归杞合剂的制备及质量标准研究

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0.030～0.484 g/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.

Preparation and Quality Standard of Guiqi Mixture

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.