中药、天然药物免疫毒性（过敏性、光变态反应）.doc

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指导原则编号:
中药、天然药物免疫毒性(过敏性、光过敏反应)
研究的技术指导原则
二○○五年三月
目录
一、概述·····················································································································································1
二、基本内容·········································································································································2
(一)基本原则····························································································································2
(二)过敏反应试验··················································································································3
1、试验中应考虑的问题······································································································3
2、I型过敏反应试验·············································································································4
3、II、Ⅲ型过敏反应试验··································································································6
4、Ⅳ型过敏反应试验···········································································································6
(三)光过敏反应试验············································································································6
(四)结果分析及评价············································································································7
(五)常见问题及处理············································································································8
(六)不同剂型的中药、天然药物试验项目的选择············································10
三、参考文献·······································································································································10
四、附录··················································································································································11
(一)主动皮肤过敏试验···································································································11
(二)主动全身过敏试验····