光纤药物溶出度实时测定仪测定头孢呋辛酯片的溶出度

Process monitoring dissolution of Cefuroxime axetil tablets by fiber-chemical sensor

目的检测头孢呋辛酯片的溶出度,比较不同厂家的生产工艺及质量。方法采用光纤药物溶出度实时测定仪(FODT)检测头孢呋辛酯在0.1 mol·L-1盐酸中的溶出度,并与《中国药典》方法比较。结果两种方法所得结果无显著差异,3个厂家头孢呋辛酯片的溶出过程基本相似,在15 min溶出>92%,均符合药典规定。结论 FODT法用于检测固体制剂溶出度,不需取样即可获得完整的溶出曲线和相关数据,为评价药品内在质量、制剂稳定性提供了参考。

OBJECTIVE To detect the dissolution of Cefuroxime axetil tablets,and to compare the production technology and internal quality of different manufacturers.METHODS The dissolubility of Cefuroxime axetil tablets was detected in 0.1 mol·L-1 HCl mediums by fiber-optic dissolution test（FODT） system,and compared with the Chinese Pharmacopoeia（Ch P） method.RESULTS The dissolution results of measurement have not significant difference compared with the Ch P.The dissolution rate of samples exceeded 92% in 15 min and accorded with the Ch P.CONCLUSION FODT monitors the dissolution of solid preparation without sampling and continuous detection,and gets overall data.Assessments of internal quality and preparation stability have been provided.