摘要
目的:通过比较不同温度对静注人免疫球蛋白(IVIG)质量的影响,为该类制品的运输和储存温度控制提供科学依据。方法:设置不同的考核温度,采用高效液相色谱法、聚丙烯酰胺凝胶电泳法和该品种药典规定的部分检测项目和方法进行分析。结果:37℃孵放7d或45℃以上温度孵放1d,免疫球蛋白将形成聚合体和裂解片断;高温(60℃以上)使免疫球蛋白快速聚合,形成大量二聚体或高分子聚合体。聚合体形成后使生物学活性及部分理化性质明显降低和改变。结论:静注人免疫球蛋白应严格执行4℃冷藏保存条件,运输时间超过24h必须使用冷藏车进行冷链运输。
Objective ： To compare different temperature influencing the quality of IgG for intravenous use, and pro- vide scientific testimony for the temperature control of transportation and storage of the products. Methods： To deter- mine the quality of the products after incubated in different temperature, using HPLC, SDS - PAGE and some meth- ods required by Chinese Pharmacopeia. Results：Products incubated in 37 ℃ for 7 days or more than 45 ℃ for 1 day , polymers and fragments will be formed. High temperature （60 ℃ ） will make IgG form dipolymer or macromol- ecule polymers rapidly. Bioactivity and some physicochemieal property will be decreased and altered obviously. Conclusion：Storage condition for the products should be carried out strictly. Refrigerated van should be used when the transportation duration is more than 24 hours.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2009年第9期1475-1478,共4页
Chinese Journal of Pharmaceutical Analysis
