CN105596995A - Traditional Chinese medicine combination for treating hepatitis and preparation and preparation method thereof - Google Patents
Traditional Chinese medicine combination for treating hepatitis and preparation and preparation method thereof Download PDFInfo
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Classifications
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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Abstract
The invention relates to a traditional Chinese medicine combination for treating hepatitis and a preparation and a preparation method thereof. The combination is mainly prepared by processing Rhizoma curcumae, fleur-de-lis, Acorus calamus, Fritillaria cirrhosa, Radix curcumae and purple lythrum herb according to a certain weight part ratio. The combination is based on tonifying spleen and liver, strengthening body resistance and improving immunity, regulating both qi and blood and combining tonification and purgation, microchannels inside and outside the liver and human excretion system are dredged through qi regulating, blood activating and collateral dredging, and viruses and immune complexs are eliminated timely, so that effect of removing pathogenic factors to reinforce vital qi, regulating qi and activating blood and protecting the liver is realized, and the traditional Chinese medicine combination has good effect on treating acute hepatitis A, hepatitis B and chronic hepatitis.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, particularly a kind of Chinese medicine composition that is used for the treatment of hepatitis and preparation thereof andMethod for making.
Background technology
Hepatitis comprises oxyhepatitis and chronic hepatitis, is a kind of common and frequently-occurring disease, and especially hepatitis type B virus causesHepatopathy, serious harm people's is healthy, after morbidity, as not in time treatment, very easily develop into cirrhosis and be even converted intoLiver cancer. The hepatopathy such as virus hepatitis, liver fibrosis, fatty liver, alcoholic liver pathology, medicamentous liver lesion and liver cancer more in recent yearsMore become the principal disease that threatens compatriots' health.
Hepatitis viruse enters human body, and to cause hepatic injury be a chronic allergy course of damage, causes hepatomegaly, leadsCause liver cell inflammation, hepatitis directly affects people's life, family and society, interpersonal getting along amiably and peacefully. FacingOn bed, the medicine of western medical treatment hepatitis is mainly IFN-α and Lamivudine. Clinical studies show IFN-α is to after treatmentThe hepatitis C patients that can produce lasting virological response can alleviate the degree of its liver fibrosis, but some people pairInterferon is insensitive, and after application, recurrence rate is high, and side effect is large, expensive. Lamivudine can effectively suppress HBVDNA'sCopy, and have the serum conversion of some patients were HBeAg/antiHBe. Treating 2 years heptic fibrosis has alleviating in various degree, orDelay the process of liver fibrosis, but the main limitation of Lamivudine being variation, the incidence of 1 year and 5 years is respectively 15～32% and 67～69%. After variation, the defect such as develop immunity to drugs, Histological change may increase the weight of; In recent years, traditional Chinese medicineThe research for the treatment of hepatitis has obtained larger achievement, also demonstrates comparatively significantly advantage; Treatment on, taking promoting blood circulation and removing blood stasis asMain, supplementing qi and nourishing yin is auxiliary, and in conjunction with the principle of reatment of diagnosis and treatment, promoting blood circulation and removing blood stasis, strengthen the body resistance to consolidate the constitution as Chinese medicine hepatitisBasic therapy. Although be used for the treatment of and prevent the traditional Chinese medicine research of hepatitis and be widely used, in current treatment hepatitisMedicine effect curative effect is not remarkable, acts on singlely, and specific aim is poor, and treatment cycle is long, and recurrence rate is high, can not treat both principal and secondary aspect of disease.
Summary of the invention
The invention is characterized in provide a kind of safe and effective, formula rationally, can effectively treat hepatitis, liver-protective groupCompound and preparation method thereof.
For achieving the above object, the concrete technical scheme of the present invention is as follows:
Be used for the treatment of a Chinese medicine composition for hepatitis, be mainly prepared from through processing by the raw material of following parts by weight:Curcuma zedoary 15-28, iris 10-20, calamus 20-32, Bulbus Fritillariae Cirrhosae 5-10, RADIX CURCUMAE 18-22, Lythrum salicaria 8-15.
In this described composition, invigorating the spleen benefit liver, building up healthful vital energy raising immunity are basis, and qi and blood is two to be adjusted, and tonification and purgation in combination, logicalCross regulating the qi flowing in the channels, invigorate blood circulation, dredging collateral, the inside and outside microchannel of dredging liver and body discharges system, remove virus and immune complex in time, therebyReach vital QI recovered after pathogens eliminated, the work of controlled atmosphere blood, protect the effect that liver protects the liver, have treating acute hepatitis A, acute hepatitis b and chronic hepatitis etc.Good effect.
Further, prepare the raw material that described composition also comprises following weight portion: thizoma curculiginis 5-10, anisetree bark 12-20, rock are whiteDish 8-16, fruit of Chinese magnoliavine 15-25.
Further optimize described composite formula, in conjunction with theory of traditional Chinese medical science, in addition after above-mentioned raw materials, make each component furtherSynergy, multi-faceted, many-sided effect that reaches treatment hepatitis, has further improved result for the treatment of.
Preferably, preparing the raw materials used parts by weight of described composition is: curcuma zedoary 20, iris 15, calamus 28, Bulbus Fritillariae Cirrhosae 7,RADIX CURCUMAE 20, Lythrum salicaria 10, thizoma curculiginis 6, anisetree bark 15, purple bergenia herb 13, the fruit of Chinese magnoliavine 21.
In order to improve ease of use, the present invention is by the described Chinese medicine composition that is used for the treatment of hepatitis and pharmaceutically acceptableThe oral formulations made of auxiliary material, described preparation is pill, tablet, capsule, powder or granule; The described hepatitis that is used for the treatment ofChinese medicine composition and auxiliary material ratio of weight and number be 1:2-4.
Preferably, described oral formulations is tablet, and described auxiliary material comprises that ratio of weight and number is 3-5:1-2.5:0.8-1.2'sDiluent, disintegrant and adhesive.
Wherein, described diluent is that ratio of weight and number is the lactitol of 3:1 and the mixture of N-dodecyl amine xyloside; InstituteStating disintegrant is that ratio of weight and number is the locust bean gum of 2:1 and the mixture of Nipasol; Described adhesive is ratio of weight and numberFor the sodium carboxymethylcellulose of 5:2 and the mixture of triacetyl glycerine.
The selected above-mentioned auxiliary material of the present invention, without effect, three kinds of auxiliary materials are joined with the active component in each component and Chinese medical extractFang Heli, wherein diluent not only plays the effect of dilution and filling, can also take into account the characteristic of good mobility, and component is containedEvenly, drug dose is controlled, active component is played to stable effect simultaneously for amount; Use the mixed adhesive of above-mentioned consumption, canMake good bonding of tablet powder, and make tablet there is suitable hardness and brittleness, ensure tablet quality; Use above-mentioned consumption mixedClose disintegrant and match with other auxiliary materials, ensure the disintegration validity of tablet, make the active component of composition can be with the fastest speedDegree reaches maximum absorption.
Described in further the invention provides, be used for the treatment of the preparation method of the Chinese medicine composition of hepatitis, the method comprise asLower step:
1) get curcuma zedoary, iris, thizoma curculiginis and the purple bergenia herb of formula ratio, the methyl alcohol that is 1:5 by volume ratio and ethyl acetate mixedClose solution refluxing extraction three times, add raw material gross weight 3-5 mixed solution refluxing extraction 2-4h doubly at every turn, merge extractAfter, reduced pressure concentration, obtains medicinal extract stand-by;
2) get calamus, anisetree bark and the fruit of Chinese magnoliavine of formula ratio, by the ethanol water refluxing extraction of 50%-75% three times,Add raw material gross weight 3-5 alcohol reflux doubly to extract 2-3h at every turn, merge after extract, reduced pressure concentration, obtains medicinal extract stand-by;
3) get Bulbus Fritillariae Cirrhosae, RADIX CURCUMAE and Lythrum salicaria, decocting three times, each raw material gross weight 4-6 decocting liquid 2-3h doubly, closesAnd after decocting liquid, reduced pressure concentration, obtains fine powder stand-by;
4) by step 1) and step 2) medicinal extract and the step 3 that obtain) fine powder that obtains mixes, and obtains described combinationThing.
Preferred preparation method of the present invention, is through lot of experiments, reasonably plans as a whole and contrast to sum up and go out, comprehensivelyExtract and retained the active ingredient of medicine, ensured reasonability and the high efficiency of medicine.
In addition, the present invention also provides the purposes of described composition and preparation thereof, for the preparation for the treatment of hepatitis, protection liverMedicine in application.
The Chinese medicine composition that is used for the treatment of hepatitis of the present invention, in conjunction with theory of traditional Chinese medical science, is analyzed Chinese medicine material and is effectively becomePoint, be aided with the optimization of clinical application for many years simultaneously, overcome the problem of taboo combination, health is had no side effect; Each component is assistedSame-action, has easypro liver, protects liver and hepatoprotective effect, and acute hepatitis A, acute hepatitis b and chronic hepatitis etc. are had to good treatmentEffect, effect is remarkable, has no side effect.
Detailed description of the invention
Embodiment 1
Be used for the treatment of a Chinese medicine composition for hepatitis, said composition by the raw material of following parts by weight through processing preparation andBecome: curcuma zedoary 15, iris 10, calamus 20, Bulbus Fritillariae Cirrhosae 5, RADIX CURCUMAE 18, Lythrum salicaria 8.
Embodiment 2
Be used for the treatment of a Chinese medicine composition for hepatitis, said composition by the raw material of following parts by weight through processing preparation andBecome: curcuma zedoary 20, iris 15, calamus 28, Bulbus Fritillariae Cirrhosae 7, RADIX CURCUMAE 20, Lythrum salicaria 10, thizoma curculiginis 6, anisetree bark 15, purple bergenia herb 13, fiveTaste 21.
Embodiment 3
Be used for the treatment of a Chinese medicine composition for hepatitis, said composition by the raw material of following parts by weight through processing preparation andBecome: curcuma zedoary 28, iris 20, calamus 32, Bulbus Fritillariae Cirrhosae 10, RADIX CURCUMAE 22, Lythrum salicaria 15.
Preparation method:
1) get curcuma zedoary and the iris of formula ratio, the methyl alcohol that is 1:5 by volume ratio and the mixed solution of ethyl acetate reflux and carryGet three times, add the mixed solution refluxing extraction 2h of 3 times of raw material gross weights at every turn, merge after extract, reduced pressure concentration, obtains medicinal extractStand-by;
2) get calamus, Bulbus Fritillariae Cirrhosae, RADIX CURCUMAE and the Lythrum salicaria of formula ratio, by 30% ethanol water refluxing extraction threeInferior, add the alcohol reflux of 5 times of raw material gross weights to extract 2h at every turn, merge after extract, reduced pressure concentration, obtains medicinal extract stand-by;
4) by step 1) and step 2) medicinal extract that obtains mixes, and obtains described composition.
Embodiment 4
Be used for the treatment of a Chinese medicine composition for hepatitis, be prepared from through processing by the raw material of following weight portion: curcuma zedoary 15,Iris 10, calamus 20, Bulbus Fritillariae Cirrhosae 5, RADIX CURCUMAE 18, Lythrum salicaria 8, thizoma curculiginis 5, anisetree bark 12, purple bergenia herb 8, the fruit of Chinese magnoliavine 15.
Preparation method:
1) get curcuma zedoary, iris, thizoma curculiginis and the purple bergenia herb of formula ratio, the methyl alcohol that is 1:5 by volume ratio and ethyl acetate mixedClose solution refluxing extraction three times, add the mixed solution refluxing extraction 2h of 5 times of raw material gross weights at every turn, merge after extract, subtractPress and concentrate, obtain medicinal extract stand-by;
2) get calamus, anisetree bark and the fruit of Chinese magnoliavine of formula ratio, the ethanol water refluxing extraction with 75% three times adds at every turnThe alcohol reflux that enters 5 times of raw material gross weights extracts 2h, merges after extract, and reduced pressure concentration, obtains medicinal extract stand-by;
3) get Bulbus Fritillariae Cirrhosae, RADIX CURCUMAE and Lythrum salicaria, decocting three times, the decocting liquid 3h that each raw material gross weight is 4 times, merges waterAfter decocting liquid, reduced pressure concentration, obtains fine powder stand-by;
4) by step 1) and step 2) medicinal extract and the step 3 that obtain) fine powder that obtains mixes, and obtains described combinationThing.
Embodiment 5
Be used for the treatment of a Chinese medicine composition for hepatitis, be prepared from through processing by the raw material of following weight portion: curcuma zedoary 28,Iris 20, calamus 32, Bulbus Fritillariae Cirrhosae 10, RADIX CURCUMAE 22, Lythrum salicaria 15, thizoma curculiginis 10, anisetree bark 20, purple bergenia herb 16, the fruit of Chinese magnoliavine 25.
Preparation method:
1) get curcuma zedoary, iris, thizoma curculiginis and the purple bergenia herb of formula ratio, the methyl alcohol that is 1:5 by volume ratio and ethyl acetate mixedClose solution refluxing extraction three times, add the mixed solution refluxing extraction 4h of 3 times of raw material gross weights at every turn, merge after extract, subtractPress and concentrate, obtain medicinal extract stand-by;
2) get calamus, anisetree bark and the fruit of Chinese magnoliavine of formula ratio, the ethanol water refluxing extraction with 50% three times adds at every turnThe alcohol reflux that enters 3 times of raw material gross weights extracts 3h, merges after extract, and reduced pressure concentration, obtains medicinal extract stand-by;
3) get Bulbus Fritillariae Cirrhosae, RADIX CURCUMAE and Lythrum salicaria, decocting three times, the decocting liquid 2h that each raw material gross weight is 6 times, merges waterAfter decocting liquid, reduced pressure concentration, obtains fine powder stand-by;
4) by step 1) and step 2) medicinal extract and the step 3 that obtain) fine powder that obtains mixes, and obtains described combinationThing.
Embodiment 6 tablets
Preparation method:
1) lactitol and N-dodecyl amine xyloside are joined in 50% ethanol that weight adds 2 times of amounts, fully grindTo pastel, composition prepared embodiment 1, the locust bean gum of 1/2nd amounts and the mixture of Nipasol are joinedIn pastel, mix rear granulation dry; 2) by mixture, the carboxymethyl cellulose of residue locust bean gum and NipasolSodium and triacetyl glycerine mix, and obtain described tablet after compressing tablet.
Embodiment 7 tablets
Preparation method: be prepared by the method described in embodiment 6.
Embodiment 8 tablets
Preparation method: be prepared by the method described in embodiment 7.
Test the zoopery of the hepatic injury impact of 1 composition on CCl4 induction
1 test material
1.1 tested medicines:
The composition that test group 1 is prepared for embodiment 1, test group 2 is the composition described in embodiment 2, control group is citySelling medicine " Compound Liver-benepitino Remedy " is produced by Taonan Jilin Pharmaceutical Co.
1.2 experimental animals:
50 of NIH mouse, the about 22-25g of body weight, experiment condition is 22 DEG C～24 DEG C of environment temperatures, humidity 50%-56%.
2 test methods and result
Mouse is divided into 5 groups at random, 10 every group, is respectively normal group, blank group, 1 group of test, test 2 groups and control group;Normal group is with physiological saline gavage (0.3mLd-1), 5d continuously, every 0.1mL10g of 6d lumbar injection vegetable oil-1; EmptyWhite group, test group and control group are respectively with physiological saline and different pharmaceutical gavage (0.3mLd-1), 5d continuously, in 6d abdominal cavityInjection 0.1%CCl40.1mL10g-1. After 24h, put to death animal, get serum and survey AST and ALT activity, the results are shown in Table 1.
The protective action of each group of table 1 to hepatic injury mouse due to CCL4
Note: P compared with control groupa< 0.01, P compared with testing 1 groupb<0.05
From above-mentioned result of the test, Chinese medicine composition of the present invention can significantly suppress CCl4The mouse AST of inductionAnd the remarkable rising of ALT activity, test 1 group with 2 groups of all there were significant differences compared with control group property of test, compared with 1 group of test,The curative effect of testing 2 groups is better, substantially suppresses CCl4To the damaging action of liver.
Test the zoopery of the hepatic injury impact of 2 compositions on D-Gal amine (D-GalN) induction
1 test material
1.1 tested medicines:
The composition that test group 1 is prepared for embodiment 1, test group 2 is the composition described in embodiment 2, control group is citySelling medicine " Compound Liver-benepitino Remedy " is produced by Taonan Jilin Pharmaceutical Co.
1.2 experimental animals:
50 of NIH mouse, the about 22-25g of body weight, experiment condition is 22 DEG C～24 DEG C of environment temperatures, humidity 50%-56%.
2 test methods and result
Mouse is divided into 5 groups at random, 10 every group, is respectively normal group, blank group, 1 group of test, test 2 groups and control group;Normal group is with physiological saline gavage (0.3mLd-1), 7d continuously, every 0.15mL10g of 7d intraperitoneal injection of saline-1；Blank group, test group and control group are respectively with physiological saline and different pharmaceutical gavage (0.3mLd-1), 7d continuously, in 7d abdomenChamber injection D-GalN (800mgkg-1，0.15mL·10g-1), after 16h, get blood, survey AST and ALT activity, the results are shown in Table 2.
The protective action of each group of table 1 to hepatic injury mouse due to D-GalN
Note: P compared with control groupa< 0.01, P compared with testing 1 groupb<0.05
From above-mentioned result of the test, Chinese medicine composition of the present invention can significantly suppress the mouse of D-GalN inductionThe remarkable rising of AST and ALT activity, test 1 group with 2 groups of all there were significant differences compared with control group property of test, with 1 group of phase of testRatio, the curative effect of testing 2 groups is better.
Clinical testing
1. test crowd
365 routine experimenters, the age is all between 35-78 year; All experimenter is acute hepatitis A 102 through clinical diagnosisPeople, acute hepatitis B 135 people, chronic hepatitis 128 people.
2. grouping
102 routine acute hepatitis A patients are divided into 1 group of test, test 2 groups and control group, every group of 34 people at random; By 135Example acute hepatitis B patient is divided into 1 group of test, test 2 groups and control group, every group of 45 people at random; 128 routine chronic hepatitis are suffered fromPerson is divided into 1 group of 43 people of test at random, tests 2 group of 43 people, control group 42 people; Test 1 group of group of taking described in the embodiment of the present invention 1Compound; Test 2 groups of compositions of taking described in the embodiment of the present invention 2; Control group is taken street drug " Compound Liver-benepitino Remedy " by JiTaonan, woods Aodong medicine company limited company produces. All take 30 days for two groups, 0.2g (crude drug)/time, every day 3 times.
3. efficacy assessment standard
1, oxyhepatitis:
1.1 is effective: main syndrome disappears; Hepatosplenomegaly disappears or retraction, and hepatic region is without obvious tenderness and kowtow pain; Liver functionCheck; Blood, urine, feces routine inspection; The heart, kidney function test are normal; See that disease integration reduces more than 70%.
1.2 is invalid: do not reach effective standard.
2, chronic hepatitis:
1.1 is effective: main syndrome disappears or substantially disappears; Hepatosplenomegaly is stablized constant, and without obvious tenderness and kowtow pain;Liver function test; Blood, urine, feces routine inspection; Normal or the initial value of the heart, kidney function test declines more than 50%. See that disease integration reducesMore than 70%.
1.2 is invalid: do not reach effective standard.
4. result
Table 3 acute hepatitis A patient treatment effect
Table 4 acute hepatitis B patient treatment effect
Table 5 Patients with CHB effect
6. conclusion
From above-mentioned clinical testing, Chinese medicine composition of the present invention, to acute hepatitis B, acute hepatitis AAll there is good curative effect with chronic hepatitis, compare with respect to control group, all there is significant difference; With respect to 1 of embodimentThe Chinese medicine composition of stating, the traditional Chinese medicine composition for treating effect described in embodiment 2 is better, efficient on average more than 94%, and rightHealth thing toxic and side effect is a kind of soothing the liver, Chinese medicine composition of protecting liver and protecting the liver preferably.
Claims (8)
1. a Chinese medicine composition that is used for the treatment of hepatitis, is characterized in that, described composition is mainly by following parts by weightRaw material is prepared from through processing: curcuma zedoary 15-28, iris 10-20, calamus 20-32, Bulbus Fritillariae Cirrhosae 5-10, RADIX CURCUMAE 18-22, thousand bendDish 8-15.
2. the Chinese medicine composition that is used for the treatment of hepatitis as claimed in claim 1, is characterized in that, prepares described composition and also wrapsDraw together the raw material of following weight portion: thizoma curculiginis 5-10, anisetree bark 12-20, purple bergenia herb 8-16, fruit of Chinese magnoliavine 15-25.
3. the Chinese medicine composition that is used for the treatment of hepatitis as claimed in claim 2, is characterized in that, prepares described composition materialParts by weight be: curcuma zedoary 20, iris 15, calamus 28, Bulbus Fritillariae Cirrhosae 7, RADIX CURCUMAE 20, Lythrum salicaria 10, thizoma curculiginis 6, anisetree bark 15, rockChinese cabbage 13, the fruit of Chinese magnoliavine 21.
4. the Chinese medicine composition that is used for the treatment of hepatitis and pharmaceutically acceptable auxiliary material as described in as arbitrary in claim 1-3 are madeOral formulations, it is characterized in that, described preparation is pill, tablet, capsule, powder or granule; Describedly be used for the treatment of liverScorching Chinese medicine composition and auxiliary material ratio of weight and number are 1:2-4.
5. oral formulations as claimed in claim 4, is characterized in that, described preparation is tablet, and described auxiliary material comprises weight portionNumber is than diluent, disintegrant and adhesive for 3-4:1-2:0.8-1.2.
6. oral formulations as claimed in claim 5, is characterized in that, described diluent is that ratio of weight and number is the lactose of 3:1The mixture of alcohol and N-dodecyl amine xyloside; Described disintegrant is that ratio of weight and number is locust bean gum and the Nipasol of 2:1Mixture; Described adhesive is that ratio of weight and number is the sodium carboxymethylcellulose of 5:3 and the mixture of triacetyl glycerine.
7. a preparation method who is used for the treatment of as claimed in claim 2 the Chinese medicine composition of hepatitis, is characterized in that, described systemPreparation Method comprises the steps:
1) get curcuma zedoary, iris, thizoma curculiginis and the purple bergenia herb of formula ratio, the methyl alcohol that is 1:5 by volume ratio and the mixing of ethyl acetate are moltenLiquid refluxing extraction three times adds raw material gross weight 3-5 mixed solution refluxing extraction 2-4h doubly at every turn, merges after extract, subtractsPress and concentrate, obtain medicinal extract stand-by;
2) get calamus, anisetree bark and the fruit of Chinese magnoliavine of formula ratio, by the ethanol water refluxing extraction of 50%-75% three times, eachAdd raw material gross weight 3-5 alcohol reflux doubly to extract 2-3h, merge after extract, reduced pressure concentration, obtains medicinal extract stand-by;
3) get Bulbus Fritillariae Cirrhosae, RADIX CURCUMAE and Lythrum salicaria, decocting three times, each raw material gross weight 4-6 decocting liquid 2-3h doubly, merges waterAfter decocting liquid, reduced pressure concentration, obtains fine powder stand-by;
4) by step 1) and step 2) medicinal extract and the step 3 that obtain) fine powder that obtains mixes, and obtains described composition.
8. the composition as described in as arbitrary in claim 1-3 is in the application for the preparation of in treatment hepatitis, liver-protective medicine.
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