摘要
目的清咽解毒颗粒由15味中药组成,其中金银花、连翘、黄芩等有一定的抑菌作用,研究对该品种微生物限度检查方法进行方法学验证,了解直接采用常规法进行微生物限度检查对结果的干扰情况,以确立该品种的微生物限度检查方法。方法按照中华人民共和国药典(2005年版)一部附录微生物限度检查法项下规定,对3个批次的清咽解毒颗粒进行了微生物限度检查方法学验证。结果清咽解毒颗粒所含的抑菌成分不影响其微生物限度检查结果。结论通过对该品种的方法学验证确定该制剂可采用常规法进行微生物限度检查,不需去除抑菌成分。
Objective Qingyan jiedu granules is the preparation variety of No. 2 Hospital of Shanxi Medical University, composed of 15 herbs ; of which, Lonicera Japonica, Forsythia Suspensa and Radix Scutellariae act on anti - bacteria. The paper was to study the methodological validation of microbial limit test for this variety and understand directly the intervention to the results of microbial limit test with conventional method so as to establish the method of microbial limit test for this variety. Methods According to the iplementation under microbial limit test in Chinese Pharmacopoeia（2005 version）, volume I, the methodologi- cal validation was conducted for the microbial limit test of 3 - batch qingyan jiedu granules. Results The anti - bacterial components contained in qingyan jiedu granules could not impact the results of its microbial limit test. Conclusion The methodological validation determines that this preparation can be examined with conventional microbial limit test, no need to remove anti- bacterial components.
出处
《世界中西医结合杂志》
2010年第11期951-952,共2页
World Journal of Integrated Traditional and Western Medicine
关键词
清咽解毒颗粒
微生物限度检查
方法验证
Qingyan jiedu granules
Microbial limit test
Methodological validation
