中国药物警戒 ›› 2023, Vol. 20 ›› Issue (12): 1351-1356.
DOI: 10.19803/j.1672-8629.20230589

• 临床药物质量监测及评价专栏 • 上一篇    下一篇

注射用腺苷钴胺细菌内毒素检查方法学研究

郝钢1, 韩峰1△, 周刚1, 武星1, 颜皓1, 李旭扬1, 候海玲1, 宁霄2#, 崔黎1*   

  1. 1内蒙古自治区药品检验研究院，内蒙古 呼和浩特 010020;
    2中国食品药品检定研究院食品化妆品检定所，北京 100050
  • 收稿日期:2023-09-21 出版日期:2023-12-15 发布日期:2023-12-15
  • 通讯作者: *崔黎,女,本科,主任药师,药物质量标准研究。E-mail:413647638@qq.com; #为共同通信作者。
  • 作者简介:郝钢,男,硕士,副主任药师,药理学和药物安全性评价。△为并列第一作者。
  • 基金资助:
    国家重点研发计划（2021YFC2401100）

Methodological study of adenosylcobalamin bacterial endotoxin examination for injection

HAO Gang1, HAN Feng1△, ZHOU Gang1, WU Xing1, YAN Hao1, LI Xuyang1, HOU Hailing1, NING Xiao2#, CUI Li1,*   

  1. 1Inner Mongolia Institute of Drug Inspection, Hohhot Inner Mongolia 010020, China;
    2Institute for Food and Cosmetics Testing, National Institutes for Food and Drug Control, Beijing 100050, China
  • Received:2023-09-21 Online:2023-12-15 Published:2023-12-15

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摘要： 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。

关键词: 注射用腺苷钴胺, 细菌内毒素, 方法学研究, 限值, 干扰试验, 质量控制

Abstract: 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.

Key words: adenosylcobalamin for injection, bacterial endotoxin, methodological research, limits, interference test, quality control

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