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芪龙活络颗粒质量标准研究

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目的 建立芪龙活络颗粒的质量标准。方法 采用薄层色谱法对制剂中黄芪、川牛膝、鸡血藤药材进行定性鉴别;采用高效液相色谱法测定丹酚酸B的含量,色谱柱为Eclipse XDB-C18 柱(150 mm×4。6 mm,5 μm),流动相为乙腈-0。1%磷酸溶液(23∶77,V/V),流速为 1。0 mL/min,检测波长为 286 nm,柱温为 30℃,进样量为 10 μL。结果 薄层色谱斑点清晰,且阴性对照无干扰。丹酚酸B的进样量在 0。062 4~1。248 μg范围内与峰面积线性关系良好(r = 1。000,n = 5);精密度、稳定性、重复性试验结果的RSD均小于2。00%(n = 6);平均回收率为 107。61%,RSD为 4。28%(n = 6)。5 批样品中丹酚酸B的含量为 1。09~1。32 mg/g。结论 该方法专属性好、结果准确,可用于芪龙活络颗粒的质量控制。暂订芪龙活络颗粒中丹酚酸B的含量应不低于 1。0 mg/g。
Quality Standard of Qilong Huoluo Granules
Objective To establish the quality standard of Qilong Huoluo Granules.Methods Thin-layer chromatography(TLC)method was used to qualitatively identify Cyathulae Radix,Astragali Radix,and Spatholobi Caulis in the preparation.High-performance liquid chromatography(HPLC)method was used to determine the content of salvianolic acid B in the preparation,the chromatographic column was Eclipse XDB-C18 column(150 mm×4.6 mm,5 μm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(23 ∶ 77,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 286 nm,the column temperature was 30℃,and the injection volume was 10 μL.Results The TLC spots were clear,and the negative control had no interference.The linear range of salvianolic acid B was 0.062 4-1.248 μg(r = 1.000,n = 6).The RSDs of precision,stability,and repeatability test results were all lower than 2.00%(n = 6).The average recovery of salvianolic acid B was 107.61%with an RSD of 4.28%(n = 6).The content of salvianolic acid B in five batches of samples was in the range of 1.09-1.32 mg/g.Conclusion This method is specific and accurate,which can be used for the quality control of Qilong Huoluo Granules.The content of salvianolic acid B in Qilong Huoluo Granules is temporarily set at no lower than 1.0 mg/g.

Qilong Huoluo GranulesTLCHPLCCyathulae RadixAstragali RadixSpatholobi Caulissalvianolic acid B

魏玲、丁小凡、张贺廷、陈浩、刘畅、席永宽

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安徽省阜阳市中医医院,安徽 阜阳 236025

安徽中医药大学第一附属医院,安徽 合肥 230031

芪龙活络颗粒 薄层色谱法 高效液相色谱法 黄芪 川牛膝 鸡血藤 丹酚酸B

安徽省阜阳市卫生健康委员会科研课题

FY2021-032

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(9)
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