中药天然药物局部刺激性与溶血性研究技术指导.docVIP

【 Z 】 G P T 4 - 1 指导原则编号: 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