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Process for producing a stable low concentration, injectable solution of noradrenaline

机译:生产稳定的低浓度去甲肾上腺素注射液的方法

摘要

In a first aspect, the present invention relates to a process for producing a stable, injectable solution with low content of noradrenaline, which includes dissolving noradrenaline and optionally an excipient in deoxygenated or degassed water, filtrating the resulting noradrenaline solution in a nitrogen current, distributing the solution in a nitrogen current, and sterilization, preferably hot. The invention further provides a stable, injectable solution with low content of noradrenaline, substantially free of anti-oxidizing and preservative agents, as well as uses thereof in the medical and pharmaceutical fields.
机译:在第一方面,本发明涉及一种制备去甲肾上腺素含量低的稳定的可注射溶液的方法,该方法包括将去甲肾上腺素和任选的赋形剂溶解在脱氧或脱气的水中,在氮气流中过滤得到的去甲肾上腺素溶液,分配将溶液在氮气流中灭菌,最好加热。本发明进一步提供了一种稳定的,可注射的溶液,其具有低含量的去甲肾上腺素,基本上不含抗氧化剂和防腐剂,及其在医学和制药领域的用途。

著录项

  • 公开/公告号US10251848B2

    专利类型

  • 公开/公告日2019-04-09

    原文格式PDF

  • 申请/专利权人 SINTETICA S.A.;

    申请/专利号US201515118864

  • 申请日2015-02-26

  • 分类号A61K31/137;A61K9;A61K47/02;A61K9/08;A61L2;

  • 国家 US

  • 入库时间 2022-08-21 12:10:05

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