CIESC Journal

• 生物化学工程与技术 • 上一篇    下一篇

促肝细胞生长素冻干粉针剂的性状与结构

尹双青; 姚日生; 刘鹏举   

  1. 安徽丰原药业股份有限公司马鞍山药厂
  • 出版日期:2007-10-05 发布日期:2007-10-05

Characteristics and configuration of hepatocyte growthpromoting factor freeze-dried powder injection

YIN Shuangqing;YAO Risheng;LIU Pengju   

  • Online:2007-10-05 Published:2007-10-05

摘要: 借助X-衍射分析和显微成像研究促肝细胞生长素原药、辅料及冻干粉针剂的结构,结合对冻干制剂的含水量以及水溶解时限的测定,确定注射用促肝细胞生长素的合理冻干时间。结果表明,促肝细胞生长素原药和右旋糖酐溶液的冻干品为无定形结构,右旋糖酐不影响甘露醇的结晶,促肝细胞生长素多肽链干扰了甘露醇的结晶并使其晶型发生改变。当冷冻干燥时间低于30 h时,产品的组成是不均一的。因此,冻干粉针剂的结晶相由其中甘露醇的结晶构成,甘露醇的晶粒构成了粉针剂的骨架支撑材料,无定形的右旋糖酐是促肝细胞生长素的保护剂和分散剂,而形成性状良好的促肝细胞生长素冻干粉针剂所需冻干时间为36小时。

Abstract:

The characteristics and configuration of hepatocyte growthpromoting factor freeze-dried powder injection were studied with optical micrography and X-ray diffraction analysis,and the suitable freezedrying time of hepatocyte growthpromoting factor for injection was determined by the freezedrying testThe results indicated that the bulk drug and dextran had amorphous configurations and mannitol was crystalline and the freezedried powder included tiny mannitol crystals dispersed in the powder uniformlyThe crystal form of mannitol in the freezedried powder injection changed and the grains became tinierWhen the time for freezedrying was less than 30 h,the powder configuration was not homogeneousThe amorphous dextran was used as the protective agent and disperser for hepatocyte growthpromoting factor,the grains of mannitol constituted the framework of freezedried powder injectionIt was necessary to take 36 h to produce a good form of hepatocyte growthpromoting factor freezedried powder injection.