口炎清咀嚼片质量标准研究

Quality Standard of Kouyanqing Chewable Tablet

目的：建立口炎清咀嚼片的质量标准。方法：采用薄层色谱（TLC）法对金银花、玄参和甘草进行定性鉴别；采用高效液相色谱法测定绿原酸的含量：色谱柱为Hypersil ODS（150mm×4．6mm，5μm），流动相为甲醇-0．2％磷酸溶液（19：81），检测波长为327nm，流速为0．8mL·min^-1。结果：TLC斑点清晰集中；绿原酸检测浓度在11．3～101．7μg·mL^-1范围内与峰面积积分值呈良好线性关系（r=0．9991）；平均回收率为99．04％，RSD=1．31％（n=9）。结论：所建标准可用于口炎清咀嚼片的质量控制。

OBJECTIVE： To establish the quality standard of Kouyanqing chewable tablet.METHODS： Flos Lonicerae Japonicae, Radix Scrophulariae and Radix Et Rhizoma Glycyrrhizae in the tablet were identified by TLC. The content of Chlorogenic acid was determined by HPLC. The chromatographic separation was performed on Hypersil ODS column （150 mm × 4.6 mm, 5μm） with mobile phase consistd of methanol- 0.8% phosphoric acid solution（ 19 ： 81） with a flow rate of 0.8 mL · min ^-1. The detection wavelength was set at 327 nm. RESULTS： The TLC spots were clear and concentrated. There was a good linear relationship for Chlorogenic acid within the range of 11.3～101.7μg· mL^-1（ r = 0.999 1）. The average recovery was 99.04% （RSD = 1.31%, n = 9）. CONCLUSION： This method is sensitive, accurate, reproducible and specific, and it can be used for the quality control of Kouyanqing chewable tablet.