新霉素B第二版国际标准制定的合作研究。

Q4 Medicine Pharmeuropa bio & scientific notes Pub Date : 2014-01-01
S Jorajuria, C Raphalen, V Dujardin, A Daas
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引用次数: 0

摘要

组织了一项国际合作研究,以制定世界卫生组织(世卫组织)新霉素b的第二项国际标准(IS)。来自不同国家的七个实验室参加了这项研究。候选材料的效价通过敏感微生物的微生物测定来估计。为保证连续批WHO IS的连续性,以第1批新霉素B IS作为对照。根据研究结果,2012年世卫组织生物标准化专家委员会(ECBS)会议通过了新霉素B的第二版标准,指定效力为每瓶17640国际单位(IU)。新霉素B的第二份IS可从欧洲药品和保健质量理事会(EDQM)获得。
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Collaborative study for the establishment of the 2nd international standard for neomycin B.

An international collaborative study was organised to establish the World Health Organization (WHO) 2nd International Standard (IS) for neomycin B. Seven laboratories from different countries participated. Potencies of the candidate material were estimated by microbiological assays with sensitive micro-organisms. To ensure continuity between consecutive batches of the WHO IS, the 1st IS for neomycin B was used as reference. Based on the results of the study, the 2nd IS for neomycin B was adopted at the meeting of the WHO Expert Committee for Biological Standardization (ECBS) in 2012 with an assigned potency of 17640 International Units (IU) per vial. The 2nd IS for neomycin B is available from the European Directorate for the Quality of Medicines & HealthCare (EDQM).

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来源期刊
Pharmeuropa bio & scientific notes
Pharmeuropa bio & scientific notes Medicine-Medicine (all)
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0.70
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