胶囊壳变更对头孢氨苄胶囊溶出曲线的影响研究  

Effect of Capsule Shell Change on the Dissolution Curve of Cefalexin Capsules

作　　者：王威[1] Wang Wei(Harbin Pharmaceutical Group Pharmaceutical General Factory,Harbin 150086,China)

机构地区：[1]哈药集团制药总厂,黑龙江哈尔滨150086

出　　处：《哈尔滨医药》2024年第2期87-89,共3页Harbin Medical Journal

摘　　要：目的评价胶囊壳变更对头孢氨苄胶囊溶出曲线的相似性是否有影响。方法按照《中国药典》2020年版四部通则0931第二法(浆法)测定变更胶囊后头孢氨胶囊与参比制剂在不同pH溶出介质中的溶解度,采用非模型依赖法中相似因子法(f^(2)),比较头孢氨苄胶囊与参比制剂溶出曲线的相似性。结果使用3个不同厂家胶囊壳制备的头孢氨苄胶囊,对比头孢氨苄胶囊与参比制剂溶出曲线,其中2个批次头孢氨苄胶囊与参比制剂曲线相似,另外1个批次头孢氨苄胶囊在pH 6.8磷酸介质中溶出曲线与参比制剂溶出曲线不相似。结论头孢氨苄胶囊的胶囊壳变更对产品溶出曲线的相似性产生影响。Objective To the effect of capsule shell change on the similarity of dissolution curves of cefalexin capsules.Methods According to the second method(plasma method)of Chinese pharmacopoeia(2020 edition),the solubility of cefaxime capsules and reference preparations in different pH dissolution media was determined,the similarity of dissolution curves between cefalexin capsules and reference preparations was compared by the method of similarity factor in the non-model dependent method.Results The dissolution curves of cefalexin capsules were compared with those of the reference preparation,and the dissolution curves of two batches of cefalexin capsules were similar to those of the reference preparation,the dissolution curve of another batch of cefalexin capsules in Ph6.8 phosphate medium was not similar to that of the reference preparation.Conclusion The effect of the change of the capsule shell on the similarity of the dissolution curve of cefalexin capsules was studied.

关 键 词：头孢氨苄胶囊 桨法 溶出曲线 相似因子 

分 类 号：R734.2[医药卫生—肿瘤]