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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。
Objective To establish a method to analyze the dissolution of cefadroxil granules and compare the dissolution behavior of different dosage forms of the same drug. Methods The dissolution rate of three formulations of cefadroxil was monitored by the reference substance method and the real-time optical fiber drug dissolution testing instrument. The dissolution profiles of different formulations were compared by using the dissolution curve. Results The dissolution rate of cefadroxil granules could reflect the release characteristics of the three formulations of the drug release behavior of each characteristic. Conclusion The optical fiber drug dissolution instrument has the characteristics of real-time, on-line and process monitoring. The obtained dissolution curve can directly reflect the drug release characteristics of different dosage forms, providing a reference for comprehensive evaluation of drug intrinsic quality and clinical use.