摘要
目的:观察Beagle犬静脉长期注射痰热清注射液可能出现的毒性反应,为其临床安全用药提供实验数据。方法:32条Beagle犬,雌雄各半,按体质量随机分为低质量浓度(2.5 mL·kg^(-1)),中质量浓度(5.0 mL·kg^(-1)),高质量浓度(10.0 mL·kg^(-1))的痰热清注射液组和空白组,每组8条;清醒状态下,前肢内侧皮下头静脉滴注给药,连续给药13周,停药恢复4周。观察Beagle犬的一般状况、体质量、摄食量,于给药中期(第6周),给药期结束(第13周),恢复期结束(第17周)分别进行心电图、眼科、血液学、血清生化、凝血、大体解剖,计算所有动物主要脏器的脏器系数及组织病理学改变。结果:各质量浓度组均未见明显毒性反应,但高质量浓度组Beagle犬给药3个月可见纤维蛋白酶原减少及肝血窦内吞噬黄褐色色素的Kupffer细胞增多;恢复期未见纤维蛋白酶原减少,但是吞噬黄褐色色素的Kupffer细胞仍然存在。结论:Beagle犬连续静脉注射原液2.5 mL·kg^(-1)(低质量浓度),5.0 mL·kg^(-1)(中质量浓度)和10.0 mL·kg^(-1)(高质量浓度)的痰热清注射液3个月,各质量浓度组均未见明显毒性反应;但对于临床长期大质量浓度高浓度使用时,建议就肝功能和凝血功能变化作进一步观察。
Objective:To observe the possible toxicity of long-term intravenous injection of Tanreqing injection in Beagle dogs,so as to provide experimental data for its clinical safe medication. Method:A total of32 Beagle dogs(16 males and 16 females)were randomly divided into the low-(2.5 mL·kg^(-1)),medium-(5.0 mL·kg^(-1)),and high-dose(10.0 mL·kg^(-1))Tanreqing injection groups and control group according to their body mass indices,with eight dogs in each group. In the waking state,the dogs were treated with intravenous injection of corresponding drugs into the medial cephalic vein of forelimb for 13 weeks,followed by four-week drug withdrawal. After the observation of general condition,body mass,and food consumption,the Beagle dogs were subjected to electrocardiography,ophthalmoscopy,hematological examination,serum biochemistry,and blood coagulation test in the middle of medication(week 6),at the end of medication(week 13),and during recovery(week 17). Then the gross anatomy was conducted for calculating the major organ coefficients and observing the histopathological changes. Result: No obvious toxic reaction was found in each group,but the decreased fibrinogen and increased Kupffer’s cells phagocytizing yellow-brown pigment in hepatic sinusoids were observed in the high-dose Tanreqing injection group following three months of medication. Reduction of fibrinogen was not observed in recovery period,but Kupffer’s cells that phagocytized yellow-brown pigment still existed. Conclusion: The intravenous injection of Tanreqing injection at 2.50 mL·kg^(-1)(low dose),5.00 mL·kg^(-1)(medium dose)or 10.00 mL·kg^(-1)(high dose)for three months in Beagle dogs resulted in no obvious toxic reaction. However,it is still suggested to test the liver function and blood coagulation after longterm administration of high-dose Tanreqing injection.
作者
王帆
路发凯
张联众
杜学航
杜习杰
张小利
WANG Fan;LU Fa-kai;ZHANG Lian-zhong;DU Xue-hang;Du Xi-jie;ZHANG Xiao-li(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Shanghai Kai Bao Pharmaceutical Co.,Ltd.,Shanghai 201401,China;Center for Disease Control and Prevention,Pingchuan District,Baiyin city,Gansu 730913,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2021年第18期73-79,共7页
Chinese Journal of Experimental Traditional Medical Formulae
基金
上海市2019年度“科技创新行动计划”生物医药领域科技支撑项目(19401901000)。
