头孢呋辛酯片处方工艺研究及溶出曲线一致性评价

Study on Formulation of Cefuroxime axetil Tablets and Evaluation Consistency of Dissolution Curve

由头孢呋辛酯,交联聚维酮、微晶纤维素、羟丙纤维素、二氧化硅和硬脂酸镁,制备了头孢呋辛酯片,并考察处方工艺与体外溶出曲线。采用干法制粒工艺,通过设计正交试验考察粘合剂羟丙纤维素用量(A)、崩解剂交联聚维酮用量(B)、润滑剂硬脂酸镁用量(C),进行配方筛选,确定最佳处方为A1B2C2,与参比制剂进行4种介质的溶出曲线对比,发现3批样品批间稳定性好,且与参比制剂的溶出曲线一致。

Cefuroxime axetil tablets were made of cefuroxime axetil, crospovidone, microcrystalline cellulose, hyprolose, silicon dioxide and magnesium stearate, and the prescription process and the dissolution curves in vitro were investigated. Through adopting dry granulation process, designing the orthogonal test and examining the amount of adhesive hyprolose（A）, the amount of disintegrants crospovidone（B） and the amount of lubricant magnesium stearate（C）, the formulation was screened and the best prescription were A1B2C2. By comparing dissolution curves of four media with the reference formulation, it was found that the three batches of samples had good stability, and consisted with the dissolution curves of the reference formulation.