| 冻干低pH静注丙球质量稳定性观察 |
| |
| 引用本文： | 陈品全,杨琳.冻干低pH静注丙球质量稳定性观察[J].微生物学免疫学进展,1998,26(3):30-32. |
| |
| 作者姓名： | 陈品全 杨琳 |
| |
| 作者单位： | 卫生部成都生物制品研究所 |
| |
| 摘 要： | 对１４批静注丙球保留样品进行３年效期内稳定性观察结果表明：出厂后３年内制品的物理检查和热稳定性试验均合格，ｐＨ值没有变化，ＩｇＧ分子仍以单体形式存在，抗补体活性（ＡＣＡ）和ＰＫＡ含量未见升高，白喉抗毒素效价未见下降。表明我所大规模生产的静注丙球质量是稳定可靠的
|
| 关 键 词： | 静注丙球 质量指标 稳定性 |
Survey of Quality Stability for Freeze-dried low pH Intravous Immunoglobin |
| |
| Abstract: | The results of quality stability survey for 14 lots low pH IVIG reserved samples in three years storage period were introduced.It showed that physical check,heat stability test,ACA,PKA,and diphtheria antitoxin accorded with the requirements of IVIG yet.IgG of IVIG almost 100% was still monomer.This indicated that qualities of IVIG for largescale production in our institute are stable and reliable. |
| |
| Keywords: | IVIG Quality index Stability |
| 本文献已被 CNKI 维普 等数据库收录！ |
|
