光纤原位动态倍率系数法监测头孢克肟分散片溶出度

Fober-Optical In-situ Montor Dissolution Rate of Cefixime Dispersible Tablets Using Method of Dynamic Multiplying Factor

关键词:  头孢克肟分散片  溶出度  光纤原位过程分析  动态倍率系数法

Key words:  cefixime dispersible tablets  dissolution rate  fiber optic in-situ process analysis  dynamic multiplying factor

摘要:

目的 建立头孢克肟分散片体外溶出度的原位过程分析方法。方法 采用动态倍率系数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)在线监测头孢克肟分散片溶出度。结果 FOCSDT的平均标准曲线方程为Y =179 X + 0.43，回归系数r=0.999 9。头孢克肟分散片的溶出数据与美国药典方法对照无统计学差异。结论 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，为药物的内在质量提供了良好的检测手段。

Abstract:

OBJECTIVE To develop an in-situ and process monitoring method for dissolution rate of cefixime dispersible tablets. METHODS Using the six channel fiber optical chemical sensor monitored the dissolution rate of cefixime dispersible tablets by method of dynamic multiplying factor to eliminate interference of excipient. RESULTS The average standard curve equation was Y=179X+0.43, r=0.999 9. The dissolution results of measurement using the instrument have not significant difference compared with the United States Pharmacopoeia(USP30-NF25). CONCLUSION The method does not need sampling, dilution, manual operation, shows the real dissolution of immediate release drug and is a accurate and reliable method.