复方替硝唑含漱液的制备及质量控制

Preparation and quality control of compound tinidazole gargle

目的:制备复方替硝唑含漱液并建立质量控制方法。方法:以替硝唑和硫酸锌为主药制备含漱液,采用紫外分光光度法和络合滴定法分别测定替硝唑和硫酸锌的含量。结果:替硝唑和硫酸锌的平均回收率分别为100.39%和100.53%,相对标准差分别为1.61%和0.98%。结论:本制剂制备方法简便,质量稳定,含量测定方法简便、快速、可靠。

Objective： To prepare the compound tinidazole gargle and to establish the quality control method for this medicine. Methods： Tinidazole and zinc sulfate were taken as the chief components of the gargle. The contents of tinidazolewere determined by ultraviolet spectrophotometry and and zinc sulfate by compleximetric titration. Results： The average recoveries of tinidazole and zinc sulfate were 100.39% and 100.53% respectively,and the relative standard deviations（RSD） of which were 1.61% and 0. 98% respectively. Conclusions： The gargle is simple in preparation, and the quality control method is accurate, stable, reliable and easy to operation.