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目的:建立化瘀丸的质量标准。方法:采用薄层色谱法对化瘀丸中丹参、大黄炭、三七进行定性鉴别;采用高效液相色谱法对化瘀丸中丹参酮Ⅱ_A、大黄酚、大黄素甲醚进行含量测定,色谱柱为Wondasil C_(18)(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%磷酸水溶液(85∶15),流速为1.0 ml·min~(-1),检测波长为254nm,柱温为35℃,进样量10μl。结果:TLC斑点清晰,分离度好,阴性对照无干扰;丹参酮Ⅱ_A、大黄酚、大黄素甲醚分别在进样量0.212~2.12μg(r=0.999 9)、0.159~1.59μg(r=0.999 9)、0.072 6~0.726μg(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99.55%、99.56%、100.60%,RSD分别为1.57%、2.26%、2.28%(n=6)。结论:该方法快速、准确、专属性强,可作为化瘀丸质量控制的方法。
Objective: To establish the quality standard of Huayu Pills. Methods: TLC was used to qualitatively identify Salviae miltiorrhizae, Rhubarb charcoal and Panax notoginseng in Huayu pill. The contents of tanshinone Ⅱ_A, chrysophanol and physcion in Huayu pill were determined by high performance liquid chromatography (HPLC) The mobile phase consisted of methanol-0.1% phosphoric acid solution (85:15), the flow rate was 1.0 ml · min -1 and the detection wavelength was 254 nm. The column temperature was 250 ℃ × 4.6 mm, 35 ℃, injection volume 10μl. Results: TLC spots were clear, the resolution was good, and the negative control had no interference. Tanshinone Ⅱ_A, chrysophanol and physcion were respectively injected 0.212 ~ 2.12μg (r = 0.999 9) and 0.159 ~ 1.59μg ) And 0.072 6 ~ 0.726μg (r = 0.999 9), respectively. The average recoveries were 99.55%, 99.56% and 100.60%, respectively. The RSDs were 1.57%, 2.26% and 2.28% (n = 6). Conclusion: The method is rapid, accurate and specific and can be used as a quality control method for Huayu Pills.