中药天然药物研究技术指导原则

指导原则编号： [Z]GPH 2 - 1

中药、天然药物提取纯化工艺研究技术指导原则

（第二稿）

二00四年三月十八日

目 录

【概述】………………………………………………………………………2

【基本内容】…………………………………………………………………3

一、工艺路线…………………………………………………………………3

（一）提取纯化工艺…………………………………………………………4

（二）浓缩与干燥工艺………………………………………………………4

二、工艺条件…………………………………………………………………4

（一）提取与纯化工艺条件的优化…………………………………………4

（二）浓缩与干燥工艺条件的优化…………………………………………5

三、评价指标…………………………………………………………………5

（一）提取纯化工艺评价指标………………………………………………5

（二）浓缩与干燥工艺评价指标……………………………………………6

四、实验设计方法……………………………………………………………7

【起草说明】…………………………………………………………………8

【著者】………………………………………………………………………9

1中药、天然药物提取纯化工艺研究的技术指导原则

【概述】

中药、天然药物成分复杂。一般地，为提高疗效、减小剂量、便于制

剂，药材需要经过提取、纯化处理。提取、纯化是中药、天然药物制剂特

有的工艺步骤，提取、纯化技术的合理、正确运用与否直接关系到药材资

源能否充分利用, 制剂疗效能否充分发挥。

在提取、纯化及其后续的制剂过程中，常需通过浓缩、干燥等工艺过

程，以达到作为制剂原料或半成品的要求，因此, 浓缩与干燥工艺仍是本

技术指导原则研究的范畴之一。

由于中药、天然药物成分复杂，作用多样，工艺方法与技术繁多，以

及新方法与新技术的不断涌现，不同的方法与技术所应考虑的重点，需

进行研究的难点，要确定的技术参数，均有可能不同。因此，应遵循药

【Z】G P H 1 - 1指导原则编号：

中药、天然药物原料的前处理技术指导原则

二ΟΟ五年三月 目 录

一、概述·······························································································································1

二、基本内容······················································································································1

（一）鉴定与检验·····································································································1 （二）炮制与加工·····································································································2 1、净制························································································································2 2、切制························································································································2 3、炮炙························································································································2 4、粉碎······················································································································· 3 三、参考文献······················································································································3 四、著者······························································································································ 3

5个技术指导原则

兽用中药、天然药物临床试验技术指导原则 ..................................................................... 3

一、概述................................................................................................................... 3

二、兽用中药、天然药物临床试验的基本内容........................................................... 3

(一)靶动物安全性试验 ........................................................................................ 3

(二)实验性临床试验 ........................................................................................... 3

(三)扩大临床试验 ............................................................................................... 3

三、兽用中药、天然药物临床试验的共性要求........................................................... 4

(一)以中兽医学理论为指导 ................................................................................. 4

(二)试验设计原则 ............................................................................................... 4

中药天然药物临床研究资料综述撰写格式和要求技术指导原则

（一）综述撰写框架

1.概述对中药、天然药物临床研究资料进行综述，着重介绍临床研究方法、研究结果、临床应用、潜在的风险，评价其临床疗效和安全性等。

2.评价标准评价标准包括：（1）研究质量评价临床研究资料的研究质量，包括研究设计、随机性、抽样、对照、报告格式；（2）临床结果评价临床结果，包括安全性、疗效和有效性等；（3）临床应用介绍临床研究支持的中药、天然药物的临床用法。

3.结论根据临床研究资料，总结出中药、天然药物的临床应用和疗效，评价其安全性及潜在风险，并给出相关评价建议。

（二）撰写要求

1.科学性按照临床和科研指南，科学系统地梳理中药、天然药物的临床资料，对其临床疗效和安全性进行科学评价，以便于能够客观评价中药、天然药物的疗效和安全性。

2.可靠性尽可能收集有代表性和可靠的临床资料，并评价其研究质量。

3.权威性尽可能引用国内外最新、最权威的文献，引用的文献应与本综述的内容相关，且反映最先进的科学研究成果。

4.可读性整体行文应清楚，可读性高，尽量改善文献收集中出现的歧义和重复。