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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 develop levofloxacin oral tablets and to control its quality. Methods: Taking the mouthfeel and dissolution of the tablets as indexes, taking the amount of the inclusion compound of lactose, sucrose and menthol as β-cyclodextrin as the investigation factors, the orthogonal design of the three factors and three levels was adopted to optimize the effect of levodropropizizin The film’s prescription, and its quality inspection. Results: The optimized prescriptions were as follows: levodropropizine 6.0 g, sucrose powder 60.0 g, stevia 8.0 g, menthol β-cyclodextrin inclusion 6.3 (1.2) g, hydroxypropylmethylcellulose 0.6 g , Magnesium stearate 0.4 g, oral tablets of the indicators in line with the “Chinese Pharmacopoeia” 2010 edition two provisions. Conclusion: The preparation process of levodropropizizal buccal tablets is reasonable, scientific and suitable for industrialized production.