复方石韦片的质量控制

Quality control of Fufang Shiwei Tablets

目的建立复方石韦片的质量控制方法。方法应用薄层色谱法对复方石韦片中的苦参、黄芪进行定性鉴别,采用高效液相色谱法测定苦参碱。色谱柱:KromasilKR100-5C18柱(4.6mm×250mm,5μm),流动相:乙腈-0.025mol/L磷酸(1:24),三乙胺调pH值至3.5,体积流量:1mL/min,柱温:25℃,检测波长:220nm。结果在薄层色谱中均能检出苦参、黄芪;苦参碱质量浓度在16.01～320.40μg/mL范围内线性关系良好(r=0.9999),平均加样回收率为100.64%,RSD为0.87%。结论本法简单、灵敏、结果准确,可用于复方石韦片的质量控制。

Objective To establish a method for quality contral of Fufang Shiwei Tablets. Methods TLC was applied to the identification of Radix Sophorae flavescentis and Radix Astragali, and HPLC was applied to the determination of matrine. Kromasil KP100-5 C18 （4. 6 min× 250 mm, 5 μm） column was used. The mobile phase consisted of acetonitrile -0. 025 mol/L phosphoric acid （1 ： 24）, and pH of the mobile phase was adjusted to 3.5 by triethylmine. The flow rate was 1 mL/min, column temperature was 25 ℃, and the detection wavelength was 220 nm. Results Radix Sophorae flavescentis and Radix Astragall were identified by TLC. The linear range of matrine was 16.01-320.40 μg/mL, the average recovery was 100.64%, and RSD was 0.87%. Conclusion The method is simple, sensitive and accurate, and it can be applied to the quality contral of Fufang Shiwei Tablets.