不同厂家螺内酯片的溶出度考察研究  

Research on dissolution rate of spironolactone tablets from different manufacturers

作　　者：赵昕[1] 陈明明[1] 张鹏[1] 

机构地区：[1]沈阳军区联勤部药品仪器检验所,沈阳110026

出　　处：《实用药物与临床》2012年第3期154-156,共3页Practical Pharmacy and Clinical Remedies

摘　　要：目的利用光纤溶出度过程分析方法,监测螺内酯片的溶出度,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》中规定的检测螺内酯片溶出度的条件,利用光纤传感溶出度实时过程分析方法,对5个不同厂家的螺内酯片进行实时监测。结果 5个厂家药片的溶出曲线明显不同。结论光纤溶出度过程分析在线,实时反映了体外溶出特性,反映了由于不同厂家生产的药片质量的不同而造成的药片的溶出行为不同,对考察体内外相关性、评价药品内在品质及其生物等效性提供了有效方法。Objective To establish a method that can monitor the dissolution rate of spironolactone tablets by fiber-optic dissolution test system,and reflect the different quality of tablets from different manufacturers by on-line monitor of dissolution rate of tablets.Methods According to dissolution test condition of Chinese Pharmacopoeia,the dissolution of spironolactone tablets from 5 different manufacturers were tested by fiber-optic dissolution test system.Results The dissolution curves of tablets from 5 manufacturers were different.Conclusion This process analysis shows the real dissolution performance of each tablet.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.This method provides an effective way of evaluating the in vitro-in vivo correlation and bioequivalence for drug from different manufacturers.

关 键 词：螺内酯片 光纤药物溶出度实时检测仪 药物溶出度 

分 类 号：R927.2[医药卫生—药学]