益气醒脑饮的质量标准改进

目的：提升上海长征医院院内制剂益气醒脑饮的质量标准。方法：采用薄层色谱法（TLC）分别对黄芪、川芎、枳实、石菖蒲、丹参、红花6味药材进行定性鉴别，采用高效液相色谱法（HPLC）对黄芪、川芎、丹参中的主要成分毛蕊异黄酮葡萄糖苷、原儿茶酸、丹酚酸B进行定量检测。结果：在TLC色谱中，供试品色谱在与对照药材色谱相应的位置上，显示相同颜色的斑点，分离度良好，阴性对照无干扰。毛蕊异黄酮葡萄糖苷、原儿茶酸和丹酚酸B分别在质量浓度为3.30~132.24 μg·mL^-1、1.14~45.76 μg·mL^-1和6.34~252.60 μg·mL^-1范围内与峰面积呈现良好的线性关系；重复性好（RSD<1.93%），中间精密度佳（RSD<1.65%），准确度分别为101.47%（RSD为2.14%）、98.26%（RSD为2.64%）、99.39%（RSD为1.62%），供试品溶液在24 h内稳定（RSD<1.69%）。结论：该方法简便易行、准确可靠，可为益气醒脑饮质量标准的建立提供依据。

Quality improvement of Yiqi Xingnao Oral Liquid

OBJECTIVE To improve the quality standard of Yiqi Xingnao Oral Liquid made in Shanghai Changzheng Hospital.METHODS Thin layer chromatography (TLC) was applied for the qualitative identification of Astragali Radix, Chuanxiong Rhizoma, Aurantii Fructus Immaturus, Acori Tatarinowii Rhizoma, Salviae Miltiorrhizae Radix et Rhizom and Carthami Flos. High performance liquid chromatography (HPLC) was applied for the quantitative analysis of calycosin-7-glucoside, protocatechuate and salvianolic acid B.RESULTS In TLC analysis, the test samples showed the same color spots as the control drugs in the same positions, and no interference was observed from the negative control. Calycosin-7-glucoside, protocatechuate and salvianolic acid B indicated good linearity in ranges of 3.30-132.00 g·mL^-1, 1.14-45.60 g·mL^-1 and 6.30~252.00 g·mL^-1, respectively. Good reproducibility (RSD<1.93%), intermediate precision (RSD<1.65%), stability within 24 h (RSD<1.69%) were achieved. Accuracy was 101.47% (RSD=2.14%), 98.26% (RSD=2.64%), 99.39% (RSD=1.62%) for the 3 compounds, respectively.CONCLUSION The method is feasible and reliable for comprehensive and effective quality control of Yiqi Xingnao Oral Liquid.