摘要
目的:探讨我国现代化中药新药新制剂研制的创新思路与设计方法。方法:依据《药品管理法》、《药品注册管理办法》(试行)和《医疗机构制剂注册管理办法》(试行)的规定,应用中医药的基本理论,对规范研制中药新药新制剂的途径和方法进行了探讨。结果:找出了规范设计和创新研制中药新药新制剂的四项要素。结论:对开发药厂的中药新药和研制医院中药新制剂具有较好的指导作用。
Objective : Inquiry into the new creative way of thinking for research to manufacture of medicine of the our country modernization Chinese herbal medicine and design method. Methods: Basis 《the drugs management method 》《the drugs register to manage the way 》( try the line) and 《the medical treatment organization product registers to manage the way 》( try the line) of provision, the basic theories of the application Chinese medicine medicine, carried on the study to path and methods of the new medicine a research of Chinese herbal medicine. Results : Finding out the norm design researches to manufacture the new medicine seven main factors of the new - made of Chinese herbal medicine. Conclusion: The folio delivers the Chinese herbal medicine of the pharmaceutical factory new medicine and research to manufacture the new - made of the hospital Chinese herbal medicine has to compare good of leading function.
出处
《中医药学刊》
2006年第3期424-426,共3页
Study Journal of Traditional Chinese Medicine
关键词
开发创新
现代中药
新药
新制剂
设计原则
:develop the innovation
modem Chinese herbal medicine
new medicine
new product
design the principle