CN101214288B - Traditional Chinese medicinal composition for treating hepatitis and its preparation - Google Patents
Traditional Chinese medicinal composition for treating hepatitis and its preparation Download PDFInfo
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- CN101214288B CN101214288B CN2008100556360A CN200810055636A CN101214288B CN 101214288 B CN101214288 B CN 101214288B CN 2008100556360 A CN2008100556360 A CN 2008100556360A CN 200810055636 A CN200810055636 A CN 200810055636A CN 101214288 B CN101214288 B CN 101214288B
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Abstract
The present invention discloses a Chinese medicine compound for curing hepatic disease and a preparation method thereof. The Chinese medicine compound is made from according to milk veteh, kudzuvine root, Chinese thorowax, ganoderma, red paeonia, turtle shell, salvia miltiorrhiza, gynura segetum, canton love-pea vine and leafflower according to a certain weight portion. The present invention can be made into any common dosage form. The medicine compound provided by the present invention has the efficacy of replenishing qi and relieving liver-qi, invigorating blood circulation and softening hard masses, which is used to cure hepatitis, hepatic fibrosis, hepatocirrhosis and other hepatic diseases.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition that is used for the treatment of hepatopathy and preparation method thereof, belong to the field of Chinese medicines.
Background technology
Chronic hepatitis is meant the liver chronic inflammation disease of the course of disease more than half a year.Hepatic fibrosis is meant fibrous connective tissue's paraplasm in the liver, is mostly the persistence hepatic injury or exists to urge due to the fibrosis stimulating factor.Liver cirrhosis is that chronic, the progressive diffusivity of the liver due to a variety of causes changes, and early stage liver cirrhosis means does not have any specific symptom or sign clinically, liver function test Non Apparent Abnormality, but existing tangible pathological change on liver histological.Chronic viral hepatitis B is the main hazard factor of hepatic fibrosis, liver cirrhosis, hepatocarcinoma, liver failure; Slight hepatic fibrosis is called the fiber liver, when weight person has formed with the pseudolobuli of regenerated nodule, then is liver cirrhosis.
Chronic hepatitis still lacks specific Therapeutic Method at present.Any medicine all never shows its curative effect to the definite of chronic viral hepatitis, therefore still carrying out various test of cure at present, its medicine divides three classes substantially: 1. antiviral drugs: comprise interferon, cytosine arabinoside, phosphoric acid arabinose born of the same parents, acycloguanosine etc., and wherein comparatively sure with efficacy of interferon therapy.2. immunomodulator: anti-hepatis B immunoglobulin, Hepatitis B virus vaccine, transfer factor, immune ribonucleic acid, bacillus calmette-guerin vaccine, immunosuppressant, thymosin, polyporusum bellatus etc., wherein comparatively effective with immune ribonucleic acid.3. improve the medicine of hepatocyte function: as inosine, vitamins, hepatocyte growth-promoting factors etc.
Hepatic fibrosis is the common pathologic basis that Different types of etiopathogenises develops into liver cirrhosis, and the treatment of fibrosis is intended to alleviate Fibrotic degree, delays its development, and even reverses its pathology process.The treatment of fibrosis mainly comprises for this reason: 1. at virulence factor, and treatment protopathy.As hepatitis virus resisting, treatment schistosomicide, control alcoholism etc.; 2. the treatment of development anti-hepatic fibrosis is taken place; 3. as be developed to liver cirrhosis, then need its complication is prevented and treated; 4. the treatment of suiting the medicine to the illness and recovering liver function.
Hepatic tissue is reconstructed by outgrowth fibrous tissue during liver cirrhosis, is difficult for recovering normal fully from morphosis, but because liver has powerful compensatory capacity, as long as treatment in time often makes disease be in metastable state, can keeps quite over a long time.This but continue to carry out as pathological changes, develop into late period, liver failure, patient Ke Yin hepatic coma and death.And at present the medicine of early stage liver cirrhosis progressive stage mainly contains colchicine, prostaglandin E (PGE), interferon (Interferon), penicillamine, Malotilate (Malotile) etc., but doctor trained in Western medicine still lacks specific method and medicine to its treatment both at home and abroad.
At present in above-mentioned each medicine of the liver disease that is applied to, most medicines all do not obtain the clinical effectiveness of expecting in clinical practice, owing to the limitation of Western medicine anti-hepatic fibrosis, liver cirrhosis, chronic hepatitis, and have toxic and side effects mostly.Since new China sets up, use motherland's therapeutic treatment chronic hepatopathy very great development has been arranged, the study on prevention of Chinese medicine anti-hepatic fibrosis, liver cirrhosis, chronic hepatitis more and more comes into one's own, and clinical and scientific research discovers that the Chinese medicine hepatopathy especially demonstrates certain advantage in the controlling symptoms aspect.
China is one " hepatopathy big country ", though after implementing the hepatitis B immune plan, the hepatitis B morbidity is necessarily controlled, but fall ill about 1,400,000 at present every year on average, occupy the 3rd of Notifiable disease, about 1.2 hundred million people carry hepatitis B virus or its antigen in China, and about 20% can develop into chronic hepatitis in hepatitis B patient, and chronic viral hepatitis B is the main hazard factor of liver cirrhosis, hepatocarcinoma, liver failure, and hepatic fibrosis then is the only stage which must be passed bies of various chronic hepatopathys to the liver cirrhosis development.Therefore, developing safe and effective medicine comes hepatopathy is controlled and treatment is very important.
Summary of the invention
The object of the present invention is to provide a kind of new Chinese medicine composition, said composition has that QI invigorating is soothing the liver, the function of movable blood soft hard, is used for the treatment of chronic hepatitis, hepatic fibrosis, early stage liver cirrhosis.
Of the present invention in addition-individual purpose is to provide the preparation method of above-mentioned Chinese medicine composition.
The 3rd purpose of the present invention is to provide the application of above-mentioned Chinese medicine composition in the medicine of preparation treatment chronic hepatitis, hepatic fibrosis, early stage liver cirrhosis.
The present invention is achieved by the following technical solutions:
The present invention is made by the raw material of following weight parts: Radix Astragali 1-30 part, Radix Puerariae 1-20 part, Radix Bupleuri 1-20 part, Ganoderma 1-10 part, Radix Paeoniae Rubra 1-20 part, Carapax Trionycis 1-20 part, Radix Salviae Miltiorrhizae 1-20 part, Radix Notoginseng 1-10 part, Herba Abri 1-20 part, Cacumen Securinegae Suffruticosae 1-30 part.
Preferred weight portion is: Radix Astragali 5-15 part, Radix Puerariae 1-10 part, Radix Bupleuri 1-10 part, Ganoderma 1-6 part, Radix Paeoniae Rubra 1-10 part, Carapax Trionycis 1-10 part, Radix Salviae Miltiorrhizae 1-10 part, Radix Notoginseng 1-6 part, Herba Abri 1-10 part, Cacumen Securinegae Suffruticosae 5-15 part.
The preparation method of Chinese medicine composition of the present invention is as follows:
Described bulk drugs is added water or Different concentrations of alcohol extraction respectively, the extracting solution concentrate drying gets crude extract, or directly pulverizing obtains medicinal powder, or employing process for purification, for example, decoction and alcohol sedimentation technique, organic solvent extractionprocess, column chromatography, carbon dioxide supercritical extraction method, steam distillation are made with extra care and are obtained extract; Required various conventional adjuvant when above-mentioned crude extract or medicinal powder or extract are added the preparation different dosage form, as diluent, disintegrating agent, excipient, binding agent, lubricant, surfactant, filler, antiseptic, stabilizing agent, correctives, thickening agent, fluidizer etc., method of Chinese medicinal with routine is prepared into any common formulations, as tablet, dispersible tablet, effervescent tablet, oral cavity disintegration tablet, buccal tablet, chewable tablet, capsule, soft capsule, microcapsule, granule, pill, powder, drop pill, slow releasing preparation, controlled release preparation, oral liquid, injection etc.
The preferred for preparation method of Chinese medicine composition of the present invention is as follows:
With Carapax Trionycis, Ganoderma water extraction; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng Different concentrations of alcohol are extracted decompression recycling ethanol; Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae water extraction; Merging filtrate concentrates, and drying is ground into fine powder, adds adjuvant, makes any medicament on the pharmaceutics.
The most preferably preparation method of Chinese medicine composition of the present invention is as follows:
Carapax Trionycis, Ganoderma are added 8 times of water gagings extract 3 times, each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng add 8 times of amount 70% ethanol extractions 3 times, and each 1 hour, filter, merging filtrate, 60 ℃ of decompression recycling ethanols, standby; Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 8 times of water gagings and extract each 1 hour 3 times, filter, filtrate and aforementioned two kinds of extracting solution merge, and being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), be ground into fine powder, add an amount of dextrin, evenly mixed, adding the 5%PVPK30 alcoholic solution is wetting agent, granulates, drying makes granule.
Each drug mechanism is as follows among the present invention:
The Radix Astragali: temperature, sweet, return lung, spleen channel, have the effect of invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.Modern study shows, the Radix Astragali has the liver protecting, prevents the effect that hepatic glycogen reduces, and astragalus polysaccharides has the effect that promotes liver cell regeneration, and the clinical powder that utilizes is directly taken treatment hepatosplenomegaly and the inversion of hepatopathy serum albumin ratio etc.
Radix Puerariae: cool in nature, sweet in the mouth, suffering.Having induces sweat brings down a fever, and promotes the production of body fluid rash, the effect of yang invigorating antidiarrheal.Radix Puerariae isoflavone-containing composition puerarin, puerarin xyloside, daidzein, daidzin and cupreol, arachidic acid contain volume starch (content is 19-20% in the fresh Radix Puerariae) again.The flavone compound that Radix Puerariae is rich in can be removed-OH effectively, suppresses erythrocyte membrane, the oxidative damage of liver, spleen, cerebral tissue.Experiment in vitro shows, Radix Puerariae isoflavone 10-1000mg/g can obviously suppress the rising of lipid peroxidation product (LPO) malonaldehyde that Mouse Liver, nephridial tissue and White Rabbit brain tissue homogenate cause under the vibration temperature conditions, and is dose-effect relationship.Radix Puerariae can make the liver that mainly engulfs carbon granules, the carbon granules capture functions of spleen strengthen, and makes the recovery of cellular immunity functional response.Radix Puerariae helps liver to be had dispelling toxicity, detoxicating and the impaired hepatocellular effect of reparation is arranged.Pharmacological evaluation shows that Radix Puerariae has preventive effect to rat liver fibrosis.
Radix Bupleuri: nature and flavor are bitter cool, have evacuate bring down a fever, dispersing the stagnated live-QI to relieve the stagnation of QI, liter recover hepatocellular homergy and blood supply, promotes the reparation of damage and the effect of hepatocyte sun act gas.Clinically, except traditional treatment Liver depression and Qi stagnation.Also be used to treat various hepatic disease in the modern times, as liver cirrhosis.From the modern pharmacology angle, acetylcholine has the effect of regulating digestive system and nervous function, and acetylcholine can be by the acetylcholine esterase hydrolysis.Saikoside can suppress acetylcholine esterase, and the choline-like effect is intended in performance, and then to digestive system and nervous system performance regulating action, thereby the treatment liver depression. play the effect of dispersing the stagnated live-QI to relieve the stagnation of QI.Hepatic stellate cell (HSC) claims fat-storing cell (FSC) again, and under some pathological state, FSC activation and propagation and synthetic collagen and extracellular matrix (ECM) form hepatic fibrosis thereby collagen and ECM are excessively accumulated.Experimental results show that in the recent period: Radix Bupleuri can directly suppress HSC secretion collagen protein, suppress FSC activation and propagation, and then the ability of the synthetic ECM of inhibition FSC, but also can stablize the liver plasma membrane system effectively, in and the depression effect of soluble cell factor pair hepatocyte growth, prevent hepatocyte injury and necrosis.Radix Bupleuri can suppress the apoptosis of mouse liver cell, to CCI
4, D one aminogalactose and lipopolysaccharide and bacillus calmette-guerin vaccine cause the mice chronic hepatic injury that significant restoration and protection effect is arranged.
Ganoderma: flat, sweet.GUIXIN, lung, liver, kidney channel.Function with invigorating QI and tranquilization, relieving cough and asthma.Studies show that Ganoderma and compound preparation thereof have in various degree blood fat reducing and the effect of liver ester to laboratory animal, and protection hepatic injury effect is arranged; But Ganoderma single blood fat reducing reduces the liver index, alleviates the liver fat degeneration; Antagonism prevents its steatosis and cell infiltration by the hepatic injury that CCl4 causes.
Radix Paeoniae Rubra: hardship, be slightly cold, return Liver Channel.Effect with clearing away heat and cooling blood, eliminating stasis to stop pain.Modern study shows that Radix Paeoniae Rubra has stronger direct repression to hepatitis B virus DNA P, can reduce erythrocyte aggregation, improves liver microcirculation, recover hepatocellular homergy and blood supply, effects such as the reparation of promotion damage and liver cell regeneration.
Carapax Trionycis: nourishing YIN for suppressing the hyperactive YANG, hard masses softening and resolving effect are arranged.Hepatic fibrosis has significant protective effect to rat experiment to studies show that Carapax Trionycis, and early stage application can prevent or delay the formation and development of hepatic fibrosis.
Radix Salviae Miltiorrhizae: be slightly cold, hardship, GUIXIN, Liver Channel have stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, a function of the relieving restlessness that clears away heart-fire.Studies show that Radix Salviae Miltiorrhizae has significant protective effect to the liver ischemia reperfusion injury; hepatic injury has significant protective effect to rat acute; salvianolic acid B-magnesium salt has the effect of Chinese People's Anti-Japanese Military and Political College's Mus D-galactosamine hepatic injury; Radix Salviae Miltiorrhizae Injection has certain influence to isolated rat perfusion liver and portal vein blood vessel, to CCl
4The isolated rat perfusion liver of damage has protective effect, can effectively postpone and alleviate behind the ischemia effect of the irreversible hepatic injury that perfusion causes again, the effect that promotes liver regeneration is arranged; Rats'liver is partly excised the synthetic cell division propagation that reaches of back liver dna obvious facilitation is arranged; Experimental cirrhosis there is preventive and therapeutic effect; The re-absorbed effect of the liver fiber of promotion is arranged; Chronic active patient liver function is improved significantly; Heavy dose of Radix Salviae Miltiorrhizae has the curative effect of anti-hepatic fibrosis preferably; Oral red sage formulation can make the crowd who has been exposed to stronger hepatocarcinoma risk factor obtain to a certain degree effects such as protection.
Radix Notoginseng: sweet and slightly bitter taste, warm in nature, return liver, stomach warp.Has the dissipating blood stasis hemostasis, the effect of subduing swelling and relieving pain.Pharmacological evaluation shows that Radix Notoginseng has the certain protection effect to hepatocyte injury, and can obviously suppress fibroblast and collagen fiber hypertrophy in the hepatic tissue, is the medicine of comparatively ideal control hepatic fibrosis.
Herba Abri: sweet, hardship, cool in nature.Return liver, stomach warp.Function with heat-clearing and toxic substances removing, Shugan Zhitong is used for the treatment of that jaundice, side of body rib are not relaxed, gastral cavilty distending pain, acute, chronic hepatitis, mastitis.The clinical acute icterohepatitis that is used for the treatment of is to CCl
4Due to acute liver damage the certain protection effect is arranged.
Cacumen Securinegae Suffruticosae: little hardship, sweet, cold.Have clearing away heat and promoting diuresis, make eye bright, the effect of removing food stagnancy.Pharmacological evaluation proves that the Cacumen Securinegae Suffruticosae sheet has inhibitory action to hepatitis B virus, has the protection hepatocyte and improves the cellular immunity function.
The present invention is foundation with the theory of Chinese medical science, adopts the above-mentioned active drug composition prescription that cooperatively interacts, when research and compiling successive dynasties tradition name side speciality, and the clinical proved recipe that forms in conjunction with the achievement of modern scientific research.Various result of the tests show that it is definite effect aspect treatment hepatopathy illness, shows that its active drug component cooperates in order.Medicine of the present invention has that QI invigorating is soothing the liver, the effect of movable blood soft hard, be used for the treatment of chronic hepatitis, hepatic fibrosis, the insufficiency of the spleen stagnation of liver-QI of early stage liver cirrhosis, qi and blood stagnation card, disease sees that side of body rib twinge or distending pain, inappetence, distension and fullness in the abdomen, loose stool, spiritlessness and weakness, dim complexion, tongue are dark, thin fur, stringy pulse.
Below, foregoing of the present invention is described in further detail by the specific embodiment:
The specific embodiment
Embodiment 1:
Radix Astragali 20g, Radix Puerariae 15g, Radix Bupleuri 15g, Ganoderma 8g, Radix Paeoniae Rubra 15g, Carapax Trionycis 15g, Radix Salviae Miltiorrhizae 15g, Radix Notoginseng 8g, Herba Abri 15g, Cacumen Securinegae Suffruticosae 20g
Carapax Trionycis, Ganoderma are added 8 times of water gagings extract 3 times, each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng add 8 times of amount 70% ethanol extractions 3 times, and each 1 hour, filter, merging filtrate, 60 ℃ of decompression recycling ethanols, standby; Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 8 times of water gagings and extract each 1 hour 3 times, filter, filtrate and aforementioned two kinds of extracting solution merge, and being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), be ground into fine powder, add an amount of dextrin, evenly mixed, adding 60% alcoholic solution is wetting agent, granulates, drying promptly gets granule.
Embodiment 2:
Radix Astragali 20g, Radix Puerariae 6g, Radix Bupleuri 6g, Ganoderma 5g, Radix Paeoniae Rubra 6g, Carapax Trionycis 6g, Radix Salviae Miltiorrhizae 10g, Radix Notoginseng 5g, Herba Abri 6g, Cacumen Securinegae Suffruticosae 20g
Carapax Trionycis, Ganoderma are added 8 times of amount 70% ethanol extractions 3 times, each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng, Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 8 times of amount 70% ethanol extractions 3 times, and each 1 hour, filter, merging filtrate, 60 ℃ of decompression recycling ethanols, standby; Merging filtrate, being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), be ground into fine powder, add lactose, starch is an amount of, mixing is granulated, and drying adds magnesium stearate, mixing, tabletting, coating promptly gets tablet.
Embodiment 3:
Radix Astragali 10g, Radix Puerariae 10g, Radix Bupleuri 10g, Ganoderma 10g, Radix Paeoniae Rubra 10g, Carapax Trionycis 10g, Radix Salviae Miltiorrhizae 10g, Radix Notoginseng 10g, Herba Abri 10g, Cacumen Securinegae Suffruticosae 10g
Carapax Trionycis, Ganoderma are added 8 times of water gagings extract 3 times, each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng, Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 8 times of water gagings and extract 3 times, and each 1 hour, filter, merging filtrate, standby; Merging filtrate is condensed into clear paste, adds ethanol and makes and contain alcohol amount and reach 65%, leaves standstill cold preservation and spends the night, get supernatant, decompression recycling ethanol adds an amount of saccharin sodium, essence, sodium benzoate, sorbitol, tween 80, mixes, add the water standardize solution, packing promptly gets oral liquid.
Embodiment 4:
Radix Astragali 30g, Radix Puerariae 10g, Radix Bupleuri 6g, Ganoderma 3g, Radix Paeoniae Rubra 6g, Carapax Trionycis 6g, Radix Salviae Miltiorrhizae 10g, Radix Notoginseng 6g, Herba Abri 6g, Cacumen Securinegae Suffruticosae 30g
Carapax Trionycis, Ganoderma are added 8 times of water gagings extract 3 times, each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng add 8 times of amount 70% ethanol extractions 3 times, and each 1 hour, filter, merging filtrate, 60 ℃ of decompression recycling ethanols, standby; Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 8 times of water gagings and extract each 1 hour 3 times, filter, filtrate and aforementioned two kinds of extracting solution merge, and being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), be ground into fine powder, add tartaric acid, sodium bicarbonate, stevioside, xylitol mixing, granulate drying with dehydrated alcohol, add magnesium stearate, mixing, compacting promptly gets effervescent tablet in flakes.
Embodiment 5:
Radix Astragali 30g, Radix Puerariae 3g, Radix Bupleuri 10g, Ganoderma 3g, Radix Paeoniae Rubra 10g, Carapax Trionycis 3g, Radix Salviae Miltiorrhizae 3g, Radix Notoginseng 3g, Herba Abri 10g, Cacumen Securinegae Suffruticosae 20g
Carapax Trionycis, Ganoderma are added 8 times of water gagings extract 3 times, each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng add 8 times of amount 60% ethanol extractions 3 times, and each 1 hour, filter, merging filtrate, 60 ℃ of decompression recycling ethanols, standby; Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 8 times of water gagings and extract each 1 hour 3 times, filter, filtrate and aforementioned two kinds of extracting solution merge, and being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), be ground into fine powder, add lactose, mixing is used 95% alcohol granulation, drying, incapsulate, promptly get capsule.
Embodiment 6:
Radix Astragali 15g, Radix Puerariae 10g, Radix Bupleuri 10g, Ganoderma 6g, Radix Paeoniae Rubra 10g, Carapax Trionycis 10g, Radix Salviae Miltiorrhizae 10g, Radix Notoginseng 6g, Herba Abri 10g, Cacumen Securinegae Suffruticosae 15g
Carapax Trionycis, Ganoderma are added 8 times of water gagings extract 3 times, each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng add 8 times of amount 80% ethanol extractions 3 times, and each 1 hour, filter, merging filtrate, 60 ℃ of decompression recycling ethanols, standby; Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 8 times of water gagings and extract each 1 hour 3 times, filter, filtrate and aforementioned two kinds of extracting solution merge, and being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), be ground into fine powder, add low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, calcium bicarbonate, with the mode mixing that equivalent increases progressively, use 50% alcohol granulation, drying, compacting promptly gets dispersible tablet in flakes.
Embodiment 7:
Radix Astragali 10g, Radix Puerariae 3g, Radix Bupleuri 20g, Ganoderma 10g, Radix Paeoniae Rubra 20g, Carapax Trionycis 2g, Radix Salviae Miltiorrhizae 20g, Radix Notoginseng 1g, Herba Abri 20g, Cacumen Securinegae Suffruticosae 5g
Carapax Trionycis, Ganoderma are added 10 times of water gagings extract 3 times, each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae add 10 times of amount 90% ethanol extractions 3 times, and each 1 hour, filter, merging filtrate, 60 ℃ of decompression recycling ethanols, standby; Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 8 times of water gagings and extract each 1 hour 3 times, filter, merging filtrate, being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), (60 ℃ of drying under reduced pressure,-0.08Mpa), be ground into fine powder, add the Radix Notoginseng fine powder, add proper honey, evenly mixed, the pill agent.
Embodiment 8:
Radix Astragali 10g, Radix Puerariae 6g, Radix Bupleuri 6g, Ganoderma 3g, Radix Paeoniae Rubra 6g, Carapax Trionycis 6g, Radix Salviae Miltiorrhizae 6g, Radix Notoginseng 3g, Herba Abri 6g, Cacumen Securinegae Suffruticosae 10g
Carapax Trionycis, Ganoderma are added 8 times of water gagings extract 3 times, each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng add 8 times of amount 70% ethanol extractions 3 times, and each 1 hour, filter, merging filtrate, 60 ℃ of decompression recycling ethanols, standby; Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 8 times of water gagings and extract each 1 hour 3 times, filter, filtrate and aforementioned two kinds of extracting solution merge, and being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), be ground into fine powder, add an amount of dextrin, evenly mixed, adding the 5%PVPK30 alcoholic solution is wetting agent, granulates, drying promptly gets granule.
Embodiment 9:
Radix Astragali 30g, Radix Puerariae 20g, Radix Bupleuri 20g, Ganoderma 10g, Radix Paeoniae Rubra 20g, Carapax Trionycis 20g, Radix Salviae Miltiorrhizae 20g, Radix Notoginseng 10g, Herba Abri 20g, Cacumen Securinegae Suffruticosae 30g
Carapax Trionycis, Ganoderma are added 10 times of water gagings extract 3 times, each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae add 15 times of amount 50% ethanol extractions 3 times, and each 1 hour, filter, merging filtrate, 60 ℃ of decompression recycling ethanols, standby; Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 15 times of water gagings and extract each 1 hour 3 times, filter, merging filtrate, being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), be ground into fine powder, add the Radix Notoginseng fine powder, add an amount of dextrin, evenly mixed, adding 95% alcoholic solution is wetting agent, granulate, drying promptly gets granule.
Embodiment 10:
Radix Astragali 6g, Radix Puerariae 6g, Radix Bupleuri 6g, Ganoderma 3g, Radix Paeoniae Rubra 6g, Carapax Trionycis 6g, Radix Salviae Miltiorrhizae 6g, Radix Notoginseng 3g, Herba Abri 6g, Cacumen Securinegae Suffruticosae 6g
Carapax Trionycis, Ganoderma are added 15 times of water gagings extract 3 times, each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 5 times of water gagings and extract 3 times, and each 1 hour, filter, merging filtrate, standby; Merge filtrate twice, being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), be ground into fine powder, add the Radix Notoginseng fine powder, add an amount of dextrin, evenly mixed, adding 80% alcoholic solution is wetting agent, granulates, and drying promptly gets granule.
Embodiment 11:
Radix Astragali 12g, Radix Puerariae 6g, Radix Bupleuri 6g, Ganoderma 3g, Radix Paeoniae Rubra 8g, Carapax Trionycis 6g, Radix Salviae Miltiorrhizae 8g, Radix Notoginseng 2g, Herba Abri 6g, Cacumen Securinegae Suffruticosae 12g
Carapax Trionycis, Ganoderma are added 8 times of water gagings extract 3 times, each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng add 8 times of amount 70% ethanol extractions 3 times, and each 1 hour, filter, merging filtrate, 60 ℃ of decompression recycling ethanols, standby; Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 8 times of water gagings and extract each 1 hour 3 times, filter, filtrate and aforementioned two kinds of extracting solution merge, and being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), be ground into fine powder, add an amount of dextrin, evenly mixed, adding the 5%PVPK30 alcoholic solution is wetting agent, granulates, drying promptly gets granule.
Embodiment 12:
Radix Astragali 12g, Radix Puerariae 8g, Radix Bupleuri 6g, Ganoderma 4g, Radix Paeoniae Rubra 10g, Carapax Trionycis 3g, Radix Salviae Miltiorrhizae 6g, Radix Notoginseng 4g, Herba Abri 10g, Cacumen Securinegae Suffruticosae 10g
Carapax Trionycis is added 10 times of amounts of water, and high temperature and high pressure extraction filters, and is standby; Radix Bupleuri is extracted volatile oil with steam distillation, and volatile oil gets the beta-cyclodextrin clathrate with the beta-cyclodextrin inclusion compound, and is standby; Radix Bupleuri medicinal residues, Ganoderma, the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae are added 10 times of amount 70% ethanol extractions 3 times, each 1 hour, filter, merging filtrate adds the aqueous solution after Radix Bupleuri distills, 60 ℃ of decompression recycling ethanols, being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), be ground into fine powder, add the Radix Notoginseng fine powder, add volatile oil beta-cyclodextrin clathrate, add an amount of dextrin, evenly mixed, adding 90% alcoholic solution is wetting agent, granulate, drying promptly gets granule.
Embodiment 13:
Radix Astragali 14g, Radix Puerariae 9g, Radix Bupleuri 9g, Ganoderma 5g, Radix Paeoniae Rubra 9g, Carapax Trionycis 9g, Radix Salviae Miltiorrhizae 9g, Radix Notoginseng 5g, Herba Abri 9g, Cacumen Securinegae Suffruticosae 14g
Carapax Trionycis, Ganoderma are added 15 times of water gagings extract 3 times, each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng add 15 times of amount 70% ethanol extractions 3 times, and each 1 hour, filter, merging filtrate, 60 ℃ of decompression recycling ethanols, standby; Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 15 times of water gagings and extract each 1 hour 3 times, filter, filtrate and aforementioned two kinds of extracting solution merge, and being concentrated into relative density is the thick paste of 1.30-1.35 (50 ℃), drying under reduced pressure (60 ℃ ,-0.08Mpa), be ground into fine powder; Taking polyethylene glycol 4000 heating and meltings add microcrystalline Cellulose and stir and make dissolving, add above-mentioned fine powder, and mixing splashes in 5-10 ℃ the liquid paraffin, treat that drop pill cooling back takes out, and drop to the greatest extent and the erasing liquor paraffin body promptly gets drop pill.
Embodiment 14:
Radix Astragali 5g, Radix Puerariae 1g, Radix Bupleuri 1g, Ganoderma 1g, Radix Paeoniae Rubra 1g, Carapax Trionycis 1g, Radix Salviae Miltiorrhizae 1g, Radix Notoginseng 1g, Herba Abri 1g, Cacumen Securinegae Suffruticosae 5g
Carapax Trionycis, Ganoderma, the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng, Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae are ground into fine powder, add proper honey, the system honeyed pill.
Further set forth the beneficial effect of Chinese medicine composition of the present invention by following experiment:
1, the rat liver fibrosis model of selecting for use carbon tetrachloride to cause, test the therapeutical effect of Chinese medicine composition of the present invention to hepatic fibrosis:
Be subjected to the reagent thing: Chinese medicine composition of the present invention (embodiment 11)
Positive control drug: dexamethasone sodium phosphate
Other: carbon tetrachloride (analytical pure); Compound method: the refined plant oil solution that carbon tetrachloride is mixed with 40% concentration
Animal: strain: SD rat; Body weight: 230-250g; Sex: male; Every treated animal number: 20
Experimental technique: Chinese medicine composition high dose group of the present invention (36g/kg), middle dosage group (24g/kg), low dose group (12g/kg), the modeling group, dexamethasone sodium phosphate group (0.6mg/g), other establishes the normal control group.Carbon tetrachloride is made into the refined plant oil solution of 40% concentration, and except that the normal control treated animal, other animals are 2 subcutaneous injections weekly, and 1ml/g in continuous 12 weeks, simultaneously, feeds with high lipid food and contains the water of 5% ethanol.The treatment group is subjected to reagent thing or positive control drug simultaneously.Administration 4,12 all every group get 8 rat extracting bloods at random, weigh, measure Serum ALT, AST, ALP, TP, ALB, T-BIL.Get liver and weigh, each animal is got a roughly the same hepatic tissue of same leaf liver position and is fixed in 10% formalin and does check pathological section.
Experimental result: the ALT of model group animal, AST, ALP, T-BIL be apparently higher than normal rat, liver atrophy, smaller volume, jaundice, modeling success.Administration 4 during week histopathologic examination find that the model group animal liver cell is severe diffusivity steatosis, the moderate hydropic degeneration, comparatively serious with lobule central authorities pathological changes especially.The liver mild fibrosis shows that mainly portal area fibroblast increase is comparatively obvious, and lobules of liver periphery collagen fiber slightly increases, and liver cell regeneration is not obvious; The slight steatosis of Dexamethasone group animal liver cell, lobule central authorities pathological changes is heavier, does not see that hepatic fibrosis forms; Three dosage treated animals of Chinese medicine composition of the present invention hepatocyte is moderate to severe diffusivity steatosis, and the moderate hydropic degeneration does not see that hepatic fibrosis forms.Administration 12 all histopathologic examinations find that model group animal liver cell hydropic degeneration is obvious, and tangible hepatic necrosis and fatty degeneration of liver are arranged, and tangible hepatic fibrosis is arranged, the genus liver cirrhosis (+-++); The Dexamethasone group animal liver cell has significantly steatosis and hydropic degeneration, slight hepatic fibrosis is only arranged: three dosage treated animals of Chinese medicine composition of the present invention hepatocyte still has significantly steatosis and hydropic degeneration, slight hepatic fibrosis is only arranged, high, middle dosage group fibrosis is similar to Dexamethasone group or slightly light, and the low dose group fibrosis is also light than model group.Three dosage groups of the every index of liver function test Chinese medicine composition of the present invention are also low than model group.
Experiment conclusion: Chinese medicine composition of the present invention has definite effect of anti hepatic fibrosis to the Liver Fibrosis Model rat, reduces the hepatic cell fattydegeneration necrosis, promotes hepatocellular hypertrophy, reparation.
2, to the protective effect of acute liver damage due to the D-Gal:
Kunming mouse male and female dual-purpose, 18～22g is divided into following each group, that is: normal control group at random, D-Gal hydrochlorate model group, medicine of the present invention (embodiment 11) high dose group (36g/kg), middle dosage group (24g/kg), low dose group (12g/kg); Normal control and model group give normal saline, and each administration group gives relative medicine, every day 1 time, continue 10 days.After administration in the 9th day 1 hour, lumbar injection D-Gal800mg/kg, the normal control group gives the equivalent normal saline.After the modeling 24 hours, 1h after the last administration, vena orbitalis posterior is got blood, carries out liver function index (ALT, AST) and detects.The results are shown in Table 1.
Table 1: to acute liver damage Mouse Liver function effect due to the D-Gal
| Group | Dosage (g/kg) | Mice quantity (n) | ALT/U·L -1 | AST/U·L -1 |
| Dosage group high dose group in the normal control group model group low dose group | - - 12 24 36 | 10 10 10 10 10 | 35.21±4.55 235.57±102.01** 122.01±38.35 △ 78.58±23.49 △△ 63.41±19.85 △△ | 92.12±15.23 300.17±120.39** 218.25±96.35 164.12±47.28 △ 98.53±23.42 △△ |
Annotate: compare * * P＜0.01 with matched group; Compare with model group,
△P＜0.05,
△ △P＜0.01.
Experimental result shows: behind the lumbar injection D-Gal, model group mice serum ALT, AST obviously raise than normal group, 3 dosage groups of 10 days of medicine of the present invention administration in advance, and Serum ALT, AST all obviously reduce than model group.Show that medicine of the present invention has function for protecting liver and reducing enzyme activity to liver injury model, can be used for treating liver cirrhosis, acute, chronic hepatitis.
Claims (6)
1. Chinese medicine composition for the treatment of hepatopathy, it is characterized in that it is to be made by following bulk drugs: Radix Astragali 1-30 part, Radix Puerariae 1-20 part, Radix Bupleuri 1-20 part, Ganoderma 1-10 part, Radix Paeoniae Rubra 1-20 part, Carapax Trionycis 1-20 part, Radix Salviae Miltiorrhizae 1-20 part, Radix Notoginseng 1-10 part, Herba Abri 1-20 part, Cacumen Securinegae Suffruticosae 1-30 part.
2. according to the Chinese medicine composition of claim 1, it is characterized in that it is to be made by following bulk drugs: Radix Astragali 5-15 part, Radix Puerariae 1-10 part, Radix Bupleuri 1-10 part, Ganoderma 1-6 part, Radix Paeoniae Rubra 1-10 part, Carapax Trionycis 1-10 part, Radix Salviae Miltiorrhizae 1-10 part, Radix Notoginseng 1-6 part, Herba Abri 1-10 part, Cacumen Securinegae Suffruticosae 5-15 part.
3. the preparation method of claim 1 or 2 described Chinese medicine compositions is characterized in that, this method is: described materials of weight proportions medicine is directly pulverized obtained medicinal powder; Or adding water or Different concentrations of alcohol extraction respectively, the extracting solution concentrate drying gets crude extract; Or adopt decoction and alcohol sedimentation technique, steam distillation to make with extra care and obtain extract; Above-mentioned medicinal powder or crude extract or extract are mixed with adjuvant, make any medicament on the pharmaceutics.
4. the preparation method of Chinese medicine composition according to claim 3 is characterized in that, this method is: with Carapax Trionycis, Ganoderma water extraction; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng are extracted with Different concentrations of alcohol, decompression recycling ethanol; Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae water extraction; Merging filtrate concentrates, and drying is ground into fine powder, adds adjuvant, makes any medicament on the pharmaceutics.
5. the preparation method of Chinese medicine composition according to claim 4 is characterized in that, this method is: Carapax Trionycis, Ganoderma are added 8 times of water gagings extract 3 times, and each 3 hours, filter, merging filtrate, standby; The Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Notoginseng add 8 times of amount 70% ethanol extractions 3 times, and each 1 hour, filter, merging filtrate, 60 ℃ of decompression recycling ethanols, standby; Radix Bupleuri, Herba Abri, Radix Paeoniae Rubra, Cacumen Securinegae Suffruticosae add 8 times of water gagings and extract each 1 hour 3 times, filter, filtrate and aforementioned two kinds of extracting solution merge, and relative density is the thick paste of 1.30-1.35 when being concentrated into 50 ℃, at 60 ℃, drying under reduced pressure under the negative pressure 0.08MPa is ground into fine powder, add an amount of dextrin, mix homogeneously, adding the 5%PVPK30 alcoholic solution is wetting agent, granulates, drying gets granule.
6. claim 1 or 2 described Chinese medicine compositions are used to prepare the application of the medicine for the treatment of hepatitis, hepatic fibrosis, liver cirrhosis.
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|---|---|---|---|---|
| CN101897908B (en) * | 2009-12-30 | 2011-09-28 | 杨昕辰 | Traditional Chinese medicine composition for treating cirrhosis ascites and liver cancer and preparation method thereof |
| CN102716179A (en) * | 2012-06-05 | 2012-10-10 | 北京伟峰益民科技有限公司 | Traditional Chinese medicine composite for preventing or treating fibrosis diseases as well as preparation method and application of composite |
| CN109745507A (en) * | 2019-03-12 | 2019-05-14 | 张炉高 | Chinese medicine composition and preparation method thereof for treating liver fibrosis |
| CN113804815A (en) * | 2020-06-17 | 2021-12-17 | 浙江维康药业股份有限公司 | Rapid thin-layer identification method for traditional Chinese medicine for treating liver diseases |
| CN111759991A (en) * | 2020-08-04 | 2020-10-13 | 广西中医药大学第一附属医院 | Traditional Chinese medicine compound preparation for treating chronic liver diseases and preparation method and application thereof |
| CN114732848B (en) * | 2022-04-29 | 2023-08-01 | 浙江维康药业股份有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for preventing and treating Alzheimer disease |
| CN115990209B (en) * | 2022-12-12 | 2024-02-02 | 浙江维康药业股份有限公司 | Application of traditional Chinese medicine composition in preparation of anti-alcohol drugs |
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2008
- 2008-01-04 CN CN2008100556360A patent/CN101214288B/en active Active
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