羟丙基甲基纤维素酞酸酯游离膜的溶解性及附加剂的影响

Dissolution rate of hydroxypropyl methylcellulose phthalate(HPMCP)free films and effects

实验考察了新型肠溶衣材料——羟丙基甲基纤维素酞酸酯（ＨＰＭＣＰ）的游离薄膜在体外人工肠液中的溶解性能，并与肠溶型丙烯酸树酯进行了比较；同时还考察了包衣处方中常用的几种附加剂对ＨＰＭＣＰ游离膜溶解性能的影响。实验结果表明：自制的ＨＰＭＣＰ游离膜的体外溶解性能与日本样品ＨＰ－５０，ＨＰ－５５接近，优于国产肠溶型丙烯酸树酯Ⅱ、Ⅲ号；在一定用量范围内，不溶性附加剂（滑石粉、铁白粉、氧化铁）均使ＨＰＭＣＰ膜溶解时间延长；表面活性剂加快膜溶解；增塑剂苯二甲酸二丁酯用量在３０％以下时可减少膜溶解时间；色素由于用量较少，对膜溶解性影响不大。

The dissolution rate of free films prepared by using entericcoating material,HPM-CP,was determined in pH6.8 buffer solution HP-50,HP-55,and Eudragit Ⅱ,Ⅲ films were com-pared.The dissolution rate of HPMCP film was almost the same as that of HP-50 and HP-55 filmsand considerably faster than that of Eudragit films,The effects of addition of different additivesand their content change in the films on the dissolution properties of HPMCP film were exam-ined.The insoluble additives such as talcum,titanium dioxide and iron sesquioxide delayed the dis-solving time of the films,while the surfactant e.g. tween-80 resulted in an increase in film dissolu-tion rate. The plasticizer(di-butyl phthalate)shortened the dissolving time when <30%of it wasadded.Addition of pigments caused no signifficant change of the film,This study provided a refer-ence for optimum coating formulation design of drugs.