Method Validation of Microbial Limit Tests for Three Hospital Paste Preparations
- VernacularTitle:3种医院糊剂微生物限度检查方法学研究
- Author:
Xinyue ZHANG
;
Haiping WU
;
Xiaoyao ZHU
;
Jingjing HOU
;
Ying BU
- Publication Type:Journal Article
- Keywords:
Microbial limit test;
Paste;
Hospital preparations;
Method validation
- From:
China Pharmacist
2015;18(12):2198-2200
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish the method validation of microbial limit tests for hospital paste preparations, including com-pound salicylic acid paste, zinc oxide paste and compound pine tar paste. Methods:According to the microbial limit test described in China pharmacopoeia 2010 edition, the method validation of count of bacteria, fungi and yeasts and tests for specified microorganisms was established. Results:Medium dilution method could be used in bacteria, fungi and yeasts count and specified microorganisms ex-amination for compound salicylic acid paste and zinc oxide paste. For compound pine tar paste, bacteria, fungi and yeasts count and the pseudomonas aeruginosa examination could use medium dilution method, while the staphylococcus aureus examination should employ membrane filtration method. Conclusion:The methods of microbial limit tests for the three hospital paste preparations are established, which can be used to control the quality of hospital preparations effectively.
