珍珠明目滴眼液中的絮状物来源分析

Analysis on the Formation of Floccus in Pearl Clear-sighted Eye Drops

目的:明确珍珠明目滴眼液中的絮状物的形成原因,为指导合理用药提供依据。方法:对出现絮状物的珍珠明目滴眼液进行无菌检验,并取留样进行可见异物检查和无菌检验;通过实验对比不同的使用方法可能导致珍珠明目滴眼液出现的变化。结果:出现絮状物的珍珠明目滴眼液无菌检验不合格,但留样未检出可见异物,且无菌检验合格;正确使用的珍珠明目滴眼液使用过程未出现絮状物,部分不正确使用(使用过程接触到眼睛或长时间暴露空气中)的珍珠明目滴眼液在使用过程出现絮状物或可见异物。结论:出现絮状物的珍珠明目滴眼液已被微生物污染,不正确的使用方法可导致微生物污染药液,出现絮状物。

Objective：To study the reason for the formation of floccus in pearl clear-sighted eye drops so as to provide reference for instruction of reasonable use of the medicine. Methods：Tests for sterility and visible foreign matters were conducted on the retaining samples of pearl clear-sighted eye drops and sterility test on the eye drops with floccus. Different methods were used to compare if different results could be obtained in the tests. Results： Pearl clear-sighted eye drops with floccus failed in the sterility test. Improper use of pearl clear-sighted eye drops （contact eyes or expose to the air for a long time during the use）could lead the formation of floccus or visible foreign matters. Conclusion：It was proved that pearl clear-sighted eye drops with floccus were microbiological contaminated which resulted from the improper use of the eye drops.