降糖三黄片急性及长期毒性研究  

Acute and Long-Term Toxicity of Jiangtang Sanhuang Tablet

作　　者：王保华[1] 郭起岳[2] 刘月姝[2] 白建瑜 朱章志[1] 李赛美[1] WANG Baohua;GUO Qiyue;LIU Yueshu;BAI Jianyu;ZHU Zhangzhi;LI Saimei(The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,China;Guangdong Medical Laboratory Animal Center,Foshan 528248,China)

机构地区：[1]广州中医药大学第一附属医院,广东广州510405 [2]广东省医学实验动物中心,广东佛山528248

出　　处：《中医药学报》2021年第8期27-31,共5页Acta Chinese Medicine and Pharmacology

基　　金：国家自然科学基金项目(81873190);广东省名中医传承工作室项目(21206)。

摘　　要：目的:观察中药复方制剂降糖三黄片急性及长期毒性反应,为临床安全用药提供参考。方法:以最大允许浓度和给药量的降糖三黄片混悬液灌胃SD大鼠14d,对照组给予等体积去离子水,观察急性毒性反应;SD大鼠随机分为对照组和降糖三黄片低、中、高剂量组,按1g/kg、3g/kg、9g/kg连续灌胃降糖三黄片混悬液6个月,分别于给药后3个月、6个月及停药1个月进行血液指标检测、大体解剖及病理学检查,观察降糖三黄片长期毒性反应。结果:急性毒性试验各组大鼠一般状态、饮食、分泌物、排便未见异常,无大鼠死亡,肉眼尸检心、肝、脾等主要脏器组织未见明显异常;长期毒性试验各组大鼠与对照组相比,一般状况、血常规及生化学指标未见明显差异;病理检查未见与药物毒性相关的主要脏器组织形态学改变,停药后也未见药物延迟性毒性反应。结论:降糖三黄片无急性毒性、长期毒性和延迟毒性反应,在治疗剂量范围内用药安全性高。Objective:To observe the acute and the long-term toxicity of Jiangtang Sanhuang(JTSH)Tablet and to provide reference for its clinical medication safety.Methods:According to the procedures and methods for toxicological assessment,the study on the toxicology of JTSH Tablet,including acute(14 days)and long-term(180 days)oral toxicity test were performed on SD rats,which were divided into the control group and the JTSH Tablet groups of low-dose(1 g/kg),medium-dose(3 g/kg)and high-dose(9 g/kg).Blood sample test was carried out after three months of medication,six months of medication and one month after withdrawal.Results:In acute toxicity test,there were no abnormalities in terms of general state,diet,excretion and defecation of the rats;there were no deaths in the rats,and there were no obvious abnormalities in the morphology of heart,liver and spleen of the rats under naked eyes.In long-term toxicity test,there were no statistical differences in general state,blood routine examination and biochemistry indexes between the medication groups and the control group;in terms of pathological examination,there were no obvious histological changes of the organs related to medication toxicity;there was no delayed toxicity as well.Conclusion:JTSH Tablet has no acute,long-term toxicity and delayed toxicity.The clinical dosage of JTSH Tablet is safe and reliable.

关 键 词：降糖三黄片 急性毒性 长期毒性 安全性评价 

分 类 号：R285.5[医药卫生—中药学]