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

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

1. 1. Chen, L., Deng, H., Cui, H., Fang, J., Zuo, Z., Deng, J., Li, Y., Wang, X., Zhao, L. (2018). Inflammatory and inflammation-associated diseases in organs. Oncotarget, 1, 9(6), 7204-7218. [CrossRef]
2. 2. Rathod, H.J., Mehta, D.P. (2015). A review on pharmaceutical gel. International Journal of Pharmaceutical Sciences, 1(1), 33-47.
3. 3. Devi, M., Dhanalakshmi, S., Govindarajan, G.T., Tanisha, B.A., Sonalika, T., Ruth, J.E., Avinash, T., Sri C.J., Logeswaran, K., Ramasamy, M.N. (2020). A review on Phaseolus vulgaris Linn. Pharmacognosy Journal, 12(5), 1160-1164. [CrossRef]
4. 4. Rakkimuthu, R., Palmurugan, S., Shanmugapriya, A. (2016). Effect of temperature, light, pH on the stability of anthocyanin pigments in cocculus hirsutus fruits. International Journal of Multidisciplinary Research and Modern Education, 2(2), 91-96.
5. 5. Silva, H.R., Assis, D.D., Prada, A.L., Silva, J.O., Sousa, M.B., Ferreira, A.M., Amado, J.R., Carvalho, H.D., Santos, A.V., Carvalho, J.C. (2019). Obtaining and characterization of anthocyanins from Euterpe oleracea (açaí) dry extract for nutraceutical and food preparations. Revista Brasileira de Farmacognosia, 29, 677-685. [CrossRef]
6. 6. Muchuweti M, Chikwambi Z. (2008). Isolation and identification of anthocyanins in the fruit peels of starkrimson and marx red bartlett common pear cultivars and their bud mutants. American Journal of Food Technology, 3, 1-12.
7. 7. Agunos, R.I., Mendoza, D.V., Rivera, M.A. (2020). Anthocyanin colorimetric strip for volatile amine determination. International Journal of Food Science, 1-7. [CrossRef]
8. 8. Jamadar, M.J., Shaikh, R.H. (2017). Preparation and evaluation of herbal gel formulation. Journal of Pharmaceutical Research and Development, 1(2), 201-204.

9. 9. Gupta, R., Gupta, G.D. (2017). Formulation development and evaluation of anti-inflammatory potential of Cordia obliqua topical gel on animal model. Pharmacognosy Journal, 9(6)suppl, 93-98. [CrossRef]
10. 10. Aslani, A., Zolfaghari, B., Fereidani, Y. (2018). Design, formulation, and evaluation of a herbal gel contains melissa, sumac, licorice, rosemary, and geranium for treatment of recurrent labial herpes infections. Dental Research Journal, 15(3), 191-200. [CrossRef]
11. 11. Campos, L.M., de Oliveira Lemos, A.S., da Cruz, L.F., de Freitas Araújo, M.G., de Mello Botti, G.C.R., Júnior, J.L.R., Rocha, V.N., Denadai, Â.M.L., da Silva, T.P., Tavares, G.D., Scio, E. Fabri, R.L., Pinto, P.F.(2020). Development and in vivo evaluation of chitosan-gel containing Mitracarpus frigidus methanolic extract for vulvovaginal candidiasis treatment. Biomedicine and Pharmacotherapy, 130, 110609. [CrossRef]
12. 12. Aslani, A., Zolfaghari, B., Davoodvandi, F. (2016). Design, formulation and evaluation of an oral gel from Punica granatum flower extract for the treatment of recurrent aphthous stomatitis. Advanced Pharmaceutical Bulletin, 6(3), 391-398. [CrossRef]
13. 13. Mahendra, A.G., Rasika, D.B. (2019). Formulation and evaluation of topical anti-inflammatory herbal gel. Asian Journal of Pharmaceutical and Clinical Research, 12, 252-255. [CrossRef]
14. 14. Aslani, A., Ghannadi, A., Najafi, H. (2013). Design, formulation and evaluation of a mucoadhesive gel from Quercus brantii L. and coriandrum sativum L. as periodontal drug delivery. Journal of Advanced Biomedical Research, 2(2), 1-9. [CrossRef]
15. 15. Obouayeba, A.P., Diarrassouba, M., Soumahin, E.F., Kouakou, T.H. (2015). Phytochemical analysis, purification and identification of Hibiscus anthocyanins. Journal of Pharmaceutical, Chemical and Biological Sciences, 3(2), 156-168.
16. 16. Vandana, D., Shweta P. (2019). Formulatıon and evaluatıon of topıcal herbal gel contaınıng ınclusıon complex of curcumın. Asian Journal of Pharmaceutical and Clinical Research, 12(9), 196-201. [CrossRef]
17. 17. Jadhav, V.D., Talele, Swati, G., Bakliwal, Akshada, A., Chaudhari, G.N. (2015). Formulation and evaluation of herbal gel containing leaf extract of Tridax Procumbens. Journal of Pharmaceutical and Biological Sciences, 3, 65-72.
18. 18. Avinash, S., Gowda, D.V., Suresh, J., Ram, A.S., Srivastava, A., Osmani, R.M. (2016). Formulation and evaluation of topical gel using Eupatorium glandulosum michx for wound healing activity. Scholars Research Library, 8(8), 255-266.
19. 19. Aiyalu, R., Govindarjan, A., Ramasamy, A. (2016). Formulation and evaluation of topical herbal gel for the treatment of arthritis in animal model. Brazilian Journal of Pharmaceutical Sciences, 52, 493-507. [CrossRef]
20. 20. Patel, N.A., Patel, N.J., Patel, R.P. (2009). Formulation and evaluation of curcumin gel for topical application. Pharmaceutical Development and Technology, 1, 14(1), 83-92. [CrossRef]
21. 21. Mandal, S., Thimmasetty, M.K., Prabhushankar, G.L., Geetha, M.S. (2012). Formulation and evaluation of an in situ gel-forming ophthalmic formulation of moxifloxacin hydrochloride. International Journal of Pharmaceutical Investigation, 2(2), 78-82. [CrossRef]
22. 22. Sharma, B.S., Mahajon, B., Rao, B.C., Srikanth, N. (2019). Study protocol of a prospective, openlabel, single-arm, clinical trial to evaluate the efficacy of classical ayurveda medicines in the management of vicharchika (atopic eczema). Journal of Drug Research in Ayurvedic Sciences, 3(1), 27-33.