摘要
目的建立马来酸桂哌齐特注射液的细菌内毒素检查方法。方法按照《中国药典》2010年版(二部)附录细菌内毒素检查法,用2个不同生产厂家的鲎试剂(TAL)对3批马来酸桂哌齐特注射液进行干扰试验和细菌内毒素检查。结果样品的细菌内毒素限值确定为1.0 EU/mg,供试品溶液低于或等于0.25 mg/mL时,对TAL与细菌内毒素之间的凝集反应无干扰抑制作用。结论建立的细菌内毒素检查方法可行,可用于马来酸桂哌齐特注射液的检查。
Objective To establish a method for testing the bacterial endotoxin in Cinepazide Maleate Injection. Methods According to the Bacterial Endotoxin Test listed in Chinese Pharmacopeia 2010 edition（second part）, interference test and bacterial endotoxin test of three batches of Cinepazide Maleate Injection were carried out using tachypleus amebocyte lysate（TAL） from two manufactures. Results The limit of bacterial endotoxin for Cinepazide Maleate Injection was 1.0 EU/mg. There was no inhibitory interference with the agglutination of TAL by bacterial endotoxin when the concentration of diluted solution of Cinepazide Maleate Injection was not more than 0.25 mg/mL. Conclusion The method established for bacterial endotoxin test can be feasible and suitable for testing of Cinepazide Maleate Injection.
出处
《食品与药品》
CAS
2014年第5期336-338,共3页
Food and Drug
