China Pharmacist 2017;20(5):946-948

Verification and Evaluation on Microbial Limit Test of Methodology for Changyanning Tablets in ChP 2015

Xuping LIU ; Wenting ZHANG ; Luyao YI ; Jun XIONG ; Chunhua ZHANG ; Chun XIAO

Keywords

Changyanning tablets; Microbial limit; Verification and evaluation of methodology

Country

China

Language

Chinese

Abstract

Objective: To provide a method of microbial limit test for Changyanning tablets and carry out the verification of the mothod.Methods: A plate method was used in the total aerobic microbial count and the concentration of the test liquid was 1∶100.A plate method was used in the total yeast and mold count while the concentration of the test liquid was 1∶10.The direct inoculation method was used for the detection of Escherichia coli,bile-tolerant gram-negative bacteria and Salmonella enterica subsp.Results: The recoveries of the five strains were from 0.5 to 2.0.Conclusion: The method is suitable for the microbial limit examination of Changyanning tablets.