明胶胶囊的交联现象及其在体外溶出试验中的研究进展

Cross-linking of Gelatin Capsules and its Study Progress of in vitro Dissolution Test

明胶胶囊易在贮存时出现交联现象,使得胶囊剂在体外溶出度试验时出现崩解延迟和溶出迟缓现象。研究表明交联明胶胶囊在体内的溶出速率与未发生交联明胶胶囊一致,而体外溶出试验溶出介质中未加入蛋白酶,使得溶出延迟,易使药物溶出速率偏慢。目前仅USP溶出度<711>对体外溶出试验中出现胶囊交联现象的药物采取加入蛋白水解酶进行试验,而其他药典均未加入此项内容。本文综述了明胶胶囊交联现象及解决该现象的体外溶出试验研究。

Gelatin capsules can be cross-linked in storage,which contributes to slow disintegration and dissolution of capsules.In gastric fluids,cross-linked capsules can be dissolved easily in the same way as non cross-linked capsules.However,there is no enzyme in dissolution medium in vitro dissolution test,which leads to an insufficient dissolution rate.Only the current text in the USP general chapter 711 dissolution allows the addition of enzymes to the dissolution medium when gelatin capsules are corss-linked.Cross-linking of gelatin capsules and study of cross-linked capsules in vitro dissolution test were reviewed.