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人参黄连有效组分速崩片的质量标准研究

Study on the quality standard of Rapidly Disintegrating Tablets of Effective Components of Ginseng and Golden Thread
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摘要 目的建立人参黄连速崩片的含量测定控制方法。方法采用高效液相色谱法(HPLC)测定本制剂中人参皂苷Rg1、Re、Rb1、Rd、S-Rg3、盐酸小檗碱和盐酸药根碱的含量。结果本制剂中7种被测成分的含量测定方法的方法学考察结果均符合规定,显示测试结果稳定可信。结论本方法操作简单,灵敏度高,专属性强,可有效控制人参黄连有效组分速崩片的质量。 Objective To establish a control method for the content determination of Rapidly Disintegrating Tablets of Effective Components of Ginseng and Golden Thread.Methods The contents of ginsenosides Rg1,Re,Rb1,RD,S-Rg3,berberine hydrochloride and jatrorrhizine hydrochloride in this preparation were determined by high performance liquid chromatography(HPLC).Results The methodological investigation results about the content determination method for the seven components in this preparation were in line with relevatn requirements,showing the test results were stable and reliable.Conclusion The method is simple,sensitive and specific,and can be used for the quality control of Rapidly Disintegrating Tablets of Effective Components of Ginseng and Golden Thread.
作者 高旭 吕金朋 张辉 李晶峰 GAO Xu;LV Jinpeng;ZHANG Hui;LI Jingfeng(Jilin Province Ginseng Science Research Institute,Changchun University of Traditional Chinese Medicine,Changchun 130117,China;Jilin Northeast Asia Biotechnology Co.,Ltd.,Changchun 130117,China)
出处 《长春中医药大学学报》 2021年第2期309-313,共5页 Journal of Changchun University of Chinese Medicine
基金 长春市科技计划双十项目“人参黄连有效组分速崩片治疗Ⅱ型糖尿病的新药临床前研制”(18YJ004)。
关键词 人参黄连有效组分速崩片 高效液相色谱法 含量测定 质量标准 Rapidly Disintegrating Tablets of Effective Components of Ginseng and Golden Thread high performance liquid chromatography(HPLC) content determination quality standard
作者简介 高旭(1997—),男,硕士研究生,主要从事中药学研究;通信作者:张辉,男,二级教授,博士研究生导师,电话-13578688080,电子信箱-zhanghui_8080@163.com;通信作者:李晶峰,女,博士,电话-15834638882,电子信箱-972057198@qq.com。
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