Taylor L S, York P, Williams A C, Mehta V
Postgraduate Studies in Pharmaceutical Technology, School of Pharmacy, University of Bradford, West Yorkshire, United Kingdom.
Pharm Dev Technol. 1997 Nov;2(4):395-402. doi: 10.3109/10837459709022638.
Reducing sugars may be used as additives in freeze-dried formulations. The purpose of this study is to examine the effect of freezing on nonequilibrated glucose solutions using FT-Raman spectroscopy. The methods used solutions freshly prepared from either alpha- or beta-crystalline glucose, frozen at different time intervals after dissolution. Solutions frozen immediately after dissolution showed peaks in the anomeric region of the spectrum characteristic of those observed for the parent crystalline form. No change occurred in these spectra after 24 hr in the frozen state. Solutions prepared from either alpha- or beta-crystalline glucose and left for 24 hr at room temperature before freezing showed the presence of both anomers. The glass transition temperature of maximally freeze-concentrated solutions of beta-glucose, frozen immediately after dissolution, was found to be approximately 3 degrees C lower than for solutions prepared from alpha-glucose. Freezing appears to halt the interconversion of glucose anomers, enabling the formation of predominantly alpha- or beta-frozen solutions which exhibit different properties. Freezing of nonequilibrated solutions of reducing sugars may lead to variation in the properties of freeze-dried formulations.
还原糖可作为冻干制剂中的添加剂。本研究的目的是使用傅里叶变换拉曼光谱法研究冷冻对非平衡葡萄糖溶液的影响。所采用的方法是用α-或β-结晶葡萄糖新鲜配制溶液,在溶解后的不同时间间隔进行冷冻。溶解后立即冷冻的溶液在光谱的异头物区域出现了与母体结晶形式所观察到的特征峰。在冷冻状态下24小时后,这些光谱没有变化。由α-或β-结晶葡萄糖制备并在冷冻前在室温下放置24小时的溶液显示出两种异头物的存在。发现溶解后立即冷冻的β-葡萄糖最大冷冻浓缩溶液的玻璃化转变温度比由α-葡萄糖制备的溶液低约3℃。冷冻似乎会阻止葡萄糖异头物的相互转化,从而能够形成具有不同性质的主要为α-或β-冷冻溶液。还原糖非平衡溶液的冷冻可能会导致冻干制剂性质的变化。