中药注射剂原料中药材实施GAP现状及展望  

Current status and prospects of implementing GAP in Chinese medicine injection materials

作　　者：张文晋 曹也 张燕[1] 葛阳 王升[1] 康传志 万修福 许海玉[2,3] 郭兰萍 ZHANG Wen-jin;CAO Ye;ZHANG Yan;GE Yang;WANG Sheng;KANG Chuan-zhi;WAN Xiu-fu;XU Hai-yu;GUO Lan-ping(State Key Laboratory Breeding Base of Dao-di Herbs,National Resource Center for Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Center for Traditional Chinese Medicine Supervision and Scientific Research,National Medical Products Administration,Beijing 100700,China;School of Pharmacy,Anhui University of Chinese Medicine,Hefei 230012,China)

机构地区：[1]中国中医科学院中药资源中心道地药材国家重点实验室培育基地,北京100700 [2]中国中医科学院中药研究所,北京100700 [3]国家药品监督管理局中药监管科学研究中心,北京100700 [4]安徽中医药大学药学院,安徽合肥230012

出　　处：《中国中药杂志》2021年第20期5166-5172,共7页China Journal of Chinese Materia Medica

基　　金：国家食品药品监督管理总局政策研究项目;国家重点研发计划项目(2017YFC1700701,2018YFD0201100);现代农业产业技术体系建设专项(CARS-21)。

摘　　要：注射剂作为对品质要求最高的剂型之一,其对于产品质量的一致性与可控性比其他中药产品要求更高,实施GAP是保障原料中药材质量稳定、影响中药注射剂质量的重要因素。该文通过文献分析、数据调研,结合专家咨询和统计分析等方法,分析了全国中药注射剂重点品种GAP管理现状及原料药材实施GAP管理对中药注射剂质量一致性和可控性的影响,论证了在中药注射剂安全性再评价的基础上全面实施GAP的合理性、必要性及可行性。Chinese medicine injections(CMIs)have higher requirements for quality consistency and controllability than other traditional Chinese medicine products.The implementation of Good Agricultural Practice of Medicinal Plants and Animals(GAP)is an important factor that guarantees the quality stability of raw Chinese medicinal materials and affects the quality of CMIs.Through literature review,data research,expert consultation,and statistical analysis,this paper analyzes the current status of GAP management of key CMIs and the impact of GAP management of raw medicinal materials on the quality consistency and controllability of CMIs.Furthermore,it demonstrates the rationality,necessity,and feasibility of the full implementation of GAP on the basis of CMIs safety re-evaluation.

关 键 词：中药注射剂 GAP 原料药材 

分 类 号：R288[医药卫生—中药学]