Study on Quantitative Detection of Bacterial Endotoxins in Methylthioninium Chloride Injection
- VernacularTitle:亚甲蓝注射液细菌内毒素定量法研究
- Author:
Guinan XIAO
;
Zimin XU
;
Yingmei SHENG
- Publication Type:Journal Article
- Keywords:
Methylthioninium chloride injection;
Bacterial endotoxins;
Kinetic turbidimetric limulus test;
Interference test
- From:
China Pharmacy
2007;0(34):-
- CountryChina
- Language:Chinese
-
Abstract:
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.