CN102579870A - Traditional Tibetan medicine composition and preparation for treating liver diseases, and preparation method thereof - Google Patents
Traditional Tibetan medicine composition and preparation for treating liver diseases, and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Tibetan medicine composition for treating liver diseases and a preparation method thereof. The composition is prepared from 10-30 parts of turquoise, 10-30 parts of tabasheer, 20-60 parts of safflower, 4-10 parts of saffron, 25-75 parts of Meconopsis, 15-50 parts of Herba Dracocephali Tangutici, 15-50 parts of Corydalis impatiens, 15-50 parts of rock refine cream, 10-30 parts of clove, 2-5 parts of artificial ox gallstone, 10-30 parts of Indian false swertia herb, 5-15 parts of semen hertospermi, 2-5 parts of petrified bouquet and 1-3 parts of artificial musk. The preparation method comprises the following steps: evenly mixing the active pharmaceutical ingredients, micro-pulverizing into 0.01-100 mu m, adding conventional medicinal auxiliary materials, and preparing pills, micro-pills, dropping pills, tablets, capsules, granules, dispersible tablets and other clinically acceptable preparation formulations, or preparing bagged beverages or canned beverages. The composition can effectively treat liver diseases, and therefore, is very suitable for clinical popularization.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, particularly a kind of Tibetan medicine compositions that is used to treat hepatopathy, preparation and preparation method thereof belong to the Tibetan medicinal preparation field.
Background technology
Liver is the metabolism center of human body, is one of important organ of earning a bare living, the health of its functional status substantial connection human body, and liver cell is damaged, and the function of liver suffers damage, and possibly cause the serial incompatibility symptom of health.Hepatitis belongs to the traditional Chinese medical science " hepatopathy " category, and hepatopathy is many by the poison of experiencing the epidemic disease turbid damp; Or eating and drinking without temperance, impairing the spleen and stomach, so that essential substances from water and cereals dysfunction of the spleen in transportation and transformation, turbid damp internal resistance, hot and suffocating heat-transformation and making damp and hotly mix mutually, and taste are stopped up resistance, and depression of liver-QI can not catharsis; Or by internal injury caused by excess of seven emotions, liver is lost transport; Or stagnated QI transforming into fire, stagnation in liver meridian; Or deficiency of YIN-blood, liver-yang is high partially, and retention of damp-heat in the interior, and the accumulation of cold in liver meridian forms this disease; Or the urgent bile of heat leaks; Or depression of liver-QI, with the passing of time hinder network, the blood stasis retardance, it is not smooth to cause bile excretion, and bile leaks, and overflowing in skin is jaundice.The right rib distending pain of clinical main performance, certificate is pressed, inappetence, myasthenia of limbs, vomiting, headache, dizzy, tinnitus, conjunctival congestion, irritability, whole body jaundice, liver enlargement etc.According to statistics, the number that hbs antigen is carried in the whole world surpasses 2.8 hundred million, and China is hepatitis big country, and in the population of China 8-10% being arranged at present is hepatitis B virus carriers, and still has a considerable amount of newly-increased patients every year.
At present in the drug market, the treatment hepatitis medicament is mainly " lamivudine-heptodin ", but that its defective is knock-on is fast, the variation of the virus that is prone to start an inflammation of the liver, and also has interferon, and its defective is that negative conversion rate is low.Up to now, lack determined curative effect on the market, the medicine that has no side effect again.Tibetan medicine and pharmacology is widely collected the length of Chinese materia medica, ancient Hindu medicine, ancient Arabic medical science; With the traditional medicine system of uniqueness and advantageous drug resource and in world's traditional medicine, occupy critical role; And obtain the numerous common people's approval day by day, and be expected to realize treating both the principal and secondary aspects of a disease to hepatitis, thoroughly solve.
The smooth capsule of liver is that gold is scolded the exclusive product of Tibetan medicine limited company, records in Chinese patent medicine provincial standard rising national standard part standard numbering: WS-10927 (ZD-0927)-2002.The smooth capsule preparations of liver is to be processed by the medical material of following weight proportion: tophus 20.1g, Concretio Silicea Bambusae 20.1g, Flos Carthami 40.0g, Stigma Croci 8.0g, Herba meconopsis integrifoliae 59.6g, tangut dragonhead 40.1g, Corydalis impatiens (Pall.) Fisch. 40.1g, Mumiyah-asil 40.1g, Flos Caryophylli 20.1g, artificial Calculus Bovis 4.0g, Indian Herba Swertiae bimaculatae 20.1g, Herpetospermum caudigerum Wall. 12.0g, Radix Aucklandiae Fructus Aristolochiae 12.0g, Parmelia saxatilis Ach. 4.0g, Moschus 1.6g, Vermilion 1.7g.Above flavour of a drug, except that artificial Calculus Bovis, artificial Moschus's porphyrize powder, flavour of a drug such as all the other tophuss are ground into fine powder, sieve, and with above-mentioned fine powder mixing, incapsulate, and process 1000, promptly get.Be used for the caused distending pain in the chest and hypochondrium of dampness-heat in the liver and gallbladder, inappetence, acute hepatitis is seen above-mentioned patient.
Contain Radix Aucklandiae Fructus Aristolochiae, Vermilion in the smooth capsule original formulation of liver, should not take for a long time, take these article and surpass 1 all persons, should check ion concentration of mercury in blood, the urine, inspection liver, renal function surpass the prescribed limit person and stop using immediately.The former in addition prescription amount of processing: 343.6g is not the standard prescription amount of 1000 capsules.Have, traditional processing method is that hybrid medicine is ground into fine powder again, exists the granularity of medicine bigger, is difficult to absorb, and the medical material loss of effective components is big, affects the treatment.
Summary of the invention
To deficiency of the prior art, the purpose of this invention is to provide a kind of Tibetan medicine compositions of treating hepatopathy, preparation and preparation method thereof.
The term explanation:
Micronizing is meant that utilizing machinery or hydrokinetic method to overcome the solid interior cohesiveness makes it broken, thereby the material particles more than 3 millimeters is crushed to the operating technology of 10-25 micron.Be after the seventies in 20th century, for a kind of material that the development that adapts to modern high technology produces is processed new and high technology.Ultramicro powder is the final products of micronizing, has the unexistent special physicochemical property of general granule, like fine solubility, dispersibility, adsorptivity, chemical reactivity etc.Therefore ultramicro powder has been widely used on many fields such as food, chemical industry, medicine, cosmetics pesticide, dyestuff, coating, electronics and Aero-Space.
Technical scheme of the present invention is following:
A kind of Tibetan medicine compositions of treating hepatopathy of the present invention is formed as follows, is weight portion:
Tophus 10-30 part, Concretio Silicea Bambusae 10-30 part, Flos Carthami 20-60 part, Stigma Croci 4-10 part; Herba meconopsis integrifoliae 25-75 part, tangut dragonhead 15-50 part, Corydalis impatiens (Pall.) Fisch. 15-50 part, Mumiyah-asil 15-50 part; Flos Caryophylli 10-30 part, artificial Calculus Bovis 2-5 part, Indian Herba Swertiae bimaculatae 10-30 part; Herpetospermum caudigerum Wall. 5-15 part, Parmelia saxatilis Ach. 2-5 part, artificial Moschus 1-3 part;
At 30～60 ℃ of temperature dryings, mix homogeneously, superfine powder are broken into 0.01-100 μ m with medical material.
The present invention treats the Tibetan medicine compositions of hepatopathy, the preferred composition as follows, is weight portion:
Tophus 15-20 part, Concretio Silicea Bambusae 15-20 part, Flos Carthami 42-47 part, Stigma Croci 4-7 part; Herba meconopsis integrifoliae 50-55 part, tangut dragonhead 30-37 part, Corydalis impatiens (Pall.) Fisch. 30-37 part, Mumiyah-asil 30-39 part; Flos Caryophylli 10-18 part, artificial Calculus Bovis 2-3.5 part, Indian Herba Swertiae bimaculatae 15-18 part; Herpetospermum caudigerum Wall. 5-11 part, Parmelia saxatilis Ach. 2-3.5 part, artificial Moschus 1-1.5 part.
The present invention treats the Tibetan medicine compositions of hepatopathy, further preferred the composition as follows, is weight portion:
17.6 parts of tophuss, 17.6 parts of Concretio Silicea Bambusaes, 43.7 parts on Flos Carthami, 7 parts of Stigma Crocis, 52 parts of Herba meconopsis integrifoliae; 35 parts of tangut dragonheads, 35 parts of Corydalis impatiens (Pall.) Fisch.s, 38.2 parts of Mumiyah-asil, 17.6 parts of Flos Caryophyllis, 3.5 parts of artificial Calculus Boviss; 17.6 parts of Indian Herba Swertiae bimaculataes, 10.5 parts of Herpetospermum caudigerum Wall.s, 3.5 parts of Parmelia saxatilis Ach., 1.4 parts of artificial Moschuss.
The present invention treats the Tibetan medicine compositions of hepatopathy, further preferred the composition as follows, is weight portion:
15 parts of tophuss, 20 parts of Concretio Silicea Bambusaes, 42 parts on Flos Carthami, 7 parts of Stigma Crocis, 50 parts of Herba meconopsis integrifoliae; 37 parts of tangut dragonheads, 30 parts of Corydalis impatiens (Pall.) Fisch.s, 39 parts of Mumiyah-asil, 10 parts of Flos Caryophyllis, 3.5 parts of artificial Calculus Boviss; 15 parts of Indian Herba Swertiae bimaculataes, 11 parts of Herpetospermum caudigerum Wall.s, 2 parts of Parmelia saxatilis Ach., 1.5 parts of artificial Moschuss.
The present invention treats the Tibetan medicine compositions of hepatopathy, further preferred the composition as follows, is weight portion:
20 parts of tophuss, 15 parts of Concretio Silicea Bambusaes, 47 parts on Flos Carthami, 4 parts of Stigma Crocis, 55 parts of Herba meconopsis integrifoliae, 30 parts of tangut dragonheads, 37 parts of Corydalis impatiens (Pall.) Fisch.s, 30 parts of Mumiyah-asil, 18 parts of Flos Caryophyllis, 2 parts of artificial Calculus Boviss, 18 parts of Indian Herba Swertiae bimaculataes, 5 parts of Herpetospermum caudigerum Wall.s, 3.5 parts of Parmelia saxatilis Ach., 1 part of artificial Moschus.
The Tibetan medicine compositions that the present invention treats hepatopathy can add conventional pharmaceutic adjuvant according to prior art, processes clinical acceptable dosage forms such as pill, micropill, drop pill, tablet, capsule, granule, decoction pieces or dispersible tablet, also can process bag-soaked beverage or canned beverage.
Preferably,
The Tibetan medicine preparation of compositions method that the present invention treats hepatopathy is following: medical material is removed impurity; At 30～60 ℃ of temperature dryings; Mix homogeneously, superfine powder are broken into 0.01-100 μ m, add conventional pharmaceutic adjuvant; Process clinical acceptable dosage forms such as pill, micropill, drop pill, tablet, capsule, granule, decoction pieces, dispersible tablet, also can process bag-soaked beverage or canned beverage.
Further preferred, above-mentioned raw materials medical material mix homogeneously, superfine powder are broken into 0.01-0.5 μ m, 0.4-1.2 μ m, and 1-50 μ m, 40-80 μ m or 60-100 μ m encapsulatedly promptly get.
It is sick that the Tibetan medicine is classified as red crust with hepatopathy, thinks the three categories of etiologic factors of human body, promptly grand, red crust, Baconic's imbalance, and red crust belongs to the febrile disease category due to containing partially, and the Tibetan medicine serves as main the treatment with cold, cool property Tibetan medicine.
Tophus, Concretio Silicea Bambusae removing heat from the liver in the present composition, eliminating phlegm, detoxifcation; The Flos Carthami cooling blood for hemostasis, treating the liver heat, Stigma Croci promoting blood circulation to restore menstrual flow, eliminating stasis to stop pain; The Herba meconopsis integrifoliae heat-clearing and toxic substances removing protects the liver lung benefiting; The tangut dragonhead removing heat from the liver, hemostasis, the skin ulcer that heals, yellow fluid reducing; The Corydalis impatiens (Pall.) Fisch. heat-clearing and toxic substances removing, liver heat removing function of gallbladder promoting, the granulation promoting skin ulcer that heals; Mumiyah-asil has stronger antibacterial action, can kill some penicillium sp is have the microorganism of resistance, can promote the healing and the recovery of osseous tissue fast.The Flos Caryophylli warming middle-JIAO to send down the adverse QI goes " swelling " to nourish heart; Artificial Calculus Bovis's removing heat from the liver, abdomen heat, the malicious effect of preventing epidemic; Indian Herba Swertiae bimaculatae liver heat removing function of gallbladder promoting moves back all heat; The Herpetospermum caudigerum Wall. removing heat from the liver, let out liver-fire, the detoxifcation function of gallbladder promoting; Parmelia saxatilis Ach. heat clearing away, detoxifcation.Be used for nosotoxicosis, inappetence, vomiting.The Moschus promoting blood circulation to restore menstrual flow, reducing swelling and alleviating pain, the QI and blood regulating strengthen perfect square clearing away heat to alleviate pain effect;
Artificial Calculus Bovis, Flos Carthami, tangut dragonhead, Herba meconopsis integrifoliae, Indian Herba Swertiae bimaculatae, Herpetospermum caudigerum Wall., Parmelia saxatilis Ach., the equal bitter in the mouth of Corydalis impatiens (Pall.) Fisch., cool in nature in the present composition, tophus, the equal puckery of Concretio Silicea Bambusae, cold in nature all has specially good effect to liver-heat treatment aspect; Stigma Croci, the equal sweet in the mouth of Mumiyah-asil, property are put down, and help the recovery of liver function; Flos Caryophylli, Moschus, all acrid in the mouth is warm in nature, helps strengthening regulating internal organs, strengthens the property of medicine of perfect square.
The Tibetan medicine compositions of treatment hepatopathy of the present invention has the following advantages:
(1) Tibetan medicinal preparation of treatment hepatopathy of the present invention is to be guidance with Tibetan medicine and pharmacology medical knowledge opinion, according to the Six-element of medicine, the prescription that is used to treat hepatopathy that eight property, 17 imitate dialectical prescription to obtain; And theoretical in conjunction with modern medicine, prescription carried out adding simplify sanction, kept active ingredient; Rejected the toxicity medical material; Can effectively treat hepatopathy, improve drug safety, therefore very suitable popularization clinically.The detailed experiments data will be in the specific embodiment comparative illustration in addition.
(2) traditional grinding and processing method makes drug particle size more than 200 μ m in Chinese medicine, the Tibetan medicine; And the present invention is broken into 0.01-100 μ m with the crude drug superfine powder; Has the unexistent special physicochemical property of general granule; Like dissolubility, dispersibility, adsorptivity, chemical reactivity etc., improved the dissolution of crude drug composition greatly, improve bioavailability simultaneously.The detailed experiments data will be in the specific embodiment comparative illustration in addition.
(3) fine powder that obtains through micronizing of these article does not need lixiviate again, and heating decocts, and can directly be used for preparation production.The failure loss of having avoided the heating extraction process that effective ingredient is caused keeps the bioactive ingredients of powder body to greatest extent.
(4) contain the rare raw materials of multiple preciousness such as Stigma Croci, artificial Moschus, artificial Calculus Bovis in these article, but the micronizing conservation is increased operation rate.
The specific embodiment
In order to illustrate in greater detail the present invention, provide following embodiment.But scope of the present invention is not limited thereto.The present invention does not do to specify is prior art.
Embodiment 1: capsule
A kind of Tibetan medicine compositions of treating hepatopathy, form as follows:
Tophus 1.76kg, Concretio Silicea Bambusae 1.76kg, Flos Carthami 4.37kg, Stigma Croci 0.7kg; Herba meconopsis integrifoliae 5.2kg, tangut dragonhead 3.5kg, Corydalis impatiens (Pall.) Fisch. 3.5kg, Mumiyah-asil 3.82kg; Flos Caryophylli 1.76kg, artificial Calculus Bovis 0.35kg, Indian Herba Swertiae bimaculatae 1.76kg; Herpetospermum caudigerum Wall. 1.05kg, Parmelia saxatilis Ach. 0.35kg, artificial Moschus 0.14kg.
Be prepared from according to following method:
Above-mentioned medical material is removed impurity, and at 30～60 ℃ of temperature dryings, mix homogeneously, superfine powder are broken into 20 μ m, add conventional pharmaceutic adjuvant, process capsule.
The present invention rejects Radix Aucklandiae Fructus Aristolochiae and Vermilion in the former prescription; The recipe quantity of its minimizing is supplemented to the Mumiyah-asil and Flos Carthami; And on former prescription basis, being adjusted into 1000 preparations, the amount of processing is adjusted into 0.3002kg by 0.3436kg, and each medical material recipe quantity of former prescription is reduced into 87.369% on year-on-year basis.
Embodiment 2: capsule
A kind of Tibetan medicine compositions of treating hepatopathy, form as follows:
Tophus 1.5kg, Concretio Silicea Bambusae 2.0kg, Flos Carthami 4.2kg, Stigma Croci 0.7kg, Herba meconopsis integrifoliae 5.0kg; Tangut dragonhead 3.7kg, Corydalis impatiens (Pall.) Fisch. 3.0kg, Mumiyah-asil 3.9kg, Flos Caryophylli 1.0kg, artificial Calculus Bovis 0.35kg; Indian Herba Swertiae bimaculatae 1.5kg, Herpetospermum caudigerum Wall. 1.1kg, Parmelia saxatilis Ach. 0.2kg, artificial Moschus 0.15kg.
Be prepared from according to following method:
Above-mentioned medical material is removed impurity, and at 30～60 ℃ of temperature dryings, mix homogeneously, superfine powder are broken into 50 μ m, add conventional pharmaceutic adjuvant, process capsule.
Embodiment 3: capsule
A kind of Tibetan medicine compositions of treating hepatopathy, form as follows:
Tophus 2.0kg, Concretio Silicea Bambusae 1.5kg, Flos Carthami 4.7kg, Stigma Croci 0.4kg, Herba meconopsis integrifoliae 5.5kg; Tangut dragonhead 3.0kg, Corydalis impatiens (Pall.) Fisch. 3.7kg, Mumiyah-asil 3.0kg, Flos Caryophylli 1.8kg, artificial Calculus Bovis 0.2kg; Indian Herba Swertiae bimaculatae 1.8kg, Herpetospermum caudigerum Wall. 0.5kg, Parmelia saxatilis Ach. 0.35kg, artificial Moschus 0.1kg.
Be prepared from according to following method:
Above-mentioned medical material is removed impurity, and at 30～60 ℃ of temperature dryings, mix homogeneously, superfine powder are broken into 1 μ m, add conventional pharmaceutic adjuvant, process capsule.
Embodiment 4: pill
A kind of Tibetan medicine compositions of treating hepatopathy, form as follows:
Tophus 2kg, Concretio Silicea Bambusae 2.5kg, Flos Carthami 5kg, Stigma Croci 0.5kg, Herba meconopsis integrifoliae 4kg; Tangut dragonhead 4.5kg, Corydalis impatiens (Pall.) Fisch. 4.5kg, Mumiyah-asil 4.0kg, Flos Caryophylli 1.5kg, artificial Calculus Bovis 0.3kg; Indian Herba Swertiae bimaculatae 1.5kg, Herpetospermum caudigerum Wall. 1.25kg, Parmelia saxatilis Ach. 0.45kg, artificial Moschus 0.18kg.
Be prepared from according to following method:
Above-mentioned medical material is removed impurity, and at 30～60 ℃ of temperature dryings, mix homogeneously, superfine powder are broken into 0.1 μ m, add conventional pharmaceutic adjuvant, process pill.
Embodiment 5: tablet
A kind of Tibetan medicine compositions of treating hepatopathy, form as follows:
Tophus 2.5kg, Concretio Silicea Bambusae 1.2kg, Flos Carthami 2.5kg, Stigma Croci 0.45kg, Herba meconopsis integrifoliae 2.8kg; Tangut dragonhead 4.8kg, Corydalis impatiens (Pall.) Fisch. 4.8kg, Mumiyah-asil 4.5kg, Flos Caryophylli 2.6kg, artificial Calculus Bovis 0.47kg; Indian Herba Swertiae bimaculatae 2.6kg, Herpetospermum caudigerum Wall. 0.75kg, Parmelia saxatilis Ach. 0.3kg, artificial Moschus 0.12kg.
Be prepared from according to following method:
Above-mentioned medical material is removed impurity, and at 30～60 ℃ of temperature dryings, mix homogeneously, superfine powder are broken into 100 μ m, add conventional pharmaceutic adjuvant, process tablet.
Embodiment 6: granule
A kind of Tibetan medicine compositions of treating hepatopathy, form as follows:
Tophus 2.8kg, Concretio Silicea Bambusae 1.5kg, Flos Carthami 3.5kg, Stigma Croci 0.9kg, Herba meconopsis integrifoliae 7.0kg; Tangut dragonhead 2.0kg, Corydalis impatiens (Pall.) Fisch. 2.0kg, Mumiyah-asil 1.8kg, Flos Caryophylli 2.8kg, artificial Calculus Bovis 0.25kg; Indian Herba Swertiae bimaculatae 1.8kg, Herpetospermum caudigerum Wall. 0.55kg, Parmelia saxatilis Ach. 0.25kg, artificial Moschus 0.28kg.
Be prepared from according to following method:
Above-mentioned medical material is removed impurity, and at 30～60 ℃ of temperature dryings, mix homogeneously, superfine powder are broken into 0.01 μ m, add conventional pharmaceutic adjuvant, process granule.
Embodiment 7: bag-soaked beverage
A kind of Tibetan medicine compositions of treating hepatopathy, form as follows:
Tophus 1.76kg, Concretio Silicea Bambusae 1.76kg, Flos Carthami 4.37kg, Stigma Croci 0.7kg; Herba meconopsis integrifoliae 5.2kg, tangut dragonhead 3.5kg, Corydalis impatiens (Pall.) Fisch. 3.5kg, Mumiyah-asil 3.82kg; Flos Caryophylli 1.76kg, artificial Calculus Bovis 0.35kg, Indian Herba Swertiae bimaculatae 1.76kg; Herpetospermum caudigerum Wall. 1.05kg, Parmelia saxatilis Ach. 0.35kg, artificial Moschus 0.14kg.
Be prepared from according to following method:
Above-mentioned medical material is removed impurity, and at 30～60 ℃ of temperature dryings, mix homogeneously, superfine powder are broken into 60-100 μ m fine powder, divide the filter paper bag of packing into, carry out outer package again, promptly get bag-soaked beverage.
During use, the filter paper bag that medicated powder is housed is dipped in the boiled water, drinks soak and get final product.
Embodiment 8: the fill beverage
A kind of Tibetan medicine compositions of treating hepatopathy, form as follows:
Tophus 1.76kg, Concretio Silicea Bambusae 1.76kg, Flos Carthami 4.37kg, Stigma Croci 0.7kg; Herba meconopsis integrifoliae 5.2kg, tangut dragonhead 3.5kg, Corydalis impatiens (Pall.) Fisch. 3.5kg, Mumiyah-asil 3.82kg; Flos Caryophylli 1.76kg, artificial Calculus Bovis 0.35kg, Indian Herba Swertiae bimaculatae 1.76kg; Herpetospermum caudigerum Wall. 1.05kg, Parmelia saxatilis Ach. 0.35kg, artificial Moschus 0.14kg.
Be prepared from according to following method:
Above-mentioned medical material is removed impurity, and at 30～60 ℃ of temperature dryings, mix homogeneously, superfine powder are broken into 20 μ m, and add 50-100 weight multiple water and brew, water temperature 80-100 ℃, brew 1-10 time, get the water liquid after brewing, filtration, antibacterial, fill promptly get the fill beverage.
Experimental example 1: particle size is to the influence test of release degree
Method according to micronizing of the present invention prepares three kinds of compositions microgranules that mean diameter is 20 μ m, 50 μ m, 100 μ m;
Pulverizing the preparation mean diameter according to conventional mechanical is the compositions microgranule of 200 μ m;
Quicken release test: each 250mg of the microgranule of each particle diameter of precision weighing, each 6 parts, place 6 250ml culture bottles respectively, accurately add the dissolution fluid 250ml of 0.1M; Lid with band aluminum film is tightened, and jolting is at once used the culture bottle traverse after mixing; Fixing, 37 ℃ of water bath heat preservations, per minute vibrations 100 times; In placing 1,2,3,4,5,6 hour, extract appearance 10ml and measure, see table 1.
Pharmaceutical composition contains Flos Carthami in S-A Hydroxysafflor yellow A.
Table 1 particle size is to the result of the test that influences of release degree
Table 1 presentation of results: granularity is more little, and the effective ingredient release concentration is big more.General mechanical activation comminution the most carefully reaches 200 μ m, and micronizing of the present invention is to 0.01-100 μ m, and the release degree of effective ingredient increases.
Experimental example 2: anxious poison experiment
1, test material
Experimental animal: SPF level Kunming mouse, male and female half and half, Shandong University's Experimental Animal Center provides, the quality certification number: scxk (Shandong) 20090001.
Trial drug: embodiment 1 capsule, embodiment 2 capsules, embodiment 3 capsules and the smooth capsule of former preparation liver (the Qinghai gold is scolded Tibetan medicine Pharmaceutical limited company and provided).
2, test method
With embodiment 1 capsule, embodiment 2 capsules, embodiment 3 capsules and the smooth capsule 's content of former preparation liver are dissolved in respectively in the pure water, process the suspension that ultimate density is equivalent to 0.9g crude drug/mL, and the mouse stomach amount is equivalent to clinical Coming-of-Age Day 1200 times of dosage.
Get 100 of Kunming mouses (male and female half and half), body weight 18-22g is divided into 5 groups at random by body weight, 20 every group, is respectively embodiment 1 Capsules group, embodiment 2 Capsules group, embodiment 3 Capsules group and smooth Capsules group of former preparation liver and blank group.Water 12h is can't help in the mice fasting before the administration; Weigh; Each is organized mice and irritates stomach respectively by body weight and give above-mentioned corresponding suspension, the 0.4ml/10g body weight, and the blank group gives the pure water of equivalent; Irritate behind the stomach mice situations such as drinking-water, observation mice diet, outward appearance, behavior, secretions, Excreta and death of freely ingesting.
3, result of the test
After the mouse stomach administration, after blank group and embodiment 1,2,3 Capsules group gave mouse stomach, mice did not see the overt toxicity reaction and the phenomena of mortality of drug-induced; After the smooth Capsules group of former preparation liver gave mouse stomach, the part mice amount of drinking water that occurs ingesting was few, prostrate, and activity significantly reduces; Lethargy, oliguria, the urine color is buff, even dead.Death condition is seen table 2.
The smooth capsule acute toxicity of table 2 liver trial test dead mouse result (n=20)
The result shows that dosage is the 36g/kg body weight, and during 1200 times of quite clinical adult's dosage, the smooth capsule of liver of embodiment 1, embodiment 2, embodiment 3 is not seen toxic reaction, and the mice general mortality rate is 0; The smooth capsule of former preparation liver has tangible poisoning symptom, and the mice general mortality rate is 15%, and the smooth capsule safety of liver of pointing out freshly prepd embodiment 1, embodiment 2, embodiment 3 is apparently higher than the smooth capsule of former preparation liver.
Experimental example 3: the clinical observation of treatment liver gallbladder damp-heat type chronic hepatitis patient
1. case choice criteria
1.1 Western medicine diagnose standard
The Western medicine diagnose standard that meets new Chinese medicine treatment chronic hepatitis clinical research guideline:
(1) the acute hepatitis course of disease surpasses half a year, or original B-mode, third type, hepatitis D or HbsAg carry history.
(2) have hepatitis symptom, sign and abnormal liver function.
(3) same cause of disease detects positive.
Though date of the onset is indeterminate or do not have history of virus hepatitis, inspections such as iconography meet chronic hepatitis and change, or can make diagnosis according to symptom, sign, chemical examination analysis-by-synthesis.
1.2 tcm syndrome diagnostic criteria
Chinese medical discrimination belongs to syndrome of dampness-heat of liver and gallbladder;
Main symptom: yellow skin and eye, yellow distinct, the pain over the hypochondriac region, the vexed abdominal distention of gastral cavity, dysphoria with smothery sensation, xerostomia and hardship, yellowish or reddish urine, red tongue, yellow and greasy fur.
Inferior card: inappetence, nausea and vomiting, sleepy weak, skin pruritus, constipation with dry stool or rare half congealed, stringy and rolling pulse number.
1.3 case is included standard in
(1) meets viral hepatitis diagnostic criteria and tcm syndrome diagnostic criteria;
(2) age 18-65 year.
1.4 case exclusion standard
(1) do not meet the Western medicine diagnose standard;
(2) do not meet the tcm syndrome diagnostic criteria;
(3) age < 18 or>65 years old person;
(4) confirm on inspection by hepatitis and autoimmune hepatitis person due to the factors such as drug intoxication, ethylism;
(5) merge hepatocarcinoma, perceptual encephalopathy, and the serious primary disease of serious cardiovascular and cerebrovascular vessel, lung, kidney, endocrine and hemopoietic system, psychotic;
(6) gestation or preparation gravid woman, women breast-feeding their children;
(7) allergic constitution, or to multiple drug allergy person.
1.5. reject the case standard
Gone into to organize case but met one of following person, should reject:
(1) mistaken diagnosis, mistake are received;
(2) meet exclusion standard;
(3) one times medicine is not used;
(4) the no any detection record person in treatment back;
(5) owing to using certain medicine, consequently can't evaluate efficacy.
1.6. withdraw from (coming off) case standard
(1) do not accomplish going into to organize case and should being regarded as coming off of clinical protocol:
(2) patient withdraws from (curative effect is too poor, untoward reaction etc.) voluntarily;
(3) lose visit;
(4) researcher makes it withdraw from that (compliance is poor; Concomitant disease appears; Serious adverse events).
1.7. end the standard of test comprehensively
(1) research side finds serious safety issue;
(2) curative effect is too poor;
(3) scheme has significant error;
2. observation index
Relevant symptoms, sign and tongue fur pulse condition changed before and after the patient took medicine.
3. therapeutic evaluation standard
(1) clinical recovery: symptom, sign disappear or basic the disappearance;
(2) produce effects: symptom, sign are obviously improved;
(3) effective: symptom, sign all take a favorable turn;
(4) invalid: symptom, sign all do not have obvious improvement, even increase the weight of.
4, test method
The chronic hepatitis that will meet diagnostic criteria belongs to syndrome of dampness-heat of liver and gallbladder patient 240 examples, is divided into 4 groups at random, is respectively 1 group of embodiment, 2 groups of embodiment, 3 groups of embodiment and reference examples group, every group 60 example.Each is organized the patient and takes corresponding embodiment capsule, one time 3,2 times on the one; The matched group patient takes the smooth capsule of former preparation liver, one time 3,2 times on the one; Eliminating cold for resuscitation mouth of a river clothes.Taking 28 days continuously is a course of treatment.Observe patient's sings and symptoms before and after the administration.
Patient's period in a medicine is taken similar or related drugs without must not agree, does not drink, and does not smoke, and diet is suitable light.
5, result of the test
Result of the test is seen table 3.
Table 3 treatment chronic hepatitis belongs to the result of syndrome of dampness-heat of liver and gallbladder
Table 3 result shows; The smooth capsule total effective rate of the liver of embodiment 1, embodiment 2, embodiment 3 all is higher than the smooth capsule of former preparation liver; The clinical efficacy of the smooth capsule for treating chronic hepatitis of liver of prompting embodiment 1, embodiment 2, embodiment 3 all is superior to the smooth capsule of former preparation liver, and is wherein best with embodiment 1 curative effect.
Claims (10)
1. a Tibetan medicine compositions of treating hepatopathy is characterized in that, forms as follows, is weight portion:
Tophus 10-30 part, Concretio Silicea Bambusae 10-30 part, Flos Carthami 20-60 part, Stigma Croci 4-10 part; Herba meconopsis integrifoliae 25-75 part, tangut dragonhead 15-50 part, Corydalis impatiens (Pall.) Fisch. 15-50 part, Mumiyah-asil 15-50 part; Flos Caryophylli 10-30 part, artificial Calculus Bovis 2-5 part, Indian Herba Swertiae bimaculatae 10-30 part; Herpetospermum caudigerum Wall. 5-15 part, Parmelia saxatilis Ach. 2-5 part, artificial Moschus 1-3 part; At 30～60 ℃ of temperature dryings, mix homogeneously, superfine powder are broken into 0.01-100 μ m with medical material.
2. the Tibetan medicine compositions of treatment hepatopathy as claimed in claim 1 is characterized in that, forms as follows, is weight portion:
Tophus 15-20 part, Concretio Silicea Bambusae 15-20 part, Flos Carthami 42-47 part, Stigma Croci 4-7 part; Herba meconopsis integrifoliae 50-55 part, tangut dragonhead 30-37 part, Corydalis impatiens (Pall.) Fisch. 30-37 part, Mumiyah-asil 30-39 part; Flos Caryophylli 10-18 part, artificial Calculus Bovis 2-3.5 part, Indian Herba Swertiae bimaculatae 15-18 part; Herpetospermum caudigerum Wall. 5-11 part, Parmelia saxatilis Ach. 2-3.5 part, artificial Moschus 1-1.5 part.
3. the Tibetan medicine compositions of treatment hepatopathy as claimed in claim 2 is characterized in that, forms as follows, is weight portion:
17.6 parts of tophuss, 17.6 parts of Concretio Silicea Bambusaes, 43.7 parts on Flos Carthami, 7 parts of Stigma Crocis, 52 parts of Herba meconopsis integrifoliae; 35 parts of tangut dragonheads, 35 parts of Corydalis impatiens (Pall.) Fisch.s, 38.2 parts of Mumiyah-asil, 17.6 parts of Flos Caryophyllis, 3.5 parts of artificial Calculus Boviss; 17.6 parts of Indian Herba Swertiae bimaculataes, 10.5 parts of Herpetospermum caudigerum Wall.s, 3.5 parts of Parmelia saxatilis Ach., 1.4 parts of artificial Moschuss.
4. the Tibetan medicine compositions of treatment hepatopathy as claimed in claim 2 is characterized in that, forms as follows, is weight portion:
15 parts of tophuss, 20 parts of Concretio Silicea Bambusaes, 42 parts on Flos Carthami, 7 parts of Stigma Crocis, 50 parts of Herba meconopsis integrifoliae; 37 parts of tangut dragonheads, 30 parts of Corydalis impatiens (Pall.) Fisch.s, 39 parts of Mumiyah-asil, 10 parts of Flos Caryophyllis, 3.5 parts of artificial Calculus Boviss; 15 parts of Indian Herba Swertiae bimaculataes, 11 parts of Herpetospermum caudigerum Wall.s, 2 parts of Parmelia saxatilis Ach., 1.5 parts of artificial Moschuss.
5. the Tibetan medicine compositions of treatment hepatopathy as claimed in claim 2 is characterized in that, forms as follows, is weight portion:
20 parts of tophuss, 15 parts of Concretio Silicea Bambusaes, 47 parts on Flos Carthami, 4 parts of Stigma Crocis, 55 parts of Herba meconopsis integrifoliae, 30 parts of tangut dragonheads, 37 parts of Corydalis impatiens (Pall.) Fisch.s, 30 parts of Mumiyah-asil, 18 parts of Flos Caryophyllis, 2 parts of artificial Calculus Boviss, 18 parts of Indian Herba Swertiae bimaculataes, 5 parts of Herpetospermum caudigerum Wall.s, 3.5 parts of Parmelia saxatilis Ach., 1 part of artificial Moschus.
6. like the Tibetan medicine preparation of compositions method of the arbitrary described treatment hepatopathy of claim 1-5; It is characterized in that, medical material is removed impurity, at 30～60 ℃ of temperature dryings; Mix homogeneously; Superfine powder is broken into 0.01-100 μ m, adds conventional pharmaceutic adjuvant, processes clinical acceptable dosage forms such as pill, micropill, drop pill, tablet, capsule, granule, decoction pieces, dispersible tablet or processes bag-soaked beverage or canned beverage.
7. the Tibetan medicine preparation of compositions method of treatment hepatopathy as claimed in claim 6 is characterized in that, behind the raw medicinal material mix homogeneously, superfine powder is broken into 0.01-0.5 μ m, 0.4-1.2 μ m, and 1-50 μ m, 40-80 μ m or 60-100 μ m encapsulatedly promptly get.
8. according to claim 1 or claim 2 the Tibetan medicine compositions of treatment hepatopathy is characterized in that, forms as follows:
Tophus 1.76kg, Concretio Silicea Bambusae 1.76kg, Flos Carthami 4.37kg, Stigma Croci 0.7kg; Herba meconopsis integrifoliae 5.2kg, tangut dragonhead 3.5kg, Corydalis impatiens (Pall.) Fisch. 3.5kg, Mumiyah-asil 3.82kg; Flos Caryophylli 1.76kg, artificial Calculus Bovis 0.35kg, Indian Herba Swertiae bimaculatae 1.76kg; Herpetospermum caudigerum Wall. 1.05kg, Parmelia saxatilis Ach. 0.35kg, artificial Moschus 0.14kg;
Be prepared from according to following method:
Above-mentioned medical material is removed impurity, and at 30～60 ℃ of temperature dryings, mix homogeneously, superfine powder are broken into 20 μ m, add conventional pharmaceutic adjuvant, process capsule.
9. according to claim 1 or claim 2 the Tibetan medicine compositions of treatment hepatopathy is characterized in that, forms as follows:
Tophus 1.76kg, Concretio Silicea Bambusae 1.76kg, Flos Carthami 4.37kg, Stigma Croci 0.7kg; Herba meconopsis integrifoliae 5.2kg, tangut dragonhead 3.5kg, Corydalis impatiens (Pall.) Fisch. 3.5kg, Mumiyah-asil 3.82kg; Flos Caryophylli 1.76kg, artificial Calculus Bovis 0.35kg, Indian Herba Swertiae bimaculatae 1.76kg; Herpetospermum caudigerum Wall. 1.05kg, Parmelia saxatilis Ach. 0.35kg, artificial Moschus 0.14kg;
Be prepared from according to following method:
Above-mentioned medical material is removed impurity, and at 30～60 ℃ of temperature dryings, mix homogeneously, superfine powder are broken into 60-100 μ m fine powder, divide the filter paper bag of packing into, carry out outer package again, promptly get bag-soaked beverage.
10. according to claim 1 or claim 2 the Tibetan medicine compositions of treatment hepatopathy is characterized in that, forms as follows:
Tophus 1.76kg, Concretio Silicea Bambusae 1.76kg, Flos Carthami 4.37kg, Stigma Croci 0.7kg; Herba meconopsis integrifoliae 5.2kg, tangut dragonhead 3.5kg, Corydalis impatiens (Pall.) Fisch. 3.5kg, Mumiyah-asil 3.82kg; Flos Caryophylli 1.76kg, artificial Calculus Bovis 0.35kg, Indian Herba Swertiae bimaculatae 1.76kg; Herpetospermum caudigerum Wall. 1.05kg, Parmelia saxatilis Ach. 0.35kg, artificial Moschus 0.14kg;
Be prepared from according to following method:
Above-mentioned medical material is removed impurity, and at 30～60 ℃ of temperature dryings, mix homogeneously, superfine powder are broken into 20 μ m, and add 50-100 weight multiple water and brew, water temperature 80-100 ℃, brew 1-10 time, get the water liquid after brewing, filtration, antibacterial, fill promptly get the fill beverage.
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| CN105582381A (en) * | 2016-01-22 | 2016-05-18 | 久美彭措 | Preparation method of Tibetan medicine for treating children's liver disease |
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| CN105497648A (en) * | 2016-01-22 | 2016-04-20 | 久美彭措 | Tibetan medicine for treating liver diseases of children |
| CN105582381A (en) * | 2016-01-22 | 2016-05-18 | 久美彭措 | Preparation method of Tibetan medicine for treating children's liver disease |
| CN108159204A (en) * | 2017-12-28 | 2018-06-15 | 中国藏学研究中心 | A kind of Tibetan medicinal composition with removing toxic substances hepatoprotective effect |
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