Depyrogenation in key manufacturing processes of Reduning injection.
- Author:
Miao LI
1
;
Yuling XU
;
Juan SONG
;
Yongxiang WANG
;
Yingzhi PAN
;
Zhengzhong WANG
;
Wei XIAO
;
Tao LIU
Author Information
- Publication Type:Journal Article
- MeSH: Adsorption; Endotoxins; isolation & purification; Injections; Pyrogens; isolation & purification; Ultrafiltration
- From: China Journal of Chinese Materia Medica 2011;36(6):663-665
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo investigate the effect of removing bacterial endotoxin in the key processes of Reduning injection.
METHODThe content of bacterial endotoxins was detected by kenitic-turbidimetry and the removal efficacy was studied before and after using 0.8% of activated carbon and ultrafiltration with molecular weight cut-off of 10 x 10(3).
RESULTThe adsorption rate of bacterial endotoxins was 78.7% by using activated carbon, while the removal efficacy of bacterial endotoxins was 99.6% with ultrafiltration membrane at cut-off molecular weight 10 x 10(3).
CONCLUSIONThe key technology can effectively guarantee the safety of Reduning injection.
