养阴口香合剂中枳壳的质量控制研究*
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(1. 贵州省食品药品检验所,贵州 贵阳 550004; 2. 贵州万顺堂药业有限公司,贵州 贵阳 550018)

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R286.0

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收稿日期: 2019 - 01- 03
* 基金项目: 国家药典委员会国家药品标准提高行动计划项目( 编号:554)
第一作者简介: 郭璐玫(1987-),女,硕士,主管药师,研究方方向:中药检验及质量研究。
△通信作者: 刘兴鹏,E-mail:24617309@ qq.com


Quality Control of Aurantii Fructus in Yangyin Kouxiang Mixture
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Affiliation:

(1. Guizhou Institute for Food and Drug Control, Guiyang 550004, China;2. Guizhou Wanshuntang Pharmaceutical Co., Ltd.Guiyang 550018, China)

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    摘要:

    目的研究并控制养阴口香合剂中枳壳的质量。方法 采用薄层色谱法对枳壳进行鉴别研究;采用高效液相色谱法测定枳壳中柚皮苷和新橙皮苷的含量,色谱柱为Waters Xbridge C18柱(250 mm × 4.6 mm, 5 μm),流动相为乙腈-水(20 ∶ 80),柱温为30 ℃,流速为1.0 mL·min-1,检测波长283 nm。结果 薄层色谱斑点清晰,分离度较好;高效液相色谱测定柚皮苷对照品在0.05680 μg~0.7100 μg范围内线性关系良好(r=0.9999),平均回收率为100.21%;新橙皮苷对照品在0.03053 μg~0.3817 μg范围内线性关系良好(r=0.9999),平均回收率为98.33%。结论 本研究方法准确可靠,重复性好,可用于养阴口香合剂中枳壳的质量控制。

    Abstract:

    Objective To study and control quality of Aurantii Fructus in Yangyin Kouxiang Mixture. Methods Thin layer chromatography(TLC) was used for qualitative identification of Aurantii Fructus. High performance liquid chromatography (HPLC) was used for content determination of naringin and neohesperidin in Aurantii Fructus(AF) on a Waters Xbridge C18(250 mm × 4.6 mm,5 μm), and the mobile phase was acetonitrile-water(20 : 80) at the column temperature of 30 ℃. The flow rate was 1.0 mL·min-1 and the detection wavelength was 283 nm. Results The TLC spots were clear and showed a good separation. HPLC showed the calibration curve of naringin had a good linear relationship in the mass range of 0.05680 μg~0.7100 μg(r=0.9999) and the average recovery was 100.21%; the calibration curve of neohesperidin had a good linear relationship in the mass range of 0.03053 μg~0.3817 μg(r=0.9999) and the average recovery was 98.33%. Conclusion The method is accurate with good reproducibility, which can be used for the quality control of Aurantii Fructus in Yangyin Kouxiang Mixture.

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