Piquet Y, Janvier G, Selosse P, Doutremepuich C, Jouneau J, Nicolle G, Platel D, Vezon G
Centre Régional de Transfusion Sanguine, Bordeaux, France.
Vox Sang. 1992;63(4):251-6. doi: 10.1111/j.1423-0410.1992.tb01230.x.
In order to increase the safety of blood products, we have developed a procedure for the virus inactivation of fresh frozen plasma. Several batches have been prepared and with the first 10 batches, each of them composed of 60 litres of plasma, we have determined a set of biological parameters. Virus inactivation was realised using TnBP (1%) and Octoxynol 9 (1%). After their elimination with castor oil using chromatography on insolubilized C18 resin, glycine was added and the pH of the plasma was adjusted to 7.4. Plastic bags were aseptically filled with a mean volume of 200 ml of plasma. The mean levels of coagulation factors were all over 0.7 U/ml and their recovery from initial plasma was nearly the same as total protein except for factor VIII:C. The net loss in factor VIII:C was 16%, when including the dilution of plasma. In vivo and in vitro tests demonstrated that in the final product there were no activated factors. As in fresh frozen plasma, the protein concentration was over 50 g/l and the potassium level lower than 5 mmol/l. According to these results, virus-inactivated plasma has the same qualities of fresh frozen plasma and could now replace it.
为提高血液制品的安全性，我们开发了一种新鲜冰冻血浆病毒灭活程序。已制备了几批产品，对于首批10批产品，每批由60升血浆组成，我们确定了一组生物学参数。使用TnBP（1%）和辛苯昔醇9（1%）实现病毒灭活。在用蓖麻油通过固定化C18树脂色谱法去除它们之后，加入甘氨酸并将血浆的pH值调节至7.4。用平均体积为200毫升的血浆无菌填充塑料袋。凝血因子的平均水平均超过0.7 U/ml，除因子VIII:C外，它们从初始血浆中的回收率与总蛋白几乎相同。当包括血浆稀释时，因子VIII:C的净损失为16%。体内和体外试验表明，最终产品中没有活化因子。与新鲜冰冻血浆一样，蛋白质浓度超过50 g/l，钾水平低于5 mmol/l。根据这些结果，病毒灭活血浆具有与新鲜冰冻血浆相同的质量，现在可以替代它。
