复方替硝唑凝胶的制备及质量控制

目的制备复方替硝唑凝胶并建立其质量控制方法。方法以替硝唑、氯霉素为主药，卡波姆-940、丙二醇等为辅料制备凝胶；采用双波长分光光度法测定主药含量。结果替硝唑、氯霉素检测质量浓度的线性范围分别为6.4～12．8mg／L和8.0～16.0mg／L，平均回收率分别为100．72％和99．64％，RSD分别为0.30％和0．98％。结论该制剂制备方法可行，所建立的质量控制方法简单、可靠。

Preparation and Quality Control of Compound Tinidazole Gel

Objective To prepare compound tinidazole gel and to establish the quality control methed of this medicine.Methods Tinidazole and chloromycetin were used as the principal agents,carbomer-940,propylene glycol as preservatives to prepare compound tinidazole gel. The contents of the chief componmts were determined by the dual-wavelength spectrophotometric method.Results The linear ranges for the concentration determination of tinidazole and chloromyeetin were 6.4-12.8 mg/L and 8.0-16.0mg/L respectively.The average recovery rates of tinidazole and chloromyeetin were 100.72% and 99.64% respectively,the relative standards deviations(RSD)were 0.30% and 0.98% respectively.Conclusion The preparation method is practicable and the established quality control method is simple,reliable.