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《West China Journal of Pharmaceutical Sciences》 2004-05
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Tachypleus amebocyte lysate test for bacterial endotoxins in raltitrexed for injection

TONG Hui-zhen,WU Zhao-di,XIAO Gui-nan (Guangdong Institute for Drug Control, Guangzhou 510180, China)  
OBJECTIVE To investigate the feasibility of bacterial endotoxins test for Raltitrexed in injection. METHODS Gel clot method of tachypleus amebocyte lysate(TAL) test was applied to detect bacterial endotoxins in Raltitrexed for injection.. RESULTS According to the maximal dose of clinical administration, the limit of bacterial endotoxins in Raltitrexed for injection was confirmed to be 14.7 EU·mg -1. Three batches of Raltitrexed for injection showed no interference with the test. After the samples were diluted to 0.02 mg·ml -1, the contents of bacterial endotoxins in all samples were not more than 14.7 EU·mg -1.CONCLUSION TAL test provides a new way to detect the content of bacterial endotoxins in Raltitrexed for injection. Samples can be diluted to 0.02 mg·ml -1 to avoid their interfering effects on routine bacterial endotoxins test.
【CateGory Index】: R927
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【References】
Chinese Journal Full-text Database 1 Hits
1 XIAO Gui-nan,LI Jin-fei,WU Zhao-di(Guangdong Institute for Drug Control,Guangzhou 510180,China);Tachypleus amebocyte lysate test for bacterial endotoxins in Aceglutamide and sodium chloride injection[J];West China Journal of Pharmaceutical Sciences;2006-04
【Co-citations】
Chinese Journal Full-text Database 3 Hits
1 LI Ai-min,YANG Xiao-ling(Tongling Worker's Hospital,Tongling 244000,China);On about bacterial endotoxin test in mailuoning injection[J];Anhui Medical and Pharmaceutical Journal;2007-03
2 XIAO Gui-nan, WU Zhao-di,LI Jin-fei, CHEN Xiao-fang (Guangdong Institute for Drug Control, Guangzhou, Guangdong 510180 );Study of tachypleus amebocyte lysate test for bacterial endotoxins in ceftriaxone sodium injection[J];Academic Journal of Guangdong College of Pharmacy;2003-02
3 CHEN Hua-long 1,WANG Li-bei 1,WU Zhao-di 2(1.Shaoguan Institute for Drug Control,Shaoguan 512028;China;2.Guangdong Institute for Drug Control,Guangzhou 510180;China);Study of Test for Bacterial Endotoxins in Calcium Folinate for Injection[J];Strait Pharmaceutical Journal;2004-06
【Secondary References】
Chinese Journal Full-text Database 1 Hits
1 LIU Hua~(1,2) HUANG Ming~2 ZHOU Li~2 (1.China Pharmaceutical University,Jiangsu Nanjing 210000,China;2.Sichuan Provincial Institute of Food and Drug Control,Sichuan Chengdu 610036,China);Study of tachypleus amebocyte lysate test for bacterial endotoxins in Glycyl-Glutamine[J];Journal of Pediatric Pharmacy;2007-05
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