掩味头孢呋辛酯干混悬剂的制备及含量测定

Preparation and content determination of taste-masked cefuroxime axetil for dry suspension

目的制备掩味头孢呋辛酯干混悬剂,并建立HPLC法对其含量进行测定。方法采用热熔喷雾冷冻技术制备掩味的头孢呋辛酯微粒,并将微粒及辅料通过流化床制粒法制备干混悬剂。色谱条件为Diamonsil-C18（250×4.6 mm,5μm）作色谱柱,流动相为0.2 mol/L磷酸二氢铵溶液-甲醇（58∶42）,流速为1.0 m L/min,检测波长为278 nm,柱温为30℃,进样量为20μL。结果所得制剂为类白色颗粒,气味芳香,味甜。头孢呋辛酯在25.00~750.0μg/m L的范围内浓度与峰面积呈良好的线性关系（r=0.9995）,样品平均回收率为99.88%,RSD为0.25%。结论本方法可成功制得掩味的头孢呋辛酯干混悬剂,检测方法准确、可靠、专属性强,适用于头孢呋辛酯干混悬剂的含量测定。

Objective To prepare taste-masked cefurxime axetil dry suspension and determine the content by HPLC. Methods Using the hot-melt spray technology to produce cefuroxime axetil particles for taste masking,then mixing the particles and other materials through the fluidized bed to produce dry suspension. HPLC was used to determine the content of cefurxime axetil with Diamonsil-C18column（ 250 × 4. 6 mm,5 μm）. The mobile phase consisted of 0. 2 mol / L ammonium dihydrogen phosphate solution and methanol（ 58 ∶42）,at a flow rate of 1. 0 m L / min,at detection wavelength278 nm. The column temperature was 30 ℃,and the sample volume was 20 μL. Results The preparation was off-white granule with cheerful fragrance and sweet taste. The linear range of cefurxime axetil was 25. 00 ~ 750. 0 μg / m L（ r = 0. 9995） with an average recovery of 99. 88%,RSD = 0. 25%.Conclusion The taste-masked cefurxime axetil dry suspension is successfully prepared by this method. The analytical method is accurate,reliable and specific and can be used to the content of cefuroxime axetil dry suspension.