摘要
目的建立尼可刹米注射液的细菌内毒素检查方法。方法按2005年版《中国药典(二部)》附录ⅪE细菌内毒素检查法,对不同批号的样品进行干扰试验和细菌内毒素检查。结果高质量浓度尼可刹米注射液对鲎试剂(TAL)与细菌内毒素的凝集反应有干扰作用,经稀释后可排除干扰。结论该样品最大不干扰质量浓度为0.9mg/mL,可采用细菌内毒素检查法进行质量控制。
Objective To establish a method of bacterial endotoxin test for Nikethamide Injection. Method According to the appendix XIE in Vol. Ⅱ of the Chinese Pharmacopoeia （2005 edition）, the different samples were used for the investigation of interference test and bacterial endotoxin test. Results The high concentration of Nikethamide Injection had the interference effect on TAL and agglutination reaction of bacterial endotoxin. The interference was eliminated after dilution. Conclusion The noninterference concentration of Nikethamide Injection is 0. 9 mg/mL. Bacterial endotoxin test could be used to control the quality.
出处
《中国药业》
CAS
2010年第6期32-33,共2页
China Pharmaceuticals
