【摘要】 建立了盐酸氟桂利嗪（1）胶囊有区分力的溶出度检测方法，并对自研仿制制剂与参比制剂的溶出曲线相似性进行评价。通过调整篮法转速或（和）添加不同浓度Tween-80，优化了各介质的溶出检测条件，并对1胶囊在不同介质中的溶出曲线进行了考察。结果表明，1胶囊在盐酸（pH 1.2,50 r/min）、乙酸盐缓冲液（pH 4.5,100 r/min）、含0.15%Tween-80的磷酸盐缓冲液（pH6.8,100r/min）和0.10%Tween-80水溶液（100r/min）中的溶出曲线具有区分力。1胶囊在盐酸中15 min的溶出率均≥85%，在其余介质中溶出曲线的相似因子（?₂）均≥50，表明1仿制制剂与参比制剂在上述介质中的溶出行为基本一致。更多还原

【Abstract】 A distinguishable dissolution method for flunarizine hydrochloride（1） capsules was established,and the similarity of dissolution curves between the self-developed generic preparation and the reference preparation was evaluated. By adjusting the rotation speed of basket method and/or adding different concentrations of Tween-80, the dissolution test conditions of each medium were optimized, and the dissolution curves of 1 capsules in different media were investigated. The results showed that the dissolution curves of 1 capsules in hydrochloric acid（pH 1.2, 50 r/min）,acetate buffer solution（pH 4.5, 100 r/min）, phosphate buffer solution containing 0.15% Tween-80（pH 6.8, 100 r/min）and 0.10% Tween-80 aqueous solution（100 r/min） were distinguishable. The dissolution rates at 15 min of 1 capsules in hydrochloric acid were all no less than 85%, and the similarity factor（?₂） values between dissolution curves in other media were no less than 50, which indicated that the dissolution behavior of 1 from the generic and reference preparations in above media was basically the same.更多还原