芪参健骨颗粒的急性毒性研究

Report of Acute Toxicity Test of Qishen Jiangu Granules

目的：明确芪参健骨颗粒的急性毒性，对其进行安全性评价。方法：SPF级ICR小鼠，雌雄各半，以不同的剂量灌胃给予小鼠芪参健骨中试流浸膏药液，观察小鼠的毒性反应，采用Bliss法计算半数致死量值（LD50值）。以240g生药／kg剂量灌胃给予大鼠芪参健骨中试流浸膏药液，观察其毒性反应情况，测定最大耐受量（MTD）。结果：以芪参健骨颗粒生药量计，芪参健骨颗粒对雌性小鼠的LD50为299．50g/kg，95％可信限为239．02—340．76g／kg；对雄性小鼠的LD50为387．49g／kg，95％可信限为331．73～480．27g／kg。对大鼠的最大耐受剂量〉240g／生药kg。结论：芪参健骨颗粒在拟订临床用药剂量的50倍以上是安全的。

Objective ： To clear the acute toxicity of the Qishen Jiangu Granules and safety evaluation. Methods ： SPF ICR mice, male and female mice were evenly divided to observe the toxicity of mice which were given different dose of Qishen Jiangu liquid extract and calculate the value of the median lethal dose （ LD50 ） with Bliss method. The toxicity of the rat was observed and the maximal tolerance dose（MTD） was calculated by intragastric administration of Qishen Jiangu liquid extract with the dose 240 g/kg. Results ： Calculated by crude drug of Qishen Jiangu Granules, LD50 of female mice was 299.50 g/kg and 95% confidence limit was 239.02 -340.76 g/kg. For male mice, LD50 was 299.50 g/kg, and 95% confidence limit was 331.73 -480.27 g/kg. MTD of rat was larger than 240 g/kg. Conclusion：The result showed that Qishen liangu Granules is safe when the dose is 50 times larger than the draft clinical dosage.