骨增合剂的质量标准研究

Study on Quality Standard for Guzeng Mixture

关键词:  骨增合剂  芍药苷  葛根素  补骨脂素  质量标准  薄层色谱法  大孔树脂-紫外法

Key words:  Guzeng Mixture  paeoniflorin  puerarin  psoralen  quality standard  TLC  resin-UV

摘要:

[目的]完善骨增合剂的质量控制标准。[方法]采用薄层色谱法对骨增合剂中白芍、葛根、补骨脂、淫羊藿4味主药进行定性鉴别,并用大孔树脂-紫外法对君药淫羊藿中有效成分淫羊藿苷的含量进行测定。[结果]4味主药代表性成分斑点分离效果好,对比明显;君药中淫羊藿苷含量在2.5～22.5μg/mL范围内线性关系良好,平均加样回收率95.5%(n=5,RSD=1.52%),精密度RSD=1.93%。[结论]方法操作简便、灵敏、准确、重现性好,取得了较为满意的结果,可作为该制剂的质量控制方法。

Abstract:

[Objective] To perfect the quality standard for Guzeng (bone-increasing)Mixture. [Methods] TLC was performed for the qualitative discrimination of the main Chinese Herbal cpmponents in Guzeng Mixture, including Radix Paeoniae Alba, Radix Puerariae, Fructus psoraleae and Herba epimedii. Epimedium glycoside, the effective content of epimedium herb was measured by Resin-UV method. [Results] Good spots separation of the four main herbs was obtained with significant contrasting. The calibration curve of epimedium glycoside was linear at range of 2.5-22.5μg/m (r=0.997). The average recovery rate was 95.5% (n=5,RSD= 1.52%). The precision degree of RSD was 1.93%. [Conclusion] The method is simple, accurate and reproducible. So it can be used for the quality control of this mixture.