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目的对注射用法莫替丁进行细菌内毒素检查法研究,建立其细菌内毒素检查方法,并且提高药品检验标准。方法按《中国药典》2005年版二部附录ⅪE细菌内毒素检查法,用不同厂家不同规格的鲎试剂对不同批号的注射用法莫替丁进行了干扰试验和细菌内毒素检查。结果本品稀释到0.5mg.mL-1浓度对细菌内毒素检查法无干扰作用,按拟定标准,12个厂家生产的25批该品种均符合规定。结论本品按限值L=0.25EU.mg-1进行细菌内毒素检查是可行的。
OBJECTIVE To study the bacterial endotoxin test for famotidine for injection and establish its bacterial endotoxin test method and to improve the test standard of the drug. Methods According to the bacterial endotoxin test method of Appendix XII of Appendix ⅡE of Chinese Pharmacopoeia, 2005 edition, interference test and bacterial endotoxin test were carried out on different batches of famotidine for injection by using different reagents of different specifications. Results The product was diluted to 0.5mg.mL-1 concentration of bacterial endotoxin test without interference, according to the proposed standard, 12 batches of 25 batches of the varieties are in line with the provisions. Conclusion This product is limited to L = 0.25EU.mg-1 bacterial endotoxin test is feasible.