清热消炎宁片重复给药的毒理学研究  

Toxicology study on repeated administration of Qingre Xiaoyanning tablets

作　　者：赵莉 扶丽君 周芷伊 易帅 王衡新 ZHAO Li;FU Li-jun;ZHOU Zhi-yi;YI Shuai;WANG Heng-xin(Institute of Pharmaceutical Research,Hinye Pharmaceutical Co.,Ltd,Changsha 410331,Hunan Province,China)

机构地区：[1]天地恒一制药股份有限公司药物研究院,湖南长沙410331

出　　处：《中国临床药理学杂志》2024年第1期82-86,共5页The Chinese Journal of Clinical Pharmacology

基　　金：湖南省重点研发计划基金资助项目(2023SK2080)。

摘　　要：目的探究清热消炎宁片对SD大鼠重复给药毒性的影响。方法将120只SD大鼠随机分为空白组(纯水)和低、中、高剂量实验组(2.63、5.25、10.50 g·kg^(-1)清热消炎宁干膏粉),每组30只。4组大鼠均连续给药4周,设置恢复期4周。给药末期及恢复期末进行解剖,观察4组大鼠的一般状况、体质量增长、血液学及血生化指标、主要脏器系数、观察肉眼及镜下组织形态。结果实验期间,低、中、高剂量实验组的一般状况、体质量增长、凝血指标、组织病理学与空白组比较均未见明显异常。给药末期,高剂量实验组和空白组的平均血红蛋白浓度分别为(370.70±3.78)和(365.90±5.77)g·L^(-1),葡萄糖分别为(5.98±0.63)和(6.61±0.93)mmol·L^(-1),尿素氮(BUN)分别为(4.72±1.01)和(5.78±1.64)mmol·L^(-1),肝系数分别为3.05±0.17和2.89±0.19,在统计学上差异均有统计学意义(P≤0.05或P≤0.01)。恢复期末,低剂量实验组和空白组的直接胆红素分别为(0.38±0.18)和(0.19±0.18)μmol·L^(-1),中剂量实验组和空白组的BUN分别为(4.45±0.56)和(5.65±1.16)mmol·L^(-1),在统计学上差异均有统计学意义(均P≤0.05)。结论清热消炎宁片重复给药对SD大鼠无明显的毒性。Objective To explore the effect of Qingre Xiaoyanning tablets on chronic toxicity in SD rats.Methods A total of 120 SD rats were randomly divided into blank group(water)and experimental-L,-M,-H groups(2.63,5.25 and 10.50 g·kg^(-1)Qingre Xiaoyanning dry paste powder),with 30 rats per group.Four groups were administered continuously for 4 weeks with a recovery period of 4 weeks.SD rats were dissected as planned.The general condition,weight gain,hematological and biochemical indexes,major organ coefficients,macroscopic and microscopic tissue morphology were observed.Results There were no significant differences in the general condition,body mass growth,coagulation index and histopathology of rats between the experimental-L,-M,-H groups and the blank group.End of administration,the mean hemoglobin concentrations of experimental-H and blank groups were(370.70±3.78)and(365.90±5.77)g·L^(-1),glucose were(5.98±0.63)and(6.61±0.93)mmol·L^(-1),blood urea nitrogen(BUN)were(4.72±1.01)and(5.78±1.64)mmol·L^(-1),liver coefficients were 3.05±0.17 and 2.89±0.19,and the differences were statistically significant(P≤0.05,P≤0.01).Resumption of the fin al,direct bilirubin of experimental-L and blank groups were(0.38±0.18)and(0.19±0.18)μmol·L^(-1),BUN of experimental-M and blank groups were(4.45±0.56)and(5.65±1.16)mmol·L^(-1),and the differences were statistically significant(all P≤0.05).Conclusion Repeated administration of Qingre Xiaoyanning tablets showed no significant toxicity in SD rats.

关 键 词：清热消炎宁片 干膏粉 大鼠 重复给药 毒性试验 

分 类 号：R97[医药卫生—药品]