注射用腺苷钴胺细菌内毒素检查方法学研究

Methodological study of adenosylcobalamin bacterial endotoxin examination for injection

目的建立注射用腺苷钴胺细菌内毒素检查法质量标准,为该药品国家标准制修订提供参考。方法依照《中华人民共和国药典》(2020年版)(简称“《中国药典》”)四部通则1143细菌内毒素检查法,采用不同厂家的鲎试剂对8家生产企业24批次注射用腺苷钴胺进行细菌内毒素检查方法学研究。结果制定注射用腺苷钴胺细菌内毒素限定值为40 EU·mg^(-1),适用《中国药典》1143项细菌内毒素检查法检查。结论注射用腺苷钴胺可以采用细菌内毒素检查法进行质量控制,其细菌内毒素限值可定为每1 mg腺苷钴胺中含内毒素的量不得过40 EU。

Objective To establish a quality standard for the bacterial endotoxin test method of adenosine cobalt amine for injection,so as to provide reference for the formulation and revision of the national standard for this drug.Methods According to the 1143 bacterial endotoxin test method in the 2020 edition(Part 4)of the Chinese Pharmacopoeia,bacterial endotoxin test methodology was studied on 24 batches of adenosine cobalt amine injection from 8 production enterprises using different manufacturers of horseshoe crab reagents.Results A bacterial endotoxin limit of 40 EU·mg^(-1) for adenosine cobalt amine injection was established,which was suitable for the examination of 1143 bacterial endotoxin detection methods in the four general principles of the Chinese Pharmacopoeia in 2020.Conclusion Adenosylcobalamin for injection can be controlled by bacterial endotoxin examination,and the limit of bacterial endotoxin can be set as follows,the content of endotoxin per mg of adenosylcobalamin shall not exceed 40 EU.