摘要
目的对36批卡托普利片溶出过程进行评价。方法采用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,转速为75r.min-1,220nm作为测定波长,550nm作为参比波长,测定光程为2mm。结果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。结论光纤药物溶出/释放度原位过程监测法能够快速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。
Objective To evaluate the dissolution processes of Captopril Tablets（36 batches）.Methods The release processes of Captopril 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 75r·min-1.The detection wavelength was set at 220nm while the reference wavelength was 550nm.The detection length was 2mm.Results This process analysis can test the whole process of drug dissolution and get dissolution graph.It can provide useful information in preparation process improving,monitoring the stability of preparation and the quality control.Conclusion This process analysis can reflect the real dissolution and obtain the total information.
出处
《中国药事》
CAS
2010年第10期989-990,1007,共3页
Chinese Pharmaceutical Affairs
关键词
光纤溶出度过程监测法
溶出度
卡托普利片
fiber optic chemical sensor dissolution test
dissolution
Captopril Tablets
