文章摘要
孙强.风热感冒颗粒质量标准的研究和探讨[J].中国药品标准,2019,(3):212-223
风热感冒颗粒质量标准的研究和探讨
Research and discussion on quality standard of Fengre Ganmao Granules
投稿时间:2019-02-22  修订日期:2019-05-21
DOI:
中文关键词: 风热感冒颗粒  牛蒡子  牛蒡苷  连翘  连翘苷  连翘酯苷A  (R-S)-告依春  薄层色谱鉴别  高效液相色谱法  标准提高
英文关键词: Fengre Ganmao granules  Fructus Arctii  Arctiin  Forsythia?Suspensa?(?Thunb)  Forsythin  Forsythoside A  (R,S)-epigoitrin  TLC  HPLC  The improvement of quality standard
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作者单位E-mail
孙强 泰安市食品药品检验检测中心 mobile1127@163.com 
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中文摘要:
      目的:对风热感冒颗粒的质量标准进行增修提高。方法:建立风热感冒颗粒中牛蒡子、牛蒡苷、连翘、连翘苷和(R-S)-告依春的薄层色谱鉴别的方法;建立HPLC 法测定风热感冒颗粒中连翘苷和连翘酯苷A的含量,使用Waters Hss C18(4.6mm×250mm,5μm)色谱柱,柱温35 ℃,以乙腈-0.2%磷酸水溶液为流动相,梯度洗脱,流速1.0mL·min-1,检测波长277nm。结果:薄层色谱中特征斑点明显,分离度好;连翘苷和连翘酯苷A的质量浓度分别在9.2~230μg·mL-1、10.56~314μg·mL-1范围内线性关系良好,平均回收率分别为98.4% 和98.7%,RSD 分别为 0.70%和1.0%。14批样品中连翘苷和连翘酯苷A含量范围分别为0.08~0.16mg·g-1和0.12~0.27mg·g-1,两者含量总和为0.20~0.43mg·g-1。结论:本文方法可对风热感冒颗粒进行准确地定性和定量测定,能够有效评价与控制风热感冒颗粒质量。
英文摘要:
      Abstract :Objective To revise and improve the quality standard of Fengre Ganmao granules.Methods:The TLC methods for the identification of Fructus Arctii, Arctiin, Forsythia?Suspensa?(?Thunb)?,(R,S)-epigoitrin and Forsythin in Fengre Ganmao granules were established.HPLC was adopted to determine the content of Forsythin and Forsythoside A in Fengre Ganmao granules.The Waters Hss C18 column (4.6mm×250mm,5μm) was used as the analytical column,the mobile phase was acetonitrile-0.2% phosphoric acid at a flow rate of 1 mL·min-1 in gradient elution.The column temperature was 35℃ and the detection wavelength were 277nm.Results:The TLC showed the spots were clear and the separation was good.The calibration curves were linear in the ranges of 9.2~230μg·mL-1、10.56~314μg·mL-1 for Forsythin and Forsythoside A respectively.The mean recoveries of Forsythin and Forsythoside A were 98.4% and 98.7% with RSDs of 0.70% and 1.0%.For the 25 batches of samples,the amounts of Forsythin and Forsythoside A were 0.08~0.16mg·g-1和0.12~0.27mg·g-1,and the sum of the two was 0.20~0.43mg·g-1.Conclusion:The simple and accurate methods for qualitative and quantitative detection of Fengre Ganmao granules can be used in the evaluation and control of the quality of Fengre Ganmao granules.
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