CN101502627A - Chinese medicine health product preparation for preventing and treating alcoholic liver disease and preparation method thereof - Google Patents
Chinese medicine health product preparation for preventing and treating alcoholic liver disease and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine health product preparation for preventing and treating alcohol liver disease and a preparation method. According to the parts by weight, the traditional Chinese medicine health product preparation is prepared by adopting the following raw materials: 250 to 328 parts of pueraria flower, 250 to 328 parts of semen hoveniae, 250 to 328 parts ofradix puerariae, 125 to 164 parts of fructus amomi, 250 to 328 parts of dark plum fruit, 250 to 328 parts of date and 125 to 164 parts of liquoric root. The traditional Chinese medicine health product preparation can effectively prevent the alcohol from causing GSH exhaustion and MDA rising of the liver, reduce fatty degeneration of liver cells and has the function of preventing alcoholic liver damage; the health product preparation has condense medicinal odour, stable and controllable preparation technique and product quality, obvious curative effect and fast effect; the provided formulation has convenient in use, reduces the oral dosage; and in the formulation, all the drug contents are obtained from natural resources, has lower cost and is conveniently to promote and broad masses of the people are willing to adopt the traditional Chinese medicine health product preparation.
Description
Technical field:
The present invention relates to a kind of Chinese medicine health care product preparation of preventing and treating alcoholic liver disease and preparation method thereof, belong to health product technology field.
Background technology:
Alcoholic liver disease Alcoholic Liver Disease is a kind of common preventable diseases, causes mainly due to long-term excessive drinking.Countries in the world alcoholic liver disease sickness rate and the financial burden that thereupon brings are all along with socio-economic development is in rising trend, and therefore the research about alcoholic liver disease is subjected to extensive concern.China is the native place of wine, is to produce wine big country, and the crowd of drinking ranks prostatitis, the world.Alcoholic liver disease also is more common hepatopathy in the west, causes the dead ratio of liver cirrhosis to rank the TOP V of American-European countries's cause of death because of drinking.Thereby exploitation has the product of assistant protection function to be subjected to the national governments and the people's generally attention to chemical liver injury.
China excessive drinking in recent years and alcoholic are increasing, have had a strong impact on stablizing of the healthy and family of people, society.Wine has pharmacological action widely to human body, and acute heavy drinking can cause nausea, vomiting, hypomnesis, absent minded, the impaired and emotional instability of fine movement ability, when serious even can cause death because of paralysis of respiratory muscle.The diseases such as can causing mental disorder, gastric ulcer and fatty liver, alcoholic hepatitis, liver cirrhosis of drinking for a long time, have rising that data shows esophageal carcinoma, onset of liver cancer rate as if also with drink relevant.Therefore, research and development are relieved the effect of alcohol and the product of preventing and treating alcoholic liver disease will have huge market prospect.
Alcoholic liver disease is because the hepatic disease due to the long-term heavy drinking (being addicted to drink).After known ethanol entered hepatocyte, through liver alcohol dehydrogenase, peroxisome catabolic enzyme and hepatomicrosome Alcohol oxidase were that three approach are oxidized to acetaldehyde.Excessive consumption of alcohol, a large amount of acetaldehyde have tangible toxic action to hepatocyte, directly and indirectly cause hepatocellular degeneration, necrosis, and fibrosis, seriously can develop into liver cirrhosis.The traditional Chinese medical science thinks, wine be thing, gas heat and matter is wet, abnormal smells from the patient is sun all.Few drink, then gentle promoting the circulation of blood the mind invigorating resisting cold; Throw off restraint drink, then make expectorant benefit fire, consumption gas decreases smart.Prove that now drunk (acute ethanol poisoning) and alcoholic often cause the infringement in various degree of liver, cardiovascular and cerebral tissue.The harm of traditional Chinese medical science control alcoholism has perfect theory and rich experience.On method of treatment, concentrate on to control and wet with pyretic toxicity if pass in interior the remuval of damp and hot medication of then should holding concurrently.
What the successive dynasties were used to prevent and treat alcoholic liver disease and prevented and treated alcoholism is liquid preparation (decoction or oral liquid) mostly, and comparatively primary solid preparation such as big honeyed pills, effect has " Flos puerariae lobatae is separated awake soup ", " Flos puerariae lobatae ball etc. " more significantly, but tangible weak point is arranged all in practice: big as the decoction prescription, dose is big, processes such as decoction trouble is not suitable for commercialization; The big prescription of pill, heavy dose, former powder are used as medicine, and have shortcomings such as onset is slow, bioavailability is low.
Summary of the invention:
The objective of the invention is to: a kind of Chinese medicine health care product preparation of preventing and treating alcoholic liver disease and preparation method thereof is provided.The flavour of a drug of health-care preparation of the present invention are simplified, and preparation technology and constant product quality are controlled, and be evident in efficacy, and the dosage form taking convenience that is provided, and have reduced patient's taking dose.
The present invention constitutes like this: a kind of Chinese medicine health care product preparation of preventing and treating alcoholic liver disease, according to listed as parts by weight, it is that crude drug is made for 125～164 parts with 250～328 parts of Flos puerariae lobataes, 250～328 parts of Semen Hoveniae (Fructus Hoveniae)s, 250～328 parts of Radix Puerariaes, 125～164 parts of Fructus Amomis, 250～328 parts of Fructus Mumes, 250～328 parts in Fructus Jujubae and Radix Glycyrrhizae.
Preferred scheme is: according to listed as parts by weight, it is that crude drug is made for 157 parts with 314 parts of Flos puerariae lobataes, 314 parts of Semen Hoveniae (Fructus Hoveniae)s, 314 parts of Radix Puerariaes, 157 parts of Fructus Amomis, 314 parts of Fructus Mumes, 314 parts in Fructus Jujubae and Radix Glycyrrhizae.
Described Chinese medicine health care product preparation is an oral formulations, is preferably capsule.
The preparation method of the Chinese medicine health care product preparation of control alcoholic liver disease of the present invention is: weighting raw materials material in proportion, Radix Puerariae is pulverized, and sieve, it is standby to collect fine powder; Flos puerariae lobatae, Semen Hoveniae (Fructus Hoveniae), Fructus Amomi, Fructus Mume, Fructus Jujubae and Radix Glycyrrhizae powder are broken into coarse powder, and adding Radix Puerariae coarse powder, soaked 0.5～1.5 hour with 6～12 times of water gagings, extract 2～3 times, each 1～2 hour, filter, merging filtrate, be evaporated to the extractum of 60 ℃ of relative densities 1.08～1.10, reconcentration is to the thick paste of relative density 1.29～1.32, and is standby; With standby Radix Puerariae fine powder and thick paste mixing, add appropriate amount of auxiliary materials and make various preparation, promptly.
Specifically, the weighting raw materials material is pulverized Radix Puerariae in proportion, crosses 100 mesh sieves, and it is standby to collect fine powder; Flos puerariae lobatae, Semen Hoveniae (Fructus Hoveniae), Fructus Amomi, Fructus Mume, Fructus Jujubae and Radix Glycyrrhizae powder are broken into coarse powder, and add the Radix Puerariae coarse powder, and soaked 1 hour with 10 times of water gagings, extracted 1.5 hours, filter, collect filtrate, medicinal residues add 8 times of water gagings again and extracted 1.5 hours, filter, merging filtrate, be evaporated to the extractum of 60 ℃ of relative densities 1.08～1.10, transfer to the thick paste that is concentrated into relative density 1.29～1.32 in the jacketed pan, standby; With the starch mix homogeneously of standby Radix Puerariae fine powder and thick paste and 185～205 weight portions, granulate, 60 ℃ of drying under reduced pressure 2～4 hours, granulate is crossed 20 mesh sieves, and filled capsules promptly gets capsule.
Chinese medicine health care product preparation of the present invention is made with extra care with seven flavor natural Chinese medicinal herb prescriptions and is formed, Flos puerariae lobatae cold nature in the side, and sweet in the mouth is equalled little hardship, and the effect of relieving acute alcoholism and recuperating the spleen, liver-protecting and stomach-nourishing is arranged, be good antialcoholic drug, be used for insobriety, headache, giddy, excessive thirst, chest and diaphragm is glutted, and acid regurgitation etc. injure the disease of gastric qi.Semen Hoveniae (Fructus Hoveniae) is flat, sweet in the mouth; Go into the heart, liver, spleen channel; The preventing or arresting vomiting that relieves the effect of alcohol, the relieving restlessness of quenching the thirst, dispelling wind and removing obstruction in the collateral, it is damp and hot to disappear, and tonneau two is just; Cure mainly the chest and diaphragm dysphoria with smothery sensation due to the insobriety, wind syndrome of head, the lower abdomen contracture, thirsty vexed, vomiting, diseases such as difficulty in urination and defecation; Be a kind of good medicine that relieves the effect of alcohol.Radix Puerariae is cool in nature, and abnormal smells from the patient is sweet, hot, flat, goes into spleen, stomach warp, quench the thirst, and toxin expelling, sharp defecation is relieved the effect of alcohol, and goes dysphoria with smothery sensation, the tool heat-clearing and toxic substances removing, spasmolysis and analgesia, the yang invigorating expelling pathogenic factors from muscles, rash antidiarrheal increases brain and coronary blood flow, improves effects such as brain microcirculation; Be used for diseases such as hypertension, hyperlipidemia, coronary heart disease, angina pectoris, cerebral thrombosis, headache, dizziness, neck pain, sudden deafness, pneumonia.The Fructus Amomi acrid in the mouth is warm in nature; Go into spleen, stomach warp; Have circulation of qi promoting and in, appetite-stimulating indigestion-relieving, warming spleen and stopping diarrha, the antiabortive effect of regulating the flow of vital energy; Control the stomachache painful abdominal mass and expand anorexia dyspepsia, dysphagic vomiting, diarrhea due to cold pathogen cold-dysentery, pregnant fetal movement.Fructus Mume acid, puckery, flat; Return liver, spleen, lung, large intestine channel; Have the effect of astringing lung-QI and relieving cough, relieving diarrhea with astringents, relieving pain by calming ascaris, promoting the production of body fluid to quench thirst, be used for chronic cough of deficiency lung, the chronic diarrhea dysentery, ascariasis of biliary tract stomachache, Tianjin wound waits disease yearningly.Fructus Jujubae is sweet in flavor and warm in property nontoxic, the spleen reinforcing stomach function regulating, and supplementing QI for promoting the production of body fluid transfers battalion to defend, and separates poison of drug; Control the insufficiency of stomach lack of appetite, the weak loose stool of spleen, qi-blood-body fluid deficiency, disharmony of nutrient QI with defensive QI, severe palpitation etc.The Radix Glycyrrhizae nature and flavor are sweet, flat, give birth to trembling with fear partially, process with warm partially, return spleen, stomach, the heart, lung meridian; Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, nourishing the lung to arrest cough, relieving spasm to stop pain, the mediation property of medicine; Be used for weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, epigastric pain, carbuncle sore tumefacting virus, alimentary toxicosis etc.It is bright that seven flavor medicine in the side, Flos puerariae lobatae are solely gone into sun, makes and damp and hotly separate relieving acute alcoholism and recuperating the spleen from muscle; Semen Hoveniae (Fructus Hoveniae) is gone into spleen, lung two warps, moistening five ZANG-organs, diuresis, alcoholic intoxication, and the two is all monarch drug; Be aided with Radix Puerariae, Fructus Amomi air making-up and spleen enlivening, relieving QI stagnancy in the stomach, suffering is loose and is relieved the effect of alcohol, heat-clearing and toxic substances removing; Assistant is with Fructus Mume, Fructus Jujubae promoting diuresis with drugs of tasteless flavour, drives that damp and hot inside and outside branch disappears from urinating, the effect of blood yiqi nourishing blood to tranquillize the mind, warming middle-JIAO and strengthening the spleen, the relieving dyspepsia of relieving the effect of alcohol; Make dredge with Radix Glycyrrhizae invigorating the spleen and replenishing QI, expectorant stagnate, relieving spasm to stop pain, effects such as coordinating the actions of various ingredients in a prescription.The same usefulness of all medicines is played the branch wet merit of wine that disappears altogether, reaches the effect of relieving alcoholism and protecting the liver.
Curative effect in order to ensure Chinese medicine health care product preparation of the present invention, the applicant has carried out corresponding experimental study to its preparation technology and pharmacological function: according to the ingredient of square taste of Chinese medicine, the physicochemical property of bound drug, adopt orthonormal design of experiments, optimize prescription and preparation technology, made it to become process stabilizing, quality controllable, pure Chinese medicinal preparation safely and effectively; Animal experiment studies show that, wine is given in prophylactic after the promptly first administration, and health-care preparation of the present invention has good antialcoholism action, can prolong the lethargy incubation period of alcoholism mice, shortens the lethargy time, reduces concentration of alcohol in the blood; After healthy population was taken health-care preparation of the present invention earlier, drinking white spirit can improve or eliminate because alcoholism symptoms such as the dizziness due to the excessive drinking, vomiting, confusion, dysequilibrium, slurred speechs.The main contents of experimental study are as follows:
One, technology correlational study:
1. the selection of dosage form and foundation
What the successive dynasties were used to prevent and treat alcoholic liver disease and prevented and treated alcoholism is liquid preparation (decoction or oral liquid) mostly, and comparatively primary solid preparation such as big honeyed pills, effect has " Flos puerariae lobatae is separated awake soup ", " Flos puerariae lobatae ball etc. " more significantly, but tangible weak point is arranged all in practice, big as the decoction prescription, dose is big, and processes such as each decoction trouble is not suitable for commercialization; The big prescription of pill, heavy dose, former powder are used as medicine, and have shortcomings such as onset is slow, bioavailability is low.Conform to the desired design target.The needs that meet modern society.The present invention is on the basis of in Ming Dynasty's " Prescriptions for Universal Relief " " Flos puerariae lobatae ball ", simplifies through prescription to develop." Flos puerariae lobatae ball " former prescription is made up of ten four Chinese medicines, the present invention is selected 5 flavor medical materials (Flos puerariae lobatae, Fructus Amomi, Radix Puerariae, Fructus Mume, Radix Glycyrrhizae) wherein, and increased Semen Hoveniae (Fructus Hoveniae), and being all monarch drug with Flos puerariae lobatae, other adds Fructus Jujubae, the QI invigorating effect in the increase side; Former side's 14 flavor medicines are reduced to 7 flavors; by modern biological extraction purification and preparation means; make capsule or tablet; improved bioavailability; reduced dosage; improve the controllability and the stability of product quality, strengthened realization industrialization and commercial feasibility, the large-scale production of being more convenient for, storage, transportation, sale and use etc.Trial product is found through on probation: take before the wine, it is comfortable to drink, and is difficult for liquor-saturatedly, and capacity for liquor increases, and takes after drinking, and it is fast to sober up, and drains soon, can in time alleviate the drunk phenomenon of feeling bad.Conform to the design object of expection, meet the needs of modern society.
2. the selection of process route
2.1 each the effective elements of the medicine and character in the foundation side design product process route of the present invention.
Monarch drug in Flos puerariae lobatae and the Semen Hoveniae (Fructus Hoveniae) side of being, effective ingredient such as isoflavone-containing, saponin; The chemical constituent of Flos puerariae lobatae is mainly osajin and saponins compound.Pharmacological research finds that the contained isoflavonoid of Flos puerariae lobatae has effects such as Antialcoholic liver-protecting, and its saponins compound has effects such as lowering blood sugar and blood fat and antimutagenic, has very big value of exploiting and utilizing.The effective ingredient of Semen Hoveniae (Fructus Hoveniae) is saponin and glucosides, alkaloid, fatty acid etc., and the active component that its treatment alcoholism protects the liver is at water-soluble portion.Other a few flavor medicines then contain flavone, volatilization wet goods effective ingredient.The effective ingredient characteristic of each herbal medicine and production reality in this process synthesis consideration side have selected water for extracting solvent.Relatively play the use of organic solvent, select that purified water do to extract that solvent is safer for use, economy, environmental protection, fast, the bioavailability advantages of higher of absorption.Be difficult for exsiccant shortcoming for water extract, adopted the former powder instead of part of part Radix Puerariae starch in the preparation, make easy drying of the granule that makes and granulate as additive and thick paste mixing granulation.In technological parameter is investigated, selected total flavones, total saponins and paste-forming rate etc. to investigate and study respectively for index.
3. the screening of process conditions
3.1 the investigation of medical material water absorption rate
Get each three parts of the about 100g of the medical material that is ground into coarse powder and mix homogeneously, the accurate title, decide, and adds water 500ml respectively, behind the shake well, placed 24 hours, filters, and takes by weighing every part of medical material weight again, calculates water absorption rate, the results are shown in Table 1.
Table 1 medicinal material coarse powder water absorption rate is investigated
| Sequence number | Medical material heavy (g) | Suction back medical material heavy (g) | Medical material weightening finish (g) | Water absorption rate (doubly) |
| 1 | 102.533 | 295.295 | 192.762 | 1.88 |
| 2 | 100.476 | 280.328 | 179.852 | 1.79 |
| 3 | 100.582 | 287.665 | 187.083 | 1.86 |
The result shows that the water absorption of medical material is about 2 times of medical material weight, so when decocting for the first time, should add the water of 2 times of medical material amounts.
3.2 extraction process by water such as Semen Hoveniae (Fructus Hoveniae) examination
Adopting the test of 3 factors, 3 horizontal quadratures, is examination factor design L with solvent load (A), extraction time (B), extraction time (C)
9(3
4) orthogonal table tests every group parallel three parts.With dried cream content is evaluation index, the screening optimised process.Get coarse powder 40g, use water boiling and extraction, filter, filtrate decompression reclaims, and drying gets dry extract.The factor level arrangement sees Table 2, the results are shown in Table 3, and variance analysis sees Table 4.
Table 2 factor level table
| Level | Quantity of solvent (A)/doubly | Extraction time (B)/h | Extraction time (C) |
| 1 2 3 | 6 8 10 | 1 1.5 2 | 1 2 3 |
Table 3 orthogonal experiments
Table 4 variance analysis
| Soruces of variation | Sum of deviation square | Degree of freedom | Mean square | The F value | P |
| A B C E | 0.198 0.182 0.085 0.279 | 2 2 2 18 | 0.099 0.091 0.043 0.016 | 6.19 5.69 2.69 | <0.01 <0.05 >0.05 |
F
0.05(2，18)＝3.55，F
0.01(2，18)＝6.01
During water boiling and extraction, there are appreciable impact quantity of solvent and extraction time to dried cream amount, and the extraction time influence is little, and each factor is A to the order that influences of measurement result〉B〉C, optimised process is A
2B
2C
3, promptly 8 times of amounts are extracted three times, each 1.5h.Because extraction time does not have the significance influence to the result, extracts twice so select for use.Be that selection process is A
2B
2C
2, 8 times of water gagings are considered water absorption rate, add 10 times of the water yields for the first time, extract twice, each 1.5h.
3.3 the research of preparations shaping technology
Water such as powder of Radix Puerariae and Semen Hoveniae (Fructus Hoveniae) are carried thick paste by the equivalent method mixing and stirring of rising progressively, put again in the mixer, fully mix, make evenly.Put in the dry granulation machine, add appropriate amount of starch and 50% alcohol granulation, sieve (20 order), 60 ℃ of drying under reduced pressure 3 hours, granulate (crossing 20 mesh sieves), the 0.5g capsule of packing into (" 0 " number capsule).
3.3.1 drying, granulate, mensuration water content
Dry: as the granule of making to be placed 60 ℃ of baking ovens, take out, cool.
Granulate: the dried granule that will cool, after 20 mesh sieves.
Moisture determination: precision takes by weighing the about 2g of dried particles behind the above-mentioned granulate, by " first method under an appendix IX.H of Chinese pharmacopoeia version in 2000 the moisture determination method item, oven drying method is measured, according to experimental result, the count particles water content.
3.3.2 content uniformity detects
Capsule model: select " 0 " number capsulae vacuus for use
Loading amount: every dress 0.5g (＜± 10%)
Fill method: adopt capsule filler to load
By " [content uniformity] method detects under an appendix capsule of Chinese pharmacopoeia version in 2005 item.Measured value is compared with product indicia loading amount of the present invention (0.5g/ grain), calculates its content uniformity value (%).
Two, pharmacological function correlational study
1. health-care preparation of the present invention protects the liver function test
Method: animal: 50 of Kunming mouses are divided into five groups, 10 every group at random.Dosage design is established basic, normal, high three dosage by 1 times, 10 times, 30 times of everyone every day of edible 4g, promptly 100,1000,3000mg/kgBW.Establish negative control group and 5600mg/kgBW ethanol positive controls simultaneously.To be tried thing and according to dosage mix in animal food, and feed to each dosage treated animal once a day, negative control group and hepatic injury positive controls give the equivalent deionized water.Continuous irrigation stomach 31 days is weighed weekly, adjusts dosage.To be tried each group of thing on the 31st day and the liver-yang control group mice gives 50% (V/V) ethanol 0.14ml/10gBW in experiment, after the fasting 12 hours, get liver and make the 0.1g/ml liver homogenate, survey triglyceride (TG), malonaldehyde (MDA) and reduced glutathion (GSH) content respectively; Get liver simultaneously and carry out fat stains, microscopy.The result carries out the variance analysis statistics with " SPSS11.0 " software.Preliminary experiment results is as follows:
1.1 mouse liver MDA
With lipid peroxide catabolite malonaldehyde in the TBA colorimetric method for determining hepatic tissue, positive controls is compared with the feminine gender group, and MDA content obviously raises in the hepatic tissue, and difference has utmost point significance (P＜0.01); Tried middle and high each the dosage group MDA content of thing and reduce, and difference there is significance (P＜0.05 or P＜0.01) than positive controls.Illustrate that being tried thing can reduce MDA content in the hepatic tissue.
1.2 mouse liver GSH measures:
With the content of reduced glutathion (GSH) in the DTNB colorimetric method for determining hepatic tissue, positive controls is compared GSH content with the feminine gender group and is obviously reduced, and difference has utmost point significance (P＜0.01).Tried that dosage group GSH content is higher than positive controls in the thing, difference has utmost point significance (P＜0.01).Illustrate and tried the exhaustion that thing can effectively stop GSH.
1.3 mouse liver triglyceride (TG)
Measure with phosphoglycerol oxidase peroxidase method (test kit), positive controls and negative control compare, and liver TG content obviously raises, and difference has utmost point significance (P＜0.01).Tried thing low dose group TG content and be starkly lower than positive controls, difference has significance (P＜0.05).Illustrate and tried the content that thing can reduce TG in the liver.
Conclusion (of pressure testing): this test is duplicated mice ethanol liver injury model with 5600mg/kg BW ethanol, and on this basis capsule of the present invention is protected the liver Function detection.Result of the test shows that this is tried thing and can stop ethanol to cause liver GSH exhaustion and MDA to raise effectively, alleviates hepatic cell fattydegeneration, has the function of prevention ethanol liver damage.
2. preparation security of the present invention is estimated
Acute oral toxicity test
According to Ministry of Public Health " health food check and assessment technique standard " (version in 2003) capsule of the present invention is carried out 30 days feeding trials.Result of the test shows: in being subjected to the amount of reagent scope, capsule of the present invention does not all have obvious influence to body weight, food, utilization rate, hematological indices, biochemical indicator and the dirty/body ratio of rat, main organs is not also seen the specificity pathological change, under this experiment condition, maximal dose is 10g/kgBW, does not observe illeffects.The feeding trial result was negative in 30 days, did not see that the histopathology relevant with being tried thing changes.
3. conclusion:
Health-care preparation of the present invention protects the liver the Function detection result of the test and shows, this is tried thing and can stop ethanol to cause liver GSH exhaustion and MDA to raise effectively, alleviates hepatic cell fattydegeneration, has the function of prevention ethanol liver damage.The security inspection result meets Ministry of Public Health " health food check and assessment technique standard " (version in 2003), and safety non-toxic has the function of auxiliary therapy to chemical liver injury.
Compared with prior art, Chinese medicine health care product preparation provided by the present invention can stop ethanol to cause liver GSH to exhaust effectively and MDA raises, and alleviates hepatic cell fattydegeneration, has the function of prevention ethanol liver damage; Prophylactic is promptly taken medicine earlier and is afterwards drunk, and good antialcoholism action is arranged, and can improve or eliminate because alcoholism symptoms such as the dizziness due to the excessive drinking, vomiting, confusion, dysequilibrium, slurred speechs.The flavour of a drug of this health-care preparation are simplified, and preparation technology and constant product quality are controlled, and be evident in efficacy, effect rapidly, the dosage form taking convenience that is provided has reduced patient's taking dose; And each medicine is taken from natural resources in the side, and cost is cheap relatively, is convenient to promote, and the numerous common people are also glad to adopt.
The specific embodiment:
Embodiments of the invention 1: the preparation of capsule:
Take by weighing Flos puerariae lobatae 314 grams, Semen Hoveniae (Fructus Hoveniae) 314 grams, Radix Puerariae 314 grams, Fructus Amomi 157 grams, Fructus Mume 314 grams, Fructus Jujubae 314 grams, Radix Glycyrrhizae 157 grams and starch 195 grams.Radix Puerariae is pulverized, crossed 100 mesh sieves, it is standby to collect the 105g fine powder.Flos puerariae lobatae, Semen Hoveniae (Fructus Hoveniae), Fructus Amomi, Fructus Mume, Fructus Jujubae and Radix Glycyrrhizae Six-element are ground into coarse powder, and add the rest radix puerariae coarse powder, with putting in the extraction pot, add 10 times of water gagings and soaked 1 hour, extracted 1.5 hours, filter, collect filtrate, medicinal residues add 8 times of water gagings again and extracted 1.5 hours, filter, and merge filtrate twice, concentrating under reduced pressure (vacuum 0.08Mpa, 80 ℃) to the extractum of relative density 1.08～1.10 (60 ℃), transfer to the thick paste that is concentrated into relative density 1.29～1.32 in the jacketed pan, standby.With standby Radix Puerariae fine powder and thick paste and starch mix homogeneously, granulate, cross 20 mesh sieves, 60 ℃ of drying under reduced pressure 3 hours, granulate is crossed 20 mesh sieves, and filled capsules promptly gets 1000 of capsules (every loading amount 0.5g).Said preparation is oral, and each 4, every day 2 times.
Embodiments of the invention 2: the preparation of chewable tablet
It is an amount of to take by weighing Flos puerariae lobatae 300 grams, Semen Hoveniae (Fructus Hoveniae) 328 grams, Radix Puerariae 286 grams, Fructus Amomi 150 grams, Fructus Mume 328 grams, Fructus Jujubae 328 grams, Radix Glycyrrhizae 164 grams and starch.Radix Puerariae is pulverized, sieved, it is standby to collect fine powder.Flos puerariae lobatae, Semen Hoveniae (Fructus Hoveniae), Fructus Amomi, Fructus Mume, Fructus Jujubae and Radix Glycyrrhizae Six-element are ground into coarse powder, and add the rest radix puerariae coarse powder, and soaked 1.5 hours with 8 times of water gagings, extracted 1 hour, filter, collect filtrate, medicinal residues add 6 times of water gagings again and extracted 1 hour, filter, merge filtrate twice, be evaporated to the extractum of relative density 1.08～1.10 (60 ℃), reconcentration is to the thick paste of relative density 1.29～1.32, and is standby.
Granulate: with standby Radix Puerariae fine powder and thick paste (adding appropriate amount of starch in case of necessity) mix homogeneously, drying under reduced pressure (vacuum 0.08Mpa, 80 ℃) 3h pulverizes, and crosses 80 mesh sieves; Other gets mannitol 138g, aspartame 2g, crosses 80 mesh sieves respectively, adds mixing in the aforementioned mixture; Take by weighing hypromellose 100g, be prepared into the solution of mass concentration 3% with the purified water dissolving; Hypromellose solution is added compound, fully stir, 14 mesh sieves are granulated, dry 4h in 60～80 ℃ of baking ovens; Above-mentioned dried granule carries out granulate with 20 mesh sieves.
Tabletting: add magnesium stearate 6g and essence powder 2.5g in granule, compacting heavily is 1000 in the tablet of 0.48g (diameter 10toni) in flakes.
The bag film-coat: film coating agent is that solvent is made into 10% concentration with 40% alcoholic solution, realizes coating in the film coating machine.This tablet is oral, and each 4, every day 2 times.
Embodiments of the invention 3: take by weighing Flos puerariae lobatae 328 grams, Semen Hoveniae (Fructus Hoveniae) 280 grams, Radix Puerariae 328 grams, Fructus Amomi 125 grams, Fructus Mume 250 grams, Fructus Jujubae 280 grams, Radix Glycyrrhizae 130 grams.Radix Puerariae is pulverized, sieved, it is standby to collect fine powder.Flos puerariae lobatae, Semen Hoveniae (Fructus Hoveniae), Fructus Amomi, Fructus Mume, Fructus Jujubae and Radix Glycyrrhizae Six-element are ground into coarse powder, and add the rest radix puerariae coarse powder, soaked 0.5 hour with 12 times of water gagings, extracted 2 hours, filter, collect filtrate, medicinal residues add 8 times of water gagings again and extract 2 times, each 1 hour, filter, merge three times filtrate, be evaporated to the extractum of relative density 1.08～1.10 (60 ℃), reconcentration is to the thick paste of relative density 1.29～1.32, and is standby.With standby Radix Puerariae fine powder and thick paste mixing, add appropriate amount of auxiliary materials, make granule, powder, soft capsule, effervescent tablet, buccal tablet, drop pill, micropill or liquid preparation according to conventional method.
Claims (6)
1. Chinese medicine health care product preparation of preventing and treating alcoholic liver disease, it is characterized in that: according to listed as parts by weight, it is that crude drug is made for 125～164 parts with 250～328 parts of Flos puerariae lobataes, 250～328 parts of Semen Hoveniae (Fructus Hoveniae)s, 250～328 parts of Radix Puerariaes, 125～164 parts of Fructus Amomis, 250～328 parts of Fructus Mumes, 250～328 parts in Fructus Jujubae and Radix Glycyrrhizae.
2. according to the Chinese medicine health care product preparation of the described control alcoholic liver disease of claim 1, it is characterized in that: according to listed as parts by weight, it is that crude drug is made for 157 parts with 314 parts of Flos puerariae lobataes, 314 parts of Semen Hoveniae (Fructus Hoveniae)s, Radix Puerariae 314g part, 157 parts of Fructus Amomis, 314 parts of Fructus Mumes, 314 parts in Fructus Jujubae and Radix Glycyrrhizae.
3. according to the Chinese medicine health care product preparation of claim 1 or 2 described control alcoholic liver diseases, it is characterized in that: described Chinese medicine health care product preparation is an oral formulations.
4. according to the Chinese medicine health care product preparation of the described control alcoholic liver disease of claim 3, it is characterized in that: described oral formulations is a capsule.
5. as the preparation method of the Chinese medicine health care product preparation of control alcoholic liver disease as described in each among the claim 1-4, it is characterized in that: weighting raw materials material in proportion, Radix Puerariae is pulverized, sieve, it is standby to collect fine powder; Flos puerariae lobatae, Semen Hoveniae (Fructus Hoveniae), Fructus Amomi, Fructus Mume, Fructus Jujubae and Radix Glycyrrhizae powder are broken into coarse powder, and adding Radix Puerariae coarse powder, soaked 0.5～1.5 hour with 6～12 times of water gagings, extract 2～3 times, each 1～2 hour, filter, merging filtrate, be evaporated to the extractum of 60 ℃ of relative densities 1.08～1.10, reconcentration is to the thick paste of relative density 1.29～1.32, and is standby; With standby Radix Puerariae fine powder and thick paste mixing, add appropriate amount of auxiliary materials and make various preparation, promptly.
6. according to the preparation method of the Chinese medicine health care product preparation of the described control alcoholic liver disease of claim 5, it is characterized in that: weighting raw materials material in proportion, Radix Puerariae is pulverized, cross 100 mesh sieves, it is standby to collect fine powder; Flos puerariae lobatae, Semen Hoveniae (Fructus Hoveniae), Fructus Amomi, Fructus Mume, Fructus Jujubae and Radix Glycyrrhizae powder are broken into coarse powder, and add the Radix Puerariae coarse powder, and soaked 1 hour with 10 times of water gagings, extracted 1.5 hours, filter, collect filtrate, medicinal residues add 8 times of water gagings again and extracted 1.5 hours, filter, merging filtrate, be evaporated to the extractum of 60 ℃ of relative densities 1.08～1.10, transfer to the thick paste that is concentrated into relative density 1.29～1.32 in the jacketed pan, standby; With the starch mix homogeneously of standby Radix Puerariae fine powder and thick paste and 185～205 weight portions, granulate, 60 ℃ of drying under reduced pressure 2～4 hours, granulate is crossed 20 mesh sieves, and filled capsules promptly gets capsule.
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| CN102579958A (en) * | 2012-03-31 | 2012-07-18 | 西南大学 | Alcoholism-relieving and liver-protecting composition, extract, preparation method and preparation of extract |
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| CN105560475A (en) * | 2015-12-21 | 2016-05-11 | 新疆环拓生物科技有限公司 | Traditional Chinese medicine composition for preventing chemical liver injury and preparation method thereof |
| CN106389999A (en) * | 2016-11-04 | 2017-02-15 | 徐建 | Traditional Chinese medicine composition for removing drunkenness and application of traditional Chinese medicine composition |
| CN109924377A (en) * | 2018-12-07 | 2019-06-25 | 西北农林科技大学 | A kind of liver-protection health-care beverage of Quick sobering and preparation method thereof |
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