痔瘘洗液质量控制方法研究

Quality Control Method of Hemorrhoids Fistula Lotion

目的:建立痔瘘洗液质量控制方法。方法:采用TLC法对大黄及黄柏进行定性鉴别;采用HPLC法对山银花中绿原酸进行含量测定。以环己烷-乙酸乙酯-甲酸(12∶3∶0.2)为展开剂,置氨蒸气中检视;黄柏的展开剂为乙酸乙酯-丁酮-甲酸-水(10∶6∶1∶0.5)为展开剂,置紫外光灯(365 nm)下检视;绿原酸的色谱条件为:Agilent Eclipse XDB-C18(4.6 mm×250 mm,5μm)色谱柱;流动相:乙腈-0.4%磷酸溶液(10∶90);检测波长:327 nm;流速:0.8 mL/min,柱温:40℃。结果:绿原酸在浓度2.442-122.1μg·mL-1范围内与峰面积线性关系良好,R=1.0000;平均加样回收率为101.30%(RSD%=1.05%);重复性好(RSD%=0.64%)。结论:所建立的质量分析方法准确、可靠、简单、易行,能够对痔瘘洗液的质量进行有效控制。

Objective：To establish a quality control method for hemorrhoid lotion. Methods： Thin-layer chromatography （TLC） method was applied for the qualitative identification rhubarb and Cortex Phellodendri; HPLC was used to determine the content of Lonicera Chlorogenic acid. Rhubarb by thin-layer chromatography for identification, cyclohexane-ethyl acetate- formic（12：3：0.2） as the agent, Ammonia vapor into to view; Cortex Phellodendri developing solvent is ethyl acetate-butanone- formic-water（10：6：l：0.5）, in UV light （365 nm）to view; Chlorogenic acid chromatographic conditions, chromatographic column： Agilent Eclipse XDB-C18（4.6 mm-250 mm,5μm）; Mobile phase： acetonitrile -0.4% phosphoric acid （10：90）; Detection wave- length： 327 nm; flow velocity： 0.8 mL/min; Column temperature： 40℃. Results： Chlorogenic acid showed a good linear rela- tionship, R=1.0000, at a concentration 2.442-122.1μg·mL-1 within the range and peak area; The average adding sample re- covery was lO1.30%（RSD%=1.05%）, with repeatability （RSD%=0.64%）. Conclusion： The qualitative analysis method is accurate, reliable, simple, easy and capable for quality control of hemorrhoids fistula lotion.