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局部皮肤温度的热成像作为注射用药物质量和安全性评估的一部分。

Thermal imaging of local skin temperature as part of quality and safety assessment of injectable drugs.

作者信息

Urakov Aleksandr, Urakova Natalya, Samorodov Aleksandr, Shabanov Petr, Yagudin Ilnur, Stolyarenko Anastasia, Suntsova Darya, Muhutdinov Nikita

机构信息

Department of General and Clinical Pharmacology, Izhevsk State Medical University, Izhevsk, Russia.

Department of Inventions and Patents, Institute of Thermology, Izhevsk, Russia.

出版信息

Heliyon. 2023 Dec 15;10(1):e23417. doi: 10.1016/j.heliyon.2023.e23417. eCollection 2024 Jan 15.

Abstract

Injection of high-quality drugs can occasionally cause unexpected and unexplained local complications. As the current standard for drug quality control does not include an assessment of the local irritation effects of drugs, this effect may cause postinjection complications. Simultaneously, local irritation effects of the drugs can be assessed based on local tissue inflammation. The dynamics of local temperature can assess inflammation. Infrared monitoring of local skin temperature dynamics at subcutaneous, intramuscular, and intravenous injection sites of drugs under experimental and clinical conditions can improve their quality and safety. Therefore, there is a need to include dynamic thermography in the standard of biological evaluation of the quality and safety of drugs in the dosage form "solution for injections." This eliminates the local irritation and necrotizing activity of drugs and minimizes the development of local pain syndrome, aseptic inflammation, necrosis, and abscess.

摘要

注射高质量药物偶尔会引发意想不到且无法解释的局部并发症。由于当前药物质量控制标准不包括对药物局部刺激作用的评估,这种作用可能导致注射后并发症。同时,可基于局部组织炎症来评估药物的局部刺激作用。局部温度动态变化能够评估炎症情况。在实验和临床条件下,对药物皮下、肌肉内及静脉注射部位的局部皮肤温度动态变化进行红外监测,可提高药物的质量和安全性。因此,有必要将动态热成像纳入“注射用溶液”剂型药物质量和安全性生物评价标准中。这可消除药物的局部刺激和坏死活性,并将局部疼痛综合征、无菌性炎症、坏死及脓肿的发生降至最低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/134a/10771983/32e3a0956d15/gr1.jpg

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