CN1274356C - Composite Chinese medicine for treating heptic fibrosis and cirrhosis due to hepatitis B and its mfg. method - Google Patents

Abstract

The present invention discloses a traditional Chinese medicine composition for treating posthepatitic fibrosis and cirrhosis due to hepatitis B, which is prepared from the following components, in the weight percentages, 30 to 40 of red sage root, 20 to 30 of astragalus root, 10 to 20 of Chinese caterpillar fungus or cordyceps mycelial, 10 to 20 of flavescent sophora root and 5 to 10 of peach seed. The composition also comprises turtle shell, safflower, angelica, suberect spatholobus stem, common leafflower herb with root, red peony root, ganoderma lucidum, tuckahoe, kudzuvine root and curcuma aromatica salisb in the balancing amount of 10 to 20% of the total weight. The composition can also be made into decoction or extract tablets, and the extract tablets are dried in vacuum during the production. The angelica and the turtle shell are individually processed, and the extract tablets are obtained by the processes of pelletization, tabletting, coating, etc. The present invention solves the problems of the existing medicines, such as multiple auxiliary materials, low active components, poor therapeutic effect, high production cost, etc. The formula of the latest dose-effect relationship has the advantages of advanced technique, fewer medicine auxiliary materials, high effective component content, good therapeutic effect, short therapeutic course without toxic or side effect, low production cost, etc. The composition is broadly suitable for treating posthepatitic fibrosis and cirrhosis due to hepatitis B.

Description

Treatment hepatitis B hardened Chinese medicine composition of heptic fibrosis regulating liver-QI and manufacture method thereof

Technical field the present invention relates to a kind of hardened Chinese medicine composition of treatment hepatitis B heptic fibrosis regulating liver-QI and manufacture method thereof, more particularly, relate to a kind of manufacture method for the treatment of compatibility, dose-effect relationship and the dosage form liver extract thereof of the hardened Chinese medicine composition of hepatitis B heptic fibrosis regulating liver-QI.

Background technology in recent years, the existing relatively more most advanced and sophisticated theoretical research of relevant treatment hepatitis B hardened medicine of heptic fibrosis regulating liver-QI and Therapeutic Method, according to theory of Chinese medical science: the cause of disease of chronic hepatitis B heptic fibrosis and liver cirrhosis and pathogenesis are that pathogenic factor (hepatitis B virus) is invaded human body, souvenir is not gone, cause positive exogenous pathogen to be contained, the damp and hot blood stasis ， mass in the abdomen mass in the abdomen of not holding concurrently to the greatest extent, stagnation of liver-QI spleen kidney qi blood deficiency.So blood circulation promoting and blood stasis dispelling, hard masses softening and resolving are for treating the basic rule of treatment of this disease.Take into account eliminating pathogenic factor for supporting vital QI, tonify deficiency invigorating the liver and kidney, replenishing QI to invigorate the spleen, depressed liver-energy dispersing and QI regulating and nourishing blood to suppress the hyperactive liver etc. simultaneously, can make the treatment of liver cirrhosis obtain obvious effects.According to modern medicine: pass through immunology, animal experiment, the liver biopsy pathology, particularly use cell, molecule and biology of gene means: now illustrate, the pathogeny of hepatitis B heptic fibrosis, be in human body, to duplicate because of hepatitis B virus, cause patient's immune system attack self hepatocyte, cause long-term inflammation of liver and damage, cause Kupffer Cell and platelet and discharge various cytokines such as transforming growth factor (TGF β 1 etc.), excite hepatic stellate cell (HSC) activation, promote the secretion of extracellular matrix (ECM), I, the III Collagen Type VI deposits and formation hepatic fibrosis and sinus hepaticus capillary trend, cause the hepatocyte malnutrition, the portal vein blood flow is obstructed and causes liver cirrhosis.Though antiviral, immunoregulation, antiinflammatory, protect the liver, improve the liver microcirculation be the prevention hepatic fibrosis measure.Though but the cause of disease is gone sometimes, and the initiative hepatic fibrosis still continues development, so it is the basic key of anti-hepatic fibrosis that blocking-up forms each link of cell, molecule and the gene of hepatic fibrosis, the inventor once published thesis and was collected in the elaboration of doing to explain the profound in simple terms in " hepatitis B patient must be read " book that I show in " the 6th the viral hepatitis academic conference in the whole nation ".

Yet, in the prior art, disclosed relevant paper and information, its formal research many places still lack sophisticated medicine and effective therapy in experimental stage.The tool statistics has 10% to be hepatitis B virus carriers approximately in China's population, dying from liver cirrhosis due to hbv every year has 400,000 people approximately, and dying from hepatocarcinoma person has 100,000 people approximately, so the active drug of development treatment primary disease is the task of top priority.Current, external medicine only has colchicine, IFN-, and its curative effect is all unreliable, and side effect is big and cost an arm and a leg.Domestic now unique " FUFANG BIEJIA RUANGAN PIAN " of only having the development of 302 hospitals of PLA, Inner Mongol Fu Rui drugmaker to produce of having gone on the market is a kind of, is principal agent with the Carapax Trionycis, and it includes, and adjuvant is many, effective component content is very low, curative effect slow and anemia of pregnant woman's forbidding.Therefore, pressed for a kind of effective medicine and treated hepatitis B heptic fibrosis and liver cirrhosis disease, reduced mortality rate, for the mankind benefit.

Summary of the invention the object of the present invention is to provide a kind of non-low-level repetition, reasonable recipe, dosage uniqueness, best in quality, safety non-toxic and treatment hepatitis B heptic fibrosis evident in efficacy Chinese medicine composition and technology advanced person, cost reduces and the manufacture method of the extractum sheet that production efficiency is high.

In order to achieve the above object, the invention provides following technical scheme: develop the hardened Chinese medicine composition of a kind of treatment hepatitis B heptic fibrosis regulating liver-QI, the raw material of said composition and weight percentage are: A, Radix Salviae Miltiorrhizae 30%-40%, B, Radix Astragali 20%-30%, C, Cordyceps and/or Cordyceps mycelium 10%-20%, D, Radix Sophorae Flavescentis 10%-20%, E, Semen Persicae 5%-10%.With A, B, each raw material of C, D through pulverizing, mixing, and to add weight be 3-6 water doubly is cooled to 60 ℃ through being heated to immediately after boiling, insulation is 2-3 hour under 60-45 ℃ of temperature, be heated to and be cooled to 60 ℃ immediately after boiling, add quantitative C again, under 6045 ℃ of temperature, be incubated 1-2 hour again, filtration, extracting juice.Described compositions or make by following step: (1) is boiled A, B, D, E and is carried secondary after pulverizing, mixing, after being cooled to 60 ℃ immediately after boiling for the first time, 60-45 ℃ of insulation 2-3 hour, after after boiling for the second time, being cooled to 60 ℃ immediately again, 60-45 ℃ of insulation 1-2 hour, concentrate after filtration,, get thick extractum, (2) C Cordyceps and/or Cordyceps mycelium are carried out vacuum drying, pulverizing, sieve fine powder, (3) thick extractum that (1), (2) process are obtained respectively and fine powder are evenly mixed, through vacuum drying, make preparation.

When the concrete preparation present composition, can carry out step (1), (2), (3) with described raw material after, the mixture of thick extractum behind the vacuum drying and fine powder is pulverized and screening, granulate vacuum drying, granulate, tabletting and coating.

The present invention's technical scheme preferably is: several conducts that also add any one or arbitrary proportion in the following raw material in the raw material add raw material, its total amount accounts for above-mentioned A, B, C, D, the 10%-20%:F Carapax Trionycis of E raw material gross weight, the G Flos Carthami, the H Radix Angelicae Sinensis, the I Caulis Spatholobi, the J Herba Phyllanthi Urinariae, K Radix Paeoniae Rubra, L Ganoderma or Ganoderma spore powder, the M Poria, the N Radix Puerariae, the O Radix Curcumae, make according to the following steps: (1) is with Radix Salviae Miltiorrhizae, the Radix Astragali, Semen Persicae and Radix Sophorae Flavescentis, with additional raw material Flos Carthami, Caulis Spatholobi, Radix Paeoniae Rubra, Poria, Herba Phyllanthi Urinariae, Radix Puerariae, in Radix Curcumae and the Radix Angelicae Sinensis one or more, boil jointly 2 times, be cooled to 60 ℃ immediately after boiling for the first time, 60-45 ℃ of insulation 2-3 hour, after boiling for the second time, be cooled to 60 ℃ immediately again, again 60-45 ℃ of insulation 1-2 hour, after filtration, concentrate, get thick extractum, wherein the Radix Angelicae Sinensis medicinal residues behind Radix Angelicae Sinensis employing Radix Angelicae Sinensis fine powder or the distillating extracting oil; (2) Cordyceps and/or Cordyceps mycelium are carried out vacuum drying, pulverizing, sieve fine powder; (3) thick extractum that (1), (2) step are obtained respectively and fine powder are mixed, vacuum drying, pulverizing and screening, granulation, vacuum drying, granulate, tabletting and coating; When in the additional raw material Carapax Trionycis being arranged, after step (2) is with the Carapax Trionycis processed with vinegar separately the Carapax Trionycis that obtains of decocting extract concentrated solution and Cordyceps and/or the common vacuum drying of Cordyceps mycelium, pulverizing, sieve fine powder; When in the additional raw material Ganoderma or Ganoderma spore powder being arranged, adding and pulverize jointly, sieve before the pulverizing of step (2) or (3) with other raw material.

Above-mentioned prescription of the present invention is established according to theory of Chinese medical science and modern medical theory, and the composition and the effect of each component of the present invention (" No. three, hepatitis B "): 1 Radix Salviae Miltiorrhizae: the property hardship is slightly cold.This medicine merit is with four soup, master's " cold and heat gather ， Po Disorder and remove abdominal mass, end stuffy sensation with restlessness, and benefiting QI and nourishing blood breaks stagnated blood, tissue regeneration promoting blood " of " herbal collection will " meaning; Cold because of its feeble QI again, so melt three one of nourishing blood and promoting blood circulation removing heat from blood, be non-not the belonging to of pioneer of curing the disease, so be the main medicine of blood circulation promoting and blood stasis dispelling; By modern medicine: Radix Salviae Miltiorrhizae can improve the liver microcirculation, hepatoprotective falls enzyme, promotes liver cell regeneration, anti peroxidation of lipid, the effect that particularly suppresses HSC activation and propagation is the strongest, suppress the synthetic and degraded of I, II, III Collagen Type VI, by animal experiment and clinical all sure.Monomer whose (active ingredient) salvianolic acid A is one of water soluble ingredient of Radix Salviae Miltiorrhizae, and it is synthetic to suppress the interior collagen of fibroblast proliferation and cell.Monomer salvianolic acid B suppresses HSC and TGF β 1; 2 Radixs Astragali: the sweet tepor of property.Invigorating the spleen and replenishing QI, the yang invigorating consolidating superficial resistance.Be the main medicine of setting upright QI invigorating, the modern medicine confirmation Radix Astragali can be regulated immunologic function.Degraded I, III, the effect of IV Collagen Type VI are arranged; 3 Cordyceps (or Cordyceps mycelium): warm in nature.The merit of the kidney invigorating, tonify deficiency, yin nourishing, benefit essence, beneficial marrow are arranged, setting upright and invigorate blood circulation based on the kidney invigorating, is very famous and precious traditional nourishing and fit keeping function Chinese medicine; Cordyceps composition complexity, Cordyceps polysaccharide is one of its composition.Known Cordyceps active ingredient is monomer-Cordyceps mycelium, has the effect that suppresses hepatitis B virus, immunoregulation, alleviates hepatitis disease, improves the interior microcirculation of liver and improve blood plasma albumin level.The gene expression and the protein excretion that particularly can suppress HSC activation and inhibition TGF β 1.Suppress the synthetic of collagen in the hepatic fibrosis later stage, promote its degraded.So the approach of Cordyceps anti-hepatic fibrosis is multi-level, multipath, many target spots, can influence each stage of hepatic fibrosis; 4 Semen Persicaes: property is bitter sweet flat, and the removing blood stasis dissipating blood stasis has confirmed that now the effect of its extract amygdalin inhibition HSC activation and propagation is very strong, can improve the hepatic tissue collagenase activity again, promotes collagen decomposition, makes hepatic fibrosis be difficult for formation; 5 Radix Sophorae Flavescentiss: property bitter cold, heat clearing and damp drying, diuretic.It is oxymatrine that radix sophorae or Herba Sophorae alopecuroidis extract its effective ingredient, has no side effect energy anti-hepatitis virus, immunoregulation, antiinflammatory, cloudy disconnected hepatocellular apoptosis.Particularly can suppress HSC propagation, reduce the expression of TGF β 1 and suppress the interior collagen of liver synthetic, thereby reach the effect that the blocking-up hepatic fibrosis forms; 6 Ganodermas: property is bitter flat nontoxic.Traditional valuable ingredient of Chinese medicine of invigorating the spleen and replenishing QI, strengthening by means of tonics, strengthening the body resistance.GuangZhou Green Foodstuffs Engineering Co., Ltd produce it " scholar's board " Ganoderma spore be the Ganoderma growth and maturity phase from the light vaporific tiny spores that cap ejects, have the whole hereditary active substance of Ganoderma.The clinical application in modern age finds that Ganoderma spore has the immunologic function regulating action stronger than Ganoderma.The said firm sprouts the Ganoderma spore in the dormancy activate to handle, and can promote the biological active substances of multiple tool active gene such as ganoderan etc., protects the liver by strengthening the body resistance, nourishing the liver QI invigorating; 7 Carapax Trionycis: property is salty flat, nourishing YIN and clearing away heat, hard masses softening and resolving.Promote albumin synthetic (setting upright), promote the degraded of collagen; 8 Radix Paeoniae Rubra: the property picric acid is slightly cold.Removing heat from blood and promoting blood circulation.Nourishing YIN and hard masses softening and resolving effect do not have Carapax Trionycis obvious; 9 Flos Carthamis: the hot temperature of property is the warming the meridian and activating blood circulation medicine.Scalable LAK, NK cell activity, raising immunoglobulin, antiinflammatory; 10 Radix Angelicae Sinensis: property Gan Xinwen.Enrich blood and blood, nourishing blood to suppress the hyperactive liver.Effect with immunoregulation and inhibition precancerous lesion; 11 Caulis Spatholobis: the bitter sweet temperature of property, enrich blood, blood circulation promoting and blood stasis dispelling; 12 Poria: property is sweet light flat.Spleen invigorating, promoting diuresis to eliminate damp pathogen.Suppress the precancerous lesion effect; 13 Herba Phyllanthi Urinariaes (having another name called Phyllanthusamarus): the sweet cold of the little hardship of property.The medical herbs of clearing away heat-damp and promoting diuresis, liver heat removing tomorrow, active ingredient is that triterpenes has the anti-hepatitis virus effect, and experimental hepatic fibrosis is had certain preventive effect; 14 Radix Puerariaes: property Gan Xinping, the heat clearing away of inducing sweat; 15 Radix Curcumaes: the property toil is slightly cold, and promoting QI circulation for relieving depression, promoting blood circulation and breaking stagnation are similar with Semen Persicae, ends pain in the hepatic region, function of gallbladder promoting.

In implementing process of the present invention, this compositions Radix Salviae Miltiorrhizae, the Radix Astragali, Cordyceps, Semen Persicae, Radix Sophorae Flavescentis are requisite composition, but Semen Persicae, the unsuitable heavy dose of Radix Sophorae Flavescentis, Semen Persicae and Cordyceps must share and can play synergism, existing injection is only used single medicinal material, and its therapeutic effect can be very poor.In addition, the dosage range of the Chinese medicine of each flavor is clinical and the summary of various tests in the compound recipe, all obviously influences therapeutic effect, invalid even harmful if amount ranges exceeds or descends, and when taking, each patient all can add vitamin E.

Compatibility of the present invention is by middle medical knowledge, method, side, medicine: the mechanism that forms " mass in the abdomen " according to liver cirrhosis due to hbv.The method of the upright eliminating pathogenic factor for supporting vital QI blood stasis dispelling of determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs is to form the prescription of eliminating pathogenic factor for supporting vital QI blood stasis dispelling.So Fang Ze is the coalition of reason, method and medicine.Medicine by monarch, minister, help, make, multi-flavor medicine multicomponent multivariate and multifunctional characteristics solve too many levels, reach the effect of multidigit point at many levels, obviously are better than singly using Herba indigoferae Pseudotinctoriae.And each medicine neither interferes with each other, and is nontoxic, learns from other's strong points to offset one's weaknesses on the contrary, optimizes prescription, and the pharmacological action that performance is maximum reaches best therapeutic effect.Blood circulation promoting and blood stasis dispelling is the basic of treatment primary disease, so be principal agent with tradition and modern the most effective generally acknowledged drug for invigorating blood circulation and eliminating stasis Radix Salviae Miltiorrhizae, its function of promoting blood circulation to disperse blood clots is better than Semen Persicae, Flos Carthami, Radix Paeoniae Rubra.Dose accounts for total amount 30%～40%, does not surpass this scope, otherwise the too quickly healthy energy of hindering of blood stasis dispelling.Semen Persicae in the fundamental component and additional composition Radix Curcumae, Flos Carthami, Caulis Spatholobi, Carapax Trionycis, Radix Paeoniae Rubra account for total amount 10%～20% for strengthening the power of blood circulation promoting and blood stasis dispelling.Effect of anti hepatic fibrosis the best when share in view of Semen Persicae and Cordyceps, so the proportion that Semen Persicae accounts for therein is higher than other additional compositions, Carapax Trionycis hard masses softening and resolving, proportion can not lack.But removing blood stasis is of a specified duration excessively, too quickly, overcutting is then just being hindered.Compatibility Radix Astragali replenishing QI to invigorate the spleen on the basis of blood circulation promoting and blood stasis dispelling, " spleen is strong then long-pending from disappearing ", " QI and blood is transferred and is reached and strongly fragrant loosing ", more in addition the kidney invigorating of Cordyceps spleen invigorating tonify deficiency for setting upright, resist the fine main force, with Radix Salviae Miltiorrhizae be monarch drug altogether.If the fraud of the heresy of staying is only arranged with Cordyceps simply, explanation must be based on blood circulation promoting and blood stasis dispelling, sets upright and does not hinder eliminating evil.If list is used the Radix Astragali, without other medicines, curative effect is also bad.Semen Persicae, Flos Carthami removing blood stasis and hinder healthy energy, but liver cirrhosis with the passing of time healthy energy hindered, weakened body resistance evil thought, simulataneous insufficiency and excessive, and liver being bold and firm viscera, blood stored in the liver is so should not send an expedition against dissipation too.Therefore Semen Persicae is unsuitable heavy dose of, does not just hinder with Carapax Trionycis, Radix Paeoniae Rubra removing blood stasis, and adding Ganoderma (the nourishing the liver QI invigorating with Radix Astragali complementation, is set upright, because of its famous and precious consumption little), Caulis Spatholobi again, to share common principal drug assistance be ministerial drug.Radix Sophorae Flavescentis, Herba Phyllanthi Urinariae, Radix Puerariae are eliminating evil, and it is adjuvant drug altogether that assistant is not robbed the moon with Chinese Angelica blood replonishing easing the affected liver, the eliminating dampness by diuresis of Poria invigorating spleen for diuresis.Though Radix Sophorae Flavescentis can be principal agent again, amount is unsuitable excessive, and heavy dose is on the contrary not as low dose of good effect.The Radix Curcumae pungent drugs can disperse and bitter drugs can descend, fragrance should reach, and has both gone into edema caused by disorder of QI with promoting QI circulation for relieving depression, goes into blood system again with the removing heat from blood removing blood stasis, draws the through Liver Channel of all medicines and is messenger drug.By modern medicine: though Modern Molecular Biotechnology also proves each single medicinal material the influence of TGF β 1mRNA level there is concordance preferably, variant to regulating TGF β 1.Therefore influence synthetic and degraded just is not quite similar to the collagen of HSC.Single medicinal material also exists difference with strong and weak to the effect of each target spot of collagen formation simultaneously.It is the strongest with the effect of propagation that Radix Salviae Miltiorrhizae, Semen Persicae suppress the HSC activation.It is the most remarkable that Cordyceps mycelium reduces the effect of TGF β 1mRNA and protein expression thereof.It is the most remarkable that drug supporting healthy energy suppresses the effect of type i collagen mRNA expression and protein expression thereof.Radix Sophorae Flavescentis removes anti-liver fibre again can anti-hepatitis virus.In a word, the too many levels of herbal mixture, the effect of many target spots have improved comprehensive therapeutic effect.Only act on single link with the Western medicine chemical synthetic drug or target spot is compared, its outstanding substantive distinguishing features and obvious improvement is arranged.

In implementation process, vacuum drying all carries out under 40-50 ℃ and negative pressure, and vacuum can be controlled flexibly, as long as negative pressure, dry under negative pressure state, be in order to shorten drying time and can suitably to reduce temperature, do not suffer a loss or reduce loss with the active ingredient that keeps the medicine each component; Carapax Trionycis is refining separately, behind the processed with vinegar separately decocting handle with Cordyceps that can not high-temperature process vacuum drying separately, oil is carried in Radix Angelicae Sinensis fine powder or distillation, medicinal residues and other component boil altogether obtains through refining thick extractum, because decompression makes the relation of pressure and temperature be adjusted in optimum state, make active ingredient be difficult for the heat loss during system cream; Filter the back and adopt up-to-date highly enriched extraction process to get thick extractum, do not add starch and other adjuvant, improved the content of active ingredient, alleviated tablet weight, volume and the amount of swallowing, thereby alleviated patient's the intestines and stomach burden; The extractum coating tablets can adopt international advanced high molecular film material, avoided employing sugar-coat and colouring or capsule to wrap up Chinese medicine tablet, the dry extract hygroscopicity is strong, thin-film material moisture-resisting, heat resistanceheat resistant, cracking resistance, mildew-resistant, lucifuge, and the effect duration and the Production Time of making that can prolong product have shortened 8 times.In addition, product of the present invention is nontoxic through acute toxicity test of pharmaceutical college of Shanghai Medical Univ and long term toxicity test proof, and western drug institute efficiency test proof is effective, and the institute for drug control, Shenzhen is up to the standards.

Compared with prior art, the concrete advantage that the present invention has is illustrated by " FUFANG BIEJIA RUANGAN PIAN " (being called for short " soft liver sheet ") contrast of producing with 302 hospitals of PLA developments, Inner Mongol Fu Rui drugmaker: 1, dosage form: the soft liver sheet tabletting after the pulverizing medicinal materials of making a living, and the present invention is the extractum sheet; 2, adjuvant: soft liver sheet adjuvant is many, and the extractum sheet is few, and volume is little; 3, hardness: soft liver sheet difference of hardness, 15 minutes disintegrations, easily pulverize and go bad, and extractum sheet hardness is good, 60 minutes disintegrations, is difficult for pulverizing rotten; 4, active ingredient: soft liver sheet content is low, and it is not bitter to distinguish the flavor of, and per 0.5 gram tablet only is equivalent to 0.15 gram dry extract, is difficult for dissolving in the stomach, and extractum sheet content height, bitter in the mouth, the every 0.35 pure extractum of gram, easily dissolving in the stomach; 5, dosage: 4 of the each clothes of soft liver sheet, 3 times on the 1st, every day, total amount 6 grams were equivalent to only 2 grams of extractum sheet, and 7 of each clothes of extractum sheet, 3 times on the 1st, every day, total amount 7.35 grams met the Chinese medicine routine dose; 6, drug effect: soft liver sheet is relatively poor, extractum sheet definite effect; 7, the course of treatment: soft liver sheet curative effect is slow, and the course of treatment is long, 6 months courses of treatment, and extractum sheet curative effect is fast, and short treating period, 4 months courses of treatment, late result is also good; 8, safety: soft liver sheet is anemia of pregnant woman's forbidding, and this medicine Carapax Trionycis is a principal agent, does not but have the indication of diet three-coloured amaranth, and the nearly all free of toxic effects at a specified future date of extractum sheet, Carapax Trionycis is taken phase diet three-coloured amaranth, anemia of pregnant woman's forbidding; 9, price: every 1.6 yuan of soft liver sheet retail prices, every 1.0 yuan of extractum sheets, and its composition and content doubles than the former, and prescription is advanced; 10, production efficiency: soft liver sheet production equipment is big, if the sugaring garment piece parcel production time is 16 hours, and the film coating equipment of extractum sheet is simple, only needs 1-2 name operator, and 2 hours production times, rate of drying is fast, and the medicine heat loss is little.

Below by concrete case effective therapeutic effect of this compositions is described:

Case one name: Zhang Bin, the man 33 years old, finds during health check-up in 1991: the HBsAg positive, the HBeAg positive, anti--the HBc positive (being commonly called as " great three positive "), go to a doctor for many years in the Shenzhen each public hospital and oneself see advertisement the medicine does no good to is to each chemical examination over 7 years in 1998 all " great three positive ".In May, 98 is through turning out cloudy property of Shenzhen Donghu Hospital chemical examination HBeAg, but liver function test wherein glutamate pyruvate transaminase (ALT) be increased to 92 units (normal value is below 40), HBV DNA 8.3 * 10 ⁷Copy/ml, hepatic fibrosis chemical examination: hyaluronic acid (HA) 101ng/ml (normal value 50), serum II I procollagen type (PCIII) 120 μ g/L (normal value 80), laminin (LN) 190ng/ml (normal value 100), glycocholic acid (CG) 2.2.Inappetence, complexion are gloomy, weak, and a spider angioma is found in the throat, 1cm under the right rib of hepatomegaly, and B ultrasonic: the liver luminous point increases slightly, is diagnosed as through Shenzhen Donghu Hospital (public infectious hospital): chronic active hepatitis merging hepatic fibrosis.Went to inventor's outpatient service place (daybreak doctor trained in Western medicine internal medicine clinic is answered by the Shenzhen) on May 26, give embodiment 1 prescription (being above-mentioned composition fundamental component and content), each total amount 10 grams 3 times on the 1st, add vitamin E simultaneously.Appetite improvement after two months, feeling of fatigue disappear.But ALT still fluctuates about 80 units, and HBV DNA is still positive.The clothes medicine-feeding is two months again, and liver function is recovered normally fully, and no complexion is gloomy, and it is normal that hepatomegaly is recovered, and B ultrasonic is normal.6th month check HBV DNA 6.4 * 10 ⁴, HA 58ng/ml, PCIII 76 μ g/L, LN 94ng/ml, CG 1.8.It is slightly high to remove HA, and it is normal that all the other indexs are recovered fully.Continue to strengthen and take medicine in May, 99 HA 11, PCIII 88, and LN 95, CG 1.8 (normal fully), and the throat spider angioma disappears, and the patient has rosy cheeks, and is energetic, great rejoicing.Stop to obey this compositions, calendar year 2001 JIUYUE follow-up study on the 25th, HBV DNA 2.72 * 10 ³(belong to negative), the fine four indices of liver still all normal (above chemical examination is Shenzhen Donghu Hospital's chemical examination), illustrating after the drug withdrawal 2 years does not still have recurrence, and the late result that throws a flood of light on this compositions (" No. three, hepatitis B ") is also special good.

Case two names: Chen Taian, the man, 35 years old, 1986 through the chemical examination discovery HBsAg positive, anti--the HBe positive, anti--the HBc positive (" small three positive "), unusual repeatedly from after this 10 years liver functions, through the People's Hospital, Baoan District, private clinic and clothes advertisement medicine multi-treatment be invalid, 97 years weak, become thin, the complexion mirk, B ultrasonic: the liver luminous point increases slightly.Be diagnosed as through Shenzhen Donghu Hospital: chronic active hepatitis → early stage liver cirrhosis.Invalid through this institute treatment 1 year, in April, 98, HA 106.8, and LN is normal, and CG 1761, HBV DNA 6.73 * 10 ⁶Then transfer this out-patient treatment, give present embodiment 4 (No. three, hepatitis B) extractum sheet and vitamin E, after 5 months, patient's symptom is obviously improved, and whole laboratory indexes and B ultrasonic all recover normal after 8 months.Continue to strengthen and take medicine 4 months.After 1 year, follow up a case by regular visits in August, 2000, HA 30, and LN 99, and CG 7.7, and IVC 53, HBV DNA 6.5 * 10 ⁴Normal fully.After 2 years June calendar year 2001 HBV DNA 10 ⁴, JIUYUE PCIII 3.32, and IVC 100, and LN 28.84 is normal.There are not any liver cirrhosis due to hbv symptom and sign.Late result certainly.

Case three names: Tan Yuebao, the man, 43 years old, abdominal distention in 1994, liver function test ALT 377 lost compensatory liver cirrhosis one ascites after Shenzhen Donghu Hospital is diagnosed as hepatitis B, lived this institute's treatment.Postpone separating symptom through this institute's symptomatic treatment.But liver function, B ultrasonic, four of liver fibres and hepatitis B infectiousness index are all unusual repeatedly for many years, fail to respond to any medical treatment.Transferred chemical examination hepatic fibrosis index: the PCIII 132 of the preceding East Lake of my outpatient service hospital in 1999, IVC 103, and CG 3.4 (three indexs all raise) is through obeying embodiment 6 (No. three, hepatitis B) extractum sheet 6 months, hepatitis B infectiousness index is turning out cloudy property all, only surplus two antibody positives.10th month (March calendar year 2001) HA 80, LN 121, IVC 84 (slightly high), CG 1.5, all normal (more than be Shenzhen Donghu Hospital's chemical examination).

Be drawing explanation of the present invention below the description of drawings:

Fig. 1 is the process chart that Chinese medicine composition of the present invention is made the extractum sheet, with reference to Fig. 1, the technical process of making the extractum sheet comprises: (1) crude drug Radix Salviae Miltiorrhizae, the Radix Astragali, Semen Persicae, Flos Carthami and Caulis Spatholobi etc. are carried medicinal residues behind the oil with Radix Angelicae Sinensis fine powder or distillation and boil jointly and carry secondary after putting in order, after filtration, concentrate, get thick extractum, and (2) Carapax Trionycis carries out independent processed with vinegar, decocting, filter, concentrate with Cordyceps and carry out cold drying jointly, pulverize, sieve fine powder, (3) then, with (1), (2) the thick extractum mix homogeneously of process acquisition is through vacuum drying, pulverize and screening, granulate, vacuum drying, granulate, tabletting and coating.Wherein, add before the pulverizing of Ganoderma spore powder in (2) process and handle jointly with other composition.

By specific embodiment this utility model is carried out more detailed description below the specific embodiment:

Each composition and the content of embodiment are summarized in table 1

Composition and the content one of table 1 embodiment 1-6 are pulled table

The example composition	1	2	3	4	5	6
							A(g)	2000	1500	1200	2000	1750	1650
B(g)	1500	1100	1200	1500	1250	1100
							C(g)	1000	600	600	600	750	1000
D(g)	600	550	600	650	750	1000
							E(g)	300	280	400	250	375	250
F(g)			240		100
							G(g)		100			110	500
H(g)		100	160		100
							I(g)				150	70
J(g)				150	70
							K(g)		50		150	85
L(g)				150	110
							M(g)		100			70
N(g)		100			100
							O(g)				150	100
Add up to (g)	5400	4480	4400	5750	5780	5500

Note: the medicine name of table Chinese and English letter representative is respectively: A Radix Salviae Miltiorrhizae, the B Radix Astragali, C Cordyceps or Cordyceps mycelium, D Radix Sophorae Flavescentis, E Semen Persicae, F Carapax Trionycis, G Flos Carthami, H Radix Angelicae Sinensis, I Caulis Spatholobi, J Herba Phyllanthi Urinariae, K Radix Paeoniae Rubra, L Ganoderma, M Poria, N Radix Puerariae, 0 Radix Curcumae.

Embodiment 1

Get A Radix Salviae Miltiorrhizae 2000 grams, the B Radix Astragali 1500 grams, C Cordyceps 1000 grams, D Radix Sophorae Flavescentis 600 grams, E Semen Persicae 300 grams, meter 5400 grams, earlier with A, B, each composition of D, E through pulverizing, mixing, and to add weight be that the water of 22000 grams are cooled to 60 ℃ through being heated to after boiling immediately, and insulation is 3 hours under 50-45 ℃ of temperature, adds quantitative C again, be heated to and be cooled to 60 ℃ immediately after boiling, be incubated 1 hour again under 50-45 ℃ of temperature, filtration, extracting juice can be taken.The percentage by weight that accounts for of each composition wherein: A Radix Salviae Miltiorrhizae 37%, the B Radix Astragali 27.8%, C Cordyceps 18.5%, D Radix Sophorae Flavescentis 11.1%, E Semen Persicae 5.6%.

Embodiment 2

Prescription is as table 1, the crude drug Radix Salviae Miltiorrhizae, the Radix Astragali, Radix Sophorae Flavescentis, Semen Persicae, Flos Carthami, Radix Paeoniae Rubra, Poria and Radix Puerariae are carried medicinal residues behind the oil with Radix Angelicae Sinensis fine powder or distillation and are boiled jointly and carry secondary after putting in order, be cooled to 60 ℃ after boiling for the first time immediately 60-55 ℃ of insulation 2 hours, after after boiling for the second time, being cooled to 60 ℃ immediately again, 50-45 ℃ of insulation 2 hours, after filtration, concentrate, get thick extractum, and Cordyceps is carried out cold drying jointly, pulverize, sieve fine powder, then with (1), (2) the thick extractum mix homogeneously of process acquisition is through 45 ℃ of vacuum dryings, pulverize and 100 mesh sieve branches, granulate, vacuum drying under the similarity condition again, granulate, mixing, compress tablet coating, check and packing get final product.Wherein, Radix Salviae Miltiorrhizae 37.2% in the fundamental component, the Radix Astragali 27.3%, and Cordyceps 14.9%, Radix Sophorae Flavescentis 13.6%, 6.9%, 5 kind of auxiliary composition sum of Semen Persicae is 11.2% of a fundamental component total amount.

Embodiment 3

Prescription is as table 1, method is respectively 50-55 ℃ of insulation 3 hours with embodiment 2, twice insulations, after boiling for the second time, be cooled to 60 ℃ immediately again after, 50-55 ℃ of insulation 1 hour, wherein, Radix Salviae Miltiorrhizae 30.0% in the fundamental component, the Radix Astragali 30.0%, Cordyceps mycelium 15.0%, Radix Sophorae Flavescentis 15.0%, 10.0%, 2 kind of auxiliary composition sum of Semen Persicae is 10.0% of a fundamental component total amount.

Embodiment 4

Prescription is as table 1, method is with embodiment 3, the group medicine does not have Carapax Trionycis and Radix Angelicae Sinensis to be handled, and adds before the pulverizing of Ganoderma spore powder in (3) process and handles jointly with other composition, wherein, Radix Salviae Miltiorrhizae 40.0% in the fundamental component, the Radix Astragali 30.0%, Cordyceps mycelium 12.0%, Radix Sophorae Flavescentis 13.0%, 5.0%, 5 kind of auxiliary composition sum of Semen Persicae is 15.0% of a fundamental component total amount.

Embodiment 5

Prescription is as table 1, and method is with embodiment 4, and wherein, Radix Salviae Miltiorrhizae 35.9% in the fundamental component, the Radix Astragali 25.6%, and Cordyceps mycelium 15.4%, Radix Sophorae Flavescentis 15.4%, 7.7%, 10 kind of auxiliary composition sum of Semen Persicae is 18.6% of a fundamental component total amount.

Embodiment 6

Prescription is as table 1, and method is the same, and wherein, Radix Salviae Miltiorrhizae 33.0% in the fundamental component, the Radix Astragali 22.0%, and Cordyceps 20.0%, Radix Sophorae Flavescentis 20.0%, 5.0%, a kind of auxiliary composition of Semen Persicae is 10.0% of a fundamental component total amount.

Claims (3)

1, the hardened Chinese medicine composition of a kind of treatment hepatitis B heptic fibrosis regulating liver-QI, it is characterized in that: the raw material of compositions and weight percentage are:

A, Radix Salviae Miltiorrhizae 30%-40%

B, the Radix Astragali 20%30%

C, Cordyceps and/or Cordyceps 10%-20%

D, Radix Sophorae Flavescentis 10%-20%

E, Semen Persicae 5%-10%,

Described compositions is made by following step: (1) is boiled A, B, D, E and is carried secondary after pulverizing, mixing, after being cooled to 60 ℃ immediately after boiling for the first time, 60-45 ℃ of insulation 2-3 hour, after after boiling for the second time, being cooled to 60 ℃ immediately again, 60-45 ℃ of insulation 1-2 hour, concentrate after filtration,, get thick extractum, (2) C Cordyceps and/or Cordyceps mycelium are carried out vacuum drying, pulverizing, sieve fine powder, (3) thick extractum that (1), (2) process are obtained respectively and fine powder are evenly mixed, through vacuum drying, make preparation.

2, the described method for compositions of preparation claim 1 is characterized in that: after carrying out step (1), (2), (3) with described raw material, the mixture of thick extractum behind the vacuum drying and fine powder is pulverized and screening, granulated vacuum drying, granulate, tabletting and coating.

3, compositions according to claim 1, it is characterized in that: several conducts that also add any one or arbitrary proportion in the following raw material in the raw material add raw material, its total amount accounts for the 10%-20%:F Carapax Trionycis of the described composition material gross weight of claim 1, the G Flos Carthami, the H Radix Angelicae Sinensis, the I Caulis Spatholobi, the J Herba Phyllanthi Urinariae, K Radix Paeoniae Rubra, L Ganoderma or Ganoderma spore powder, the M Poria, the N Radix Puerariae, the O Radix Curcumae, make according to the following steps: (1) is with Radix Salviae Miltiorrhizae, the Radix Astragali, Semen Persicae and Radix Sophorae Flavescentis, with additional raw material Flos Carthami, Caulis Spatholobi, Radix Paeoniae Rubra, Poria, Herba Phyllanthi Urinariae, Radix Puerariae, in Radix Curcumae and the Radix Angelicae Sinensis one or more, boil jointly 2 times, be cooled to 60 ℃ immediately after boiling for the first time, 60-45 ℃ of insulation 2-3 hour, after boiling for the second time, be cooled to 60 ℃ immediately again, again 60-45 ℃ of insulation 1-2 hour, after filtration, concentrate, get thick extractum, wherein the Radix Angelicae Sinensis medicinal residues behind Radix Angelicae Sinensis employing Radix Angelicae Sinensis fine powder or the distillating extracting oil; (2) Cordyceps and/or Cordyceps mycelium are carried out vacuum drying, pulverizing, sieve fine powder; (3) thick extractum that (1), (2) step are obtained respectively and fine powder are mixed, vacuum drying, pulverizing and screening, granulation, vacuum drying, granulate, tabletting and coating; When in the additional raw material Carapax Trionycis being arranged, after step (2) is with the Carapax Trionycis processed with vinegar separately the Carapax Trionycis that obtains of decocting extract concentrated solution and Cordyceps and/or the common vacuum drying of Cordyceps mycelium, pulverizing, sieve fine powder; When in the additional raw material Ganoderma or Ganoderma spore powder being arranged, adding and pulverize jointly, sieve before the pulverizing of step (2) or (3) with other raw material.

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