亚甲蓝注射液细菌内毒素定量法研究

Study on Quantitative Detection of Bacterial Endotoxins in Methylthioninium Chloride Injection

目的:考察亚甲蓝注射液的细菌内毒素检查法的可行性。方法:采用动态比浊法鲎试验检查样品中的细菌内毒素,并与凝胶法结果进行比较。结果:亚甲蓝注射液在浓度为0.125mg.mL-1时对试验无干扰;所测样品(10mg·mL-1)的细菌内毒素含量均小于0.25EU·mg-1,与凝胶法结果基本一致。结论:可建立该制剂的细菌内毒素检查法。

OBJECTIVE： To establish a method for detecting bacterial endotoxins in methylthioninium chloride injection （MCI） quantitatively. METHODS： Kinetic turbidimetrie limulus test was applied to detect bacterial endotoxins in MCI quantitatively, and compared with gel- clot method. RESULTS： MCI was uninterfered 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· mL^-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.