乌及丸的质量控制方法研究

Study on quality control for Wu Ji Pill

目的建立乌及丸的质控方法。方法采用显微鉴别法定性鉴别处方中海螵蛸、高良姜和白及。用TLC法定性鉴别处方中延胡索、甘草、高良姜。采用HPLC法测定处方中芍药苷的含量,色谱柱为VP-ODS(5μm,4.6 mm×150 mm),以乙腈-0.1%磷酸(15∶85)为流动相;检测波长为230 nm;柱温:30℃;流速:1.0 ml/min。结果薄层定性鉴别斑点清晰,分离效果良好,专属性强;芍药苷在2.5~80μg/ml范围内与峰面积呈良好的线性关系,Y=5 456.1 X-4 956.7,r=0.999 4,平均加样回收率为100.8%,RSD为0.89%(n=6)。结论本文试验方法可控制乌及丸的质量。

Objective To establish the quality standard for hospital pharmaceutical preparation of Wu Ji Pill.Methods Microscopic identification was used to identify sepiae endoconcha, alpiniae officinarum rhizome and bletillae rhizome; corydalis rhizoma was identified by TLC and the contents of Paeoniflorin were determined by RP-HPLC.Chromatography conditions were VP-ODS（ 5 μm,4. 6 mm × 150 mm） column. The mobile phase was acetonitrile-0. 1% phosphoric acid（ 15∶ 85）. UV detection wavelength was set at 230 nm and the column temperature was 30 ℃with the flow rate of 1. 0 ml/min. Results The method of TLC had good resolution with clear spots and negative control showed no interference. The good linearity was obtained within the range of 2. 5 ～ 80 μg/ml（ Y = 5 456. 1 X-4 956. 7,r = 0. 999 4） for Paeoniflorin and the average recovery was 100. 8%（ RSD = 0. 89%,n = 6）. Conclusion The established method can be applied in the quality control of Wu Ji Pill.