论文部分内容阅读
目的:建立痛经康口服液质量控制方法。方法:采用薄层色谱方法对痛经康口服液中丹参、元胡、红花进行鉴别,采用反相高效液相色谱法对羟基红花黄色素A进行含量测定,色谱柱:C18柱(250 mm×4.6 mm,5μm),甲醇-乙腈-0.7%磷酸(26∶2∶72)为流动相,流速1.0 mL.min-1,检测波长403 nm,柱温:27℃。结果:丹参、元胡、红花的薄层色谱鉴别供试品溶液色谱在与对照药材或对照品相应位置上出现相同颜色的斑点,阴性对照无干扰。羟基红花黄色素A进样量在0.13～2.6μg之间与峰面积呈良好线性关系R2=1。平均加样回收率为100.4%,RSD=1.168%(n=9)。结论:薄层色谱斑点清晰无干扰,含量测定方法简便、稳定,可用于痛经康口服合剂质量控制。
Objective: To establish the quality control method of Tongjingkang oral liquid. Methods: TLC method was used to identify Danshen, Yuanhu and safflower in Tongjingkang oral liquid. The content of hydroxysafflor yellow A was determined by RP-HPLC. The column was C18 column (250 mm × 4.6 mm, 5μm). The mobile phase was methanol-acetonitrile-0.7% phosphoric acid (26:2:72). The flow rate was 1.0 mL.min-1. The detection wavelength was 403 nm and the column temperature was 27 ℃. Results: Thin-layer chromatography of Salvia miltiorrhiza, Yuanhu, and safflower identified spots of the same color on the corresponding positions of the reference drug or reference substance in the chromatogram of the test solution without any interference with the negative control. The hydroxysafflor yellow A injection volume between 0.13 ~ 2.6μg and the peak area showed a good linear relationship R2 = 1. The average recovery was 100.4%, RSD = 1.168% (n = 9). Conclusion: TLC spots clear and no interference, content determination method is simple and stable, can be used for the quality control of Tongjingkang oral mixture.