首页|基于一测多评法对止得咳颗粒中7种成分的质量控制

基于一测多评法对止得咳颗粒中7种成分的质量控制

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

Zhideke Granules(止得咳颗粒)QAMSHPLCrelative correlation factors

梁洁、梁炎丽、陈辉华、陆春莲、郑飘雪、孙正伊、黄春燕、赵立春、陈日兰

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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

广西中医药大学附属瑞康医院,广西南宁 530011

钦州市检验检测院,广西钦州 535000

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止得咳颗粒 一测多评 高效液相色谱法 相对校正因子

广西创新驱动发展专项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)广西壮瑶药重点实验室项目广西中医药多学科交叉创新团队项目广西研究生教育创新计划项目广西高等学校千名中青年骨干教师培育计划项目壮瑶药协同创新中心项目广西壮族自治区民族药资源与应用工程研究中心项目广西中医药重点学科壮药学项目广西重点研发计划项目广西科技基地和人才专项广西科技基地和人才专项广西一流学科中药学(民族药学)项目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

桂科AA17202046zyyzdxk-2023165桂科基字[2014]32号GZKJ2309YCSW2022354桂教人[2019]5号桂教科研[2013]20号桂发改高技函[2020]2605号GZXK-Z-20-64桂科AB21196016桂科AD20238058桂科AD21238031桂教科研[2018]12号202406

2024

中华中医药学刊
中华中医药学会 ,辽宁中医药大学

中华中医药学刊

CSTPCD北大核心
影响因子:1.007
ISSN:1673-7717
年,卷(期):2024.42(7)