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目的:采用光纤化学传感技术,实时、在位监测米非司酮片的溶出度。方法:运用E_(1cm)~(1%)值法监测米非司酮片的溶出全过程。结果:本法监测的溶出过程曲线与《中国药典》2005年版方法手动取样测定所拟合的曲线基本一致。结论:光纤药物溶出度监测仪可以准确测定固体药物的体外溶出度,真实地反映药物溶出的全过程。
OBJECTIVE: To monitor the dissolution of mifepristone tablets in real time using optical fiber chemical sensing technology. Methods: The total dissolution of mifepristone tablets was monitored by E_ (1cm) ~ (1%) value method. Results: The curve of the dissolution process monitored by this method was basically consistent with the curve fitted by the manual sampling method of the 2005 edition of Chinese Pharmacopoeia. Conclusion: The optical fiber drug dissolution monitor can accurately measure the in vitro dissolution of solid drugs and truly reflect the whole process of drug dissolution.