Invastigation on methods of quality control of Xiaoer Shenzhu Jianpi pills
10.19778/j.chp.2024.03.005
- VernacularTitle:小儿参术健脾丸的质量控制方法研究
- Author:
Juan DU
1
;
Chao DONG
;
Xianhai SHI
;
Yuhong CUI
;
Chunfang WANG
Author Information
1. 山西省检验检测中心(山西省标准计量技术研究院),太原 030031
- Keywords:
Xiaoer Shenzhu Jianpi pills;
quality control;
improvement of standard;
Atractylodis Macrocephalae Rhizoma;
Glycyrrhizae Radix Et Rhizoma;
Citri Reticulatae Pericapium
- From:
Drug Standards of China
2024;25(3):244-250
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To improve the quality standard of Xiaoer Shenzhu Jianpi Pills.Methods:The microscopic identification method was used to qualitatively identify Hordei Fructus Germinatus.TLC was used to qualitatively i-dentify of Atractylodis Macrocephalae Rhizoma,Glycyrrhizae Radix Et Rhizoma,Citri Reticulatae Pericapium.HPLC was adopted to determine the contents of hesperidin and ammonium glycyrrhizinate.Results:The microscop-ic identification of Hordei Fructus Germinatus had strong specificity and high viewing rate.The TLC identification spots of Atractylodis Macrocephalae Rhizoma,Glycyrrhizae Radix Et Rhizoma,Citri Reticulatae Pericapium were clear,with good separation and durability.The linear ranges of hesperidin and ammonium glycyrrhizinate were 0.060 0-1.501 0 μg and 0.020 1-0.502 2 μg,respectively(r≥0.999 8).The average recoveries(n=9)were 99%,96%and RSDs were 2.8%and 1.8%.The RSDs of precision,stability and repeatability of the two components were less than 3.0%.Conclusion:The newly established quality standard increases the quality control research of microscopic identification,thin layer chromatography and content determination.The experimental method is accurate and reliable,simple and fast,and has good applicability.It can be used for the quality control and evaluation of Xiaoer Shenzhu Jianpi Pills.