中药天然药物中试研究技术指导原则

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

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】

【基本内容】

一、工艺路线

（一）提取纯化工艺

（二）浓缩与干燥工艺

二、工艺条件

（一）提取与纯化工艺条件的优化

（二）浓缩与干燥工艺条件的优化

三、评价指标

（一）提取纯化工艺评价指标

（二）浓缩与干燥工艺评价指标

四、实验设计方法 【起草说明】

【著者】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，应遵循药品研究的一般规律，注重对其个性特征的研究，尊重传统组方、用药理论与经验，通过研究揭示其本质，以评价其工艺选择及其作为药品对于具体适应症的治疗的利弊。应根据药物的具体情况，结合生产实际进行必要的研究，以明确具体工艺参数，做到工艺科学、合理、稳定、可行，以保证产品安全有效，质量稳定。 本指导原则就中药、天然药物的提取、纯化及浓缩、干燥工艺研究过程中，方法、工艺路线的确定，工艺条件的优选，实验设计方法、评价指标的建立等进行了讨论。

【基本内容】

一、工艺路线

中药、天然药物提取纯化的工艺路线是以保证中药、天然药物的安全、有效为目的，根据中医临床用药及组方特点，以及制剂成型要求所制定的工艺、方法、条件和程序的最基本的规定，直接影响药物的安全、有效性，决定着制剂质量的优劣，也关系到大生产的可行性和经济效益。因此，工艺路线是中药、天然药物工艺科学性、合理性和可行性的基础和核心。工艺路线的设计应以使中药、天然药物的生产工艺具有科学性、先进性及生产的可行性为原则。

指导原则编号: 【Z】GP T 4 - 1 中药、天然药物刺激性和溶血性研究的

技术指导原则

二○○五年三月

1目 录

一、概述····················································································································································1 二、基本内容·········································································································································2 （一）基本原则····························································································································2 （二）刺激性试验·······················································································································3 （三）光毒性试验·······················································································································4 （四）溶血性试验······················································································································5 （五）结果分析及评价············································································································6 （六）常见问题及处理············································································································7 （七）不同剂型的中药、天然药物试验项目的选择············································9 三、参考文献·······································································································································10 四、附录··················································································································································11 （一）刺激性试验方法·········································································································11 1、血管刺激性试验···············································································································11 2、肌肉刺激性试验···············································································································12 3、皮肤刺激性试验···············································································································12 4、粘膜刺激性试验···············································································································15 （二）光毒性试验方法·········································································································20 （三）溶血性试验方法·········································································································22 1、常规体外试管法（肉眼观察法）·········································································22 2、改进的体外溶血性试验法（分光光度法）·····················································24 3、体外红细胞计数法··········································································································25 4、体内溶血试验法（红细胞计数法）····································································25 五、著者·················································································································································25

指导原则编号： 【Z】G P T 1 -1

中药、天然药物一般药理学研究技术指导原则

（第二稿）

二OO四年三月十八日 目 录

一、概述 …………………………………………………………1

二、一般药理学研究的基本原则……………………………………2

（一）试验管理……………………………………………………2

（二）试验设计……………………………………………………2

三、一般药理学研究的基本内容……………………………………2

（一）受试物……………………………………………………2

（二）试验系统……………………………………………………2

（三）样本数和对照……………………………………………………3

（四）给药途径…………………………………………………3

（五）剂量或浓度………………………………………………………3

（六）给药次数和测量时间……………………………………………4

（七）观察指标…………………………………………………………4

（八）结果及分析……………………………………………………6

四、不同情况的一般药理学研究的一般要求……………………6

五、名词解释………………………………………………………7

六、参考文献…………………………………………………………7

七、起草说明 …………………………………………………………8

八、著者 …………………………………………………………10

中药、天然药物一般药理研究技术指导原则

一、概述

药理学研究分为三类，即主要药效学（Primary

Pharmacodynamic）、次要药效学（Secondary Pharmacodynamic）和

安全性药理学（Safety Pharmacology）。另外根据实验要求可能需

要对安全性药理学进行追加和/或补充的研究（Follow-up and

Supplemental Safety Pharmacology Studies）。一般药理学（general