光纤药物溶出度实时测定仪监测头孢氨苄片的溶出度 ____

目的：建立考察头孢氨苄片溶出过程的方法，初步评价制剂质量。方法：用光纤溶出度实时测定仪，以对照品法实时监测头孢氨苄片的溶出过程。结果：选取样品A6为参比制剂，其它样品为受试制剂，以10min、12min、14min、16min、20min和30min的溶出数据，采用相似因子f2法进行分析和比较溶出过程，同一厂家7批样品f2在50～100之间，溶出过程相似，另有3批f2小于50；不同厂家间f2均小于50。结论：光纤溶出度实时测定仪能够有效测定固体药物的体外溶出度，样品溶出过程的批内、批间差异均较大。

Aim:To establish a analysis method for the whole processes of dissolution of Cefalexin Tablets. Method: The release processes of Cefalexin Tablets were determined simultaneously with FODT-601 Fiber-optic Medicine Dissolution Process Real Time Test System. Results: The sample A6 was selected to be the reference, others were the test samples. We compare their dissolution rates at 10min、12min、14min、16min、20min and 30min by similar factor method. The f2 factor of sample A2、A3、A4、A5、A7 and A9 were between 50 to 100.Others’were less than 50. Conclusion: This process analysis can reflect the real disslution of solid medicine.The variance inter- batch and the variance intra- batch was comparatively large.