【摘要】 目的:建立测定头孢拉定胶囊中的高分子杂质(头孢拉定聚合物)的方法。方法:采用凝胶色谱法。色谱柱为Sephadex G-10(40~120μm)凝胶柱,流动相A为0.2 mol.L-1磷酸盐缓冲液(pH 8.0),流动相B为水,流速为1.0 ml.min-1;检测波长为254 nm。结果:头孢拉定胶囊的高分子杂质含量均小于0.5%。结论:方法灵敏、准确、简便,可用于本品的质量控制,对提高临床有效性及安全性有利。以此方法测定国内10个厂家头孢拉定胶囊的高分子杂质,结果发现,香港澳美制药厂的产品高分子杂质含量最低,优于其它厂家。更多还原

【Abstract】 AIM: To develop a method for the determination of high molecular weight impurities in Cephradine Capsule.METHODS: Gel filtration chromatography was adopted.The analytical column was Sephadex G-10 gel column.The mobile phase was consisted of A,（0.2）(mol·L^-1) phosphate buffer（pH（8.0）） and B,water.The flow rate was（1.0）(ml·min^-1).The detection wavelength was at UV 254 nm.RESULTS: The content of high molecular weight impurities in Cephradine Capsule is less than（0.5）%.CONCLUSION: The method is sensitive,accurate,simple and convenient enough to be used for the quality control of Cephradine Capsule.更多还原