| 引用本文: | 苏华,廖欣,江静怡,陆崟,乔立业.消白颗粒的质量标准提升研究[J].中国现代应用药学,2016,33(3):308-312. |
| SU Hua,LIAO Xin,JIANG Jingyi,LU Yin,QIAO Liye.Study on Improved Quality Standard for Xiaobai Granules[J].Chin J Mod Appl Pharm(中国现代应用药学),2016,33(3):308-312. |
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| 摘要: |
| 目的 建立并提升消白颗粒制剂的质量标准。方法 采用TLC对消白颗粒中的黄芪、地黄、首乌、补骨脂进行定性鉴别；采用HPLC-ELSD测定制剂中黄芪甲苷的含量。色谱条件：Lichrospher-C18柱(4.6 mm×250 mm，5 mm)，以乙腈-水(32∶68)为流动相，流速 1.0 mL·min-1，柱温 25 ℃，蒸发光散射检测器检测。结果 消白颗粒中黄芪、地黄、首乌、补骨脂的TLC斑点清晰，分离度良好，阴性无干扰。黄芪甲苷在0.311 5~2.803 9 μg(r=0.999 9)内呈良好的线性关系，平均回收率为99.4%(RSD=2.67%)。结论 该方法简便、准确、重复性好，可作为消白颗粒的质量标准。 |
| 关键词: 消白颗粒 薄层鉴别 含量测定 质量标准 |
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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重点项目(14ZJZ08) |
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| Study on Improved Quality Standard for Xiaobai Granules |
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SU Hua, LIAO Xin, JIANG Jingyi, LU Yin, QIAO Liye
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Dapartment of Preparation, Nanjing General Hospital of Nanjing Military Region, Nangjing 210002, China
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| Abstract: |
| OBJECTIVE To establish and improve the quality standard of Xiaobai granules. Methods TLC was used to identify Astragali Radix, Rehmanniae Radix, Polygoni Multiflori Radix, and Psoralen in Xiaobai granules. Astragloside Ⅳ in preparation was determination by HPLC-ELSD on Lichrospher-C18(4.6 mm×250 mm, 5 μm) chromatographic column, the mobile phase was acetonitrile-water(32∶68) at a flow rate of 1.0 mL·min-1, and column temperature was 25 ℃. RESULTS TLC spots were clear and well-separated without negative interference. The calibration curves of astragaloside Ⅳ demonstrated linear relationship in the range of 0.311 5-2.803 9 μg(r=0.999 9), average recovery rate was 99.4%(RSD=2.67%). CONCLUSION the method established is simple, accurate and reproducible, which can be used for the quality control of Xiaobai granules. |
| Key words: Xiaobai granules TLC content determination quality standard |
