【摘要】 建立了盐酸氟西汀胶囊溶出度的测定方法,并评价了仿制药与原研药的溶出曲线一致性。采用高效液相色谱(HPLC)法,检测波长为227 nm,以水、0.1 mol/L盐酸溶液、醋酸盐缓冲液(pH=4.5)、磷酸盐缓冲液(pH=6.8)为溶出介质(体积为500 mL),采用桨法(转速为50 r/min)分别考察自制品与原研药的溶出度。结果表明:盐酸氟西汀检测质量浓度线性范围为9.04～63.28μg/mL;精密度、稳定性、重复性试验的相对标准偏差RSD小于2.0%;4种溶出介质中的平均回收率分别为100.24%(RSD=0.6%,n=9),99.33%(RSD=0.7%,n=9),100.11%(RSD=0.7%,n=9),100.17%(RSD=0.6%,n=9)。在4种溶出介质中,3批盐酸氟西汀胶囊自制品与原研药15 min时的溶出均大于80%。该方法适用于盐酸氟西汀胶囊溶出度的测定;盐酸氟西汀胶囊自制品与原研药的体外溶出曲线具有相似性,故其质量一致性较好。更多还原

【Abstract】 A method for determining the dissolution rate of fluoxetine hydrochloride capsules was established, and the consistency of the dissolution curves of the generic and original drugs was evaluated. The high-performance liquid chromatography(HPLC) method was performed to detect the dissolution of generic and original preparations of fluoxetine hydrochloride tablet on the column of 227 nm, with dissolution medium of water, 0.1 mol/L hydrochloric acid solution,acetate buffer solution(pH=4.5) and phosphate buffer solution(pH=6.8), and the volume of dissolution medium was 500 m L, the rotation speed was 50 r/min. The linear range of fluoxetine hydrochloride was 9.04 ～63.28 μg/mL, the relative standard deviations(RSD) of precision, stability and reproducibility tests were less than 2.0%, recoveries in 4 dissolution mediums were 100.24%(RSD=0.6%, n=9), 99.33%(RSD=0.7%, n=9), 100.11%(RSD=0.7%, n=9), 100.17%(RSD=0.6%, n=9). In the 4 dissolution mediums, the dissolution rate in 15 min of the three batches and the original were more than 80%.The HPLC method is suitable for the dissolution determination of fluoxetine hydrochloride capsules, meanwhile, the in vitro dissolution curves of generic and original preparations of fluoxetine hydrochloride capsules show similarity, so the quality consistency is good.更多还原