缓释/控释制剂的风险管理  

Risk management of controlled release preparations

作　　者：刘树林 叶华[2] 翟永松[3] 王满元[3] 高子淳[4] 

机构地区：[1]国药控股北京有限公司,北京100077 [2]中央民族大学管理学院,北京100081 [3]首都医科大学中医药学院,北京100069 [4]北京市石景山中医医院,北京100043

出　　处：《中国医药导报》2014年第30期120-124,共5页China Medical Herald

基　　金：首都中医药与护理学研究专项项目(编号12ZYH09)

摘　　要：风险管理对于缓释/控释制剂的用药安全十分重要。本文通过统计《中国药典》2010年版二部收载的缓释/控释制剂品种、规格、剂型和服用方法 ,并结合文献分析缓控/释制剂存在的风险,探讨造成此类制剂风险的原因,并为构建风险管理体系提出相应建议。建议提高缓释/控释制剂注册审批的技术要求,严格控制生产工艺及质量监测,发挥药师的药学服务作用,提高医生和患者对于缓释/控释制剂的认识。It is very important to construct and perfect risk management system for controlled release preparations（CRP） by strengthening administration. Based on statistics of related varieties, specifications, dosage forms and administration methods of CRP in Chinese Pharmacopoeia（2010）, this paper analyzes the potential risk of CRP, investigates the causes of insufficient, and offer suggestions about risk management system. To ensure the safety of drug usage for the patients, risk management system should be set up by improving the technical requirements for registration, strictly controlling the production process and quality monitoring, playing the role of pharmacists in pharmacy services and raising awareness of doctor and patient for CRP, etc.

关 键 词：缓释/控释制剂 风险管理 药学 

分 类 号：R97[医药卫生—药品]