of hepatic fibrosis rats hepatic fibrosis
| Group | n | S0 | S1 | S2 | S3 | S4 | R |
| 2 groups of vitamin E groups of 1 group of preparation of normal group | 10 14 13 12 14 | 10 0 0 0 0 | 0 0 7 5 6 | 0 3 5 5 6 | 0 9 1 2 2 | 0 2 0 0 0 | 0.079 0.819 * 0.457 # 0.516 # 0.506 # |
Annotate: the Ridit check,
*Compare with normal group P＜0.01;
#Compare with model group P＜0.01.
The different preparation prophylactics in table 2. supporting vital QI and dispersing blood stasis side are to CCl
4The influence of hepatic fibrosis rats liver function (x ± s)
| Group | n | ALT (U/L) | AST (U/L) | T.BIL (μmol/L) | Total protein (g/L) | Alb (g/L) |
| 2 groups of vitamin E groups of 1 group of preparation of normal group | 10 14 13 12 13 | 37.7±13.2 182.1±67.5 * 104.3±41.8 #，△ 140.6±34 # 106.4±45.9 # | 101.4±15.0 190.1±55.0 164.6±25.9 169.5±29.0 127.7±37.2 | 11.3±2.7 18.9±6.1 * 13.6±4.1 # 14.9±3.2 # 14.1±3.3 # | 55.3±3.9 55.2±2.0 53.4±3.3 51.2±2.6 55.8±4.2 | 29.3±1.1 26.1±1.3 27.1±1.7 27.0±2.1 27.7±1.1 |
Annotate:
*Compare with normal group P＜0.05;
#Compare with model group P＜0.05;
△Compare for 2 groups with preparation P＜0.05.
The different preparation prophylactics in table 3. supporting vital QI and dispersing blood stasis side are to CCl
4The influence of hepatic fibrosis rats hepatic tissue hydroxyproline, triacylglycerol and mda content, SOD activity level (x ± s)
| Group | n | Hydroxyproline (μ g/g liver) | Triacylglycerol (μ g/g liver) | Malonaldehyde (μ mol/g albumen) | SOD (NU/g liver) |
| 2 groups of vitamin E groups of 1 group of preparation of normal group | 10 14 13 12 13 | 239.7±39.9 408.1±63.2 * 264.1532.5 #，△ 306.9±48.5 # 296.2±49.8 # | 6.1±0.8 15.1±2.6 * 10.5±3.1 #，△ 12.9±2.1 # 12.6±3.7 # | 5.7±1.4 21.5±5.7 * 7.8±1.5 #，△ 11.3±2.8 # 4.5±1.3 # | 852.5±58.5 716.7±158.5 * 872.9±116.7 # 852.5±69 # 1062±83 # |
Annotate:
*Compare with normal group P＜0.05;
#Compare with model group P＜0.05;
△Compare for 2 groups with preparation P＜0.05.
(2) to N-nitrosodimethylamine (dimethylnitrosamine, DMN) therapeutical effect of Liver Fibrosis Model
Pharmacological model: adopt the inductive rat liver fibrosis model of DMN lumbar injection.The i.e. dosage lumbar injection of 1 μ g DMN/kg rat body weight, every day 1 time, weekly for three days on end, totally 4 weeks.
Model grouping and administration: (N-acetylcysteine, NAC) group is established normal group, totally 5 groups in addition to be divided into model control group, supporting vital QI and dispersing blood stasis square preparation I group, supporting vital QI and dispersing blood stasis square preparation II group and acetylcysteine behind the Cheng Mo.Supporting vital QI and dispersing blood stasis square preparation I group is organized the supporting vital QI and dispersing blood stasis side's gastric infusion with 4.6g/kg rat body weight dosage from the 5th week with II, the acetylcysteine group is from giving in the 5th week and the dosage gastric infusion of 100mg/kg rat body weight (be equivalent to 65kg body weight adult etc. 10 times of amounts of body weight), equal every day 1 time.
Drug action: the hepatic tissue pathology inspection shows, after supporting vital QI and dispersing blood stasis square preparation I, the II treatment, obviously alleviates the rat model liver tissues inflammatory, alleviates the collagen deposition of hepatic tissue; And obviously alleviate liver tissue fibrosis by stages, do not have significant difference with the acetylcysteine group, wherein preparation I group effect is good.
Table 4 is that the different preparation for treating in supporting vital QI and dispersing blood stasis side are to the influence by stages of DMN hepatic fibrosis rats hepatic fibrosis.
Serum and hepatic tissue biochemical analysis are found, supporting vital QI and dispersing blood stasis square preparation I, II all significantly reduce the rat model serum ALT activities, to a certain degree reduce serum total bilirubin and improve the serum albumin level, significantly alleviate rat model hepatic tissue collagen (hydroxyproline) content, and improve rat model hepatic tissue superoxide dismutase (SOD) activity, have good curing experimental rat fibrosis effect.Relatively, effects such as reduction hepatic tissue collagen (hydroxyproline) content of preparation I group and SOD activity improving all obviously are better than the Formulation II group between the 2 kinds of preparation groups in supporting vital QI and dispersing blood stasis side.
Table 5 is the different preparation for treating in supporting vital QI and dispersing blood stasis side to the influence of DMN hepatic fibrosis rats liver function (x ± s).
Table 6 is the different preparation for treating in supporting vital QI and dispersing blood stasis side to DMN hepatic fibrosis rats hepatic tissue hydroxyproline content and the active influence of SOD (x ± s).
The different preparation for treating in table 4. supporting vital QI and dispersing blood stasis side are to the influence of DMN hepatic fibrosis rats liver function (x ± s)
| Group | n | S0 | S1 | S2 | S3 | S4 | R |
| 2 groups of NAC groups of 1 group of preparation of normal group model group preparation | 7 7 8 8 12 | 7 0 0 0 0 | 0 0 1 1 1 | 0 1 5 3 5 | 0 2 1 3 4 | 0 4 1 1 2 | 0.083 0.772 * 0.364# 0.436# 0.415# |
Annotate: the Ridit check,
*Compare with normal group P＜0.05;
#Compare with model group P＜0.05.
The different preparation for treating in table 5. supporting vital QI and dispersing blood stasis side are to DMN hepatic fibrosis rats hepatic tissue hydroxyproline content and the active influence of SOD (x ± s)
| Group | n | ALT (U/L) | AST (U/L) | T.BIL (μmol/L) | Total protein (U/L) | Alb (U/L) |
| 2 groups of NAC groups of 1 group of preparation of normal group model group preparation | 7 7 8 8 10 | 33.1±11.4 101.6±22.2 * 78.8±14.3 # 80.2±11.8 # 67.7±36.1 # | 54.9±18.2 95.9±22.2 87.8±10.7 85.8±12.2 76.5±25.5 | 15.5±1.2 17.1±3.2 16.6±1.5 16.9±3.2 18.8±2.8 | 60.1±16.9 52.4±10.9 54.4±10.5 54.1±12.5 60.4±11.21 | 32.4±1.7 24.7±1.9 * 29.1±4.8# 28.3±4.4 30.9±5.5 # |
Annotate:
*Compare with normal group P＜0.05; Compare with model group #P＜0.05.
The different preparation for treating in table 6. supporting vital QI and dispersing blood stasis side are to DMN hepatic fibrosis rats hepatic tissue hydroxyproline content and the active influence of SOD (x ± s)
| Group | n | Hydroxyproline (μ g/g liver) | SOD(10 3* NU/g albumen) |
| 2 groups of NAC groups of 1 group of preparation of normal group model group preparation | 7 7 8 8 10 | 225.7±20.6 614.6±100.3 * 434.7±38.4 #，△ 485.9±151.2 # 482.1±124.4 # | 237.2±43.4 181.8±21.2 * 286.8±25.7 #，△ 258.5±51.2 # 252.2±47.6 # |
Annotate:
*Compare with normal group P＜0.05; Compare with model group #P＜0.05.
△Compare for 2 groups with preparation P＜0.05.
The present invention is compound preparation and old preparation of known technology and the comparative study of chemicals drug effect that component is made by the Chinese crude drug extract, the result confirms, compound preparation of the present invention has preferable prevention and the effect for the treatment of hepatic fibrosis, has clear superiority aspect anti-experimental character rat liver fibrosis and the anti-liver fat peroxide injury.
Claims (6)
1, a kind of compound Chinese medicinal preparation for the treatment of chronic hepatopathy is characterized in that the Chinese medicine extract by following weight percentage ratio proportioning is an effective ingredient, adds adjuvant and makes,
Radix Salviae Miltiorrhizae extract 25～55%, Herb Gynostemmae Pentaphylli extract 12～40%, schisandrol extract 5-12%, Cordyceps mycelium extract 12～30%, Pollen Pini extract 6-12%, Semen Persicae extract 5-30%, surplus is adjuvant.
2, by the compound Chinese medicinal preparation of the described treatment chronic hepatopathy of claim 1, it is characterized in that the percentage by weight of described effective ingredient is:
Radix Salviae Miltiorrhizae extract 38% Herb Gynostemmae Pentaphylli total glycosides 25% Chinese Magnoliavine Fruit alcohol extract 6%
Cordyceps mycelium 19% Pollen Pini extract 6% Semen Persicae extract 6%.
3, by the compound Chinese medicinal preparation of claim 1 or 2 described treatment chronic hepatopathys, it is characterized in that containing in the described Radix Salviae Miltiorrhizae extract salvianolic acid B 2.5～10%; Contain schisandrin 0.3～2.0% in the Fructus Schisandrae Chinensis extrat; Contain adenosine 0.1～5.0% in the Cordyceps mycelium extract; Contain total saponins 0.5～8.0% in the Herb Gynostemmae Pentaphylli extract.
4, the preparation method of the compound Chinese medicinal preparation of the described treatment chronic hepatopathy of claim 1, it is characterized in that by following step: take by weighing Radix Salviae Miltiorrhizae, Semen Persicae, Herb Gynostemmae Pentaphylli by the set of dispense ratio and decoct with water, collecting decoction is got supernatant, is condensed into extractum, cooling, add ethanol, make to contain alcohol amount and reach 70%, leave standstill, filter, get filtrate and concentrate also dry; Other takes by weighing fermented Cordyceps powder, and Fructus Schisandrae Chinensis adds alcohol heat reflux, and cooling merges ethanol liquid, filters the filtrate concentrate drying; Other takes by weighing Pollen Pini ethanol warm macerating, merges leachate, and concentrate drying becomes dried cream, gets above-mentioned three kinds of dried cream, mixes and pulverizes, and adds starch, mixing, preparation compound preparation.
5, by the compound preparation of claim 1 or 2, its dosage form is tablet, capsule, granule, dispersible tablet, slow releasing tablet, drop pill or oral liquid.
6, by the compound Chinese medicinal preparation of the described treatment chronic hepatopathy of claim 1, wherein said chronic hepatopathy is chronic hepatitis and/or hepatic fibrosis.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008134932A1 (en) * | 2007-04-29 | 2008-11-13 | Shanghai Sundise Chinese Medicine Technology Development Co., Ltd. | Use of a vegetable drug composition in the manufacturing of a pharmaceutical preparation for the treatment of portal hypertension caused by hepatocirrhosis |
| CN103191173A (en) * | 2013-04-01 | 2013-07-10 | 上海现代中医药股份有限公司 | Five-ingredient botanical composition for treating hepatic fibrosis and preparation method thereof |
| CN103191189A (en) * | 2013-04-01 | 2013-07-10 | 上海现代中医药股份有限公司 | Five-ingredient botanical composition for treating hepatic fibrosis and preparation method thereof |
| CN116966222A (en) * | 2023-07-07 | 2023-10-31 | 哈尔滨珍宝制药有限公司 | Traditional Chinese medicine composition for treating liver fibrosis as well as preparation and application thereof |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1069542C (en) * | 1999-07-19 | 2001-08-15 | 上海中医药大学 | Medicine for treating chronic hepatism and its preparing process |
| CN1247229C (en) * | 2003-06-04 | 2006-03-29 | 上海中医药大学 | Chinese medicinal preparation for improving kidney fibrosis and its production |
| CN100394946C (en) * | 2004-12-17 | 2008-06-18 | 上海中医药大学 | Traditional Chinese medicine formulation for improving pulmonary fibrosis |
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- 2006-07-25 CN CN2006101067201A patent/CN1899415B/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008134932A1 (en) * | 2007-04-29 | 2008-11-13 | Shanghai Sundise Chinese Medicine Technology Development Co., Ltd. | Use of a vegetable drug composition in the manufacturing of a pharmaceutical preparation for the treatment of portal hypertension caused by hepatocirrhosis |
| US9161959B2 (en) | 2007-04-29 | 2015-10-20 | Shanghai Sundise Chinese Medicine Technology Development Co., Ltd | Use of a vegetable drug composition in the manufacturing of pharmaceutical preparation for the treatment of portal hypertension caused by hepatocirrhosis |
| CN103191173A (en) * | 2013-04-01 | 2013-07-10 | 上海现代中医药股份有限公司 | Five-ingredient botanical composition for treating hepatic fibrosis and preparation method thereof |
| CN103191189A (en) * | 2013-04-01 | 2013-07-10 | 上海现代中医药股份有限公司 | Five-ingredient botanical composition for treating hepatic fibrosis and preparation method thereof |
| CN116966222A (en) * | 2023-07-07 | 2023-10-31 | 哈尔滨珍宝制药有限公司 | Traditional Chinese medicine composition for treating liver fibrosis as well as preparation and application thereof |
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