制药用水微生物检验方法合理性的探讨

Discussion of Rationality of Pharmaceutical Water Microbiological Testing Methods

关键词:  制药用水  微生物  检验方法  中国药典  美国药典  欧洲药典  比较

Key words:  pharmaceutical water  microbiological  testing methods  Chinese Pharmacopoeia  USP  European Pharmacopoeia  comparison

摘要:

目的 比较各国药典制药用水微生物检验方法的规定，通过实验研究，探讨各种方法的合理性。方法 在分析比较国内外药典异同点的基础上，分别采用中国药典、欧洲药典和美国药典的方法对浙江省内5家制药企业的水系统进行测定。结果 国内外药典在制药用水污染菌的检出效率上存在差异，特别是对生长缓慢的寡养菌差异显著。结论 欧洲药典的方法有利于水系统中污染菌的回收，尤其是对一些寡营养和缓慢生长菌的回收。

Abstract:

OBJECTIVE To compare pharmaceutical water microbiological testing methods of national pharmacopoeia and explore rationalities of various methods. METHODS The water system of five pharmaceutical companies in Zhejiang province were tested with Chinese Pharmacopoeia, European Pharmacopoeia and United States Pharmacopoeia methods on the basis of analysis and comparison of their similarities and differences. RESULTS There were significant differences in the detection efficiency of pharmaceutical water pollution bacteria among domestic and international pharmacopoeia, especially for slow-growing oligonucleotide bacteria. CONCLUSION European Pharmacopoeia methods are conducive to recycling of contaminated bacteria in the water system, especially oligotrophic and slow-growing bacteria.