双层推拉式渗透泵控释制剂仿制药处方工艺研究的一般考虑  

General considerations on generic preparation study of double-layered push-pull osmotic pump controlled-release preparations

作　　者：韩云川 司晓菲 徐晓宏 李飞 HAN Yun-chuan;SI Xiao-fei;XU Xiao-hong;LI Fei(Center for Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国新药杂志》2022年第13期1254-1258,共5页Chinese Journal of New Drugs

摘　　要：口服渗透泵控释制剂在减少给药次数、平稳血药浓度、减少药物不良反应等方面有其独特优势,已在心血管系统、泌尿系统、内分泌系统、精神神经系统等适应证使用,得到临床医生和患者认可,并且其具有较高技术含量和经济效益,受到行业关注。渗透泵型控释制剂具有一定技术难度,对该类制剂的研发及生产要求高于普通口服固体制剂。本文主要结合双层推拉式渗透泵控释制剂特点,就该类制剂仿制药处方工艺研究方面展开探讨。Oral osmotic pump controlled-release preparation has its unique advantages in reducing the times of administration,stabilizing the blood drug concentration,reducing the side effects of drugs,ect.It has been used in cardiovascular,urinary,endocrine,psychoneural and other indications,and has been recognized by clinicians and patients.It has high technical content and economic benefits,and has attracted the attention of the industry.Osmotic pump controlled-release preparations have certain technical difficulties,thus the requirements for the development and production of such preparations are higher than ordinary oral solid preparations.Based on the characteristics of double-layered push-pull osmotic pump controlled-release preparations,the formulation and process study of this kind of generic drugs are discussed in this article.

关 键 词：双层推拉式渗透泵控释制剂 仿制药 处方工艺研究 

分 类 号：R95[医药卫生—药学]