| 地龙参麦口服液质量标准提高研究 |
| 投稿时间：2020-03-29 修订日期：2020-05-14 点此下载全文 |
| 引用本文：刘栋,华之卉,郝哲,屈俊,王丽军,李明春.地龙参麦口服液质量标准提高研究[J].药学实践杂志,2021,39(1):68~72 |
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| 基金项目:军队医疗机构制剂标准提高科研专项课题（14ZJZ02） |
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| 中文摘要:目的 完善地龙参麦口服液的质量标准。方法 采用薄层色谱法（TLC）对地龙参麦口服液中黄芪、麦冬和五味子进行定性鉴别。采用HPLC法测定制剂中五味子醇甲、羟苯乙酯的含量，色谱柱为Wondasil C18柱(250 mm×4.6 mm，5 μm)，流动相为乙腈-水(梯度洗脱)，流速为1.0 ml/min，检测波长为254 nm，柱温为30 ℃。结果 TLC色谱图斑点清晰，分离度良好，阴性无干扰。五味子醇甲和羟苯乙酯检测质量浓度线性范围分别为5.81～58.06 μg/ml (r=0.999 9)、25.29～252.94 μg/ml (r=0.999 9)；平均加样回收率分别为99.35% (RSD为1.02%)和99.72% (RSD为0.76%)。结论 该方法简便、快速、准确，能更全面有效地控制地龙参麦口服液的质量。 |
| 中文关键词:地龙参麦口服液 高效液相色谱 薄层色谱 五味子醇甲 羟苯乙酯 |
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| Study on the quality control improvement of Dilong Shenmai oral liquid |
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| Abstract:Objective To improve the quality control of Dilong Shenmai oral liquid.Methods TLC was used for the qualitative identification of Astragali Radix, Ophiopogonis Radix and Schisandrae Chinensis Fructus in Dilong Shenmai oral liquid. HPLC was used to determine the contents of schisandrin and ethylparaben in the preparation. Wondasil C18 column (250 mm×4.6 mm, 5 μm) was used with acetonitrile-water as the mobile phase at the flow rate of 1.0 ml/min for gradient elution. The detection wavelength was set at 254 nm, and column temperature was 30 ℃.Results TLC spots were clear and well-separated without negative interference. The linear ranges of schisandrin and ethylparaben were 5.81-58.06 μg/ml (r=0.999 9) and 25.29-252.94 μg/ml (r=0.999 9). The average recoveries were 99.35% (RSD=1.02%) and 99.72% (RSD=0.76%).Conclusion This method is simple, quick and accurate. It can be used for effective quality control of Dilong Shenmai oral liquid. |
| keywords:Dilong shenmai oral liquid HPLC TLC schisandrin ethylparaben |
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