HPLC法同时测定加味白头翁汤凝胶灌肠剂中秦皮甲素和盐酸小檗碱的含量

目的：建立反相高效液相色谱法同时测定医院制剂加味白头翁汤凝胶灌肠剂中秦皮甲素和盐酸小檗碱的含量。方法：色谱柱为DiamonsilC18（250mm×4.6mm,5μm）;采用梯度洗脱的方法,流动相：溶液A为乙腈,溶液B为含5%三乙胺的0.33mol·L^-1磷酸二氢钾缓冲液（pH=3.0）。0～9min,溶液A：溶液B为12∶88;9～10min,A∶B为30∶70;10～22min,A∶B为30∶70。流速：1.0mL·min^-1;秦皮甲素和盐酸小檗碱的检测波长分别为334nm和349nm。结果：秦皮甲素和盐酸小檗碱分别在4～200μg·mL^-1和1～50μg·mL^-1范围内线性良好;平均加样回收率分别为96.63%（RSD=2.52%）和97.37%（RSD=1.84%）。结论：本方法准确、重现性好,可用于加味白头翁汤凝胶灌肠剂的质量控制。

Determination of Aesculin and Berberine Hydrochloride in Enema of Pulsatillae Decoction by HPLC

OBJECTIVE： To establish a RP - HPLC method for simultaneous determination of the contents of aesculin and berberine hydrochloride in the enema of Pulsatillae Decoction. METHODS： Content determination was carried out on a Diamonsil C18 （250 mm ×4. 6 mm,5 μm） chromatographic column. The mobile phase was stated as follows： solution A was acetonitrile, and solution B was 0. 33 mol·L -1 phosphate buffer （ containing 5% triethylamine） （pH = 3. 0） （the ratios of A/B at 0 ～ 9 min,9 ～ 10,10 ～ 22 min were 12：88,30：70 and 30：70, respectively） in gradient elution with a flow rate of 1. 0 mL·min^ -1. The detection wavelength for aesculin was set at 334 nm and that for berberine hydrochloride was set at 349 nm. RESULTS： The linear range was 4 ～200 μg·mL -1 for aesculin and 1 ～ 50 μg·mL^ -1 for berberine hydrochloride. The average recoveries of aesculin and berberine hydrochloride were 96. 63% （RSD = 2. 52% ） and 97. 37% （RSD = 1. 84% ）,respectively. CONCLUSION： This method is accurate and reproducible,and it is applicable for the quality control of the enema of Pulsatillae Decoction.