摘要:目的 建立棍其勒-13味丸的质量标准。方法：采用显微鉴别法定性鉴别处方中的诃子、广枣、红花、石膏、石榴、木香、肉豆蔻和沉香；采用薄层色谱鉴别法定性鉴别处方中的枫香脂和木香。采用HPLC法对处方中的羟基红花黄色素A进行含量测定，色谱柱为Agela Venusil XBP C18（250 mm×4.6 mm ,5μm），流动相为乙腈-甲醇-0.7%磷酸溶液（用三乙胺调pH到6.04）(2：28：70)，流速 1.0 ml·min﹣1，柱温 30℃，检测波长 403 nm，进样量 10μl。结果结果通过显微鉴别观察到的药材结构清晰，薄层色谱鉴别供试品色谱斑点清晰，专属性强；羟基红花黄色素A的线性关系好，回归方程为y=3228006.9390x-116997.8884，r=1.0000。平均回收率为 101.1% (ＲSD =1.9%)。结论本文所建立的质量标准方法可行性强，专属性好，灵敏度高，可用于棍其勒-13味丸的质量控制。

Objective: To establish the quality standard of Gunqile-13 Wei Wan. Methods: Using microscopic identification to statutorily identify Terminalia chebula, Choerospondiatis axllaris (Roxb.) Burrt et Hili, Carthamus tinctorius, CaSO4·2H20, Punica granatum, Aucklandia lappa Decne, Myristica fragrans Houtt., Aquilaria sinensis of the prescription. Using thin layer chromatography to identify Liquidambar Formosana Hance and Aucklandia lappa Decne. Using HPLC to determinate the content of hydroxysafflor yellow A in Gunqile-13 Wei Wan. The chromatographic column was Agela Venusil XBP C18 (250 mm×4.6 mm ,5μm), the mobile phase was acetonitrile-methanol-0.7% phosphoric acid solution (adjusted the pH to 6.04 with triethylamine) (2:28:70), the flow rate was 1.0 ml·min﹣1, the column temperature was 30°C, the detection wavelength was 403nm, and the injection volume was 10 μl. Results: Microscopic identification has achieved ideal identification results. The TLC spots was fairly clear, and the Negative control has no interference. Hydroxysafflor yellow A had a good linear relationship. The regression equation was y=3228006.9390x-116997.8884, r=1.0000. The average recovery rate was 101.1% (RSD = 1.9%). Conclusion: The qualitative and quantitative analysis methods established were simple, accurate and sensitive, and can be used for the quality control of Gunqile-13 Wei Wan.

R917

内蒙古蒙中药标准建设项目(No. JYCZ18-027-3)