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目的制备琥珀酸去甲文拉法辛(desvenlafaxine succinate,DVS)缓释片,确定最佳处方及制备工艺,并进行体外释放特性研究。方法建立紫外分光光度法测定DVS缓释片的体外释放度,以体外释放度为评价指标,通过单因素考察,确定DVS缓释片的最佳处方及制备工艺。结果最佳处方及工艺:以HPMC K15M为骨架材料,用量50%;MCC为填充剂;硬脂酸镁为润滑剂,用量8%;湿法制粒后,以70 k N的压力压片。制备的DVS缓释片体外释放行为良好,可持续释药24 h,符合试验要求。结论 DVS缓释片的制备工艺稳定可靠,体外释放度测定方法简便易行。
Objective To prepare sustained-release tablets of desvenlafaxine succinate (DVS), determine the best prescription and preparation process, and study the in vitro release characteristics. Methods The UV-Vis spectrophotometry was used to determine the in vitro release of DVS sustained-release tablets. The in vitro release was used as the evaluation index to determine the best formulation and preparation of DVS sustained-release tablets. Results The best prescription and process: HPMC K15M as the skeleton material, dosage 50%; MCC as filler; magnesium stearate as lubricant, dosage 8%; wet granulation, the pressure of 70 kN tablets. The prepared DVS sustained-release tablets in vitro release behavior well, sustainable release 24 h, in line with the test requirements. Conclusion The preparation of DVS sustained-release tablets is stable and reliable, and the method of determination of in vitro release is simple and easy.