制药用水微生物限度检查新方法的研究

目的：建立新的制药用水微生物限度检查方法，更好地指导国内企业控制制药用水的微生物污染。方法：比较中国药典（2010年版）、欧洲药典（EP 7.0）及美国药典（USP 35）制药用水微生物限度检查方法，通过数据分析确立最优条件：采用R2A琼脂培养基，按薄膜过滤法，30~35 ℃培养不少于5 d。结果：新方法在污染菌的检出率上较现行中国药典制药用水微生物检验方法存在显著提高。结论：本研究建立的制药用水微生物限度检查方法有更高的检出率，能够更好的反映制药用水微生物污染的真实情况，可作为中国药典2010年版增补本收载方法。

Objective: To develop a new microbial limit testing method for controlling microbial contamination of pharmaceutical water (PW) from domestic pharmaceutical industry. Methods: Microbial limit testing methods for PW under ChP 2010,EP 7.0 and USP 35 for estimating the level of samples'microbial contamination were compared and the optimum condition was established through data analysis.The optimum condition was achieved for culture with R2A agar medium at 30-35 ℃ for not less than 5 days in accordance with the membrane filtration method. Results: The relevance ratio of microorganisms by the new method was significantly improved compared to the current ChP.2010 method. Conclusion: The developed method has a higher level of relevance ratio.It is a better method to indicate the actual condition of microbial contamination for PW.It can be added into ChP 2010 edition supplements.

[1] ChP 2010.Vol Ⅱ(中国药典2010年版.二部)[S].2010:411
[2] EP 7.0[S].Vol 2.2011:2319
[3] USP 35-NF 30[S].Vol 1.2012:886
[4] CHEN Rui-zhang(陈瑞章), HU Jiang-bin(胡江滨).Preliminary research on the flexible standard for drugs—comparative analysis of standards for omeprazole enteric-coated capsules in Chinese and US Pharmacopeias(药品弹性标准初探-对比分析中美两国药典奥美拉唑肠溶胶囊标准)[J].Chin Pharm J (中国药学杂志), 2010, 45(17):1297
[5] JIANG Hong-liang(姜宏亮).Suggestion of inspection items of purified water in Pharmacopoeia of People's Republic of China(2000 edition)(关于2000版中国药典纯化水检查项目的建议)[J].Drug Stand China(中国药品标准), 2004, 5(1):23
[6] ChP 2010.Vol Ⅱ(中国药典2010年版.二部)[S].2010:Appendix(附录)216
[7] Ministry of Health of the People's Republic of China (中华人民共和国卫生部).Good Manufacturing Practice (2010 Revision)[药品生产质量管理规范(2010年修订)][S].2011:101, 17