WHO儿童基本药物目录第3版中的药品在我国上市情况分析  

Analysis of Post Marketed Medicines Which Were Included in the 3rd Edition of WHO Essential Medicines List for Children in China

作　　者：刘伟[1] 李恒[1] 郭娟娟[1] 秦芙红[1] 章锦丽 

机构地区：[1]郑州大学药学院,郑州450001 [2]河南省食品药品监督管理局

出　　处：《中国药事》2012年第12期1330-1336,共7页Chinese Pharmaceutical Affairs

摘　　要：目的揭示WHO儿童基本药物目录第3版中的药品在我国的可获得性,为我国建立儿童基本药物目录提供数据参考。方法检索SFDA数据库,逐项统计该目录中收录的251种药物在我国关于原料药、剂型、规格、批准文号、生产单位的信息。结果我国已有该目录中217种原料药、29种剂型、257种规格药品的上市信息,涉及到13425个药品批准文号,2316家生产单位。结论在我国该目录中收录的药品原料药的可获得性较高,但剂型和规格明显不足,重复生产较为严重,各类药品市场分布差异较大,虽具备了一定的建立我国儿童基本药物的基础,仍需根据我国实际情况合理遴选药物,积极研发儿童药物制剂,改善当前我国儿童药品市场的现状,切实保障儿童用药安全、有效。Objective To reveal the availability of the medicines that were included in the 3rd edition of WHO Essential Medicines List for Children in China, so as to provide reference data for the establishment of the China＇s essential medicines list for children. Methods By searching SFDA database, statistics of the information of the medicines were collected including the number of the bulk drugs, formulations, specifications, approval licenses and production enterprises. Results There are 217 kinds of bulk drugs, 29 types of formulations and 257 classes of specifications included in the list, involving 13425 medicines approval licenses and 2316 production enterprises in China. Conclusion The availability of the bulk drugs included in the list is high, however, the formulations and specifications are obviously inadequate, and the condition of repetitive product is serious; the distribution of all kinds of medicines is discrepant; our country has a certain basis of the establishment of essential medicines for children, but we still need to reasonably select pediatric drugs according to actual situation, actively develop the preparation for children and improve the current market situation of pediatric medicines, so as to feasibly protect the safety and effectiveness during the use of pediatric medicines.

关 键 词：儿童基本药物目录 我国上市情况 可获得性 

分 类 号：R956.1[医药卫生—药学] R985