PHASEOLUS VULGARIS L. ÖZÜ İÇEREN JELİN FORMÜLASYONU VE İNFLAMASYON TEDAVİSİNDEKİ ETKİNLİĞİNİN DEĞERLENDİRİLMESİ - TEK KOL AÇIK ETİKETLİ KLİNİK ÇALIŞMA

Yıl 2023, Cilt: 47 Sayı: 2, 497 - 507, 20.05.2023

Anita Desai , Laxman Vijapur , Mahantesh Salımath Supriya Suragond

https://doi.org/10.33483/jfpau.1212628

Öz

Amaç: Bu çalışmanın amacı, Phaseolus vulgaris L. ekstraktından antosiyanin içeren bir jel geliştirmek, test etmek ve bunun anti-enflamatuar aktivitesini incelemektir.
Gereç ve Yöntem: Phaseolus vulgaris L., çözücü olarak metanol içinde %1 HCl (v/v) ile maserasyonu yapılarak tohum kabuğundan antosiyanin ekstrakte edilmiştir. Antosiyanin jelleri, karbopol-940, sodyum-CMC, kitosan ve etanol, lavanta yağı, propilen glikol, metil paraben ve propil paraben gibi diğer bileşenler dahil olmak üzere çeşitli polimerler kullanılarak üretilmiştir. Antosiyanin jelin tüm formülasyonları FTIR, pH, viskozite, yayılabilirlik, ekstrüde edilebilirlik, ilaç içeriği ve in vitro ilaç salınım çalışmaları için incelenmiştir. Optimal formülasyon daha sonra klinik bir araştırma ile tespit edilmiştir.
Sonuç ve Tartışma: Antosiyanin jelleri için formülasyonlar, farklı konsantrasyonlarda karbopol-940, sodyum-CMC, kitosan gibi çeşitli jelleştirici ajanlar kullanılarak yapılabilmektedir. Kitosan (F3) kullanılarak formüle edilen jel, azalmış viskozite, gelişmiş ekstrüdasyon ve yeterli miktarda ilaç salınımı ile bileşimin daha iyi sonuçlar göstermiştir. Kitosan'ın % 2'si ile F3 formülasyonu, klinik çalışmada anti-enflamatuar aktivite için en iyi seçim olarak bulunmuştur. Bu nedenle, antosiyanin ile deneklerde orta ila belirgin iyileşme sağlayanmıştır ve antosiyaninin anti-enflamatuar potansiyeli olduğu kanıtlanmıştır.

Anahtar Kelimeler

Anti-enflamatuar, antosiyanin, Phaseolus vulgaris L., topikal jel

FORMULATION OF GEL CONTAINING PHASEOLUS VULGARIS L. EXTRACT AND TO EVALUATE ITS EFFICACY IN THE MANAGEMENT OF INFLAMMATION - A SINGLE ARM OPEN LABELLED CLINICAL STUDY

Öz

Objective: The research works objective was to develop and test a gel that contained anthocyanin of Phaseolus vulgaris L. extract and to study it’s anti-inflammatory activity.
Material and Method: By macerating Phaseolus vulgaris L. with 1% HCl (v/v) in methanol as the solvent, anthocyanin was extracted from the seed coat. Anthocyanin gels were produced utilizing a variety of polymers, including carbopol-940, sodium-CMC, chitosan, and other ingredients, including ethanol, lavender oil, propylene glycol, methyl paraben, and propyl paraben. All of the formulations of anthocyanin gel were studied for FTIR, pH, viscosity, spreadability, extrudability, drug content, and in-vitro drug release studies. The optimal formulation was then carried through a clinical investigation.
Result and Discussion: Formulations for anthocyanin gels can be made utilizing various gelling agents, such as carbopol-940, sodium-CMC, chitosan at different concentrations. Gel formulated using Chitosan (F3) showed better results of composition with decreased viscosity, enhanced extrudability, and a respectable amount of drug release. Formulation F3 by 2% of chitosan was best choice for anti-inflammatory activity in clinical study. Hence, Anthocyanin proved it’s potential for inflammation that implies moderate to marked improvement with significant results in subjects.

Anahtar Kelimeler

Anthocyanin, anti-inflammatory, Phaseolus vulgaris L., topical gel

Kaynakça

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