硒酵母咀嚼片处方及工艺研究  

Study on Formula and the Production Process of Selenium Yeast Chewable Tablets

作　　者：李振宇 杨茹 LI Zhenyu;YANG Ru(Heilongjiang Beiyelong Pharmaceutical Technology Co.,Ltd.,Harbin Heilongjiang 150036,China;Harbin Pharmaceutical Group Co.,Ltd.,Harbin Heilongjiang 150010,China.)

机构地区：[1]黑龙江北野龙医药科技有限公司,黑龙江哈尔滨150036 [2]哈药集团股份有限公司,黑龙江哈尔滨150010

出　　处：《药品评价》2021年第12期719-721,共3页Drug Evaluation

摘　　要：目的:研发一种精准补硒新产品。方法:参考《中国居民膳食指南》《中国居民膳食营养素参考摄入量》及我国日均硒摄入量,经计算确定每人每日最佳补硒量并筛选合适剂型、剂量,辅料经正交试验筛选最佳配比,进而确定科学合理的处方,并经生产工艺优化而制得新产品。结果:稀释剂甘露醇:麦芽糊精:L-HPC=4∶4∶1时硬度适中,外表光滑美观;50%酒精作为润湿剂较佳;硬脂酸镁∶滑石粉=2∶1时润滑助流效果较佳,此时休止角为30°,堆密度为0.61 g/cm;柠檬酸∶甜菊糖苷=5∶1时酸甜味道最佳;栀子黄含量为0.05%时,颜色较美观。采用常规的湿法制粒法生产,其中50%酒精与物料比为1∶10时制软材较好,40~50 kN压力下片剂硬度为适宜的60 N。结论:本实验所生产的硒酵母咀嚼片具有补硒科学精准,易于生产、便于携带、服用方便、口感较好等特点。Objective:According to the current situation that the specification of selenium supplement drugs and health food on the market in China are different,and most of them fail to achieve precise selenium supplement,according to the"Dietary Guide of Chinese Residents""Reference Intake of Nutrients in Dietary of Chinese Residents"and China's average daily selenium intake,and by the formula selection,the production process optimization,quality testing,developed a new accurate filling selenium product.Methods:the optimal amount of selenium supplement per day was determined by calculation,and the appropriate dosage form and dosage were selected.The optimal proportion of excipients was selected by orthogonal test,and then the scientific and reasonable prescription was determined.The new product was prepared by optimizing the production process.Results:When the diluent mannitol:maltodextrin∶L-HPC=4∶4∶1,the hardness was moderate,the appearance was smooth and beautiful;50%alcohol was the best wetting agent;magnesium stearate∶talc=2∶1,the lubrication effect was better,the angle of repose was 30°and the bulk density was 0.61 g/cm;citric acid∶stevioside=5∶1,the sour and sweet taste was the best;gardenia yellow content was 0.05%,the color was more beautiful.The conventional wet granulation method was used.The soft material was better when the ratio of 50%alcohol to material was 1∶10.The hardness of tablet was 60 N under 40-50 kN pressure.Conclusion:The selenium yeast chewable tablets is produced in this experiment have the characteristics of scientific and accurate selenium supplement,easy production,easy carrying,convenient taking and good taste.

关 键 词：硒 工艺学 制药 硒酵母 咀嚼片 处方 工艺 

分 类 号：TS218[轻工技术与工程—粮食、油脂及植物蛋白工程]