祁荣,何仲贵,张汝华,许学军
QI Rong 1; HE Zhong gui 1; ZHANG Ru hua 1; XU Xue jun 2 (1 School of Pharmacy;

• 1:沈阳药科大学药学院
• 2:沈阳药科大学药学院
• 3:沈阳药科大学药学院
• 4:石河子大学医学院第一附属医院 辽宁沈阳110016

摘要(Abstract)：

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.

关键词(KeyWords)： 吲哚美辛;HPMCP包衣片;溶出度测定;统计分析
indometacin; HPMCP coated tablets; drug release detemination; statistical analysis

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 祁荣,何仲贵,张汝华,许学军
QI Rong 1; HE Zhong gui 1; ZHANG Ru hua 1; XU Xue jun 2 (1 School of Pharmacy;

参考文献(References)：

• [1]中华人民共和国药典委员会.中华人民共和国药典[Z].北京:化学工业出版社,2000.291-292.
• [2]夏锦辉,刘昌孝.固体药物制剂的体外溶出度的统计学评价分析[J].中国药学杂志,2000,35(2):130-131.