摘要
目的建立盐酸雷尼替丁胶囊体外溶出一致性评价方法,为其仿制药的一致性评价工作提供理论依据。方法采用桨法,以900 mL水及pH 1.2、pH 4.5、pH 6.8缓冲溶液(脱气)为溶出介质,转速为50 r·min^(-1),UV法测定吸光度值,对照品法计算溶出度。结果盐酸雷尼替丁在4种介质中的浓度范围内,线性关系良好;平均回收率分别为99.09%(RSD 0.31%),99.70%(RSD 0.65%),99.09%(RSD 0.20%),100.35%(RSD 0.26%),溶出方法的准确度较好;3批仿制制剂在4种介质中的批间均一性良好,且与参比制剂的体外溶出行为相似。结论建立的溶出曲线检测方法简便、准确,可用于盐酸雷尼替丁胶囊仿制药一致性评价及质量研究工作。
OBJECTIVE To establish a new method for the determination of the dissolution rate of ranitidine hydrochloride capsules,and to provide basis for the consistency evaluation of the dissolution of generic capsules and the original capusles.METHODS The stirring paddle method was used with the dissolution medium of water,pH 1.2 hydrochloric acid solution,pH 4.0 sodium acetate solution and pH 6.8 phosphate solution,and the volume of dissolution medium was 900 mL,the rotation speed was 50 r·min^(-1).The dissolution curve was determined by UV method with reference substance.RESULTS The method showed good linearity,precision and high recovery in 4 dissolution media,and the average recoveries were 99.09%(RSD0.31%),99.70%(RSD 0.65%),99.09%(RSD 0.20%),100.35%(RSD 0.26%)respectively;3 batches of generic capsules showed good uniformity in 4 dissolution media,and the dissolution behaviors of generic capsules were consistent with that of the original.CONCLUSION The new method established in this study is simple and accute,which is suitable for the quality consistency evaluation of ranitidine hydrochloride capsules.
作者
邓回香
王西凤
DENG Hui-xiang;WANG Xi-feng(Hunan Hansen Pharmaceutical Co.,Ltd.,Yiyang 413000,China)
出处
《海峡药学》
2021年第11期89-92,共4页
Strait Pharmaceutical Journal
关键词
盐酸雷尼替丁胶囊
溶出曲线
一致性评价
Ranitidine hydrochloride capsule
Dissolution curve
Consistency evaluation
