论文部分内容阅读
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 solubility of free film of HPMCP, an enteric-coating material, was evaluated experimentally in vitro and compared with enteric-coated acrylic resin. In addition, The effect of several additives commonly used in coating prescription on the solubility of HPMCP free films. The results showed that in vitro solubility of HPMCP free-standing membrane was similar to that of Japanese samples HP-50 and HP-55, which was better than that of domestic enteric-coated acrylates Ⅱ and Ⅲ. In a certain range of dosage, insoluble additives Powder, iron powder, iron oxide) all make the HPMCP membrane dissolve for a long time; the surfactant accelerates the dissolution of the membrane; the dosage of plasticizer dibutyl phthalate can reduce the membrane dissolution time below 30% Little effect on membrane solubility.