Content determination of seventeen amino acids in Gualoupi Injection and its intermediates and research on their change laws
10.3969/j.issn.1001-1528.2024.03.001
- VernacularTitle:瓜蒌皮注射液及其中间体中17种氨基酸含量测定及其变化规律研究
- Author:
Xiang TAO
1
,
2
;
Jing-Xian ZHANG
;
Qing HU
;
Jian SUN
;
Ying DONG
;
Jin-Guo DING
;
Hong YU
;
Ying-Ying SHEN
;
Xiu-Hong MAO
;
Shen JI
Author Information
1. 上海中医药大学,上海 201203
2. 上海市食品药品检验研究院,国家药品监督管理局中药质量控制重点实验室,上海 201203
- Keywords:
Gualoupi Injection;
intermediates;
amino acids;
content determination;
change laws;
OPA-FMOC online derivatization;
principal component analysis;
heatmap analysis
- From:
Chinese Traditional Patent Medicine
2024;46(3):709-717
- CountryChina
- Language:Chinese
-
Abstract:
AIM To determine the contents of aspartic acid,glutamic acid,serine,glycine,threonine,citrulline,arginine,alanine,γ-amino-butyric acid,tyrosine,valine,phenlalanine,isoleucine,ornithine,leucine,lysine and proline in Gualoupi Injection and its intermediates,and to analyze their change laws.METHODS The OPA-FMOC online derivatization analysis was performed on a 45℃ thermostatic Waters XBridge C18 column(4.6 mm×100 mm,3.5 μm),with the mobile phase comprising of phosphate buffer solution-[methanol-acetonitrile-water(45 : 45 : 10)]flowing at 1 mL/min in a gradient elution manner,and the detection wavelengths were set at 262,338 nm.Principal component analysis and heatmap analysis were adopted in chemical pattern recognition for the corresponding intermediates in ten processes of six batches of samples.RESULTS Seventeen amino acids showed good linear relationships within their own ranges(R2>0.998 0),whose average recoveries were 83.4％-119.5％with the RSDs of 0.91％-7.94％.Different batches of samples in the same process were clustered,and the corresponding intermediates in different processed were clustered into three groups.Alcohol precipitation and cation exchange column demonstrated the biggest influences on amino acid composition.CONCLUSION This experiment can provide important references for the critical factors on quality control of Gualoupi Injection,thus ensure the stability and uniformity of final product.
