康视明合剂质量标准的提高研究
Improved Quality Standard for Kangshiming Mixtures
徐玥 1蔡烽 1张钦 1洪婷 1徐燕丰1
作者信息
摘要
目的::制定康视明合剂质量控制方法。方法:采用薄层色谱法( TLC)鉴别处方中的当归、黄柏、黄芪;采用高效液相色谱法( HPLC)对处方中的葛根素及芍药苷含量进行定量测定。结果:TLC法能定性检出当归、黄柏、黄芪,斑点清晰,且阴性对照无干扰。定量分析中葛根素和芍药苷分别在1.64~49.20μg·ml-1(r=0.9999)和4.22~63.30μg·ml-1(r=0.9996)范围内与峰面积呈良好线性,葛根素平均回收率为99.63%,RSD=2.14%(n=9);芍药苷平均回收率为99.05%,RSD=2.70%(n=9)。结论:本方法准确、可靠、专属性强,可用于康视明合剂的质量控制。
Abstract
Objective:To improve the quality standard for Kangshiming mixtures. Methods:The identification of Angelicae Sinen-sis Radix, Astragali Radix and Phellodendri Chinensis Cortex was carried out by TLC. The contents of puerarin and paeoniflorin in the preparations were determined by HPLC. Results:The spots displayed in TLC were clear without interference from the negative control. The linear range for puerarin was 1. 64-49. 20μg·ml-1(r=0. 999 9) and 4. 22-63. 30μg·ml-1(r=0. 999 6) for paeoniflorin. The average recovery was 99. 63%(RSD=2. 14%,n=9) and 99. 05%(RSD=2. 70%,n=9) for puerarin and paeoniflorin, respectively. Conclusion:The method is accurate, reliable and specific, and can be used in the quality control of Kangshiming mixtures.
关键词
康视明合剂/薄层色谱法/高效液相色谱法/质量标准Key words
Kangshiming mixtures/TLC/HPLC/Quality standard引用本文复制引用
基金项目
上海市卫生局中药新药及院内制剂研发项目(2011ZJ003)
出版年
2014