Study On The Standardization Of The Formula Granule Of The Yinchenhao Decoction

Yinchenhao decoction was recorded in“Shanghanlun”by Zhang Zhongjing.Yinchen was conducted monarch meidicine,Zhizi was conducted official medicine,Dahuang was conducted adjuvant medicine.It is a classical prescription for treating damp heat jaundice.Modern pharmacological research shows that this decoction has a good effect in the treatment of liver,gallbladder,antipyretic,anti-inflammatory,analgesic,antibacterial,anti-virus etc.At present,China was at the front of liver diseases internationally.For traditional Chinese medicine treatment of liver disease,it frequently uses Yinchenhao Decoction as the basic prescription.So Yinchenhao decoction widely used in clinical therapy.However,the market is only using single formula particles for the moment.It was lacking of traditional Chinese medicine decoction process.In this study,compound recipe was boiled together.This measure takes account of traditional compound decoction and modern Chinese medicine technology.The pattern which combined formula granule with single formula particles,closing to the guiding ideology as syndrome differentiation and revising with symptoms in traditional Chinese medicine.Objective:The study takes Yinchenhao decoction as research object and selecting dispensing granules as a new type of pieces model.Standardization research contains extraction process,purification and concentration,forming process and contrasting efficacy with traditional decoction and single formula particles.To promoting the modernization of traditional Chinese medicine and providing some reference for formula particles acting on international convention.Methods:1.Medicinal pieces inspection consults 2015 edition of“Chinese Pharmacopoeia”.Determine of water content,ash,extract,thin layer chromatography and high performance thin layer chromatography.2.Confirming extraction process from soaking time,boiling time,the amount of adding water to make sure its range.Taking chlorogenic acid,geniposide,aloe emodin,rhein,emodin,chrysophanol and extraction ratio as screening indexes.The experimental results are presented as the OD value of the final process optimization index.Adopting 3 factor and 3 level response surface analysis to determine the optimal extraction conditions.3.For purification and concentration,adopting simple filtration impurity after water extraction and adding accessories to prill after vacuum concentration.Selecting appearance,moisture,solubility,hygroscopicity etc as evaluating indicators.Eventually,choosing the most two suitable accessories from the 6 kinds of commonly used excipients.Orthogonal design using the ratio of two kinds of excipients,the concentration of wetting agent and the amount of addition as screening level.According to the 2015 edition of"Chinese Pharmacopoeia"granules,checking these granules.4.For Quality standard and preliminary stability,testing moisture,particle size,TLC and HPLC.Drafting quality standard（protocol）and investigating long term stability and accelerated stability tests.5.Comparative test of component content and efficacy,selecting some active ingredients as investigation indexes and activities of ALT,AST,TP,ALB,TBIL,SOD,MDA,pathological changes of liver HE staining to contrasting three different forms of Yinchenhao decoction.Results:1.Three pieces can be used according to 2015 edition of“Chinese Pharmacopoeia”.2.Determining the extraction process of Yinchenhao decoction is 730 m L water for soaking 60 min,Yinchen for boiling 46 min,rejoining Zhizi and Dahuang for boiling 23 min.3.Particle preparation technology is concentrated to extract the density of1.12¹.17 g/cm³ under 50℃.Then adding 4 times the amount of extract material（lactose:mannitol is equal to 1.25）and wetting with 40%ethanol.Finally sifted with 10mesh screen,drying 1 h in the oven at 50℃.4.Drafting quality standard（protocol）and the results for investigating long term stability and accelerated stability tests are all qualified.5.Chlorogenic acid content was similar with three kind methods of Yinchenhao decoction.Geniposide content in formula granule was less than that in single formula granule and traditional decoction.The aloe emodin,rhein,emodin,chrysophanol contents in traditional decoction were more than these in the other two formula granules.The four contents were similar with formula granule and single formula granule.In CCl₄ leading to liver injury pharmacological experiment,three kind methods of Yinchenhao decoction can all protect liver injury.The formula granule has the better effect than the other two methods.Conclusion:The Yinchenhao decoction formula granule with portable,taken easily,well quality controlling advantages,combined traditional Chinese medicine decoction,filled the blank of single formula granule market.The optimized preparation process can ensure the stability of the particle quality and the validity of the composition.In comparison of pharmacological experiments,the active ingredient contents in formula granule were only after the contents in traditional decoction.While it has the best effect on liver injury protecting.On the basis of classic formula granule and addition and subtraction with different symptoms,the formula granule is close to the guiding ideology of traditional Chinese medicine and conforming to the modernization of traditional Chinese medicine.