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Dergiler / Manas Journal of Agriculture Veterinary and Life Sciences / 2026 / Cilt: 16 Sayı: 1

Bir İntra Artiküler Hiyalüronik Asit Jel İmplantın Bazı İn Vitro Biyouyumluluk Testleri ile Sitotoksisitesinin ve Genotoksisitesinin Değerlendirilmesi

Evaluation of Cytotoxicity and Genotoxicity af An Intra-Articular Hyaluronic Acid Gel Implant by Some In Vitro Biocompatibility Tests.

Yasin Ozkabadayı(Kırıkkale Üniversitesi Veteriner Fakültesi Histoloji-Embriyoloji Anabilim Dalı)0000-0003-0326-3407
Rümeysa Çelik(KIRIKKALE ÜNİVERSİTESİ, SAĞLIK BİLİMLERİ ENSTİTÜSÜ, VETERİNER HİSTOLOJİ-EMBRİYOLOJİ (DR))0009-0006-4089-8793
Yasemin Sezgin(KIRIKKALE ÜNİVERSİTESİ, VETERİNER FAKÜLTESİ, HASTALIKLAR VE KLİNİK BİLİMLERİ BÖLÜMÜ, VETERİNERLİK FARMAKOLOJİ VE TOKSİKOLOJİSİ ANABİLİM DALI)0009-0006-7119-3200
Sayfa
74–83
Yayın Tarihi
2026-06-23
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Yapay Zeka Hızlı Bakış & Çıkarımlar

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⚡ TL;DR(1 Cümlede Hızlı Çıkarım)

Bu çalışma, sitotoksisite testlerinin sonuçlarında bir farklılık olduğunu göstermektedir.

📌 3 Maddede Bu Makale

🎯
Amaç & Hipotez:Tıbbi cihazların biyouyumluluğunu test etmenin ilk adımı sitotoksisite testidir.
📊
Temel Bulgular & Veri:Biyouyumluluk risk değerlendirmesinin önemli bir ayağı olan genotoksisite testleri de karsinojenite, mutajenite ve genital toksisiteyi analiz etmek için yapılır.
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Sonuç & Katkı:Bu çalışma, sitotoksisite testlerinin sonuçlarında bir farklılık olduğunu göstermektedir.
🔬Tür:Laboratuvar & Saha Deneyi
📍Kapsam:Genişletilmiş Akademik Örneklem
⚙️Değişkenler:Biyouyumluluk · sitotoksisite · genotoksisite

Özet

Tıbbi cihazların biyouyumluluğunu test etmenin ilk adımı sitotoksisite testidir. Biyouyumluluk risk değerlendirmesinin önemli bir ayağı olan genotoksisite testleri de karsinojenite, mutajenite ve genital toksisiteyi analiz etmek için yapılır. Tıbbi cihazların klinik kullanım öncesinde biyouyumluluk testlerine tabii tutulması hem risk değerlendirmesi hem de ruhsatlandırma süreci için bir zorunluluktur. Bu çalışmada, hiyalüronik asit bazlı yeni üretilen ticari bir tıbbi cihazın MTT testi ve agar difüzyon testleri ile sitotoksisitesi, in vitro mikronükleus testi ile de genotoksisitesi değerlendirildi. MTT testinde 1/1 konsantrasyonda hücre canlılığı %52,41 ± 3,44 olup numune sitotoksik olarak değerlendiridi. Agar difüzyon testinde ise numunenin uygulandığı hücrelerde reaksiyon yok ve derece=0 sonucuyla sitotoksik olmadığı belirlendi. İn vitro mikronükleus testinde ise istatistiksel hesaplamalar sonucunda numunenin genotoksik olmadığı gözlendi. Bu çalışma, sitotoksisite testlerinin sonuçlarında bir farklılık olduğunu göstermektedir. Bu farklılığın nedenleri, jel benzeri test örneğinin kimyasal bileşiminden ziyade fiziksel özelliklerinin, test ortamındaki hücre davranışını ve hücre zarının yüzey özelliklerini etkilemesinden kaynaklanmaktadır. Bu nedenle, biyouyumluluk testleri seçilirken ve sonuçlar değerlendirilirken, test örneğinin fiziksel ve kimyasal özelliklerinin dikkate alınması ve gerektiğinde hem doğrudan hem de dolaylı sitotoksisite testleri yapılarak örnek için uygun testlerin seçilmesi önerilir.

Abstract

The first step in testing the biocompatibility of medical devices is cytotoxicity testing. Genotoxicity tests, another important aspect of biocompatibility risk assessment, are also performed to analyze carcinogenic, mutagenic, and genital toxicity. Subjecting medical devices to a series of tests, such as cytotoxicity and genotoxicity tests, before clinical use is a necessity for both risk assessment and the licensing process. In this study, the cytotoxicity of a newly produced commercial medical device based on hyaluronic acid was evaluated using MTT and agar diffusion tests, and its genotoxicity was evaluated using the in vitro micronucleus test. In the MTT test, cell viability at a 1:1 concentration was 52.41% and 3.44%, indicating that the sample was cytotoxic. In the agar diffusion test, there was no reaction in the cells to which the sample was applied, and the result was grade=0, indicating that it was not cytotoxic. In the in vitro micronucleus test, statistical calculations showed that the sample was not genotoxic. Direct cytotoxicity testing of viscous/gel-like samples may lead to false positive or false negative results. Therefore, when selecting tests and evaluating results, it is recommended to consider the physical and chemical properties of the sample and to apply both direct and indirect cytotoxicity tests when necessary. In conclusion, to accurately evaluate the results of biocompatibility tests, tests appropriate to the sample must be selected.

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Bu Makaleye Atıf Yap

Ozkabadayı, Y., Çelik, R., Sezgin, Y. (2026). Bir İntra Artiküler Hiyalüronik Asit Jel İmplantın Bazı İn Vitro Biyouyumluluk Testleri ile Sitotoksisitesinin ve Genotoksisitesinin Değerlendirilmesi. Manas Journal of Agriculture Veterinary and Life Sciences, Cilt: 16 Sayı: 1, 74–83. https://doi.org/10.53518/mjavl.1869207

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