| 引用本文: | 刘栋,宋晓红,汤长明,王丽军,李明春,程艳芹.软肝缩脾丸的质量标准研究[J].中国现代应用药学,2017,34(4):542-548. |
| LIU Dong,SONG Xiaohong,TANG Changming,WANG Lijun,LI Mingchun,CHENG Yanqin.Study on Quality Standard for Ruangan Suopi Pill[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(4):542-548. |
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| 摘要: |
| 目的 建立并提升软肝缩脾丸的质量标准。方法 采用显微鉴别法、薄层色谱法对软肝缩脾丸中的黄芪、丹参、赤芍、鳖甲、大黄、五味子、桃仁、三七进行定性鉴别；采用HPLC测定芍药苷、丹酚酸B的含量。色谱柱为Wondasil C18柱（250 mm×4.6 mm，5 μm），流动相为乙腈-0.1%磷酸溶液，梯度洗脱，流速：1.0 mL·min-1，检测波长230，286 nm，柱温：30 ℃，进样量：10 μL。结果 4味药材的显微特征明显；5味药材的薄层色谱斑点清晰，分离度良好，阴性无干扰；HPLC显示芍药苷在9.79~195.80 μg·mL-1（r=0.999 9）、丹酚酸B在11.45~229.00 μg·mL-1 （r=0.999 9）内线性关系良好，平均回收率分别为100.6%，101.9%，RSD分别为1.26%，1.05%。结论 本方法简便、快捷、结果准确、重复性好，可用于软肝缩脾丸的质量控制。 |
| 关键词: 软肝缩脾丸 显微鉴别 薄层色谱法 高效液相色谱法 质量标准 芍药苷 丹酚酸B |
| DOI：10.13748/j.cnki.issn1007-7693.2017.04.015 |
| 分类号: |
| 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（14ZJZ02） |
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| Study on Quality Standard for Ruangan Suopi Pill |
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LIU Dong1, SONG Xiaohong1, TANG Changming1, WANG Lijun1, LI Mingchun2, CHENG Yanqin2
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1.Department of Preparation, NO.153 Central Hospital of PLA, Zhengzhou 450042, China;2.Department of Pharmacy, NO.401 Hospital of PLA, Qingdao 266071, China
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| Abstract: |
| OBJECTIVE To establish and improve the quality standard of Ruangan Suopi pill. METHODS Microscopic identification and TLC were conducted for the qualitative identification of Astragali radix, Salviae miltiorrhizae radix et rhizoma, Paeoniae radix rubra, Trionycis carapax, Rhei radix et rhizoma, Schisandrae chinensis fructus, Persicae semen, Notoginseng radix et rhizoma in Ruangan Suopi pill; HPLC was performed to determine the contents of paeoniflorin and salvianolic acid B. It was performed on column of Wondasil C18(250 mm×4.6 mm, 5 μm) with mobile phase of acetonitrile -0.1% phosphonic acid in linear gradient elution mode at the flow rate of 1.0 mL·min-1, the UV detection wavelength of 230 nm and 286 nm, the column temperature of 30 ℃ and the volume of 10 μL. RESULTS The microscopic identification showed microscopic characteristics of four traditional Chinese medicines. TLC spots of the five traditional Chinese medicines were clear and well-separated without negative interference. The HPLC experiment results showed the good linearities in the range of 9.79-195.80 μg·mL-1 (r=0.999 9) for paeoniflorin, 11.45-229.00 μg·mL-1 (r=0.999 9) for salvianolic acid B, respectively. The average recovery rates of two compounds were 100.6%, 101.9%, and RSD were 1.26%, 1.05%. CONCLUSION The method is rapid, convenient, accurate, repeatable, and suitable for quality control of Ruangan Suopi pill. |
| Key words: Ruangan suopi pill microscopic identification TLC HPLC quality standard paeoniflorin salvianolic acid B |
