Validation of microbial limit tests for compound Hongjingtian oral liquid

VernacularTitle:复方红景天口服液微生物限度检查方法的验证
Author: Yalin CHEN ¹ ; Xu FENG ; Hong CHEN ; Jie LUAN ; Long ZHAO ; Jiachun WANG
Author Information

1. 海军医学研究所
Keywords: compound Hongjingtian oral liquid; microbial limit test; validation of the method
From: Journal of Pharmaceutical Practice 2016;34(2):177-178
CountryChina
Language:Chinese
Abstract: Objective To establish a method of microbial limit tests for compound Hongjingtian oral liquid and to per-form the validation of the method.Methods The validation on the microbial limit test method was conducted according to the counting method of bacteria,mycetes and yeasts and the control bacteria test method stated in the appendix of China pharmaco-poeia (2010 edition).Results The recoveries were over 70% when culture diluting method was used for staphylococcus aureus and routine test method was used for Escherichiacoli,Bacillus subtilis,Candida albicans and Aspergillus niger.In the test of positive control bacteria,the growth was detected,while the negative control was no growth detected.Conclusion The micro-bial limit test for compound Hongjingtian oral liquid is validated in this study.The amount of staphylococcus aureus can be de-termined using diluted culture method ;while the amounts of Escherichiacoli,Bacillus subtilis,Candida albicans,Aspergillus niger can be determined by conventional method.