盐酸决奈达隆片仿制药与原研药的溶出度一致性评价

Consistency Evaluation of the Dissolution of Generic and Original Preparations of Dronedarone Hydrochloride Tablet

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（pH 4.5）、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（p H6.8,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（f_2）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2.147-25.764μg/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f_2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。

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 of288 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 was1 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（f_2）. RESULTS：The linear range of dronedarone hydrochloride was 2.147-25.764 μg/ml;RSDs of precision,stability and reproducibility tests were lower than2.0%;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,f_2 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.