Quality evaluation for Beidougen Formula Granules
10.3969/j.issn.1001-1528.2024.03.002
- VernacularTitle:北豆根配方颗粒质量评价
- Author:
Gui-Yun CAO
1
;
Xue-Song ZHUANG
;
Bo NING
;
Yong-Qiang LIN
;
Dai-Jie WANG
;
Wei-Liang CUI
;
Hong-Chao LIU
;
Xiao-Di DONG
;
Meng-Meng HUANG
;
Zhao-Qing MENG
Author Information
1. 山东宏济堂制药集团股份有限公司,山东省中医药治疗呼吸系统疾病技术创新中心,山东 济南 250103
- Keywords:
Beidougen Formula Granules;
standard decoction;
content determination;
HPLC specific chromatograms;
cluster analysis
- From:
Chinese Traditional Patent Medicine
2024;46(3):717-723
- CountryChina
- Language:Chinese
-
Abstract:
AIM To evaluate the quality of Beidougen Formula Granules.METHODS Fifteen batches of standard decoctions and three batches of formula granules were prepared,after which paste rate and contents,transfer rates of magnoflorine,daurisoline,dauricine were determined.HPLC specific chromatograms were established,and cluster analysis was adopted in chemical pattern recognition.RESULTS For three batches of formula granules,the paste rates were 15.1%-16.6%,the contents of magnoflorine,daurisoline,dauricine were 18.93-19.39,9.42-9.60,6.79-6.85 mg/g with the transfer rates of 34.42%-35.25%,43.81%-44.65%,27.27%-27.51%from decoction pieces to formula granules,respectively,and there were seven characteristic peaks in the specific chromatograms with the similarities of more than 0.95,which demonstrated good consistence with those of standard decoctions and accorded with related limit requirements.Fifteen batches of standard decoctions were clustered into two types,and the medicinal materials produced from Jilin,Hebei,Shangdong could be used for the preparation of formula granules.CONCLUSION This reasonable and reliable method can provide references for the quality control and clinical application of Beidougen Formula Granules.
