羟丙基甲基纤维素酞酸酯假胶乳的制备及应用于消炎痛肠溶包衣片的质量评价

实验制备了肠溶辅料羟丙基甲基纤维素酞酸酯（ＨＰＭＣＰ）假胶乳水性分散液，并以消炎痛片为底物，分别采用ＨＰＭＣＰ假胶乳及ＨＰＭＣＰ有机溶媒包衣液制备其肠溶薄膜包衣片。考察并比较了两种包衣系统的消炎痛包衣片的崩解时限、抗胃液性能及在人工肠液中的释药动力学。实验结果表明：两种包衣系统均能使包衣片产生良好的肠溶性；包衣片在人工胃液中的药物泄漏率均符合ＵＳＰⅩⅫ要求；经统计学检验两种包衣系统的不同包衣水平间的体外累积释药Ｔｄ值，均无显著性差异（Ｐ＞０．５），说明在一定包衣增重范围内，衣膜对包衣片释药速度影响不大。

PREPARATION AND EVALUATION OF HPMCP PSEUDOLATEX AS AN AQUEOUS ENTERIC COATING SYSTEM FOR INDOMETHACIN TABLET

HPMCP pseudolatices were prepared by Emulsion-solvent evaporation technique.Using Indomethacin tablets as substrates,two different enteric-coated tablets produced from HPMCP aqueous dispersion or HPMCP organic solution were obtained.The enteric qualities such as disintegration time,gastric reisitance and drug release behavior were investigated.It can be seen from the results that both aqueous and organic solvent coating system presented good enteric properties to Indomethacin coated tablets.At all coating levels using either of these two systems the release of active material in 0.1 NHCl through the enteric coating by diffusion was less than 2.5% on the average and this met the requirement of USP Ⅹ Ⅻ.Moreover,the Td values of in vitro drug release of coated tablets with any coating thickness in the two systems when treated statistically showed no significant differences(P>0.5).This indicated that HPMCP films formed in the two systems had little effect on the dissolution profiles of coated tablets.