光纤药物溶出度过程监测仪对31批对乙酰氨基酚片溶出度的评价  

The Process Monitoring of the Dissolution of Paracetamol Tablets(31 Batches) with Fiber-optic Dissolution Test System

作　　者：李忠红[1] 樊夏雷[1] 卢京光[2] 王雪琴 

机构地区：[1]江苏省药品检验所,南京210008 [2]青岛市药品检验所 [3]河南省药品检验所

出　　处：《中国药事》2008年第5期417-419,共3页Chinese Pharmaceutical Affairs

摘　　要：对31批对乙酰氨基酚片溶出过程进行了评价。实验采用FODT-601型光纤药物溶出/释放度原位过程监测仪,以水为溶出介质,桨法,转速50r.min-1,275nm作为测定波长,550nm作为参比波长,测定光程为1mm。采用本实验方法对药物溶出的全过程进行了监测,同时显示完整的药物溶出曲线图,对改进制剂工艺、监控制剂工艺稳定性及控制产品质量提供了有益的参考。实验结果显示光纤药物溶出/释放度原位过程监测法能够有效测定固体药物的体外溶出度,并能真实地反映药物溶出的全过程。In this article we evaluated the dissolution processes of paracetamol tablets （31batches）. The release processes of paracetamol tablets were determined directly with FODT--601 fiber--optic medicine dissolution/release rate process monitoring system. Water was used as dissolution medium, the rotation rate of paddle was 50r · min^-1. The detection wavelength was set at 275nm while the reference wavelength was 550nm. The detection length was lmm. This procession analysis can test the whole process of drug and get dissolution graph. It can provide useful information in preparation process improving, monitoring the stability of preparation and the quality control. This procession analysis can reflect the real dissolution and obtain the total information.

关 键 词：光纤溶出度过程监测法 溶出度 对乙酰氨基酚片 

分 类 号：R927.14[医药卫生—药学]