光纤传感过程分析不同剂型头孢氨苄的溶出度

目的:建立紫外光纤监测头孢氨苄五种固体剂型的溶出度的方法,比较同一药物不同剂型溶出行为差异。方法:采用《中国药典》2010年版中头孢氨苄片溶出度测定方法,结合六通道光纤传感原位过程分析仪原位、在线监测头孢氨苄5种不同固体制剂溶出度。结果:不同剂型头孢氨苄溶出曲线能够反映释药特性,5种剂型释药行为各具特点。结论:光纤药物溶出仪具有实时、在线、过程监测的特点,所得溶出曲线可直观反映不同剂型药物释药特点,为全面评价药物内在质量和临床用药提供参考。

Dissolution Determination of Cephalexin from Different Preparations by Optical Fiber in Situ Process Analysis

ABSTRACT Objective: To develop a UV optical fiber in situ process monitoring method for the dissolution behavior of five cephalexin solid dosage forms and compare the drug dissolution behavior of different cephalexin preparations.Methods: The dissolution of five different cephalexin preparations was on line monitored according to the dissolution method for cephalexin tablets in Chinese Pharmacopeia (2010 edition) combined with a six channel optical fiber chemical sensor in situ dissolution monitor. Results: The dissolution curves could show the drug release characteristics of different cephalexin preparations, and the five different preparations exhibited various drug release features. Conclusion:An in situ, real time, on line and process analysis of dissolution can be obtained by optical fiber dissolution test system automatically. The release characteristics of different preparations can be presented through dissolution curves directly, which can provide reference for the overall assessment of drug internal quality and clinical medication.