十味百合胶囊质量标准研究

Study on the Quality Standard of Shiwei Lily Capsule

目的 建立十味百合胶囊的质量标准.方法 采用薄层色谱法对方中三七进行定性鉴别;采用高效液相色谱法测定胶囊中芍药苷含量,色谱柱Thermo ODS-2 HYPERSIL（150×46.5 nm）,流速0.8 mL·min-1,流动相乙腈-水（17∶84）,检测波长230nm,柱温30℃.结果 薄层色谱中三七定性鉴别斑点清晰,专属性强;高效液相色谱中芍药苷线性范围2.112 ～ 11.374 μg/mL（r=1.0000,n=5）,平均回收率99.75％（RSD=0.90％,n=5）.结论 所建立的方法标准专属性好,操作方便,重现性好,结果可靠,可用于十味百合胶囊的质量控制.

Objective ：To establish a quality standard for Shiwei Lily Capsule. Methods ：TLC was used to make the qualitative identifi- cation of Notoginseng and HPLC to determine paeoniflorin content in the capsule. The column was Thermo ODS -2 HYPERSIL（ 150×46. 5 nm） ;the flow rate was 0. 8 mL · min-1,the mobile phase was acetonitrile -water（17：84） , the detection wavelength 230nm and the column temperature 30℃. Results ：The qualitative identification spots were clear and specific in TLC. The paeoniflorin in HPLC had a lin- ear range of 2. 112 - 11. 374 ixg/mL（ r = 1. 0000, n = 5 ） , with the average recovery rate 99. 75% （ RSD = 0. 90% , n = 5 ）. Conclusion： The method is specific, easy to operate and reliable with good reappearance and can be used for the quality control of Shiwei Lily Capsule.