头孢克洛缓释片处方开发及释放度一致性研究  

Study on Formulation Development and Release Consistency of Cefaclor Sustained Release Tablets

作　　者：魏京璐 杨淑慎[1] 王晓峰 Wei Jinglu;Yang Shushen;Wang Xiaofeng(Northwest A＆F University,Yangling 712100,China;Yangzijiang Pharmaceutical Group Co.,Ltd.,Taizhou,225300,China)

机构地区：[1]西北农林科技大学,陕西杨凌712100 [2]扬子江药业集团有限公司,江苏泰州225300

出　　处：《山东化工》2018年第16期39-41,共3页Shandong Chemical Industry

摘　　要：头孢克洛属于第二代口服头孢类抗生素,1976年由美国礼来公司研制开发,目前国内外已开发出本品的片剂、胶囊剂、颗粒剂、干混悬剂以及缓释、复方等多种规格和给药形式,根据市场调研及问卷分析,本文选择开发服用次数少,临床反映良好的头孢克洛缓释片进行研究。以原研单位的希刻劳头孢克洛缓释片Ⅱ为参比,本文进行了系统的处方工艺研究,对处方进行重新开发,检测释放度,进行体外释药相似性评价,旨在提升产品质量,达到与参比制剂的质量和疗效的一致性。Cefaclor belong to the second generation of oral cephalosporins antibiotics,developed in 1976 by eli lilly,at home and abroad have developed this product of tablet,capsule,granule,dry suspension agent and slow release,a variety of specifications and dosage forms,such as compound according to market research and questionnaire analysis,this article choose take fewer development,clinical reflect good cefaclor zyban for research.With the original unit of carved lowe ？ cefaclor zyban Ⅱ for reference,this article has carried on the system of prescription craft research,redevelopment of prescription test release,in vitro drug release similarity evaluation,aimed at improving the quality of products,with the consistency of the quality and efficacy of reference preparations.

关 键 词：头孢克洛 缓释片 参比制剂 释放度 

分 类 号：R96[医药卫生—药理学]