Toxicity of Danshen Injection in Beagle's Dogs by Repeated iv Injection  

作　　者：CHENG Jian-ming WANG Meng LIU Jing ZHU Li-ping XU Rui TAO Li QIAO Yan SHEN Jiao BAI Wen-xia MEI Sheng-yao SUN Bao-hai 

机构地区：[1]College of Pharmacy,Nanjing University of Chinese Medicine [2]Jiangsu Provincial Institute of Materia Medica,Nanjing University of Technology

出　　处：《Chinese Herbal Medicines》2013年第3期189-198,共10页中草药（英文版）

基　　金：National Natural Science Foundation of China(81173540)

摘　　要：Objective To re-evaluate the potential toxicity of Danshen Injection(DI) in Beagle's dogs by repeated iv injection.Methods DI was iv given to the dogs at the doses of 0,1.6,5.4,and 16.0 g/(kg·d)(4 per sex per group) for 13weeks.During the test period,the clinical signs,mortality,body weights,food consumption,rectal temperature,ophthalmoscopy,electrocardiography,urinalysis,hematology,serum biochemistry,organ weights,gross findings,and histopathology were examined.Results Dogs iv given with DI at the doses of 0,1.6,5.4,and 16.0 g/(kg·d) for13 weeks had no drug-related changes in mortality,body weight,food consumption,temperature,electrocardiography,ophthalmoscopy,urinalysis parameters,and organ weights.The hematological parameter data showed a significant decrease in red blood cells and hemoglobin concentration in the high-dose group and a significant increase in activated partial thromboplastin time suggesting an effect on haemopoiesis.For biochemical parameters,a significant decrease in glucose and a significant increase in total bilirubin were observed in the high-dose group,and the latter was considered to be toxicologically insignificant as lack of histopathological correlate.However,the histopathological examinations of the injection site showed that DI could cause dose-dependent focal inflammation.Conclusion That the iv injection with DI into dogs at 16 g/(kg·d) for 13 weeks could cause the decreases in red blood cell parameters and glucose,as well as the lesions of the injection site.The no observed adverse effect level is5.4 g/(kg·d),which suggests that safe clinical dosing be possible.Objective To re-evaluate the potential toxicity of Danshen Injection(DI) in Beagle's dogs by repeated iv injection.Methods DI was iv given to the dogs at the doses of 0,1.6,5.4,and 16.0 g/(kg·d)(4 per sex per group) for 13weeks.During the test period,the clinical signs,mortality,body weights,food consumption,rectal temperature,ophthalmoscopy,electrocardiography,urinalysis,hematology,serum biochemistry,organ weights,gross findings,and histopathology were examined.Results Dogs iv given with DI at the doses of 0,1.6,5.4,and 16.0 g/(kg·d) for13 weeks had no drug-related changes in mortality,body weight,food consumption,temperature,electrocardiography,ophthalmoscopy,urinalysis parameters,and organ weights.The hematological parameter data showed a significant decrease in red blood cells and hemoglobin concentration in the high-dose group and a significant increase in activated partial thromboplastin time suggesting an effect on haemopoiesis.For biochemical parameters,a significant decrease in glucose and a significant increase in total bilirubin were observed in the high-dose group,and the latter was considered to be toxicologically insignificant as lack of histopathological correlate.However,the histopathological examinations of the injection site showed that DI could cause dose-dependent focal inflammation.Conclusion That the iv injection with DI into dogs at 16 g/(kg·d) for 13 weeks could cause the decreases in red blood cell parameters and glucose,as well as the lesions of the injection site.The no observed adverse effect level is5.4 g/(kg·d),which suggests that safe clinical dosing be possible.

关 键 词：Beagle's dogs Danshen Injection iv injection Salvia miltiorrhiza repeated dose toxicity 

分 类 号：R285.5[医药卫生—中药学]