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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。
OBJECTIVE: To establish a method for monitoring the dissolution of cefalexin five solid dosage forms by ultraviolet light and to compare the dissolution behavior of different dosage forms of the same drug. Methods: The dissolution of cephalexin tablets in the 2010 edition of Chinese Pharmacopoeia was used in combination with the six-channel fiber-optic in situ process analyzer in situ for on-line monitoring of the dissolution of cephalexin in five different solid preparations. Results: The cefalexin dissolution curves of different formulations can reflect the drug release characteristics, and the drug release behaviors of the five formulations have their own characteristics. 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 and provide a reference for the comprehensive evaluation of the intrinsic quality and clinical application of the drug.