中国药房2011，Vol.22Issue(37)：3526-3527,2.
3种橡胶膏剂控制菌检查的方法学验证
Methodology Validation of Control Bacterial Examination of 3 Kinds of Adhesive Plasters
赵新霞 1杨淑先 1刘英 1陶明1
作者信息
- 1. 河南省食品药品检验所,郑州市450003
- 折叠
摘要
Abstract
OBJECTIVE: To establish the methodology validation of control bacterial examination of 3 kinds of adhesive plasters. METHODS: The tests in which Staphylococcus aureus and Pseudomonas aeruginosa were examined, was carried out according to the method in volume one of Chinese Pharmacopoeia (2010 edition). In this test, the method of test sample was adding the sample into 30 mL sterile isopropyl myristate, shaking, then adding 100 mL sterile buffered sodium chloride peptone buffer solution (pH7.0), extracting the aqueous solution with ratio of 1:10. RESULTS: The result showed that the plaster layer was dissolved completely, and the method of control bacteria examination was routine method. The results of examination were equal to the requirements of Chinese Pharmacopoeia. CONCLUSION: The method is effective and feasible, and it can be used for control bacterial examination of 3 kinds of adhesive plasters.关键词
橡胶膏剂/供试品溶液/制备/微生物限度检查/方法学验证Key words
Adhesive plaster/ Test solution/ Preparation/ Microbiological limit examination/ Methodology validation分类
医药卫生引用本文复制引用
赵新霞,杨淑先,刘英,陶明..3种橡胶膏剂控制菌检查的方法学验证[J].中国药房,2011,22(37):3526-3527,2.
