用光纤化学传感器连续在位监测甲硝唑片的体外溶出度

CONTINUOUS IN SITU MONITORING OF THE DISSOLUTION RATE OF METRONIDAZOLE TABLETS USING A FIBER-OPTIC CHEMICAL SENSOR

采用８０年代发展的新技术——光纤化学传感器连续在位监测了甲硝唑片的体外溶出过程，溶出曲线用三参量双指数函数拟合。方法的回收率为９９．７～１０２．３％，日内、日间精密度的相对标准偏差（ＲＳＤ）均小于３．０％。经与ＵＳＰ（ＸＸＩＩ）方法对照，各时间甲硝唑累积溶出量和拟合后提取的参数（除延迟时间Ｔｌａｇ）均无显著差异（ｐ＞０．０５）。甲硝唑片的主要溶出方式为未崩解片剂表面直接溶出．

A new approach to the continuous monitoring in situ of the dissolution rate ofmetronidazole tablets using fiber-optic chemical sensor( FOCS )without fiItering and sampling isreported.It provided increasing amount of information on the dissolution test of tablets.The range ofrecovery(%)of the proposed method was 99.7￣102.3%,The precision(RSD)of within-day andday-to-day was less than 4%.The three parameter biexponential(TPBE)function was used to fit thedissolution curve,The results of measurement for the dissolution test of metronidazole tablets usingFOCS were in agreement with those of USP(XXII) method,and the FOCS methed was simple andaccurate。