高效液相色谱法测定清肝利胆口服液中5种成分的含量  

Determination of Five Components in Qinggan Lidan Oral Liquids by HPLC

作　　者：郭星 王乾蕾 王斌 窦月 王永凤 GUO Xing;WANG Qian-lei;WANG Bin;DOU Yue;WANG Yong-feng(Zhongshan Institute for Food and Drug Control,Zhongshan 528437,China;Guangzhou Xiangxue Pharmaceutical Co.,Ltd.,Guangzhou 510530,China)

机构地区：[1]中山市食品药品检验所,广东中山528437 [2]广州市香雪制药股份有限公司,广东广州510530

出　　处：《食品与药品》2022年第3期233-238,共6页Food and Drug

基　　金：广东省市场监督管理局科技项目(编号:2021CS09);广东省药品监督管理局科技创新项目(编号:2021ZDB04)。

摘　　要：目的建立HPLC法测定清肝利胆口服液中5种成分的含量。方法高效液相色谱-蒸发光散射检测法(HPLC-ELSD)测定绿原酸、灰毡毛忍冬皂苷乙、川续断皂苷乙的含量;高效液相色谱-二极管阵列检测器法(HPLC-DAD)测定粉防己碱、防己诺林碱的含量。结果5种成分实现完全分离;上述成分进样量的线性范围分别为0.35~8.98μg(r=0.9993)、1.24~18.62μg(r=0.9992)、0.15~3.91μg(r=0.9997)、0.08~7.86μg(r=0.9999)、0.10~10.57μg(r=1.0000)。平均加样回收率(n=6)分别为100.30%,99.50%,102.17%,97.87%,98.84%。5批样品中上述5个成分的含量范围分别为:1.66~2.59,6.08~9.04,0.77~1.97,0.02~0.04,0.11~0.15 mg/ml。结论本法可为制定清肝利胆口服液的质量标准提供参考。Objective To establish an HPLC method for the determination of five components in Qinggan Lidan Oral Liquids.Methods The contents of chlorogenic acid,macranthoidin B and dipsacoside B were determined by HPLC-ELSD.The contents of tetrandrine and fangchinoline were determined by HPLC-DAD.Results The five components were completely separated.The linear ranges of above-mentioned components were 0.35-8.98μg(r=0.9993),1.24-18.62μg(r=0.9992),0.15-3.91μg(r=0.9997),0.08-7.86μg(r=0.9999)and 0.10-10.57μg(r=1.0000),respectively.The average recoveries(n=6)were 100.30%,99.50%,102.17%,97.87%and 98.84%,respectively.The content ranges of five ingredients(n=5)were 1.66-2.59,6.08-9.04,0.77-1.97,0.02-0.04 and 0.11-0.15 mg/ml,separately.Conclusion This method can provide references for establishing the quality standard of Qinggan Lidan Oral Liquids.

关 键 词：清肝利胆口服液 高效液相色谱-蒸发光散射检测法 高效液相色谱-二极管阵列检测器法 多成分含量测定 

分 类 号：R927.1[医药卫生—药学]