基于一测多评法对止得咳颗粒中7种成分的质量控制  

Quality Control of 7 Components in Zhideke Granules(止得咳颗粒)Based on QAMS Method

作　　者：梁洁 梁炎丽 陈辉华 陆春莲 郑飘雪 孙正伊[5] 黄春燕 赵立春 陈日兰[5] LIANG Jie;LIANG Yanli;CHEN Huihua;LU Chunlian;ZHENG Piaoxue;SUN Zhengyi;HUANG Chunyan;ZHAO Lichun;CHEN Rilan(College of Pharmacy,Guangxi University of Chinese Medicine,Nanning 530200,Guangxi,China;Guangxi Key Laboratory of Zhuang and Yao Ethnic Medicine,Nanning 530200,Guangxi,China;Key Laboratory of TCM Extraction and Purification and Quality Analysis,Guangxi University of Chinese Medicine,Nanning 530200,Guangxi,China;Guangxi Zhuang Yao Medicine Center of Engineering and Technology,Nanning 530200,Guangxi,China;Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine,Nanning 530011,Guangxi,China;Qinzhou Inspction and Test Institute,Qinzhou 535000,Guangxi,China)

机构地区：[1]广西中医药大学药学院,广西南宁530200 [2]广西壮瑶药重点实验室,广西南宁530200 [3]广西高校中药提取纯化与质量分析重点实验室,广西南宁530200 [4]广西壮瑶药工程技术研究中心,广西南宁530200 [5]广西中医药大学附属瑞康医院,广西南宁530011 [6]钦州市检验检测院,广西钦州535000

出　　处：《中华中医药学刊》2024年第7期6-10,共5页Chinese Archives of Traditional Chinese Medicine

基　　金：广西创新驱动发展专项(桂科AA17202046);国家中医药管理局高水平中医药重点学科建设项目-少数民族药学(壮药学)(zyyzdxk-2023165);广西壮瑶药重点实验室项目(桂科基字[2014]32号);广西中医药多学科交叉创新团队项目(GZKJ2309);广西研究生教育创新计划项目(YCSW2022354);广西高等学校千名中青年骨干教师培育计划项目(桂教人[2019]5号);壮瑶药协同创新中心项目(桂教科研[2013]20号);广西壮族自治区民族药资源与应用工程研究中心项目(桂发改高技函[2020]2605号);广西中医药重点学科壮药学项目(GZXK-Z-20-64);广西重点研发计划项目(桂科AB21196016);广西科技基地和人才专项(桂科AD20238058,桂科AD21238031);广西一流学科中药学(民族药学)项目(桂教科研[2018]12号);广西中医药大学第三批“岐黄工程”高层次人才团队培育项目(202406)。

摘　　要：目的建立一测多评法同时测定止得咳颗粒中黄芩苷、射干苷、野鸢尾苷、汉黄芩苷、黄芩素、次野鸢尾黄素及汉黄芩素的含量。方法采用henomenex Kinetex XB-C_(18)色谱柱(4.6 mm×250 mm,5μm),柱温25℃;流动相为甲醇(A)-0.2%磷酸(B),梯度洗脱,流速0.8 mL·min^(-1),检测波长为270 nm,以黄芩苷为内参物,建立射干苷、野鸢尾苷、汉黄芩苷、黄芩素、次野鸢尾黄素和汉黄芩素的相对校正因子,并考察相对校正因子的耐用性。比较外标法和一测多评法对止得咳颗粒中7种成分含量的测定结果。结果7种成分分别在0.2390~1.1950 mg,0.0060~0.0302 mg,0.0160~0.0800 mg,0.0326~0.1630 mg,0.0055~0.0276 mg,0.0029~0.0143 mg和0.0036~0.0178 mg范围内有良好线性关系(r=0.9999),平均加样回收率(RSD)分别为97.11%(0.94%)、97.87%(1.33%)、97.44%(1.34%)、97.85%(0.89%)、97.24%(1.16%)、101.90%(2.24%)和99.46%(0.71%),一测多评法测定结果与外标法测定结果无显著性差异。结论方法稳定可靠,可用于止得咳颗粒的质量控制。Objective To establish a quantitative analysis of multi-components by single maker(QAMS)method for the determination of baicalin,tectoridin,iridin,wogonoside,baicalein,irisflorentin and wogonin in Zhideke Granules(止得咳颗粒).Methods The analysis was performed on a phenomenex Kinetex XB-C_(18)column(4.6 mm×250 mm,5μm).The mobile phase was methanol(A)-0.2%phosphoric acid aqueous solution in a linear gradient mode.The flow rate was 0.8 mL·min^(-1).The detection wave-lengths were set at 270 nm.The baicalin was used as the internal marker to calculate the relative correlation factors(RCF)including tectoridin,Iridin,wogonoside,baicalein,irisflorentin and wogonin by HPLC,and the durability of the RCF was examined.The external standard method and QAMS were compared to determine the 7 components in Zhideke Granules.Results Seven components showed good linear relationships within the ranges of 0.2390~1.1950 mg,0.0060~0.0302 mg,0.0160~0.0800 mg,0.0326~0.1630 mg,0.0055~0.0276 mg,0.0029~0.0143 mg,0.0036~0.0178 mg(r=0.9999),respectively.And the average recoveries(RSD)of each components were 97.11%(0.94%),97.87%(1.33%),97.44%(1.34%),97.85%(0.89%),97.24%(1.16%),101.90%(2.24%)and 99.46%(0.71%).The results calculated with QAMS were consistent with the results by the external standard method.Conclusion The method is stable and reliable,and can be used for the quality control of Zhideke Granules.

关 键 词：止得咳颗粒 一测多评 高效液相色谱法 相对校正因子 

分 类 号：R284.1[医药卫生—中药学]