【摘要】 目的　研究细菌内毒素定量检测技术在大容量注射剂质量控制中的应用。方法　应用动态比浊法定量检测大容量注射剂类药品中细菌内毒素的含量 ,分析实验中的问题并解决。结果　动态比浊法可准确地检测出大容量注射剂中的内毒素含量 ,为药品及中间品的质量控制提供强有力的保证。结论　细菌内毒素的定量检测法可替代家兔热原检查法和鲎试剂凝胶法。更多还原

【Abstract】 OBJECTIVE To study the application of quantitative detection of bacterial endotoxin in large volume injections by Kinetic turbidimetric assay. METHODS According to the appendix of China Pharmacopoeia(2000 edeition)study the feasibility of quantificationally detecting bacterial endotoxin in large volume injections. RESULTS Kinetic turbidimetric assay can accurately detect bacterial endotoxin in injections. CONCLUSION The technology of quantitative detection of bacterial endotoxin can replace the rabbit pyrogen test or gel-clot TAL test to guarantee the safety of end-product drugs as well as in-process solutions and raw materials.更多还原