CN101332284A - Chinese traditional medicine composition for treating ulcerative colitis and its preparation method - Google Patents
Chinese traditional medicine composition for treating ulcerative colitis and its preparation method Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition used for curing chronic hepatitis and a preparation method thereof. The traditional Chinese medicine composition is made of raw material medicines with the weight proportion by parts: 40 to 160 parts of Chinese thorowax root, 40 to 160 parts of debark peony root, 40 to 160 parts of angelica, 40 to 160 parts of India madder root, 40 to 160 parts of largehead atractylodes rhizome, 40 to 160 parts of Tuckahoe, 40 to 160 parts of turtle carapace, 40 to 160 parts of massa medicata fermentata hunanensis, 60 to 240 parts of Codonopsis pilosula nannfeldt, 60 to 240 parts of Lalang Grass Rhizome, 24 to 96 parts of immature orange fruit, 20 to 80 parts of green tangerine peel, 12 to 48 parts of villous amomum fruit, 12 to 48 parts of earthworm and 12 to 48 parts of liguorice. The traditional Chinese medicine composition of the invention has the pharmacological efficacies of antagonizing hepatic damage, protecting liver, regulating immune function, reducing aminopherase, improving liver function and on the like, and the clinical efficacy observation experiments prove that the traditional Chinese medicine composition has the exact efficacies to the chronic hepatitis, in particular to chronic active hepatitis, chronic persisting hepatitis and early cirrhosis; and the clinical application is of safety and no toxicity and side effects.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, relating in particular to a kind of is the Chinese medicine composition of the treatment chronic hepatitis that forms of feedstock production with the Chinese herbal medicine, the invention still further relates to the preparation method of this Chinese medicine composition, belongs to the field of Chinese medicines.
Background technology
Chronic hepatitis is common clinical, frequently-occurring disease, and wherein the chronic hepatitis B sickness rate is higher.The diseases related seroepidemiological survey results such as population of China hepatitis B that in April, 2008, Ministry of Public Health was announced show, calculate by the hepatitis B surface antigen carrying rate 7.18% that investigation draws, still there are about 9,300 ten thousand people of hepatitis B surface antigen carrier in China, and China's hepatitis B preventing and controlling still face severe situation.The prolonged difficulty of chronic hepatitis more, its pathogeny, mostly be because the lasting existence of hepatitis B virus (HBV), simultaneously also may be owing to composite factors such as body's immunity disorder, liver tissue injury and microcirculation disturbance cause, even these factor reciprocal causations, therefore present chronic hepatitis has become the disease of refractory, and the medicine for the treatment of viral chronic hepatitis both at home and abroad is a lot of, method is also many, and at present domestic also do not have a kind of medicine of specific treatment chronic hepatitis to address the above problem comprehensively.
Present chemical medicine many with antiviral agents and immunomodulator as main treatment means, as interferon, vidarabine, acycloguanosine, their independent or use in conjunction, but because the research of these medicines and application just have been in the elementary step, so therapeutic effect is still very far away from people's expection.
The advantage of Chinese medicine whole regulation and control aspect chronic hepatitis treatment more and more comes into one's own, and the therapeutic effect of its determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs has obtained certainly.Up to now; the Chinese patent medicine of the treatment chronic hepatitis that the market is common mainly contains GANSU KELI (its crude drug is formed Herba Lysimachiae Clethroids); (its material medicine is formed Radix Bupleuri to the hepatoprotective granule; Herba Artemisiae Scopariae; Radix Isatidis; Fructus Schisandrae Chinensis; Pulvis Fellis Suis; Semen phaseoli radiati); (its material medicine is formed Radix Curcumae to the grand granule of sharp liver; Herba Artemisiae Scopariae; Radix Isatidis; the Radix Astragali; Radix Angelicae Sinensis; Fructus Schisandrae Chinensis; Radix Glycyrrhizae; Radix Et Caulis Acanthopanacis Senticosi extractum); (its material medicine is formed Rhizoma Polygoni Cuspidati to two brave liver heat removing granules; Herba Hedyotidis Diffusae; Rhizoma Menispermi; Rhizoma Bistortae; Herba Artemisiae Scopariae; Rhizoma Imperatae; Radix Rubiae; Herba Epimedii; Radix Glycyrrhizae; Rhizoma Smilacis Glabrae; silkworm excrement; Flos Chrysanthemi Indici; tangerine); (its material medicine is formed the Radix Astragali to yiganning granules; Radix Codonopsis; Herba Hedyotidis Diffusae; Herba Artemisiae Scopariae; Herba Taraxaci; Radix Polygoni Multiflori Preparata; Fructus Toosendan; Radix Salviae Miltiorrhizae; the Radix Paeoniae Alba; Poria; 13 flavors such as the Rhizoma Atractylodis Macrocephalae); (its material medicine is formed Radix Notoginseng to the safe capsule of nine flavor livers; Radix Curcumae; Fructus Tribuli; Rhizoma Curcumae Longae; Radix Et Rhizoma Rhei; Radix Scutellariae; Scolopendra; Rhizoma Dioscoreae, Fructus Schisandrae Chinensis); (its material medicine is formed Coriolous Dersicolor (Fr.) Quel to compound recipe wood chicken granule; Radix Sophorae Tonkinensis; Semen Cuscutae; Cortex Juglandis mandshuricae); (its material medicine is formed tophus to 25-component tophus ball; the Fructus Chebulae; iron filings; Lignum Santali Albi; the Radix Aucklandiae; Herba Aconiti bonga; Stigma Croci; Margarita; Corallium Japonicum Kishinouye; Moschus; 25 flavors such as Calculus Bovis); (its material medicine is formed Herba Sedi to protect proheparinum tablet; Rhizoma Polygoni Cuspidati; Radix Salviae Miltiorrhizae; Ganoderma) etc. tens kinds.Above-mentioned these Chinese patent medicines all have certain curative effect for chronic hepatitis, but also all exist in various degree the treatment type have biased, can not treating both the principal and secondary aspects of a disease etc. defective, so the Chinese medicine composition of the treatment chronic hepatitis of development determined curative effect, treating both the principal and secondary aspects of a disease is needing to demand the problem that solves at present urgently.
Summary of the invention
The object of the invention provides a kind of Chinese medicine composition for the treatment of chronic hepatitis.This Chinese medicine composition plays soothing the liver circulation of qi promoting, replenishing QI to invigorate the spleen, nourshing blood and promoting blood circulation by oral or external, regulating the flow of vital energy, it is bloated to separate, invigorating the stomach and promoting digestion, removing obstruction in the collateral to relieve pain, the softening the hard mass effect of painful abdominal mass that disappears is improved various clinical signs or symptoms such as chronic hepatitis thereby reach obvious, and then is fundamentally treated chronic hepatitis.
Another object of the present invention provides the preparation method of this Chinese medicine composition.
The present invention seeks to be achieved through the following technical solutions.
A kind of Chinese medicine composition for the treatment of chronic hepatitis, this Chinese medicine composition is mainly made by each crude drug of following weight parts: 40～160 parts of Radix Bupleuri (processed with vinegar), 40～160 parts of the Radix Paeoniae Albas (processed with vinegar), 40～160 parts of Radix Angelicae Sinensis (wine is processed), 40～160 parts in Radix Rubiae, 40～160 parts of the Rhizoma Atractylodis Macrocephalaes (parched with bran), 40～160 parts in Poria, 40～160 parts of Carapax Trionycis (processed with vinegar), 40～160 parts of XIANGQU, 60～240 parts of Radix Codonopsis, 60～240 parts of Rhizoma Imperataes, 24～96 parts of Fructus Aurantii Immaturuss (parched with bran), 20～80 parts on Pericarpium Citri Reticulatae Viride (parched with bran), 12～48 parts of Fructus Amomis, 12～48 parts in 12～48 parts of Pheretimas (stir-fry) and Radix Glycyrrhizae;
Preferably, the weight portion of each crude drug is: 80～120 parts of Radix Bupleuri (processed with vinegar), 80～120 parts of the Radix Paeoniae Albas (processed with vinegar), 80～120 parts of Radix Angelicae Sinensis (wine is processed), 80～120 parts in Radix Rubiae, 80～120 parts of the Rhizoma Atractylodis Macrocephalaes (parched with bran), 80～120 parts in Poria, 80～120 parts of Carapax Trionycis (processed with vinegar), 80～120 parts of XIANGQU, 90～180 parts of Radix Codonopsis, 90～180 parts of Rhizoma Imperataes, 34～68 parts of Fructus Aurantii Immaturuss (parched with bran), 34～60 parts on Pericarpium Citri Reticulatae Viride (parched with bran), 18～34 parts of Fructus Amomis, 18～34 parts of Pheretimas (stir-fry), 18～34 parts in Radix Glycyrrhizae;
Preferred, the weight portion of each crude drug is: 80 parts of Radix Bupleuri (processed with vinegar), 80 parts of the Radix Paeoniae Albas (processed with vinegar), 80 parts of Radix Angelicae Sinensis (wine is processed), 80 parts in Radix Rubiae, 80 parts of the Rhizoma Atractylodis Macrocephalaes (parched with bran), 80 parts in Poria, 80 parts of Carapax Trionycis (processed with vinegar), 80 parts of XIANGQU, 120 parts of Radix Codonopsis, 120 parts of Rhizoma Imperataes, 48 parts of Fructus Aurantii Immaturuss (parched with bran), 40 parts on Pericarpium Citri Reticulatae Viride (parched with bran), 24 parts of Fructus Amomis, 24 parts in 24 parts of Pheretimas (stir-fry) and Radix Glycyrrhizae.
Chinese medicine composition of the present invention is based on Chinese medicine to pathogenetic research of chronic hepatitis deep layer and Therapeutic Principle thereof, in conjunction with inventor's clinical practice experience for many years, filter out soothing the liver circulation of qi promoting, replenishing QI to invigorate the spleen, nourshing blood and promoting blood circulation, regulating the flow of vital energy, it is bloated to separate, the disappear crude drug of painful abdominal mass of invigorating the stomach and promoting digestion, removing obstruction in the collateral to relieve pain, softening the hard mass, according to the theory of Chinese medical science prescription, be prepared from according to certain weight proportion.
The compatibility of Chinese medicine composition of the present invention is according to being:
Theory of Chinese medical science is thought, general chronic hepatitis is many by acute viral hepatitis obstinate or inappropriate medication, and make the heresy of damp and hot folder poison, invade taste, pent up liver and gall, go into the kidney and the impairment of QI-blood for a long time, cause internal organs dysfunction, form the pathogenesis pathology of complexity such as " the evil difficulty of damp and hot poison are dispelled to the greatest extent, stagnation of liver-QI spleen kidney qi blood deficiency " eventually.Again because of primary disease cause a disease because of, though be the heresy of damp and hot folder poison, right abnormally climatic pathogens can not solely be hurted sb.'s feelings, the gathering of heresy, its gas must void, so deficiency of vital QI, the spleen impaired renal function is the prerequisite that causes primary disease in fact.Liver is first of the five internal organs, evil poison invasion, and when it, more because of blood stored in the liver, let out earlier by main flow for liver, and liver is subjected to heresy, and is strongly fragrant and with the passing of time fire-transformation must cause the QI and blood obstacle, and venation block forms the blood stasis syndrome, is that the basic pathology of primary disease changes.Many in common knowledge, the medicine of the viral chronic hepatitis of treatment in the present age is a lot of, and method is also many, but eliminating damp-heat, soothing liver and strengthening spleen, QI and blood regulating is the main rule of treatment primary disease in fact.The sage of the past cures sage's (Zhang Zhongjing) cloud: see the disease of liver, knowing the liver disease will be transmitted into the spleen, tonifying the spleen in the ban ", thus the descendant often with tonifying the spleen for executing the well-established law for the treatment of the liver disease.
The inventor according to the above-mentioned rule of treatment, in conjunction with individual's clinical practice experience for many years, develops Chinese medicine composition of the present invention just.Chinese medicine composition of the present invention has conventional Chinese medicine ten five tastes, wherein Radix Bupleuri, Fructus Aurantii Immaturus, and Pericarpium Citri Reticulatae Viride is monarch, dispersing the stagnated live-QI to relieve the stagnation of QI, promoting QI to circulate and dispersing the agglomeration of the pathogens; Join Radix Angelicae Sinensis, Radix Paeoniae Alba nourishing blood to suppress the hyperactive liver, in case too soothing the liver and fraud impairment of YIN; Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Poria are minister, and replenishing QI to invigorate the spleen is joined Fructus Amomi, XIANGQU, strengthen the fortune function of spleen, the effect that with assistant's spleen, be good for the stomach, helps digestion; Radix Rubiae, Rhizoma Imperatae, Carapax Trionycis, Pheretima are assistant, clearing away heat and cooling blood, disperse blood stasis and dredge collateral, nourishing YIN for suppressing the hyperactive YANG, hard masses softening and resolving; Radix Glycyrrhizae is for making, and nature and flavor are sweet flat, and the effect of detoxifcation, enhancing coordinating the actions of various ingredients in a prescription is arranged.So all medicines share, have soothing the liver circulation of qi promoting, replenishing QI to invigorate the spleen, nourshing blood and promoting blood circulation regulates the flow of vital energy that it is bloated to separate, and invigorating the stomach and promoting digestion, removing obstruction in the collateral to relieve pain, the softening the hard mass effects such as painful abdominal mass that disappear also have transaminase lowering simultaneously and improve effect such as liver function.Chronic persisting type and active type hepatitis, laboratory examination all has Glutamate pyruvate transaminase rises or abnormal liver function, and clinical manifestation is seen more hepatalgia, and is dizzy weak, the food of receiving is not good enough, abdominal distention is detested oil, diarrhea with loose stool, yellow urine, hepatosplenomegaly, or showing liver palm (liver palm), spider angioma, tongue is thin in vain or yellow greasy, stringy pulse or stringy and rolling pulse etc.Blood stored in the liver, main catharsis, property happiness bar reaches and dislikes pent-up, The spleen governs the blood, main fortuneization, the paddy of water tendering is precise and tiny, the property happiness dry and dislike wet, if the acute hepatitis patient, obstinate, damp and hot stopping over, damage liver spleen, the liver failing to maintain the normal flow of QI can not reach by bar, and depression of liver-QI is done during then hepatalgia, or distending pain; Spleen loses fortuneization, and then poor appetite is dull, abdominal distention, loose stool; Prolonged illness must the impairment of QI-blood, and disease is seen dizziness, weak; If qi depression to blood stasis, with the passing of time venation block must see hepatosplenomegaly or syndromes such as existing liver palm, spider angioma.So control suitable soothing the liver circulation of qi promoting, QI invigorating reason spleen, compensate qi and blood, promoting blood circulation to remove obstruction in the collateral, dissolving lump and resolving mass, composition side's medicine of Chinese medicine composition of the present invention has these effects just all sidedly.
The used material medicine of respectively distinguishing the flavor of of the present invention can be bought in the Chinese medicine shop and obtain, its specification all meets national medical standard, and (wherein, the drug standard of XIANGQU can be referring to " National Drug Administration's Chinese patent medicine provincial standard rising national standard part " (internal medicine taste fascicle); XIANGQU can be bought from pharmacy and obtain, for example Hunan Jiuzhitang Co., Ltd.).
Chinese medicine composition of the present invention can be prepared into any acceptable clinically suitable formulations by this area conventional formulation method, can be oral formulations or external preparation, described oral formulations is preferably from tablet, granule, capsule, powder, pill, oral liquid, syrup or drop pill etc.; Described external preparation is preferably emplastrum or spray etc.
Preferably, a kind of method for preparing the Chinese medicine composition of above-mentioned treatment chronic hepatitis, this method may further comprise the steps:
(1), takes by weighing each crude drug by described weight proportion;
(2), Radix Bupleuri (processed with vinegar), Radix Angelicae Sinensis (wine is processed), the Rhizoma Atractylodis Macrocephalae (parched with bran), Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran) and Fructus Amomi are extracted volatile oil, it is standby to collect volatile oil; Medical filtration gets filtrate and medicinal residues, and is standby;
(3), the medicinal residues of step (2) gained and Radix Rubiae, Rhizoma Imperatae, Radix Codonopsis, Poria, XIANGQU, the Radix Paeoniae Alba (processed with vinegar), Pheretima (stir-fry), Radix Glycyrrhizae merge, and decocts with water, decoction liquor is filtered, filtrate for later use;
(4), Carapax Trionycis (processed with vinegar) is decocted with water, decoction liquor is filtered, and gained filtrate and step (2) and the merging of step (3) gained filtrate are concentrated, are dried to extract powder;
(5), the extract powder of step (4) gained mixes with the volatile oil of step (2) gained, adds right amount of auxiliary materials again, mixing is made the preparation intermediate, makes preparation through preparations shaping technology again, promptly.
In the above-mentioned preparation method, preferred, adopt steam distillation to extract volatile oil in the step (2), the water that wherein adds 10 times of medical material weight extracts, and extracts volatile oil 3 hours;
Preferably, the number of times that decocts with water described in the step (3) is 2 times, and the amount that at every turn adds water is 10 times of weight of medical material, and each the decoction extracted 2 hours;
In the step (4), preferably Carapax Trionycis is decocted with water 3 times, wherein, add the weight of 10 times of medical materials of water at every turn, decocted 2 hours at every turn.
The present invention also provides another method for preparing the Chinese medicine composition of above-mentioned treatment chronic hepatitis, and this method may further comprise the steps:
(1), takes by weighing each crude drug by described weight proportion;
(2), Radix Bupleuri (processed with vinegar), the Radix Paeoniae Alba (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Radix Rubiae, the Rhizoma Atractylodis Macrocephalae (parched with bran), Poria, XIANGQU, Radix Codonopsis, Rhizoma Imperatae, Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran), Fructus Amomi, Pheretima (stir-fry) and Radix Glycyrrhizae are decocted with water, extract volatile oil simultaneously, collect volatile oil, standby; Decoction liquor filters, filtrate for later use;
(3), Carapax Trionycis (processed with vinegar) is decocted with water, the filtrate of decoction liquor and step (2) gained merges, and concentrates, and is dried to extract powder;
(4), the collected volatile oil of the extract powder of step (3) gained and step (2) mixes, and adds right amount of auxiliary materials, mixing is made the preparation intermediate, makes preparation through preparations shaping technology again, promptly.
In the above-mentioned preparation method, preferred, the described number of times that decocts with water of step (2) is 2 times, and wherein, the water of 10 times of medical material weight of the 1st adding extracted 4 hours, collected volatile oil, and decocting liquid filters, filtrate for later use; Add the water of 10 times of medical material weight the 2nd time, extracted 1 hour, decocting liquid filters, merging filtrate;
In the step (3), preferably Carapax Trionycis is decocted with water 3 times, wherein, add 10 times of weight of water at every turn, decocted 2 hours at every turn, collecting decoction filters.
Chinese medicine composition of the present invention has soothing the liver reason spleen; blood circulation promoting and blood stasis dispelling; hard masses softening and resolving; helping digestion, it is full to remove; improve liver function; effects such as transaminase lowering; pharmacodynamics test shows; Chinese medicine composition of the present invention has tangible anti-experimental character hepatic injury; the liver protecting; regulate effects such as immunologic function; the clinical observation evidence; Chinese medicine composition of the present invention is to chronic hepatitis; especially chronic active hepatitis; chronic persistent hepatitis and early stage liver cirrhosis all have definite curative effect; toxicity trial proves; medicine of the present invention has no side effect to human body, to the blood of human body; internal organs etc. do not have harmful effect.
Using method and consumption: the dosage of Chinese medicine composition of the present invention depends on factors such as concrete dosage form, patient's age, health status.As guidance: for oral formulations, its effective dose is calculated with contained crude drug amount in the Chinese medicine composition of the present invention, is each 8-10g, 3 times on the one.
The specific embodiment
Further describe the present invention by the following examples, it should be understood that these embodiment only are used for the purpose of illustration, never limit the scope of the invention.
The preparation of embodiment 1 granule
(1) arrangement of medical material: Radix Bupleuri (processed with vinegar), the Radix Paeoniae Alba (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Radix Rubiae, the Rhizoma Atractylodis Macrocephalae (parched with bran), Poria, Carapax Trionycis (processed with vinegar), XIANGQU (available from Hunan Jiuzhitang Co., Ltd.), Radix Codonopsis, Rhizoma Imperatae, Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran), Fructus Amomi, Pheretima (stir-fry), Radix Glycyrrhizae are removed impurity respectively, clean or coarse pulverization;
(2) take by weighing Radix Bupleuri (processed with vinegar) 20kg, the Radix Paeoniae Alba (processed with vinegar) 20kg, Radix Angelicae Sinensis (wine is processed) 20kg, Radix Rubiae 20kg, the Rhizoma Atractylodis Macrocephalae (parched with bran) 20kg, Poria 20kg, Carapax Trionycis (processed with vinegar) 20kg, XIANGQU 20kg, Radix Codonopsis 30kg, Rhizoma Imperatae 30kg, Fructus Aurantii Immaturus (parched with bran) 12kg, Pericarpium Citri Reticulatae Viride (parched with bran) 10kg, Fructus Amomi 6kg, Pheretima (stir-fry) 6kg and Radix Glycyrrhizae 6kg;
(3) Radix Bupleuri (processed with vinegar), the Radix Paeoniae Alba (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Radix Rubiae, the Rhizoma Atractylodis Macrocephalae (parched with bran), Poria, XIANGQU, Radix Codonopsis, Rhizoma Imperatae, Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran), Fructus Amomi, Pheretima (stir-fry) and Radix Glycyrrhizae are put add water in the multi-functional extraction pot and extract twice continuously, extracted 4 hours for the first time, amount of water is 10 times of medical material weight, collect volatile oil, standby; Decocting liquid filters with 40 mesh sieves, and medicinal residues continued extracting in water 1 hour, and amount of water is 10 times of medical material weight, and decocting liquid filters, and merges filtrate twice, and is standby;
(4) Carapax Trionycis (processed with vinegar) is put in the multi-functional extraction pot, pressurization decocts three times, adds 10 times of weight of water at every turn, decocts 1 hour at every turn, and extract medicinal liquid and filter with 40 mesh sieves, merging filtrate, standby;
(5) step (3), (4) gained medicinal liquid are merged, vacuum concentration to relative density is 1.11～1.15 (55 ℃), and is centrifugal, supernatant is 185 ℃ ± 5 ℃ with inlet temperature, leaving air temp is 95 ℃ ± 5 ℃, and the shower nozzle electric machine frequency is a spray drying under the condition of 40Hz ± 5Hz, extract powder;
(6) step (5) gained extract powder with an amount of lactose mixing, mixes the back material pelletization, and the granule that makes adds the volatile oil of step (3) gained again, mixing, and packing promptly gets the granule finished product.Contain effective dose 10.4g in every bag of granule.
The preparation of embodiment 2 tablets
(1) arrangement of medical material: Radix Bupleuri (processed with vinegar), the Radix Paeoniae Alba (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Radix Rubiae, the Rhizoma Atractylodis Macrocephalae (parched with bran), Poria, Carapax Trionycis (processed with vinegar), XIANGQU (available from Hunan Jiuzhitang Co., Ltd.), Radix Codonopsis, Rhizoma Imperatae, Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran), Fructus Amomi, Pheretima (stir-fry), Radix Glycyrrhizae are removed impurity respectively, clean or coarse pulverization;
(2) take by weighing Radix Bupleuri (processed with vinegar) 8kg, the Radix Paeoniae Alba (processed with vinegar) 8kg, Radix Angelicae Sinensis (wine is processed) 8kg, Radix Rubiae 8kg, the Rhizoma Atractylodis Macrocephalae (parched with bran) 8kg, Poria 8kg, Carapax Trionycis (processed with vinegar) 8kg, XIANGQU 8kg, Radix Codonopsis 12kg, Rhizoma Imperatae 12kg, Fructus Aurantii Immaturus (parched with bran) 4.8kg, Pericarpium Citri Reticulatae Viride (parched with bran) 4kg, Fructus Amomi 2.4kg, Pheretima (stir-fry) 2.4kg and Radix Glycyrrhizae 2.4kg;
(3) with Radix Bupleuri (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Fructus Aurantii Immaturus (parched with bran), the Rhizoma Atractylodis Macrocephalae (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran) and Fructus Amomi, put in the multi-functional extraction pot and add 10 times of weight of water, steam distillation extraction volatile oil 3 hours, collection volatile oil, the leaching medicinal liquid, medicinal liquid and medicinal residues are standby;
(4) medicinal residues with the Radix Paeoniae Alba (processed with vinegar), Radix Rubiae, Poria, XIANGQU, Radix Codonopsis, Rhizoma Imperatae, Pheretima (stir-fry) and Radix Glycyrrhizae and step (2) gained merge, and extracting in water 2 times adds 10 times of weight of water at every turn, the each extraction 2 hours, extract medicinal liquid and filter with 40 mesh sieves, merging filtrate, standby;
(5) Carapax Trionycis (processed with vinegar) is put in the multi-functional extraction pot, decocted three times, add 10 times of weight of water at every turn, decocted 2 hours at every turn, extract medicinal liquid and filter with 40 mesh sieves, merging filtrate, standby;
(6) step (3), (4) and (5) gained medicinal liquid being merged, is 185 ℃ ± 5 ℃ with inlet temperature behind the vacuum concentration, and leaving air temp is 95 ℃ ± 5 ℃, and the shower nozzle electric machine frequency is a spray drying under the condition of 40Hz ± 5Hz, extract powder;
(7) step (6) gained extract powder and 0.6% silicon dioxide and appropriate amount of starch mixing are to the 29kg that always weighs; mixing the back material granulates with dry-pressing granulator; volatile oil and magnesium stearate, purified water and silicon dioxide to gross weight that the granule that makes adds step (3) gained again are 30kg; granulate; the reuse tablet machine is pressed into lamellar; the bag film-coat promptly gets the tablet finished product.Contain effective dose 1.04g in every tablet of tablet.
The preparation of embodiment 3 capsules
(1) arrangement of medical material: Radix Bupleuri (processed with vinegar), the Radix Paeoniae Alba (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Radix Rubiae, the Rhizoma Atractylodis Macrocephalae (parched with bran), Poria, Carapax Trionycis (processed with vinegar), XIANGQU (available from Hunan Jiuzhitang Co., Ltd.), Radix Codonopsis, Rhizoma Imperatae, Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran), Fructus Amomi, Pheretima (stir-fry), Radix Glycyrrhizae are removed impurity respectively, clean or coarse pulverization;
(2) take by weighing Radix Bupleuri (processed with vinegar) 4kg, the Radix Paeoniae Alba (processed with vinegar) 4kg, Radix Angelicae Sinensis (wine is processed) 4kg, Radix Rubiae 4kg, the Rhizoma Atractylodis Macrocephalae (parched with bran) 4kg, Poria 4kg, Carapax Trionycis (processed with vinegar) 4kg, XIANGQU 4kg, Radix Codonopsis 6kg, Rhizoma Imperatae 6kg, Fructus Aurantii Immaturus (parched with bran) 2.4kg, Pericarpium Citri Reticulatae Viride (parched with bran) 2kg, Fructus Amomi 1.2kg, Pheretima (stir-fry) 1.2kg and Radix Glycyrrhizae 1.2kg;
(3) Radix Bupleuri (processed with vinegar), the Radix Paeoniae Alba (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Radix Rubiae, the Rhizoma Atractylodis Macrocephalae (parched with bran), Poria, XIANGQU, Radix Codonopsis, Rhizoma Imperatae, Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran), Fructus Amomi, Pheretima (stir-fry) and Radix Glycyrrhizae are put in the multi-functional extraction pot, adding water extracts twice continuously, extract volatile oil simultaneously, extracted 4 hours for the first time, amount of water is 10 times of medical material weight, collect volatile oil, decocting liquid filters with 40 mesh sieves, medicinal residues continued extracting in water 1 hour, amount of water is 10 times of medical material weight, decocting liquid filters, and merges filtrate twice, and is standby;
(4) with Carapax Trionycis (processed with vinegar), to put in the multi-functional extraction pot, pressurization decocts three times, adds 10 times of weight of water at every turn, decocts 1 hour at every turn, and extract medicinal liquid and filter with 40 mesh sieves, merging filtrate, standby;
(5) step (3) and (4) gained filtrate are merged, vacuum concentration to relative density is 1.11～1.15 (55 ℃), and is centrifugal, supernatant is 185 ℃ ± 5 ℃ with inlet temperature, leaving air temp is 95 ℃ ± 5 ℃, and the shower nozzle electric machine frequency is a spray drying under the condition of 40Hz ± 5Hz, extract powder.
(6) step (5) gained extract powder and appropriate amount of starch mixing mix the back material pelletization, and the granule that makes adds the volatile oil of step (3) gained again, mixing, and filled capsules promptly gets the capsule finished product.Contain effective dose 1.73g in every seed lac wafer content.
The preparation of embodiment 4 pills
(1) arrangement of medical material: Radix Bupleuri (processed with vinegar), the Radix Paeoniae Alba (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Radix Rubiae, the Rhizoma Atractylodis Macrocephalae (parched with bran), Poria, Carapax Trionycis (processed with vinegar), XIANGQU (available from Hunan Jiuzhitang Co., Ltd.), Radix Codonopsis, Rhizoma Imperatae, Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran), Fructus Amomi, Pheretima (stir-fry), Radix Glycyrrhizae are removed impurity respectively, clean or coarse pulverization;
(2) take by weighing Radix Bupleuri (processed with vinegar) 16kg, the Radix Paeoniae Alba (processed with vinegar) 16kg, Radix Angelicae Sinensis (wine is processed) 16kg, Radix Rubiae 16kg, the Rhizoma Atractylodis Macrocephalae (parched with bran) 16kg, Poria 16kg, Carapax Trionycis (processed with vinegar) 16kg, XIANGQU 16kg, Radix Codonopsis 24kg, Rhizoma Imperatae 24kg, Fructus Aurantii Immaturus (parched with bran) 9.6kg, Pericarpium Citri Reticulatae Viride (parched with bran) 8kg, Fructus Amomi 4.8kg, Pheretima (stir-fry) 4.8kg and Radix Glycyrrhizae 4.8kg;
(3) Radix Bupleuri (processed with vinegar), the Radix Paeoniae Alba (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Radix Rubiae, the Rhizoma Atractylodis Macrocephalae (parched with bran), Poria, XIANGQU, Radix Codonopsis, Rhizoma Imperatae, Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran), Fructus Amomi, Pheretima (stir-fry) and Radix Glycyrrhizae are put in the multi-functional extraction pot, adding water extracts twice continuously, extract volatile oil simultaneously, extracted 4 hours for the first time, amount of water is 10 times of medical material weight, collect volatile oil, decocting liquid filters with 40 mesh sieves, medicinal residues continued extracting in water 1 hour, amount of water is 10 times of medical material weight, decocting liquid filters, and merges filtrate twice, and is standby;
(4) Carapax Trionycis (processed with vinegar) is put in the multi-functional extraction pot, pressurization decocts three times, adds 10 times of weight of water at every turn, decocts 1 hour at every turn, and extract medicinal liquid and filter with 40 mesh sieves, merging filtrate, standby;
(5) step (3) and (4) gained filtrate are merged, vacuum concentration to relative density is 1.11～1.15 (55 ℃), and is centrifugal, supernatant is 185 ℃ ± 5 ℃ with inlet temperature, leaving air temp is 95 ℃ ± 5 ℃, and the shower nozzle electric machine frequency is a spray drying under the condition of 40Hz ± 5Hz, extract powder;
(6) volatile oil and the suitable quantity of water or the Mel mixing of step (5) gained extract powder and step (3) gained mix the back material and make wet ball with pellet processing machine to mould method for making, perhaps make wet ball with the pill cylinder with general method for making, wet ball oven dry, and coating promptly gets the pill finished product.Contain effective dose 3.5g in every gram coated pill.
The preparation of embodiment 5 emplastrumes
(1) arrangement of medical material: Radix Bupleuri (processed with vinegar), the Radix Paeoniae Alba (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Radix Rubiae, the Rhizoma Atractylodis Macrocephalae (parched with bran), Poria, Carapax Trionycis (processed with vinegar), XIANGQU (available from Hunan Jiuzhitang Co., Ltd.), Radix Codonopsis, Rhizoma Imperatae, Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran), Fructus Amomi, Pheretima (stir-fry), Radix Glycyrrhizae are removed impurity respectively, clean or coarse pulverization;
(2) take by weighing Radix Bupleuri (processed with vinegar) 80kg, the Radix Paeoniae Alba (processed with vinegar) 80kg, Radix Angelicae Sinensis (wine is processed) 80kg, Radix Rubiae 80kg, the Rhizoma Atractylodis Macrocephalae (parched with bran) 80kg, Poria 80kg, Carapax Trionycis (processed with vinegar) 80kg, XIANGQU 80kg, Radix Codonopsis 90kg, Rhizoma Imperatae 90kg, Fructus Aurantii Immaturus (parched with bran) 34kg, Pericarpium Citri Reticulatae Viride (parched with bran) 34kg, Fructus Amomi 18kg, Pheretima (stir-fry) 18kg and Radix Glycyrrhizae 18kg;
(3) Radix Bupleuri (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Fructus Aurantii Immaturus (parched with bran), the Rhizoma Atractylodis Macrocephalae (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran) and Fructus Amomi are put in the multi-functional extraction pot and added 10 times of weight of water, steam distillation extracted volatile oil 3 hours, collect volatile oil, the leaching medicinal liquid, medicinal liquid and medicinal residues are standby;
(4) medicinal residues with the Radix Paeoniae Alba (processed with vinegar), Radix Rubiae, Poria, XIANGQU, Radix Codonopsis, Rhizoma Imperatae, Pheretima (stir-fry) and Radix Glycyrrhizae and step (3) gained merge, and extracting in water 2 times adds 10 times of weight of water at every turn, the each extraction 2 hours, extract medicinal liquid and filter with 40 mesh sieves, merging filtrate, standby;
(5) Carapax Trionycis (processed with vinegar) is put in the multi-functional extraction pot, decocted three times, add 10 times of weight of water at every turn, decocted 2 hours at every turn, extract medicinal liquid and filter with 40 mesh sieves, merging filtrate, standby;
(6) step (3), (4) and (5) gained filtrate being merged, is 185 ℃ ± 5 ℃ with inlet temperature behind the vacuum concentration, and leaving air temp is 95 ℃ ± 5 ℃, and the shower nozzle electric machine frequency is a spray drying under the condition of 40Hz ± 5Hz, extract powder;
(7) volatile oil and the ground substance of plaster ointment mixing of step (6) gained extract powder and step (3) gained, to gross weight be the cream group of 1200kg, the reuse coating machine is made lamellar with cream group, promptly gets the cataplasma finished product; Contain effective dose 5.2g in the every unguentum.
The preparation of embodiment 6 powders
(1) arrangement of medical material: Radix Bupleuri (processed with vinegar), the Radix Paeoniae Alba (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Radix Rubiae, the Rhizoma Atractylodis Macrocephalae (parched with bran), Poria, Carapax Trionycis (processed with vinegar), XIANGQU (available from Hunan Jiuzhitang Co., Ltd.), Radix Codonopsis, Rhizoma Imperatae, Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran), Fructus Amomi, Pheretima (stir-fry), Radix Glycyrrhizae are removed impurity respectively, clean or coarse pulverization;
(2) take by weighing Radix Bupleuri (processed with vinegar) 120kg, the Radix Paeoniae Alba (processed with vinegar) 120kg, Radix Angelicae Sinensis (wine is processed) 120kg, Radix Rubiae 120kg, the Rhizoma Atractylodis Macrocephalae (parched with bran) 120kg, Poria 120kg, Carapax Trionycis (processed with vinegar) 120kg, XIANGQU 120kg, Radix Codonopsis 180kg, Rhizoma Imperatae 180kg, Fructus Aurantii Immaturus (parched with bran) 68kg, Pericarpium Citri Reticulatae Viride (parched with bran) 60kg, Fructus Amomi 34kg, Pheretima (stir-fry) 34kg and Radix Glycyrrhizae 34kg;
(3) Radix Bupleuri (processed with vinegar), the Radix Paeoniae Alba (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Radix Rubiae, the Rhizoma Atractylodis Macrocephalae (parched with bran), Poria, XIANGQU, Radix Codonopsis, Rhizoma Imperatae, Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran), Fructus Amomi, Pheretima (stir-fry) and Radix Glycyrrhizae are put add water in the multi-functional extraction pot and extract twice continuously, extracted 4 hours for the first time, amount of water is 10 times of medical material weight, collect volatile oil, standby; Decocting liquid filters with 40 mesh sieves, and medicinal residues continued extracting in water 1 hour, and amount of water is 10 times of medical material weight, and decocting liquid filters, and merges filtrate twice, and is standby;
(4) Carapax Trionycis (processed with vinegar) is put in the multi-functional extraction pot, pressurization decocts three times, adds 10 times of weight of water at every turn, decocts 1 hour at every turn, and extract medicinal liquid and filter with 40 mesh sieves, merging filtrate, standby;
(5) step (3), (4) gained filtrate are merged, vacuum concentration to relative density is 1.11～1.15 (55 ℃), and is centrifugal, supernatant is 185 ℃ ± 5 ℃ with inlet temperature, leaving air temp is 95 ℃ ± 5 ℃, and the shower nozzle electric machine frequency is a spray drying under the condition of 40Hz ± 5Hz, extract powder;
(6) step (5) gained extract powder is ground into fine powder, and with the volatile oil mixing of appropriate amount of starch and step (3) gained, packing promptly gets the powder finished product.Contain effective dose 10.4g in every bag of powder.
The pharmacodynamics test of test example 1 Chinese medicine composition of the present invention
One, the test material and the method for inspection
1, given the test agent: the tablet that the embodiment of the invention 2 is prepared, make 50% (0.5g/ml), 25% (0.25g/m), 12.5% (0.125g/ml) decocting in water concentrated solution, refrigerator is preserved standby.
2, other medicines: oleanolic acid tablet (Changsha City No.1 Tranditional Chinese Medicine Factory's product), face the time spent to be made into 1% (0.01g/m) suspension, refrigerator is preserved standby.
3, reagent: carbon tetrachloride is an analytical pure, and natrium carbonicum calcinatum, sucrose, hydrosulfurous acid are chemical pure.Phenobarbital, glucose, starch, sodium chloride are pharmaceutical, and sheep red blood cell (SRBC), chicken red blood cell, guinea pig serum are from sheep, chicken and Cavia porcellus.
4, laboratory animal: LACA white mice, rat, the Wister rat is available from animal section of Hunan Medical University.
5, the method for inspection: F check.
Two, test method and result
1, reduce the ALT rising that carbon tetrachloride infringement rat liver causes:
(1) improvement Mu Shi method: rat body weight 139.5 ± 20.9g.Male and female are regardless of, random packet, and first group of blank is left intact, and the 2nd～5 group in experiment the 1st, 4 day ih carbon tetrachloride 1ml/kg respectively, causes animal liver infringement model.Played 2～5 groups of ig distilled water 20ml/kg respectively on the 1st day, ih oleanolic acid 0.5g/kg; Ig given the test agent 5g/kg and given the test agent 2.5g/kg, continuous 6 days, broken end was got blood in the 7th day, by improvement Mu Shi method, surveyed ALT with 721 spectrophotometers.The results are shown in Table 1.
Table 1 given the test agent is to the influence (improvement Mu Shi method) of hepatic injury rat ALT
| Group | Number of animals (only) | ALT(X±SD，u) | The P value |
| (1) blank | 13 | 88.6±19.3 | |
| (2) carbon tetrachloride+distilled water | 15 | 137.5±48.5 | ＜0.01△ |
| (3) carbon tetrachloride+oleanolic acid tablet | 16 | 92.6±28.7 | ＜0.01△△ |
| (4) carbon tetrachloride+given the test agent (5g/kg) | 15 | 101.9±34.0 | ＜0.05△△ ＜0.05△△△ |
| (5) carbon tetrachloride+given the test agent (2.5g/kg) | 14 | 106.1±23.7 | ＜0.05△△ ＞0.05△△△ |
Annotate: the difference of △ (1) and (2); The difference of △ △ (2) and (3), (4), (5); The difference of △ △ △ (3) and (4), (5)
(2) reitman-frankel method: Wister rat body weight 148.0 ± 31.0g, male and female are regardless of, random packet, the 1st group is left intact blank.The 2nd～5 group in the 1st, 4,7 day difference of experiment ih carbon tetrachloride 5ml/kg.The 3rd～5 group respectively at the 1st day ig given the test agent 10g/kg, 5g/kg, 2.5g/kg, and continuous 9 days, broken end was got blood in the 10th day.Press reitman-frankel method and measure ALT with the UV-256FW spectrophotometer.The results are shown in Table 2.
Table 2 given the test agent is to the influence (reitman-frankel method) of hepatic injury Wister rat ALT
| Group | Number of animals (only) | ALT(X±SD，u) | The P value |
| (1) blank | 12 | 28±1 | |
| (2) carbon tetrachloride | 15 | 12.7±47 | ＜0.005△ |
| (5) carbon tetrachloride+given the test agent (2.5g/kg) | 14 | 58±4 | ＜0.05△△ |
| (4) carbon tetrachloride+given the test agent (5g/kg) | 12 | 57±2 | ＜0.05△△ |
| (5) carbon tetrachloride+given the test agent (10g/kg) | 13 | 44±1 | ＜0.02△△ |
Annotate: the difference of △ (1) and (2), the difference of △ △ (2) and (3), (4), (5)
2, improve the level of carbon tetrachloride hepatic injury mouse liver cell pigment P-450: LACA white mice body weight 20-24g.The male and female dual-purpose, random packet.The 1st group of ig distilled water 20ml/kg, the 2nd group of ip sodium phenobarbital 0.075g/kg, once a day, continuous 7 days; 3rd, 4 groups respectively at the 1st, 4 day ih carbon tetrachloride 2.5ml/kg of experiment, causes the hepatic injury model, the ig distilled water 20ml/kg respectively from the 2nd day simultaneously, and given the test agent 2.5g/kg, continuous 7 days, one day 1 time, fasting was 18 hours after the drug withdrawal, put to death animal.Suddenly get liver.The sticking liquid of dehematizing, the preparation sample, the content with 721 spectrophotometric instrumentation liver cell pigment P-450 the results are shown in Table 3.
Table 3 given the test agent is to the influence of LACA mouse liver cell pigment P-450
| Group | Number of animals (only) | Liver weight in wet base (X ± SD) (g/10g body weight) | The P value | Cytochrome P-450 (x ± SD) (the nmoL/g liver is heavy) | The P value |
| (1) distilled water | 7 | 6.40±0.04 | 25.1±3.1 | ||
| (2) sodium phenobarbital | 8 | 0.55±0.09 | ＜0.05△ | 68.9±6.6 | ＜0.001△ |
| (3) carbon tetrachloride+distilled water | 8 | 0.41±0.05 | ＞0.05△△△ | 3.91±1.18 | ＜0.001△△ |
| (4) carbon tetrachloride+given the test agent | 6 | 0.38±0.06 | 5.61±1.13 | ＜0.05△△△ |
Annotate: the difference of △ (1) and (2), the difference of △ △ (1) and (3), the difference of △ △ △ (3) and (4).
3, reduce some immunologic function of intact animal: Wister rat body weight 198 ± 24g.The male and female dual-purpose, random packet.The 1st group of blank is left intact, the 2nd group of ig given the test agent 5g/kg, continuous 9 days, every day 1 time; 3rd, testing beginning the 1st, 4,7 day for 4,5 groups, ih carbon tetrachloride 5ml/kg, the 4th, 5 group from the 1st day difference ig distilled water 20ml/kg, given the test agent 5g/kg, every day 1 time.Continuous 9 days.Every Mus is respectively at the 7th, 10 day ip sheep red blood cell (SRBC) 1.2ml/ (2,000,000,000 erythrocyte/ml) only.9th, 10 days ip1% soluble starch liquid 5ml/ only, 1 hour ip1% chicken red blood cell liquid 3ml behind the 10th day ip starch fluid, extracted peritoneal exudate through 5 hours, survey the macrophage phagocytic percentage rate, animal hearts was got the mensuration that blood system does not carry out sheep red blood cell (SRBC) half hemolysis value (HC50) and T lymhocyte transformation rate in the 10th day, extract spleen and thymus simultaneously, analyse its weight in wet base of title on the balance very much, the results are shown in Table 4,5 1/.
Table 4 given the test agent is to the influence of normal Wister rat immunity function
Annotate: in the parantheses is the animal number of elements
Table 5 given the test agent is to carbon tetrachloride infringement Wister rat Immune Effects
Annotate: in the parantheses is number of animals, and △ is the difference of (1) and (2),
*For (
*2) with the difference of (3), ★ be the difference of (2) and (4).
Conclusion (of pressure testing):
(1) given the test agent can obviously reduce the ALT rising that carbon tetrachloride infringement animal causes, no matter be improvement Mu Shi method or reitman-frankel method, its result is P＜0.05; (2) given the test agent can raise and be descended by the content of the liver cell pigment P-450 of carbon tetrachloride infringement back generation, and statistical significance (P＜0.05) is arranged, and liver is the certain protection effect; (3) given the test agent has certain inhibitory action to intact animal's immunologic function, as sheep red blood cell (SRBC) half hemolysis value and T lymhocyte transformation rate are suppressed obviously, the P value is all less than 0.01, but the acute immunologic function degression that carbon tetrachloride causes is not all had obvious influence (P＞0.05).
Above result of the test shows that Chinese medicine composition of the present invention has reduction ALT, hepatoprotective and influence immunologic function, and for reducing the hepatitis transaminase clinically, improving patient's symptom provides foundation.
Test example 2 Chinese medicine compositions of the present invention are to the regulating action test of rat immunity function
One, test material
1, laboratory animal: the SD rat is defended institute by Hunan Province medical professionals institute and Hunan Province's labor and provides.
2, given the test agent: the tablet that the embodiment of the invention 2 is prepared is made into variable concentrations decocting in water concentrated solution;
3, other medicines: dexamethasone sodium phosphate, Shanghai Xinyi Pharmaceutical Factory lot number 890601; Bacillus calmette-guerin vaccine, Changsha Pharmaceutic Factory No.2's lot number 900301.
Two, test method and result
1, to the influence of normal rat immunity function
The SD rat, body weight 148.5 ± 26.2g.The male and female dual-purpose, be divided into 4 groups at random, first group of ig distilled water 20ml/kg/ day, distinguish ig given the test agent 2.5g/kg/ day, 5g/kg/ day, 10g/kg/ day for the 2nd～4 group, continuous 9 days, every Mus is iv sheep red blood cell (SRBC) 1.2ml/ on the the 7th, 10 (about 2,000,000,000 erythrocyte/ml) only separately.9th, each ip1% soluble starch 5ml/ on the 10th only, after the ip soluble starch on the 10th 1 hour, ip1% chicken red blood cell 3ml/ only extracted peritoneal exudate and surveys the macrophage phagocytic percentage rate after 5 hours.Heart extracting blood on the 10th, separation of serum is surveyed sheep red blood cell (SRBC) HD50, T lymhocyte transformation rate respectively, wins thymus and spleen simultaneously respectively and claims its weight in wet base with 1/0,000 balances, checks through F, the results are shown in Table 6-7.
Table 6 given the test agent is to the influence of normal rat immunity organ weight in wet base (X ± SD)
| Group | Number of animals (only) | Thymus weight in wet base (mg/100g) | P | Spleen weight in wet base (g/100g) | P |
| The distilled water group | 9 | 236.3±72.6 | 0.589±0.271 | ||
| Given the test agent 2.5g/kg group | 8 | 197.6±70.3 | ＜0.05 * | 0.430±0.228 | ＞0.05 * |
| Given the test agent 5.0g/kg group | 9 | 171.2±71.1 | ＜0.05 * | 0.420±0.123 | ＞0.05 * |
| Given the test agent 10g/kg group | 9 | 123.7±64.3 | ＜0.01 * | 0.503±0.219 | ＞0.05 * |
*Compare with the distilled water group
Table 7 given the test agent is to the influence of normal rat immunity function (X ± SD)
*Compare with the distilled water group
2, to the influence of immunologic function degression rat immunity function
The SD rat, body weight 132 ± 27.59g, male and female dual-purpose, be divided into 5 groups at random, the 1st group of contrast ig distilled water 20ml/kg, the 2nd～5 group in beginning to test im dexamethasone sodium phosphate 5mg/kg on the the 1st, 5,9, difference ig distilled water 20ml/kg, given the test agent 2.5g/kg, 5g/kg, 10g/kg.Continuous 12 days, every Mus is iv sheep red blood cell (SRBC) 1.2ml/ on the the 9th, 12 only (concentration is seen before) separately, and each ip1% soluble starch 5ml/ on the the 11st, 12 only, 1 hour ip1% chicken red blood cell 3ml/ only behind the ip starch on the 12nd, after 5 hours, extract peritoneal exudate and survey the huge percentage rate of biting, heart extracting blood on the 12nd, separation of serum, survey the sheep red blood cell (SRBC) half hemolysis value respectively, the T lymhocyte transformation rate has been plucked thymus and spleen simultaneously respectively, claims its weight in wet base with 1/0,000 balances, through the F check, the results are shown in Table 8-9.
Table 8 given the test agent is to the influence of immunologic function degression rat immunity organ weight in wet base (X ± SD)
| Group | Number of animals (only) | Thymus weight in wet base (mg/100g) | P | Spleen weight in wet base (g/100g) | P |
| The distilled water group | 10 | 205.5±86.0 | 0.61±0.16 | ||
| Dexamethasone+distilled water group | 10 | 11.0±5.5 | ＜0.001 * | 0.28±0.08 | ＜0.001 * |
| Dexamethasone+given the test agent 2.5g/kg | 10 | 17.9±7.1 | ＜0.05 * | 0.55±0.17 | ＜0.001 * |
| Dexamethasone+given the test agent 5g/kg | 10 | 20.5±4.4 | ＜0.001 * | 0.33±0.14 | ＜0.05 ** |
| Dexamethasone+given the test agent 10g/kg | 10 | 17.1±6.0 | ＜0.05 * | 0.35±0.18 | ＜0.05 ** |
*Compare with the distilled water group:
*With dexamethasone model group ratio
Table 9 given the test agent is to the influence of immunologic function degression rat immunity function (X ± SD)
| Group | Number of animals (only) | Sheep red blood cell (SRBC) half hemolysis value (HC50) | P | T lymhocyte transformation rate (%) | P | Macrophage phagocytic percentage rate (%) | P |
| The distilled water group | 10 | 137.5±48.5 | 50.3±6.8 | 54.2±11.2 | |||
| Dexamethasone+distilled water group | 10 | 17.6±4.0 | ＜0.001 * | 31.9±8.9 | ＜0.01 * | 25.3±9.6 | ＜0.001 * |
| Dexamethasone+given the test agent 2.5g/kg group | 11 | 104.1±89.5 | ＜0.001 ** | 35.4±5.2 | ＞0.05 * | 37.5±7.9 | ＜0.01 ** |
| Dexamethasone+given the test agent 5g/kg group | 11 | 110.7±88.3 | ＜0.005 ** | 41.4±3.1 | ＜0.05 ** | 39.8±5.3 | ＜0.001 ** |
| Dexamethasone+given the test agent 10g/kg group | 11 | 115.9±81.9 | ＜0.001 ** | 44.0±2.6 | ＜0.01 ** | 18.5±6.4 | ＜0.05 ** |
*Compare with the distilled water group:
*With dexamethasone model group ratio
3, to the Immune Function of immunologic function rising rat
The SD rat, body weight 143.2+33.0g, the male and female dual-purpose, be divided into 5 groups at random, the 1st group of contrast, ig distilled water 20ml/kg/ day, the 2nd～5 group respectively at im bacillus calmette-guerin vaccine 0.5mg/ on the the 1st, 4,8,12 only, from testing second group of ig distilled water 20ml/kg/ day on the 1st 3-5 group ig given the test agent 2.5g/kg/ day, 5g/kg/ day, 10g/kg/ day, continuous 13 days.Iv sheep red blood cell (SRBC) 1.2ml/ on the the 10th, 14 is only separately for every Mus, (concentration is seen before), ip1% soluble starch 5ml/ on the the 13rd, 14 only, behind the ip starch on the 14th 1 hour, ip1% chicken red blood cell 3ml/ only got peritoneal exudate and surveys the macrophage phagocytic percentage rate after 5 hours; Animal hearts was got blood on 1, and separation of serum is surveyed sheep red blood cell (SRBC) half hemolysis value, T lymhocyte transformation rate respectively, wins thymus and spleen simultaneously, analysed balance very much with 1/ and claimed its weight in wet base, through the F check, the results are shown in Table 10-11.
Table 10 given the test agent is to the influence of immunologic function rising rat immunity organ weight in wet base (X ± SD)
| Group | Number of animals (only) | Thymus weight in wet base (mg/100g) | P | Spleen weight in wet base (g/100g) | P |
| The distilled water group | 12 | 152.5±54.2 | 0.82±0.20 |
| Bacillus calmette-guerin vaccine+distilled water group | 10 | 199.0±53.0 | ＜0.05 * | 0.74±030 | ＞0.05 * |
| Bacillus calmette-guerin vaccine+given the test agent 2.5g/kg group | 10 | 172.7±59.7 | ＞0.05 ** | 0.80±0.27 | ＞0.05 ** |
| Bacillus calmette-guerin vaccine+given the test agent 5g/kg | 11 | 167.6±53.5 | ＜0.05 ** | 0.74±0.27 | ＞0.05 ** |
| Bacillus calmette-guerin vaccine+given the test agent 10g/kg | 11 | 127.0±31.0 | ＜0.01 ** | 0.87±0.28 | ＞0.05 ** |
*Compare with the distilled water group:
*With bacillus calmette-guerin vaccine model group ratio
Table 11 given the test agent is to the influence of immunologic function rising rat immunity function (X ± SD)
| Group | Number of animals (only) | Sheep red blood cell (SRBC) half hemolysis value (HC50) | P | T lymhocyte transformation rate (%) | P | Macrophage phagocytic percentage rate (%) | P |
| The distilled water group | 10 | 120.1±81.0 | 52.1±7.1 | 44.7±7.2 | |||
| Bacillus calmette-guerin vaccine+distilled water group | 10 | 194.9±39.7 | ＜0.05 * | 60.5±7.2 | ＜0.05 * | 56.4±4.3 | ＜0.001 * |
| Bacillus calmette-guerin vaccine+given the test agent 2.5g/kg group | 10 | 172.0±84.4 | ＞0.05 ** | 55.8±4.9 | ＞0.05 * | 48.3±5.3 | ＜0.01 ** |
| Bacillus calmette-guerin vaccine+given the test agent 5g/kg group | 10 | 218.6±78.7 | ＞0.05 ** | 65.5±4.1 | ＜0.05 ** | 40.4±2.8 | ＜0.001 ** |
| Bacillus calmette-guerin vaccine+given the test agent 10g/kg group | 10 | 230.4±61.2 | ＞0.05 ** | 55.3±5.8 | ＞0.05 ** | 39.7±4.9 | ＜0.001 ** |
*Compare with the distilled water group:
*With bacillus calmette-guerin vaccine model group ratio
Conclusion (of pressure testing): given the test agent can reduce thymus weight in wet base, sheep red blood cell (SRBC) half hemolysis value, T lymhocyte transformation rate and macrophage phagocytic percentage rate to normal rat, when the 5.0g/kg, is immunosuppressive action; Can improve thymus, spleen weight in wet base, sheep red blood cell (SRBC) half hemolysis value, T lymhocyte transformation rate and macrophage phagocytic percentage rate to the immunologic function degression rat, immunologic enhancement is arranged; Can reduce thymus weight in wet base and macrophage phagocytic percentage rate to immunologic function rising rat, but, be some inhibitory action sheep red blood cell (SRBC) half hemolysis value and T lymhocyte transformation rate not statistically significant.Given the test agent has certain regulating action to the laboratory animal immunologic function, particularly presents immunosuppressive action, and preliminary prompting provides experimental basis to the recovery that chronic hepatitis patient immunologic function in the clinical observation rises.
Test example 3 Chinese medicine compositions of the present invention (decocting liquid) are to the influence test of hepatitis B human peripheral lymphocyte SCE frequency
One, materials and methods
1, object of study: 10 routine Levels in Patients with Chronic Active Hepatitis B patients, man 8, woman 2, all meets the diagnostic criteria of 84 years Nanning meeting chronic active hepatitises at 28.1 years old mean age (20-40 year).Be the inpatient.All patient HBsAg, HBbeAg, the anti-HBcIgM positive (RIA).All non-smoking, do not use hormone, contact with X-ray not in a year, non-poisonous material contact, heredity and tumor medical history.
The normal controls group: the healthy people that 10 routine HBVM are all negative is selected from worker of the court and student, age, sex and other conditions and patient and organizes approximate.There are not above-mentioned poisonous substance, X line contact history, non-smoking.
2, main agents: RPMI-1640 U.S. product: 5-bromouracil deoxyribose (BrdU), Shanghai biological preparation factory product.
3, traditional Chinese medicine composition water decocting liquid of the present invention preparation: the tablet desaccharide clothing that embodiment 2 is prepared → grind to the powder, take by weighing 5g, add distilled water 250ml and fry in shallow oil into 100ml, remove sediment; Sediment reuse 100ml distilled water is fried in shallow oil into 50ml, and last two liquid merge, and 4 ℃ of standing over night are got supernatant, the centrifugal 5min of 1000rpm/min gets supernatant, the G-4 sucking filtration, sucking filtration liquid is condensed into 10% decocting liquid in 60 ℃ of water-baths, 10%NaHC03 transfers pH value to 7.2, and packing, 4 ℃ of preservations are standby.
4, test method: cell culture, Chromosome Preparation and SCE differential stain and SCE counting reference literature [Zhao Shou unit Journal of Experimental Biology 198114 (2): 123; Yellow art is winding, the mutagenesis of Chen Ruoxing chief editor Environmental Chemistry thing, teratogenesis, carcinogenic test method.Zhejiang science tech publishing house, 1986 front pages].Bath temperature is 60 ℃ during differential stain, and the ultraviolet light irradiation time is 40min.
Grouping: each patient's blood sample originally is divided into three groups: 1. patient's spontaneous SCE group; Do not add soothing the liver reason spleen sheet decocting liquid when adding BrdU, to observe the spontaneous SCE frequency of chronic viral hepatitis B patient.2. dosing processed group: A group adds above-mentioned soothing the liver reason spleen sheet decocting liquid 5ul (being equivalent to crude drug 0.5mg) when adding BrdU; The B group adds medicinal tablet decocting liquid 20ul of the present invention (being equivalent to crude drug 2mg), is used to observe the influence of medicine of the present invention to chronic viral hepatitis B patient SCE frequency; Other establishes normal person SCE frequency matched group.
5, statistical procedures: t check.
Two, result of the test
Medicinal tablet decocting liquid of the present invention sees Table 12 to the influence of chb patient peripheral blood lymphocyte SCE frequency: table 12 medicinal tablet decocting of the present invention liquid is to the influence of chb patient peripheral blood lymphocyte SCE (X ± SD)
①② ②③ ②④ P＜0.01 ①③ ①④ P＞0.05
As seen from Table 12, spontaneous group of SCE of normal person group and patient relatively, spontaneous group of patient is apparently higher than normal person's group (P＜0.01); Patient's medication group and spontaneous group of comparison, the 5ul group has reduced by 4.297 and 4.712 respectively with 20ul group SCE, and difference has highly significant meaning (P＜0.01); Medication group and normal person organize comparison, and the SCE frequency is approaching, and difference does not have significance meaning (P＜0.05).
This result of the test shows that spontaneous group of SCE of chronic active hepatitis patient raises, and compares with the normal person, and difference has significance meaning (P＜0.01), and this result is with report is similar both at home and abroad.Medicinal tablet decocting liquid processed group SCE of the present invention is starkly lower than spontaneous group of patient (P＜0.01), similar to the normal person (P＞0.05), illustrating that medicinal tablet decocting liquid of the present invention has outward strengthens the repair ability of somatic cell to DNA damage due to the HBV, keeps the effect of somatic chromosome stability.The Hu-a-IFN of this result and Wang Peilin report reduces result consistent (Wang Peilin etc., heredity and disease, 19907 (1): 15) of hepatitis B patient SCE frequency.
The stagnation of liver-QI with deficiency of the spleen blood stasis is the important pathology link of viral hepatitis chronicity, and the medicine of the present invention of utilization soothing liver and strengthening spleen activating blood circulation method prescription is to recovering the chronic active hepatitis liver function, and especially improving albumin has curative effect preferably.
Test example 4 Chinese medicine compositions of the present invention are to the influence test of white mice hydrocortisone model hepatic protein complex functionality
One, materials and methods
1, laboratory animal: male white mouse, about every body weight 25 grams.
2, given the test agent: the tablet that the embodiment of the invention 2 is prepared;
3, other medicines: the hydrocortisone injection, every 2ml contains 10mg, normal saline.
4, test method:
Test grouping: normal control group; The hydrocortisone group; Hydrocortisone+given the test agent group; Each 10 of every group of mices.
Method: normal control group: every intramuscular injection every day normal saline 0.1ml, every day, boiled water was irritated stomach 20ml/kg, totally seven days.
The hydrocortisone group: every intramuscular injection every day hydrogen is examined 0.1ml, and (the hydrogeneous 0.5mg that examines), every day, boiled water was irritated stomach 20ml/kg, totally seven days.
Hydrocortisone+given the test agent group: annotate hydrogen and examine 0.1ml (0.5mg), totally 7 days every every day.From annotating hydrogen 2 days before examination, every day is soothing the liver, and reason spleen sheet 25% extractum liquid is irritated stomach, 20ml/kg body weight, totally 9 days.
In the tenth day sacrificed by decapitation white mice of experiment, cut open immediately and get liver, go into respectively in the BouinShi liquid and fix, paraffin embedding, section, H, E dyeing,
Observation index: observation (amplifying 1000 times) under the oily mirror is put in section
1, hepatocellular kernel number: observe the kernel number of 100 liver cell nuclears of every section counting, averaged from the other beginning of central veins of hepatic lobules to the lobules of liver periphery.
2 kernel diameters: measure the diameter of 100 kernels with the microscope mircrometer gauge in every section, the order of observation of cell nuclear is the same, averages.
Two, result of the test
Result of the test sees Table 13.
Table 13 medicine of the present invention is to the influence of hepatocyte kernel number
The kernel number is average each hepatocellular kernel number, compares in twos through between variance analysis and group, and the difference between hydrocortisone+given the test agent group and normal control group and hydrogenant pine group has the meaning (P＜0.01) of highly significant.
Table 14 medicine of the present invention is to the influence of hepatocyte kernel diameter
*Hydrocortisone group and normal control group compare, and its difference has the meaning (P＜0.01) of highly significant.
*Through between variance analysis and group, comparing in twos, hydrogen examines+and the given the test agent group examines the group comparison with hydrogen, and its difference has the meaning (P＜0.01) of highly significant.
Conclusion (of pressure testing): medicine of the present invention can make hepatocyte kernel number increase, and prevents that in addition hydrocortisone from causing the effect that the hepatocyte kernel diminishes, and points out medicine of the present invention to have the effect of enhance hepatocyte protein metabolism.
The acute toxicity test of test example 5 Chinese medicine compositions of the present invention
One, is subjected to reagent thing and laboratory animal
1, be subjected to the reagent thing: the tablet that the embodiment of the invention 2 is prepared, desaccharide clothing, drying, grind into powder, weigh, decocting in water makes concentrated solution, refrigerator is preserved standby.
2, laboratory animal: LACA white mice, Kunming kind white mice.Provide by animal section of Hunan pharmaceutical university.
Two, test method and result
Acute toxicity: the LACA mice is male, body weight 22.7 ± 2.1g, and 20, ig is subjected to reagent thing 12.5g/kg, 2 times on the 1st.Observed 7 days, all are movable normal, and none is only dead.
80 of mices, the male and female dual-purpose.Body weight 19.2 ± 3.2g.Successively divide 4 batches, 20 every batch.1 ig was observed 3 days by reagent thing 25g/kg, only dead 2 of the 4 batches of animals, and all activities of all the other animals are all normal.Can not ask the LD50 of ig.
Result of the test: be subjected to reagent thing animal ig, with maximum concentration and heap(ed) capacity (12.5g/kg, 2 times/day), 100 only dead 2, can not ask the LD50 of ig, be equivalent to clinical consumption 400 surplus times.
The long term toxicity test of test example 6 Chinese medicine compositions of the present invention
One, is subjected to reagent thing and laboratory animal
1, be subjected to the reagent thing: the tablet that the embodiment of the invention 2 is prepared, desaccharide clothing, drying, grind into powder, weigh, decocting in water makes concentrated solution, is made into various variable concentrations (50%, 25%, 12.5%), refrigerator is preserved standby.
2, laboratory animal: the SD rat is defended institute by Hunan Province's labor and provides.
Two, method and result
The SD rat, body weight 192 ± 30g, 80.The male and female dual-purpose is divided into 4 groups at random, 20 every group.The 1st group of ig distillation 20ml/kg, the 2nd～4 group respectively ig be subjected to reagent thing 20g/kg, 5g/kg, 2.5g/kg, every day 1 time, continuous 90 days.In 5 of every group of execution in the 91st day (putting to death at random), weigh, survey routine blood test, hepatic and renal function, carry out the heart, liver, nephridial tissue cut sections for microscopic examination: put to death 5 after the drug withdrawal again, weigh equally, survey routine blood test, liver, renal function, carry out the heart, liver, nephridial tissue cut sections for microscopic examination.The result carries out F check and X
2Check the results are shown in Table 15-17.
Table 15 Chinese medicine composition of the present invention is to the influence (X ± SD g) of rat body weight
| Group | Before the administration | After the drug withdrawal | Increment rate (%) | Before the administration | After the drug withdrawal 15 days | Increment rate (%) |
| (1) distilled water group | 188±22 | 270±50 | 45.1 | 178±22 | 241±33 | 35.3 |
| (2) small dose group | 180±19 | 249±72 | 35.0 | 191±48 | 230±48 | 20.4 |
| (3) dosage group in | 202±31 | 239±42 | 18.3 | 185±31 | 234±46 | 26.5 |
| (4) heavy dose of group | 207±35 | 232±14 | 12.1 | 186±29 | 228±30 | 22.6 |
| P | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 |
Table 16 Chinese medicine composition of the present invention is to the influence of administration conventional hepatic and renal function of rat serum after 90 days (X ± SD)
| Group | RBC | Hb | WBC | N | L | SGPT | RUN |
| (individual/m3) | (g％) | (individual/m3) | (％) | (％) | (u) | (g％) | |
| 1. distilled water group | 696±84 | 14.1±0.7 | 9740±1606 | 20.2±8.6 | 79.8±8.6 | 53.8±8.8 | 7.4±1.3 |
| 2. small dose group | 719±87 | 15.3±0.7 | 9560±4973 | 26.6±7.9 | 73.4±7.9 | 78.4±45.0 | 8.8±2.0 |
| 3. middle dosage group | 766±54 | 14.2±1.1 | 10360±2003 | 18.0±8.4 | 82.0±8.4 | 55.6±8.7 | 7.2±0.5 |
| 4. heavy dose of group | 656±118 | 14.1±0.8 | 9720±4273 | 20.8±8.7 | 79.2±8.7 | 72.4±26.6 | 7.5±0.5 |
| P | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 |
Table 17 Chinese medicine composition of the present invention to drug withdrawal after the influence (X ± SD) of 15 days rat routine blood test hepatic and renal functions
| Group | RBC | Hb | WBC | N | L | SGPT | RUN |
| (individual/mm3) | (g％) | (individual/mm3) | (％) | (％) | (u) | (g％) | |
| 1. distilled water group | 591±49 | 13.1±0.9 | 10780±2685 | 35.6±4.6 | 64.0±4.8 | 62.8±12.7 | 7.3±0.6 |
| 2. small dose group | 567±71 | 12.5±0.8 | 10520±2346 | 31.6±6.7 | 68.4±6.7 | 54.2±3.7 | 7.4±0.4 |
| 3. middle dosage group | 632±24 | 12.4±6.7 | 11560±2965 | 37.6±5.1 | 62.0±5.7 | 53.8±3.9 | 7.7±0.6 |
| 4. heavy dose of group | 569±86 | 13.5±0.6 | 11520±2317 | 39.2±13.2 | 60.8±13.2 | 47.0±7.8 | 8.4±1.3 |
| P | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 |
*1. with 2. 3. ratio P＞0.05; 1. with 4. difference P＜0.05
The animal successive administration is after 90 days and drug withdrawal after 15 days, and every treated animal is put to death 5, except that carrying out routine blood test, hepatic and renal function detect, wins the heart, liver, kidney carries out naked eyes and the microscope tissue slice is observed.Result of the test, the weight of animals, hair color, diet, RBC, WBC, RUN, SGPT etc. are not had by the reagent thing obviously influences, and difference not obvious (P＞0.05) between the matched group.Tissue is carried out the result of naked eyes and the observation of microscope tissue slice: perusal finds no abnormal phenomena, no significant difference between each group of pathology section examination result.Result of the test explanation Chinese medicine composition successive administration of the present invention 90 days is observed 15 days to several avirulences of animal after the drug withdrawal.
Test example 7 traditional Chinese medicine composition for treating chronic hepatitis B II clinical trial phases of the present invention are summed up
One, case is selected
Totally 438 examples.Diagnosis is according to the chronic hepatitis diagnostic criteria of the whole nation, Nanning in 1984 hepatitis meeting revision, tcm syndrome differentiation and typing is divided into stagnation of QI due to depression of the liver, stagnation of liver-QI with deficiency of the spleen, the hepatic and renal YIN deficiency, qi depression to blood stasis four types, and 306 examples (CAHP180 example, CPHP126 example) are organized in treatment, matched group 132 examples (CAHP76 example, CPHP56 example).Two groups of inpatient's 418 examples, clinic case 20 examples, when being admitted to hospital, 22 routine diseases do the liver biopsy, pathological diagnosis 12 examples are CAH (2 examples also have liver cirrhosis), 10 examples are CPH, all livers are worn case pathology and are consistent with clinical diagnosis, and two groups of HBV infection aspect age, sex, the course of disease, typing and before the treatment and liver function injury situation have comparability (P＞0.05) (seeing Table 18,19,20).
Table 18 liang group physical data contrast table
Table 19 a liang group TCM Syndrome Type distributes
Table 20 liang group liver function and HBVM are relatively
| ALT | TTT | A1b | A/C | HBsAg | HbeAg | |
| Be subjected to reagent thing group | 115.4±50.8 | 14.2±4.63 | 38.3±5.71 | 1.40±0.37 | 277 | 157 |
| The oleanolic acid tablet group | 120.1±53.0 | 14.4±4.31 | 39.0±4.99 | 1.42±0.35 | 118 | 60 |
| P | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 | ＞0.05 |
Two, observational technique
Divide the second phase to carry out, first phase utilization double-blind method is established concurrent control.By clinical and pathological diagnosis patient is divided into CPH or CAH when being admitted to hospital, and then with CAH and patient's CPH random assortment to treatment group (treating) and matched group (treating) with oleanolic acid tablet with being subjected to the reagent thing.[this phase is totally 295 examples, medicine group 163 examples wherein of the present invention [CAHP104 example, CPHP59 example].Oleanolic acid tablet group 132 examples [CAH76 example, CPH56 example].The second phase is treated group self front and back relatively after the matched group medicine uses up, observe separately and being subjected to reagent thing curative effect [this phase is observed case 143 examples altogether].
Be subjected to the reagent thing: the tablet that the embodiment of the invention 2 is prepared;
Control drug: oleanolic acid tablet, outward appearance, size, shape, color and luster and be subjected to the reagent thing identical.
Instructions about how to take medicine: be subjected to the reagent thing: 10 slices/time (every is equivalent to crude drug 1g), tid; Oleanolic acid tablet: 10 slices/time (every contains agent pier fruit acid 6mg), Tid.Be a course of treatment January, observed for three courses of treatment altogether.All patients visit half a year to one year, and part was visited 2 years, and viewing duration is not taken the medicine of antiviral, immunomodulating, liver protection effect.
Three, observation index
1, symptom, sign.
2, liver function: II, ALT, TTT, A/G, A1b.
3, HBVM:HBsAg, HBsAb; HBeAg, HBeAb; HBcAb, HBcAbIgM (all with RIA or ELISA); HBV-DNA (biotin method).In being admitted to hospital, finish per course of treatment, and each is checked once when leaving hospital and when leaving hospital back 3,6, December.
Detect when 4, routine blood test, routine urinalysis, platelet, ECG, BUN etc. are admitted to hospital or according to circumstances.
Four, therapeutic evaluation
1, comprehensive (always) therapeutic evaluation.
2, symptom, sign are improved situation.
3, liver function is improved situation.
4, antivirus action.
5, untoward reaction.
Five, statistical method
TTT, A, A/G, ALT are with matching or T detection in groups.Total effects judge, HBVM negative conversion rate, symptom and sign improve uses X
2Check or Ridit analyze.
Six, comprehensive therapeutic effect judgment criteria: press Ministry of Public Health " the clinical research guideline of treatment by Chinese herbs viral hepatitis ".
Chronic persistent hepatitis (CPH):
1, clinical cure standard: 1. main syndrome disappears; 2. hepatosplenomegaly disappearance or retraction, hepatic region do not have obvious tenderness and kowtow pain; 3. liver function test is normal; 4. do not require that hepatitis B replication index (HBVDNA, DNAP, HBeAg, HbcAb-IgM) turns out cloudy.
2, basic criterion of cure: the every index of clinical cure is followed up a case by regular visits to no abnormal changer half a year, and hepatitis B patient's serum hepatitis B virus copy flag thing is turned out cloudy, and does not require that HBsAg turns out cloudy.
3, invalid standard: do not reach above-mentioned requirements person.
Chronic active hepatitis (CAH):
1, improvement standard: 1. main disease disappears, or basic the disappearance; 2. hepatosplenomegaly is stablized constantly, and does not have and obviously to kowtow tenderness; 3. the normal or initial value of liver function test descends more than 50%, and continues three months persons.
2, basic criterion of cure: 1. conscious disease disappears; 2. hepatosplenomegaly is stablized constant or is dwindled, and does not have and kowtows tenderness; 3. liver function test is normal; 4. above every index is stablized person more than a year.
3, invalid standard: do not reach above-mentioned standard person.
Seven, chronic hepatitis traditional Chinese medical science typing standard:
1, caused by hepatic stagnation qi stagnation: hypochondriac pain is obvious, companion poor appetite, abdominal distention, weak, yellowish urine, constipation or see jaundice, Tai Bai or yellow greasy.Stringy and rolling pulse or string are slow.
2, liver-depression and spleen-insufficiency type: tired, dizzy, abdominal distention, poor appetite, loose stool, or hypochondriac pain, feel sick, detest oil, light red tongue, white and thin fur or white greasy, the slow or stringy and rolling pulse of stringy pulse.
3, liver-kidney yin deficiency: dull pain in liver, waist soreness, feverish sensation in the palms and soles, restless sleep, the xerostomia hardship, the tip of the tongue limit is red, yellow and thin fur or no fur, stringy and thready pulse/stringy and rapid pulse.
4, qi stagnation and blood stasis type: darkish complexion, the side of body twinge or distending pain, the side of body has mass in the abdomen down, or sees liver palm, spider angioma, purplish tongue or ecchymosis is arranged, yellow fur approaches, stringy pulse or puckery.
Six, observed result
(1) efficient comparison
1, the comparison of total effective rate sees Table 21.
The comparison of table 21 total effective rate
| n | Basic cure (%) | Take a turn for the better *(％) | Invalid (%) | |
| Be subjected to reagent thing group | 306 | 133(43.5) | 109(35.8) | 64(20.9) |
| The oleanolic acid tablet group | 132 | 38(28.8) | 41(31.1) | 53(40.1) |
*CPH is a clinical cure
Analyze through Ridit, two groups of curative effect differences have significance meaning (P＜0.05), are subjected to reagent thing curative effect to be better than oleanolic acid tablet.
2, the efficient comparison of CAH, CPH (table 22)
Two groups of efficient comparisons of table 22CAH, CPH
CAH, CPH is soothing the liver, and reason spleen sheet treatment total effective rate is respectively 78.3% and 80.2%, compare with oleanolic acid tablet, P＜0.01, difference has significance meaning (X
2Value is respectively 7.836 and 7.652).
3, the efficient comparison of two groups of different pattern of syndrome
The table 23 liang different pattern of syndrome effective percentage of group relatively
The comparison that Δ is cured substantially for the different pattern of syndrome of same medicine in the group
*Efficient relatively ☆ CPH is a clinical cure for same pattern of syndrome treatment group and matched group.
Be subjected to the reagent thing that stagnation of liver-QI with deficiency of the spleen, stagnation of QI due to depression of the liver, the hepatic and renal YIN deficiency, the basic cure rate of qi depression to blood stasis four types and effective percentage are respectively 58.2%, 37.7%, 21.3%, 11.1% and 88.2%, 81.1%, 70.2%, 44.4%.Various basic cure rate is through X in the group
2Check, P＜0.01 (X
2=40.56), best with the liver-depression and spleen-insufficiency type curative effect, caused by hepatic stagnation qi stagnation takes second place.The various basic cure rate of oleanolic acid tablet compares P＞0.05 (X
2=7.37).Various curative effect difference does not have the significance meaning.Identical pattern of syndrome compares, and it is 88.2% that liver-depression and spleen-insufficiency type is subjected to reagent thing effective percentage, and oleanolic acid tablet is 68.4%, and both compare, P＜0.05 (X
2=4.61), illustrate and be subjected to reagent thing curative effect to be better than oleanolic acid tablet the liver-depression and spleen-insufficiency type chronic viral hepatitis B.Other three types are subjected to reagent thing effective percentage all to be higher than oleanolic acid tablet, but P＞0.05, the difference not statistically significant.
(2) symptom, sign are improved situation
1, select that five kinds of primary symptoms of chronic hepatitis are weak, poor appetite, hypochondriac pain, abdominal distention, loose stool carry out statistical analysis, the results are shown in Table 24.
Doing well,improving situation before and after the table 24 liang group treatment
As seen from the above table, be subjected to the reagent thing to improve cardinal symptom, the especially symptom of digestive tract of chronic hepatitis, obviously be better than oleanolic acid tablet.
2 liang of groups are treated the influence (table 25,26) of front and back to enlargement liver spleen
Two groups of liver and spleen retraction situations of table 25 CAHP
*Be enlargement liver spleen example number
*The P1P2X2 value is respectively 3.469 and 5.129, and △ P is two groups and controls back retraction value (d ± sd) compare
Two groups of enlargement liver retractions of table 26 CPHP situation
*Be enlargement liver example number
1. (more 2. hepatosplenomegaly is little measures 3. by B ultrasonic that the liver spleen dwindles more than the 0.5cm for bouncing back for d ± sd) for the two groups of retraction values in treatment back for △ P.
From last table as seen, be subjected to the effect of reagent thing aspect retraction enlargement liver spleen, obviously be better than oleanolic acid tablet.
The variation of (three) two groups of treatment front and back liver functions
By table 27,28 as seen.Before knot was treated and finished, no matter matched group still is treatment group ALT, TTT all obvious decline, but the TTT normalization rate is subjected to reagent thing group apparently higher than oleanolic acid tablet group (P＜0.05).No matter CAH, CPH are subjected to the reagent thing aspect improving albumin, recovering A/G, all obviously are better than oleanolic acid tablet.
The variation of ATL, TTT, A/G, A1b before and after two groups of treatments of table 27 CAH (X ± SD)
| n | Before the treatment | Difference before and after controlling | P | Normalization rate | X 2P | |
| ALT(u) | ||||||
| Be subjected to the reagent thing | 141 | 128.4±95.3 | 89.9±87.6 | ＜0.01 | 62.4 | X 2＝4.56 |
| Oleanolic acid tablet | 52 | 130.4±60.63 | 82.7±90.63 | ＜0.01 | 46.2 | P＞0.05 |
| TTT(u) | ||||||
| Be subjected to the reagent thing | 125 | 13.22±4.50 | 5.24±5.80 | ＜0.01 | 60.0 | X 2＝12.56 |
| Oleanolic acid tablet | 52 | 14.8±4.43 | 4.5±6.38 | ＜0.01 | 30.8 | P＜0.05 |
| A/G | ||||||
| Be subjected to the reagent thing | 167 | 1.29±0.33 | 0.17±0.32 | ＜0.01 | 53.9 | X 2＝10.65 |
| Oleanolic acid tablet | 73 | 1.35±0.33 | 0.039±0.28※ | ＞0.5 | 27.3 | P＜0.01 |
| A1b(g/L) | ||||||
| Be subjected to the reagent thing | 149 | 37.4±5.06 | 2.40±4.55 | ＜0.01 | ||
| Oleanolic acid tablet | 53 | 37.6±5.29 | 1.22±4.14※ | ＜0.05 |
Difference before and after two groups of treatments of ※ (d ± sd) relatively, P＜0.05
The variation of ATL, TTT, A/G, A1b before and after two groups of treatments of table 28 CPHP (X ± SD)
| n | Before the treatment | Treatment back difference | P | Normalization rate | X 2P | |
| ALT(u) | ||||||
| Be subjected to the reagent thing | 57 | 109.1±80.8 | 92.9±77.7 | ＜0.01 | 64.9 | X 2＝2.697 |
| Oleanolic acid tablet | 30 | 109.8±36.91 | 64.81±70.22 | ＜0.001 | 46.7 | P＞0.05 |
| TTT(u) | ||||||
| Be subjected to the reagent thing | 63 | 12.0±3.71 | 4.98±5.00 | ＜0.01 | 66.7 | X 2＝5.98 |
| Oleanolic acid tablet | 28 | 13.85±3.93 | 3.86±6.37 | ＜0.05 | 39.3 | P＜0.05 |
| A/G | ||||||
| Be subjected to the reagent thing | 100 | 1.43±0.32 | 0.09±0.22 | ＜0.01 | 63.0 | X 2＝1.91 |
| Oleanolic acid tablet | 44 | 1.52±0.36 | 0.01±0.31※ | ＞0.5 | 45.8 | P＞0.1 |
| A1b(g/L) | ||||||
| Be subjected to the reagent thing | 78 | 38.8±5.52 | 2.19±3.13 | ＜0.01 | ||
| Oleanolic acid tablet | 22 | 40.2±4.86 | 1.54±2.19※ | ＜0.01 |
Difference before and after two groups of treatments of ※ (d ± sd) relatively, P＜0.05
(4) two groups of case HBVM
The variation (n) of table 29 liang group case HBVH
As known from Table 29, be subjected to reagent thing group HBsAg, HBeAg, HBVDNA negative conversion rate to be respectively 14.1%, 48.4%, 58.7%, but compare difference not statistically signigicant (P＞0.05) with oleanolic acid tablet.
(5) be subjected to of the influence (table 30) of reagent thing to different each index of pattern of syndrome of 306 routine chbs
Know by table 30, be subjected to the reagent thing best, be better than its alloytype liver-depression and spleen-insufficiency type ALT, TTT, A/G normalization rate and hepatomegaly relaxation shrinkage curative effect.
Table 30 is influenced by different each index of pattern of syndrome of reagent thing
(6) side effect is observed
306 examples are organized in treatment, and abdominal distention is felt in the back, an example is felt nauseating (all disappearing after the drug withdrawal) except that there being 4 examples to take medicine, generation without any side effects, and blood, routine urinalysis during the treatment, platelet, BUN, ECG there is no unusual performance.
(7) follow up a case by regular visits to situation: to being subjected to reagent thing group treatment back clinical cure or basic 80 examples of curing in the recent period, carry out 1.5-2 and follow up a case by regular visits to, the results are shown in Table 31.
Table 31 is subjected to reagent thing group 80 routine clinical cure cases to follow up a case by regular visits to situation
| Follow up a case by regular visits to | Stable | Basicly stable | Recurrence | |
| CAH | 50 | 29(58.0) | 14(28.0) | 7(14.0) |
| CPH | 30 | 21(70.0) | 6(20.0) | 3(10.0) |
| Add up to | 80 | 52(62.5) | 20(25.0) | 10(12.5) |
The clinical observation conclusion:
1, being subjected to the reagent thing is 78.3% to the CAH total effective rate, basic cure rate 38.9%; To the CPH total effective rate is 80.2%, and basic cure rate is 50.0%.From the efficacy analysis of different pattern of syndrome, liver-depression and spleen-insufficiency type is evident in efficacy, and total effective rate is 88.2%, and basic cure rate is 58.2%; Secondly be caused by hepatic stagnation qi stagnation, total effective rate reaches 81.2%, and basic cure rate is 39.9.Liver-depression and spleen-insufficiency type and stagnation of liver-QI stagnate the type total effective rate with cure rate and liver-kidney yin deficiency and qi stagnation and blood stasis type relatively have significant difference substantially.Therefore drug main of the present invention will be applicable to liver-depression and spleen-insufficiency type and caused by hepatic stagnation qi stagnation hepatitis.
2, be subjected to the reagent thing can obviously improve liver function.ALT normalization rate CAH is 62.4%; CPH is 64.9%.TTT normalization rate CAH is 60.0%; CPH is 66.7%.The normal again CAH of A/G is 53.9%; CPH is 63.0%.Increase rate CAH is 2.40 ± 4.55 before and after the Alb treatment; CPH is 2.19 ± 3.13.Medicine of the present invention and oleanolic acid tablet compare, and except that reducing the ALT there was no significant difference, other all is better than oleanolic acid tablet.
3, be subjected to the reagent thing can obviously improve the liver spleen of symptom, retraction enlargement.In symptoms such as improving weak, poor appetite, hypochondriac pain, abdominal distention, loose stool obvious curative effects is arranged, all be better than oleanolic acid tablet.Medicine retraction CAH hepatomegaly rate of the present invention is 61.9%, and the splenomegaly rate is 50.9%, and the swollen rate of retraction CPH liver is 69.8%, and curative effect obviously is better than oleanolic acid tablet.
4, be subjected to the reagent thing that HBsAg, HBeAg, HBV-DNA negative conversion rate are respectively 14.1%, 48.4%, 58.7%, compare there was no significant difference with oleanolic acid tablet.
5, late result
Follow up a case by regular visits to being subjected to reagent thing treatment back clinical cure or basic 80 examples of curing to carry out 1.5-2, its stable and basicly stable rate are 87.5%, illustrate that to be subjected to reagent thing late result better.
6, no toxicity
Treatment group 306 examples are removed and felt abdominal distention after 4 examples are taken medicine, and are outside 1 example is felt sick, without any side effects.
Claims (15)
1, a kind of Chinese medicine composition for the treatment of chronic hepatitis, it is characterized in that, each crude drug that comprises following weight portion is made: 40～160 parts of Radix Bupleuri (processed with vinegar), 40～160 parts of the Radix Paeoniae Albas (processed with vinegar), 40～160 parts of Radix Angelicae Sinensis (wine is processed), 40～160 parts in Radix Rubiae, 40～160 parts of the Rhizoma Atractylodis Macrocephalaes (parched with bran), 40～160 parts in Poria, 40～160 parts of Carapax Trionycis (processed with vinegar), 40～160 parts of XIANGQU, 60～240 parts of Radix Codonopsis, 60～240 parts of Rhizoma Imperataes, 24～96 parts of Fructus Aurantii Immaturuss (parched with bran), 20～80 parts on Pericarpium Citri Reticulatae Viride (parched with bran), 12～48 parts of Fructus Amomis, 12～48 parts in 12～48 parts of Pheretimas (stir-fry) and Radix Glycyrrhizae.
2, according to the described Chinese medicine composition of claim 1, it is characterized in that, the weight portion of each crude drug is: 80～120 parts of Radix Bupleuri (processed with vinegar), 80～120 parts of the Radix Paeoniae Albas (processed with vinegar), 80～120 parts of Radix Angelicae Sinensis (wine is processed), 80～120 parts in Radix Rubiae, 80～120 parts of the Rhizoma Atractylodis Macrocephalaes (parched with bran), 80～120 parts in Poria, 80～120 parts of Carapax Trionycis (processed with vinegar), 80～120 parts of XIANGQU, 90～180 parts of Radix Codonopsis, 90～180 parts of Rhizoma Imperataes, 34～68 parts of Fructus Aurantii Immaturuss (parched with bran), 34～60 parts on Pericarpium Citri Reticulatae Viride (parched with bran), 18～34 parts of Fructus Amomis, 18～34 parts of Pheretimas (stir-fry), 18～34 parts in Radix Glycyrrhizae.
According to the described Chinese medicine composition of claim 2, it is characterized in that 3, the weight portion of each crude drug is: 80 parts of Radix Bupleuri (processed with vinegar), 80 parts of the Radix Paeoniae Albas (processed with vinegar), 80 parts of Radix Angelicae Sinensis (wine is processed), 80 parts in Radix Rubiae, 80 parts of the Rhizoma Atractylodis Macrocephalaes (parched with bran), 80 parts in Poria, 80 parts of Carapax Trionycis (processed with vinegar), 80 parts of XIANGQU, 120 parts of Radix Codonopsis, 120 parts of Rhizoma Imperataes, 48 parts of Fructus Aurantii Immaturuss (parched with bran), 40 parts on Pericarpium Citri Reticulatae Viride (parched with bran), 24 parts of Fructus Amomis, 24 parts of Pheretimas (stir-fry), 24 parts in Radix Glycyrrhizae.
4, according to any one described Chinese medicine composition of claim 1-3, it is characterized in that: this Chinese medicine composition is any acceptable clinically preparation.
5, according to the described Chinese medicine composition of claim 4, it is characterized in that: described preparation is oral formulations or external preparation.
6, according to the described Chinese medicine composition of claim 5, it is characterized in that: described oral formulations comprises tablet, granule, capsule, powder, pill, oral liquid, syrup or drop pill; Described external preparation comprises emplastrum or spray.
7, a kind of method for preparing any one described Chinese medicine composition of claim 1-3, this method may further comprise the steps:
(1), takes by weighing each crude drug by described weight proportion;
(2), Radix Bupleuri (processed with vinegar), Radix Angelicae Sinensis (wine is processed), the Rhizoma Atractylodis Macrocephalae (parched with bran), Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran) and Fructus Amomi are extracted volatile oil, collect volatile oil, standby; Medical filtration gets filtrate and medicinal residues, and is standby;
(3), the medicinal residues of step (2) gained and Radix Rubiae, Rhizoma Imperatae, Radix Codonopsis, Poria, XIANGQU, the Radix Paeoniae Alba (processed with vinegar), Pheretima (stir-fry) and Radix Glycyrrhizae merge, and decocts with water, decoction liquor is filtered, filtrate for later use;
(4), Carapax Trionycis (processed with vinegar) decocts with water, decoction liquor is filtered, gained filtrate and step (2) and the merging of step (3) gained filtrate are concentrated, are dried to extract powder;
(5), the collected volatile oil of the extract powder of step (4) gained and step (2) mixes, and adds adjuvant again, mixing is made the preparation intermediate, makes preparation through preparations shaping technology again, promptly.
8, in accordance with the method for claim 7, it is characterized in that: adopt steam distillation to extract volatile oil in the step (2), wherein add the water of 10 times of medical material weight, extracted volatile oil 3 hours.
9, in accordance with the method for claim 7, it is characterized in that: the number of times that decocts with water described in the step (3) is 2 times, adds the water of 10 times of medical material weight at every turn, and each the decoction extracted 2 hours.
10, in accordance with the method for claim 7, it is characterized in that: in the step (4) Carapax Trionycis is decocted with water 3 times, wherein, add the water of 10 times of medical material weight at every turn, decocted 2 hours at every turn.
11, a kind of method for preparing any one described Chinese medicine composition of claim 1-3, this method may further comprise the steps:
(1), takes by weighing each crude drug by described weight proportion;
(2), Radix Bupleuri (processed with vinegar), the Radix Paeoniae Alba (processed with vinegar), Radix Angelicae Sinensis (wine is processed), Radix Rubiae, the Rhizoma Atractylodis Macrocephalae (parched with bran), Poria, XIANGQU, Radix Codonopsis, Rhizoma Imperatae, Fructus Aurantii Immaturus (parched with bran), Pericarpium Citri Reticulatae Viride (parched with bran), Fructus Amomi, Pheretima (stir-fry) and Radix Glycyrrhizae are decocted with water, extract volatile oil simultaneously, collect volatile oil, standby; Decoction liquor filters, filtrate for later use;
(3), Carapax Trionycis (processed with vinegar) is decocted with water, decoction liquor filters, and the filtrate of filtrate and step (2) gained merges, and is concentrated, is dried to extract powder;
(4), the collected volatile oil of the extract powder of step (3) gained and step (2) mixes, and adds adjuvant, mixing is made the preparation intermediate, makes preparation through preparations shaping technology again, promptly.
12, in accordance with the method for claim 11, it is characterized in that: the number of times that decocts with water described in the step (2) is 2 times, and wherein, the water of 10 times of medical material weight of the 1st adding decocts and extracted 4 hours, collects volatile oil; Add the water of 10 times of medical material weight the 2nd time, decoct and extracted 1 hour.
13, in accordance with the method for claim 11, it is characterized in that: in the step (3) Carapax Trionycis is decocted with water 3 times, wherein, the water that at every turn adds 10 times of medical material weight decocts, and decocts 2 hours at every turn.
14, the purposes of any one described Chinese medicine composition of claim 1-3 in preparation treatment chronic hepatitis or early stage liver cirrhosis medicine.
15, according to the described purposes of claim 14, it is characterized in that: described chronic hepatitis comprises chronic active hepatitis or chronic persistent hepatitis.
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