Evaluation of Toxicity Test on Infusible Platelet Membrane in Mice: A Short Report

Blood platelet units are generally stored in blood banks for 3–5 days, afterwards they are discarded. Prepared infusible platelet membrane (IPM) from fresh or outdated human platelets correct the prolonged bleeding times in thrombocytopenic animals such as rabbits. Abnormal Toxicity is an European Pharmacopoeia standard for assessment of biological products and the test material is administered to the mice. In this study, abnormal toxicity of IPM was evaluated in experimental animal model such as mice. In this experimental study, infusible platelet membrane (IPM) was prepared from outdated platelet concentrates. Platelet concentrates were pooled, disrupted by freeze-thaw procedure, pasteurized for 20 hours to inactivate the possible viral or bacterial contaminants with a sodium caprylate stabilizer, formulated by sucrose and human serum albumin and finally lyophilized. We injected 0.5 ml of IPM (2 mg/kg) intravenously into each 5 health mice, weighing 17-22 grams. According to the EU Pharmacopeia, the test will be passed if none of animals die during 24 hours after injection. If more than one animal dies, the preparation fails the test. If one of the animals just dies, the test is repeated. In our experiment all five mice were alive. In this research the results showed that IPM as a platelet substitute is free of abnormal toxicity and safe and it may be used in human clinical trial studies as a feasible approach to develop a platelet substitute in the future. However, further studies are required to confirm the different aspects of its safety as well.