ABSTRACT
Objective:To study the stability of safflower yellow for injection respectively mixed with fructose injection,invert sugar injection,invert sugar electrolyte injection,glucose and sodium chloride injection,5% glucose injection,10% glucose injection and 0.9% sodium chloride injection. Methods:The physical appearance,number of particles and pH value were observed at room temper-ature after mixing safflower yellow respectively with above injections for 8 hours at the same concentration as that in clinical use. The content of safflower yellow was determined by high performance liquid chromatography (HPLC). Results: There was no significant difference in appearance,pH or safflower yellow content after the mixing,and the number of insolubility particles met the requirement in Chinese Pharmacopeia (2015 edition).Conclusion:Safflower yellow for injection is stable after dissolved in the 7 varieties of infu-sions in 8h.
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.