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
梁洁 1梁炎丽 2陈辉华 2陆春莲 2郑飘雪 2孙正伊 3黄春燕 4赵立春 5陈日兰3
作者信息
- 1. 广西中医药大学药学院,广西南宁 530200;广西壮瑶药重点实验室,广西南宁 530200;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;广西壮瑶药工程技术研究中心,广西南宁 530200
- 2. 广西中医药大学药学院,广西南宁 530200;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
- 3. 广西中医药大学附属瑞康医院,广西南宁 530011
- 4. 钦州市检验检测院,广西钦州 535000
- 5. 广西壮瑶药工程技术研究中心,广西南宁 530200
- 折叠
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-C18色谱柱(4.6 mm × 250 mm,5 μm),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0.239 0～1.195 0 mg,0.006 0～0.030 2 mg,0.016 0～0.080 0 mg,0.032 6～0.163 0 mg,0.005 5～0.027 6 mg,0.002 9～0.014 3 mg 和 0.003 6～0.017 8 mg 范围内有良好线性关系(r=0.999 9),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.
Abstract
Objective To establish a quantitative analysis of multi-components by single maker(QAMS)method for the deter-mination of baicalin,tectoridin,iridin,wogonoside,baicalein,irisflorentin and wogonin in Zhideke Granules(止得咳颗粒).Meth-ods The analysis was performed on a phenomenex Kinetex XB-C18 column(4.6 mm ×250 mm,5 μm).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 de-tection wave-lengths were set at 270 nm.The baicalin was used as the internal marker to calculate the relative correlation fac-tors(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.Re-sults Seven components showed good linear relationships within the ranges of 0.239 0～1.195 0 mg,0.006 0～0.030 2 mg,0.016 0～0.080 0 mg,0.032 6～0.163 0 mg,0.005 5～0.027 6 mg,0.002 9～0.014 3 mg,0.003 6～0.017 8 mg(r=0.999 9),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 calculat-ed 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Key words
Zhideke Granules(止得咳颗粒)/QAMS/HPLC/relative correlation factors引用本文复制引用
基金项目
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)
广西科技基地和人才专项(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)
出版年
2024
NETL
NSTL
万方数据