中国药业Issue(24):72-73,74,3.
小儿化毒散微生物限度检查方法验证
Validation of Microbiological Test Method for Xiaoer Huadu Powder
陈敏 1张健宇 2高翔3
作者信息
- 1. 陕西省医疗器械中心,陕西 西安 710065
- 2. 陕西省杨凌示范区食品药品检验所,陕西 西安 712100
- 3. 陕西省食品药品检验所,陕西 西安 710065
- 折叠
摘要
Abstract
Objective To establish a microbial limit test method for Xiaoer Huadu Powder. Methods The counting method of bacteria, mould and yeast,and the control bacteria test method were performed the validation according to the requirement of the Chinese Phar-macopoeia(2010 version,Part 1). Results Xiaoer Huadu Powder had strong inhibiting effect on Staphylococccus aureus and bacillus subtilis. Conclusion The bacterial counting adopts the membrane filtration method(500 mL/film),the mold and yeast counting adopt the plate method. The control bacteria escherichia coli,coliform,salmonella and pseudomonas aeruginosa adopt the direct inoculation method,staphylococccus aureus adopts the membrane-filter procedure(400 mL/film).关键词
小儿化毒散/微生物限度检查/方法验证Key words
Xiaoer Huadu Powder/microbial limit test/method validation分类
医药卫生引用本文复制引用
陈敏,张健宇,高翔..小儿化毒散微生物限度检查方法验证[J].中国药业,2014,(24):72-73,74,3.