盐酸苯海拉明缓释片的制备  

Preparation of diphenhydramine hydrochloride sustained-release tablets

作　　者：刘欣洋 董锐 于洋懿 葛冰 胡湘婷 韩翠艳(指导)[1] LIU Xinyang;DONG Rui;YU Yangyi;GE Bing;HU Xiangting;HAN Cuiyan(College of Pharmacy,Qiqihar Medical University,Qiqihar 161006,China)

机构地区：[1]齐齐哈尔医学院药学院,黑龙江齐齐哈尔161006

出　　处：《中国高新科技》2024年第2期113-116,共4页

基　　金：2021年度黑龙江省大学生创新创业训练计划项目(202111230026)。

摘　　要：目的 :制备24h缓释的盐酸苯海拉明缓释片。方法 :建立盐酸苯海拉明紫外分光光度法的含量测定方法;以片剂成型情况确定制备工艺;以释放度为评价指标,筛选盐酸苯海拉明缓释片的骨架材料,确定处方;根据优选的处方工艺制备盐酸苯海拉明缓释片,考察其质量。结果 :紫外分光光度法:在纯化水中的标准曲线:y=0.0015x+0.015,r=0.9998,线性范围:130.5~451.7μg/mL;在模拟胃液中的标准曲线:y=0.0016x-0.0074,r=0.9993,线性范围:130.5~401.5μg/mL;在模拟小肠液中的标准曲线:y=0.0016x-0.0041,r=0.9991,线性范围:130.4~401.5μg/mL;在模拟结肠液中的标准曲线:y=0.0016x-0.0179,r=0.9991,线性范围:150.5~401.5μg/mL。精密度和回收率符合规定。优选的处方工艺为:盐酸苯海拉明75mg、乙基纤维素360mg、滑石粉15mg,粉末直接压片,压力70N。通过优选的处方及制备工艺制备的盐酸苯海拉明缓释片,片剂表面光滑整洁,片重差异及在不同释放介质中的释放度均在80%以上。结论 :以乙基纤维素为骨架材料制备的不溶性盐酸苯海拉明骨架片,可缓慢释放24h,制备工艺简单,造价成本低。Objective:to prepare 24h extended-release diphenhydramine hydrochloride sustained-release tablets.Methods:diphenhydramine hydrochloride content determination method is established by ultraviolet spectrophotometry,the preparation process is determined by the forming of the tablets.To screen of the skeleton material of diphenhydramine hydrochloride sustained-release tablets to determine the prescription took by the degree of release.The diphenhydramine hydrochloride extended-release tablets is prepared according to a preferred prescribing process and its quality is examined.Results:in UV spectrophotometry:standard curves in purified water:y=0.0015x+0.015,r=0.9998,linear range:130.5-451.7μg/mL;standard curves in simulated gastric juice:y=0.0016x―0.0074,r=0.9993,linear range:130.5-401.5μg/mL;standard curve in simulated small intestinal fluid:y=0.0016x-0.0041,r=0.0091,linear range:130.4-401.5μg/mL;standard curve in simulated colonic fluid:y=0.0016x―0.0179,r=0.0091,linear range:150.5-401.5μg/mL.Precision and recovery rates comply with regulations.The preferred prescription process is:diphenhydramine hydrochloride 75 mg,ethylcellulose 360 mg,talc 15 mg,powder direct tableting,pressure 70N.Diphenhydramine hydrochloride sustained-release tablets prepared by preferred prescription and preparation process,the tablet surface is smooth and tidy,the difference in tablet weight and the degree of release in the same release medium are more than 80%.Conclusion:the insoluble diphenhydramine hydrochloride skeleton tablets prepared with ethyl cellulose as the skeleton material can be slowly released for 24h,the preparation process is simple,and the cost is low.

关 键 词：盐酸苯海拉明缓释片 标准曲线 乙基纤维素 释放度 

分 类 号：R969[医药卫生—药理学]