| 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,2019,20(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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| 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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