美洛昔康肠道2次脉冲释药组合片的研制

Preparation of twice-pulse release complex tablets in intestinal tract of meloxicam

目的:制备美洛昔康肠道内两次脉冲释药系统,并考察其体外释放影响因素。方法:以美洛昔康为模型药物,以欧巴代OY-P-7171为肠溶包衣、以EudragitNE30 D为延时脉冲包衣材料制备2种包衣片,用释放度测定法考察影响药物释放的因素。结果:组合制剂在人工胃液中不释放药物、在人工肠液中可以实现2次脉冲释药。释药时滞分别约为2和4 h。结论:服用美洛昔康组合片治疗风湿性关节炎,将给药后药物单次快速释药方式变成2次脉冲释药,不仅可减少胃刺激,而且能满足关节炎的时辰药理学治疗要求。

Objective： To investigate two-pulse release tablets in intestinal tract of meloxicam,and to establish the method of drug release.Methods： Opaday OY-P-7171 was used as entric coating materials and Eudragit NE 30 D as the film of delayed pulse release system.The behavior of coated tablets was evaluated in vitro by dissolution tests.Results： The two-pulse tablets did not release drug in 0.1 mol·L-1 HCl solution,but released two pulses at lag time of 2 and 4 h in phosphate buffer solution（pH 7.4）.Conclusion： The prepared two-pulse release tablets of meloxicam meet the require of chronopharmacology for treating arthritis.