地黄益智颗粒的质量标准研究  

Stduies on quality standard of Dihuang Yizhi Granules

作　　者：林国钡[1] 谢燕[1] 李国文[1] 安红梅[2] 

机构地区：[1]上海中医药大学健康营养研究室,上海201203 [2]上海中医药大学附属龙华医院,上海200032

出　　处：《中华中医药杂志》2012年第11期2785-2788,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：上海科委中药现代化项目(No.10DZ1971200);上海市青年科技启明星计划项目(No.11QA1406500);国家自然科学基金(No.81072789)~~

摘　　要：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.

关 键 词：地黄益智颗粒 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R286[医药卫生—中药学]