益康片质量标准研究

Study on Quality Specifications Standard of Yikang tablets

目的:研究与修订益康片的质量标准。方法:薄层色谱法鉴别复方中人参、三七、何首乌、丹参等药味。气相色谱法测定维生素E含量,以三十二烷作为内标,色谱柱为HP-20M(10 m×0.53 mm),FID,氦气,流速:3.5 ml.min-1。结果:在TLC中能检出人参、三七、何首乌和丹参。维生素E在0.4121～3.7089 mg.ml-1范围内线性关系良好(r=0.9999),平均回收率为97.32%(n=5),RSD%=1.32%。结论:本定性定量方法准确易行,重复性好,可作为益康片的质量标准基础。

Objective：To establish the quality control standard of Yikang tablets.Method：Radix ginseng,Radix gotoginseng, Radix polygoni multiflori,and Radix salviae miltiorrhizae in Yikang tablets were identified by TLC.The content of vitamin E was determined by GC.The GC system consisted of HP-20 M（10 m×0.53 mm）,and FID detector;helium was used as carrier gas（the flow rate was 3.5 ml·min^-1）,and dotriacontane was adopted as internal standard.Results： The TLC spots of Radix ginseng, Radix notoginseng,Radix polygoni multiflori,and Radix salviae miltiorrhizae in Yikang tablets were distinctive and coincident with the respective standards.By using our chromatographic conditions,vitamin E could be baseline separated with other constituents in the sample,determined with satisfactory accuracy and precision,with average recovery was 97.32%. The RSD%（n=5） was 1.32%.The linear range was 0.4121 to 3.7089 mg·ml^-1 （r=0.9999）oConclusion： The established method is accurate, feasible and repreducible.