目的:对蒙药制剂尤日勒-13味丸的质量标准进行优化与提升。方法:对尤日勒-13味丸处方中木香、栀子、菊花、石榴、荜茇进行显微鉴别;创建薄层色谱(TLC)法对尤日勒-13味丸方中木香、栀子及丹参进行定性鉴别;并高效液相色谱(HPLC)法对君药木香中的木香烃内酯(CL)及去氢木香内酯(DL)含量进行同时测定,色谱条件为SinoPak SP分析色谱柱(4.6 mm× 250 mm, 5 μm),以甲醇水(6535)为流动相,流速为1.0 mL/min,柱温30℃,检测波长为225 nm。结果:在尤日勒-13味丸中粉末中,木香、栀子、菊花、石榴、荜茇的显微性状明显;木香、栀子及丹参在薄层色谱定性鉴别显示强专属性;CL的线性回归方程为y=315.83 x-3.9247(0.0501～0.2504 mg/mL),DL线性回归方程为y=276.65x-5.5702(0.0497～0.2494 mg/mL),精密度、稳定性和重复性试验的RSD分别为1.13%和1.17%、3.43%和3.04%、0.65%和0.26%,平均回收率在规定范围内(85.0%～110.0%)。结论:本研究所建立的尤日勒-13味丸的鉴别和含量测定方法相较于内蒙古自治区医院制剂标准,不仅增加了所鉴定药材的种类及君药的主要成分测定,还具有操作便捷、强专属性、重复性好等优点,适用于尤日勒-13味丸的质量控制。

Objective: To optimize and enhance the quality standard of Yurijle-13 pill, a Mongolian medicinal preparation. Methods: :Microscopic identification was carried out on the powder of the formula encompassing Aucklandia lappa Decne, Gardenia jasminoides Ellis, Chrysanthemum morifolium Ramat, Punica granatum L, and Piper longum L in Yurijle-13 pill. Thin Layer Chromatography (TLC) was established for the identification of Aucklandia lappa Decne, Gardenia jasminoides Ellis, and Salvia miltiorrhiza Bge in Yurijle-13 pill. High Performance Liquid Chromatography (HPLC) was developed to concurrently determine the contents of the principal ingredient, Costunolide (CL), and Dehydrocostus lactone (DL) in the Aucklandia lappa Decne of Yurijle-13 pill by using a SinoPak SP analytical column (4.6 mm×250 mm, 5 μm), with a mixture of methanol and water (6535) as the mobile phase, a flow rate of 1.0 mL/min, a column temperature of 30 ℃, and a detection wavelength of 225 nm. Results: :The microscopic characteristics of the powder of Aucklandia lappa Decne, Gardenia jasminoides Ellis, Chrysanthemum morifolium Ramat, Punica granatum L, and Piper longum L in Yurijle-13 pill were distinct. Aucklandia lappa Decne, Gardenia jasminoides Ellis, and Salvia miltiorrhiza Bge demonstrated strong specificity in TLC qualitative identification. The linear regression equation for CL was y=315.83x-3.9247 (within the concentration range of 0.0051 to 0.2504 mg/mL), and that for DL was y=276.65x-5.5702 (within the concentration range of 0.0497 to 0.2494 mg/mL). The RSDs for the tests of precision, stability, and reproducibility were 1.13% and 1.17%, 3.43% and 3.04%, and 0.65% and 0.26%, respectively, and the average recovery rates were within the specified range (85.0% to 110.0%). Conclusion: :Compared with the Inner Mongolia Autonomous Region hospital preparation approved, the method for identification and content determination of Yourile-13 pill established in this study not only increase the types of identified medicinal materials and the main components of the drug, but also has the advantages of convenient operation, strong specificity and good repeatability, which is suitable for the quality control of Yourile-13 pill.