目的 通过考察国内不同药品生产企业头孢氨苄甲氧苄啶胶囊的溶出情况,评价其药品质量,并对溶出度检查方法的合理性进行探讨.方法 采用桨法(转速为50r/min),分别以piH1.2盐酸溶液、pH4.0醋酸盐缓冲液、pH6.8磷酸盐缓冲液和水为溶出介质,绘制各企业头孢氨苄甲氧苄啶胶囊中主成分头孢氨苄的溶出曲线.结果 12家企业中仅有5家企业的产品在4种介质中的溶出曲线是相似的,并且与日本橙皮书中收载的头孢氨苄胶囊参比制剂的溶出曲线相似;各企业产品以水为溶出介质的区分度明显好于0.1 mol/L盐酸溶液.结论 国产头孢氨苄甲氧苄啶胶囊溶出度不同企业间有显著差异;产品质量有待提高;溶出度方法亟待改进.%Objective To evaluate the quality and discuss the rationality of the dissolution test method by determining the dissolution of compound cefalexin capsules from different pharmaceutical manufactures.Methods The dissolution curve of cefalexin was determined in the following four kinds of media,namely pH 1.2 sodium chloride hydrochloric acid solution,pH 4.0 acetate buffer solution,pH 6.8 phosphate buffer solution and water,using the paddle method at 50r/min.Results The dissolution curves of five manufactures in four kinds of media were similar and similar to that of the reference preparation.The discrimination of each manufacture product by using water as the dissolution medium was significantly better than that of 0.l mol/L hydrochloric acid solution.Conclusion There are significant differences in the quality among the compound cefalexin capsules from different manufactures.Attentions should be paid to the quality of domestic compound cefalexin capsules and the dissolution method needs to be improved.
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