清肠合剂质量标准的建立

Quality Standard for Qingchang Mixture

目的:建立清肠合剂质量标准。方法:采用TLC法对清肠合剂中当归、赤芍、黄柏进行定性鉴别;采用HPLC法,对清肠合剂中阿魏酸进行含量测定,色谱柱为Wondasil C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸水溶液(17∶83),流速为1.0 ml·min^(-1),检测波长为316 nm,柱温为30℃。结果:TLC斑点清晰,分离度好,阴性对照无干扰;阿魏酸在进样浓度39.6~316.8μg·ml^(-1)范围内与峰面积呈良好线性关系(r=0.999 9),平均加样回收率为98.75%,RSD为1.21%(n=9)。结论:该方法快速、准确、专属性强,可作为清肠合剂质量控制的方法。

Objective： To establish the quality standard for Qingchang mixture. Methods： TLC was adopted to identify angelica sinensis, paeoniae radix and phellodendri cortex. HPLC was used to determine the content of feruhc acid on a Wondasil C18 （250 mm×4.6 mm,5 μm） analytical column, the mobile phase was composed of acetonitrile-0.1% phosphoric acid solution（ 17 ： 83）, the flow rate was 1.0 ml ·min^-1, and the detection wavelength was 316 nm and the column temperature was 30℃. Results： The TLC spots were clear and well-separated without any negative interference. The calibration curve of ferulic acid was in good linearity over the range of 39.6-316.8 μg·ml^-1 - 1 （ r = 0.999 9 ）, the average recovery was 98.75 % and RSD was 1.21% （ n = 9 ）. Conclusion： The method is fast and accurate with good specificity, which can be used for the quality control of Qingchang mixture.