Safety evaluation on human coagulation factor Ⅷ
MU Lei;LU Tao;WANG Qianchuan;LI Wei;YU Wei;Rongsheng Pharmaceutical Co. ,Ltd.;
Objective To evaluate the safety of a plasma derived human coagulation factor Ⅷ( FⅧ). Methods Abnormal toxicity test were performed on rat guinea pig according to Chinese Pharmacopoeia. Hemolysis test of rabbit erythrocyte was performed by tube method in vitro. Rabbit vascular irritation test was performed by self-control method. The toxicity of the reagent residues was analyzed. Results No abnormal toxicity,no hemolysis reaction,no irritant reaction were found in the above tests. All the reagent residues were in safe ranges. Conclusion According to the results of pharmacological,toxicological test and the virus safety test,this FⅧ product is safety for clinical use.
【CateGory Index】： R965