风热感冒颗粒质量标准的研究和探讨

Research and discussion on the specification of Fengre Ganmao Granules

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WatersHssC18(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。

Objective:To revise and improve the specification of Fengre Ganmao granules. Methods:The TLC methods for identification of Arctii Fructus, Arctiin, Forsythiae Fructus, forsythin and (R, S)-epigoitrin in Fengre Ganmao granules were established. HPLC was adopted to determine the contents of Forsythin and Forsythoside A in Fengre Ganmao granules. The HPLC test was performed in Waters Hss C 18 column (4.6 mm×250 mm, 5 μm) under the gradient elution of acetonitrile-0.2% phosphoric acid. The flow rate was 1 mL·min^-1 , the column temperature was 35 ℃ and the detection wavelength were 277 nm. Results:The TLC chromatograms showed the characteristic spots were clear and there were good resolutions. The linear ranges of forsythin and forsythoside A fell into 9.2-230 μg·mL -1 and 10.56-314 μg·mL ^-1 respectively. The mean recoveries of forsythin and forsythoside A were 98.4% and 98.7% with RSDs of 0.70% and 1.0%. The contents of forsythin and forsythoside A in 14 batches of samples were 0.08-0.16 mg·g^-1 and 0.12-0.27 mg·g^-1 respectively, and the sum of two components was 0.20-0.43 mg·g^-1 . Conclusion:The established methods are applicable to qualitative and quantitative determination of Fengre Ganmao granules, and can be used for evaluation and quality control of Fengre Ganmao granules.