目的比较中、美、英、欧药典制药用水微生物检查法，为《中国药典》的修订提供参考，为推动制药用水微生物检查法与国际接轨提供合理化建议。方法通过采用不同的检查方法、培养基、培养条件对20个样本进行实验，并对不同实验条件进行两两配对的 t检验，统计分析比较方法的差异性。结果采用R2A培养基，30～35℃，120 h ，薄膜过滤法，培养效果较好。同时，《中国药典》2010年版的方法可行。结论可以采用 R2A 培养基、30～35℃、120 h、薄膜过滤法对制药用水进行微生物限度检查。
Comparative study of the microbiological test of pharmaceutical water by using Ch .P,USP,BP or EP method
Objective In order to provide a reference for the revision of Chinese Pharmacopoeia (Ch .P .) and offer a rational propos-al to promote the microbiological test of pharmaceutical water .Method Different media and cultural conditions were used to detect samples 20 pharmaceutical water .The difference among different methods was inspected and statistically analyzed by a paired t-test .Result The results exhibited that using R2A medium ,30-35 ℃ ,120 h ,membrane filtration method to examine the microbi-ological of pharmaceutical water was better than other methods .Meanwhile ,the method recorded in Ch .P of 2010 was reasona-ble .Conclusion Using R2A medium ,30-35 ℃ ,120 h ,and membrane filtration method is workable for microbial limit tests .
Chinese and foreign pharmacopoeiapharmaceutical watermicrobiological test
NETL
NSTL
万方数据
维普
