盐酸决奈达隆片仿制药与原研药的溶出度一致性评价 点击下载
论文标题: | 盐酸决奈达隆片仿制药与原研药的溶出度一致性评价 |
英文标题: | |
中文摘要: | 目的:建立盐酸决奈达隆片的溶出度测定方法,并评价仿制药与原研药的质量一致性。方法:采用紫外-可见分光光度法,检测波长为288 nm。以磷酸盐缓冲液(pH4.5)、0.1 mol/L 盐酸溶液[加入0.5%十二烷基硫酸钠(SDS)]、磷酸盐缓冲液(pH6.8,加入0.5%SDS)、水为溶出介质,溶出介质体积为1 000 ml,转速为75 r/min,分别考察盐酸决奈达隆片仿制药与原研药的溶出度,并通过计算相似因子(f2)来评价其溶出曲线的相似性。结果:盐酸决奈达隆检测质量浓度线性范围为2.147~25.764 μg/ml;精密度、稳定性、重复性试验的RSD<2.0%;4种溶出介质中的回收率分别为99.53%~101.05%(RSD=0.48%,n=9)、98.95%~100.05%(RSD=0.39%,n=9)、99.54%~100.20%(RSD=0.24%,n=9)、98.54%~100.06%(RSD=0.44%,n=9)。在4种溶出介质中,3批盐酸决奈达隆片仿制药与原研药溶出曲线的f2分别为56、60、63、68,68、52、59、67, 65、68、76、62。结论:该方法适用于盐酸决奈达隆片的溶出度测定;盐酸决奈达隆片仿制药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。 |
英文摘要: | OBJECTIVE: To establish a method for the dissolution determination of Dronedarone hydrochloride tablet, and evaluate the quality consistency of its generic and original preparations. METHODS: UV spectrometry was performed on the column of 288 nm, dissolution media of Phosphate buffer solution (pH4.5),0.1 mol/L Hydrochloric acid solution [adding into 0.5% sodium dodecyl sulfate (SDS)], Phosphate buffer solution [pH6.8, adding into 0.5%SDS] and water, volume of dissolution medium was 1 000 ml, rotation speed was 75 r/min, the dissolution of generic and original preparations of Dronedarone hydrochloride tablet was detected, and the similarity of dissolution curve was evaluated by calculating the similarity factor (f2). RESULTS: The linear range of dronedarone hydrochloride was 2.147-25.764 μg/ml; RSDs of precision, stability and reproducibility tests were lower than 2.0%; recoveries 4 dissolution media were 99.53%-101.05%(RSD=0.48%,n=9), 98.95%-100.05% (RSD=0.39%,n=9), 99.54%-100.20% (RSD=0.24%,n=9) and 98.54%-100.06%(RSD=0.44%,n=9). In the 4 dissolution media, f2 of the dissolution curve of 3 batches of generic and original preparations of Dronedarone hydrochloride tablet was 56, 60, 63, 68, 68, 52, 59, 67, 65, 68, 76, 62, respectively. CONCLUSIONS: The method is suitable for the dissolution determination of Dronedarone hydrochloride tablet; meanwhile, the in vitro dissolution curves of generic and original preparations of Dronedarone hydrochloride tablet show similarity, so the quality consistency is good. |
期刊: | 2016年第27卷第30期 |
作者: | 赵欣,陈国华,吴琼珠,滕海堂,郁婷婷 |
英文作者: | ZHAO Xin,CHEN Guohua,WU Qiongzhu,TENG Haitang,YU Tingting |
关键字: | 盐酸决奈达隆片;原研药;仿制药;溶出曲线;相似因子;多介质;一致性评价 |
KEYWORDS: | Dronedarone hydrochloride tablet; Original preparation; Generic preparation; Dissolution curve; Similarity factor; Various media; Consistency evaluation |
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