储存温度对静注人免疫球蛋白质量影响的研究___
Study of storage temperature influencing on quality of immunoglobulin for human intravenous injection
分类号：
出版年·卷·期（页码）：2009,29 (9):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
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-----英文摘要：---------------------------------------------------------------------------------------
Objective:To compare different temperature influencing the quality of IgG for intravenous use, and provide scientific testimony for the temperature control of transportation and storage of the products．Methods:To determine the quality of the products after incubated in different temperature,using HPLC,SDS-PAGE and some methods 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 macromolecule polymers rapidly．Bioactivity and some physicochemical 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.
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