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目的研究总藤黄酸亲水凝胶骨架片体外释药速率的影响因素并考察其体外释放特性。方法以藤黄酸(GA)释放度为考察指标,采用单因素试验法,考察填充剂用量、黏合剂类型、制备方法、压片压力和转速对药物体外释放行为的影响,并采用正交试验设计对处方进行优选,确定最佳制备工艺条件。结果以羟丙基甲基纤维素(HPMC K15M)为骨架材料,预胶化淀粉和乳糖为填充剂,制备了12 h缓释片。该制剂2 h释放约35%,6 h释放约65%,10 h释放约85%,12 h释放约95%,满足缓释片释放要求。结论本方法制备的总藤黄酸缓释片外观及可压性良好,具有良好的释放性能。且工艺简单易行,生产成本低。
Objective To study the factors that affect the in vitro drug release rate of total gambogic acid hydrophilic gel matrix tablets and investigate its in vitro release characteristics. Methods The release of gambogic acid (GA) was taken as the index. The effects of the amount of filler, the type of adhesive, the preparation method, the pressure and speed of tabletting on the in vitro release behavior were investigated by single factor test. Design prescribing optimization, to determine the best preparation conditions. Results Hydroxypropyl methylcellulose (HPMC K15M) was used as matrix material and pregelatinized starch and lactose were used as filler to prepare 12 h sustained-release tablets. The preparation released about 35% in 2 h, about 65% in 6 h, about 85% in 10 h and about 95% in 12 h, which satisfied the requirement of sustained-release tablets. Conclusion The total gambogic acid sustained-release tablets prepared by this method have good appearance and compressibility, and have good release properties. The process is simple and easy, and the production cost is low.