补正续骨丸小鼠急性毒性实验研究

Acute Toxicity Experiment of Buzheng Xugu Pill in Mice

目的:进行补正续骨丸小鼠灌胃给药毒性实验研究。方法:由于无法测出补正续骨丸小鼠灌胃给药的半数致死量(LD50),故以补正续骨丸所能配制的最大给药浓度和小鼠所能承受的最大灌胃给药容积,进行小鼠灌胃给药的最大给药量的测定。结果:该药在所能配成的最大浓度0.46 g/m L和小鼠所能承受的最大灌胃给药容积40 m L/Kg的情况下,1日内小鼠灌胃给药2次,给药量18.40 g/kg(12.63 g生药/kg),此剂量为成人每日口服量的122.67倍(成人体质量按60 kg计)动物无死亡,观察14 d,未见明显毒性反应。动物在观察期结束后进行大体解剖,肉眼观察心、肝、脾、肺、肾等主要脏器,未见异常改变。结论:通过本次为期14 d的动物实验观察,补正续骨丸对小鼠机体无损害现象,未发生急性毒性反应,为临床用药安全提供了较可靠的依据,值得进一步观察使用。

Objective ： To carry on the acute toxicity experiments of Buzheng Xugu Pill in mice. Methods ： Because una- ble to detect the median lethal dose （ LDs0 ） of Buzheng Xugu pill, prepare the maximum concentration and the maximum delivery volume of intragastric administration which mice can withstand, determine the maximum dosage of the drug. Re- sults ： The maximum concentration of Buzheng Xugu Pill was 0.46 g/mL and the maximum delivery volume of intragastric administration which mice can withstand was 4 0 ml / kg. Give the intragastric administration twice a day with dosage of 18.40 g/kg of crude drugs （ 12.63 gCkg）. The dose was 122.67 times for adults daily dosage （adult weight by 60 kg）. Animals were without death. The observation lasted for 14 days, with no obvious toxic effects. Animals at the end of the observation period showed gross anatomy and the macroscopic observation showed heart, liver, spleen, lung, kidney and other major organs with no abnormal changes. Conclusion：By the 14 -day animal experimental observation, Buzheng Xu- gu Pill has no harm to animals and acute toxicity reaction, providing the reliable basis for clinical medication safety. It is worthy of further clinical observation.