过程分析比较不同剂型头孢羟氨苄溶出度

Study the Drug Dissolution of Cefadroxil from Different Preparation by Process Analysis

关键词:  头孢羟氨苄  光纤传感药物溶出度过程检测仪  过程分析  溶出度

Key words:  cefadroxil  fiber-optic dissolution test system  process analysis  dissolution

摘要:

目的 建立过程分析测定头孢羟氨苄颗粒药物溶出度的方法，比较同一药物不同剂型溶出行为差异。方法 采用对照品法，光纤药物溶出度实时测定仪过程监测头孢羟氨苄3种剂型溶出度，利用溶出度曲线比较不同剂型药物释药特性。结果 头孢羟氨苄颗粒的溶出度方法能够反映其释药特性，3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。

Abstract:

OBJECTIVE To establish a method which can on-line monitor the dissolution of cefadroxil granules. Compare the drug dissolution behavior of different cefadroxil preparation. METHODS Control article method was applied in the study. Monitor the dissolution of cefadroxil from three different preparation by fiber-optic dissolution test system. Compare the characteristics of drug release from three different preparations by dissolution curves. RESULTS The release characteristics of cefadroxil granules can be presented through this method. There is different feature from three different preparations. CONCLUSION An in-situ, real time, on-line and process analysis of dissolution of drug can be obtained by fiber-optic dissolution test system automatically. The release characteristics of different preparation can be presented through dissolution curves directly. An overall assessment of internal quality and clinical medication can be provided.