CAJ | 학술논문

目的：观察生理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 mL)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。结论丹红注射液在生理剂量下用药风险低,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。
목적：관찰생리제량단홍주사액대저영양모형소서생리급생화지표적영향,병평개기안전성。검험해체계재중약주사제안전성재평개중적실용개치。방법선취생장기ICR소서32지,제비옥미저영양소서모형,분위정상대조조(급여0.9%록화납용액),이급단홍주사액소、중、대3개제량(0.2,0.4급0.6 mL)조,매조8지；련속복강급약7 d,우제8천취혈양후처사,완정부취9충장기조직,검측상관생리、생화지표。채용손익지수-총적분( BDI-GS)체계평개단홍주사액안전성。결과단홍주사액대주요장기혹조직손상교경,BDI치균>0.85,GS치균>9.0；불동제량단홍주사액대비장급이선적BDI치균>1.0,표현출량호적보익급건강효응,여정상대조조비교차이유통계학의의( P<0.05혹P<0.01)。동시,표현출량호적강혈당효응。결론단홍주사액재생리제량하용약풍험저,안전성량호。동시,저영양모형결합BDI-GS체계가이작위림상중약주사제안전성재평개적일충신방식。
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.