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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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基于一测多评法对小儿豉翘清热颗粒中9个成分的质量控制

Quality control of 9 components in Xiao'er Chiqiao Qingre granules by multi-components with a single-marker(QAMS)

作者(英文):
分类号:R917
出版年·卷·期(页码):2018,38 (11):1922-1930
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:建立一测多评(QAMS)法测定小儿豉翘清热颗粒中栀子苷、芍药苷、连翘酯苷A、黄芩苷、连翘苷、千层纸素A-7-O-β-D-葡萄糖醛酸苷、汉黄芩苷、黄芩素、汉黄芩素9个成分的含量。方法:采用超高效液相色谱法,Acquity UPLC BEH C18色谱柱(2.1 mm×100 mm,1.7 μm);乙腈(A)-0.2%磷酸水溶液为流动相(B),梯度洗脱;流速0.25 mL·min-1,柱温25℃,检测波长220 nm。以黄芩苷为内参物,建立栀子苷、芍药苷、连翘酯苷A、连翘苷、千层纸素A-7-O-β-D-葡萄糖醛酸苷、汉黄芩苷、黄芩素、汉黄芩素与内参物黄芩苷的相对校正因子(f),通过f计算小儿豉翘清热颗粒中9个成分的含量,并进行验证,将该方法与外标法(ESM)的测定结果进行对比分析,以验证QAMS方法的准确性、重复性及可行性。结果:栀子苷、芍药苷、连翘酯苷A、黄芩苷、连翘苷、千层纸素A-7-O-β-D-葡萄糖醛苷、汉黄芩苷、黄芩素、汉黄芩素的质量浓度分别在9.953~199.1 μg·mL-1、5.994~119.9 μg·mL-1、4.390~87.80 μg·mL-1、9.819~196.4 μg·mL-1、1.802~36.04 μg·mL-1、1.408~28.17 μg·mL-1、2.551~51.02 μg·mL-1、0.140 2~2.804 μg·mL-1、0.361 3~7.225 μg·mL-1范围内线性关系良好;加样回收率在95.7%~102.5%;以黄芩苷为内参物,测得的f值分别为4.621 1、4.105 5、1.825 3、1.796 5、1.040 2、1.339 8、0.647 4、0.888 7,且建立的QAMS法计算结果与外标法(ESM)的计算结果之间无显著性差异。结论:本实验建立的QAMS法可作为一种简便快捷的质量评价模式,用于小儿豉翘清热颗粒中9个成分的质量控制。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To determine 9 components,including geniposide,paeoniflorin,forsythoside A,baicalin, forsythin,oroxylin A-7-O-glucuronide,wogonoside,baicalein and wogonin in Xiao'er Chiqiao Qingre granules by multi-components with a single-marker(QAMS) method.Methods: The UPLC separation was achieved on an Acquity UPLC BEH C18 column(100 mm×2.1 mm,1.7 μm) with acetonitrile(A)-0.2% phosphoric acid solution(B) as mobile phase at a flow rate of 0.25 mL·min-1 with gradient elution.The column temperature was set at 25℃.The determination wavelength was 220 nm.With baicalin as the internal reference standard,the relativecorrection factors(f) of geniposide,paeoniflorin,forsythoside A,forsythin,oroxylin A-7-O-glucuronide,wogonoside,baicalein and wogonin were calculated.The method was evaluated by comparison of the quantitative results between external standard method(ESM) and QAMS.Results: Geniposide、paeoniflorin、forsythoside A、baicalin、forsythin、oroxylin A-7-O-glucuronid、wogonoside、baicalein and wogonin had good relations within the range of 9.953-199.1 μg·mL-1,5.994-119.9μg·mL-1,4.390-87.80 μg·mL-1,9.819-196.4 μg·mL-1,1.802-36.04 μg·mL-1,1.408-28.17 μg·mL-1,2.551-51.02 μg·mL-1,0.140 2-2.804 μg·mL-1 and 0.361 3-7.225 μg·mL-1,respectivley.The recoveries were within 95.7% and 102.5%.With baicalin as the internal reference standard,the relative correction factors(f) were 4.621 1,4.105 5,1.825 3,1.796 5,1.040 2,1.339 8,0.647 4 and 0.888 7, respectively.No significant difference was observed between the results of two methods.Conclusion: The QAMS method is simple and fast,and can be used to determine the multiple components in Xiao'er Chiqiao Qingre granules.

-----参考文献:---------------------------------------------------------------------------------------

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