Study on quality standards for Kangjun Xiaoyan preparations
10.19778/j.chp.2025.05.008
- VernacularTitle:抗菌消炎制剂质量标准的研究
- Author:
Nan ZHANG
1
;
Shao WANG
1
;
Yun AI
1
;
Yunxia WANG
1
Author Information
1. 西安市食品药品检验所,西安 710119
- Publication Type:Journal Article
- Keywords:
Kangjun Xiaoyan preparations;
TLC;
HPLC;
macranthoidin B;
content determination;
quality standard
- From:
Drug Standards of China
2025;26(5):493-500
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish the quality for Kangjun Xiaoyan preparations.Methods:Rheum officinale Baill,Isatidis indigotica Fort,Miq.Were identified by TLC;microscopic identification method was used to distin-guish Lysimachia christinae Hance and Scutellaria baicalensis Georgi;using maranthoidin B as an indicator compo-nent for the detection of adulteration in Lonicera macranthoides Hand.;the content of chlorogenic acid and baicalin were determined by HPLC.Results:Four types of medicinal herbs in the sample can identify by TLC and negative sample without interference,the examination item for maranthoidin B can accurately determine whether adulterated L.macranthoides is present in the sample;the methodological validation of content determination showed that there was a good linear relationship between chlorogenic acid and baicalin injection mass in the range of 89.8-5 845.4 and 108.2-7 047.0 ng respectively(r=0.999 3 and 0.999 9).The average recoveries were 97.55%and 102.05%with RSDs 1.2%and 1.6%.Conclusion:The established methods were simple,accurate,reliable and reproducible.It can be effectively used for the quality control of Kangjun Xiaoyan preparations.