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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

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【作者】 王智李凤娟张鸿辉余蓉杨成民

【Author】 Wang Zhi1 Li Fengjuan2 Zhang Honghui3 Yu Rong1 Yang Chengmin3,4 1(West China School of Pharmacy,Sichuan University,Chengdu 610041,China) 2(School of Pharmaceutical Science and Technology,Tianjin University,Tianjin 300072,China) 3(Tianjin Union Biotechnology Co.,Ltd,Tianjin 300457,China) 4(Transfusion Institute of Chinese Academy of Medical Sciences,Chengdu 610081,China)

【机构】 四川大学华西药学院生物制药教研室天津大学药物科学与技术学院天津协和生物科技发展有限公司天津协和生物科技发展有限公司 成都610041天津300072天津300457成都610041天津300457 中国医学科学院输血研究所成都610081

【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
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