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[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] The purpose of this research was to prepare the chewable tablets of Arctium lappa and determine its content. [Method] With the method of wet granulation and tabletting with Arctium lappa extract, dextrin and mannitol as raw materials, the prescription was optimized by single factor and orthogonal test The best recipe and the HPLC method were used for the determination of content.Results The prepared Arctiin chewable tablets had good taste and chewable tablets requirements.The optimal prescriptions were Arctium lappa extract 30.0%, dextrin 28.0%, mannitol Alcohol 35.0%, aspartame 1.5%, citric acid 3.0%, mint flavor 1.5% and magnesium stearate 1.0%. The content of arctiin in the chewable tablet is 18.1 mg / g. Arctiin is in the range of 0.5-4.0 μg (R = 0.999 9), the average recovery rate was 99.4% and the RSD was 1.64%. [Conclusion] The prepared Arctium chewables prescription is reasonable and the preparation process is simple. HPLC method can be used for the quality of Arctium lappa chewable tablets control.