医院制剂榆参洗剂质量标准研究

Study on Quality Standard of Yushen Lotion of Hospital Preparations

目的建立榆参洗剂的质量控制方法。方法采用薄层色谱法(TLC)法鉴别方中黄柏、苦参。采用高效液相色谱(HPLC)法测定榆参洗剂中盐酸小檗碱的含量,色谱柱为Ultimate XB-C18柱(150 mm×4. 6 mm,5μm),流动相为乙腈-0. 1%磷酸溶液(28∶72),流速为1 m L/min,柱温为30℃,检测波长为265 nm。结果薄层色谱鉴别方法专属性强,斑点清晰,且阴性无干扰;盐酸小檗碱质量浓度线性范围为0. 013 005~0. 130 050 g/L(r=0. 999 9,n=6)。结论该方法结果准确、重复性好,可有效控制该制剂的质量。

Objective To establish the quality standard of Yushen Lotion. Methods The TLC method was used to identify Phellodendri Chinensis Cortex and Sophora Flavescentis Radix in Yushen Lotion. The HPLC method was used to determie berberine hydrochloride in Yushen Lotion. The Ultimate XB- C18 column（150 mm x4.6 ram, 5 μm） was adopted, the mobile phase was acetonitrile-0.1% phosphoric acid solution（28：72）, the flow rate was 1 mL/min, the column temperature was 30 ℃, and the detection wavelength was 265 ran. Results The TLC identification method was highly specific with clear spots, and negative control without interference. Berberine hydrochloride was linear in the range of 0. 013 005-0. 130 050 g/L（r =0. 999 9, n =6）. Conclusion This method is accurate and reproducibly, which can be used for the quality control of Yushen Lotion.