摘要
目的以盐酸苯海拉明和咖啡因为模型药物,研制盐酸苯海拉明咖啡因口腔崩解片。方法采用盐酸苯海拉明与硬脂酸熔融制粒掩味,交联羧甲基纤维素钠(CCMC-Na)为崩解剂,用干粉直接压片法制备盐酸苯海拉明咖啡因口腔崩解片。采用正交实验优化处方,达到最短崩解时间和最佳矫味效果。结果最优处方中含主药盐酸苯海拉明25 mg、咖啡因60 mg、硬脂酸25 mg、阿司帕坦40 mg、蓝莓香精7 mg、甘露醇45 mg、MCC 210 mg、CCMC-Na 25 mg、SDS 8 mg、硬脂酸镁5 mg。结论盐酸苯海拉明咖啡因口腔崩解片制剂可行,质量可控。
Objective To optimize the formulation and preparation of diphenhydramine hydrochloride and caffeine orally disintegrating tablet.Methods Melt granulation technology of steric acid and API was used to mask the unpleasant tasting of diphenhydramine hydrochloride.The tablets were prepared by direct pressing the dry powder with CCMC-Na as disintegrating agent.The formulation was optimized by orthogonal experiments to achieve the shortest disintegration time and the best taste correction.Results The optimized formula of orally disintegrating tablet was as follows:diphenhydramine hydrochloride 25 mg,caffeine 60 mg,stearic acid 25 mg,aspatan 40 mg,blueberry essence 7 mg,mannitol 45 mg,MCC 210 mg,CCMC-NA 25 mg,SDS 8 mg and magnesium stearate 5 mg.Conclusion This preparation method for orally disintegrating tablet of diphenhydramine hydrochloride and caffeine is practical and easy for quality control.
作者
樊莉
曾媛
谢向阳
刘辉
熊菁
张莹
原源
FAN Li;ZENG Yuan;XIE Xiangyang;LIU Hui;XIONG Jing;ZHANG Ying;YUAN Yuan(Department of Pharmaceutics,School of Pharmacy,Naval Medical University,Shanghai 200433,China;Medical Security Center,the General Hospital of Central Theater Command of the PLA,Wuhan 430070,China;College of Pharmacy,Hubei University of Chinese Medicine,Wuhan 430065,China;Drug Supply Station of Medical Support Center,No.905 Hospital of Naval Medical Univeresity,Shanghai 200052,China)
出处
《药学实践与服务》
CAS
2023年第1期45-49,共5页
Journal of Pharmaceutical Practice and Service
关键词
口腔崩解片
盐酸苯海拉明
咖啡因
orally disintegrating tablet
diphenhydramine hydrochloride
caffeine
