论文部分内容阅读
目的:研究盐酸哌甲酯双相控释渗透泵片的制备方法和工艺优化。方法:以双层渗透泵缓控释片的制备工艺为基础,结合双相释药行为的原理,制备具有两个不同释放相的双释放制剂。通过对含药层和助推层的单因素考察试验,确定各辅料的用量。对压片及包衣工艺参数进行考察,研究得到最佳压片方法以及最佳包衣参数。结果:制备的盐酸哌甲酯双相控释渗透泵片具有两个不同的释放相,优化处方制得的盐酸哌甲酯双相控释渗透泵片外观合格,含药量重复性好,在体外释药曲线在0~2h内快速释放,2~10h符合零级释放,重复性较好。结论:本制备方法科学、简便、完整,可用于制备盐酸哌甲酯双相控释渗透泵片。
Objective: To study the preparation and optimization of methylphenidate biphasic controlled release osmotic pump tablets. Methods: Based on the preparation of controlled-release tablets with double-layer osmotic pump, the dual-release preparation with two different release phases was prepared based on the principle of biphasic drug release. Through the drug-containing layer and push the single-factor study test to determine the amount of various materials. The tabletting and coating process parameters were investigated, and the best tabletting method and the best coating parameters were obtained. Results: The prepared methylphenidate biphasic controlled release osmotic pump tablet had two different phases. The modified methylphenidate biphasic controlled release osmotic pump tablet obtained by optimized prescription had good appearance and good drug repeatability. In vitro release curve in 0 ~ 2h rapid release, 2 ~ 10h consistent with zero-order release, reproducibility is better. Conclusion: The preparation method is scientific, simple and complete and can be used to prepare methylphenidate biphasic controlled release osmotic pump tablets.