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麝香化瘀醒脑颗粒质量标准研究

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目的 建立麝香化瘀醒脑颗粒的质量标准。方法 采用薄层色谱(TLC)法定性鉴别制剂中的麝香、黄芪、大黄;采用高效液相色谱(HPLC)法测定制剂中人参皂苷Rb1 的含量,色谱柱为UltimateTM C18 柱(250 mm×4。6 mm,5µm),流动相为乙腈-水(梯度洗脱),流速为 1。0 mL/min,检测波长为 203 nm,柱温为 40℃,进样量为 10µL。结果 麝香、黄芪、大黄的TLC图斑点清晰,分离度好,且阴性对照无干扰;人参皂苷Rb1 质量浓度在 78。04~780。40µg/mL范围内与峰面积线性关系良好(R2=0。999 1,n=6);精密度、稳定性、重复性试验结果的RSD均小于 3。0%;平均加样回收率为 96。84%,RSD为 3。16%(n=9)。结论 该方法操作简便,重复性好,结果准确可靠,可用于麝香化瘀醒脑颗粒的质量控制。
Study on Quality Standard of Shexiang Huayu Xingnao Granules
Objective To establish a quality standard for Shexiang Huayu Xingnao Granules.Methods The Moschus,Astragali Radix and Rhei Radix et Rhizoma in the preparation were identified qualitatively by the thin-layer chromatography(TLC)method.The content of ginsenoside Rb1 in the preparation was determined by high-performance liquid chromatography(HPLC)method;the chromatographic column was the UltimateTM C18 column(250 mm×4.6 mm,5 µm),the mobile phase was acetonitrile-water(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 203 nm,the column temperature was 40℃,and the injection volume was 10 µL.Results The TLC chromatograms of Moschus,Astragali Radix and Rhei Radix et Rhizoma had clear spots and good resolution,and there was no interference from the negative reference.The linear range of ginsenoside Rb1 was 78.04-780.40 µg/mL(R2=0.999 1,n=6).The RSDs of precision,stability and repeatability tests were all lower than 3.0%.The average recovery rate of ginsenoside Rb1 was 96.84%with an RSD of 3.16%(n=9).Conclusion This method is simple,repeatable,accurate and reliable,which can be used for quality control of Shexiang Huayu Xingnao Granules.

Shexiang Huayu Xingnao GranulesTLCHPLCMoschusAstragali RadixRhei Radix et Rhizomaginsenoside Rb1

黄江、黄锐、杨思进、白雪、杨云芳

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西南医科大学附属中医医院,四川 泸州 646000

麝香化瘀醒脑颗粒 薄层色谱法 高效液相色谱法 麝香 黄芪 大黄 人参皂苷Rb1

全国中药特色技术传承人才培训项目国家中医临床研究基地建设单位科研项目

国中医药人教函[2023]96号西南医大中医院202033号

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(10)
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