Study On The Quality Of Maxingzhike Syrup

Maxingzhike syrup is a traditional Chinese patent medicine,it is composed of four traditional Chinese medicines: ephedra,bitter almond,licorice,and gypsum.Maxingzhike syrup has the functions of relieving cough,expectorating phlegm and relieving asthma,it is widely used in clinical.There are many manufacturers of Maxingzhike syrup nationwide,but the quality standards are relatively simple and cannot truly reflect the quality of the drug.Therefore,in this thesis the comprehensive quality study on Maxingzhike syrup was carried out,in order to provide a reference for improving the quality standard of Maxingzhike syrup.The specific research contents and results are as follows:(1)Quality evaluation of Maxingzhike syrup based on current standards.41 batches of samples were inspected according to the current standard,and the pass rate was 100%.(2)Establishment of a multi-component determination method and quality evaluation of Maxingzhike Syrup.HPLC methods were established for the determination of ephedrine hydrochloride,pseudoephedrine hydrochloride,amygdalin,glycyrrhizin and glycyrrhizic acid in Maxingzhike syrup,and an analytical method of calcium content in Maxingzhike Syrup was established by atomic absorption spectrophotometry.The reference limits of the four main components in Maxingzhike Syrup were set according to the quality requirements of the original medicinal materials in the Chinese Pharmacopoeia.According to the reference limit,the quality of commercial products was evaluated and the results were as follows: ephedra was calculated according to ephedrine hydrochloride,the unqualified rate was 4.9%;bitter almonds was calculated according to amygdalin,the unqualified rate was 65.9%;licorice was calculated according to liquiritin,the unqualified rate was 22.0%;plaster was calculated according to calcium,and the unqualified rate was 58.5%.(3)Study on the preparation process affecting the quality of Maxingzhike syrup.Aiming at the unqualified index,the preparation process was investigated in order to find the reasons for the low content of the analytes.The results indicated that the extraction of amygdalin was greatly improved by the crushing process without oil pressing compared with the oil pressing process.Oil pressing process of bitter almond would lose part of the active ingredients,and the reduction of bitter almond oil was not conducive to the dissolution of active ingredients.Exploration on gypsum decocting process showed that the amount of water added in decocting will greatly affect the dissolution of active ingredients.Based on the process research results and considering the production cost and production efficiency,the optimized production process is to crush bitter almond without oil pressing,and the amount of water should be 10 times when gypsum is decocted.(4)Study on the excipients and exogenous contaminants.A high-performance liquid chromatography method for the determination of the preservatives benzoic acid,sorbic acid and the sweetener sodium saccharin was established.The results showed that sorbic acid and sodium saccharin were not detected in Maxingzhike syrup,and benzoic acid exceeded 120% of the standard addition in 6 batches of samples.The results of ICP-MS analysis showed that no excessive residue was found for the heavy metals and harmful elements.Illegal addition of antitussive drugs was screened by HPLC-TOFMS,and no illegal addition was found.(5)According to the current standard inspection,the failure rate is 0,but according to the methods and limits established by the exploratory researches,only 6 of 41 batches of samples are qualified,and the failure rate is 85.4%.The comprehensive evaluation indicated that the quality of Maxing cough syrup is not good.It is recommended to add the content measurement items and preservative inspection items in the inspection standard,and optimize the preparation process to improve the quality of Maxingzhike syrup.