咽炎片中5个成分的含量测定及质量分析

Content Determination and Quality Analysis of Five Components in YanYan Tablets

目的建立HPLC法同时测定咽炎片中5个成分芍药苷、黄芩苷、哈巴俄苷、肉桂酸、款冬酮的含量测定方法,考察咽炎片的整体质量情况。方法采用Ag ilent ZORBAX SB-C 18色谱柱(4.6 mm×250 mm,5μm);以乙腈-0.1%磷酸水溶液为流动相进行梯度洗脱,检测波长为230 nm(芍药苷)、280 nm(黄芩苷、哈巴俄苷、肉桂酸)、213 nm(款冬酮);柱温为30℃;流速为0.8 mL·min^(-1)。采用SPSS 20.0软件对5个成分的含量测定结果进行统计学分析。结果芍药苷、黄芩苷、哈巴俄苷、肉桂酸、款冬酮分别在6.35~402.74μg·mL^(-1)、1.89~120.91μg·mL^(-1)、1.22~77.95μg·mL^(-1)、1.04~66.39μg·mL^(-1)、1.25~80.40μg·mL^(-1)范围内线性关系良好,平均加样回收率(n=9)在96.61%~99.91%。通过测定50批咽炎片中5个成分的含量,发现咽炎片的质量情况一般,部分生产企业存在原料药把关不严、使用劣质药材投料或未按处方足量投料的问题,现行咽炎片质量标准有待完善。结论该方法精密度、稳定性、重复性良好,为咽炎片的质量控制提供科学依据。

OBJECTIVE To establish an HPLC method for the simultaneous determination of five components paeoniflorin,baicalin,harpagoside,cinnamic acid and veronicone in YanYan tablets,and to investigate the overall quality of YanYan tablets.METHODS The Agilent Zorbax SB-C 18 column(4.6 mm×250 mm,5μm)was used with the mobile phase of acetonitrile-0.1% phosphoric acid solution with Gradient elution.The detection wavelengths were 230 nm(paeoniflorin),280 nm(baicalin,harpagoside,cinnamic acid)and 213 nm(asparagine);The column temperature was 30℃;The flow rate was 0.8 mL·min^(-1).The content determination results of five components were statistically analyzed by SPSS 20.0 software.RESULTS The linear range was 6.35-402.74μg·mL^(-1) for paeoniflorin,1.89-120.91 g·mL^(-1) for baicalin,1.22-77.95μg·mL^(-1) for hapaoside,1.04-66.39μg·mL^(-1) for cinnamic acid and 1.25-80.40μg·mL^(-1) for aspartate,respectively.The average recoveries(n=9)ranged from 96.61% to 99.91%.Through the determination of the content of 5 components in 50 batches of pharyngitis tablets,it was found that the quality of YanYan tablets was general,and some manufacturers had the problems of lax control of raw materials,use of substandard medicinal materials or insufficient feeding according to the prescription,and the current quality standards of YanYan tablets need to be improved.CONCLUSION The method has good precision,stability and repeatability,and provides a scientific basis for the quality control of YanYan tablets.