Investigation on the quality standard of pharmaceutical excipient steviol glycosides
10.19778/j.chp.2025.05.012
- VernacularTitle:药用辅料甜菊糖苷的质量标准研究与建议
- Author:
Yongfang LI
1
;
Qing YANG
;
Cancan DING
;
Qiao ZHANG
;
Zhizhou JIANG
;
Yongfu XIE
;
Yuanyuan LI
;
Shuai HUANG
Author Information
1. 武汉生物工程学院医药学院,武汉 430415;桂林莱茵生物科技股份有限公司,广西桂林 541199
- Publication Type:Journal Article
- Keywords:
steviol glycosides;
pharmaceutical excipient;
quality standard;
TLC;
HPLC
- From:
Drug Standards of China
2025;26(5):527-532
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To propose suggestions for the revision of quality standard of steviol glycosides through research on its major manufacturer's products.Methods:The inspection items in the current quality standards were inspected,with domestic and international quality standard of steviol glycosides.Results:Specific rotation was from-33.39° to-39.50°,pH was from 5.3 to 6.7,impurity absorbency was lower than 0.096 0,while the contents of weight loss on drying were lower than 5.0％,residue on ignition were lower than 0.043％,methanol residual were lower than 0.01％,ethanol residual were lower than 0.06％,residue on arsenic were lower than 0.000 054％,lead wasn't detected.The content of rebaudioside A and 13 kinds of steviol glycosides were 8.23％-68.48％and 85.78％-96.13％.Conclusion:The main components of the commercial steviol glycosides products were rebaudioside A and stevioside,with low safety risk of elemental impurities and solvent residues.It provided suggestions for the revision of quality standard of steviol glycosides in the Chinese Pharmacopoeia.
