摘要
目的对5个厂家法莫替丁片进行溶出度实时监测,考察各产品的质量。方法设定波长266 nm,基准校正波长550 nm、温度37℃、转速100 r.min-1、数据采集间隔时间30 s、监测时间30min,以900 ml的磷酸二氢钾缓冲液(pH4.5)为溶出介质,转篮法,用光程为5 mm的光纤探头监测法莫替丁片的溶出曲线。结果5个不同厂家法莫替丁片的溶出度均符合《中国药典》规定,但是各溶出曲线存在差异。结论光纤药物溶出度实时测定仪能准确、连续、定量地反映药物的溶出过程,获得的数据更加完整、真实,可比较出不同厂家之间同品种药物的溶出过程的差异。
Objective To study the quality of famotidine tablets from five different pharmaceutical factories with the new method for fiber-optic real time dissolution test system. Method Each famotidine tablets was dissolved in 900 ml of potassium dihydrogen phosphate buffer （pH 4.5） at 37℃, and the dissolution was monitored with 5mm fiber optic probe. The paddle method was used at the rate of 100 r · min^-1, and signals were detected at 266 nm against the reference wavelength of 550 nm. Dissolution data were collected every 30 seconds during a 30-min run. Results The dissolution of famotidine tablets produced by all the five factories are qualified to the standards of Chinese pharmacopoeia, but a significant different 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 different in dissolution for the same drug among different manufactories can be detected in suit.
出处
《东南国防医药》
2009年第2期134-138,共5页
Military Medical Journal of Southeast China
关键词
法莫替丁片
光纤传感系统
溶出度
Famotidine tablets
Fiber-optic sensor
Dissolution
