ABSTRACT
Objective To evaluate the tonic and health effects of Xuebijing injection,a traditional Chinese medicine injection,by means of corn low-nutritional mice model combined with benefit-damage index-general score (BDI-GS) evaluation system under a physiological dosage.Further,to investigate the scientific and practical benefits of the evaluation system in efficacy and safety re-evaluation of clinical traditional Chinese medicine injections.Methods Healthy ICR mice during growth period were randomly divided into blank control group and low,middle and high dose groups.All the mice were fed with corn diets,and treated by intraperitoneal injection once a day.The mice in the blank control group were injected with 0.4 ml 0.9％ sodium chloride injection,and the mice in the low,medium and high dose groups were injected with 0.2,0.4 and 0.6 ml Xuebijing injection,respectively,for seven days.On the 8th day,the mice were killed,dissected,and took nine kinds of organs including heart,lung,thymus,spleen,pancreas,kidney,gonad and femur.The weight BDI,index BDI and the corresponding weight BDI general score (GSw) and index BDI general score (GSI) were calculated,and the serum biochemical parameters were measured.Results Under the physiological dose,Xuebijing injection shows good safety of continuous infusion,tonic and health effects,and slight damages on the rest of organs.More specifically,the values of weight BDI and index BDI were all higher than 9.0,and values of GSw and GSI were all higher than the basic value of 9.0.Furthermore,these parameters increased in a dose-dependent manner.In addition,the total protein level of (47.6 ± 4.30) g/L in the high dose groups was significantly higher than (43.18 ± 2.60) g/L in the blank control group (P＜0.05).Conclusions The Xuebijing injection has a lower risk for conventional usage.This injection is safe under the physiological dosage and much safer in higher dosage designed in this study.The low-nutritional model combined with BDI-GS evaluation system can be used for re-evaluating the function and safety of clinical traditional Chinese medicine injections.
ABSTRACT
Objective To evaluate the tonic and health effects of Xuebijing injection,a traditional Chinese medicine injection,by means of corn low-nutritional mice model combined with benefit-damage index-general score (BDI-GS) evaluation system under a physiological dosage.Further,to investigate the scientific and practical benefits of the evaluation system in efficacy and safety re-evaluation of clinical traditional Chinese medicine injections.Methods Healthy ICR mice during growth period were randomly divided into blank control group and low,middle and high dose groups.All the mice were fed with corn diets,and treated by intraperitoneal injection once a day.The mice in the blank control group were injected with 0.4 ml 0.9％ sodium chloride injection,and the mice in the low,medium and high dose groups were injected with 0.2,0.4 and 0.6 ml Xuebijing injection,respectively,for seven days.On the 8th day,the mice were killed,dissected,and took nine kinds of organs including heart,lung,thymus,spleen,pancreas,kidney,gonad and femur.The weight BDI,index BDI and the corresponding weight BDI general score (GSw) and index BDI general score (GSI) were calculated,and the serum biochemical parameters were measured.Results Under the physiological dose,Xuebijing injection shows good safety of continuous infusion,tonic and health effects,and slight damages on the rest of organs.More specifically,the values of weight BDI and index BDI were all higher than 9.0,and values of GSw and GSI were all higher than the basic value of 9.0.Furthermore,these parameters increased in a dose-dependent manner.In addition,the total protein level of (47.6 ± 4.30) g/L in the high dose groups was significantly higher than (43.18 ± 2.60) g/L in the blank control group (P＜0.05).Conclusions The Xuebijing injection has a lower risk for conventional usage.This injection is safe under the physiological dosage and much safer in higher dosage designed in this study.The low-nutritional model combined with BDI-GS evaluation system can be used for re-evaluating the function and safety of clinical traditional Chinese medicine injections.