植入制剂质量控制研究进展  

Progress in quality control of implantations

作　　者：林晓鸣 郭宁子 杨化新[2] 刘阳[2] 刘万卉[1] LIN Xiao-ming;GUO Ning-zi;YANG Hua-xin;LIU Yang;LIU Wan-hui(School of Pharmacy, Yantai University, Yantai 264005 , China;National Institutes for Food and Drug Control, Beijing 102629 , China)

机构地区：[1]烟台大学药学院,烟台264005 [2]中国食品药品检定研究院,北京102629

出　　处：《中国新药杂志》2019年第5期528-535,共8页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项资助项目(2017ZX09101001;2015ZX09303001);北京市科技计划课题资助项目(Z151100000115013)

摘　　要：植入制剂是一种特殊的缓控释制剂,与传统制剂相比,植入制剂有减少给药次数、延长药物作用时间、避免首过效应等特点,临床上用于抗肿瘤、避孕、治疗眼部疾病和糖尿病等。植入制剂的质量控制与其生产工艺和产品特性密切相关,本文汇总分析了有关植入制剂产品质量控制相关文献,综述了植入制剂的发展与国内外上市产品现状、制备方法和释药机理、质量控制及其研究动态,从而为有效控制植入制剂质量,科学地评价其安全性和有效性提供参考。Implantation is a critical part of controlled release formulations,which has characteristics like reducing the time of drug administration,prolonging action times and avoiding first-pass effect compared to traditional medicinal preparations,and clinically used for anti-tumor,contraception,treatment of eye diseases,diabetes and so on. The quality control of implantation is closely related to its production process and product characteristics. This review analyzes the relevant academic articles on quality control of implantations products,and summarizes the development of implantations and the current situation of domestic and foreign commercial used products,preparation methods and drug release mechanisms,quality control and its research dynamics. We hope this review will provide reference for quality research and evaluation of safety and effectiveness of implantations.

关 键 词：植入制剂 植入给药系统 质量控制 体外评价方法 

分 类 号：R972.6[医药卫生—药品]