肺热普清散质量标准研究

Exploration on Quality Standard for Feirepuqing Powder

目的建立肺热普清散的定性鉴别标准,为其质量标准的提高提供依据,并初步确定高效液相色谱(HPLC)法测定羟基红花黄色素A的色谱条件。方法采用薄层色谱法对方中主要药味红花、降香、木香进行定性鉴别,采用HPLC法考察羟基红花黄色素A的测定条件。结果薄层色谱结果显示,供试品溶液色谱中,在与对照品溶液色谱相应位置上显相同颜色斑点,且阴性无干扰。HPLC试验结果显示,最佳色谱条件为色谱柱Kromasil C18柱(250 mm×4.6 mm,5μm),流动相甲醇-0.1%磷酸溶液(30∶70),检测波长403 nm,柱温30℃,流速1.0 mL/min。结论所建立的薄层色谱鉴别方法简便、准确、重现性好,可作为肺热普清散定性研究的依据。所确定的色谱条件为进一步建立其定量检测标准打下了基础。

Objective To establish the qualitative identification standard of Feirepuqing Powder to provide the basis for increasing its quality standard and preliminarily determining the chromatographic conditions of hydroxy safflower yellow A detected by HPLC. Methods The TLC method was adopted to qualitatively identify the main medicinal material safflower, dalbergia wood, radix auckladiae in the description. The HPLC method was adopted to investigate the determination conditions of hydroxy safflower yellow A. Results The TLC results showed that the same color spots in the chromatography of the test solution were displayed in the corresponding positions of the control solution without the negative interference. The HPLC results showed that the optimal chromatographic conditions were as follows：the Kromasil C,s column （250 mm ×4. 6 mm,5 μm）,the mobile phase was methanol-0. 1% phosphoric acid solution（30：70）,the detective wavelength was set at 403 nm,the column temperature was set at 30℃ and the flow rate was 1.0 mL/min. Conclusion The established TLC method is simple and accurate with good repeatability and can be used as the basis for the qualitative research of Feirepuqing Powder. The determined chromatographic conditions lays a basis for further establishing its quantitative determination standard.