清咽宁颗粒的质量标准研究

摘要

The quality standards of Qingyanning Granules were established by thin-layer chromatography for Shandougen, Xuanshen, Maidong, Shegan in preparation for qualitative analysis, with the content of Yejuhua of chlorogenic acid as index, using high performance liquid chromatography determination in chlorogenic acid square. Chromatographic column was as follows: Agilent HC-C18 column ( 250 mm × 4. 6 mm, 5 μm ) , mobile phase was as follows: acetonitrile-0. 4% phosphoric acid solution ( 11:89 ) , flow rate of 1 mL/min, the column temperature of 25 ℃, and the detection wavelenth of 327 nm. The results showed that in the qualitative identification of detected in the Shandougen, Xuanshen, Maidong, Shegan, thin spots were clear and well separated, and specificity. Chlorogenic acid in 0. 108~0. 540 μg range and peak area showed a good linear relationship between y=0. 0006 x-0. 0031 ( r=0. 9999 ) , the average recovery was 100. 57%, RSD was 1. 55% ( n=6 ) , 1 g sample contained chlorogenic acid 0. 1112 mg. The quality control method is accurate, reliable, reproducible, and can be used for quality control of Qingyanning Granules.%建立清咽宁颗粒的质量控制标准方法。采用薄层色谱法对制剂中山豆根、玄参、麦冬、射干进行定性鉴别；以野菊花中绿原酸的含量为指标,采用高效液相色谱法测定方中绿原酸的含量,色谱柱： Agilent HC-C18柱,250 mm ×4.6 mm 5μm；流动相：乙腈-0.4％磷酸溶液(11：89),流速1 mL/min,柱温25℃,检测波长327 nm。结果表明：定性鉴别中检出山豆根、玄参、麦冬、射干,薄层斑点清晰,且分离度好、专属性强；绿原酸在0.108~0.540μg 范围内与峰面积呈良好的线性关系 y=0.0006x-0.0031(r=0.9999)；测得平均回收率为100.57％, RSD为1.55％(n=6),每1 g样品中含绿原酸0.1112 mg。所建立的质量控制方法准确、可靠、专属性强,可用于清咽宁颗粒的质量控制。