保健食品叶蓝明目胶囊制剂工艺及功效成分含量测定研究  

Study on Preparation Technology and Functional Component Determination of Yelan Mingmu Capsules

作　　者：李想 孙思琪 刘晓云 任雪阳 王宇 董英 宋若兰 魏胜利[1] 王秀环 折改梅[1] LI Xiang;SUN Si-qi;LIU Xiao-yun;REN Xue-yang;WANG Yu;DONG Ying;SONG Ruo-lan;WEI Sheng-li;WANG Xiu-huan;SHE Gai-mei(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区：[1]北京中医药大学中药学院,北京102488

出　　处：《食品与药品》2022年第4期314-318,共5页Food and Drug

基　　金：北京市科技计划课题:基于智能定制的“精准药材”全程溯源关键技术研究(编号:Z201100005420005)。

摘　　要：目的优化保健食品叶蓝明目胶囊的制剂工艺,并建立其功效成分叶黄素含量测定方法。方法以休止角、吸湿率和临界相对湿度为考察指标筛选最佳辅料,优化制剂工艺。通过堆密度测定,确定胶囊型号及装量。采用高效液相色谱法(HPLC)测定胶囊剂中叶黄素的含量。色谱柱:Eclipse Plus C_(18)色谱柱(250 mm×4.6 mm,5μm);流动相:甲醇-水(95:5),等度洗脱;柱温:室温;检测器波长:445 nm;进样量:10μl;流速:0.8 ml/min。结果填充剂药用糊精用量为原料粉重的22%,润滑剂二氧化硅用量为原料粉重的0.66%,混合20 min。灌装0号胶囊,装量规格为每粒0.3 g。以叶黄素粉代替叶黄素对照品建立含量测定方法,测定胶囊剂中叶黄素含量为18.87 mg/g。结论该制剂工艺稳定、可行。建立的方法适用于叶黄素的含量测定。Objective To optimize the preparation technology of health food Yelan Mingmu Capsules and determine the functional component xanthophyll.Methods The preparation process was optimized through screening of optimum excipients with angle of repose,moisture absorption and critical relative humidity as indexes.The type and loading capacity of the capsules were determined by bulk density measurement.For determination of xanthophyll of Yelan Mingmu Capsules,HPLC was adopted.The analysis was performed on an Eclipse Plus C_(18) column(250 mm×4.6 mm,5μm),using methanol-water(95:5)at a flow rate of 0.8 ml/min as mobile phase of isocratic elution.The column was kept at room temperature.The detector wavelength was 445 nm,and the injection volume was 10μl.Results The dosages of medical dextrin used as filling agent and silica used as lubricant were 22%and 0.66%of the weight of raw powder,respectively,and the raw powder and the excipients were mixed for 20 min.No.0 capsules were adopted,which were filled 0.3 g of powder per capsule.The content of xanthophyll was 18.87 mg/g.Conclusion The preparation process is stable and feasible,and the HPLC method is suitable for the determination of xanthophyll.

关 键 词：叶黄素 保健食品 制剂工艺 含量测定 

分 类 号：R943[医药卫生—药剂学]