丹红注射液对低营养小鼠生理与生化指标的影响  

Impacts of Danhong Injection on Physiological and Biochemical Indicators in Malnourished Mice

作　　者：谭浩[1] 王浩[2] 靳瑾[2] 卞兰芳[1] 沈秀[2] 龙伟[2] 樊赛军[2] 周则卫[2] 

机构地区：[1]天津市黄河医院药剂科,天津300110 [2]中国医学科学院北京协和医学院放射医学研究所,天津300192

出　　处：《医药导报》2015年第5期598-602,共5页Herald of Medicine

摘　　要：目的观察小剂量丹红注射液对低营养模型小鼠生理及生化指标的影响,并评价其安全性。检验该体系在中药注射剂安全性再评价中的实用价值。方法选取生长期ICR小鼠32只,制备玉米低营养小鼠模型,分为正常对照组(给予0.9%氯化钠溶液),以及丹红注射液小、中、大3个剂量(0.2,0.4及0.6 m L)组,每组8只;连续腹腔给药7 d,于第8天取血样后处死,完整剖取9种脏器组织,检测相关生理、生化指标。采用损益指数-总积分(BDI-GS)体系评价丹红注射液安全性。结果丹红注射液对主要脏器或组织损伤较轻,BDI值均>0.85,GS值均>9.0;不同剂量丹红注射液对脾脏及胰腺的BDI值均>1.0,表现出良好的补益及健康效应,与正常对照组比较差异有统计学意义(P<0.05或P<0.01)。同时,表现出良好的降血糖效应。结论丹红注射液在小剂量下用药风险低,安全性良好。同时,低营养模型结合BDI-GS体系可以作为临床中药注射剂安全性再评价的一种新方式。Objective To explore the impacts of Danhong injection on physiological and biochemical indicators in malnourished mice at physiological low doses, evaluate its safety, and test the practical value of safety re-evaluation of Traditional Chinese Medicinal （ TCM） injections. Methods A total of 32 ICR mice during growth period were selected to set up corn deficient nutrition mice model. Mice were assigned into the normal control group （given 0. 9% saline）, Danhong injection at low, medium and high dosages （0. 2, 0. 4 and 0. 6 mL） groups （n=8 in each group）;Mice were administered with respective medications intraperitoneally for 7 consecutive days. Blood samples were taken and mice were executed on the 8th day. All 9 kinds of organ or tissue were obtained completely, to measure related physiological and serum biochemical parameters. The safety of Danhong injection was evaluated by using Benefit and Damage Index - General Score （ BDI-GS ） system. Results The Danhong injection showed only slight damages on major organs or tissues, the BDI values were all above 0. 85, and the GS values were all above 9. 0;BDI values for Danhong injection at different dosages were all above 1. 0 for spleen and pancreas, showing better replenishing and healthy effects, and the differences were of statistical significance compared with the normal control group （P〈0. 05 or P〈0. 01）. Meanwhile, it exerted obviously hypoglycemic effect. Conclusion Danhong injection is of rather low risk under physiological dosages, and therefore is safe to use. The mal-nutrition model combined with the BDI-GS system may be developed as a novel approach for safety re-evaluation of TCM injection in clinic.

关 键 词：丹红注射液 低营养模型 损益指数-总积分评价体系 安全性 

分 类 号：R286[医药卫生—中药学] R285.5[医药卫生—中医学]