Preparation Process And Quality Standard Research Of Yinju Jiedu Oral Liquid

Yinju Jiedu Oral Liquid is developed by combination of experience and effect and modern preparation technology,which is consisted of sichuan honeysuckle、Wild chrysanthemum、isatis root、Cortex、Psoralea.It has the effect of clearing heat and releasing fire and nourishing yin to supplement kidney,which has been used in clinic for many years in the form of decoction and has better clinical curative effect in view of gingivitis during pregnancy without untoward reaction.This topic main research:Preparation process and Quality standard research of Yinju Jiedu Oral Liquid.The study of the preparation process mainly includes extraction,enrichment,purification and molding.In the extract process,through investigate the decoction curve of chlorogenic acid of Yinju Jiedu oral liquid and the extraction rate of chlorogenic acid of sichuan honeysuckle and other ingredients in the compatibility separate,we confirmed that the sichuan yinhua decoct first and the optimum way of sichuan honeysuckle‘s residues and other ingredients decoct togher.In sichuan yinhua decoction experiment,we investigate the dissolution curve and the extraction rate of each index of chlorogenic acid were compared between Single decoction and Single decoction mixture,which get result that sichuan yinhua decocting 30 min with 8-fold water firstly.according to the composite score of extracting of Linarin,harpagoside,R,S-epigoitrin,psoralen and psoralen,yield of dry extract rate as index,examine the influence of water amount,decocting duration and numbers of time to the extrcting effect by adopting orthogonal test,and then choose that the optimum way of sichuan honeysuckle‘s residues and other ingredients preferably was as follows:8 folds of water,extracting for 3 times,1h each time.In study of enrichmen technology,we investigate the effects of normal pressure concentration and decompression concentration on the index composition,the final concentration was decompression concentrating to 0.18 g / mL with 50-60 ℃.In study of enrichmen technology,filtration,centrifugal,macroporous resin respectively three methods of examining the effects of liquid were investigated,the result of the investigate is that the method of macroporous resin is best.HPLC wassued to establish HPLC fingerprint of Yinju Jiedu Oral Liquid.Recovery rate of fingerprints of six components [chlorogenic acid,Linarin,harpagoside,R,S-epigoitrin,psoralen,psoralen] and HPLC fingerprint similarity were taken as the index to optimize the type of macroporous resin among 10 types.Weights of the recovery rates of six components and similarity were determined by mixed weight of AHP-CRITIC,in order to obtain the comprehensive index as the evaluation criterion.The significantly influencing factors were firstly evaluated by PBD,then purification conditions were optimized by BBD,The optimized purification technology was as follows: the ratio of dia-height was 1:7,pH value was 4.5,sample concentration was0.18 g/mL,ratio of sample to resin was 0.96 g/g,77% ethanol’s dosage was 8 BV.In study of molding technology,the range of PH values and the type and dosage of preservatives were examined.According the examine,we choose to control PH4.0~5.5 and add 0.2 % sorbic acid.To study the preparation of quality standards:the HPLC fingerprint of fingerprints of the Liquid of raw material,intermediate product,and Yinju Jiedu Oral Liquid wer established and compared.,the multi-components in Yinju Jiedu Oral Liquid was determined,the medicine yinpian of Cortex and Psoralea thin layer identification method were established.establish the HPLC method for determining six kinds of Yinju Jiedu Oral Liquid,According to the test results of sample determination,make the contnent limit,chlorogenic acid shall not be less than 1.978%,Linarin shall not be less than0.801%,harpagoside shall not be less than 0.110%,R,S-epigoitrin shall not be less than0.014%,psoralen shall not be less than 0.385%,psoralen shall not be less than0.339%,all by dry product.Establish a standard fingerprint of Yinju Jiedu Oral Liquid.With reference peak as S peak,Similarity between the fingerprint of sample and standard fingerprint shall more than 0.90 and t 13 common peaks are existed.The area of uncommon peaks should be less than 10%.The similarities of the Yinju Jiedu Oral Liquid were over 0.9,the same with the liquid of raw materialand and intermediate product.The correlation was good between the extracts from the liquid of raw material,intermediate productand Yinju Jiedu Oral Liquid.This validated method that combined fingerprint and determining content is suitable for the quality evaluation and quality control of Yinju Jiedu Oral Liquid.