左羟丙哌嗪口含片的处方工艺研究及质量控制  

Preparation and Quality Control of Levodropropizine Buccal Tablets

作　　者：李厚洋[1] 吴开慧[1] 

机构地区：[1]常德市第一人民医院药剂科,湖南常德415003

出　　处：《中国药师》2014年第7期1124-1127,共4页China Pharmacist

摘　　要：目的:研制左羟丙哌嗪口含片并对其进行质量控制。方法:以含片口感,溶出度为考察指标,以乳糖,蔗糖,薄荷脑β-环糊精包合物用量为考察因素,采用3因素3水平正交设计法优化左羟丙哌嗪口含片的处方,并对其质量进行考察。结果:优化所得最佳处方:左羟丙哌嗪6.0 g,蔗糖粉60.0 g,甜菊素8.0 g,薄荷脑β-环糊精包合物6.3(1.2)g,羟丙甲基纤维素0.6 g,硬脂酸镁0.4 g,口含片的各项指标符合《中国药典》2010年版二部规定。结论:左羟丙哌嗪口含片的制备工艺合理,科学,可适合工业化生产。Objective：To study the formula,preparation technology and quality control of levodropropizine buccal tablets.Methods：According to the orthogonal design method with 3 factors and 3 levels,the formula was optimized using the taste and dlissolution rate as the evaluation indices,and the amount of lactosum,sugar and menthol β-cyclodextrin inclusion compound as the influencing factors.The quality of levodropropizine buccal tablets was also evaluated.Results：The optimal formula of levodropropizine buccal tablets was as follows：levodropropizine 6.0g,sugar 60.0g,steviosin 8.0g,menthol β-cyclodextrin inclusion compound 6.3 （1.2） g,hydroxypropyl methyl cellulose 0.6g,and magnesium stearate 0.4g.The indicators of buccal tablets were all accorded with the requirements of Chinese pharmacopeia （2010 edition）.Conclusion：The preparation process of levodropropizine buccal tablets is rational and scientific,which can be used in the industrial production.

关 键 词：左羟丙哌嗪 含片 薄荷脑β-环糊精包合物 处方 工艺研究 

分 类 号：R944.4[医药卫生—药剂学]