林蛙油平贝母软胶囊制剂及质量标准研究  

Peparations and its quality standard of the Ranae Oviductus and Fritillaria Ussuriensis soft capsules

作　　者：王冬雪[1] 金成山[1] 金莉莉[1] 于晓龙 郭建鹏[1] 

机构地区：[1]延边大学药学院,吉林延吉133002 [2]青岛黄海制药有限公司,山东青岛266001

出　　处：《延边大学学报（自然科学版）》2016年第1期91-94,共4页Journal of Yanbian University（Natural Science Edition）

基　　金：吉林省科技发展计划项目(20140204034YY;20150311051YY)

摘　　要：采用单因素平行试验与正交设计试验,以基质吸附率和沉降体积比为考察指标,将林蛙油与平贝母制成保健食品软胶囊,优选软胶囊内容物制剂.优选后的内容物制剂为:原料细粉与大豆油比例为1∶1.5,蜂蜡为1.5%,吐温-80为0.5%,内容物为假塑性流体.采用酸性染料比色法测定总生物碱的含量,高效液相(HPLC)测定1-甲基海因含量,并以总生物碱和1-甲基海因的含量建立主要药效学成份的质量标准.经测定3批样品中总生物碱的平均含量为17.61g·g^(-1),1-甲基海因的平均含量为8.56g·g^(-1).检测表明,本文所制软胶囊的质量符合规定.By using single-factor parallel experimental and orthogonal test,with the base adsorption and sedimentation ratio as the evaluation indexes,a type of soft capsule which is health food made fromRanae Oviductus and Fritillaria Ussuriensis,the content preparation of soft capsule is optimized.The optimized contents consist of the raw material powder and soybean oil in ratio of 1∶1.5,1.5% beeswax and 0.5% Tween-80,furthermore,the content is pseudo-plastic fluid.The content of the total alkaloids is determined by acid dye colorimetric method and the 1-methyl hydantoin is determined by the high performance liquid chromatography（HPLC）method.Quality standards of main pharmacodynamic component based on the content of the total alkaloids and 1-methyl hydantoin is established.In three batches of samples,the average content of total alkaloids is 17.61g·g^（-1）,1-methyl hydantoin is 8.56g·g^（-1）.The quality of prepared soft capsule accords with the regulations.

关 键 词：沉降体积比 流变学性质 重新分散性 总生物碱 1-甲基海因 

分 类 号：R283.6[医药卫生—中药学]