复方妥布霉素-氟米龙滴眼液的研制及质量控制

Preparation and Quality Control of Compound Tobramycin and Flurometholone Eye Drops

目的:研制复方妥布霉素-氟米龙滴眼液并探讨其质量控制方法。方法:根据各种原辅料不同的溶解特性,采取分步调剂并灭菌的制备方法。采用高效液相色谱法及抗生素微生物检定法分别测定氟米龙及妥布霉素的含量,并建立了质量标准。结果:制得的复方妥布霉素-氟米龙滴眼液质量稳定可控,含量测定方法准确可靠。结论:制备工艺合理,质量控制方法可行。

Objective:To study the preparation of t he compound tobramycin and flurometholone e ye drops and establish its quality c ontrol method.Methods:Prepare and sterilize respectively in different means du e to their diffe rent dissolution character.The con tent of flurometholone by H PLC and microorg anism assay for tobramycin was determined and to establish the quality co ntrol standard.Results:The eye drops has good stablity.The dete rm ination method of the content is ac curate and reliable.Conclusion:The prepara tion techniques is reasonable.