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阐述了中药二类新药目前研究和申报资料中存在的一些问题。认为研制单位对有效部位及有效部位群的确立依据仍缺乏足够重视 ,及在有效部位含量测定中忽视“科学、合理、先进”的指导原则等问题。提出了解决方法 :应以相关的文献资料为依据 ,坚持中医理论 ,借鉴西药开发模式和做必要的比较实验等方法为有效成分的确定提供依据 ;以强化中药创新意识 ,重视相应配套制剂研究 ,对含量控制以外的成分作物质类型的分析研究和建立其中某一相对量多的单体成分的测定等方法来提高质量标准。
Explained some problems in the current research and application data of new drugs of Chinese medicine. It is believed that the development unit still lacks sufficient emphasis on the establishment of effective sites and effective site groups, and ignores the “scientific, reasonable, and advanced” guidelines in determining the content of effective sites. Proposing a solution: It should be based on relevant literature, adhere to the theory of traditional Chinese medicine, learn from Western medicine development models and make necessary comparison experiments to provide basis for the determination of effective ingredients; to strengthen awareness of traditional Chinese medicine innovation, pay attention to the corresponding preparations research, Analytical studies on the components other than content control are carried out, and the determination of a relatively large amount of monomer components is established to improve the quality standards.