李小品 (潜江市药品检验所 湖北潜江433100） 周素文 (湖北省药品检验所）
摘 要 目的：考察细菌内毒素检查法对红花注射液进行检查的可行性。方法：用细菌内毒素检查法对红花注射液进行干扰试验；用细菌内毒素检测法对家兔热原试验不同结果的红花注射液进行比较试验。结果：供试品对鲎试剂与内毒素的反应无干扰作用。家兔热原检查法阴性结果与细菌内毒素检查法结果相吻合，而热原检查阳性结果却不吻合。结论：用细菌内毒素检查法检测红花注射液热原不可行。
关键词 细菌内毒素检测法; 热原试验; 红花注射液
中图分类号：R927.12
文献标识码：A
文章编号：1008-049X(2007)09-0885-02
Comparison of Pyrogen Tests of Safflower Injection by Simultaneous Use of Bacteria Endotoxin Test and Rabbits Test
Li Xiaopin（Qianjiang Institute for Drug Control, Hubei，Qianjiang,433100 China）; Zhou Shuwen( Hubei Institute for Drug Control)
ABSTRACT Objective: To investigate the feasibility of bacteria endotoxin test for examination the Safflower Injection.Method: The bacteria endotoxin test was used to interfere test on Safflower injection. The different results of rubbits pyrogen test of Safflower Injection were compared by bacteria endotoxin test.Result: The samples were no showed interferential efforts on the King Crab reagent. The negative result of the rabbits test and the result of of bacteria endotoxin test were matched .But the positive result of the pyrogen test of rabbits and the result of bacteria endotoxin test were no matched.Conclusion: Examination the pyrogen of the Safflower injection by the bacteria endotoxin test is not feasible.
KEY WORDS Bacteria Endotoxin test；Pyrogen test；Safflower Injection
参 考 文 献
1 中国药典［S］.2005年版.二部.附录.XIE.85
2 冀建明.叶良君.克林霉素磷酸酯氯化钠注射液细菌内毒素检查法的可行性研究［J］.中国药师,2006.9(4):330-331
3 USP［S］. XXIII .1998.1-7 资料来自:中国药师-专业站 |