玉米须总黄酮提取物口腔崩解片的制备及质量控制  

Preparation and Quality Control of Oral Disintegrating Tablet with Extracts of Total Flavonoids from Zea mays

作　　者：景怡[1] 胡天惠[2] 

机构地区：[1]江苏淮阴工学院,江苏淮安223003 [2]甘肃中医学院,兰州730000

出　　处：《中国实验方剂学杂志》2012年第19期36-38,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：江苏省淮阴工学院青年教师基金项目(HGC1111)

摘　　要：目的:制备玉米须总黄酮提取物口腔崩解片并建立其质量控制方法。方法:采用粉末直接压片法制备,应用单因素试验考察压力、润滑剂和矫味剂;以崩解时限为参数,采用正交试验法优选崩解剂;以溶出度及含量均匀度为指标,考察其质量。结果:优选的处方为玉米须总黄酮提取物23%,交联聚乙烯吡咯烷酮(PVPP)15%,微晶纤维素(MCC)35%,桔子香精-甘露醇-阿司帕坦1.2∶5∶2,制得的口腔崩解片在30 s内崩解完全,口感良好。溶出度及含量均匀度都符合2010年版《中国药典》要求。结论:该制备工艺与质量控制方法简单可行。Objective：To prepare oral disintegrating tablet with extracts of total flavonoids from Zea mays,and establish its quality control method.Method：Tablets were prepared by direct compression from powder,Single factor test was employed to investigate pressure,lubricants and flavoring agent;With disintegration time as index,disintegrating agent was optimized by orthogonal design.Its quality was investigated with dissolution and content uniformity as indexes.Result：Optimized formulation was as follows：extracts of total flavonoids from Z.mays 23%,cross-linked polyvinylpyrrolidone 15%,microcrystalline cellulose 35%,orange flavor-mannitol-aspartame 1.2 ∶ 5 ∶ 2,These prepared tablets could disintegrate completely within 30 s and had good taste.Dissolution and content uniformity were in line with requirement of 2010 edition of ＇Chinese Pharmacopoeia＇.Conclusion：This preparation and quality control were simple and feasible.

关 键 词：玉米须总黄酮 口腔崩解片 崩解时间 质量控制 

分 类 号：R283.6[医药卫生—中药学]