胃灵散质量标准研究

Study on the Quality Control of Weiling Powder

目的 :建立胃灵散的质量标准。方法 :采用 TL C法对胃灵散中的延胡索、甘草进行了定性鉴别。并用 HPL C法对制剂中的白芍所含芍药苷进行了含量测定。ODS分析色谱柱 :( 4mm× 2 5 0 mm,7μm) ,流动相 :甲醇 -冰醋酸 -水 ( 30∶ 1∶ 6 9) ,流速 :1 .0 ml/ min,检测波长 :2 30 nm。结果 :胃灵散中的延胡索乙素、甘草酸铵与其它成分分离良好。高效液相色谱法 ( HPLC)测定芍药苷、可达基线分离 ,芍药苷对照品在 0 .35～ 1 .75μg· ml- 1 内呈线性关系 ,r=0 .9999,平均回收率为 98.8% ,RSD为 0 .86 % ( n=5 )。结论 :该法简便快速 ,结果准确 ,重现性好 ,可作为该制剂的质量控制方法。

Objective:To develop the quality control of Weiling powder. Methods: Corydalis yanhusuo W. T. Wang and Glycyrrhizae uralensis Fisch in Weiling powder were identified by TLC, and paeoniflorin in Weiling powder separated and determined by HPLC. The chromatographic conditions were as follows:ODS analytic chromatographic column (4.6 mm×250 mm, 7 μm), the mobile phase consisted of methanol water acetic acid (30∶1∶69), at a rate of 1.0 ml/min. The wavelength for detection was 230 nm. Results: The standard curves of paeoniflorin was linear in the concentration range of 0.35～1.75 μg·ml 1 . The average recovery was 98.8%.( n =5, RSD 0.86%). Conclusion:This method was sensitive, quick and accurate for the quality control of this preparation.