吲哚美辛HP MCP肠溶片的制备及溶出度考察

Investigation on the preparation and drug release of indometacin HPMCP-coated tablets

以吲哚美辛为模型药物 ,采用本室新研制开发的肠溶材料羟丙甲纤维素邻苯二甲酸酯(HPMCP)包衣 ,制备了吲哚美辛肠溶片。通过考察吲哚美辛HPMCP包衣片的溶出度 ,并与吲哚美辛HP55(日本信越公司同类材料 )包衣片及 5种市售吲哚美辛肠溶片的溶出度进行比较来研究HPMCP包衣膜的性质。用相似因子法和chow’s法对溶出实验数据进行统计分析 ,结果表明HPMCP包衣片与HP55包衣片溶出行为完全相似 ,相似因子F2 =70 1 ( 5 0≤F2 ≤ 1 0 0 ) ,HPMCP包衣片片心药物溶出速率明显快于 5种市售片。

Hydroxypropyl methylcellulose phthalate (HPMCP) was a new kind of enteric coating material researched and developed in our lab. In order to study the characteristics of HPMCP coating film, indometacin was selected as a model drug and coated with HPMCP to prepare enteric coated tablets. The drug release in simulated intestinal juice (pH 6 8) was determined and compared with that of HP 55 coated tablets (Shin Etsu) and five different kinds of indometacin enteric coated tablets sold in the market. The drug release data were also analyzed by the statistical methods, and the results suggested that the drug release behaviour of HPMCP coated tablets was perfectly similar to that of HP 55 coated tablets ( F 2=70 1>50), and the drug release rate was noticeably faster than that of the tablets sold in the market.