吉非替尼片的工艺研究和溶出曲线评价

Technical Study and Dissolution Curve Evaluation of Gefitinib Tablets

目的对吉非替尼片工艺进行研究,并评价自制片的溶出曲线。方法对关键工艺步骤粉碎、混合、干燥进行研究,拟定吉非替尼片的溶出度测定方法,评价自制制剂和参比制剂的溶出曲线相似性。结果自制制剂和参比制剂的体外溶出相似,样品加速6个月后体外溶出相似。结论吉非替尼片处方设计合理,制备工艺可行,产品稳定性好。

Objective To study the preparation process of Geftinib Tablets and to evaluate the dissolution curves of the self-made tablets. Methods The key process steps including grinding, mixing and drying were studied, and the dissolution profles of the self-made and reference tablets were evaluated. Results The in vitro dissolution profles of the self-made and the reference tablets were similar. After 6 months of acceleration, their in vitro dissolution profles were still similar. Conclusion The formulation of Geftinib Tablets is reasonable, the preparation process is feasible and the product stability is good.