银杏叶提取物掩味方法筛选及口腔崩解片制备

Study on masking methods to dispel the bitterness of Extractum Ginkgo Siccum(EGS) and its preparation of orally disintegrating tablets

目的研究用不同方法对银杏叶提取物掩味,并将其制备成口腔崩解片,对所得的片剂进行质量考察。方法以明胶为载体材料,采用研磨法、溶剂法及喷雾干燥法3种固体分散技术掩味;以口服后有无苦感为掩味评价指标,比较了研磨法、溶剂法及喷雾干燥法对银杏叶提取物的掩味效果;采用粉末直接压片制备其相应的口腔崩解片。结果3种掩味方法均基本可达到掩盖银杏叶提取物苦味的目的,制得的口腔崩解片口腔中60 s内完全崩解,且无苦味,无砂粒感,硬度均在2.0以上,脆碎度均小于0.5%,可满足片剂生产的基本要求,研磨法制备的片剂外观最好。结论采用固体分散技术可以达到掩盖银杏叶提取物苦味的目的,其口腔崩解片质量合格。

Objective To study different methods for masking the bitterness of extract of Ginkgo biloba （EGb）, to prepare its orally disintegrating tablets and to test their quantities. Methods Using gelatin as drug carrier, three solid dispersion methods were estimated. The masking powders were prepared through griding, coevaporation and spraydrying methods respectively. Three kinds of orally disintegrating tablets were prepared by direct compression methods subsequently. Results All of the three kinds of tablets gave satisfactory result. The tablets which tasted no bitterness and courseness were all disintergrated in the oral cavity within 60 s. The hardenss were above 2.0 and the friability were less than 0.5 %. The tablets prepared with grinding method looked better than the other two. Conclusions Solid dispersion method can meet the requirements of masking bitterness of extract of Ginkgo biloba, and the quantities of tablets were all up to grade.