摘要
中药创新研究的基础问题包括 :建立新型中药临床使用标准、规范和加强新中药制剂质量和质量控制研究、规范和完善新中药药效学实验及临床评价方案 ,加强新中药知识产权保护研究、加强新型中药管理规范与研究等几个方面。目前在新型中药临床运用规范、质量控制、临床与药效学评价、知识产权保护、管理等方面都存在不足 ,是需要加强和研究的重要基础工作。
The fundamental questions in the study on innovated Chinese medicinal materials(CMM) include: setting up appropriate criteria and standards for clinical use of innovated CMM; reinforcing the study on quality and quality control of innovated CMM preparations;standardizing and improving the pharmacodynamic experiment and clinical evaluation for innovated CMM;strengthening the study on protection of intellectual rights for innovated CMM;improving the criteria of management for innovated CMM. At present,more attention and greater effort should be directed at questions such as standardization of clinical use of innovated CMM;quality control; evaluation of clinical and pharmacodynamic effects,protection of intellectual rights,management,etc.
关键词
中医
医效学
创新研究
新药研究
知识产权保护
CMM, study on innovated CMM, clinical evaluation, pharmacodynamics, intellectual rights, pharmaceutical control
