连榆烧伤膏无菌检查方法适用性研究

Applicability of the sterility test method for Lianyushaoshang ointment

目的:建立连榆烧伤膏无菌检查的方法。方法:按《中国药典》2015年版,采用薄膜过滤法进行方法适用性试验。结果:验证试验中各菌株与阳性对照菌生长同步,而阴性对照没有菌生长。结论:采用该方法对连榆烧伤膏进行无菌检查,方法可行、有效。

Objective:To establish a standard for the sterility test of Lianyushaoshang ointment.Methods:The sterility tests of Lianyushaoshang ointment were performed by membrane-filtration procedure based on Chinese pharmacopoeia(2015).Results:The growth of strains synchronized with the bacteria in positive control in the verification test and there was no bacterium growth in negative control.Conclusion:The method for the sterility test of the Lianyushaoshang ointment is feasible and effective.