Feasibility Study on Bacterial Endotoxin Test for Safflower Yellow for Injection / 中国药师
China Pharmacist
;
(12): 583-586, 2017.
Article
Dans Chinois
| WPRIM
| ID: wpr-510064
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.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
langue:
Chinois
Texte intégral:
China Pharmacist
Année:
2017
Type:
Article
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