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指导原则编号: 【 Z 】 G C L 1 - 1
中药、天然药物申请临床研究的医学
理论及文献资料撰写原则
二〇〇五年三月
目
录
一、概述. ··················································································································································1
二、撰写的基本要. ····························································································································1
(一)处方组成,功能、主治病证(适应症)·······························································2
(二)立题目的·····································································································································2
(三)立题依据·····································································································································2
1、处方来源·············································································································································2
2、对主治病证病因病机、治法与处方的论述···································································2
3、文献综述 ···········································································································································3
(四)对申报品种创新性、可行性分析················································································3
1、国内外相关品种研究、生产、使用现状的分析························································3
2、和已有国家标准的同类品种的比较··················································································3
3、可行性分析 ····································································································································3
三、参考文献·········································································································································4
四、著者 ···································································································
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