复方苦豆子栓剂的质量标准考察

Study on the Quality Standard of Compound Herb Sophorae alopecuroidis Suppository

目的:建立复方苦豆子栓剂的质量标准。方法:经酸水法提取有效成分后,用RP-HPLC法测定苦参碱的含量。色谱柱为依利特C18柱(250nm×4.5nm,5μm),流动相为乙腈-无水乙醇-水-三乙胺(15:22.5:62.5:0.01),检测波长215nm,流速为1mL/min。结果:苦参碱在0.74μg～5.18μg范围内线性关系良好,r=0.9991(n=6),平均回收率为98.50%,RSD为1.38%(n=5)。结论:测定方法简单,重现性好,可用于该制剂的质量控制。

Objective：To establish quality standard of compound Herb Sophorae alopecuroidis suppository. Method： Effective ingredient in the suppository was extracted by acid water. Matrine content was determined by RP-HPLC. RP-HPLC was performed on Elite C18 column（4.6 nm×250 nm,5 μm）with acetonitrile-anhydrous ethanol-water- triethy lamine（15： 22.5：62.5：0.01）as mobile phase, detection wavelength was set 215 nm and flow rate was at 1.0 mL/min. Result：The liner range of matrine was 0.74 μg-5.18 μg,r=0.999 1.The average recovery rate was 98.50%,RSD was 1.38%（n=5）. Conclusion ： The method is proved to be simple, reproducible and can be used for the quality control of the preparation.