在临床中测定[99m锝]锝-美布非宁和[99m锝]锝-依替非宁放射化学纯度的优化质量控制方法。

IF 1.6 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Charlotte Pirot, Damien Peyronnet, Jonathan Vigne
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引用次数: 0

摘要

目的:在基于mebrofenin(Cholediam)的锝-99m[99mTc]放射性标记试剂盒供应中断的情况下,医药机构允许进口备用放射性药物诊断剂etifenin(Techida),以确保核医学科对肝胆疾病患者的持续管理。根据《欧洲药典》和《产品特征概要》(SPC),这些试剂盒在测量放射化学纯度(RCP)方面仍存在问题。本研究旨在从反应速度和可靠性的角度,确定并优化临床上最适合测定[99m锝]锝-甲氧苄啶和[99m锝]锝-乙氧苄啶的放射化学纯度(RCP)的薄层色谱法(TLC)。方法:使用六种不同的 TLC 方法和一种高效液相色谱 (HPLC) 方法对[99m锝]锝-乙替菲宁(n=4)和[99m锝]锝-甲溴芬宁(n=5)进行单独控制,以确定杂质([99m锝](TcO2)n 和 Na[99m锝]TcO4)、RCP(%)和分析持续时间(分钟)。根据药典和 SPC 的建议选择了两种 TLC 方法,另外两种方法完全相同,但增加了一个加热步骤,另外两种方法是 SPC 和药典方法的混合,选择这些方法是为了优化 RCP 测定参数:放射性-高效液相色谱分析可有效地从 Na[99mTc]TcO4 (保留时间为 2.76±0.03 分钟)中分离出[99mTc]Tc-etifenin 和[99mTc]Tc-mebrofenin,保留时间分别为 8.05±0.02 分钟和 8.94±0.07 分钟。高效液相色谱法显示,[99m锝]锝-美布非宁中不含 Na[99m锝]TcO4,[99m锝]锝-乙替菲宁中的 Na[99m锝]TcO4含量为 0.2%。在 TLC 方法中,我们确定了最合适的方法,它能在 31.5±1.1 分钟内确保最符合要求的 RCP(98.3±0.9%)。此外,与药典和 SPC 建议的方法相比,该方法可节省 15 分钟的时间:结论:我们提出的 TLC 方法可将质量控制平均加快 15 分钟,同时保证可靠的 RCP。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Optimised quality control method for determination of the radiochemical purity of [99mTc]Tc-mebrofenin and [99mTc]Tc-etifenin in a clinical context.

Objectives: In the context of a supply disruption of mebrofenin (Cholediam)-based kits for radiolabelling with technetium-99m [99mTc], the medicine agencies allowed the importation of a back-up radiopharmaceutical diagnostic agent, etifenin (Techida), to ensure continuous management of patients with hepatobiliary disorders in nuclear medicine departments. There are still issues regarding the measurement of radiochemical purity (RCP) with these kits based on the European Pharmacopoeia and the Summary of Product Characteristics (SPC). This study aims to identify and to optimise, in a clinical context, the most suitable thin layer chromatography (TLC) method for the determination of the RCP in terms of speed of response and reliability for [99mTc]Tc-mebrofenin and [99mTc]Tc-etifenin.

Methods: [99mTc]Tc-etifenin (n=4) and [99mTc]Tc-mebrofenin (n=5) were individually controlled using six different TLC methods and one high-performance liquid chromatography (HPLC) method for impurity identification ([99mTc](TcO2)n and Na[99mTc]TcO4), RCP (%) and duration of analysis (min). Two TLC methods were selected according to the recommendations of the Pharmacopoeia and SPC, two others were exactly the same but with a heating step, and the other two corresponded to a mix between the methods of the SPC and the Pharmacopoeia that were chosen to optimise RCP determination parameters.

Results: Radio-HPLC analysis allowed effective separation of [99mTc]Tc-etifenin and [99mTc]Tc-mebrofenin with a retention time of 8.05±0.02 min and 8.94±0.07 min, respectively, from Na[99mTc]TcO4 (retention time 2.76±0.03 min). HPLC showed an absence of Na[99mTc]TcO4 for [99mTc]Tc-mebrofenin and 0.2% for [99mTc]Tc-etifenin. Among the TLC methods, we identified the most suitable method which ensures the most compliant RCP (98.3±0.9%) in a time of 31.5±1.1 min. Also, it allowed a time saving of 15 min compared with the methods proposed by the Pharmacopoeia and the SPCs.

Conclusion: We propose a TLC method that accelerates quality control by an average of 15 min while guaranteeing a reliable RCP.

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来源期刊
CiteScore
3.40
自引率
5.90%
发文量
104
审稿时长
6-12 weeks
期刊介绍: European Journal of Hospital Pharmacy (EJHP) offers a high quality, peer-reviewed platform for the publication of practical and innovative research which aims to strengthen the profile and professional status of hospital pharmacists. EJHP is committed to being the leading journal on all aspects of hospital pharmacy, thereby advancing the science, practice and profession of hospital pharmacy. The journal aims to become a major source for education and inspiration to improve practice and the standard of patient care in hospitals and related institutions worldwide. EJHP is the only official journal of the European Association of Hospital Pharmacists.
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