医疗机构中药制剂安全性研究  

Research on Safety of Hospital Traditional Chinese Medicine Preparations

作　　者：袁彩[1] 单丽芳[1] 张林[1] 赵卫权[2] 高天[3] 何畏[2] 

机构地区：[1]成都中医药大学药学院,成都610041 [2]四川省食品药品监督管理局,成都610017 [3]成都中医药大学附属医院,成都610072

出　　处：《世界科学技术-中医药现代化》2015年第7期1577-1583,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

摘　　要：目的:评估医疗机构中药制剂安全性及使用风险,为医疗机构中药制剂的研发、注册申请、临床使用以及技术审评和监督管理提供参考依据。方法:通过收集2012-2014年四川省食品药品监督管理局审批的医疗机构中药制剂资料,筛选出21个由临床经验方开发的中药制剂,对其所含药材、配制工艺、急性毒性等数据进行统计分析。结果:21个中药制剂品种中共涉及中药材98种,药材用量均在2010版《中国药典》规定的范围之内;16个品种的配制工艺仅有水煎煮、粉碎等传统工艺,其余5个品种的配制工艺涉及了醇提或醇沉工艺。急性毒性实验数据均通过小鼠实验得到,制剂的临床使用量都远远小于最大耐受量(MTD)或半数致死量(LD50)。结论:临床使用的经验方开发的中药制剂具有较高的安全性。This study was aimed to provide a reference for the development, registration, and clinical use of hospital traditional Chinese medicine （TCM） preparations, in order to analyze and assess their safety and risk. It also provided a reference for the technical review and supervision of hospital TCM preparations. Through collecting review materials of hospital TCM preparations from 2012 to 2014 in the Sichuan Food and Drug Administration, 21 preparations developed by clinical experiences were screened out. Analysis was made on their ingredients, preparation process and acute toxicity data. The results showed that 98 kinds of Chinese herbal medicines were contained in 21 preparations. The dosages of herbs were in compliance with theChina Pharmacopoeia2010 Edition. Preparation processes of 16 preparations were made by water extraction, grinding and other traditional techniques. The preparation processes of the remaining 5 preparations were involved with alcohol extraction or alcohol precipitation. Acute toxicity test data were obtained with experimental data in mice. Clinical usages of preparation were much lower than MTD or LD50. It was concluded that these hospital TCM preparations developed by clinical experiences were with high safety.

关 键 词：医疗机构中药制剂 安全性 急性毒性 临床经验方 

分 类 号：R932[医药卫生—生药学]