f_2因子法评价头孢克肟颗粒溶出曲线相似性

Research of dissolution characteristics of cefixime granules at f_2 factor

目的评价待上市产品与市售产品体外溶出行为的相似性。方法桨法测定溶出度,紫外分光光度法检测,用威布尔分布模型提取溶出参数t50、td、m,并采用f2相似因子法评价受试制剂和市售参比制剂溶出曲线的相似度。结果在4种溶出介质0.1mol/L盐酸、纯水、pH 6.8与pH 7.2磷酸盐缓冲液下,受试制剂与参比制剂的相似因子分别为56.66、69.24、69.46和77.64。结论受试制剂与参比制剂在4种不同介质下溶出曲线相似,提示该试验药品处方合理,生产工艺稳定可靠。

Objective To observe the similarity of dissolution profiles of cefixime granules between two different kinds of manufactures. Methods To determine the dissolution percentage by authorized methods from ChP 2010, the methods were authenticated in different mediums introduced, and the similary of dissolution curve was evaluated by f2 factor. Results To compare with cefixime granules of reference product, the similarity factors of the dissolution curve from manufacturers were 56.66, 69.24, 69.46 and 77.64 in mediums of aid, water, PBS 6.8 and PBS 7.2, respectively. Conclusion The dissolution of characteristics of manufactures from pharmcy factory a was similar to the reference product.