动态浊度法和凝胶法检测甘露醇注射液中细菌内毒素的含量  

Detection of Bacterial Endotoxin in Mannitol Injection with Kinetic Turbidimetry and Gel Clot Test

作　　者：王复馨[1] 雒琪[1] 李军[1] 

机构地区：[1]山东省立医院药剂科,济南250021

出　　处：《医药导报》2003年第10期714-716,共3页Herald of Medicine

摘　　要：目的:采用动态浊度法和凝胶法检测甘露醇注射液中细菌内毒素的含量,以控制药品质量,减少临床热原反应的发生。方法:按《中华人民共和国药典》2000年版附录中细菌内毒素检测法及其指导原则的规定,系统考察甘露醇注射液对鲎试剂与细菌内毒素凝集反应的干扰,确定采用动态浊度法和凝胶法检测细菌内毒素的不干扰浓度。结果:甘露醇注射液经4倍稀释后可应用动态浊度法定量检测。凝胶法最佳检测条件为供试品1:8稀释,鲎试剂灵敏度(λ)=0.06 EU·mL-1;供试品(冷藏)1:4稀释,鲎试剂灵敏度(λ)=0.125 EU·mL-1。结论:应用动态浊度法定量检测甘露醇注射液细菌内毒素含量,结果准确;凝胶法可用于日常检测。以上两法均可替代家兔法用于甘露醇注射液的热原检查。Objective:To detect the content of bacterial endotoxin in mannitol injection with kinetic turbidometry and gel clot test for the control of the quality of the drug and prevention of pyrogen reaction in clinical practice. Methods: According to the Methods of Detection of Bacterial Endotoxin and Guidelines for Detection of Bacterial Endotoxin in the Appendix of The Pharmacopoeia of the People's Republic of China of the year 2000 edition, a systematic study was carried out of the interference of mannitol injection with limulus reagent and agglutination reaction to bacterial endotoxin. The authors were then determined to use kinetic turbidimetry and gel clot test for detecting the non-interference concentration of bacterial endotoxin. Results: The bacterial endotoxin in the mannitol injection could be detected quantitatively with kinetic turbidimetry if the solution had been diluted for 4 times. The requirements for optimal detection with the gel clot test were: 1:8 dilution of the specimen, sensitivity of the limulus reagent(λ) =0.06 EU·mL-1 ; 1:4 dilution of the specimen(refrigerated) , sensitivity of the limulus reagent ( λ ) = 0.125 EU· mL-1 . Conclusion: Accurate results can be obtained in the quantitative detection of bacterial endotoxin in the mannitol injection with kinetic turbidimetry and the gel clot test may be used in routine duties. Pyrogen tests in rabbits for bacterial endotoxin in the mannitol injection can be replaced by both of the methods presented in this paper.

关 键 词：甘露醇注射液 动态浊度法 凝胶法 细菌内毒素 

分 类 号：R977.7[医药卫生—药品] R927.12[医药卫生—药学]