国产滴眼液中常用抑菌剂的应用分析与评价

Analysis and evaluation of bacteriostatic agent application in domestic eye drops

目的为促进国产滴眼液制剂质量提高,并为未来的研发方向提供思路。方法结合连续4年专项评价工作的相关结果与相关文献的发现,从应用背景、药典标准、问题讨论等方面对国产滴眼液中常用抑菌剂的应用现状进行分析和评价。结果与结论研究发现国产滴眼液中抑菌剂应用逐渐被重视,但目前存在检测标准尚需统一的问题,未来需要开展标准统一的进一步工作。同时,建议企业在新品研发过程中考虑单剂量包装,降低抑菌剂依赖。

Objective To promote the quality improvement of the domestic eye drops,and provide suggestions for future research and development.Methods Analysis and evaluation of the current situation of bacteriostatic agent application indomestic eye drops were conducted based on the related laboratory results of special evaluation for 4 consecutive years,in combination with the finding of related research literature. The analysis focused on the application background,pharmacopoeia standard of different countries,problem discussion and so on. Results and Conclusion The application of antibacterial agents in domestic eye drops has drawn more and more attention. However,the testing standards were not unified,and these should be addressed in the future.Meanwhile,it is suggested that enterprises consider single dose packaging during the development of new product to reduce the dependence of bacteriostatic agents.