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麦芽糖糊精作为模型蛋白乳酸脱氢酶冻干过程中的冻干保护剂。

Maltodextrins as lyoprotectants in the lyophilization of a model protein, LDH.

作者信息

Corveleyn S, Remon J P

机构信息

Laboratory of Pharmaceutical Technology, University of Gent, Belgium.

出版信息

Pharm Res. 1996 Jan;13(1):146-50. doi: 10.1023/a:1016006106821.

Abstract

PURPOSE

Maltodextrins, partially hydrolysed starches, were evaluated as potential lyoprotectants and the effect of combinations of maltodextrins and PEG 8000 on the protection of lactate dehydrogenase (LDH) was examined.

METHODS

LDH activity assays were performed immediately before freezing and after reconstruction. The activity recovery was used as the parameter to evaluate the lyoprotectants. Differential Scanning Calorimetry (DSC) was used to measure the glass transition temperature (Tg') of the solutions. DSC and X ray diffraction were used to characterise the freeze-dried products.

RESULTS

Maltodextrins were found to protect LDH against inactivation during freeze-drying. The lyoprotection obtained by these maltodextrins is dependent on their D.E. value and the concentration used. The maltodextrin formulations performed as good or better than those containing sucrose and maltose, depending on the concentration used. Freeze dried cakes of maltodextrin formulations were amorphous. In the case of low D.E. maltodextrins, lyoprotection was improved by the addition of PEG 8000 as a cryoprotectant.

CONCLUSIONS

Maltodextrins could be considered as potential lyoprotectants in lyophilization of proteins.

摘要

目的

评估麦芽糊精(部分水解淀粉)作为潜在冻干保护剂的性能,并研究麦芽糊精与聚乙二醇8000(PEG 8000)组合对乳酸脱氢酶(LDH)的保护作用。

方法

在冷冻前及复溶后立即进行LDH活性测定。将活性回收率用作评估冻干保护剂的参数。采用差示扫描量热法(DSC)测量溶液的玻璃化转变温度(Tg')。使用DSC和X射线衍射对冻干产品进行表征。

结果

发现麦芽糊精可保护LDH在冻干过程中不被灭活。这些麦芽糊精获得的冻干保护作用取决于其葡萄糖当量(D.E.)值和所用浓度。根据所用浓度,麦芽糊精配方的表现与含蔗糖和麦芽糖的配方相当或更佳。麦芽糊精配方的冻干饼呈无定形。对于低D.E.值的麦芽糊精,添加PEG 8000作为冷冻保护剂可提高冻干保护作用。

结论

麦芽糊精可被视为蛋白质冻干过程中的潜在冻干保护剂。

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