国产酒石酸美托洛尔片的溶出度质量评价

目的：通过考察国内7家不同生产企业的酒石酸美托洛尔片与参比制剂（商品名：倍他洛克^TM）的体外溶出情况评价药品质量。方法：参照日本《药品品质再评价工程拟定流程》中对溶出度试验条件的规定，分别考察不同厂家的酒石酸美托洛尔片在水、pH 1.2的氯化钠盐酸溶液、pH 4.0的醋酸盐缓冲液及pH 6.8的磷酸盐缓冲液4种介质中的体外溶出行为，溶出方法为浆法，转速为50 r·min^-1。采用相似因子法比较7家企业的酒石酸美托洛尔片与参比制剂溶出行为的差异。结果： 7家企业酒石酸美托洛尔片的溶出行为存在较大差异，C、F、G企业样品在4种溶出介质中的f₂值均小于50，溶出曲线与参比制剂不相似。结论：国内某些生产企业的酒石酸美托洛尔片与参比制剂的溶出行为有显著差异，仿制药品的质量应予以关注。

Dissolution Evaluation of Metoprolol Tartrate Tablets

Objective: To evaluate the quality of metoprolol tartrate tablets from 7 different domestic manufacturers by determining their dissolution. Methods: The dissolution of different metoprolol tartrate tablets were determined in the following 4 kinds of mediums, namely water, pH 1.2 sodium chloride hydrochloric acid solution, pH 4.0 acetate buffer solution and pH 6.8 phosphate buffer solution. The dissolution tests were proceeded by paddling at 50 r·min^-1. The differences in the dissolution rates among the reference preparation and the 7 domestic products were evaluated by a similarity factor method. Results: The dissolution curves of metoprolol tartrate tablets from the 7 domestic manufacturers were different. The f₂ factors of products from manufacturers C, F and G were under 50. The drug release behavior showed significant difference with that of the reference preparation. Conclusion: There are significant differences in the quality among the metoprolol tartrate tablets from different manufactures. Attentions should be paid to the quality of domestic metoprolol tartrate tablets.