妇科灌肠液质量标准的建立  

Establishment of Quality Standard for Fuke Enema

作　　者：李婷[1] 张义生[1] 杨柳[1] 何靓 王薇[1] 孙晓静[1] 李力[1] 解小霞[1] Li Ting;Zhang Yisheng;Yang Liu;He Liang;Wang Wei;Sun Xiaojing;Li Li;Xie Xiaoxia(Wuhan Hospital of Traditional Chinese Medicine,Traditional Chinese Medicine Pharmaceutical Laboratory of State Administration of Traditional Chinese Medicine,Wuhan 430014,China)

机构地区：[1]武汉市中医医院国家中医药管理局中药制剂三级实验室,武汉430014

出　　处：《中国药师》2021年第3期579-582,共4页China Pharmacist

基　　金：武汉市中青年医学骨干人才培养工程项目(编号:武卫生计生通[2015]9号);2015年黄鹤英才资助项目(编号:武人才[2016]1号)。

摘　　要：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.

关 键 词：妇科灌肠液 质量标准 羟基红花黄色素A 蒙花苷 

分 类 号：TQ460.72[医药卫生—药物分析学]