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目的:观察不同粒径的超微参附汤对小鼠灌胃给药的急性毒性反应,评价其安全性,为临床研究提供依据。方法:以不同粒径的超微参附汤最大浓度、最大体积进行小鼠灌胃,测定其1日最大给药量。结果:超微参附汤小鼠1日最大给药量-800目为8.352g、-400目为8.472g、-200目为8.664g、传统饮片为10.248g,分别相当于成人临床日用量的167倍、169倍、173倍、102倍,未见由药物引起的毒性反应。结论:超微参附汤及传统饮片参附汤均安全。
OBJECTIVE: To observe the acute toxicity of ultra-micro-shen-shen decoction with different particle sizes on mice by intragastric administration and to evaluate its safety, so as to provide basis for clinical research. METHODS: Mice were intragastrically administered with the maximum and maximum volume of ultra-micro-shenfu soup with different particle sizes, and the maximum daily dose was determined. RESULTS: The maximum daily dose of the Super-micro-Shenyi Decoction mice was 8.352g at the -800-mesh, -8.472g at the -400-mesh, 8.664g at the-200-mesh, and 10.248g at the traditional decoction pieces. These were equivalent to those for the adult clinical daily dose. 167-fold, 169-fold, 173-fold, and 102-fold, no drug-induced toxicity. Conclusion: Super-micro-Shenfu Decoction and traditional decoction pieces Shenfu decoction are safe.