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g审审2407审审4口腔喷雾剂的研究-study on g trial 2407 trial 4 oral spray.docx

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g审审2407审审4口腔喷雾剂的研究-study on g trial 2407 trial 4 oral spray

4. pH 调节剂的稳定性考察 204.1 G-2407-4 在 pH6-10 缓冲液中的稳定性 204.2 不同浓度 G-2407-4 在 A 溶液中的稳定性考察 204.3 G-2407-4 经 A 溶液调节 pH 值后的稳定性考察 215. 防腐剂的筛选·····························································215.1 专属性考察······························································225.2 防腐剂在 pH4-9 缓冲液中的稳定性 235.3 处方的稳定性研究························································245.3.1 低温（-18℃）条件下处方的稳定性考察····································245.3.2 高温（60℃）条件下处方的稳定性考察······································246．处方的的确定······························································257. 制备工艺的确定···························································25三、结论·····································································26四、讨论·····································································26 第三章 G-2407-4 口腔喷雾剂局部刺激性研究····································27 一、仪器与试药······························································27 1. 实验仪器·································································272. 实验材料·································································273. 实验动物·································································27二、方法与结果·······························································271. 溶液的配制·······························································271.1 阴性对照液的配制························································271.2 阳性对照液的配制························································271.3 供试液的配制····························································272. 实验分组·································································273. 实验方法·································································284. 实验结果·································································28三、结论·····································································29四、讨论·····································································29 第四章 G-2407-4 口腔喷雾剂的质量控制研究·····································30 一、仪器与试药·····································