Acute toxicity testing and safety evaluation of Yangxue Qufeng Zhitong granules
Objective:To conduct acute toxicity experiments and safety evaluations of Yangxue Qufeng Zhitong granules on ICR mice.Method:A total of 40 ICR strain mice weighing(18.0-2.0)g were selected for this experiment.They were randomLy divided into a blank control group(n=20)and an experimental group(n=20)using a random number table method.The maximum dose tolerance test of Yangxue Qufeng Zhitong Granules was conducted using the acute toxicity test limit method.Each mouse in the experimental group was given 3.6g of raw medicine/mL concentration and 0.4mL/10(g.BW)volume by gavage.The drug was administered twice a day with a daily cumulative dose of 288g of raw medicine/(kg·BW)(the highest daily dose for clinical people is 1.07g of raw medicine/(kg·BW),which is 270 times the highest daily dose for clinical people),while the blank control group was given the same volume of deionized water for 7 days.Observe animal reactions,mortality rate,appearance,limb movement,feeding,drinking,excretion,and other manifestations.After 7 consecutive days of observation,the rats were euthanized using the neck cutting method,and all rats were subjected to anatomical and histological observation.Result:All experimental mice survived healthy and significantly increased in weight compared to before treatment.After the experiment,there was no significant statistical difference between the experimental group and the blank control group(P＞0.05).No abnormalities were observed in the appearance,limb movement,feeding,drinking water,and excretion of all experimental mice,and no significant acute toxic reactions or mouse deaths were observed.Compared with the control group,there were no significant histopathological differences observed in the heart,lungs,trachea,kidneys,bladder,adrenal gland,brain,cerebellum,brainstem,spleen,thymus,testes,epididymis,ovaries,esophagus,stomach,small intestine,large intestine,liver,submandibular gland,pancreas,and thyroid tissues of the experimental group.Conclusion:The median lethal dose of Yangxue Qufeng Zhitong Granules orally administered by gavage is higher than 2.88 × 105mg/(kg·BW),indicating that its high-dose application does not have significant toxicity.Yangxue Qufeng Zhitong Granules are actually non-toxic compounds.
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