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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240 g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299.50 g/kg,95%可信限为239.02~340.76 g/kg;对雄性小鼠的LD50为387.49 g/kg,95%可信限为331.73~480.27 g/kg。对大鼠的最大耐受剂量>240 g/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 determine the acute toxicity of Qishen Jiangu granules and to evaluate its safety. Methods: SPF grade ICR mice were divided into male and female mice by intragastric administration of different doses of Astragalus membranaceus. The toxicity of mice was observed and the half-lethal dose (LD50) was calculated by Bliss method ). To 240 g crude drug / kg dose gavage given Astragalus Jujube in the flow test extract liquid, observe the toxicity, measured the maximum tolerated dose (MTD). Results: The LD50 of Qi-Qiang Jiangu Granule to female mice was 299.50 g / kg and the 95% confidence limit was 239.02 ~ 340.76 g / kg. The LD50 of male mice was 387.49 g / kg, with a 95% confidence limit of 331.73 ~ 480.27 g / kg. The maximum tolerated dose to rats> 240 g / raw kg. Conclusion: Qishenjiangyu granule is more than 50 times more than the dose of clinical medicine.