中药、天然药物局部刺激性和溶血性研究技术指导.doc

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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
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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············································································································
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(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························································································