瑞格列奈片的制备与质量标准研究.pdfVIP

摇 广东药学院学报 摇 Journal of Guangdong Pharmaceutical College摇 Dec.2009,25(6) 555 瑞格列奈片的制备和质量标准研究 丁钢,龙晓英,袁飞,陈莉,钟雪萍,叶美华,朱树强 (广东药学院 中药学院,广东 广州510006 ) 摘要:目的制备瑞格列奈片,并建立其质量标准。 方法 以溶出度、硬度、外观为指标,通过正交试验L9 4 (3 )筛选出最优处方;采用高效液相法测定瑞格列奈的含量、含量均匀度和溶出度。 结果 优选出的瑞格 列奈片的处方组成为:微晶纤维素颐PVP鄄K30颐CCNa 的质量比为74颐5颐20;含量测定方法学考察结果:瑞格 -1 列奈质量浓度在9.905~99.05 滋g ·mL 范围内与峰面积呈良好线性关系,回收率为100.83%、RSD 为 0.98%(n=9),最低检测限为2.0 ng,最低定量限为8.0 ng;含量均匀度为6.84;30 min 累积溶出度为 98.25%。 结论筛选的处方合理,制备工艺简单可行,制备的瑞格列奈片符合制剂质量要求。 关键词:瑞格列奈片;正交试验;HPLC;含量测定;质量标准 中图分类号:R94摇 文献标识码:A摇 文章编号:1006-8783(2009)06-0555-05 Preparation and quality standard of repaglinide tablets DING Gang,LONG Xiao鄄ying,YUAN Fei,CHEN Li,ZHONG Xue鄄ping,YE Mei鄄hua,ZHU Shu鄄qiang (School of Traditional Chinese Medicine,Guangdong Pharmaceutical College,Guangzhou,Guangdong 510006,China) Abstract:Objective To prepare repaglinide tablets and establish the quality standard. Methods Orthogonal array testing was conducted to optimize the formulation with the indices of dissolution rate, appearance and hardness. HPLC method was established to measure content,content uniformity and dissolution rate. ResultsTheoptimumformulationof repaglinidetabletswasMCC颐PVP K鄄30颐CCNa=74颐 -1 5颐20,and a good linear relationship was obtained in the range of9.905~99.05 滋g ·mL ,r=1.0 000. The average recovery was 100.83%,withRSD 0.98%(n=9).The LOD was2.0 ng and the LOQ was 8郾0 ng,content uniform was 6.84,and dissolution was 99.25%.Conclusion The reasonable formulation was obtained and preparationwas simple,and the prepared tablets met the requirements. Key words:repaglinide tablets;orthogonal array test;HPLC;content determination;quality standard [2] 摇 摇 瑞格列奈(repaglinide,RG)是由德国诺和诺德