归杞合剂的制备及质量标准研究

Preparation and Quality Standard of Guiqi Mixture

目的制备归杞合剂，建立其质量控制方法。方法用当归、枸杞子、黄芪等制备归杞合剂；采用薄层色谱（TLC）法对合剂中当归、枸杞子进行定性鉴别；采用高效液相色谱（HPLC）法测定当归中阿魏酸含量；对制剂进行稳定性试验。结果所得制剂为棕色至棕褐色的液体；各项检查均符合2010年版《中国药典（一部）》相关规定；阿魏酸质量浓度在0．030～0．484g／L范围内与峰面积有良好线性关系，回收率为99．10％，RSD=1．30％（n：5）。结论该制剂制备工艺可靠，质量可控。

Objective To prepare Guiqi Mixture and to establish its quality control method. Methods Radix Angelicae Sinensis, Fructus Lycii, Radix astragali, etc.,were used to prepare Guiqi Mixture; the thin layer chromatography （TLC） was adopted to qualitatively identity Radix Angelicae Sinensis and Fructus Lycii; the high performance liquid chromatography （HPLC） method was adopted to determine the content of ferulic acid in Radix Angelicae Sinensis; the stability test of the preparation was carried out. Results The obtained prepara- tion was a brown to chocolate brown liquid. All the detections conformed to the relevant provisions in the Chinese Pharmacopoeia （edition 2010, Vol. I）; the mass concentration of ferulic acid in the range of 0. 030-0. 484 g/L（ r=0. 9964） and the peak area had a good linear relationship; the recovery rate was 99. 10% and RSD was 1.30% （n =5）. Conclusion The formulation preparation technol- ogy is simple and reliable with the controlable quality.