Evaluation of the safety of Shenjinhuoxue mixture

Objective: To evaluate the safety of Shenjinhuoxue mixture by acute toxicity test in mice and long-term toxicity test in rats,in order to provide evidence for clinical application of the mixture.Methods: Forty mice were randomized into test group(240 g crude drug/kg) and control group[0.9% sodium chloride solution(NaCl)].Each mouse was given gavage of the mixture or 0.9% NaCl.The activities,weight variation and death were observed and recorded for 14 days.Eighty rats were randomized into Shenjinhuoxue mixture high,middle and low dosage groups(60,21,6 g crude drug/kg) and control group of 20 rats each.The mixture was given by gavage to the rats once a day,and the dosage was adjusted according to the weight changes of the rats every week.The administration lasted 60 days.The weight,general condition and food intake of rats before and after drug administration were observed.Ten rats were sacrificed randomly 24 h after the last dose of the mixture and 3 weeks later.The hematological indexes were determined and histopathological changes were observed.Results: The median lethal dose(LD50) was not detected in acute toxicity test of mice,and the maximum tolerance dose was 240 g crude drug/kg which was 160 times as much as the clinical daily dose.After gavage of the mixture for 60 days and 3 weeks after discontinuation of administrating the mixture,there were no significant differences in general appearance,weight,food intake,haematogenesis function,liver and kidney functions,mass indexes of important organs of the rats between control and test groups.Significant toxic injury of heart,liver,spleen,lung and kidney was not found by histopathological examination in all groups.Conclusion: The toxicity of Shenjinhuoxue mixture is low at high-dose and in long course of treatment.The clinical daily dose of 1.5 g crude drug/kg is safe.