为了有效加强对药包材产品的质量控制,便于包装生产企业生产出符合药品包装要求的产品以及方便药品生产企业的使用,国家食品药品监督管理局推出了一系列关于药品包装材料的新标准。电解分析法作为检测薄膜、片材透湿性的试验方法出现在部分新标准中。在此之前,我国标准中用于检测薄膜、片材透湿性的方法仅有称重法一种,而 ISO 标准中有称重法、红外线法、电解分析法等方法。
ISO 15106-3 是现在应用较广泛、编写较全面的电解分析法透湿性测试标准。标准中对于电解分析法的测试原理有如下的叙述: The gas transmission cell is designed in such a way that, with the test specimen inserted, it is divided into a dry chamber and a controlled-humidity chamber. The dry side of the specimen is swept by a flow of dry carrier gas, and water vapour permeating through the specimen from the controlled-humidity chamber is carried by the carrier gas into an electrolytic cell. This cell contains two spiral wire electrodes, coated with a thin layer of phosphorous pentoxide, mounted on the inside wall of a glass capillary. The carrier gas is passed through the capillary where the moisture it holds is quantitatively absorbed by the phosphorous pentoxide and decomposed electrolytically into hydrogen and oxygen by the application of a D.C. voltage of about 70V to the electrodes. The mass of the moisture which permeates through the specimen and is decomposed per unit time is calculated from the electrolytic current required.(气体渗透腔是按这种方式设计的,当插入测试试样时它就会被分成一个干腔和一个湿度可控的湿腔。试样的干燥一侧被干燥载气气流吹扫,水蒸气从湿腔渗透通过试样后会被载气气流携带至一个电解腔中。这个腔中包含有两个螺旋线的电极,并在玻璃毛细管内侧覆有一薄层五氧化二磷。载气气流过毛细管,在这里载气气流中的湿气将被五氧化二磷定量地吸收,通过向两电极上施加直流 70V 的电压可将吸收的湿气电解成氢和氧。渗透通过试样并在单位时间内被电解的水蒸气的质量将从得到的电流中计算出来。)电解分析法的测试原理如图 1 所示。