八正颗粒的质量标准提高研究
Improvement in quality standard for bazheng granules
史亚柱 1刘皈阳 2李翔 2黎春彤 2冯春景2
作者信息
- 1. 解放军第203医院，黑龙江 齐齐哈尔161000
- 2. 解放军总医院第一附属医院，北京100048
- 折叠
摘要
目的：建立八正颗粒的质量标准。方法采用薄层色谱法对八正颗粒中的大黄、栀子、车前子、灯心草、甘草进行定性鉴别；采用HPLC法对制剂中的栀子进行含量测定。结果大黄、栀子、车前子、灯心草、甘草的薄层色谱斑点清晰,重现性好,专属性强,阴性对照无干扰。含量测定中,栀子苷在2．32~46．4μg/mL范围内线性关系良好(r=0．9999),平均回收率为99．41%,RSD=1．46%(n=6)。结论所建立的定性、定量方法简便易行,重现性好,为八正颗粒提供了有效的质量控制方法。
Abstract
Objective To establish the quality standard for Bazheng granules. Methods Five major compo-nents ( including rheum officinale,fructus gardenia,semen plantaginis,medulla junci and radix glycyrrhiza) were iden-tified by TLC. The content of geniposide was determined by HPLC. Results The spots of TLC of all varieties were distinctive with good reproducibility,and there was no interference with the negative references. Geniposide had good linear relation during 2. 32~46. 4 μg/mL ( r=0. 9999 ) . The average recovery was 99. 41% with RSD 1. 46% ( n=6). Conclusion TLC and HPLC methods are rapid and accurate with good reproducibility,so it is effective for the quality control of Bazheng granules.
关键词
八正颗粒/质量标准/薄层鉴别/高效液相色谱法Key words
Bazheng granules/Quality standard/TLC/HPLC引用本文复制引用
基金项目
军队医疗机构制剂标准提高科研专项课题(14ZJ-Z20-3)
出版年
2016
NETL
NSTL
维普
万方数据