Study On The Preparation Process And Quality Evaluation Of Xingsu Zhike Tablets

Cough is a protective reflex of the body,occasional or mild cough can be considered a normal response,do not need to take antitussive drugs.When the cough is severe and frequent,which has a negative impact on the life and health of the patient,antitussive drugs must be selected,especially the rapid antitussive drugs are the best.Xingsu Zhike prescriptions are commonly used cough sputum drugs,the existing drug dosage forms are mainly liquid preparations and granules,among them,the liquid preparation of the drug dispersion is large,easy to cause the degradation of some chemical components of the drug,and the liquid preparation is inconvenient to carry,store and transport,in addition,the liquid preparation is also easy to produce physical stability and other problems;however,the poor storage of granule is easy to absorb moisture and agglomerate,which affects the efficacy of granule.When insoluble excipients are added in the preparation process,drug dissolution will be affected.In view of the shortcomings of the above dosage forms,and in order to meet the purpose of rapid antitussive drugs,this paper combined with the modern production technology of traditional Chinese medicine,on the basis of the original dosage forms to improve the rapid release tablets,its advantages lie in:（1）The drug is stable and easy to carry and transport.（2）After rapid disintegration of tablet,the surface area of the drug can be increased,the active ingredients can be dissolved out quickly.（3）Easy to take,good compliance.This topic applies orthogonal experimental methods,starting from the extraction process,preparation process and quality research were studied.In terms of extraction processes:the extraction and encapsulation conditions of Chen pi,Zisu ye and exhu volatile oil in the complex were screened;the above-mentioned slag slag combined bitter almonds to take ethanol reflux extraction,and the extraction conditions are preferred;The extraction conditions of radix platycodonis licorice were screened by water decoction.In terms of preparation process:the filling agent,disintegrating agent,wetting agent,drug dipping powder and auxiliary material ratio were carried out orthogonal experiments,and the best preparation conditions were screened.Quality research:the bitter almonds,chen skins,purple leaves,exhu and licorice in the complex were identified with thin color spectrum;According to the Chinese pharmacopoeia（2015 edition）,the quality of Xingsu Zhike Tablets was inspected;In addition,with orange pistine,bitter almond glycoside and ammonium glyphosate as the characteristic peak,the ten batches of Xingsu Zhike Tablets were fingerprinted.The research results of this subject are as follows:extraction process:Chen pi,zisu leaf and exhu were added 6 times the amount of water distilled 5h,the resulting volatile oil and beta-cyclo-dextrin saturated water solution with 1:8 mix,stirred 1h package at 30℃conditions;the above residue and bitter almond were combined and added 8 times the amount of 70%ethanol solution to heat reflux for1 hour for alcohol extraction:Platycodon and licorice add 10 times water and fry for 2h,fry twice.The resulting mixture of alcohol extract and water extract was used to condense and dry the paste to a density of 1.2g/cm~3.In the preparation process:Filler selection lactose:microcrystalline cellulose（1:1）;the disintegrating agent was PVPP:CMS-Na=（1:1）content was 8%of the tablet weight;The wetting agent was 60%ethanol solution;the primary and secondary ratio is 1:4;0.1%magnesium stearate as a lubricant.In terms of quality research:In terms of qualitative identification,quality inspection,content determination and other aspects,Xingsu Zhike Tablets all meet the requirements of the fourth part of the 2015 edition of the Chinese pharmacopoeia.The established fingerprint can fully reflect the chemical composition of the Xingsu Zhike Tablets,which is conducive to the overall quality control of the Xingsu Zhike Tablets.Experiments show that the preliminary stability results of the Xingsu Zhike Tablets is good.