目的:建立测定盐酸曲美他嗪片溶出度的方法.方法:溶出度测定采用桨法,分别以900 mL水、pH1.0盐酸溶液和pH 6.8磷酸盐缓冲液为溶出介质,转速为50、75、100 r·min-1进行溶出条件的筛选.含量测定采用紫外分光光度法,检测波长为232nm.考察样品在30 min时的体外溶出情况.结果:确立了以900 mL水为溶出介质、桨法转速为50 r·min-1的溶出方法;在30 min内,样品溶出达到80％以上.结论:所建方法简便、准确、结果可靠,可用于盐酸曲美他嗪片溶出度测定.%OBJECTIVE: To establish a method for determining the dissolution of Trimetazidine hydrochloride tablets. METHODS: Dissolution of tablets was determined by paddle method. 900 mL water, pHl.O hydrochloric acid solution and phosphoric acid buffer solution (pH 6.8) were used as dissolution medium at the rotation speed of 50, 75, 100 r·min-1 for selecting dissolution condition. The content determination was conducted by UV spectrophotometry with detection wavelength of 232 nm. The dissolution of sample was investigated at 30 min. RESULTS: The method of dissolution tests for Trimetazidine hydrochloride tablets had been established with 900 mL water as dissolution media and paddle rotation speed of 50 r·min-1. The dissolution rate of samples was no less than 80% at 30 min. CONCLUSION: This method is simple, accurate, reliable, and it can be used to determine the dissolution of Trimetazidine hydrochloride tablets.
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