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小儿感冒颗粒质量标准提升研究

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目的 提升小儿感冒颗粒的质量标准。方法 采用薄层色谱(TLC)法对菊花、连翘、地黄、白薇进行定性鉴别;采用超高效液相色谱(UPLC)法同时测定对羟基苯乙酮、木犀草苷、3,5-O-二咖啡酰基奎宁酸、迷迭香酸的含量,色谱柱为Shim-pack XR-ODS ⅡC18柱(100 mm × 2。0 mm,2 μm),流动相为乙腈-0。05%醋酸(30∶70,V/V),流速为0。2 mL/min,检测波长为254 nm,柱温为25 ℃,进样量为10μL。结果 菊花、连翘、地黄、白薇的TLC图斑点清晰,分离度好,阴性对照无干扰。对羟基苯乙酮、木犀草苷、3,5-0-二咖啡酰基奎宁酸、迷迭香酸质量浓度分别在 2。499~62。475 μg/mL、1。974~49。350 μg/mL、1。893~47。325 μg/mL、2。040~51。000 μg/mL 范围内与峰面积线性关系良好(r=0。999 8,0。998 4,0。999 6,0。997 8,n=6);精密度、稳定性、重复性试验结果的RSD均小于2。0%;平均加样回收率分别为98。97%,99。90%,98。84%,99。53%,RSD分别为0。45%,0。85%,0。58%,1。09%(n=6)。结论 所建方法操作简便,结果准确可靠,可用于更好地控制小儿感冒颗粒质量。
Improvement of Quality Standard of Xiaoer Ganmao Granules
Objective To improve the quality standard of Xiaoer Ganmao Granules.Methods Thin-layer chromatography(TLC)method was used to qualitatively identify Chrysanthemi Flos,Forsythiae Fructus,Rehmanniae Radix,Cynanchi Atrati Radix et Rhizoma.The ultra-high-performance liquid chromatography(UPLC)method was used to simultaneously determine the contents of p-hydroxyacetophenone,luteoloside,3,5-O-dicaffeoylquinic acid,and rosmarinic acid;the chromatography column was the Shim-pack XR-ODSⅡ column(100 mm × 2.0 mm,2 μm),the mobile phase was acetonitrile-0.05%acetic acid(30∶70,V/V),the flow rate was 0.2 mL/min,the detection wavelength was 254 nm,the column temperature was 25℃,and the injection volume was 10 μL.Results The TLC chromatograms of Chrysanthemi Flos,Forsythiae Fructus,Rehmanniae Radix,Cynanchi Atrati Radix et Rhizoma showed clear spots,good separation,with no interference from the negative reference.The linear ranges of p-hydroxyacetophenone,luteoloside,3,5-O-dicaffeoylquinic acid,and rosmarinic acid were in the range of 2.499 to 62.475 μg/mL,1.974 to 49.350 μg/mL,1.893 to 47.325 μg/mL and 2.040 to 51.000 μg/mL,respectively(r=0.999 8,0.998 4,0.999 6,0.997 8,n=6).The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above four components were 98.97%,99.90%,98.84%,99.53%,with RSDs of 0.45%,0.85%,0.58%,1.09%(n=6)respectively.Conclusion The established method is easy,accurate and reliable,which can be used to better control the quality of Xiaoer Ganmao Granules.

Xiaoer Ganmao Granulesquality standardUPLCcontent determinationTLC

贾睿琦、张生潭、赵庆林、姚晨、黄东杰、武红娜

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河北省沧州市食品药品检验所,河北 沧州 061000

河北省沧州中西医结合医院,河北 沧州 061000

小儿感冒颗粒 质量标准 超高效液相色谱法 含量测定 薄层色谱法

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(24)