3种医院糊剂微生物限度检查方法学研究

Method Validation of Microbial Limit Tests for Three Hospital Paste Preparations

目的:建立复方水杨酸糊、氧化锌糊和复方松馏油糊3种医院糊剂微生物限度检查方法。方法:按《中国药典》2010年版二部微生物限度检查法中对细菌、霉菌及酵母菌计数方法和控制菌检查法进行验证。结果:复方水杨酸糊和氧化锌糊细菌、霉菌及酵母菌计数和控制菌检查均采用培养基稀释法;复方松馏油糊细菌、霉菌及酵母菌计数检查和铜绿假单胞菌菌检查采用培养基稀释法,金黄色葡萄球菌检查采用薄膜过滤法。结论:确立了3种医院糊剂微生物限度检查方法可有效控制其质量。

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.