论文部分内容阅读
制备盐酸伊伐布雷定片,并考察其质量.以溶出曲线、外观等为指标,用正交试验设计方法对处方工艺进行筛选与优化.制备盐酸伊伐布雷定片,与原研药进行质量对比,使其与原研药质量保持一致,以保证自研产品与原研药临床效果的一致性;通过加速试验和长期试验考察其稳定性.盐酸伊伐布雷定优选处方组成为:辅料微晶纤维素、一水乳糖、交联羧甲基纤维素钠、羟丙纤维素、二氧化硅和硬脂酸镁,流化床制粒.该处方工艺制备的产品符合标准,与原研药质量一致且质量稳定.本处方工艺可行,所得产品质量稳定,符合质量标准.“,”Ivabradine hydrochlorid tablet was prepared and its quality was investigated.The optimization of formulations and manufacturing technology of Ivabradine hydrochlorid tablet were carried out by the orthogonal experiment design method with the dissolution curve and the appearance of tablets as the index.Through comparing the preparing sample with the reference drug,the quality of the sample was consistency with the reference drug,and the stability of the sample was investigated through accelerated test and long-time test.The most optimal prescription of the tablet was fluilized-bed granulating active ingredient with prescribed amout of lactose,monohydrate,microcrystalline cellulose,hydroxypropyl cellulose,magnesium stearate.The quality of the product reached the standard and conformed to the reference drug.The formulation process was reasonable,the quality of the product was stable and met the quality standard.