Study On The Quality Standard Of Renshenzaizao Pills

Renshenzaizao pills is a common Chinese medicine for treating stroke.It consists of 56 kinds of Chinese medicinal herbs.The current quality standard of Renshenzaizao pills is simple and it is difficult to control the quality of Renshenzaizao pills completely.The purpose of this research is to improve the quality standard of Renshenzaizao pills and ensure the safety and effectiveness of the preparation.In this work,nine crude drugs in the prescription were identified by microscope.Radix et Rhizoma Rhei,Polygoni multiflori Radix and Cyperi Rhizoma were identified by TLC.An HPLC method was developed for simultaneous determination of puerarin,paeoniflorin,liquiritin,calycosin7-O-?-D-glucopyranoside,naringin,hesperidin,ginsenoside Rg₁,2,3,5,4?-tetrahydroxystilbene-2-O-?-D-glucoside,ginsenoside Re and harpagoside in Renshenzaizao pills.Meanwhile a GC method was also established for the simultaneous determination of borneol,cinnamaldehyde,eugenol and muscone in Renshenzaizao pills.The following researches were carried out to solve the problem of drug safety.The method based on ICP-MS was developed for the determination of lead,cadmium,arsenic,mercury,copper and solubility mercury.An HPLC method was also developed for the determination of aflatoxins B₁,B₂,G₁,G₂ and ochratoxin A.Besides,The GC-MS method was established for the determination of 17 organochlorine pesticide residues in Renshenzaizao pills.The analytical method established in this project provides a basis and reference for improving the quality standard of Renshenzaizao pills,and can comprehensively control the quality of the drug.