盐酸文拉法辛缓释胶囊的体外释放度研究

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。

Release Profile of Venlafaxine Hydrochloride Sustained-Release Capsules in Vitro

OBJECTIVE： To establish a method for determining the release rate of venlafaxine hydrochloride extended release capsules in vitro. METHODS： The release was measured by basket - rotating method with the solution medium of distilled water, hydrochloric acid solution （pH = 1.2） and phosphate buffer solution （pH = 6.8）, respectively. The rotational speed was 100 r · min^-1 and the temperature was （37.0 ±0.5）℃ . The detection wavelength was 274 nm. RESULTS： The linear range of venlafaxine hydrochloride was 0.015--0.24 mg · mL^-1（r 〉 0.999 8） . The average recovery was 100.3% （RSD = 0.78 % ）, 99.5 % （ RSD - 0.79 % ）, and 102.5 % （RSD = 1.1% ）, respectively. There were no significant differences in the release parameters in the 3 medium solutions; all showed a nearly thorough release within 24 h. CONCLUSIONS： The method is simple and accurate with reliable results, and can be used for the release rate determination of venlafaxine hydrochloride sustained release capsules.