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目的:建立复方克林霉素凝胶微生物限度检查法,并进行方法验证。方法:根据《中国药典》2005年版二部附录微生物限度的检查方法即常规法、培养基稀释法和薄膜过滤法,对复方克林霉素凝胶进行方法验证,通过比较回收率来确定适宜的检查方法。结果:采用常规法试验,样品对试验菌回收率均低于70%,且不能检出控制菌。采用培养基稀释法试验,样品对试验菌回收率虽大于70%,但低于稀释剂回收率。采用薄膜过滤法试验,各试验菌回收率均大于90%,且控制菌生长良好,可基本消除复方克林霉素凝胶的抑菌作用。结论:采用薄膜过滤法检查复方克林霉素凝胶微生物限度方法有效、可行。
Objective: To establish a compound clindamycin gel microbial limit test method, and to verify the method. Methods: According to the method of microbial limit test in the appendix of Chinese Pharmacopoeia (2005 edition), ie routine method, medium dilution method and membrane filtration method, the method of compound clindamycin gel was validated, and the recovery rate was compared to determine the appropriate Inspection Method. Results: The routine test showed that the recoveries of the test samples were lower than 70%, and the control bacteria could not be detected. The medium dilution method test, the sample recovery of test bacteria, although greater than 70%, but lower than the diluent recovery. The membrane filtration test, the recovery of each test bacteria were greater than 90%, and control bacteria grew well, can basically eliminate the antibacterial effect of compound clindamycin gel. Conclusion: It is effective and feasible to check the limit of the compound clindamycin gel by membrane filtration method.