摘要
目的建立醋酸氯己定冲洗剂细菌内毒素的检查方法。方法按2015年版《中国药典(四部)》通则1143内毒素检查法,建立醋酸氯己定冲洗剂细菌内毒素的检查方法,并使用2个厂家的鲎试剂进行方法验证。结果使用稀释剂Ⅰ将醋酸氯己定冲洗剂稀释2倍后,再用细菌内毒素检查用水稀释至8倍,可消除其对鲎试剂凝集反应的干扰,细菌内毒素限值为0.5EU/mL。结论该方法可用于醋酸氯己定冲洗剂细菌内毒素的检查,为可能导致鲎试剂中单价和二价离子缺失样品的细菌内毒素检查方法的建立提供参考。
Objective To establish a bacterial endotoxins test method for Chlorhexidine Acetate Irrigation Solution.Methods The bacterial endotoxin test method for Chlorhexidine Acetate Irrigation Solution was established according to the bacterial endotoxin test method of the general rule 1143 of the Chinese Pharmacopeia(VolumeⅣ,2015 Edition),and the method was verified by tachypleus amebocyte lysate(TAL)from two different manufacturers.Results The Chlorhexidine Acetate Irrigation Solution was diluted by dilution solutionⅠto two times and then diluted by bacterial endotoxin test(BET)water to eight times,which could eliminate the interference to the agglutination reaction of TAL.The limit value of bacterial endotoxin was 0.5 EU/m L.Conclusion The method can be used for bacterial endotoxin test of Chlorhexidine Acetate Irrigation Solution,which can provide a reference for the establishment of the bacterial endotoxin test method for samples that may lead to the loss of monovalent and divalent ions when reacting with TAL.
作者
黄婧
白玲玲
王婷
苏华
王银娟
HUANG Jing;BAI Lingling;WANG Ting;SU Hua;WANG Yinjuan(Department of Pharmacy,General Hospital of Eastern Theater Command,Nanjing,Jiangsu,China 210002)
出处
《中国药业》
CAS
2021年第7期55-57,共3页
China Pharmaceuticals
基金
全军医疗机构制剂标准提高科研专项课题重点项目[14ZJZ08]。
关键词
醋酸氯己定冲洗剂
细菌内毒素
凝胶法
干扰试验
稀释剂Ⅰ
鲎试剂
Chlorhexidine Acetate Irrigation Solution
bacterial endotoxin
gel method
interference test
dilutionsolutionⅠ
tachypleus amebocyte lysate
