消渴痹通胶囊含量测定

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英文篇名：Determination of Xiaoke Bitong Capsule 作者：李晓兵 ; 何蕊 ; 位鸿 ; 刘鹤 ; 成光宇 ; 王秀阁 英文作者：LI Xiaobing;HE Rui;WEI Hong;LIU He;CHENG Guangyu;WANG Xiuge;Integrated Traditional Chinese and Western Medicine Experimental Center, Affiliated Hospital of Changchun University of Chinese Medicine;College of Pharmacy, Changchun University of Chinese Medicine; 关键词：消渴痹通胶囊 ; 毛蕊异黄酮葡萄糖苷 ; 高效液相色谱法 ; 含量测定 英文关键词：Xiaoke Bitong Capsule;;calycosin-7-glucoside;;high performance liquid chromatography;;content determination 中文刊名：CZXX 英文刊名：Journal of Changchun University of Chinese Medicine 机构：长春中医药大学附属医院中西医结合实验中心;长春中医药大学药学院; 出版日期：2019-02-26 14:47 出版单位：长春中医药大学学报 年：2019 期：v.35 基金：吉林省科技攻关计划项目(20160204010YY) 语种：中文; 页：CZXX201903028 页数：4 CN：03 ISSN：22-1375/R 分类号：101-104

摘要

目的建立高效液相色谱法测定消渴痹通胶囊中毛蕊异黄酮葡萄糖苷含量的分析方法。方法对不同批号样品采用加热回流提取,提取溶液采用反相色谱柱岛津Inertsil ODS-C18(4.6 mm×250 mm,5μm)检测,以乙腈:0.2%甲酸水梯度为流动相,流速1.0 mL/min,检测波长260 nm。结果毛蕊异黄酮葡萄糖苷在0.050 5～0.505 0 mg范围内与峰面积积分值成良好的线性关系(r=0.999 5),毛蕊异黄酮葡萄糖苷平均加样回收率为99.16%,RSD为2.35%。根据本品3批样品含量测定结果,暂定本品每个胶囊含黄芪以毛蕊异黄酮葡萄糖苷(C22H22O10)计,不得少于0.038 0 mg。结论该方法简单、灵敏、稳定、可靠,可用于不同批次样品中毛蕊异黄酮葡萄糖苷的含量测定,并以此作为其质量控制标准。
        Objective To establish a method for determination of calycosin-7-glucoside in Xiaoke Bitong Capsule by high performance liquid chromatography(HPLC). Methods Samples were extracted by heating reflux in different batch numbers. Extraction solution was carried out on a Inertsil ODS-C18 column(4.6 mm×250 mm, 5 μm). The mobile phase was acetonitrile: 0.2% formic acid water gradient elution, the flow was 1.0 mL/min, and the detection wavelength was 260 nm. Results Calycosin-7-glucoside had a good linearity with the peak areas at the range of 0.050 5 ～ 0.505 0 μg(r = 0.999 5). The average recovery was 99.16% and the RSD was 2.35%. According to the results of the determination of the contents of the three batches of this product, it is tentatively determined that the granules contained in each capsule should not be less than 0.0380 mg based on calycosin-7-glucoside(C22 H22 O10). Conclusion The established method is simple, sensitive, specific, and reproducible, which can be used to determine the content of calycosin-7-glucoside in different batches of samples, and it can be used as the quality control standard.

引文

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