基于动态倍率系数法光纤药物溶出度过程分析奋乃静片溶出度

目的：建立奋乃静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辅料对药物溶出的干扰，利用光纤药物溶出度实时测定仪（FODT）在线监测奋乃静片溶出度，并与《中国药典》进行对比。结果 FODT测定奋乃静片的过程溶出数据与《中国药典》方法对照无统计学差异，在10、17、60 min时溶出度绝对误差分别为4．15％、1．90％、1．53％。结论 FODT法无需手动取液、稀释等操作，结合相应的数学模型能实时监测药物溶出全过程，得到完整药物体外溶出曲线，为药物的内在质量评价提供了良好的检测手段。

Fiber-Optical In-situ montoring dissolution rate of perphenazine tablets using method of dynamic multiplying factor

Objective To develop an in-situ and process monitoring method for vitro dissolution rate of Per-phenazine tablets.Methods We adopted dynamic multiplying factor method to eliminate interference of excipient with the process of dissolution.We monitored the on-line dissolution rate of Perphenazine tablets by fiber optical chemical real-time sensor （FODT）.Results The dissolution results of FODT hadn＇t statis-tical difference compared with Chinese pharmacopoeia,and within 10,17,60 minutes the absolute error of dissolution was 4.15%,1.90% and 1.53%.Conclusion The method of FODT avoids the possible errors in the process of sampling and dissolution by hand.It can monitor the whole process of drug dissolution in combination with mathematical model and get a complete dissolution curve of drug in vitro.Therefore,it provides an effective means for evaluating the immanent quality of drug.