过程分析考察不同厂家尼莫地平片的溶出度  

Compaison Dissolution Rate of Nimodipine Tablets from Different Manufacturers with Process Analysis

作　　者：孔彬 李新霞[2] 张奇洲[2] 胡旭 熊海江 刘欢 陈坚[2] 

机构地区：[1]新疆富科思生物技术发展有限公司,乌鲁木齐830011 [2]新疆医科大学药学院,乌鲁木齐830054

出　　处：《中国药品标准》2008年第4期279-282,共4页Drug Standards of China

基　　金："十一五"国家科技支撑计划课题(2006BAK03A16)

摘　　要：目的:利用光纤溶出度过程分析方法,过程监测尼莫地平片的溶出度,通过瞬时在线监测药片溶出情况而反映不同厂家生产的药片质量的差异。方法:采用中国药典中规定的检测尼莫地平片溶出度的条件,利用光纤传感溶出度实时过程分析方法对5个不同厂家的尼莫地平片进行了实时监测。结果:5个厂家间的溶出曲线明显不同,可真实地反映每粒药片的溶出过程。结论:光纤溶出度过程分析在位在线,反映了体外溶出特性,并真实地反映了由于不同厂家生产的药片质量的不同而造成的不同厂家药片的溶出行为不同,对考察体内外相关性,提供了评价药品内在品质的方法,为评价生物等效性提供了有效途径。Objective： To establish a method which can monitor the dissolution rate of Nimodipine Tablets by fiber-optic dissolution test system. The method can on-line monitor the dissolution rate of tablets and reflect the different quality of tablets from different manufacturers. Method： According to dissolution test condition of Ch. P, the dissolution of Nimodipine tablets from five different manufacturers were test by fiber-optic dissolution test system. Results ： The dissolution curves of tablets from five manufacturers are different. This process analysis shows the real dissolution performance of each tablet. Conclusion：An in-situ, real time detection can be carried out on fiber-optic dissolution test system. And in vitro dissolution properties of the tablets are reflected. So the quality of tablets from different manufacturers can be evaluated by the system. The In Vitro-ln Vivo Correlation can be compared with the system. This method provides an effective way of evaluating bioequivalence for the drug from different manufacturers.

关 键 词：过程分析 尼莫地平片 光纤药物溶出度实时检测仪 药物溶出度 

分 类 号：R972[医药卫生—药品] R927.11[医药卫生—药学]