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采用双波长法消除赋形剂的干扰,利用六通道光纤化学传感原位过程分析仪(FOCSDT)在线监测阿莫西林分散片溶出度。FOCSDT的平均校准曲线方程为y=188.38x+0.7607,回归系数r为0.9998。阿莫西林分散片的溶出数据与中国药典(Ch.P)方法对照无显著性差异。FOCSDT法无需取液、稀释等手工操作,能实时监测药物溶出全过程,为速释制剂内在质量的检测提供良好的手段。
Dual-wavelength method was used to eliminate the interference of excipients. The dissolution of amoxicillin dispersible tablets was monitored on-line with a six-channel FOCSDT in-situ process analyzer. The average calibration curve equation of FOCSDT is y = 188.38x + 0.7607, and the regression coefficient r is 0.9998. The dissolution data of amoxicillin dispersible tablets showed no significant difference with the Chinese Pharmacopoeia (Ch.P) method. FOCSDT method without liquid extraction, dilution and other manual operations, real-time monitoring of drug dissolution of the whole process for the rapid release of the internal quality of preparations provide a good measure.