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目的:改进乙肝清热解毒片的质量标准。方法:增加茜草的薄层色谱,修订虎杖的含量测定方法为HPLC法测定虎杖苷的含量。HPLC色谱条件:采用SUNTEK Kromasil C18(4.6 mm×250 mm,5μm)色谱柱,流动相为乙腈-水(18∶82),流速1.0mL.min-1,柱温30℃,检测波长306 nm。结果:茜草的薄层色谱斑点分离良好;虎杖苷的含量测定方法专属性高,虎杖苷峰与其他峰分离良好,0.0615～0.6152μg范围内呈良好的线性关系,加样回收率为98.4%(RSD=1.8%)。结论:通过对乙肝清热解毒片质量标准的改进,使标准更具有专属性,更有利于该产品的质量控制。
Objective: To improve the quality standard of Qingrejiedu tablets. Methods: The TLC of Rubia cordifolia was increased, and the method of determination of Polygonum cuspidatum was used to determine the content of polydatin by HPLC. HPLC chromatographic conditions: The mobile phase was acetonitrile-water (18:82) at a flow rate of 1.0 mL · min-1 using a SUNTEK Kromasil C18 column (4.6 mm × 250 mm, 5 μm) with a detection wavelength of 306 nm at 30 ° C. Results: The TLC spots of Rubia cordifolia were well separated. The detection method of polydatin was specific and the pollen peak was well separated from other peaks. The linear range was 0.0615 ~ 0.6152μg, the recoveries were 98.4% RSD = 1.8%). Conclusion: By improving the quality standard of Qingganjiedu tablets, the standard is more specific and more conducive to the quality control of this product.