pH敏感结肠宁靶向微丸的急性毒性

目的研究pH敏感结肠宁靶向微丸对小鼠的急性毒性，为该药的安全评价提供重要的基础研究资料。方法首先进行小鼠急性毒性的预实验，然后进行小鼠急性最大给药量实验。急性最大给药量实验小鼠40只随机分成试药组和空白对照组，雌雄各半，试药组灌胃，灌胃量40mL·kg-1·d-1空白组给蒸馏水，观察毒理反应。比较1d、7d和14d体重，实验结束后，称重肝脏、脾脏和肾脏，进行脏体比值比较。结果急性毒性实验过程无小鼠死亡，有被毛竖立、肢体轻微震颤、反应迟钝、饥饿感、频繁排便、视网膜苍白等症状，半数致死量无法获得。小鼠急性最大给药量实验第14d的肝脏、脾脏和肾脏的脏体比值有差异，但不显著（P〉0．05），最大给药量是78．496g·kg-1·d-1，是成人日用药量的237．9～314．0倍。结论小鼠最大给药量与成人日用量的比值大于100，提示pH敏感结肠宁靶向微丸在推荐的使用剂量范围内，具有较高的安全性；小鼠急性症状提示超量服用也有些毒副作用。

Acute Toxicity of pH-triggered Jie-chang-ning Colon-targeted Pellets

Objective To study the acute toxicity of the pH-triggered Jie-chang-ning colon-targeted pellets to mice and provide important basic data for further safety evaluation. Methods On the basis of the acute toxicity pre- experiment,the maximum daily dosage test was finished. 40 mice were randomly divided into drug-treated and con- trol groups （male：female=l：l）. The drug-treated mice were administrated orally with the pH-triggered Jie-chang-ning colon-targeted pellets with intragastric volume 40 mL ＂kg-1 ＂d-L The clinical responses were observed. The mice weight on the 1st, 7th, 14th day, was weighed and compared. The viscera index of liver, kidney and spleen was compared on the 14th day. Results The mice didn＇t die in the acute toxicity experiment, but erect hairs, slight tremor body, dull, hunger, frequent defecation and pale retina appeared. The half lethal dose（LD50） wasn＇t determined. The viscera index of hver, kidney and spleen wasn＇t significantly different between the drug-treated and the control groups. The maximum daily dosage was 78.496 g·kg-1·d-1, which was 237.9 - 314.0 times of adult people. Conclusion The maximum daily colon-targeted that side effects dosage was more than 100 times dose of adult people, which explains the pH-triggered pellets is safe within the recommended maybe appear for excessive use. dosage range. The symptoms in the mice acute Jie-chang-ning toxicity explain