艾司奥美拉唑镁肠溶片溶出曲线相似性评价

目的：评价艾司奥美拉唑镁肠溶片自研制剂与参比制剂（RLD）体外溶出行为的相似性。方法依据中国药典质量标准建立溶出度检查法和高效液相色谱（HPLC）测定方法，对所建立的HPLC方法按照人用药品注册技术要求国际协调会（ICH）要求进行了方法学验证；以pH 1.2盐酸溶液、pH 4.5磷酸盐缓冲液、pH 6.8磷酸盐缓冲液、pH 1.2盐酸溶液（2 h）与pH 6.0磷酸盐缓冲液、pH 1.2盐酸溶液（2 h）与pH 6.8磷酸盐缓冲液和纯化水为溶出介质，采用不同的转速，对3批自研制剂和RLD进行溶出行为比较。结果 HPLC方法准确度、重复性、线性等验证结果均符合规定，满足分析要求；自研制剂与RLD在不同溶出介质中相似因子F2均大于50。结论自研制剂与RLD溶出行为相似。

Comparability evaluation of dissolution curve of esomeprazole magnesium enteric tablets

Objective To evaluate the similarity of dissolution behavior in vitro of self-made and reference listed drug(RLD) of esomeprazole magnesium enteric tablets. Methods The dissolution test method and HPLC method were established according to Chinese pharmacopoeia. The HPLC method was validated according to ICH guidance. The dissolution behavior of the 3 batches of the self-made drug and RLD were compared in dissolution medium of pH 1.2 HCl solutuion,pH 4.5 phosphate buffer,pH 6.8 phosphate buffer,pH 1.2 HCl solutuion(2 h)and pH 6.0 phosphate buffer,pH 1.2 HCl solutuion(2 h)and pH 6.8 phosphate buffer,and puri?fied water with different rotation rates. Results The HPLC validation results for linearity,repeatability,recovery,etc. all met the re?quirement. The similarity factors F2 between the self-made drug and RLD were greater than 50 in different dissolution mediums. Con?clusion The dissolution behaviors of the self-made drug and RLD are similar.