紫外光纤法过程监测头孢克肟5种固体剂型的体外溶出度

UV Fiber-optical Process Monitoring for Dissolution Behavior of 5 Solid Dosage Forms of Cefixime

摘要: 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。

Abstract: OBJECTIVE To develop an UV fiber-optical process monitoring method for dissolution behavior of five solid dosage forms of cefixime. METHODS Using the six channel fiber optical chemical sensor linked with-dissolving apparatus the dissolution rate of cefixime dispersible tablets was monitored by dynamic multiplying factor to eliminate interference of excipient. RESULTS The dissolution results measured by the instrument have no significant difference compared with the USP30-NF25. CONCLUSION The method needs no sampling and dilution. It can monitor the drug dissolution real-time.