HPLC法同时测定11个厂家养阴清肺糖浆中4种成分

Simultaneous determination of the four components in Yangyin Qingfei Syrup from 11 pharmaceutical companies by HPLC

目的建立养阴清肺糖浆(地黄、玄参、麦冬、甘草、牡丹皮、川贝母、白芍、薄荷脑)中芍药苷、哈巴俄苷、丹皮酚、甘草酸的定量测定方法,采用多指标评价不同厂家及同一厂家不同批次的含有量差异。方法采用HPLC法,色谱柱为Agilent SB-C18(4.6 mm×250 mm,5μm),流动相为乙腈-0.1%磷酸水溶液(梯度洗脱);检测波长为254 nm;体积流量为0.8 mL/min;柱温为30℃。结果芍药苷、哈巴俄苷、丹皮酚和甘草酸质量浓度分别在0.010 56～10.056 mg/mL、0.000 78～0.078 mg/mL、0.009 46～0.946 0 mg/mL、0.004 84～0.484 0 mg/mL范围内与峰面积呈良好的线性关系。不同厂家芍药苷、哈巴俄苷、丹皮酚、甘草酸质量浓度分别为0.323～0.624 mg/mL、0.000 3～0.038 mg/mL、0.008～0.471 mg/mL、0.038～0.230 mg/mL;同一厂家不同批次的质量浓度分别为0.446～0.523 mg/mL、0.013～0.015 mg/mL、0.320～0.361 mg/mL、0.159～0.188 mg/mL。结论采用多指标对样品质量进行评价,结果表明不同厂家样品质量差异较大,不稳定;同一厂家不同批次样品质量相对稳定,含有量差异较小。

AIM To establish a method for determining paeoniflorin,harpagoside,paeonol and glycyrrhizic acid in Yangyin Qingfei Syrup（Rehmanniae Radix,Scrophulariae Radix,Ophiopogonis Radix,Glycyrrhizae Radix et Rhizoma,Moutan Cortex,Fritiliariae cirrhosae Bulbus,Paeoniae Radix alba,L-menthol）,and to compare the qualities of the four components in Yangying Qingfei Syrup from different pharmaceutical companies and three runs in a single pharmaceutical company by multiple index analysis.METHODS HPLC with Agilent SB-C18（4.6 mm × 250 mm,5 μm） column was used with acetonitrile-0.1% phosphoric acid（gradient elution） as a mobile phase.The detection wavelength was set at 254 nm.Flow rate was 0.8 mL / min,and column temperature was 30 ℃.RESULTS The linear separate ranges were 0.010 56-10.056 mg / mL for paeoniflorin,0.000 78-0.078 mg / mL for harpagoside,0.009 46-0.946 0 mg / mL for paeonol,0.004 84-0.484 0 mg / mL for glycyrrhizic acid.The contents of four components in Yangying Qingfei Syrup from different pharmaceutical companies were 0.323-0.624 mg / mL,0.000 3-0.038 mg / mL,0.008-0.471 mg / mL,0.038-0.230 mg / mL,respectively.The contents of four components from three runs in a single pharmaceutical company were 0.446-0.523 mg / mL,0.013-0.015 mg / mL,0.320-0.361 mg / mL,0.159-0.188 mg / mL,respectively.CONCLUSION By using multiple index analysis,there are great differences in the quality among different pharmaceutical companies,while the qualities of three runs in a single pharmaceutic company were relatively stable.