维生素B12注射液细菌内毒素检查方法的建立

目的：建立维生素B12注射液的细菌内毒素检查方法。方法：按《中国药典》2010年版二部（附录Ⅺ E）的细菌内毒素检查方法及指导原则进行实验。结果：维生素B12注射液的最大不干扰浓度为0.25 mg·mL-1。在内毒素限值确定为400 EU·mg-1情况下，用灵敏度为0.25 EU·mL-1的鲎试剂按凝胶限度检查法对6批次供试品进行细菌内毒素检查，结果均符合规定。结论：建议药典增加维生素B12注射液的细菌内毒素检查项，规定每1 mg维生素B12中含内毒素的量应小于400 EU。

Development of Bacterial Endotoxin Test Method for Vitamin B12 Injection

Objective： To establish a detection method of the bacterial endotoxin in Vitamin B12 injec_tion. Methods： The experiments were done according to the bacterial endotoxin detection method and guid_ing principles in Chinese Pharmacopoeia 2010 edition （appendix Ⅺ E）. Results： The maximum undisturbed concentration of vitamin B12 injection was 0.25 mg·mL-1 in the bacterial endotoxin test. Six batches of sam_ples were detected by using limulus reagents wit sensitivity at 0.25 EU·mL-1, and the results were all qual_ified to the standards under the threshold of bacterial endotoxin within 400 EU·mg-1. Conclusion： The bacterial endotoxin inspection items should be supplied in Chinese Pharmacopoeia, and the amount of bac_terial endotoxin in Vitamin B12 should be under 400 EU per mg.