双山颗粒的质量标准研究

Research on the Quality Standard of Shuangshan Granules

目的:建立双山颗粒的质量标准。方法:参照《中华人民共和国药典》2020年版四部通则相关方法,建立鉴别双山颗粒中山药、山萸肉、肉苁蓉3味饮片的薄层色谱(TLC)法;建立高效液相色谱(HPLC)法分析双山颗粒中莫诺苷和松果菊苷的含量。结果:TLC法能有效鉴别方中3味饮片;定量分析方法中,莫诺苷、松果菊苷质量浓度分别在17.49~291.56μg·mL^(-1)、16.46~274.28μg·mL^(-1)范围内线性关系良好,平均加样回收率分别为92.66%(RSD为0.81%)、104.26%(RSD为0.74%)。结论:建立的质量标准简便准确、专属性强,可用于双山颗粒的质量控制。

Objective To establish the quality standard of Shuangshan Granules.Methods According to the relevant methods presented in the fourth general rules of Pharmacopoeia of the People's Republic of China(2020),a TLC method was established to identify 3 Chinese medicinal materials in Shuangshan Granules,including Dioscoreae Rhizoma,Corni Fructus and Cistanches Herba;Establish an HPLC method for analyzing the content of Morroniside and Echinacoside in Shuangshan granules.Results TLC method can effectively identify three decoction pieces in the formula;Morroniside and Echinacoside concentration graph respectively showed a good linear relationship at a range of 17.49-291.56μg·mL^(-1)and 16.46-274.28μg·mL^(-1),with average sample recovery rates of 92.66%(RSD 0.81%)and 104.26%(RSD 0.74%),respectively.Conclusion The established quality standard is simple,accurate,and has strong specificity,and can be used for the quality control of Shuangshan granules.