HUANG Yixiao, CHEN Peng, ZHAO Longshan, GUO Ye, GUO Jingjing, AN Ming
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.