Study on the improvement of quality standard for Jubei mixture
- VernacularTitle:桔贝合剂质量标准提升研究
- Author:
Ting HONG
1
;
Zhiqiang ZHOU
1
;
Xiaowu XIAO
1
;
Dandan CHEN
2
;
Isheng Y YANG
1
Author Information
1. Jiangxi Provincial Institute for Drug Control/NMPA Key Laboratory for Quality Evaluation of Chinese Patent Medicine/Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality，Nanchang 330029，China
2. College of Pharmacy，Jiangxi University of Chinese Medicine，Nanchang 330004，China
- Publication Type:Journal Article
- Keywords:
Jubei mixture;
quality standard;
chemical reaction;
thin-layer chromatography;
high-performance liquid
- From:
China Pharmacy
2022;33(21):2603-2608
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To improve the quality standard for Jubei mixture . METHODS The chemical reaction of trinitrophenol and hydrocyanic acid was used to identify Armeniacae Amarum solution . Platycodon grandiflorus ，Fritillaria thunbergii，Scutellaria baicalensis ，the leaves of Eriobotrya japonica and Glycyrrhiza uralensis in Jubei mixture were identified by thin-layer chromatography （TLC）. High-performance liquid chromatography was used to simultaneously determine the contents of four active components ，such as amygdalin ，baicalin，wogonoside and monoammonium glycyrrhizinate in Jubei mixture . RESULTS Trinitrophenol test paper showed brick red . TLC spots of five medicinal materials were clear ，without interference from negative control . The linear ranges of amygdalin ，baicalin，wogonoside and monoammonium glycyrrhizinate were 0.066 8-1.335 5 μg（R2＝0.9994），0.189 8-3.796 9 μg（R2＝0.999 9），0.062 6-1.251 3 μg（R2＝0.999 9），0.041 8-0.835 5 μg（R2＝0.999 8）， respectively. RSDs of precision ，repeatability and stability tests were all lower than 2%. The average recoveries were 98.2%， 99.5%，98.3%，99.6%，and RSDs were 0.7%，1.6%，1.5%，1.1%（n＝6）. The contents of 15 batches of samples were different ， and the content of sample from company A was generally lower than those from companies B and C . CONCLUSIONS The standard established can reflect the inherent quality of Jubei mixture well .
