摘要
目的:使用光纤药物溶出度实时测定仪FODT-601,实时监测国内6个不同厂家尼莫地平片的溶出度曲线,以评价其工艺质量。方法:设定测定波长238 nm、基准校正波长550 nm、温度37℃、转速75 r.min-1、数据采集间隔时间30 s、监测时间30 min,以900 mL醋酸盐缓冲液(pH4.5;含0.3%十二烷基硫酸钠)为溶出介质,桨法,用光程为2 mm的光纤探头监测尼莫地平片的溶出曲线。结果:6个不同厂家尼莫地平片的溶出度均符合《中国药典》规定,但各溶出曲线存在差异。结论:光纤药物溶出度实时测定仪准确、连续、定量地反映了药物的溶出过程,获得的数据信息更加完整、真实,可比较出不同厂家之间同种药品的溶出过程差异。
Objective：To monitor the in situ dissolution of nimodipine tablets produced by six factories and to investigate the difference in qualities between the tablets by using fiber-optic sensor dissolution test system FODT-601. Method： Each nimodipine tablet was dissolved in 900 mL of acetate buffer （pH4.5） containing 0.3% sodium dodecyl sulfate at 37℃, and the dissolution was monitored with 2 mm fiber optic probe. The paddle method was used at the rate of 75 r·min^- 1 and signals were detected at 238 nm against the reference wavelength of 550 nm. Dissolution data were collected every 30 seconds during a 30-min run. Results： The dissolutions of nimodipine tablets produced by all the six factories are qualified to the standards of Chinese pharmacopoeia, but a significant difference was observed in their dissolution curves. Conclusion： The fiber-optic sensor dissolution test system is capable of monitoring the real dissolution process of a drug and supplying more complete and accurate details of the dissolution process, so that the difference in dissolution for the same drug among different manufactories can be detected in situ.
出处
《药学与临床研究》
2008年第4期270-273,共4页
Pharmaceutical and Clinical Research
基金
南京军区卫生专业人才培养"122"工程资助项目(编号:07M109)
关键词
尼莫地平片
光纤传感系统
溶出度
Nimodipine tablets
Fiber-optic sensor
Dissolution
