实验动物在血液制品中的应用

Laboratory Animals' Application in Producing Blood Products

目的:阐述实验动物在血液制品生产质量控制过程中应用的重要性。方法:按《中华人民共和国药典》2005年版三部要求及相关项目的技术规范进行血液制品质量控制。结果:血浆数量150吨,可同时生产以下品种的产品,人血白蛋白共30批次,总瓶数约40万瓶(折10g);免疫球蛋白类:共30批次,总瓶数约30万瓶(折2.5g);人纤维蛋白原:共30批次,总瓶数约15万瓶(折0.5g);人凝血酶原复合物:共30批次,总瓶数约12万瓶(折300IU);人凝血因子Ⅷ:共30批次,总瓶数约10万瓶(折200IU)。需使用家兔870只、豚鼠300只小鼠750只。结论:实验动物应用于血液制品生产质量控制发挥了非常重要的作用。

Objective：the importance of laboratory animals in controlling the production quality of blood products.Method：the quality of blood products was controlled according to the ＂People＇s Republic of China Pharmacopoeia＂（2005） and the normative stipulation of correlation techniques.Result：150 tons of plasma could be produced into the following products：400000 bottles of Human Albumins（10g）,300000 bottles of Human Immunoglobulin（2.5g）,150000 bottles of Human Fibrinogen（0.5g）,120000 bottles of Human Prothrombin Complex（300IU） and 100000 bottles of Human Coagulation FactorⅧ（200IU）,in which 870 rabbits,300 guinea pigs and 750 mice were needed.Conclusion：laboratory animals play a very important role in controlling the production quality of blood products.