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作 者:顾进华[1,2] 刘自扬 苏富琴[1] 龚旭昊[1,2] 王学伟[1] 李慧杰 GU Jin-hua;LIU Zi-yang;SU Fu-qin;GONG Xu-hao;WANG Xue-wei;LI Hui-jie(China Institute of Veterinary Drug Control(Center for Veterinary Drug Evaluation of the Ministry of Agriculture and Rural affairs),Beijing,100081,China;Key Biology Laboratory of Chinese Veterinary Medicine,Ministry of Agriculture and Rural Affairs,P.R.China,Beijing,100081,China)
机构地区:[1]中国兽医药品监察所(农业农村部兽药评审中心),北京100081 [2]农业农村部中兽医生物学重点实验室,北京100081
出 处:《中国兽药杂志》2022年第12期62-68,共7页Chinese Journal of Veterinary Drug
基 金:“十四五”国家重点研发计划项目“中兽药有效性、安全性评价策略及关键技术研究”课题,课题编号:2022YFD1801105。
摘 要:通过深入研究兽用中药特点及近年来人用及兽用中药审批情况,提出兽用中药药学评价“以临床价值为导向”的理念,遵循中兽医药理论指导,探索制定兽用中药药学相关研究指导原则,准确把握兽用中药处方工艺和质量可控等药学研究/评价方法和要点,开展全过程质量控制和兽用中药整体质量评价。By further study on the characteristics of Veterinary Chinese Medicine and registration approval of Chinese medicine for human and veterinary use in recent years, it is proposed that the evaluation of Veterinary Chinese Medicine should adhere to the idea of "clinical value orientation", following the theoretical guidance of Chinese Veterinary Medicine, to investigate and establish the pharmaceutical guidelines on Veterinary Chinese Medicine, exactly grasp the pharmaceutical research/evaluation methods and key points such as the processing technology and quality control of Veterinary Chinese Medicine, and carry out the whole process quality control and the overall quality evaluation of Veterinary Chinese Medicine.
分 类 号:S851.66[农业科学—预防兽医学]
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