Verification and Evaluation on Microbial Limit Test of Methodology for Changyanning Tablets in ChP 2015
- VernacularTitle:肠炎宁片2015年版药典微生物限度检查法验证与评价
- Author:
Xuping LIU
;
Wenting ZHANG
;
Luyao YI
;
Jun XIONG
;
Chunhua ZHANG
;
Chun XIAO
- Keywords:
Changyanning tablets;
Microbial limit;
Verification and evaluation of methodology
- From:
China Pharmacist
2017;20(5):946-948
- CountryChina
- 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.
