周芷伊 1赵莉 1王衡新 1蒋飞荣 2舒长宏 2邓姣梅 2潘任桃 2邓友田2
作者信息
- 1. 天地恒一制药股份有限公司,湖南长沙 410331
- 2. 湖南安生美药物研究院有限公司,湖南长沙 410000
- 折叠
摘要
Abstract
Objective To explore the effects of the Huoluo Xiaotong Capsule,a polypill of traditional Chinese medicine,on the acute and long-term toxicity of SD rats,so as to provide a basis for clinical safe drug use.Methods A total of 40 SD rats were randomly divided into a blank control group and a Huoluo Xiaotong Capsules group,with 20 animals in each group.The SD rats in the Huoluo Xiaotong Capsules group were given the maximum dosage of medication by gavage,while the blank control group was given an equal volume of deionized water to observe acute toxicity reactions;160 SD rats were randomly divided into the control group and the low,medium and high dose groups of Huoluo Xiaotong Capsules.40 animals in each group were given 2.80,5.70 and 11.30 g crude drug/kg by gavage for six consecutive months.General observation,ophthalmic examination,urine examination,hematology,blood biochemistry,electrolytes,coagulation and organ coefficient determination,histopathological examination,and long-term toxicity of Huoluo Xiaotong Capsules were observed 3 months,6 months after administration,and 4 weeks after drug withdrawal,respectively.Results In the acute toxicity test,there were no significant abnormalities in the clinical observation and weight of the rats in each group,and no rats died.There were no significant abnormalities in the surface and section of each organ,and the maximum tolerable dose(MTD)was≥30.20 g of crude drug/kg,which was equivalent to 267 times the daily dose taken in humans.The long-term toxicity test showed that the high-dose group of Huoluo Xiaotong Capsules had a significant impact on the weight loss of male animals,but it could recover after stopping the medication for 4 weeks.No abnormality related to drug toxicity was found in general observation,ophthalmic examination,urine examination,hematology,blood biochemistry,electrolyte,coagulation and organ coefficient determination,histopathological examination,etc.The no observed adverse effect level(NOAEL)observed in long-term toxicity tests was 11.30 g crude drug/kg,which was equivalent to 100 times the daily dose taken in humans.Conclusion Huoluo Xiaotong Capsules have high safety within the therapeutic dose range,and long-term repeated use has no accumulated toxicity,with low safety risks.关键词
活络消痛胶囊/急性毒性试验/长期毒性试验/中医药Key words
Huoluo Xiaotong Capsules/Acute toxicity test/Long-term toxicity test/Traditional Chinese medicine分类
医药卫生
