芪术胃安颗粒的毒理学实验

Study on the Toxic Effect of Qizhuwei'an Granules

目的:观察动物口服芪术胃安颗粒的急性毒性和长期毒性。方法:按临床剂量的370倍或1110倍测定1次或1d最大给药量。以高、中、低三个剂量的芪术胃安颗粒提取物,连续给大鼠灌胃60d,观察给药60d时的大鼠体征、血液学、肝、肾功能、脏器系数、组织病理学变化及停药2周后上述指标的变化。结果:1次/d或3次/d总剂量分别30g/kg和90g/kg(相当于生药238g/kg和715g/kg),此剂量相当于临床成人(体重按70kg计)剂量的370倍和1110倍。长期毒性实验中,按公斤体重计算相当临床的46.3～185倍的剂量均无明显毒性反应。结论:芪术胃安颗粒规定剂量下服用安全可靠。

Objective:To study both the acute and chronic toxic effects of Qizhuwei'an Granules. Methods:The maximal dose per time or per day was determined with the dose 370 times or 1110 times as much as the clinical dose. There were 3 groups of large, middle, small dose of the Qizhuwei'an Granules. After continuously feeding rats orally for 60 days, we observed the rats' apperance, behavior, blood, organ coefficient, and pathologic changes of liver and kidney. The above physiological signs were inspected again 2 weeks after cease of feeding.Results:The dosage of 30 g/kg according with 238 g/kg crude materials and 90 g/kg according with 715 g/kg were respectively 370 and 1110 times as much as the clinical dosage to adults(presumed weight 70 kg). The experiment of chronic toxicity showed that the dosage ranged 46.3～185 times as much as the clinical dosage led to no remarkable toxic effect.Conclusion:Qizhuwei'an Granules is absolutely safe under the priscribed dosage.