Feasibility Study on Bacterial Endotoxin Test for Safflower Yellow for Injection / 中国药师
China Pharmacist
; (12): 583-586, 2017.
Artigo
em Chinês
| WPRIM (Pacífico Ocidental)
| ID: wpr-510064
Biblioteca responsável:
WPRO
ABSTRACT
Objective:
To establish a bacterial endotoxin test for safflower yellow for injection to control the drug quality and reduce the incidence of clinical pyrogenic reaction.Methods:
The bacterial endotoxin test was carried out according to the methods and guid-ing principles in Chinese Pharmacopoeia ( 2015 edition, volumeⅣ) . A systematic study was carried out to investigate the interference of safflower yellow for injection with limulus reagent and agglutination reaction to bacterial endotoxin in order to detect the non-interfer-ence concentration of bacterial endotoxin.Results:
Safflower yellow for injection with the concentration below or equal to 0. 4 mg· ml-1 had no interference with tachypiens amebocyte lysate.Conclusion:
Bacterial endotoxin test ( gel method) can be used for the limit test of bacterial endotoxin of safflower yellow for injection, and the results are accurate and reproducible.
Texto completo:
Disponível
Base de dados:
WPRIM (Pacífico Ocidental)
Idioma:
Chinês
Revista:
China Pharmacist
Ano de publicação:
2017
Tipo de documento:
Artigo