应用显微红外法研究头孢呋辛酯片剂晶型

Study on polymorphs of cefuroxime axetil in tablets by FT-IR microspectroscopy

制备头孢呋辛酯α和β两种晶型,将α,β和无定型三种晶型分别制成片剂.应用显微红外光谱法对不同制备工艺的头孢呋辛酯片剂中药物晶型进行研究.实验结果表明:α和β和无定型粉末压片与无定型湿法压片的片剂在60min溶出度分别为51.5±0.8%,42.3±0.8%,70.4±1.2%,61.7±1.0%.湿法压片造成片剂中部分无定型头孢呋辛酯向α晶型转变,而粉末压片未造成片剂中头孢呋辛酯晶型发生转变.应用显微红外光谱法可用于片剂中药物晶型的检测,该方法简便、可靠,可应用于片剂工业生产的在线检测.

The α, β forms of eefuroxime axetil and polymorphs of cefuroxime axetil tablets were prepared. The polymorphs of cefuroxime axetil in tablets was studied by FT-IR 60 min respectively, while amorphous forms tablets prepared by wet granulation tabletting was 61.7±1.0% at 60 min. The amorphous forms of cefuroxime axetil was transformed in the wet granulation tableting, while the polymorphs of cefuroxime axetil was not transformed in the powder tableting. The application of FT-IR mierospectroscopy can be used for the detection of drug crystal forms. This method is simple, reliable and can be used for the tablets on-line detection in industrial production.