消炎解毒丸质量标准的研究

Study on the quality standard for Xiaoyan Jiedu pill

目的 建立消炎解毒丸的质量标准,为本产品提供完善、可控的质量标准.方法 采用薄层色谱法鉴别消炎解毒丸中的金银花、防风、连翘、甘草;采用HPLC法测定咖啡酸质量分数,色谱柱为DIKMADiamonsil C18柱（250 mm×4.6 mm,5μm）,流动相为甲醇-磷酸缓冲盐（体积比23∶77）,检测波长为323nm,柱温为40℃.结果 在薄层色谱中检出金银花、防风、连翘、甘草,各药材薄层色谱斑点清晰,阴性无干扰;HPLC法测定中咖啡酸在0.031 2～0.780 0 μg范围内线性关系良好（r=0.999 95）,平均回收率为99.52％,RSD值为1.53％（n=6）.结论 本方法快速、简便、精密度好、灵敏度高,提高了消炎解毒丸的质量控制标准.

Objective To improve the quality standard of Xiaoyan Jiedu pill,and provide the optimum and controllable quality standards for the product.Methods TLC was used to identificate the Lonicerae Japonicae Flos,Saposhnikoviae Radix,Forsythiae Fructus,and Glycyrrhizae Radix.HPLC was used to determine the content of caffeic acid.The column was DIKMA Diamonsil C18（250 mm×4.6 mm,5μm）.The mobile phase was methanol-phosphate buffered saline （23∶77）.The detection wavelength was 323 nm.The column temperature was 40 ℃.Results Lonicerae Japonicae Flos,Saposhnikoviae Radix,Forsythiae Fructus,and Glycyrrhizae Radix were detected in TLC with good spots and no negative interference.There was a good linerity within the concentration range of 0.031 2-0.780 0 μg for caffeic acid （r=0.999 95）.The average recovery was 99.52% （RSD=1.53%,n =6）.Conclusion The quality standard was fast,simple,with good precision and high sensitivity,which improves the standard of quality control of Xiaoyan Jiedu pill.