摘要
目的:为促进四川省医疗机构制剂的可持续发展提供参考。方法:通过分析四川省食品药品监督管理局2010-2013年发布的医疗机构制剂批件信息,介绍四川省医疗机构制剂的发展现状,对比医疗机构制剂与药品的注册特性,了解其发展趋势与存在的问题。结果与结论:2010-2013年,四川省共有医疗机构制剂2 989个,其中中药制剂2 441个(占81.67%),化学药制剂548个(占18.33%);分为33种剂型,根据数量排序列前6位的分别是丸剂、口服溶液剂、散剂、胶囊、颗粒剂、洗剂。目前,四川省医疗机构制剂存在品种和数量较多、剂型发展不平衡;质量标准拟定依据滞后,制剂室设备、设施较陈旧等问题。与药品的注册特性相比,医疗机构制剂为固定处方、配制工艺成熟、分布地域差异性较大;配制范围、使用范围都存在局限性;申报与审批要求低于药品;缺少确定工艺可行性的批量生产过程的配制现场检查;不良反应收集力度不足。建议充分发挥四川省的中药制剂特色优势,强化医疗机构制剂质量管理,建立长期、完善的抽验检查制度,构建区域制剂配制中心,实施医疗机构制剂室分类管理制度。
OBJECTIVE： To provide reference for promoting the sustainable development of pharmaceutical preparations in medical institutions of Sichuan province. METHODS： Through analyzing the preparations approval documents of medical institutions issued by Sichuan Food and Drug Administration during 2010--2013, the development trend and problems of pharmaceutical preparation in medical institutions of Sichuan province were investigated by introducing the situation of preparation supervision and development in medical institutions of Sichuan province, comparing the characteristics of preparation and drug registration. RESULTS ＆ CONCLUSIONS： Sichuan Food and Drug Administration has approved 2 989 pharmaceutical preparations in medical institutions during 2010--2013, including 2 441 TCM preparations （accounting for 81.67 % ） and 548 chemical medicine preparations （accounting for 18.33% ）; there are 33 dosage forms in total, and the top 6 dosage forms in the list of number are pill, oral solution, powder, capsule, granules and lotion. At present, there are some problems in pharmaceutical preparations of medical institutions in Sichuan province, such as a large number of preparation types, unbalanced development of dosage forms, lagged quality standard and obsolete equipment and facilities. Compared with the characteristics of drug registration, the preparations of medical in- stitutions in Sichuan province show the characteristics as fixed prescription, mature preparation technology and great geographical distribution difference; the range of preparation and application are limited; the requirements of preparation declaration and approv- al are lower than those of drugs; the preparation site inspection of volume production is absent for the determination of technology feasibility; ADR information collection is poor. It is suggested to give full play to the advantage of TCM preparation, intensify the quality control of pharmaceutical preparations in medical institutions, establish long-term and perfect sample inspection system, build regional preparation center, and carry out the classification management system of pharmaceutical preparation departments in medical institutions.
出处
《中国药房》
CAS
CSCD
2014年第45期4232-4235,共4页
China Pharmacy
关键词
医疗机构制剂
批件信息
监管
区域制剂中心
发展对策
Pharmaceutical preparations in medical institutions
Preparations approval document
Supervision
Regional preparation center
Development strategies
