妇科灌肠液质量标准的建立

Establishment of Quality Standard for Fuke Enema

目的:建立妇科灌肠液的质量标准。方法:采用TLC法对妇科灌肠液中大血藤、紫花地丁、三棱进行定性鉴别;采用HPLC法对妇科灌肠液中羟基红花黄色素A、蒙花苷进行含量测定,色谱柱:Wondasil C18(250 mm×4.6 mm,5μm);流动相:甲醇-乙腈-0.5%磷酸水溶液,梯度洗脱;流速:1.0 ml·min^(-1);检测波长:403 nm、330 nm;柱温:30℃;进样量:10μl。结果:TLC斑点清晰,分离度好,阴性对照无干扰;羟基红花黄色素A、蒙花苷分别在进样浓度40.80~204.00μg·ml^(-1)(r=0.999 9)、60.00~300.00μg·ml^(-1)(r=0.999 9)范围内与峰面积呈良好线性关系,平均加样回收率分别为99.56%、98.68%,RSD分别为2.25%、1.94%(n=6)。结论:该方法快速、准确、专属性强,可作为妇科灌肠液质量控制的方法。

Objective: To establish the quality standard for Fuke enema.Methods: TLC was adopted to identify Sargentodoxae Caulis,Violae Herba and Sparganii Rhizoma;the contents of hydroxy safflower yellow A and mongolicin in Fuke enema were determined by HPLC on a Wondasil C18(250 mm×4.6 mm,5 μm) analytical column,and the mobile phase was composed of methanol-acetonitrile-0.5% phosphoric acid solution with gradient elution,the flow rate was 1.0 ml·min^(-1),the detection wavelengths were 403 and330 nm,the column temperature was 30℃,and the volume injection was 10 μl.Results: TLC spots were clear and well-separated without negative interference;the calibration curves of hydroxy safflower yellow A and mongolicin were linear over the range of 40.80-204.00 μg·ml^(-1)(r= 0.999 9) and 60.00-300.00 μg·ml^(-1)(r= 0.999 9),and the average recovery was 99.56% and 98.68% with the RSDs of 2.25% and 1.94%(n = 6),respectively.Conclusion: The method is fast and accurate with good specificity,and can be used for the quality control of Fuke enema.