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目的建立紫外光纤监测头孢克肟5种固体剂型的溶出度的方法。方法采用美国药典中头孢克肟片溶出度测定方法,结合六通道光纤传感原位过程分析仪原位、在线监测头孢克肟5种不同固体制剂溶出度。结果原位光纤法测定头孢克肟固体制剂的溶出数据与美国药典方法对照无统计学意义。结论原位光纤法无需取液、稀释等手工操作,能实时监测药物溶出全过程,为药物内在质量的检测提供良好的手段。
Objective To establish a method for monitoring the dissolution of five solid dosage forms of cefixime by ultraviolet light. Methods The dissolution of cefixime in tablets of the United States Pharmacopoeia was studied in combination with the six-channel fiber-optic in situ process analyzer in situ for on-line monitoring of the dissolution of cefixime in five different solid preparations. Results In-situ optical fiber method for the determination of cefixime solid dissolution data and the United States Pharmacopoeia control method was not statistically significant. Conclusion The in situ optical fiber method can be used for real-time monitoring of the whole process of drug dissolution without manual operation such as taking liquid and diluting, which provides a good means for the detection of intrinsic quality of drugs.