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目的:研究西格列汀二甲双胍片的最优处方,以期得到与原研捷诺达相似的溶出曲线。方法:以溶出度、外观、硬度和偏重差异为考察指标,通过单因素实验,筛选出最优处方,比较自制制剂和参比制剂在4种介质中的溶出曲线。结果:选用MCC为稀释剂,PVP K30为黏合剂,SDS为增溶剂,硬脂富马酸钠为乳化剂。MCC采用外加的方法,PVP K30为27 mg·片~(-1),SDS为14 mg·片~(-1),硬脂富马酸钠为7 mg·片~(-1)。15 min之内,自制制剂和参比制剂在4种溶出介质中的溶出度均大于85%,两者的溶出曲线相似。结论:西格列汀二甲双胍片的制备方法简单可行,满足大生产的需要。
Objective: To study the optimal formulation of sitagliptin metformin tablets in order to obtain a similar dissolution curve with the original Kennard . Methods: Taking dissolution, appearance, hardness and weight difference as indexes, the optimal prescription was screened by single factor experiment, and the dissolution profiles of homemade and reference preparations in four kinds of media were compared. Results: MCC was selected as diluent, PVP K30 as binder, SDS as solubilizer and sodium stearyl fumarate as emulsifier. MCC applied an additional method, PVP K30 was 27 mg · tablets -1, SDS 14 mg · tablets -1, sodium stearyl fumarate 7 mg · tablets -1. Within 15 min, the dissolution rates of homemade preparations and reference preparations in all four dissolution media were all above 85%. The dissolution curves of the two preparations were similar. Conclusion: The preparation of sitagliptin metformin tablets is simple and feasible to meet the needs of large-scale production.