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目的以溴新斯的明为模型药物制备日服1次缇释片,并对缓释片释放特征进行初步考察。方法采用亲水凝胶骨架与薄膜包衣控释技术制备溴新斯的明缓释片,以药物释放行为为评价指标,对处方及工艺进行单因素考察结果溴新斯的明缇释片体外药物释放可维持24 h,药物释放曲线符合一级动力学方程In(100-Q)=-0.147 4 t+4.775 4,体内药动学研究表明缓释片t_(1/2)(5.1±1.8)h,较普通片t_(1/2)(3.5±1.1)h延长,具有较为明显的缓释效果。结论亲水凝胶骨架与薄膜包衣控释技术联合应用可以成功制备易溶性药物溴新斯的明的缓释制剂。
OBJECTIVE To prepare bromhexin as a model drug on a daily basis, and to investigate the release characteristics of sustained-release tablets. Methods The sustained-release tablets of bromine neostigmine were prepared by controlled release of hydrophilic gel matrix and film coating. The drug release behavior was taken as the evaluation index. The prescription and the process were investigated by single factor test. The drug release was maintained for 24 h, and the drug release curve was in accordance with the first-order kinetic equation In (100-Q) = - 0.147 4 t + 4.775 4. In vivo pharmacokinetic studies showed that the sustained release tablets t 1/2 (5.1 ± 1.8 ) h, which was longer than t_ (1/2) (3.5 ± 1.1) h of ordinary tablets, with a more obvious sustained-release effect. Conclusion The combination of hydrophilic gel matrix and controlled release of film coating can successfully prepare the sustained-release preparation of neostigmine-soluble drug.