摘要
目的:采用湿法制粒,对伏格列波糖片制备工艺及质量评价进行考察,优化处方工艺。方法:在预试验的基础上,影响因素主要考察崩解剂、黏合剂和润滑剂,以溶出度相似因子(f_(2))作为考察指标,采用正交设计法,优选处方工艺,并对最佳工艺进行验证性实验。结果:最优化的条件为:崩解剂(6%(质量分数)低取代羟丙纤维素),黏合剂(5%(质量分数)羟丙甲纤维素),润滑剂(1%(质量分数)硬脂富马酸钠)。结论:该设计合理,易于操作,自制制剂与参比制剂的溶出行为相似。
Objective:To investigate the preparation technology and quality evaluation of Voglibose tablet by wet granulation method,and optimize the formulation technology.Methods:On the basis of pre-test,disintegrators,adhesives and lubricants were used as influencing factors,dissolution similarity factor(f_(2))was used as investigating index,orthogonal design method was used to optimize the formulation process,and the best process was verified.Results:The optimum conditions were:disintegrator(6%low-substituted hydroxypropyl cellulose),binder(5%hydroxypropyl methylcellulose),lubricant(1%sodium stearate fumarate).Conclusion:The design is reasonable and easy to operate.The dissolution behavior of the self-made preparation is similar to that of the reference preparation.
作者
王书兰
张怡
梁星
尹可欣
陈家香
熊莉平
WANG Shulan;ZHANG Yi;LIAN Xing;YIN Kexin;CHEN Jiaxiang;XIONG Liping(Southwest Pharmaceutical Co.,Ltd.,Chongqing 400038,China)
出处
《山东化工》
2025年第14期52-54,共3页
Shandong Chemical Industry
关键词
伏格列波糖片
溶出度
相似因子
voglibose tablet
dissolution
similarity factor
