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珊瑚七十味丸经口给予小鼠和大鼠的急性毒性研究OA

Acute toxicity of Shanhu Qishiwei Pills in mice and rats by oral administration

中文摘要英文摘要

目的:研究珊瑚七十味丸的急性毒性,为其长期毒性试验的剂量设计和临床安全用药提供参考.方法:珊瑚七十味丸三个最大给药量组的小鼠和大鼠在24 h内分别灌胃1次、2次、3次珊瑚七十味丸药液,每次间隔8h;小鼠每次按40 mL·kg-1给予浓度为0.2 g·mL-1的珊瑚七十味丸药液,大鼠每次按20 mL·kg-1给予浓度为0.25 g·mL-1的珊瑚七十味丸药液;随后观察动物在14 d内出现的毒性反应.结果:观察期内未出现动物死亡.珊瑚七十味丸对大鼠的体重虽有影响,但均能恢复;可导致动物(尤其是雌性)的饲料消耗量减少.珊瑚七十味丸在最大给药量下可对实验动物血液学及血液生化学指标产生影响.主要表现为总蛋白浓度(TP)升高、血糖(Glu)和平均红细胞血红蛋白浓度(MCHC)降低的趋势,并观察到丙氨酸氨基转移酶(ALT)和总胆红素(TBIL)等肝相关指标的变化.值得注意的是,这些变化的具体方向及程度表现出一定的种属和性别差异性.结论:珊瑚七十味丸经口给予小鼠和大鼠的最大给药剂量分别为24 g·kg-1和15 g·kg-1,分别相当于临床成人日用剂量的1 440倍和900倍,故安全范围较大.但珊瑚七十味丸对小鼠和大鼠的体重、饲料消耗量、血液学和血液生化学等指标均有一定的影响,故在临床应用中应注意监测.

Objective:To study the acute toxicity of Shanhu Qishiwei Pills,and to provide reference for the dose design of long-term toxicity test and clinical safe medication.Methods:Mice and rats in the three groups with the maximum dosages of Shanhu Qishiwei Pills were administered the medicinal solution of Shanhu Qishiwei Pills via gavage once,twice,and three times respectively within 24 hours,with an 8-hour interval between each administration.Mice were given the medicinal solution of Shanhu Qishiwei Pills at a concentration of 0.2 g·mL-1 at a dose of 40 mL·kg-1 each time,while rats were administered the medicinal solution at a concentration of 0.25 g·mL-1 at a dose of 20 mL·kg-1 each time.Subsequently,the animals were observed for toxic reactions over a 14-day period.Results:No animal death occurred during the observation period.Although Shanhu Qishiwei Pills exert an influence on the body weight of rats,the affected rats can all recover their original weight.Shanhu Qishiwei Pills might have effects on the hematological and biochemical indicators of experimental animals at the maximum administered dose.The main manifestations included an increase in total protein concentration(TP),a decrease in blood glucose(Glu)and mean corpuscular hemoglobin concentration(MCHC),as well as changes in liver-related indicators such as alanine aminotransferase(ALT)and total bilirubin(TBIL).It was noteworthy that the specific direction and extent of these changes exhibited certain species and gender differences.Female rats exhibited increased RBC,TBIL,and TP levels.Male rats showed decreased MCHC levels but increased LymPh and Glu levels.Conclusion:The maximum oral administration doses of Shanhu Qishiwei Pills to mice and rats by oral administration are 24 g·kg-1 and 15 g·kg-1,respectively,which are 1 440 times and 900 times of the daily dose for clinical adults.Therefore,the safety range is relatively wide.However,Shanhu Qishiwei Pills have certain effects on the body weight,feed consumption,hematology.Therefore,close monitoring should be conducted during clinical application.

李一叶;张霆;李然;王中元;张敬文;宋贵丽;王张

成都中医药大学 药学院,四川 成都 611137成都中医药大学 药学院,四川 成都 611137成都中医药大学 民族医药学院,四川 成都 611137成都中医药大学 药学院,四川 成都 611137成都中医药大学 药学院,四川 成都 611137||成都中医药大学 民族医药学院,四川 成都 611137成都中医药大学 药学院,四川 成都 611137成都中医药大学 民族医药学院,四川 成都 611137

医药卫生

珊瑚七十味丸急性毒性小鼠大鼠血液学血液生化学

Shanhu Qishiwei Pillsacute toxicitymicerathematologyblood biochemistry

《中药与临床》 2026 (1)

13-19,7

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