应用光纤药物溶出仪对萘哌地尔片溶出度的考察___

摘要 目的：运用光纤药物溶出仪对萘哌地尔片溶出度进行全程的实时、原位测定，并与该品种已有国标溶出度测定结果进行比较。方法：运用FODT-601光纤药物溶出仪，选择280 nm/550 nm双波长法，消除赋形剂干扰，按国标溶出度检查法，测定溶出度曲线，并与紫外分光光度法测定结果进行比较。结果：光纤药物溶出仪测定法在6.17~49.36 μg•mL-1范围内，浓度（C）与吸收度（A）呈良好的线性关系，浓度对应的溶出量（Q,%） 与吸收度（A）也呈良好的线性关系，相关系数均在0.999以上 3个浓度各3份样在6个通道的平均回收率分别为101.0%,102.1%,101.2% 对应的RSD（n=18)分别为1.1%，0.7%，0.7%，其溶出曲线与紫外分光光度法测定的溶出曲线无显著性差异（P>0.05）。结论：萘哌地尔片光纤药物溶出仪测定结果与紫外分光光度法测定结果基本一致，而且光纤药物溶出度仪测定方法具有操作简便、测定快速、获取信息量更大的优点。

Abstract Objective:To examine the feasibility of a real time and process monitoring method of the dissolution of naftopidil tablets,and compared with medicine standard test method.Method:The dissolutions of six tablets were determined simultaneously with 601 fiber-optic medicine dissolution/release rate process monitoring system(FODT-601).The interference of adjutants was cancelled by two wavelengths(280 nm/550 nm）.The dissolution curve shown were completed by computer.Results:The calibration curve of naftopidil was linear in the range of 6.17-49.36 μg•mL-1(r>0.999) and the average recoveries at low,medium and high concentration were 101.0%,102.1%,101.2% with the RSD of 1.1%，0.7%，0.7%(n=18),respectively.Conclusion:The fiber-optic medicine dissolution/release rate process monitoring method can determine the dissolution of medicine effectively.