Résumé
OBJECTIVE:To establish a method for detecting bacterial endotoxins in methylthioninium chloride injection (MCI) quantitatively. METHODS: Kinetic turbidimetric limulus test was applied to detect bacterial endotoxins in MCI quantitatively, and compared with gel-clot method. RESULTS: MCI was un-interfered with the test for bacterial endotoxins at the concentration of 0.125 mg?mL-1; the content of bacterial endotoxins in all samples tested (10 mg?mL-1) were not more than 0.25 EU?mg -1, which were in accordance with the result of gel-clot method. CONCLUSIONS: Kinetic turbidimetric limulus test provides a new way to detect bacterial endotoxins in MCI quantitatively.
Résumé
OBJECTIVE: To establish a method for endotoxin assay in aminoglycoside antibiotics for injection.METHODS: Kinetic turbidimetric limulus test was used for endotoxin assay in aminoglycoside antibiotics for injection.The recovery rate of bacterial endotoxin was determined though pre-interference experiments in which quantitative endotoxin was added to different concentrations of aminoglycosides with the concentration optimized,then an interference test on 4 different samples was conducted.RESULTS: At a concentration of 0.5 mg?mL-1,aminoglycosides didn't interfere with the limulus test if the amount of standard endotoxin was at 5.000,0.500,and 0.050 EU?mL-1,respectively.CONCLUSIONS: The kinetic turbidimetric limulus test could be used for endotoxin assay in aminoglycoside antibiotics for injection.
Résumé
AIM: The kinetic turbidimetric Limulus test was used in the endotoxin assay of Ceftazidime injection. METHODS: The validation test was fulfiled, when the amount of endotoxin spiked in Ceftazidime injection sample (Lot. No. 010202) in which concentration of its dilution solution were 10, 5,2,1,0.5 g·L-1. They were recovered in 60.08%, 82.90%, 85.22%, 94.00%, 92.67%; with the amount of endotoxin spiked in Ceftazidime sample (Lot. No. 010103, 010104, 010202), their 1 g·L-1 dilution were recovered in 109.9%, 101.7% and 86.56%. RESULTS: With standard endotoxin working curve is 5.00, 0.500, 0.0500 ZU·L-1. The 1 g·L-1 solution to Ceftazidime was effective to eliminate the interference in Limulus test. CONCLUSION: The kinetic turbidimetric Limulus test provide a new way to the detection of endotoxin in Ceftazidime injection.
Résumé
100MIC.The endotoxin could be released more and more with the time.CONCLUSION:It is reasonable to choose antibiotics to refer to the characteristics of the endotoxin release by germs.
Résumé
OBJECTIVE:To apply the kinetic turbidimetric Limulus test to the endotoxin assay of Levocarnitine sodium chloride injection.METHODS:The16-fold dilution of Levocarnitine sodium chloride injection was prepared.The content of bacterial endotoxin in Levocarnitine sodium chloride injection was determined with kinetic turbidimetric Limulus test after screen test and validation test.RESULTS:The16-fold dilution of Levocarnitine sodium chloride injection was effective to e?liminate the interference in Limulus test.The average recovery was in the range of50%～200%.CONCLUSION:The kinetic turbidimetric Limulus test provides a new and quick method for the quantitative determination of bacterial endotoxin in Levo?carnitine sodium chloride injection.
Résumé
Object To determine the bacterial endotoxin in BREVISCAPINI INJECTION (BI) by kinetic turbidimetric limulus test Methods By spiking the amount of standard endotoxin into BI sample, the interference test was fulfiled to detect the recovery in the range of 50% 200% Results A 12 fold dilution to BI sample is effective to eliminate the interference in limulus test Conclusion The kinetic turbidimetric limulus test provides an efficient way to detect the bacterial endotoxin in BI sample
Résumé
Objective: The kinetic turbidimetric limulus test was used in the endotoxin assay of Sodium Ferulate for injection. Methods: The preliminary validation test was fulfilled, when the standard endotoxin spiked in Sodium Ferulate for injection sample (Lot. No. 20000704) and its 10 fold dilution、 20 fold dilution、 40 fold dilution、 60 dilution、 80 fold dilution. The recoveries were 0.20%, 74.70%, 87.93%, 87.09%, 98.55%, 119.2% respectively. The optimum detection concentration found was 60 fold dilution. During the formal interference tests of 3 batches of Sodium Ferulate for injection (Lot. No. 20000308 20000704 20000315), the recoveries were 120.4%,98.55% and 85.40% respectively. Results: 5.00,0.500,0.0500 Eu/mL of standard endotoxin were used. The standard endotoxin was quantitatively added into the 60 fold dilution of Sodium Ferulate for injection. The recoveries were all 50%～200% and no interference action was found.Conclusion: The kinetict turbidimetric limulus test provided a new way to the detection of endotoxin in Sodium Ferulate for injection.
Résumé
AIM The kinetic turbidimetric Limulus test was used in the endotoxin assay of Ceftazidime injection. METHODS The validation test was fulfiled ,when the amount of endotoxin spiked in Ceftazidime injection sample(Lot.No.010202) in which concentration of its dilution solution were 10,5,2,1,0 5 g?L -1 . They were recovered in 60 08%, 82 90%, 85 22%, 94 00%, 92 67%; with the amount of endotoxin spiked in Ceftazidime sample (Lot.No. 010103, 010104, 010202),their 1 g?L -1 dilution were recovered in 109 9%, 101 7% and 86 56%. RESULTS With standard endotoxin working curve is 5 00, 0 500, 0 0500 ZU?L -1 . The 1 g?L -1 solution to Ceftazidime was effective to eliminate the interference in Limulus test. CONCLUSION The kinetic turbidimetric Limulus test provide a new way to the detection of endotoxin in Ceftazidime injection.