盐酸格拉司琼口腔崩解片的试制

Trial-manufacturing of the Granisetron Hydrochloride orally disintegrating tablets

目的:研制盐酸格拉司琼口腔崩解片,并对其进行质量评价。方法:以崩解时间和口感为主要指标,优化处方和工艺,采用全粉末直接压片法制备盐酸格拉司琼口腔崩解片。结果:结果表明所制备的盐酸格拉司琼口腔崩解片崩解时间在35 s以内,口感良好,其他指标均符合有关规定。结论:所筛选的处方合理,制备工艺简便,适宜于大生产,质量可控。

Objective： Research to manufacture the granisetron hydrochloride orally disintegrating tablets and to evaluate it＇s quality. Methods： Using disintegration time and oral feeling as the main evaluation parameter , grading-up prescription and product craft, the tablets were prepared by powder direct eompression. Results： The dissolution time of Granisetron Hydrochloride disintegrating tablet in oral cavity was 35 s and had a good oral feeling, the other parameter all meets the provision. Conclusion： This prescription is reasonable and product craft is simple , it can be used in industrial product and quality controllable.