论文部分内容阅读
冻干低ｐＨ静脉注射免疫球蛋白(简称蓉生静丙)自1992年试生产并正式用于临床以来,5年多的临床应用显示该制品的安全、有效及良好的稳定性。为了解采用相同生产工艺生产的液体低ｐＨ静注免疫球蛋白在2～8℃存放的稳定性,将中试期间(1988～1989年)及试生产至正式生产期间(1993～1
Lyophilized low pH intravenous immunoglobulin (Rongsheng static C) since 1992 trial production and formally used in clinical, more than 5 years of clinical application of the product shows the safety, effectiveness and good stability. In order to understand the stability of liquid low pH intravenous immunoglobulin produced by the same production process stored at 2 ~ 8 ℃, during the trial period (1988 ~ 1989) and the trial production to the official production period (1993 ~ 1