首页|淫芎颗粒质量标准研究

淫芎颗粒质量标准研究

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目的 建立淫芎颗粒的质量标准.方法 采用薄层色谱法对制剂中川芎、白芍进行定性鉴别;采用高效液相色谱法同时测定制剂中芍药苷、甘草苷、阿魏酸、柚皮苷、橙皮苷、淫羊藿苷、甘草酸铵的含量,色谱柱为 Agilent Zorbax SB-C18 柱(250 mm×4.6 mm,5 μm),流动相为乙腈-0.3%磷酸溶液(梯度洗脱),流速为 1.0 mL/min,检测波长为 230 nm,柱温为 30℃,进样量为 10 μL.结果 薄层色谱斑点清晰,分离度良好,且阴性对照无干扰.芍药苷、甘草苷、阿魏酸、柚皮苷、橙皮苷、淫羊藿苷、甘草酸铵的质量浓度分别在 8.886~222.156 μg/mL、3.935~98.385 μg/mL、3.805~95.118 μg/mL、4.457~111.416 μg/mL、4.574~114.360 μg/mL、3.512~87.794 μg/mL、4.274~106.850 μg/mL范围内与各自峰面积线性关系良好(r≥0.999 1,n=7);精密度、稳定性、重复性试验结果的RSD均小于 3.0%;平均加样回收率分别为 99.68%,99.19%,100.31%,100.70%,99.74%,98.77%,98.99%,RSD分别为1.57%,1.89%,2.77%,1.52%,1.58%,1.27%,2.18%(n=9);平均含量分别为 5.743,0.547,0.472,1.426,1.376,1.982,1.480 μg/mL(n=2).结论 该方法操作方便、结果准确、专属性和重复性好,可用于淫芎颗粒的质量控制.
Quality Standard of Yinxiong Granules
Objective To establish the quality standard of Yixiong Granules.Methods The thin-layer chromatography(TLC)method was used for the qualitative identification of Chuanxiong Rhizoma and Paeoniae Radix Alba in the preparation.The high-performance liquid chromatography(HPLC)method was used for the content determination of paeoniflorin,liquiritin,ferulic acid,naringin,hesperidin,icariin,and ammonium glycyrrhizinate in the preparation.The chromatographic column was Agilent Zorbax SB-C18 column(250 mm×4.6 mm,5 μm),the mobile phase was acetonitrile-0.3% phosphoric acid solution with gradient elution,the flow rate was 1.0 mL/min,the detection wavelength was 230 nm,the column temperature was 30℃,and the injection volume was 10 μL.Results TLC spots were clear,with good separation,and the negative control had no interference.The linear ranges of paeoniflorin,liquiritin,ferulic acid,naringin,hesperidin,icariin,and ammonium glycyrrhizinate were 8.886-222.156 μg/mL,3.935-98.385 μg/mL,3.805-95.118 μg/mL,4.457-111.416 μg/mL,4.574-114.360 μg/mL,3.512-87.794 μg/mL,and 4.274-106.850 μg/mL(r≥0.999 1,n=7),respectively.The RSDs of precision,stability,and repeatability test results were all lower than 3.0% .The average recoveries of the above seven components were 99.68%,99.19%,100.31%,100.70%,99.74%,98.77%,and 98.99% y,with RSDs of 1.57%,1.89%,2.77%,1.52%,1.58%,1.27%,and 2.18% (n=9),respectively.The average contents of in samples were 5.743,0.547,0.472,1.426,1.376,1.982,and 1.480 μg/mL(n=2),respectively.Conclusion The method is simple,accurate,with good specificity and repeatability,which can be used for the quality control of Yinxiong Granules.

Yinxiong GranulesTLCHPLCqualitative identificationcontent determination

曹丽萍、林晓燕、梅全喜、冯晓婷、李佳瑞、梁奇

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广东省深圳市宝安区中医院,广东 深圳 518133

淫芎颗粒 薄层色谱法 高效液相色谱法 定性鉴别 含量测定

广东省深圳市中药特色技术传承人才培训项目广东省深圳市医疗卫生三名工程

SZZYSM202206005

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(13)