注射用兰索拉唑细菌内毒素检查法研究

Study on the Bacterial Endotoxin Test in Lansoprazole for Injection

目的 :建立注射用兰索拉唑细菌内毒素检查方法。方法:按《中国药典2010年版二部》附录ⅪE细菌内毒素检查法及相关规定,使用两个厂家鲎试剂对3批注射用兰索拉唑进行干扰试验和细菌内毒素检查。结果:稀释样品浓度至0.1 mg/m L时,可排除干扰。结论:注射用兰索拉唑可适用细菌内毒素检查法控制质量。

OBJECTIVE To establish the bacterial endotoxin inspection method of Lansoprazole for Injection. MEHTODS According to bacterial endotoxin inspection method and the related regulations of the Chinese Pharmacopoeia 2010 volume Ⅱappendix Ⅺ E,different products of tachypleus amebocyte lysate（ TAL） were used for the investigation of interference and bacterial endotoxin test on three batches of sample. RESULTS Lansoprazole for Injection did not interfere with bacterial endotoxin test when it was diluted to the concentration of 0. 1mg/m L. CONCLUSION It is feasible to control quality of Lansoprazole for Injection by bacterial endotoxin test.