Hypotensive Test of Rats by Intravenous Immunoglobulin
Chen Xueyan, Wu Ming(The National Institute for Control of Pharmaceutical and Biological Products)
In the paper, 32 lots of intravenous immunoglobulin (IVIG)were tested by an animal model,the hypotensive test of rats. A linear correlation was found between prekallikrein activator (PKA)activity and hypotensive reaction if the inflow of human IVIG was made rapid (r=0.96,n=23). The preliminary observations indicated that it would be satisfactory that the PKA activity was below 35IU/ ml and the size of reduction in blood pressure was not 15% higher than that of control animal's level.The rat model can provide a method for safe usage of the intravenous immunoglobulin and reliable detection of and control over the residual PKA activity in blood products.