橙皮苷栓剂的研制及质量评价  

The preparation of hesperidin suppository and its quality evaluation

作　　者：金辉[1] 林迦勒[1] 王陈翔[1] 周子晔[1] JIN Hui;LIN Jiale;WANG Chenxiang;ZHOU Ziye(Department of Pharmacy, the First Affilliated Hospital of Wenzhou Medical University, Wenzhou 325015, China)

机构地区：[1]温州医科大学附属第一医院药学部,浙江温州325015

出　　处：《温州医科大学学报》2019年第1期20-23,共4页Journal of Wenzhou Medical University

基　　金：温州市科技计划项目(Y20130218)

摘　　要：目的:制备一种主药为橙皮苷的栓剂,同时建立质量控制体系,并对其进行质量评价。方法:以橙皮苷为原料药,聚乙二醇400、聚乙二醇6000和甘油为基质,热熔法制备栓剂,并对其外观、药物含量均匀度、融变时限、重量差异进行评价。结果:橙皮苷栓剂外观呈棕色,室温下硬度较好,含量均匀度、重量差异、融变时限均符合栓剂要求。结论:本法制备的橙皮苷栓质量符合栓剂质量要求,适合作为橙皮苷的新剂型开发。Objective: To prepare hesperidin suppository and establish a quality control method.Methods: Hesperidin was used as an active ingredient.Polyethylene glycol 400,polyethylene glycol 6000 and glycerol were chosen as substrates.Fusion method was applied to prepare the hesperidin suppository.The content uniformity,appearance,melting time and weight variation were evaluated.Results: The hesperidin suppository showed brown appearance and desirable hardness at room temperature.The content uniformity,weight variation and melting time of hesperidin suppository prepared by this method met the requirements of quality control.Conclusion: The hesperidin suppository prepared by this method meet the quality requirements of suppository and may be developed as a new formulation of hesperidin.

关 键 词：橙皮苷 栓剂 制备工艺 质量评价 

分 类 号：R944.2[医药卫生—药剂学]