目的:建立地黄益智颗粒的质量标准。方法:采用薄层色谱法(TLC)对处方中的石菖蒲、盐益智、丹参、熟地黄进行定性鉴别,采用高效液相色谱法对颗粒中的丹酚酸B进行含量测定。结果:TLC鉴别斑点清晰、分离度好、阴性无干扰,可用于石菖蒲、盐益智、丹参、熟地黄的鉴别;高效液相色谱方法精密度、稳定性、重现性、准确性良好,丹酚酸B在0.0907-2.0149μg范围内与峰面积线性关系良好,平均回收率为97.08%,RSD为3.58%(n=9)。结论:本研究建立的方法准确可靠,专属性强,重现性好,可用于地黄益智颗粒的质量控制。
Objective: To establish the quality standard of Dihuang Yizhi Granules.Methods: Thin layer chromatography(TLC) was applied to the qualitative identification of Acorus tatarinowii Schott.,Alpinia oxyphlla Miq.,Salvia miltiorrhiza Bge.,Rehmannia glutinosa Libosch.and High performance liquid chromatography(HPLC) was applied to the quantitative determination of salvianolic acid B in Dihuang Yizhi Granules.Results: The main spots were clear and separated well without interference of negative sample,so this qualitative method can be applied for identification of Acorus tatarinowii Schott.,Alpinia oxyphlla Miq.,Salvia miltiorrhiza Bge.,Rehmannia glutinosa Libosch..The HPLC method was precise,stable,repeatable and accurate.The salvianolic acid B showed a good linearity in the range of 0.0907-2.0149 μg.The average recovery was 97.08% with a RSD was 3.58%(n=9).Conclusion: The method is accurate,reliable,specific and reproducible and can be used for quality control of Dihuang Yizhi Granules.