基于流通池装置的新溶出方法用于尼莫地平片的一致性评价  

A new method based on flow-through cell apparatus to evaluate dissolution consistency of nimodipine tablets

作　　者：李辉 赵悦清[1] 蒋妮谚含 程泽能 LI Hui 1,2 ,ZHAO Yueqing 1 ,JIANG Niyanhan 1 ,CHENG Zeneng 1(1 Xiangya School of Pharmaceutical Science,Central South University,Changsha 410013;2 Hunan Traditional Chinese Medical College,Zhuzhou 412012,Chin)

机构地区：[1]中南大学湘雅药学院,长沙410013 [2]湖南中医药高等专科学校,株洲412012

出　　处：《中国药科大学学报》2018年第3期301-309,共9页Journal of China Pharmaceutical University

摘　　要：建立一种新的溶出度检查方法,以更好地模拟药物在体内的溶出行为,用于评价药物制剂间的质量差异。选择尼莫地平片为研究对象,采用流通池溶出仪,依据体内外相关性原理,建立了一种新的溶出方法,用于考察国内尼莫地平片仿制药与其原研药溶出行为的一致性;并使用桨法溶出仪,以常规的四条溶出曲线法作为对照,评价了新溶出方法的区分效能。结果显示:所建立的新溶出方法不仅具有较好的体内相关性,并且能更好地揭示药物制剂间的质量差异。该研究将进一步为流通池法评价药物在体内外相关性方面的应用提供理论依据。A new method of dissolution test was established to better simulate the in vivo dissolution behavior of drugs from preparations and to distinguish the quality difference between drug preparations. With flow-through cell being chosen to be the dissolution apparatus and nimodipine tablet to be the model drugs,this study developed,on the basis of IVIVC theory,a new dissolution method which was subsequently used to evaluate the dissolution consistency of domestically produced nimodipine tablet as test preparation and its reference preparation. Meanwhile,conventional four-dissolution-curves method based on paddle apparatus was selected for comparison to evaluate the efficiency of the new dissolution method. The results indicated that the new dissolution method not only had a good correlation with the in vivo process of drugs,but also could reveal the internal quality differences between pharmaceutical preparations effectively. This research will provide further theoretical support for the application of flow-through cell apparatus in IVIVC study.

关 键 词：流通池法 溶出度检查 体内外相关性 一致性评价 尼莫地平片 

分 类 号：R917[医药卫生—药物分析学]