Hom F S, Veresh S A, Ebert W R
J Pharm Sci. 1975 May;64(5):851-7. doi: 10.1002/jps.2600640528.
A method is reported for studying the effects of several factors at room temperature on the oxygen permeability of soft gelatin capsule shell films. The method involves the use of a permeability cell assembly and the spectrophotometric determïnation of oxygen with an alkaline pyrogallic acid solution. Factors investigated were relative humidity, plasticizers, equilibrium water, an insoluble additive, and film thickness. Results from the effects of film thickness and oxygen partial pressure correlated well with the permeability equation. For greatest stability of encapsulated oxygen-labile materials, it is recommended that the soft gelatin capsule shells be prepared with a low plasticizer concentration and that the finished capsules be stored at low relative humidity.
本文报道了一种研究室温下多种因素对软胶囊壳膜透氧性影响的方法。该方法包括使用渗透池组件以及用碱性焦性没食子酸溶液分光光度法测定氧气。所研究的因素有相对湿度、增塑剂、平衡水分、一种不溶性添加剂和膜厚度。膜厚度和氧分压影响的结果与渗透方程相关性良好。为使封装的对氧敏感材料具有最大稳定性，建议制备软胶囊壳时使用低浓度增塑剂，并且成品胶囊应在低相对湿度下储存。
