测试肠外药物产品中的可见微粒:比较欧洲药典方法和使用偏振光的替代方法。

IF 1.6 4区 医学 Q3 PHARMACOLOGY & PHARMACY European journal of hospital pharmacy : science and practice Pub Date : 2024-08-22 DOI:10.1136/ejhpharm-2022-003633
Paula E Borgonje, Tom Dunnewind, Lisette Bosma, Marja Tokromo-Evegaars, P C Willem Meulenhoff, Oscar Breukels
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引用次数: 0

摘要

目标:肠外用药产品应基本无可见微粒污染。为确保这一点,生产的每一批产品都必须经过 100% 的目视检查。欧洲药典》(Ph. Eur.)专论 2.9.20 描述了一种在黑白面板前使用白色光源对肠道外药物进行目视检查的方法。尽管如此,荷兰的几家配制药房仍采用偏振光进行目视检查的替代方法。本研究的目的是比较这两种方法的性能:方法:三家不同医院经过培训的技术人员使用这两种方法对预先确定的一组样品进行检查,以目测肠外药物:结果:研究结果表明,与欧洲药典方法相比,另一种目视检查方法的回收率更高,而假阳性结果没有明显差异:结论:根据上述研究结果,可以得出结论:在药房实践中,通过偏振光进行目视检查的替代方法完全可以取代欧洲药典方法,前提是对替代方法进行本地验证。
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Testing of parenteral drug products for visible particles: comparison of the Ph. Eur. method with an alternative method using polarised light.

Objectives: Parenteral drug products should be essentially free from visible particulate contamination. To ensure this, every batch produced must be subject to a 100% visual inspection. Monograph 2.9.20 of the European Pharmacopoeia (Ph. Eur.) describes a method for visual inspection of parenteral drug units in front of a black and white panel using a white light source. Nevertheless, several Dutch compounding pharmacies rely on an alternative method for visual inspection by means of polarised light. The objective of this study was to compare the performance of both methods.

Methods: Trained technicians in three different hospitals inspected a predetermined set of samples using both methods for visual inspection of parenteral drugs.

Results: The results of this study show that the alternative method for visual inspection yields a higher recovery than the Ph. Eur. method, while no significant difference in false positive results was found.

Conclusions: Based on these findings, it can be concluded that the alternative method for visual inspection by means of polarised light can very well replace the Ph. Eur. method in pharmacy practice, provided that local validation of the alternative method is performed.

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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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