牛蒡子咀嚼片的制备及含量测定  

Preparation and determination of Fructus Arctii chewable tablets

作　　者：徐翔[1,2,3] 陆莹[1,2,3] 郭建鹏[1,2] 金学军[1,2,3] 朴莲荀[1,2,3] 

机构地区：[1]延边大学长白山生物资源与功能分子教育部重点实验室,吉林延吉133002 [2]延边大学药学院,吉林延吉133002 [3]延边大学分子药物研究中心,吉林延吉133002

出　　处：《延边大学医学学报》2016年第1期28-31,共4页Journal of Medical Science Yanbian University

摘　　要：[目的]制备牛蒡子咀嚼片并确定含量测定方法.[方法]以牛蒡子提取物、糊精、甘露醇等为原料,采用湿法制粒压片工艺,通过单因素、正交试验优化处方确定最佳工艺配方,并利用HPLC法进行含量测定.[结果]制得的牛蒡子咀嚼片口感良好,符合咀嚼片要求.优选处方质量分数分别为牛蒡子提取物30.0%、糊精28.0%、甘露醇35.0%、阿斯巴甜1.5%、柠檬酸3.0%、薄荷香精1.5%、硬脂酸镁1.0%.咀嚼片样品中牛蒡苷含量为18.1 mg/g.牛蒡苷在0.5~4.0μg范围内时线性关系良好（r=0.999 9）,平均回收率为99.4%,RSD为1.64%.[结论]制得的牛蒡子咀嚼片处方合理,制备工艺简单;HPLC法可用于牛蒡子咀嚼片的质量控制.OBJECTIVE To prepare the Fructus Arctii chewable tablets and determine the content determination methods. METHODS The Fructus Arctii chewable tablets were produced by the technology such as wet granulation and tableting with Fructus Arctii extracts, dextrin, mannitol and etc. as raw materials. The formulation of Fructus Arctii chewable tablets was optimized through single factor and orthogonal experiment and the content was determined by HPLC. RESULTS The Fructus Arctii chewable tablets had a good taste in accordance with the chewable tablet requirements. The optimal formula of the tablets consisted of Fructus Arctii extract 30.0 %, dextrin 28.0 %, mannitol 35.0 %, aspartame 1.5 %, citric acid 3.0 %, mint essence 1.5 % and 1.0 % magnesium stearate, arctiin content in each chewable tablet is 18. 1 mg/g. The arctiin was linear in the range of 0.5~4.0μg （ r = 0. 999 9） and the average recovery rate was 99.4%, RSD was 1.64%. CONCLUSION The resulting prescription of the Fructus Arctii chew- able tablets was reasonable, the preparation process was simple. HPLC method could be used for the determination and the quality control.

关 键 词：牛蒡子 咀嚼片 正交试验 色谱法 高压液相 

分 类 号：R283[医药卫生—中药学]