CN103330881A - Traditional Chinese medicine pill for treating chronic-hepatitis hepatic fibrosis and preparation method thereof - Google Patents
Traditional Chinese medicine pill for treating chronic-hepatitis hepatic fibrosis and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine pill for treating chronic-hepatitis hepatic fibrosis and a preparation method thereof. The traditional Chinese medicine pill is prepared from hedyotis diffusa, acorus gramineus, red peony roots, panax pseudo-ginseng, polygonum orientale fruits, Angelica sinensis, honeycomb, radix sophorae flavescentis, leech, rhizoma sparganii, corydalis tuber, crinis carbonisatus, cowherb seeds, coix seeds, coptis roots, yam, rhizoma polygonati, white peony roots and spatholobus stems. Compared with the drugs for treating chronic-hepatitis hepatic fibrosis in the prior art, the traditional Chinese medicine composition has the advantages of good treatment effect, low cost, high curative ratio, little limitation, no adverse reactions and the like when the traditional Chinese medicine composition is adopted to treat chronic-hepatitis hepatic fibrosis.
Description
The application is that application number is 2012100258086, and denomination of invention is Chinese medicine composition and the preparation method of hepatic fibrosis " treatment chronic hepatitis ", and the applying date is the dividing an application of Chinese patent application on February 7th, 2012.
Technical field
The present invention relates to a kind of medicinal preparation, relate in particular to a kind of Chinese medicine composition that is used for the treatment of liver fibrosis
Thing.
Background technology
The fibrosis hepatopathy be because various paathogenic factors cause the change of hepatocyte fat, necrosis and inflammation, the collagen fiber hypertrophy takes place in the necrotic area then.Mainly from the fibroblast of hypertrophy, local depot fat cell and because of hepatic necrosis, local reticular fiber support subsides the collagen fiber hypertrophy, and reticular fiber merges and forms collagen fiber.Be not connected to each other as yet though the fibrous tissue of initial stage hypertrophy forms little bar rope and form at interval and during reconstruction lobules of liver structure, be called hepatic fibrosis.
Liver fibrosis is the common pathologic basis of various chronic hepatopathys, is that chronic hepatitis is to the only stage which must be passed by of liver cirrhosis and cancer development.Now confirm, the sickness rate of chronic hepatitis hepatic fibrosis is 59.4%, it is reported, hepatitis B virus and hepatitis C virus coinfection are evolved into hepatic fibrosis easily, Spain has research to observe the patient of 256 routine hepatitis B viruss and hepatitis C virus coinfection, and clinical data and Microscopic examination showed: 102 routine patients have the hepatic fibrosis in late period.
All histopathology change because hepatic fibrosis is development of chronic hepatitis to the liver cirrhosis process, are the important steps that influence the chronic hepatitis prognosis, and slowing down or stoping the hepatic fibrosis process is a considerable treatment countermeasure for the treatment of chronic hepatitis.China is the severely afflicated area of viral hepatitis, infection rate, sickness rate, mortality rate remain high, chronic hepatitis course of disease progress depends primarily on the speed of hepatic fibrosis, the speed that stops hepatic fibrosis in the hepatitis process of preventing to slow down becomes an important direction for the treatment of chronic hepatitis, in addition, the most basic treatment measure of liver cirrhosis also should be placed in the treatment of hepatic fibrosis, blocking-up, inhibition, reverse hepatic fibrosis can make the liver cirrhosis progress delay, stop to develop even alleviate to some extent.
The main pathology of hepatic fibrosis be characterized as extracellular matrix based on collagen (extra cellular matrix,
ECM) in the excess deposition of liver.Pathogenesis is that the various damage liver factors cause hepatocyte injury, and (hepatic stellate cell HSC) makes it be transformed into myofibroblast to activate hepatic stellate cell.The hepatocyte of damage and regeneration, Kupffer cell, hole endotheliocyte, NKT (NK) cell etc. produce immune mediator and cytokine under inflammatory factor, toxin etc. stimulate, mode with autocrine or paracrine acts on receptor in target cell, make myofibroblast propagation, synthetic a large amount of ECM.
Over nearly 20 years, hepatic fibrosis is obtaining certain progress, but in dried fibrosis clinical treatment field, is not obtaining tangible progress as the important international problem of hepatopathy research field aspect the research of hepatic fibrosis startup and progress substrate.The modern medicine aspect, many Western medicine are because the anti-fibrosis effect target position is single, and therapeutic effect is the woods Xiang not, and some poisonous side effect of medicine should not be used for clinical greater than therapeutical effect.
Chinese medicine is reversing hepatic fibrosis and improving clinical symptoms and showed good prospect, especially in Chinese medicine compound
Anti-hepatic fibrosis mechanisms research and experimental treatment aspect.Part Study progressively has been deep into from cell, molecular level to set forth Chinese medicine anti-hepatic fibrosis mechanisms and compound compatibility principle, numerous studies show that, in the treatment of hepatic fibrosis, Chinese medicine compound can effectively be improved patient's symptom, sign and liver function, reduce the serological index of hepatic fibrosis, have well protect the liver, the effect of anti-hepatic fibrosis.Therefore Chinese medicine has become the focus that prevents hepatic fibrosis in recent years in recent years.
Summary of the invention
Technical problem to be solved by this invention is, overcomes the deficiency of existing western medicine chronic hepatitis hepatic fibrosis,
Utilize the traditional theory of Chinese medical science of China, the Chinese medicine composition of the treatment chronic hepatitis hepatic fibrosis that provide a kind of good effect, cost is low, cure rate is high, limitation is little, has no adverse reaction.
In order to solve the problems of the technologies described above, the invention provides a kind of Chinese medicine composition that is used for the treatment of the chronic hepatitis hepatic fibrosis, it comprises: Herba Hedyotidis Diffusae, Rhizoma Acori Graminei, Radix Paeoniae Rubra, Radix Notoginseng, Fructus Polygoni Orientalis, Radix Angelicae Sinensis, Nidus Vespae, Radix Sophorae Flavescentis, Hirudo, rhizoma sparganic, Rhizoma Corydalis, Crinis Carbonisatus, Semen Vaccariae, Semen Coicis, Rhizoma Coptidis, Rhizoma Dioscoreae, Rhizoma Polygonati, the Radix Paeoniae Alba and Caulis Spatholobi.
Wherein, the ratio of weight and number of various components is Herba Hedyotidis Diffusae 13～17 weight portions, Rhizoma Acori Graminei 10～15 weight portions, Radix Paeoniae Rubra 13～17 weight portions, Radix Notoginseng 35～45 weight portions, Fructus Polygoni Orientalis 27～35 weight portions, Radix Angelicae Sinensis 20～25 weight portions, Nidus Vespae 10～14 weight portions, Radix Sophorae Flavescentis 15～21 weight portions, Hirudo 15～20 weight portions, rhizoma sparganic 18～22 weight portions, Rhizoma Corydalis 16～20 weight portions, Crinis Carbonisatus 20～24 weight portions, Semen Vaccariae 18～22 weight portions, Semen Coicis 8～12 weight portions, Rhizoma Coptidis 12～16 weight portions, Rhizoma Dioscoreae 20～25 weight portions, Rhizoma Polygonati 25～30 weight portions, the Radix Paeoniae Alba 15～19 weight portions and Caulis Spatholobi 19～23 weight portions.
Wherein, the weight fraction of various components is than also being, Herba Hedyotidis Diffusae 15～17 weight portions, Rhizoma Acori Graminei 13～15 weight portions, Radix Paeoniae Rubra 15～17 weight portions, Radix Notoginseng 40～45 weight portions, Fructus Polygoni Orientalis 31～35 weight portions, Radix Angelicae Sinensis 22～25 weight portions, Nidus Vespae 12～14 weight portions, Radix Sophorae Flavescentis 17～21 weight portions, Hirudo 17～20 weight portions, rhizoma sparganic 20～22 weight portions, Rhizoma Corydalis 18～20 weight portions, Crinis Carbonisatus 22～24 weight portions, Semen Vaccariae 20～22 weight portions, Semen Coicis 10～12 weight portions, Rhizoma Coptidis 14～16 weight portions, Rhizoma Dioscoreae 23～25 weight portions, Rhizoma Polygonati 27～30 weight portions, the Radix Paeoniae Alba 17～19 weight portions and Caulis Spatholobi 21～23 weight portions.
Wherein, the dosage form of described Chinese medicine composition can be refined pill, hydration pill, decoct, capsule, tablet, drop pill, oral liquid, powder, spray, soft extract, extractum for honey.
The present invention also provides the Chinese medicine composition tablet, and the preparation method of described tablet comprises the steps,
The first step, with Radix Paeoniae Rubra, Radix Notoginseng, Fructus Polygoni Orientalis, Radix Angelicae Sinensis, Hirudo, rhizoma sparganic, Rhizoma Corydalis, Crinis Carbonisatus, Semen Vaccariae, the Radix Paeoniae Alba and Caulis Spatholobi mix in described ratio, the adding determining alcohol is 90%～95% ethanol, heating and refluxing extraction 1～3 time, each 2 hours～4 hours, the amount of the ethanol that adds is 2～4 times of first step mixture quality, extracting solution is merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.5g crude drug/mL～0.8g crude drug/mL, sucking filtration, the relative density of filtrate is 1.08～1.10 (20 ℃), above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, and with deionized water or the distilled water eluting of 10 times of resin column volumes, the determining alcohol with 5 times of resin column volumes is 95% ethanol elution more earlier, collect ethanol elution, concentrate and be dried to powder;
Second step, remaining component is mixed in proportion, be that 80%～90% ethanol is as solvent with determining alcohol, flooded 12 hours～18 hours, adopt percolation (" Chinese pharmacopoeia version appendix in 2010 I O) with the speed of per minute 1～2ml percolation slowly, collect percolate, concentrate and be dried to powder, wherein, the amount of the ethanol of adding is second step 2～4 times of mixture quality;
The 3rd step, powder with the first step and the acquisition of second step, adding starch and determining alcohol is 60%～75% ethanol, heating is concentrated into pasty state, put into baking oven, control is at 70 ℃ ~ 90 ℃, the cooling of oven dry back, film-making, drying, molding, the mass ratio of the mixed-powder that the quality of the ethanol that adds and the 3rd step obtain is 1:1～1:3, the mass ratio of the mixed-powder that the quality of the starch that adds and the 3rd step obtain also provides the Chinese medicine composition oral liquid for 1:3～1:5 the present invention, and the preparation method of described oral liquid comprises the steps
The first step, with Radix Paeoniae Rubra, Radix Notoginseng, Fructus Polygoni Orientalis, Radix Angelicae Sinensis, Hirudo, rhizoma sparganic, Rhizoma Corydalis, Crinis Carbonisatus, Semen Vaccariae, the Radix Paeoniae Alba and Caulis Spatholobi mix in described ratio, the adding determining alcohol is 90%～95% ethanol, heating and refluxing extraction 1～3 time, each 2 hours～4 hours, the amount of the ethanol that adds is 2～4 times of first step mixture quality, extracting solution is merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.5g crude drug/mL～0.8g crude drug/mL, sucking filtration, the relative density of filtrate is 1.08～1.10 (20 ℃), above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, and with deionized water or the distilled water eluting of 10 times of resin column volumes, the determining alcohol with 5 times of resin column volumes is 95% ethanol elution more earlier, collect ethanol elution, concentrate and be dried to powder;
Second step, remaining component is mixed in proportion, be that 80%～90% ethanol is as solvent with determining alcohol, flooded 12 hours～18 hours, adopt percolation (" Chinese pharmacopoeia version appendix in 2010 I O) with the speed of per minute 1～2ml percolation slowly, collect percolate, concentrate and be dried to powder, wherein, the amount of the ethanol of adding is second step 2～4 times of mixture quality;
The 3rd step, with described powder, add water, the quality of the water that adds is 1～1.5 times of described powder amount, mixing, cold preservation 24 hours～48 hours, filter, add cane sugar powder, active carbon in the filtrate, carry out heat treated, filtration treatment, embedding processing, sterilization treatment successively, obtain oral liquid; The weight ratio of described filtrate and cane sugar powder is 1: 0.1～0.3; The weight ratio of described filtrate and active carbon is 1: 0.001～0.002; The described heat treated time is 20～40 minutes, and temperature is 100 ℃～110 ℃, and the crude drug concentration in the described oral liquid is 1.0 g/mL～1.5g/mL.
The present invention also provides the Chinese medicine composition drop pill, the preparation method of described drop pill comprises the steps, the first step, with Radix Paeoniae Rubra, Radix Notoginseng, Fructus Polygoni Orientalis, Radix Angelicae Sinensis, Hirudo, rhizoma sparganic, Rhizoma Corydalis, Crinis Carbonisatus, Semen Vaccariae, the Radix Paeoniae Alba and Caulis Spatholobi mix in described ratio, the adding determining alcohol is 90%～95% ethanol, heating and refluxing extraction 1～3 time, each 2 hours～4 hours, the amount of the ethanol that adds is 2～4 times of first step mixture quality, extracting solution is merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.5g crude drug/mL～0.8g crude drug/mL, sucking filtration, the relative density of filtrate is 1.08～1.10 (20 ℃), above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, and with deionized water or the distilled water eluting of 10 times of resin column volumes, the determining alcohol with 5 times of resin column volumes is 95% ethanol elution more earlier, collect ethanol elution, concentrate and be dried to powder;
Second step, remaining component is mixed in proportion, be that 80%～90% ethanol is as solvent with determining alcohol, flooded 12 hours～18 hours, adopt percolation (" Chinese pharmacopoeia version appendix in 2010 I O) with the speed of per minute 1～2ml percolation slowly, collect percolate, concentrate and be dried to powder, wherein, the amount of the ethanol of adding is second step 2～4 times of mixture quality;
The 3rd step, get the Polyethylene Glycol heating and melting that respectively adds 3～5 times of quality of constituent mass sum with respect to described Chinese medicine, treat to add the powder that the first step and second goes on foot acquisition after the complete fusion, stirring makes to be mixed makes spice, temperature control is at 40～90 ℃, froth breaking is left standstill in insulation, spice is placed pill in the water dropper jar of drop pill machine, control water dropper temperature is at 40～90 ℃, with dimethicone or the cooling of liquid paraffin liquid coolant, the temperature control of dimethicone or liquid paraffin is collected the semi-finished product drop pill at 0～20 ℃, remove the liquid coolant on surface, make drop pill.
The present invention also provides the preparation method of described Chinese medicine composition, when the dosage form of described Chinese medicine composition is tablet
The time, comprise the steps,
The first step, with Radix Paeoniae Rubra, Radix Notoginseng, Fructus Polygoni Orientalis, Radix Angelicae Sinensis, Hirudo, rhizoma sparganic, Rhizoma Corydalis, Crinis Carbonisatus, Semen Vaccariae, the Radix Paeoniae Alba and
Caulis Spatholobi mixes in described ratio, the adding determining alcohol is 90%～95% ethanol, heating and refluxing extraction 1～3 time, each 2 hours～4 hours, the amount of the ethanol that adds is 2～4 times of first step mixture quality, extracting solution is merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.5g crude drug/mL～0.8g crude drug/mL, sucking filtration, the relative density of filtrate are 1.08～1.10 (20 ℃), and above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first deionized water or distilled water eluting with 10 times of resin column volumes, determining alcohol with 5 times of resin column volumes is 95% ethanol elution again, collects ethanol elution, concentrates and be dried to powder;
Second step, remaining component is mixed in proportion, be that 80%～90% ethanol is as solvent with determining alcohol, flooded 12 hours～18 hours, adopt percolation (" Chinese pharmacopoeia version appendix in 2010 I O) with the speed of per minute 1～2ml percolation slowly, collect percolate, concentrate and be dried to powder, wherein, the amount of the ethanol of adding is second step 2～4 times of mixture quality;
The 3rd step, powder with the first step and the acquisition of second step, adding starch and determining alcohol is 60%～75% ethanol, heating is concentrated into pasty state, puts into baking oven, and control is at 70 ℃ ~ 90 ℃, the cooling of oven dry back, film-making, drying, molding, the mass ratio of the mixed-powder that the quality of the ethanol of adding and the 3rd step obtain is 1:1～1:3, the mass ratio of the mixed-powder that the quality of the starch of adding and the 3rd step obtain is 1:3～1:5
The present invention also provides the preparation method of described Chinese medicine composition, when the dosage form of described Chinese medicine composition is oral liquid, comprises the steps,
The first step, with Radix Paeoniae Rubra, Radix Notoginseng, Fructus Polygoni Orientalis, Radix Angelicae Sinensis, Hirudo, rhizoma sparganic, Rhizoma Corydalis, Crinis Carbonisatus, Semen Vaccariae, the Radix Paeoniae Alba and Caulis Spatholobi mix in described ratio, the adding determining alcohol is 90%～95% ethanol, heating and refluxing extraction 1～3 time, each 2 hours～4 hours, the amount of the ethanol that adds is 2～4 times of first step mixture quality, extracting solution is merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.5g crude drug/mL～0.8g crude drug/mL, sucking filtration, the relative density of filtrate is 1.08～1.10 (20 ℃), above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, and with deionized water or the distilled water eluting of 10 times of resin column volumes, the determining alcohol with 5 times of resin column volumes is 95% ethanol elution more earlier, collect ethanol elution, concentrate and be dried to powder;
Second step, remaining component is mixed in proportion, be that 80%～90% ethanol is as solvent with determining alcohol, flooded 12 hours～18 hours, adopt percolation (" Chinese pharmacopoeia version appendix in 2010 I O) with the speed of per minute 1～2ml percolation slowly, collect percolate, concentrate and be dried to powder, wherein, the amount of the ethanol of adding is second step 2～4 times of mixture quality;
The 3rd step, with described powder, add water, the quality of the water that adds is 1～1.5 times of described powder amount, mixing, cold preservation 24 hours～48 hours, filter, add cane sugar powder, active carbon in the filtrate, carry out heat treated, filtration treatment, embedding processing, sterilization treatment successively, obtain oral liquid; The weight ratio of described filtrate and cane sugar powder is 1: 0.1～0.3; The weight ratio of described filtrate and active carbon is 1: 0.001～0.002; The described heat treated time is 20～40 minutes, and temperature is 100 ℃～110 ℃, and the crude drug concentration in the described oral liquid is 1.0 g/mL～1.5g/mL.
The present invention also provides the preparation method of described Chinese medicine composition, when the dosage form of described Chinese medicine composition is drop pill
The time, comprise the steps,
The first step, with Radix Paeoniae Rubra, Radix Notoginseng, Fructus Polygoni Orientalis, Radix Angelicae Sinensis, Hirudo, rhizoma sparganic, Rhizoma Corydalis, Crinis Carbonisatus, Semen Vaccariae, the Radix Paeoniae Alba and Caulis Spatholobi mix in described ratio, the adding determining alcohol is 90%～95% ethanol, heating and refluxing extraction 1～3 time, each 2 hours～4 hours, the amount of the ethanol that adds is 2～4 times of first step mixture quality, extracting solution is merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.5g crude drug/mL～0.8g crude drug/mL, sucking filtration, the relative density of filtrate is 1.08～1.10 (20 ℃), above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, and with deionized water or the distilled water eluting of 10 times of resin column volumes, the determining alcohol with 5 times of resin column volumes is 95% ethanol elution more earlier, collect ethanol elution, concentrate and be dried to powder;
Second step, remaining component is mixed in proportion, be that 80%～90% ethanol is as solvent with determining alcohol, flooded 12 hours～18 hours, adopt percolation (" Chinese pharmacopoeia version appendix in 2010 I O) with the speed of per minute 1～2ml percolation slowly, collect percolate, concentrate and be dried to powder, wherein, the amount of the ethanol of adding is second step 2～4 times of mixture quality;
The 3rd step, get the Polyethylene Glycol heating and melting that respectively adds 3～5 times of quality of constituent mass sum with respect to described Chinese medicine, treat to add the powder that the first step and second goes on foot acquisition after the complete fusion, stirring makes to be mixed makes spice, temperature control is at 40～90 ℃, froth breaking is left standstill in insulation, spice is placed pill in the water dropper jar of drop pill machine, control water dropper temperature is at 40～90 ℃, with dimethicone or the cooling of liquid paraffin liquid coolant, the temperature control of dimethicone or liquid paraffin is collected the semi-finished product drop pill at 0～20 ℃, remove the liquid coolant on surface, make drop pill.
[0019] beneficial effect of the present invention: with respect to the medicine that is used for the treatment of the chronic hepatitis hepatic fibrosis of the prior art, adopt this Chinese medicine composition to the chronic hepatitis treating liver fibrosis have good effect, advantage such as cost is low, cure rate is high, limitation is little, have no adverse reaction.
The specific embodiment
[0021] hepatic fibrosis, disease categories such as the angelica traditional Chinese medical science " hypochondriac pain ", " gathering ", " mass in the abdomen ", the Jing-Yue Complete Works speech ": the disease of gathering; all diet; vim and vigour, the genus of cold in blood all can cause it ", from previously discussing the many and drinking and eating irregularly of formation of this disease as can be seen, damp and hot gathering, the irritability blood stagnation has the pass.Initial stage phlegm-damp stasis of blood resistance, liver be with impaired, hematogenous blockage, and wasting QI-blood with the passing of time, blood fortune is unable, and the stasis of blood hinders benefit very, and the liver network blocks for it, and the liver body is injured, and causes " gathering ".Based on the above-mentioned cause of disease, Chinese medicine composition of the present invention forms with the method for benefiting QI and nourishing blood with blood blood stasis dispelling assistant, comprises following component: Herba Hedyotidis Diffusae: bitter in the mouth, sweet, and cold in nature, go into the heart, liver, spleen, large intestine channel, have heat-clearing and toxic substances removing, the effect of promoting diuresis to eliminate damp pathogen is used for dyspnea and cough due to lung-heat, laryngopharynx swelling and pain, acute appendicitis, furuncle and phyma skin infection, venom, the puckery pain of pyretic stranguria, edema, dysentery, enteritis, jaundice due to damp-heat, cards such as cancerous protuberance often utilize Herba Hedyotidis Diffusae eliminating damp-heat, suppressing the hyperactive liver eliminating stagnation, treatment hepatitis.
Rhizoma Acori Graminei: acrid in the mouth, warm in nature, go into the heart, the stomach warp has waking up the patient from unconsciousness by dissipating phlegm, the removing dampness circulation of qi promoting, the sharp numbness of dispeling the wind, the effect of reducing swelling and alleviating pain is used for the treatment of expectorant and covers clear key, it is logical that coma, this product suffering are opened bitter dry temperature, and fragrance is walked to scurry, the merit that the refreshment of having one's ideas straightened out is not only arranged, and have removing dampness concurrently, eliminating phlegm is warded off dirty effect so be good at that to control the mind that the foul heresy of phlegm-damp hoodwinks due to the key clearly dazed and confused; Also be used for the treatment of retention of dampness in middle-JIAO, gastral cavity abdomen feeling of fullness, feeling of distension and oppression pain.The hot temperature fragrance of this product, kind removing dampness is turbid, the stomach of being amusing, circulation of qi promoting stagnate, relieving distension is full; Also be used for the treatment of forgetful, the insomnia, tinnitus, deafness.These product are gone into heart channel, happy key, beneficial intelligence, tranquilizing mind, hearing-improing and eyesight improving.
Radix Paeoniae Rubra: bitter in the mouth, cold nature is gone into Liver Channel; have clearing away heat and cooling blood, the effect of eliminating stasis to stop pain is used for maculae caused by violent heat pathogen; hematemesis and epistaxis, conjunctival congestion and swelling pain, hypochondriac pain due to stagnation of liverQI; the amenorrhea dysmenorrhea, lump in the abdomen stomachache, injury from falling down; the carbuncle skin infection, Radix Paeoniae Rubra can improve the level of plasma fibronectin linking protein (PFN), thereby strengthens the phagocytic function of reticuloendothelial system and strengthen OA; with the protection hepatocyte, prevent the liver immunologic injury and promote liver cell regeneration.
Radix Notoginseng: warm in nature, sweet in the mouth; little hardship is returned liver; the stomach warp; has hemostasis, dissipating blood stasis, detumescence; the effect of pain relieving; cure mainly: control haematemesis, hemoptysis, epistaxis; have blood in stool; dysentery, metrorrhagia, lump in the abdomen; puerperal blood faints; retention of lochia falls and pounces on blood stasis, traumatic hemorrhage; cards such as carbuncle pain; modern pharmacology proves that Radix Notoginseng can be stopped blooding; antithrombotic; promote hemopoietic; antiinflammatory; protect the liver; antitumor; analgesia; cardiovascular there is good effect, myocardial damage is had protective effect; Radix Notoginseng can significantly reduce glutamate pyruvate transaminase (ALT); globulin (CLB); the content of laminin (LN) and hepatic tissue Hyp; can significantly the raise content of low albumin (ALB) in the serum can significantly reduce the level of TGF-b1 and IL-1 in the patients with liver fibrosis serum, alleviates the degree of hepatic fibrosis.
Fructus Polygoni Orientalis: salty in the mouth, cold nature is gone into liver, stomach warp, have promoting flow of QI and blood, the effect of hard masses softening and resolving is used for abdominal distention, hepatosplenomegaly, the tuberculosis of cervical lymph nodes, cards such as clearing away heat to improve acuity of vision, Radix Angelicae Sinensis: sweet in the mouth, suffering, warm in nature, go into liver, the heart, spleen channel, enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, the effect of loosening bowel to relieve constipation, be mainly used in blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.Be used for cards such as blood deficiency and yellow complexion, dizzy cardiopalmus, menoxenia, amenorrhea dysmenorrhea, asthenia cold abdominalgia, dryness of the intestine constipation, rheumatic arthralgia, injury from falling down, ulcer sores, its can improve the uterus blood circulation, alleviate pelvic congestion, relieving dysmenorrhea, immunity that can enhancing body.
Nidus Vespae: sweet in the mouth, property is flat, goes into the stomach warp, has wind-expelling pain-stopping, the counteracting toxic substances detumescence, the effect of killing parasites for relieving itching is used for rheumatoid arthritis stubborn, wind carious pain, skin sore, laryngopharynx swelling and pain, rubella pruritus, sexual impotence, cards such as the enuresis.
Radix Sophorae Flavescentis: bitter in the mouth, cold in nature, go into liver, kidney, large intestine, small intestinal, bladder, heart channel, has heat clearing and damp drying, the effect of wind dispelling insecticide, cure mainly damp-heat dysentery, discharging fresh blood stool, jaundice; dysuria; edema; leukorrhagia; pudendal pruritus, scabies, leprosy; skin pruritus; cards such as noxious dampness skin infection, Radix Sophorae Flavescentis is to TGF-b1; tumor necrosis factor-a (TNF-a) level has tangible reduction effect, thereby suppresses the hepatic stellate cell activation; reduce and discharge ECM; and the effect of performance anti-hepatic fibrosis is expressed for having the I of inhibition Collagen Type VI; promote collagenase synthetic; influence the ECM deposition; delaying IL-10 of hepatic fibrosis process effect has and significantly increase effect, and Radix Sophorae Flavescentis is also by reducing the generation of malonaldehyde (MDA); alleviate hepatic injury; suppress the generation of hydroxyproline in the liver, produces the effect of anti-hepatic fibrosis, and Radix Sophorae Flavescentis can be by regulating the t lymphocyte subsets of peripheral blood disorder; improve cell immune response; effectively suppress copying of hepatitis B virus gene (HBV-DNA) virus, hepatic fibrosis index level among the reduction patients serum, and then reach the scavenger cell inner virus; prevent and treat the purpose of hepatic fibrosis.
Hirudo: salty in the mouth, hardship, property is flat, goes into Liver Channel, effect with removing blood stasis is used for the blood stasis amenorrhea, the treatment of diseases such as lump in the abdomen stomachache, blood-retention, traumatic blood stasis are had a pain, carbuncle erysipelas, Hirudo can be eliminated tremulous pulse week and be raised plaque, increases the myocardial nutrition blood flow, improves arrhythmia.
Rhizoma sparganic: bitter in the mouth, suffering, property is flat, goes into liver, spleen channel, have the removing blood stasis circulation of qi promoting, the effect of removing food stagnancy pain relieving is used for the blood stasis amenorrhea, dysmenorrhea, the stasis of blood stagnated and suffered from abdominal pain lump in the abdomen mass in the abdomen in the abdomen, stagnation of QI due to dyspepsia puerperal, cards such as abdominal distention, rhizoma sparganic can make hepatocellular degeneration, and necrosis and ultrastructural change thereof take a turn for the worse, and the proliferation of fibrous tissue degree alleviates.
Rhizoma Corydalis: bitter in the mouth, suffering, warm in nature, go into liver, the heart, stomach warp, benefaction is wandered away, can rise and can fall, have promoting blood circulation to remove blood stasis, the effect of promoting the circulation of QI to relieve pain cures mainly obstruction of qi in the chest and cardialgia, side of body rib, all pains of gastral cavity abdomen, headache, lumbago, colicky, bones and muscles pain, dysmenorrhea, amenorrhea, puerperal, the stasis of blood was suffered from abdominal pain, cards such as traumatic injury.
Crinis Carbonisatus: bitter in the mouth, property is put down, and goes into liver, stomach warp, has hemostasis, repercussive, diuresis, the effect of granulation promoting is used for cards such as haematemesis, epistaxis, dysentery, stranguria with blood, woman uterine bleeding and dysuria, endure cream external application hemostasia and promoting granulation, Crinis Carbonisatus can significantly shorten clotting time of mice, and bleeding time and amount of bleeding have stronger effect to staphylococcus aureus, Bacillus typhi, paratyphoid bacillus A and shigella flexneri.
Semen Vaccariae: bitter in the mouth, property is flat, goes into liver, and the stomach warp has promoting blood circulation to restore menstrual flow, the stimulating milk secretion eliminating carbuncle, the effect of inducing diuresis for treating stranguria syndrome cures mainly the blood stasis amenorrhea, dysmenorrhea, difficult labour; Lack of lactation after delivery, acute mastitis swells and ache; Pyretic stranguria, stranguria with blood, cards such as stranguria caused by urinary stone, " book on Chinese herbal medicine is stated ": Semen Vaccariae, gain the name according to it, seemingly walk and do not keep, its promoting the circulation of blood when with Radix Carpesii with also.So carefully unraveling silk all " book on Chinese herbal medicine " cures mainly, feel has different slightly, namely " solar corona " main blood through irregular and " not record " have difficult labour and two say, then should be with blood and work, have very with promoting the circulation of blood that Fang Shuzhi poultry blood is seen in examination, be many with Du's Radix Achyranthis Bidentatae, but thing specially moves in all pouring, more can bright its looses to stagnate to invigorate blood circulation, non-to burst be thing person also.But this flavor should be gone into liver, and the solid blood of liver is dirty, more takes charge of little water, thus control drench indispensable, and wind dirty be that blood is dirty, unravel silk Zhen Quan and control pathogenic wind toxic, promoting blood circulation two languages, be to see that this distinguishes the flavor of to cut especially in the moon of fainting.
Semen Coicis: cool in nature, sweet in the mouth, light is returned spleen, stomach, lung meridian.Function with spleen invigorating eliminating dampness by diuresis, clearing away heat and discharging pus, eliminating impediment, diuretic is used for weakness of the spleen and stomach, loose stool diarrhoea, or vaginal discharge diseases of women, and the insufficiency of the spleen leading to overabundance of dampness edema, dysuria, or beriberi swells and ache; Damp and hot arthralgia pain, contracture of the limbs, miserable pain; Lung abscess cough and spit purulent sputum, or enterodynia contracture stomachache." book on Chinese herbal medicine newly organized ": the kind diuretic of Semen Coicis, the gas that unlikely loss is Kidney-Yin, all wet persons that is contained in the lower part of the body the most suitablely use it, look the weight of disease, widow more than the mutatis mutandis medicine, then negative and positive are not hindered, and damp disease is easily gone.So the disease that all chance water is wet is monarch with Semen Coicis one, two liang, and the flavor that the spleen invigorating of assistant is dried, do not have not fast in the person of proving effective also, if thin its abnormal smells from the patient gentle and gently use it is also unhelpful.
Rhizoma Coptidis: bitter in the mouth, cold in nature, go into the heart, lung, gallbladder, stomach, large intestine channel, heat clearing and damp drying is arranged, eliminating fire and detoxication, the effect of cooling blood for improving eyesight is usually used in treating the fire of removing pathogen in the heart warp, the dysphoria and insomnia that heart-fire is prosperous, and the high fever coma of epidemic febrile disease, symptom such as vexed, thirsty; Also can be used for treating symptoms such as dysentery due to damp and hot, tenesmus.
Rhizoma Dioscoreae: sweet in the mouth, property are put down, go into lung, spleen, stomach warp, the spleen reinforcing nourishing the stomach is arranged, lung benefiting reinforces the kidney, the effect of YIN nourishing and the production of body fluid promoting cures mainly that weakness of the spleen and stomach, lassitude, inappetence, chronic diarrhea and dysentery, insufficiency of lung-QI are dry, diseases such as phlegm dyspnea cough, kidney qi loss, soreness of the waist and knees, lower limb flaccidity are weak, red swollen, the obesity of the frequent micturition of quenching one's thirst, seminal emission premature ejaculation, leukorrhagia nebulousurine, skin." book on Chinese herbal medicine just ": Rhizoma Dioscoreae, energy spleen invigorating tonify deficiency is grown essence and is reinforced the kidney, and controls weakness, treats five kinds of strain and seven kinds of impairment.The light property of its gas is slow, non-may be full-time, so the spleen reinforcing lung must be led ginseng, art, the kidney invigorating water must monarch Zhu,, puckery foul leukorrhea must be broken so with grinding, help mutually Gu spermatorrhea is held Herba cuscutae.All balls consolidate pill, also should smash the end for sticking with paste.Nature and flavor in a word
Weakness makes but can firmly help.
Rhizoma Polygonati: sweet in the mouth, property is flat, goes into lung, spleen, kidney channel, has the nourishing kidney lung moistening, and the effect of invigorating the spleen and replenishing QI is used for lung-dryness syndrome due to deficiency of YIN, and dry cough expectorant is few, the polydipsia of quenching one's thirst, weakness of the spleen and stomach, deficiency of spleen-QI or deficiency of spleen-YIN, deficiency of kidney essence, soreness of the waist and knees, cards such as early whitening of beard and hair.
The Radix Paeoniae Alba: bitter in the mouth, acid, cool in nature, go into liver, spleen channel, have nourishing blood to suppress the hyperactive liver, slow middle pain relieving; yin fluid astringing is received the effect of antiperspirant, cures mainly the breast abdomen pain over the hypochondriac region, dysentery stomachache, spontaneous sweating, fever due to yin deficiency; menoxenia, metrorrhagia, cards such as leukorrhagia, the Radix Paeoniae Alba has good liver-protective effect.
Caulis Spatholobi: bitter in the mouth, sweet, warm in nature, go into liver, kidney channel, blood vessel dilating is arranged, enrich blood and invigorate blood circulation, regulating menstruation, the effect of relaxing muscles and tendons and activating QI and blood in the collateral has the obvious suppression effect to platelet aggregation, promote animal kidney and the total phosphorus metabolism in uterus, be mainly used in treating the menoxenia that blood deficiency has silt, limbs pain is meciless, symptoms such as soreness of the waist and knees, pain.
Chinese medicine thinks that primary disease usually by the invasion and attack of exopathogen such as damp and hot, epidemic disease poison, keeps and do not go, and with the passing of time causes damp-heat accumulation, stasis of blood poison inner product and forms.Damp and hot evil poison is invaded human body, and pathogenic factor is delaied, and is difficult to go suddenly, delays with the passing of time, and it is the important pathogenesis of primary disease that damp-heat accumulation forms the stasis of blood.
In the whole pathological process of hepatic fibrosis, the resistance of the liver blood stasis of blood is carried throughout, with the passing of time consumes impairment of QI the moon, and zang-fu disharmony, its characteristic of disease are deficiency in origin and excess in superficiality, and the fooled deficiency and excess for the treatment of is also controlled.Speech in " treatise on blood trouble ": " blood stasis is not all right, then the disconnected no physiology of fresh blood ... blood stasis, both is not harmonious with good blood, and anti-and good blood is not on good terms " is quite reasonable so treat primary disease with the ruling by law of blood circulation promoting and blood stasis dispelling blood hard masses softening and resolving.Moreover the general course of disease of primary disease is long, easily consumes impairment of QI blood, causes the liver body and function all to decrease, and consumption gas is the deficiency of vital energy and make the capable stasis of gas then, and blood trouble is deficiency of YIN-blood and make blood vessels not smooth then.Qi being the governor of blood, qi promoting blood production, so the present invention takes to adopt the blood circulation promoting and blood stasis dispelling assistant with the method for benefiting QI and nourishing blood, each component is used in the utilization side; can strengthen the effect of blood circulation promoting and blood stasis dispelling, can make the QI and blood abundance again, blood is capable to be got freely; nourishing blood to suppress the hyperactive liver, and can protect healthy energy, in order to avoid send an expedition against too.
Further preferred, the described Chinese medicine composition that is used for the treatment of the chronic hepatitis hepatic fibrosis only is made of said components.
Wherein, the ratio of weight and number of various components can be preferably in the side: Herba Hedyotidis Diffusae 13～17 weight portions, Rhizoma Acori Graminei 10～15 weight portions, Radix Paeoniae Rubra 13～17 weight portions, Radix Notoginseng 35～45 weight portions, Fructus Polygoni Orientalis 27～35 weight portions, Radix Angelicae Sinensis 20～25 weight portions, Nidus Vespae 10～14 weight portions, Radix Sophorae Flavescentis 15～21 weight portions, Hirudo 15～20 weight portions, rhizoma sparganic 18～22 weight portions, Rhizoma Corydalis 16～20 weight portions, Crinis Carbonisatus 20～24 weight portions, Semen Vaccariae 18～22 weight portions, Semen Coicis 8～12 weight portions, Rhizoma Coptidis 12～16 weight portions, Rhizoma Dioscoreae 20～25 weight portions, Rhizoma Polygonati 25～30 weight portions, the Radix Paeoniae Alba 15～19 weight portions and Caulis Spatholobi 19～23 weight portions.
[0043] further, the ratio of weight and number of various components also can be preferably: Herba Hedyotidis Diffusae 15～17 weight portions, Rhizoma Acori Graminei 13～15 weight portions, Radix Paeoniae Rubra 15～17 weight portions, Radix Notoginseng 40～45 weight portions, Fructus Polygoni Orientalis 31～35 weight portions, Radix Angelicae Sinensis 22～25 weight portions, Nidus Vespae 12～14 weight portions, Radix Sophorae Flavescentis 17～21 weight portions, Hirudo 17～20 weight portions, rhizoma sparganic 20～22 weight portions, Rhizoma Corydalis 18～20 weight portions, Crinis Carbonisatus 22～24 weight portions, Semen Vaccariae 20～22 weight portions, Semen Coicis 10～12 weight portions, Rhizoma Coptidis 14～16 weight portions, Rhizoma Dioscoreae 23～25 weight portions, Rhizoma Polygonati 27～30 weight portions, the Radix Paeoniae Alba 17～19 weight portions and Caulis Spatholobi 21～23 weight portions.
Described Chinese medicine composition pharmaceutical dosage form can refine pill, hydration pill, decoct, capsule, tablet, drop pill, oral liquid, powder, spray, soft extract, extractum, more preferably tablet, drop pill, oral liquid for honey.
The Chinese medicine composition that the present invention is used for the treatment of the chronic hepatitis hepatic fibrosis can adopt the form of tablet for oral administration, its system
Preparation Method is as follows:
The first step, with Radix Paeoniae Rubra, Radix Notoginseng, Fructus Polygoni Orientalis, Radix Angelicae Sinensis, Hirudo, rhizoma sparganic, Rhizoma Corydalis, Crinis Carbonisatus, Semen Vaccariae, the Radix Paeoniae Alba and Caulis Spatholobi mix in described ratio, the adding determining alcohol is 90%～95% ethanol, heating and refluxing extraction 1～3 time, each 2 hours～4 hours, the amount of the ethanol that adds is 2～4 times of first step mixture quality, extracting solution is merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.5g crude drug/mL～0.8g crude drug/mL, sucking filtration, the relative density of filtrate is 1.08～1.10 (20 ℃), above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, and with deionized water or the distilled water eluting of 10 times of resin column volumes, the determining alcohol with 5 times of resin column volumes is 95% ethanol elution more earlier, collect ethanol elution, concentrate and be dried to powder;
Second step, remaining component is mixed in proportion, be that 80%～90% ethanol is as solvent with determining alcohol, flooded 12 hours～18 hours, adopt percolation (" Chinese pharmacopoeia version appendix in 2010 I O) with the speed of per minute 1～2ml percolation slowly, collect percolate, concentrate and be dried to powder, wherein, the amount of the ethanol of adding is second step 2～4 times of mixture quality;
The 3rd step, powder with the first step and the acquisition of second step, adding starch and determining alcohol is 60%～75% ethanol, and heating is concentrated into pasty state, puts into baking oven, control is at 70 ℃ ~ 90 ℃, the cooling of oven dry back, film-making, drying, molding, the mass ratio of the mixed-powder that the quality of the ethanol of adding and the 3rd step obtain is 1:1～1:3, the mass ratio of the mixed-powder that the quality of the starch that adds and the 3rd step obtain is 1:3～1:5, and the specification of the tablet that makes is 0.2 g/ sheet～0.4g/ sheet.
[0046] the present invention's Chinese medicine composition of being used for the treatment of the chronic hepatitis hepatic fibrosis can also adopt the mode of oral liquid for oral administration, and its preparation method is as follows:
The first step, with Radix Paeoniae Rubra, Radix Notoginseng, Fructus Polygoni Orientalis, Radix Angelicae Sinensis, Hirudo, rhizoma sparganic, Rhizoma Corydalis, Crinis Carbonisatus, Semen Vaccariae, the Radix Paeoniae Alba and Caulis Spatholobi mix in described ratio, the adding determining alcohol is 90%～95% ethanol, heating and refluxing extraction 1～3 time, each 2 hours～4 hours, the amount of the ethanol that adds is 2～4 times of first step mixture quality, extracting solution is merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.5g crude drug/mL～0.8g crude drug/mL, sucking filtration, the relative density of filtrate is 1.08～1.10 (20 ℃), above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, and with deionized water or the distilled water eluting of 10 times of resin column volumes, the determining alcohol with 5 times of resin column volumes is 95% ethanol elution more earlier, collect ethanol elution, concentrate and be dried to powder;
Second step, remaining component is mixed in proportion, be that 80%～90% ethanol is as solvent with determining alcohol, flooded 12 hours～18 hours, adopt percolation (" Chinese pharmacopoeia version appendix in 2010 I O) with the speed of per minute 1～2ml percolation slowly, collect percolate, concentrate and be dried to powder, wherein, the amount of the ethanol of adding is second step 2～4 times of mixture quality;
The 3rd step, with described powder, add water, the quality of the water that adds is 1～1.5 times of described powder amount, mixing, cold preservation 24 hours～48 hours, filter, add cane sugar powder, active carbon in the filtrate, carry out heat treated, filtration treatment, embedding processing, sterilization treatment successively, obtain oral liquid; The weight ratio of described filtrate and cane sugar powder is 1: 0.1～0.3; The weight ratio of described filtrate and active carbon is 1: 0.001～0.002; The described heat treated time is 20～40 minutes, and temperature is 100 ℃～110 ℃, and the crude drug concentration in the described oral liquid is 1.0 g/mL～1.5g/mL.
The Chinese medicine composition that the present invention is used for the treatment of the chronic hepatitis hepatic fibrosis can also adopt the mode of drop pill to use,
Its preparation method is as follows:
The first step, with Radix Paeoniae Rubra, Radix Notoginseng, Fructus Polygoni Orientalis, Radix Angelicae Sinensis, Hirudo, rhizoma sparganic, Rhizoma Corydalis, Crinis Carbonisatus, Semen Vaccariae, the Radix Paeoniae Alba and Caulis Spatholobi mix in described ratio, the adding determining alcohol is 90%～95% ethanol, heating and refluxing extraction 1～3 time, each 2 hours～4 hours, the amount of the ethanol that adds is 2～4 times of first step mixture quality, extracting solution is merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.5g crude drug/mL～0.8g crude drug/mL, sucking filtration, the relative density of filtrate is 1.08～1.10 (20 ℃), above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, and with deionized water or the distilled water eluting of 10 times of resin column volumes, the determining alcohol with 5 times of resin column volumes is 95% ethanol elution more earlier, collect ethanol elution, concentrate and be dried to powder;
Second step, remaining component is mixed in proportion, be that 80%～90% ethanol is as solvent with determining alcohol, flooded 12 hours～18 hours, adopt percolation (" Chinese pharmacopoeia version appendix in 2010 I O) with the speed of per minute 1～2ml percolation slowly, collect percolate, concentrate and be dried to powder, wherein, the amount of the ethanol of adding is second step 2～4 times of mixture quality;
The 3rd step, get the Polyethylene Glycol heating and melting that respectively adds 3～5 times of quality of constituent mass sum with respect to described Chinese medicine, treat to add the powder that the first step and second goes on foot acquisition after the complete fusion, stirring makes to be mixed makes spice, temperature control is at 40～90 ℃, froth breaking is left standstill in insulation, spice is placed pill in the water dropper jar of drop pill machine, control water dropper temperature is at 40～90 ℃, with dimethicone or the cooling of liquid paraffin liquid coolant, the temperature control of dimethicone or liquid paraffin is collected the semi-finished product drop pill at 0～20 ℃, remove the liquid coolant on surface, make drop pill.
In order to further specify problem, will above-mentioned preparation process be described by specific embodiment below:
The preparation of embodiment 1 Chinese medicine composition tablet of the present invention
(1) with 17g Radix Paeoniae Rubra, the 45g Radix Notoginseng, the 35g Fructus Polygoni Orientalis, the 25g Radix Angelicae Sinensis, the 20g Hirudo, the 22g rhizoma sparganic, the 20g Rhizoma Corydalis, the 24g Crinis Carbonisatus, the 22g Semen Vaccariae, the 19g Radix Paeoniae Alba and 23g Caulis Spatholobi mix, the adding determining alcohol is 95% ethanol 820g, heating and refluxing extraction 2 times, each 3 hours, extracting solution is merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.7g crude drug/mL, sucking filtration, the relative density of filtrate is 1.10 (20 ℃), above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first deionized water eluting with 10 times of resin column volumes, determining alcohol with 5 times of resin column volumes is 95% ethanol elution again, collect ethanol elution, concentrate and be dried to powder;
(2) 17g Herba Hedyotidis Diffusae, 15g Rhizoma Acori Graminei, 14g Nidus Vespae, 21g Radix Sophorae Flavescentis, 12g Semen Coicis, 16g Rhizoma Coptidis, 25g Rhizoma Dioscoreae, 30g Rhizoma Polygonati are mixed, be that 90% ethanol 450g is as solvent with determining alcohol, flooded 18 hours, adopt percolation with the speed of per minute 2ml percolation slowly, collect percolate, concentrate and be dried to powder;
(3) with the powder that obtains previously, adding starch 100g and determining alcohol is 75% ethanol 280g, and heating is concentrated into pasty state, puts into baking oven, and control is dried the back cooling at 90 ℃, and film-making, drying, molding obtain tablet, and the specification of tablet is 0.2 g/ sheet.
The preparation of embodiment 2 Chinese medicine composition drop pills of the present invention
(1) with 15g Radix Paeoniae Rubra, the 40g Radix Notoginseng, the 31g Fructus Polygoni Orientalis, the 22g Radix Angelicae Sinensis, the 17g Hirudo, the 20g rhizoma sparganic, the 18g Rhizoma Corydalis, the 22g Crinis Carbonisatus, the 20g Semen Vaccariae, the 17g Radix Paeoniae Alba and 21g Caulis Spatholobi mix, the adding determining alcohol is 95% ethanol 730g, heating and refluxing extraction 2 times, each 3 hours, extracting solution is merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.8g crude drug/mL, sucking filtration, the relative density of filtrate is 1.08 (20 ℃), above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first deionized water eluting with 10 times of resin column volumes, determining alcohol with 5 times of resin column volumes is 95% ethanol elution again, collect ethanol elution, concentrate and be dried to powder;
(2) 15g Herba Hedyotidis Diffusae, 13g Rhizoma Acori Graminei, 12g Nidus Vespae, 17g Radix Sophorae Flavescentis, 10g Semen Coicis, 14g Rhizoma Coptidis, 23g Rhizoma Dioscoreae, 27g Rhizoma Polygonati are mixed, be that 90% ethanol 400g is as solvent with determining alcohol, flooded 16 hours, adopt percolation with the speed of per minute 2ml percolation slowly, collect percolate, concentrate and be dried to powder;
(3) get 1500g Polyethylene Glycol heating and melting, treat to add the powder that obtains previously after the complete fusion, stir to make to be mixed and make spice, temperature control is at 70 ℃, froth breaking is left standstill in insulation, spice is placed pill in the water dropper jar of drop pill machine, control water dropper temperature is at 70 ℃, with dimethicone or the cooling of liquid paraffin liquid coolant, the temperature control of dimethicone or liquid paraffin is about 10 ℃, collect the semi-finished product drop pill, remove the liquid coolant on surface, make drop pill.
The preparation of embodiment 3 Chinese medicine composition oral liquids of the present invention
(1) with 17g Radix Paeoniae Rubra, the 45g Radix Notoginseng, the 35g Fructus Polygoni Orientalis, the 25g Radix Angelicae Sinensis, the 20g Hirudo, the 22g rhizoma sparganic, the 20g Rhizoma Corydalis, the 24g Crinis Carbonisatus, the 22g Semen Vaccariae, the 19g Radix Paeoniae Alba and 23g Caulis Spatholobi mix, the adding determining alcohol is 95% ethanol 820g, heating and refluxing extraction 2 times, each 3 hours, extracting solution is merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.7g crude drug/mL, sucking filtration, the relative density of filtrate is 1.10 (20 ℃), above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first deionized water eluting with 10 times of resin column volumes, determining alcohol with 5 times of resin column volumes is 95% ethanol elution again, collect ethanol elution, concentrate and be dried to powder;
(2) 17g Herba Hedyotidis Diffusae, 15g Rhizoma Acori Graminei, 14g Nidus Vespae, 21g Radix Sophorae Flavescentis, 12g Semen Coicis, 16g Rhizoma Coptidis, 25g Rhizoma Dioscoreae, 30g Rhizoma Polygonati are mixed, be that 90% ethanol 450g is as solvent with determining alcohol, flooded 18 hours, adopt percolation with the speed of per minute 2ml percolation slowly, collect percolate, concentrate and be dried to powder;
(3) with the powder that obtains, add 450g water, mixing, cold preservation 24 hours is filtered, and adds cane sugar powder 90g, active carbon 0.9g in the filtrate, carried out heat treated successively 30 minutes, heating-up temperature is 100 ℃, filtration treatment, embedding processing, sterilization treatment, obtains oral liquid, and the crude drug concentration in the described oral liquid is 1.2 g/mL.
Embodiment 4 concrete clinical experiments
1 case is selected
All from May, 2007～2010 year the court's outpatient service in April and inpatient, 167 routine patients are divided into treatment group and matched group by the prescription on individual diagnosis order to case at random.125 examples are organized in treatment, male 73 examples, women 52 examples, 18～52 years old age, average (37 ± 6. 2) year, the course of disease 1 year～7 years.Matched group 42 examples, male 28 examples, women 14 examples, 18～49 years old age, average (34 ± 6. 1) year, course of disease half a year～5 year, average (3 ± 1. 7) year.Two groups of patients learn comparison by statistics at aspects such as age, sex, severity extents, and difference does not have significance meaning (P〉0. 05).
[0052] 2 diagnostic criteria
Chronic hepatopathy and liver fibrosis diagnosis standard in " viral hepatitis is prevented and treated scheme " of 2000 the 6th time national infectious disease of reference and parasitic disease academic conference revision.Hepatic fibrosis serological index hyaluronic acid (HA normal value 2～110ug/L), III procollagen type (PC III normal value＜120 ug/L), laminin (LN normal value 98. 4～133.0ug/L) (all measuring with putting the method for exempting from) and alanine aminotransferase (ALT normal value＜40U/L) raise.
3 selected conditions
The equal HBV DNA of all cases positive, the HBeAg feminine gender, ALT raises, and renal function is normal, and B ultrasonic is got rid of liver cirrhosis.
4 Therapeutic Method
The treatment group adopts the Chinese medicine composition tablet of the embodiment of the invention 1, and is each 3, every day 3 times, oral, the treatment of matched group oral nifedipine sheet, 20mg/ time, 3 times/day, it is identical that enzyme treatment falls in two groups of hepatoprotective, and two groups was a course for the treatment of with equal 3 months all, treated 3 courses for the treatment of.
5 observation index
1. clinical symptoms, sign comprise weak, poor appetite, uncomfortable liver area etc.; 2. liver function: serum ALT (ALT), serum albumin (AIb), total bilirubin (TBiL); 3. serum fibrosis index: Serum hyaluronic acid (HA), layer connect glutinous (LN), serum III procollagen type (PC-III); More than every index before treatment and check when finishing per course for the treatment of, with the comprehensive observing clinical efficacy.
6 statistical method measurement datas are checked with t, enumeration data c2
Check.
7 results
7.1 the variation of two groups of patient's sings and symptomses
The two groups of patients in treatment back are weak, poor appetite, uncomfortable liver area all have improvement.Comparing difference does not have the significance meaning between two groups.
7.2 changes of liver function before and after two groups of treatments the results are shown in Table 1, by table 1 as can be seen, obvious variation has taken place in the patient treatment front and back liver function index of taking Chinese medicine composition of the present invention.
Changes of liver function comparison before and after the table 1 liang group patient treatment (
± s)
It is relatively preceding with the treatment of this group,
*P＜0. 05.
7.3 the variation of two groups of patient treatment front and back serum hepatic fibrosis indexs, the results are shown in Table 2, by table 2 as can be known, obvious variation has taken place in the serum hepatic fibrosis index before and after adopting traditional Chinese medicine composition for treating of the present invention, compare with matched group, adopt traditional Chinese medicine composition for treating liver fiber index of the present invention conversion more obvious, show that therapeutic effect is better.
Serum hepatic fibrosis index comparison before and after the table 2 liang group treatment (
± s, ng/mL)
It is relatively preceding with the treatment of this group,
*P＜0.05,
#P＜0.01; With comparison after the treatment of control group, △ P＜0.05.
This intellectual property of primary enforcement that all are above-mentioned is not set restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.
But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above only is preferred embodiment of the present invention, is not to be the restriction of the present invention being made other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not break away to any simple modification, equivalent variations and remodeling that above embodiment does, still belongs to the protection domain of technical solution of the present invention according to technical spirit of the present invention.
Claims (2)
1. the medicine pill for the treatment of chronic hepatitis hepatic fibrosis is characterized in that described Chinese medicinal tablet is made of Herba Hedyotidis Diffusae, Rhizoma Acori Graminei, Radix Paeoniae Rubra, Radix Notoginseng, Fructus Polygoni Orientalis, Radix Angelicae Sinensis, Nidus Vespae, Radix Sophorae Flavescentis, Hirudo, rhizoma sparganic, Rhizoma Corydalis, Crinis Carbonisatus, Semen Vaccariae, Semen Coicis, Rhizoma Coptidis, Rhizoma Dioscoreae, Rhizoma Polygonati, the Radix Paeoniae Alba and Caulis Spatholobi;
The weight fraction of each component is 15g Herba Hedyotidis Diffusae, 13g Rhizoma Acori Graminei, 15g Radix Paeoniae Rubra, 40g Radix Notoginseng, 31g Fructus Polygoni Orientalis, 22g Radix Angelicae Sinensis, 12g Nidus Vespae, 17g Radix Sophorae Flavescentis, 17g Hirudo, 20g rhizoma sparganic, 18g Rhizoma Corydalis, 22g Crinis Carbonisatus, 20g Semen Vaccariae, 10g Semen Coicis, 14g Rhizoma Coptidis, 23g Rhizoma Dioscoreae, 27g Rhizoma Polygonati, the 17g Radix Paeoniae Alba and 21g Caulis Spatholobi.
2. a preparation method for preparing the medicine pill for the treatment of chronic hepatitis as claimed in claim 1 hepatic fibrosis comprises the steps:
(1) with 15g Radix Paeoniae Rubra, the 40g Radix Notoginseng, the 31g Fructus Polygoni Orientalis, the 22g Radix Angelicae Sinensis, the 17g Hirudo, the 20g rhizoma sparganic, the 18g Rhizoma Corydalis, the 22g Crinis Carbonisatus, the 20g Semen Vaccariae, the 17g Radix Paeoniae Alba and 21g Caulis Spatholobi mix, the adding determining alcohol is 95% ethanol 730g, heating and refluxing extraction 2 times, each 3 hours, extracting solution is merged, decompression recycling ethanol and to be concentrated into liquor strength be 0.8g crude drug/mL, sucking filtration, the relative density of filtrate is 1.08 (20 ℃), above-mentioned filtrate is the macroporous adsorptive resins of 10L through volume, first deionized water eluting with 10 times of resin column volumes, determining alcohol with 5 times of resin column volumes is 95% ethanol elution again, collect ethanol elution, concentrate and be dried to powder;
(2) 15g Herba Hedyotidis Diffusae, 13g Rhizoma Acori Graminei, 12g Nidus Vespae, 17g Radix Sophorae Flavescentis, 10g Semen Coicis, 14g Rhizoma Coptidis, 23g Rhizoma Dioscoreae, 27g Rhizoma Polygonati are mixed, be that 90% ethanol 400g is as solvent with determining alcohol, flooded 16 hours, adopt percolation with the speed of per minute 2ml percolation slowly, collect percolate, concentrate and be dried to powder;
(3) get 1500g Polyethylene Glycol heating and melting, treat to add the powder that obtains previously after the complete fusion, stir to make to be mixed and make spice, temperature control is at 70 ℃, froth breaking is left standstill in insulation, spice is placed pill in the water dropper jar of drop pill machine, control water dropper temperature is at 70 ℃, with dimethicone or the cooling of liquid paraffin liquid coolant, the temperature control of dimethicone or liquid paraffin is about 10 ℃, collect the semi-finished product drop pill, remove the liquid coolant on surface, make drop pill.
Priority Applications (1)
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1268362A (en) * | 1999-03-29 | 2000-10-04 | 首都医科大学附属北京友谊医院 | Compound Chinese herb medicine for curing fibrosis of liver and hepatocirrhosis and its preparation method |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1268362A (en) * | 1999-03-29 | 2000-10-04 | 首都医科大学附属北京友谊医院 | Compound Chinese herb medicine for curing fibrosis of liver and hepatocirrhosis and its preparation method |
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| Title |
|---|
| 何山雾等: "自拟益气化纤汤治疗慢性肝炎肝纤维化30例", 《现代中医药》 * |
| 刘敏: "调肝方治疗慢性乙型肝炎肝纤维化62例临床观察", 《中医杂志》 * |
| 刘翔: "江一平治疗慢性肝炎肝纤维化经验", 《江西中医药》 * |
| 汪静等: "孙同郊治疗慢性肝炎经验", 《泸州医学院学报》 * |
| 胡永生等: "杨宏志治疗慢性乙型肝炎肝纤维化经验探赜", 《中国中医药信息杂志》 * |
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