头孢氨苄胶囊溶出曲线一致性研究  

Consistency of Dissolution Curve of Cephalexin Capsules

作　　者：韩松涛 梁冬雪 王保森 孙海涛 HAN Songtao;LIANG Dongxue;WANG Baosen;SUN Haitao(Jilin Provincial Institute for Drug Control and Research,Changchun 130000,China)

机构地区：[1]吉林省药品检验研究院,吉林长春130000

出　　处：《品牌与标准化》2023年第4期100-102,105,共4页

摘　　要：目的:建立头孢氨苄胶囊一致性评价方法。方法:采用篮法,转速100 r/min,分别以水、0.1 mol/L盐酸、pH4.5磷酸盐缓冲液和pH6.8磷酸盐缓冲液为溶出介质,溶出介质体积为900 mL;采用紫外法测定头孢氨苄胶囊溶出度,并计算其累积溶出量,绘制相应溶出曲线;评价溶出曲线的相似度。结果:在4种不同pH的溶出介质中,仿制产品和参比样品均在15 min内溶出量达到了85%以上,说明仿制产品与参比样品溶出行为基本一致,判定相似。结论:本方法可为头孢氨苄胶囊的质量一致性评价提供参考。Objective to establish a method for consistency evaluation of Cefalexin Capsules.Methods the blue method was used.The rotating speed was 100r/min.water,0.1 mol/L hydrochloric acid,pH4.5 phosphate buffer and ph6.8 phosphate buffer were used as the dissolution medium,and the volume of the dissolution medium was 900 mL;The dissolution of Cefalexin Capsules was determined by UV method,and the cumulative dissolution was calculated and the dissolution profile was drawn;The similarity of dissolution curves was evaluated Results in four different pH dissolution media,the dissolution amount of the imitation product and the reference sample reached more than 85%within 15 min,indicating that the dissolution behavior of the imitation product and the reference sample was basically the same,and the judgment was similar.Conclusion this method can provide reference for the quality consistency evaluation ofCefalexin Capsules.

关 键 词：头孢氨苄 溶出曲线 一致性评价 

分 类 号：R927[医药卫生—药学]