我国法定中药注射剂概况  

Overview of Legal Traditional Chinese Medicine Injections in China

作　　者：刘皈阳[1] 张艳君[2] 马亮[1] 郭代红[1] 

机构地区：[1]解放军总医院药品保障中心,北京市100853 [2]蚌埠医学院,蚌埠市233010

出　　处：《中国医院用药评价与分析》2010年第4期291-293,共3页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:了解我国现行的法定中药注射剂概况。方法:通过国家食品药品监督管理局网站、药品说明书以及相关材料统计中药注射剂的药品种类、规格、剂型、批准文号、处方组成等情况,并进行分析统计。结果:我国现行的法定中药注射剂共有130种、1290个批准文号,药品剂型以小容量注射液为主。同种药品有多个批准文号和生产厂家的现象比较普遍,单个品种最多有8个规格、182个批准文号、115个生产厂家。结论:我国现行的法定中药注射剂在注册、审批、质量标准等方面仍存在不足,开展中药注射剂的安全性再评价工作十分重要。OBJECTIVE：To investigate the general situation of the current legal traditional Chinese medicine injections in our country.METHODS：The data of traditional Chinese medicine injection including drug categories,specifications,dosages,approval numbers and formulations were collected from State Food and Drug Administration（SFDA） website,drug package inserts and the related documents for statistical analysis.RESULTS：There were 130 kinds of legal traditional Chinese medicine injections and 1 290 approval numbers all together,with small dosage forms showing highest percentage.The phenomenon that the same category of drugs has multiply approved numbers and manufacturers was widespread.A single category has a maximum of 8 specifications,182 approval numbers and/or 115 manufacturers were noted.CONCLUSION：There were still some shortages in the registration,approval and quality standard of traditional Chinese medicine injections.It was very important to intensify re-evaluation of the safety of traditional Chinese medicine injections.

关 键 词：中药注射剂 国家食品药品监督管理局 批准文号 合理使用 药品安全性再评价 

分 类 号：R932[医药卫生—生药学]