中文摘要：

本文根据冻干过程干燥室内的露点值和物料的水分含量有关提出一种新的方法——露点法来监控冻干过程物料的水分迁移情况。以浓度为2％（W/V）的甘露醇（冻干保护剂）为研究对象，分别取80个，160个，20个小瓶，通过不同的过充小瓶数（1个，2个），不同的溶液高度（溶液高度6．5mm，0．32mm）来检验露点法在监测整批样品冻干过程的灵敏性。与称重法对照，称重法即在冻干过程不同的时刻取出样品测量整批样品质量。实验结果表明露点法即使当过充小瓶率为0．625％，或者溶液高度为0．32mm时仍有足够的灵敏度，露点法得到的一次升华结束点与称重法结果一致。这说明非接触法露点法是一种可靠，便利的监测一次升华结束点的方法，将其应用于控制成批冻干样品大有可为。

英文摘要：

According to the fact that the dewpoint value in the drying chamber relates closely to the moisture content in a product, a new dewpoint-based method is proposed to make sure of the evolution of the moisture in freeze-drying process. In a series of tests the 2%（w/v） mannitol was used as freeze-drying protectant to check the monitoring sensitivity of the method proposed to the batch of samples in freeze-drying process, in which different numbers of vials （80,160 and 20） were filled with the mannitol solution and, among them, 1 or 2 vials in each number of vials were overfilled, and in all vials the heights of the solutions were different, ie., 0.32mm and 6.5mm. The results of the new method was compared to the weighing method, ie., the total weight of a batch of the products was weighed at different moments in the freeze-drying process. It was revealed that the sensitivity of dewpoint method to the freeze-drying process is high enough even if the proportion of overfilled vials is as few as 0.625% in a batch or the solution height is as low as 0.32mm. Such a comparison result showed that the endpoint of primary sublimation judged by the non-contacted dewpoint method conforms with that by weighing method. A conclusion is therefore drawn that the non-contact dewpoint method is reliably easy to monitor the endpoint of primary sublimation and will have broad prospects in the batch control of freeze-drying products.