湖北省医疗机构制剂室现状和情况讨论  

Discussion on current status and development strategies of manufacturing laboratory in medical institutions of Hubei province

作　　者：陈相龙 张国强 刘文斌 阮祥庆 张学义 赵瑛[2] 

机构地区：[1]湖北省食品药品监督管理局,湖北武汉430071 [2]华中科技大学同济医学院附属协和医院,湖北武汉430030

出　　处：《中国医院药学杂志》2017年第14期1327-1329,共3页Chinese Journal of Hospital Pharmacy

基　　金：湖北省重点实验室开放基金研究项目(编号:0203201406)

摘　　要：目的:为医疗机构制剂室的发展提供建议和对策。方法:汇总湖北省医疗机构制剂室的基本情况,分析其发展趋势并提出相关建议。结果:湖北省共有79家医疗机构制剂室,其所在地域、医疗机构级别和类别分布不均衡;西药制剂的同质化高,而中药制剂中独家特色制剂较多;近3年新批准医疗机构制剂数量不多;制剂室设施设备、质量检验和物料生产等方面普遍存在问题。结论:湖北省医疗机构制剂室发展存在一定的问题,建议引导制剂室合理布局,走向集中化、特色化,鼓励与药品生产企业联合注册申报制剂文号,实现医疗机构制剂室的可持续发展。OBJECTIVE To provide a reference for promoting the development of manufacturing laboratory in medical institutions.METHODS Through basic situation analysis of manufacturing laboratory in Hubei province,development trends were analyzed and suggestions were proposed.RESULTS There were 79 manufacturing laboratories in Hubei providence,with varied locations,levels,and categories.Chemical pharmaceutics showed high level of homogenization,but traditional medicines were unique depending on different medical institutions.A few pharmaceutics were approved to produce in last three years.There were general defeats existing in instruments,quality of drugs and raw materials.CONCLUSION There are some problems in the development of manufacturing laboratory in medical institutions in Hubei province.It is suggested to give rational distribution in all medical institutions,guide centralization of homogenization,specification of traditional medicine.It is also suggested that manufacturing laboratories should unite pharmaceutical enterprises to register preparations,to put manufacturing laboratories onto the sustainable track.

关 键 词：医疗机构制剂室 医疗机构制剂 发展 监管 

分 类 号：R95[医药卫生—药学]