通脉颗粒质量标准研究

目的通过对通脉颗粒的质量标准进行再研究,建立更简便易操作的定性、定量方法,提高产品的质量标准。方法采用薄层色谱法对通脉颗粒中丹参、川芎、葛根进行定性鉴别;采用高效液相色谱法对葛根素进行含量测定。结果薄层鉴别均斑点清晰,阴性对照无干扰;含量测定中葛根素进样量在0.1184～1.184μg范围内,与峰面积线性关系良好(r=0.9999,n=6),平均回收率为98.76%(RSD=1.5%,n=6)。结论所建立方法操作简单、专属性和重现性良好,可有效控制该产品的质量。

The quality standards research on Tongmai Granules

OBJECTIVE To establish a method of qualiation and quantitation that easier in operation and improve the product＇s quality standards by the restudy on the quality standards of Tongmai Granules.METHODS To qualitation identify Salvia miltiorrhiza Bge,Szechuan Lovage Rhizome,kudzu-vine root in Vessel Freeing Granule by TLC;To make a assay of puerarin by HPLC.RESULTS The spot was clear on lamella,no interference in negative contrast experiment;the sampling volume of puerarin in assay was 0.1184～1.184μg,a good linear relation with peak area（r=0.9999,n=6）,average recovery rate was 98.76%（RSD=1.5%,n=6）.CONCLUSION The established methods can which was easier operation,good specificity and reproducible controlled the products quality effectively.