莪红胶囊质量标准的建立

Quality Standard for Ehong Capsules

目的:建立莪红胶囊的质量标准。方法:采用TLC法对莪红胶囊中红花、葛根、制何首乌进行定性鉴别;采用双波长HPLC法对莪红胶囊中羟基红花黄色素A、葛根素进行含量测定,色谱柱为Wondasil C_(18)-WR(250 mm×4.6 mm,5μm),流动相为甲醇-乙腈-0.7%磷酸水溶液(16∶3∶81),流速为1.0 ml·min^(-1),检测波长为403 nm(测羟基红花黄色素A)、250 nm(测葛根素),柱温为30℃。结果:TLC斑点清晰,分离度良好,阴性对照无干扰;羟基红花黄色素A、葛根素分别在各自进样量范围内与峰面积呈良好线性关系,相关系数均在0.999 9以上,平均加样回收率分别为101.02%、100.03%,RSD分别为1.43%、2.40%(n=6)。结论:该方法快速、准确、专属性强,可作为莪红胶囊质量控制的方法。

Objective： To establish the quality standard for Ehong capsules. Methods： A TLC was adopted to identify safflower, pueraria and prepared Radix Polygoni Multiflori. The contents of hydroxyl-safflor yellow A and puerarin in Ehong capsules were deter- mined by a dual wavelength HPLC. A Wondasil C1s-WR （250 mm ×4.6 mm,5μm） was used as the analytical column, the mobile phase was composed of methanol acetonitrile-0.7% phosphoric acid aqueous solution （ 16 ： 3 ： 81 ）, the flow rate was 1.0 ml min-1, the detection wavelength was 403 nm for hydroxy safflower yellow A and 250 nm for puerarin. The column temperature was 30℃. Restilts ： The TLC spots were clear and well-separated without negative interference. The calibration curves of hydroxyl-safflor yellow A and puerarin were linear over the ranges, the average recovery was 101.02% and 100.03%, and the RSD was 1.43% and 2.40% （ n = 6）, respectively. Conclusion： The method is fast and accurate with good specificity, which can be used for the quality control of Ehong capsules.