冻干人白细胞γ干扰素的热稳定性研究

Study on the Heat Stability of Freeze Dried Human Leucocyte γ-IFN

在三种温度下对冻干人白细胞γ干扰素进行了多等温加速稳定性试验和5℃保存的稳定性考察。结果表明,样品在66℃加温11天,或56℃加温35天,或37℃加温5个月,能保持50％以上的活力;在5℃保存一年后,效价损失不超过10％,保存两年损失不超过15％。用加速降解有关公式推算的结果与实验值较为吻合。产品稳定性良好。

Freeze dried human leucocyte γ-IFN was studied on its heat stability at four different temperatures. The result showed that the residual activity was more than 50% after the preparation had been heated at 66℃ for 11 days, or 56℃ for 35 days or 37℃ for 5 months. The losses of activi ty were less than 10% and 15% after the preparation had been stored at 5℃ for one year and two years, respectively. The calculation results obtained from the formula associated with accelerated degradation tallyed with that obtained from the tests above. Thus, the heat stability of the preparation was good.