降压益肾颗粒质量标准研究

Study on Quality Standard of Jiangya Yishen Granula

目的研究降压益肾颗粒的质量控制标准。方法采用薄层色谱法对制剂中鬼针草、何首乌、川牛膝、山茱萸、泽泻、玄参进行定性鉴别,用高效液相色谱法对制剂中何首乌有效成分2,3,5,4’-四羟基二苯乙烯-2-0-β-D-葡萄糖苷进行含量测定。结果各薄层定性鉴别色谱中,所鉴别的药材薄层色谱特征明显。2,3,5,4’-四羟基二苯乙烯-2-0-β-D-葡萄糖苷在0.0163～0.522μg范围内呈良好的线性关系,相关系数为0.9999,平均回收率为99.7%,RSD=0.51%。结论薄层色谱定性和高效液相色谱含量测定方法可用于制剂的质量控制。

Objective To establish a method for quality control of Jiangya Yishen Granula. Methods Spanishneedles Herb, Radix Polygoni Multiflori, Fruems Comi, Radix Scrophulariae, Rhizoma Alismatis and Radix Cyathula were identified by TLC. A method of HPLC to determine 2,3,5,4＇-tetrahydroxystilbene-2-0-β -D-glucosid, the main effective component from Radix Polygoni Multiflori, was developed. Results The studies on the quality control showed that the characteristics for identification by TLC were distinct. The quantification method had the linear range of 0.016 3-0.522μg （r=0.999 9）. The average recovery rate was 99.7%, and its RSD was 0.51%. Conclusion The methods can be used for the quality control of the preparation.