强腰舒络散的质量标准研究

Study on the Quality Standard of Strong Waist and Relaxation

摘要: 目的：建立强腰舒络散质量标准。方法：通过薄层色谱法，对制剂中的黄芪、川芎、当归、白芍、泽兰、醋莪术、防己和醋延胡索进行定性分析，以确定其有效成分。采用高效液相色谱法，对芍药苷、阿魏酸、毛蕊异黄酮葡萄糖苷和毛蕊花糖苷进行了精确的检测。结果：薄层色谱鉴别法斑点清晰，分离度高，阴性对照无干扰，表明其专属性好；含量测定显示，芍药苷在0.42356~1.48246 µg，阿魏酸在0.04188~ 0.14658 µg，毛蕊异黄酮葡萄糖苷在0.16288~0.57008 µg，毛蕊花糖苷在0.23020~0.80570 µg，线性关系良好(r ≥ 0.9990)，仪器精密度、样品重复性、稳定性与加样回收率的RSD值均符合要求。结论：所创建的方法操作简单，重复性好，专属性强，可用于建立强腰舒络散的质量标准。

Abstract: Objective: To establish the quality standard of strong waist and relaxation. Methods: By thin layer chromatography, astrgali radix, chuanxiong rhizoma, Angelica sinensis radix, paeoniae radix alba, lycopi herba, Curcumae rhizoma, Stephania tetrandra radix and Corydalis rhizoma in the prepara-tion were qualitatively analyzed to determine their active ingredients. High performance liquid chromatography was used to accurately detect peonosides, ferulicacid, isoflavone glucosides and verbascoside by high performance liquid chromatography. Results: The thin layer chromatography identification method has clear spots, high resolution, and no interference from the negative con-trol, indicating that its specificity is good. The content determination showed that peony glycoside was 0.42356~1.48246 μg, ferulic acid was 0.04188~0.14658 μg, isoflavone glucoside was 0.16288~0.57008 μg, and verbascoside was 0.23020~0.80570 μg, with good linear relationship (r ≥ 0.9990), and the RSD values of instrument precision, sample repeatability, stability and dosing re-covery met the requirements. Conclusion: The created method is simple to operate, repeatable and exclusive, and can be used to establish quality standards for strong waist and relaxation.