关于经典名方研发中处方制剂要求的困惑与建议
Confusion and Suggestions on Prescription Conditions in Research and Development of TCM Classical Prescription
-
摘要: 《古代经典名方中药复方制剂简化注册审批管理规定》第三条关于处方制剂7个条件均存在不合理或操作困难的问题,给研发工作带来诸多困惑,建议尽早进行修订,以符合经典名方本身的规律、内涵与需求。Abstract: The seven conditions for prescription preparation on Administrative Regulations of Simplifying Registration and Approval of Ancient TCM Classical Prescriptions of Traditional Chinese Medicine Compound Preparations are unreasonable or difficult to operate,which brings a lot of confusion to the research and development work. It is suggested to revise it as soon as possible, in order to conform to the laws,connotation and needs of TCM classical prescriptions.
-
Key words:
- TCM classical prescriptions /
- administrative regulations /
- proposal
-
[1] 国家中医药管理局.关于发布《古代经典名方目录(第一批)》的通知[EB/OL].(2018-04-16)[2019-05-20].http://kjs.satcm.gov.cn/zhengcewenjian/2018-04-16/7107.html. [2] 国家药品监督管理局.《古代经典名方中药复方制剂简化注册审批管理规定》[EB/OL].(2018-06-01)[2019-05-20].http://www.nmpa.gov.cn/WS04/CL2138/228247.html. [3] 国家药典委员会.中华人民共和国药典:一部[M].北京:中国医药科技出版社,2015:119. [4] 古代经典名方中药复方制剂及其物质基准的申报资料要求公开征求意见[EB/OL].(2019-03-19)[2019-05-20].http://www.satcm.gov.cn/xinxifabu/shizhengyaowen/2019-03-29/9433.html.
点击查看大图
计量
- 文章访问数: 852
- HTML全文浏览量: 32
- PDF下载量: 628
- 被引次数: 0