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

作　　者：王智[1] 李凤娟[2] 张鸿辉[3] 余蓉[1] 杨成民[3] 

机构地区：[1]四川大学华西药学院生物制药教研室,成都610041 [2]天津大学药物科学与技术学院,天津300072 [3]天津协和生物科技发展有限公司,天津300457

出　　处：《生物医学工程学杂志》2008年第3期678-681,693,共5页Journal of Biomedical Engineering

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。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 ...

关 键 词：聚合胎盘血红蛋白溶液 冷冻干燥 高铁血红蛋白 紫外线(UV)光谱 

分 类 号：TQ460.7[化学工程—制药化工]