高效液相色谱法测定臻源胶囊中金丝桃苷和五味子醇甲含量

Determination of the contents of hypericin and schisandrol methyl in Zhenyuan Capsules by HPLC

目的 提升臻源胶囊质量标准,完善其质量控制水平。方法 利用高效液相色谱法(HPLC)测定臻源胶囊中金丝桃苷和五味子醇甲含量。结果 臻源胶囊中金丝桃苷和五味子醇甲平均含量分别为0.27 mg/g和0.34 mg/g,平均加样回收率标准偏差值(RSD)分别为1.63%和1.69%,方法学考察符合规定。结论 在臻源胶囊现有质量标准的基础上,增加了金丝桃苷和五味子醇甲作为含量测定指标,方法简便可行,结果准确,重现性好,为更好控制臻源胶囊产品质量以及探究功效物质基础提供科学依据。

Objective To improve the quality standard of Zhenyuan Capsules and improve its quality control level.Methods The contents of hypericin and schisandrol methyl in Zhenyuan Capsules were determined by high performance liquid chromatography(HPLC).Results The average contents of hypericin and schisandrin methyl in Zhenyuan Capsules were 0.27 mg/g and 0.34 mg/g,respectively,and the relative standard deviation(RSD)of average recovery was 1.63%and 1.69%,respectively.The methodological investigation conformed to the regulations.Conclusion On the basis of the existing quality standards of Zhenyuan Capsules,hypericin and schisandrin methyl are added as the content determination indicators.The method is simple and feasible,whose results are accurate and whose reproducibility is good,providing a scientific basis for better controlling the quality of Zhenyuan Capsules and exploring the material basis of its TCM effcacy.