微量凝胶法测定细菌内毒素探讨  

Determination of Bacterial Endotoxin by the Micro-Gel Method

作　　者：程宾 苏雯 王红艳 王莉 CHENG Bin;SU Wen;WANG Hongyan;WANG Li(Yunnan Institute for Food and Drug Control,Kunming,Yunnan,China 650106)

机构地区：[1]云南省食品药品监督检验研究院,云南昆明650106

出　　处：《中国药业》2024年第15期73-76,共4页China Pharmaceuticals

摘　　要：目的 建立测定样品中细菌内毒素的微量凝胶法。方法 按2020年版《中国药典(四部)》1143细菌内毒素检查法进行试验,通过预试验确定适合试验的试管内径(4,8 mm)及加样量(10,20,30,40,50,60,70μL)后,再进行完整的鲎试剂灵敏度复核试验及样品细菌内毒素检查试验,并与药典收载现行凝胶法进行比较。结果 预试验结果显示,确定采用内径为8 mm的平底玻璃试管,加样量为40μL或50μL进行微量凝胶法试验。对鲎试剂进行灵敏度复核,微量凝胶法灵敏度复核结果与药典收载现行凝胶法一致,均在灵敏度合格范围内。对样品进行细菌内毒素检查,微量凝胶法试验结果与药典收载现行凝胶法一致。结论 该微量凝胶法可作为药典收载现行凝胶法的补充或替代方法,鲎试剂缺乏的情况下可用于灭菌制剂的细菌内毒素检查。Objective To establish a micro-gel method for the determination of bacterial endotoxin in samples.Methods Test was conducted according to 1143 bacterial endotoxin test method in the China Pharmacopoeia(2020 Edition,Volume Ⅳ),the tube diameter(4,8 mm) and sample volume(0,20,30,40,50,60,70 μL) suitable for the test were determined through pre-test,and then the sensitivity check test of tachypleus amebocyte lysate(TAL) and the bacterial endotoxin test of samples were conducted and compared with the current gel method collected in the China Pharmacopoeia.Results The pre-test results showed that the flat glass test tube with the inner diameter of 8 mm and the sample volume of 40 μL or 50 μL were determined to be used for the micro-gel method.The sensitivity check test of TAL was conducted and the sensitivity check result of micro-gel method was consistent with the current gel method in the China Pharmacopoeia,and they were within the acceptable range of sensitivity.The bacterial endotoxin test of samples was conducted,and the result of the micro-gel method test was consistent with the current gel method in the China Pharmacopoeia.Conclusion The micro-gel method can be used as a supplement or alternative to the current gel method in the China Pharmacopoeia,which can be used for the bacterial endotoxin test of sterilized preparations in the absence of TAL.

关 键 词：微量凝胶法 细菌内毒素检查 鲎试剂 补充替代方法 

分 类 号：R917[医药卫生—药物分析学] R991[医药卫生—药学]