杞黄颗粒急性毒性及长期毒性的实验研究OACHSSCD

Objective:To investigate the acute and long-term toxicity of Qihuang Granules,evaluate their safety,and provide a sci-entific basis for their safe clinical application.Methods:Acute toxicity test:Thirty Sprague Dawley(SD)rats were selected and ran-domly divided into a control group and low-and high-dose Qihuang Granules groups,with 10 rats in each group and an equal num-ber of males and females.The rats received intragastric administration three times within 24 h.After drug withdrawal,the general condition of the rats was continuously observed for 7 days,after which the rats were euthanized and pathological changes were exam-ined macroscopically.Long-term toxicity test:Thirty-six SD rats were selected and randomly divided into a control group and low-and high-dose Qihuang Granules groups,with 12 rats in each group and an equal number of males and females.The rats received intragastric administration twice daily for 1 month.During this period,the general condition,body weight,and food intake of the rats were observed.At the end of the administration period,the rats were euthanized for examination of blood cells,coagulation function,biochemical and electrolyte parameters,organ weights,organ-to-body weight and organ-to-brain weight ratios,and organ pathology.Results:In the acute toxicity test,the mean body weight of male rats in the low-dose group on Day 8 was higher than that in the control group(P＜0.05),while no other abnormalities were observed.In the long-term toxicity test,food intake in female rats in both the low-dose and high-dose Qihuang Granules groups during Weeks 1 and 4 was lower than that in the control group(P＜0.001),and food intake in male rats in the high-dose group during Weeks 3 and 4 was lower than that in the control group(P＜0.01).Liver weight in male rats in both the low-dose and high-dose Qihuang Granules groups was higher than that in the control group(P＜0.05),and the liver-to-body weight ratio in male rats in the high-dose group was higher than that in the control group(P＜0.05).Some background lesions were observed in both the control group and the high-dose Qihuang Granules group,with no statistically significant difference.No other abnormalities were observed.Conclusion:Qihuang Granules showed no acute toxicity or 1-month long-term toxicity and had a relatively high safety profile within the clinical dosage range.