| 关倩明 (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年版考察方法的可行性。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
Study of Bacterial Endotoxins Test for Calcijex Injection
Guan Qianming (Guangzhou Institute for Drug control, Guangzhou 510160)
ABSTRACT Objective: To examine a limit test of bacterial endotoxins, and establish a method to determine the content by kinetic turbidimetry assay in Calcijex Injection. Method: Limit test and Kinetic turbidimetry assay were used to evaluate the interference of Calcijex Injection to TAL in CP2000. Result: The tests showed that the TAL had not being interfered effect when Calcijex Injection was diluted to more than 20 times. Conclusion: TAL Methods can be used to check and determinate the bacterial endotoxins in Calcitriolum.
KEY WORDS Calcitriolum；Bacterial Endotoxins Test
资料来自:中国药师-专业站 |
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