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中国医药导刊 ›› 2022, Vol. 24 ›› Issue (7): 702-706.

• 中药检测 • 上一篇    下一篇

姜竹茹配方颗粒质量标准研究

赵淑淑, 俞杰, 姚俊霞, 黄琪, 许豪杰   

  1. 浙江佐力药业股份有限公司, 浙江 德清 313200
  • 收稿日期:2020-09-28 修回日期:2022-10-08 出版日期:2022-07-28 发布日期:2022-07-28
  • 基金资助:
    浙江省中医药管理局中药配方颗粒科研专项(项目编号:浙中医〔2017〕11号;项目名称:中药配方颗粒产业化及临床应用关键技术研究)

Study on Quality Standards of Ginger-fried Bambusae Caulis In Taenias Formula Granules

  1. Zhejiang Jolly Pharmaceutical Co., Ltd, Zhejiang Deqing 313200, China
  • Received:2020-09-28 Revised:2022-10-08 Online:2022-07-28 Published:2022-07-28

摘要: 目的:采用高效液相色谱(HPLC)法建立姜竹茹配方颗粒的指纹图谱及含量测定方法,旨在完善姜竹茹配方颗粒质量控制方法。方法:指纹图谱研究中,采用Welch Ultimate AQ-C18色谱柱(4.6 mm×250 mm,5 μm),以乙腈-0.1%磷酸溶液为流动相梯度洗脱,流速1.0 mL·min-1,柱温30 ℃,检测波长280 nm。采用“中药色谱指纹图谱相似度评价软件系统2012年版130723版本”软件进行指纹图谱分析。含量测定研究中,以乙腈-0.1%磷酸溶液(13∶87)为流动相,流速1.0 mL·min-1,柱温30 ℃,检测波长308 nm。结果:与17批标准汤剂形成的对照图谱进行比较,4批供试品共有4个共有峰,对照图谱相似度均大于0.85;含量测定中,4-香豆酸在12.6~6 990.7 ng(r2=0.999 8)范围内呈现良好的线性关系,平均加样回收率分别为94.73%(RSD=0.58%)。 结论:该方法简便、准确,重现性良好,可为姜竹茹配方颗粒的质量控制提供参考。

关键词: font-size:medium, ">姜竹茹配方颗粒;指纹图谱;4-香豆酸;质量研究

Abstract: Objective:To establish quality standard of ginger-fried Bambusae Caulis In Taenias formula granules through the HPLC fingerprint spectrum and the determination of the content, to improve its quality control methods. Methods:The HPLC analysis was carried out using a column of Welch Ultimate AQ-C18(4.6 mm×250 mm,5 μm) with the temperature of 30 ℃.The mobile phase was consisted of acetonitrile-0.1% phosphoric acid solution with gradient elution at a flow rate of 1.0 mL·min-1, and the detection wavelength was 280 nm. Fingerprint spectrum analysis was performed using Chinese Medicine Chromatographic Fingerprint Spectrum Similarity Evalution System software (2012.130723 version). The 4-coumaric acid was tested with the detection wavelength of 308nm. The mobile phase was consisted of acetonitrile-0.1% phosphoric acid solution (13∶87) with gradient elution at a flow rate of 1.0 mL·min-1, column temperature 30 ℃. Results:Compaired with the fingerprints of 17 batches of ginger-fried Bambusae Caulis In Taenias standard decoction, there were four common peaks in the 4 batches of ginger-fried Bambusae Caulis In Taenias formula granules tested, with the similarities greater than 0.85. Good linearities of 4-coumaric acid was achieved in the ranges of 12.6~6 990.7 ng(r2=0.999 8). The average recoveries was 94.73%(RSD=0.58%). Conclusion: The method is convenient, accurate and with good repeatability, and it can provide reference evidence for quality control of ginger-fried Bambusae Caulis In Taenias formula granules.

Key words: font-size:medium, ">Ginger-fried Bambusae Caulis In Taenias formula granules; Formula fingerprint spectrum; 4-coumaric acid; Quality research

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