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目的:建立盐酸文拉法辛缓释胶囊体外释放度的测定方法。方法:分别以水、pH1.2盐酸溶液、pH6.8磷酸盐缓冲液为释放介质,采用转篮法测定释放度,转速为100r·min-1,温度为(37.0±0.5)℃,检测波长为274nm。结果:盐酸文拉法辛检测浓度的线性范围为0.015～0.24mg·mL-1(r>0.9998);平均回收率分别为100.3%(RSD=0.78%)、99.5%(RSD=0.79%)、102.5%(RSD=1.1%);在3种介质中样品的释放曲线无显著差异,并均在24h时基本释放完全。结论:该方法简便、准确,结果可靠,可用于该制剂的释放度测定。
Objective: To establish an in vitro release assay of venlafaxine hydrochloride sustained release capsules. Methods: The release rate was determined by spin basket method with water, pH1.2 hydrochloric acid solution and pH6.8 phosphate buffer as the release media. The rotation speed was 100r · min-1 and the temperature was (37.0 ± 0.5) ℃. The detection wavelength For 274nm. Results: The linear range of venlafaxine hydrochloride concentration was 0.015-0.24 mg · mL-1 (r> 0.9998). The average recoveries were 100.3% (RSD = 0.78%) and 99.5% (RSD = 0.79% 102.5% (RSD = 1.1%). There was no significant difference in the release curve of the samples between the three media, and all of them were almost completely released at 24h. Conclusion: The method is simple, accurate and reliable. It can be used to determine the release of the preparation.