清热解毒片质量标准

Quality Standard for Qingre Jiedu Tablets

摘要:

目的: 完善提高清热解毒片的质量标准。 方法: 采用薄层色谱法对方中金银花、玄参、连翘、栀子、麦冬进行定性鉴别;同时采用高效液相色谱法测定方中黄芩苷和栀子苷的含量,色谱柱COSMOSIL C₁₈-MS-Ⅱ(4.6 mm×250 mm,5 μm),流动相甲醇-0.2%磷酸溶液,梯度洗脱,流速1.0 mL·min^-1,柱温30℃,检测波长238 nm。 结果: 薄层色谱鉴别专属性强,重复性好。黄芩苷和栀子苷含量的平均回收率分别为95.4%,99.3%,RSD分别为2.2%,1.7%(n=6)。 结论: 该法简便、专属、准确,可用于清热解毒片的质量控制。

Abstract:

Objective: To improve the quality for Qingre Jiedu Tablets. Method: Lonicerae Japonicae Flos, Scrophulariae Radix, Forsythiae Fructus, Gardeniae Fructus, Ophiopogonis Radix were indentified by TLC. The content of baicalin and geniposide were determined by HPLC. Cosmosil C₁₈-MS-Ⅱ column was used with the mobile phase of methanol-0.2% phosphatic acid in a gradient manner. The detection wavelength was set up at 238 nm. The flow rate was 1.0 mL·min^-1and the column temperature was set at 30℃. Result: The average recovery was 95.4% with RSD 2.2% for baicalin, 99.3% with RSD 1.7% for geniposide (n=6). Conclusion: The method is simple, exclusive and accurate, which can be used for determination and quality control for Qingrejiedu Tablets.