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骨化三醇注射液的细菌内毒素检测
引用本文:关倩明. 骨化三醇注射液的细菌内毒素检测[J]. 中国药师, 2005, 8(5): 428-429
作者姓名:关倩明
作者单位:广州市药品检验所,广州,510160
摘    要:目的:验证凝胶法检查骨化三醇注射液细菌内毒素的方法,建立动态比浊法测定其细菌内毒素含量.方法:用不同厂家的鲎试剂对不同批号的样品分别进行干扰试验,按<中国药典>2000年版方法考察其可行性.结果:骨化三醇注射液在20倍以上稀释可消除干扰作用,凝胶法检查和动态比浊法测定均符合规定,结果准确可靠.结论:鲎试验法适用于骨化三醇注射液中细菌内毒素检测.

关 键 词:骨化三醇注射液  细菌内毒素检查
文章编号:1008-049X(2005)05-0428-02
修稿时间:2004-08-09

Bacterial Endotoxins Test for Calcijex Injection
Guan Qianming. Bacterial Endotoxins Test for Calcijex Injection[J]. China Pharmacist, 2005, 8(5): 428-429
Authors:Guan Qianming
Abstract:Objective: To establish a method to determine the content of bacterial endotoxins by kinetic turbidimetry assay in calci-jex injection. Method: The limit test and kinetic turbidimetry assay were used to evaluate the interference of calcijex injection to TAL according to CP2000. Result: The test showed that the TAL had no interfering effect when calcijex injection was diluted to more than 20 times. Conclusion: TAL Methods can be used to check and determine the bacterial endotoxins in calcijex injection.
Keywords:Calcijex  Bacterial endotoxins test  
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