Yıl: 2022 Cilt: 11 Sayı: 1 Sayfa Aralığı: 61 - 76 Metin Dili: Türkçe DOI: 10.5336/pharmsci.2021-86561 İndeks Tarihi: 15-06-2022

Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme

Öz:
Tıbbi değere sahip bitkilerden hareketle üretilen bitkisel ilaç ve geleneksel bitkisel tıbbi ürünlerin kullanımı günümüzde giderek artmaktadır. Bitkisel ilaçlar ve geleneksel bitkisel tıbbi ürünler, konvansiyonel ilaçlarda aranan kalite, etkinlik ve güvenilirlik özelliklerini taşıması ve iyi üretim uygulamaları kurallarına göre üretilmesinin yanı sıra Dünya Sağlık Örgütü tarafından yayımlanan iyi tarım uygulamaları gerekliliklerini de sağlamalıdır. Bitkisel ilaç ve geleneksel tedavide uzun yıllar kullanılan tıbbi bitkilerin güvenilirliği göz önünde bulundurularak ruhsatlandırılan geleneksel bitkisel tıbbi ürünler için standardize edilmiş halde kullanıma sunulmaları, içerik ve etkinliklerinin kanıtlanması, farmakokinetik özelliklerinin ve biyoyararlanımlarının belirlenmesi, doz-cevap ilişkilerinin ortaya konulması, konvansiyonel ilaçlarla olan etkileşimlerinin belirlenmesi oldukça önemli ve gerekli noktalardır. Bazı bitkisel bileşikler, düşük çözünürlük veya permeabilite nedeniyle düşük biyoyararlanıma sahiptir. Düşük biyoyararlanım göstermesi nedeniyle yetersiz terapötik etkinliğe sahip bitkisel bileşiklerin tedaviye kazandırılması için yenilikçi formülasyon yaklaşımları uygulanmakta ve bitkisel bileşiklerin farmakokinetik özellikleri iyileştirilmeye çalışılmaktadır. İlaç taşıyıcı sistemler ile bitkisel bileşiklerin biyoyararlanımlarında belirgin artış gözlenmektedir. Bitkisel ürünler için yasal düzenlemeler ise ülkelere göre farklılık göstermektedir. Türkiye’de bitkisel ürünlerin üretimi ve pazara çıkışıyla ilgili düzenlemeler; Türkiye İlaç ve Tıbbi Cihaz Kurumu ile Gıda, Tarım ve Hayvancılık Bakanlığı mevzuatlarına göre farklı yürütülmektedir. Bu çalışmada, bitkisel bileşiklerin farmakokinetik ve biyoyararlanım özellikleri, bitkisel ürün formülasyonları ve bu ürünlerin ruhsatlandırma aşamaları değerlendirilmiştir.
Anahtar Kelime:

Pharmacokinetics-Bioavailability Assessments andRegistration Stages of Herbal Medicines: Traditional Review

Öz:
The use of herbal medicine and traditional herbal medicinal products produced from medicinal plants has been increasing day by day. Herbal medicines and traditional herbal medicinal products must ensure to the requirements of good agricultural practice published by the World Health Organization besides they have the quality, efficacy, and safety sought in conventional medicines and produced according to good manufacturing practice. Providing standardized use, proving their content and efficacy, determining their pharmacokinetic properties and bioavailability, revealing dose-response relationships, and determining their interactions with conventional drugs are important and necessary points for herbal medicine and traditional herbal medicinal products that are licensed considering the reliability of medicinal plants used in traditional treatment for many years. Some herbal compounds have poor bioavailability due to low solubility or permeability. For this purpose, innovative formulation approaches have also been applied to bring herbal compounds with insufficient therapeutic activity due to low bioavailability into treatment and the pharmacokinetic properties of herbal compounds have been tried to be improved. Significant enhancement in bioavailability of herbal compounds is observed with drug carrier systems. The legal regulations for herbal products differ in countries. Regulations regarding the production and marketing of herbal products in Turkey are carried out differently according to the regulations of the Turkish Medicines and Medical Devices Agency and the Ministry of Food, Agriculture and Livestock. In this study, pharmacokinetics and bioavailability properties of herbal compounds, herbal products formulations, and registration stages of these products have been evaluated.
Anahtar Kelime:

Belge Türü: Makale Makale Türü: Derleme Erişim Türü: Erişime Açık
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APA Timur B, Teksin Z (2022). Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme. , 61 - 76. 10.5336/pharmsci.2021-86561
Chicago Timur Burcu,Teksin Zeynep Şafak Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme. (2022): 61 - 76. 10.5336/pharmsci.2021-86561
MLA Timur Burcu,Teksin Zeynep Şafak Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme. , 2022, ss.61 - 76. 10.5336/pharmsci.2021-86561
AMA Timur B,Teksin Z Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme. . 2022; 61 - 76. 10.5336/pharmsci.2021-86561
Vancouver Timur B,Teksin Z Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme. . 2022; 61 - 76. 10.5336/pharmsci.2021-86561
IEEE Timur B,Teksin Z "Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme." , ss.61 - 76, 2022. 10.5336/pharmsci.2021-86561
ISNAD Timur, Burcu - Teksin, Zeynep Şafak. "Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme". (2022), 61-76. https://doi.org/10.5336/pharmsci.2021-86561
APA Timur B, Teksin Z (2022). Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme. Literatür Eczacılık Bilimleri Dergisi, 11(1), 61 - 76. 10.5336/pharmsci.2021-86561
Chicago Timur Burcu,Teksin Zeynep Şafak Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme. Literatür Eczacılık Bilimleri Dergisi 11, no.1 (2022): 61 - 76. 10.5336/pharmsci.2021-86561
MLA Timur Burcu,Teksin Zeynep Şafak Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme. Literatür Eczacılık Bilimleri Dergisi, vol.11, no.1, 2022, ss.61 - 76. 10.5336/pharmsci.2021-86561
AMA Timur B,Teksin Z Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme. Literatür Eczacılık Bilimleri Dergisi. 2022; 11(1): 61 - 76. 10.5336/pharmsci.2021-86561
Vancouver Timur B,Teksin Z Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme. Literatür Eczacılık Bilimleri Dergisi. 2022; 11(1): 61 - 76. 10.5336/pharmsci.2021-86561
IEEE Timur B,Teksin Z "Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme." Literatür Eczacılık Bilimleri Dergisi, 11, ss.61 - 76, 2022. 10.5336/pharmsci.2021-86561
ISNAD Timur, Burcu - Teksin, Zeynep Şafak. "Bitkisel İlaçların Farmakokinetik-Biyoyararlanım Değerlendirmeleri ve Ruhsat Aşamaları: Geleneksel Derleme". Literatür Eczacılık Bilimleri Dergisi 11/1 (2022), 61-76. https://doi.org/10.5336/pharmsci.2021-86561