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载氧药物的冷冻干燥和冻干制品的保存稳定性
Freeze-drying of Oxygen-carrying Substances and Storage Stability of the Freeze-dried Solids
【摘要】 对以聚合胎盘血红蛋白为有效成分的载氧药物进行冷冻干燥。采用蔗糖作保护剂,减少冷冻干燥过程中高铁血红蛋白(Methemoglobin,MetHb)的增加。测定冷冻干燥前后的MetHb含量、UV光谱、十二烷基硫酸钠聚丙烯酰胺凝胶电泳(SDS-PAGE)、高效液相色谱法(HPLC)等指标。结果表明:冷冻干燥中,当蔗糖/蛋白质的重量比≥0·5时,MetHb增加得到有效控制,UV光谱中血红蛋白(Hb)的特征吸收峰、SDS-PAG、HPLC无显著改变。冻干制品分别在室温或冰箱中保存3个月,考察其稳定性。结果表明:保存过程中,MetHb的增加与蔗糖/蛋白质的重量比、保存温度有关,试验组C(蔗糖/蛋白质的重量比为1.0)在室温或冰箱中保存3个月,MetHb含量、UV特征吸收峰、SDS-PAGE、HPLC等指标均无显著改变。
【Abstract】 Oxygen-carrying substances based on poly-placental hemoglobin were put into freeze-drying. Sucrose was chosen to inhibit the methmoglobin(MetHb) formation. MetHb content, ultravioletes(UV) spectrum, Sodium dodecyl sulfate polyacrylamide gel electrophoresis(SDS-PAGE), High perfomance liquid chromatography(HPLC) were monitored during freeze-drying. As a result, when the mass ratio of sucrose to protein was above 0.5, MetHb formation was under control;the characteristic absorption of UV spectrum, SDS-PAGE and HPLC showed no visible change. Freeze-dried solids were kept under room temperature and refrigerator for 3 months. As a result, MetHb formation depended upon storage temperature and the mass ratio of sucrose to protein. For group C in which the mass ratio of sucrose to protein was 1.0; there is no marked change in MetHb content, UV spectrum, SDS-PAGE and HPLC after 3 months.
- 【文献出处】 生物医学工程学杂志 ,Journal of Biomedical Engineering , 编辑部邮箱 ,2008年03期
- 【分类号】TQ460.7
- 【被引频次】7
- 【下载频次】381