银杏酮酯口腔崩解片的制备  

Preparation of Ginkgo Biloba Ketone Ester Orally Disintegrating Tablets

作　　者：张国伟 曾媛 都胜男 刘辉 丁世芳 ZHANG Guowei;ZENG Yuan;DU Shengnan;LIU Hui;DING Shifang(Medical Support Center,General Hospital of Central Theater Command,Wuhan Hubei 430070,China)

机构地区：[1]中部战区总医院医疗保障中心,湖北武汉430070 [2]武汉大学中南医院药学部 [3]中部战区总医院心血管内科

出　　处：《联勤军事医学》2024年第4期285-288,308,共5页Military Medicine of Joint Logistics

摘　　要：目的研究银杏酮酯口腔崩解片(Ginkgo biloba ketone ester orally disintegrating tablets,GBKE-ODT)的制备工艺,并优化处方。方法以片剂的口感、崩解时间和压片难易程度作为评价指标,采用正交设计试验评价筛选GBKE-ODT的最佳处方组成,并优化制备工艺。结果本研究制备的GBKE-ODT处方:预混辅料Prosolv~?ODT作为填充剂,用量为248 mg,银杏酮酯(Ginkgo biloba ketone ester,GBKE)40 mg,阿司帕坦7.5 mg,薄荷香精1.5 mg,硬脂酸镁为3 mg,崩解时间在29 s以内。选用粉末直压工艺制备GBKE-ODT。结论GBKE-ODT崩解迅速,口感良好,溶出度高,符合ODT的质量要求。Objective To study the preparation process and optimize the formulation of Ginkgo biloba ketone ester orally disintegrating tablets(GBKE-ODT).Methods Using the taste of the tablet, the disintegration time and the degree of difficulty or ease of tablet pressing as evaluation indicators, an orthogonal design experiment was used to evaluate and screen the best prescription composition of GBKE-ODT, and to optimize the preparation process.Results The GBKE-ODT prescription prepared in this study: the filler was the premixed auxiliary materials Prosolv~? ODT 248 mg, Ginkgo biloba ketone ester(GBKE) 40 mg, aspartame 7.5 mg, mint essence 1.5 mg, magnesium stearate 3 mg, disintegration time within 29 s, and GBKE-ODT was prepared using powder direct pressing technology.Conclusion The GBKE-ODT prepared in this experiment has a rapid disintegration, good taste, high solubility, which meets the quality requirements of ODT.

关 键 词：银杏酮酯 口腔崩解片 正交试验 制备工艺 预混辅料 

分 类 号：R285.5[医药卫生—中药学]