中国中药杂志

2021, v.46(20) 5166-5172

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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

张文晋;曹也;张燕;葛阳;王升;康传志;万修福;许海玉;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;School of Pharmacy, Anhui University of Chinese Medicine;Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences;Center for Traditional Chinese Medicine Supervision and Scientific Research, National Medical Products Administration;

摘要(Abstract):

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(KeyWords): 中药注射剂;GAP;原料药材
Chinese medicine injections;GAP;raw medicinal materials

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基金项目(Foundation): 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)

作者(Author): 张文晋;曹也;张燕;葛阳;王升;康传志;万修福;许海玉;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;School of Pharmacy, Anhui University of Chinese Medicine;Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences;Center for Traditional Chinese Medicine Supervision and Scientific Research, National Medical Products Administration;

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