黄芪桂枝五物汤对小鼠的急性毒性研究

目的 采用最大给药量的方法观察黄芪桂枝五物汤（浸膏）1日内ig给予受试动物后所产生的急性毒性反应，为多次重复给药毒性试验的剂量、可能作用的靶器官和毒性反应等指标的设计及临床剂量设计与观察提供参考依据。方法 以受试物最大允许质量浓度（0.6 g/mL）、小鼠最大给药容积（40 mL/kg）1日内ig给药2次，连续观察14 d内有无毒性反应及动物死亡。结果 测得黄芪桂枝五物汤（浸膏）最大给药量为48 g/kg（为临床用量的218倍）。在此剂量下未见明显毒性反应，14 d内动物无一死亡，大体解剖未见对脏器的毒性改变。结论 在本实验条件下，黄芪桂枝五物汤（浸膏）小鼠ig给药的最大剂量为48 g/kg，未见该剂量对小鼠产生明显的急性毒性。

Acute toxicity of Huangqi Guizhi Wuwu Decoction in mice

Objective Using the method with maximum amount of administration to observe the acute toxic reaction of Huangqi Guizhi Wuwu Decoction (extract) after the test animals were ig administered in one day, and to provide the reference for designing the index such as dosage of toxic test for repeated dosing, possibly functional target organ, and toxic reaction, as well as design and observation of clinical dosage. Methods Following the criterion of maximum acceptable concentration of test materials (0.6 g/mL) and maximum administration volume of mice (40 mL/kg), the mice were administrated twice per day, and there was no toxic reaction and none of the animals died during the next 14 d. Results Measured maximal dosage of Huangqi Guizhi Wuwu Decoction (extract) was 48 g/kg (218 times dosage more than that of clinical dosage). In this dose, there was no significant toxic reaction, and none of the animals died during 14 d and visceral organ had no changes by gross anatomy. Conclusion In the situation of this experiment, the optimized dosage of Huangqi Guizhi Wuwu Decoction is 48 g/kg to the mice, and the dosage could not produce the obvious acute toxic reaction.