仿制药一致性评价快速检索原研药品信息方法探讨

朱凤昌, 王晓婧, 王爱国, 张华吉, 江翊国, 曹秀萍, 杨春宁, 郭双, 王磊, 丁丽霞

中国药学杂志 ›› 2021, Vol. 56 ›› Issue (16) : 1342-1347.

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中国药学杂志
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中国药学杂志 ›› 2021, Vol. 56 ›› Issue (16) : 1342-1347. DOI: 10.11669/cpj.2021.16.012
论著

仿制药一致性评价快速检索原研药品信息方法探讨

  • 朱凤昌1, 王晓婧2, 王爱国1,3, 张华吉1, 江翊国4, 曹秀萍1, 杨春宁1, 郭双1, 王磊1, 丁丽霞1*
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Rapid Retrieval Approach of Original Drugs Information for Generic Drugs

  • ZHU Feng-chang1, WANG Xiao-jing2, WANG Ai-guo1,3, ZHANG Hua-ji1, JIANG Yi-guo4, CAO Xiu-ping1, YANG Chun-ning1, GUO Shuang1, WANG Lei1, DING Li-xia1*
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摘要

目的 通过介绍国内外相关知名药学数据库,对检索到的仿制药信息进行分析归纳,来确定其原研药品信息。探索具有快速及可行性的仿制药原研药品信息检索方法,为我国正在进行的仿制药质量和疗效一致性评价工作提供借鉴和帮助。方法 使用药智网数据库、Pharmaprojects数据库、Thieme Pharmaceutical Substances数据库、Integrity数据库、FDA Orange Book等国内外知名数据库和网站对仿制药原研信息进行检索,并采用文献调查法、数据库检索方法、对比分析法、综合归纳法等情报学研究方法进行研究,探索快速检索原研药品的信息方法。结果 建立了“国际知名数据库检索-药品原研信息检索结果对比-原研厂商信息分析-网络搜索引擎信息辅助-信息确定”的仿制药原研信息快速检索方法,并对受国家药品监督管理局仿制药质量与疗效一致性评价办公室委托的首批289目录中未进行参比制剂备案的49个品规进行了原研药品信息检索,初步确定原研信息。结论 本研究探索建立的仿制药原研药品信息检索方法具有快速性和可行性,为仿制药一致性评价遴选参比制剂提供参考,为后续待评价品种的原研信息研究提供借鉴。

Abstract

OBJECTIVE To introduce some famous international pharmaceutical databases, analyze and summarize the information of generic drugs, retrieve and determine the original drug information, and to explore a rapid and feasible method for searching the information of the original generic drugs, which provide reference and assistance for the consistent evaluation of the quality and efficacy of generic drugs in China. METHODS The original drugs information of generic drugs were analyzed and summarized from famous international pharmaceutical databases and websites, such as Yaozhi.com database, Pharmaprojects database, Thieme Pharmaceutical Substances database, and Thomson Reuters Integrity database, and FDA Orange Book, and the original drug information was determined. The rapid approach of retrieval original drugs information for generic drugs was explored by compare the difference to the database and website. RESULTS The rapid and feasible retrieval and determinable approach of the original drugs information for generic drugs was established, and the original drugs information of 49 drugs specifications of the first batch of evaluation without reference listed drug/reference standard(RLD/RS) preparation filing was successfully retrieved and preliminarily determined. CONCLUSION The established retrieval approach of the original drugs information for generic drugs is rapid and feasible, and aiming to provide reference for the selection of RS, and provide help for the follow-up study of original research information of generic drugs to be conducted.

关键词

仿制药质量和疗效一致性评价 / 参比制剂 / 原研药品信息

Key words

quality and efficacy consistency evaluation of generic drug / RLD/RS / original drug information

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朱凤昌, 王晓婧, 王爱国, 张华吉, 江翊国, 曹秀萍, 杨春宁, 郭双, 王磊, 丁丽霞. 仿制药一致性评价快速检索原研药品信息方法探讨[J]. 中国药学杂志, 2021, 56(16): 1342-1347 https://doi.org/10.11669/cpj.2021.16.012
ZHU Feng-chang, WANG Xiao-jing, WANG Ai-guo, ZHANG Hua-ji, JIANG Yi-guo, CAO Xiu-ping, YANG Chun-ning, GUO Shuang, WANG Lei, DING Li-xia. Rapid Retrieval Approach of Original Drugs Information for Generic Drugs[J]. Chinese Pharmaceutical Journal, 2021, 56(16): 1342-1347 https://doi.org/10.11669/cpj.2021.16.012
中图分类号： R95   

参考文献

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