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目的:探讨表面活性剂在外用制剂微生物限度检查中的应用。方法:选择微生物限度检查方法验证试验所规定的试验菌株,采用两种缓冲液(含与不含表面活性剂)按《中国药典》2005年版微生物限度检查方法验证实验的要求进行试验菌株回收率的测定,考查两种方法的异同。结果:含有一定比例的表面活性剂缓冲液组试验菌株回收率高于不含表面活性剂缓冲液组。结论:表面活性剂可以改善某些样品在该缓冲液中的溶解、分散,并能有效降低供试品对试验菌株的抑制活性。
Objective: To investigate the application of surfactant in the test of microbial limit of external preparation. Methods: The microorganism limit test method was used to test the test strains. The two strains of buffer (with and without surfactant) were selected according to the requirements of the Chinese Pharmacopoeia 2005 Microorganism Limits Verification Test. The recoveries Determination, test the similarities and differences between the two methods. Results: The recoveries of test strains containing a certain proportion of surfactant buffer group were higher than those without surfactant buffer group. Conclusion: Surfactants can improve the dissolution and dispersion of some samples in this buffer, and can effectively reduce the inhibitory activity of test samples on the test strains.