Safety Evaluation of Three Traditional Chinese Medicine Injections

Abstract:

Objective: Evaluate thesafety of Xueshuantong Injection, Kudiezi Injection and Xiyanping Injection. Method: Active systemic anaphylaxis (ASA) test, passive cutaneous anaphylaxis (PCA) test, vascular irritation test and In vitro hemolysis test were used to evaluate the safety of three traditional Chinese medicine injections (TCMI). Result: In the ASA test, positive control group showed strong anaphylaxis effect, three TCMI didn't produce allergic reaction and body weight of all groups showed no significant differences. In the PCA test, all rats of positive control group caused blue spots of which the diameters were all greater than 5 mm and the IgE were significantly increased. However, three TCMI didn't produce blue spots of which the diameters were greater than 5 mm and the IgE levels showed no significant differences compared with negative control group. In the vascular irritation test, local blood vessels by near the administration site of both left and right ears of the animals did not observe irritative reaction symptoms, pathology results showed that after administration and recovery phase, blood vessels and surrounding tissues of auresunitas of the animals didn't appear apparent abnormality. In vitro hemolysis test showed that no haemolysis or agglutination phenomenon were induced by any of the three TCMI. Conclusion: Xueshuantong Injection, Kudiezi Injection and XiyanpingInjection were safety under these experimental conditions.