中药注射剂种类及其处方饮片的原料药材统计分析  

Statistical Analysis of Types and Original Materials of Traditional Chinese Medicine Injections

作　　者：郝利军 梁爱华[2] 宋经元[1,3] HAO Li-jun;LIANG Ai-hua;SONG Jing-yuan(Key Lab of Chinese Medicine Resources Conservation,State Administration of Traditional Chinese Medicine of the People's Republic of China,Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100193,China;Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Engineering Research Center of Chinese Medicine Resource,Ministry of Education,Beijing 100193,China)

机构地区：[1]中国医学科学院北京协和医学院药用植物研究所/国家中医药管理局中药资源保护重点研究室,北京100193 [2]中国中医科学院中药研究所/中药鉴定与安全性检测评估北京市重点实验室,北京100700 [3]中药资源教育部工程研究中心,北京100193

出　　处：《中国现代中药》2020年第3期322-331,共10页Modern Chinese Medicine

基　　金：国家自然科学基金(81874339)。

摘　　要：目的:统计分析中药注射剂种类及其处方饮片的原料药材,为中药注射剂上市后再评价及原料药材生产提供参考。方法:从国家药品监督管理局网站获取已上市中药注射剂数据,从国家食品药品监督管理局南方医药经济研究所米内网数据库中获取2017年中国城市公立医院13个畅销中药注射剂数据,从2015版《中华人民共和国药典》(以下简称《中国药典》)获取其收录中药注射剂数据,统计分析其种类、成分、功能主治、给药方式和处方饮片的原料药材。结果:当前已上市中药注射剂共134种,涉及处方饮片的原料药材158种,药材数量以1味和2味居多,部分药材2015版《中国药典》未收录,少数药材历版《中国药典》均未收录;功能主治方面用于治疗心脑血管疾病的中药注射剂种类最多,同时销售额前三的中药注射剂也都用于治疗心脑血管疾病。结论:中药注射剂种类繁多,绝大部分中药注射剂处方饮片的原料药材数量较少,成分相对简单,但原料药材来源复杂,药材数量与给药方式间并无明显关系,部分药材标准无法满足中药注射剂安全性需求,有待完善;用于治疗心脑血管疾病的中药注射剂种类和销售额均为最多,主要原料药材丹参和红花等需要重点关注。Objective:To get information about the types and the original materials related to decoction of traditional Chinese medicine injections,which will benefit for their post-marketing reevaluation and the production of original materials.Methods:The data of traditional Chinese medicine injections were obtained from the website of the National Medical Products Administration,the menet database of the NMPA Southern Medicine Economic Research Institute and the 2015 edition of Chinese Pharmacopoeia,respectively.The types,ingredients,functions,administrations and original materials related to decoction of traditional Chinese medicine injections were statistically analyzed.Results:There are 134 kinds of traditional Chinese medicine injections,involving 158 kinds of original materials related to decoction.The number of materials of is mostly 1 or 2.Some materials are not included in the 2015 edition of Chinese Pharmacopoeia,and a few materials are even not included in all pharmacopoeias.In terms of function,a lot of traditional Chinese medicine injections are used to treat cardiovascular and cerebrovascular diseases.Meanwhile,the top three traditional Chinese medicine injections in sales volume are also used to treat cardiovascular and cerebrovascular diseases.Conclusion:There are many kinds of traditional Chinese medicine injections,most of the traditional Chinese medicine injections have few materials and relatively simple ingredients.However,the original materials related to decoction are complex.There is no obvious relationship between the number of materials and the administrations.Some material standards can't meet the safety requirements of traditional Chinese medicine injections,which need to be improved in the future.The most types and the highest sales of traditional Chinese medicine injections contributed to treating cardiovascular and cerebrovascular diseases.Therefore,some important original materials,such as Salvia miltiorrhiza and Carthamus tinctorius,should be focused on.

关 键 词：中药注射剂 种类 功能主治 给药方式 原料药材 

分 类 号：R282[医药卫生—中药学] R944[医药卫生—中医学]