复方萘甲唑啉滴眼液无菌检查方法的验证

Validation of Aseptic Test Method for Compound Naphazoline Eye Drops

目的:研究建立复方萘甲唑啉滴眼液无菌检查方法的验证。方法:采用薄膜过滤法对复方萘甲唑啉滴眼液的无菌检查方法进行验证。通过接种6株阳性代表菌株在实验组和阳性对照组中的生长情况进行对比分析。结果:6株阳性代表菌株在实验组与阳性对照组中长势都很好,说明在两组实验中都没有出现细菌。结论:薄膜过滤法可以有效消除复方萘甲唑啉滴眼液的抑菌作用,适用于无菌检查方法的验证。

Objective： To study and establish the validation of aseptic test method for compound naphazoline eye drops. Methods： Membrane fltration method was used to verify the aseptic test method of compound naphazoline eye drops. By inoculating 6 positive representative strains, the growth of the experimental group and the positive control group were compared and analyzed. Results： The 6 positive representative strains grew well in the experimental group and the positive control group, indicating that no bacteria were found in the two groups of experiments. Conclusion： Membrane fltration method can effectively eliminate the bacteriostasis of compound naphazoline eye drops, and it is suitable for verifcation of aseptic inspection methods.