Kurkumin içeren oral farmasötik dozaj formunun geliştirilmesi ve kalite kontrol parametrelerinin uygulanması
Küçük Resim Yok
Tarih
2023
Yazarlar
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Ege Üniversitesi
Erişim Hakkı
info:eu-repo/semantics/openAccess
Özet
Halk arasında 'Zerdeçal' olarak bilinen Curcuma longa L.(Zerdeçal) rizomlarından elde edilen Kurkuminin ana vatanı Güney Asya'dır ve Ayurveda tıbbında da yaygın olarak kullanılır. Ayrıca Antik çağlardan beri kullanılan Zingiberaceae familyasının önemli bir üyesidir. Gıda endüstrisinde yaygın olarak baharat olarak kullanılmasının yanı sıra, son zamanlarda ilaç endüstrisinde yapılan çalışmalar sonucunda kurkuminin antioksidan ve antibakteriyel aktiviteler, antiinflamatuar etkiler ve kanser hücrelerinin proliferasyonunu yüksek oranda inhibe etme yeteneği dahil olmak üzere antioksidan etkilere dayalı çeşitli sağlıklı fizyolojik aktivitelere sahip olduğunu gösterilmiştir ve tıbbi kullanımı da etkilerinin anlaşılmasıyla popülerlik kazanmıştır. Piyasada halihazırda mevcut birçok Kurkumin içeren gıda takviyesi ürünü farklı formlarda bulunmaktadır. Ancak takviye edici gıda kategorisinde var olan bu ürünler genelde Tarım ve Orman Bakanlığı tarafından onaylanmakta ve ilaç gibi geleneksel Bitkisel Tıbbi Ürünlerde olduğu gibi geliştirilmesinde ve ruhsat alınmasında kalite kontrol testleri yapılmamaktadır. Bu kalite kontrol parametrelerinden en önemlisi etken maddenin miktar tayinidir. Genellikle takviye edici gıdalarda etken madde içeren hammadde tedarik edilirken talep edilen analiz sertifikasında belirtilen etken madde potensi doğru kabul edilerek ürün geliştirilir. Bu esnada tedarikçilerden elde edilen analiz sertifikaları her zaman tam ve gerçek değeri içeremeyebilmektedir. Bu çalışmanın amacı kurkumin içeren sert kapsül dozaj formülasyonu geliştirerek; akışkanlık, sıkıştırılmış (Tapped) dansite, homojenizasyon ve Dağılma çalışmaları (Disentegrasyon) yapmak, yüksek performanslı sıvı kromatografisi (HPLC) kullanılarak etken madde miktar tayini yöntemi geliştirmek, formülasyonun fizikokimyasal özelliklerini incelemek ve formülasyonun içerik miktarı HPLC ile geliştirilen yöntem ile tayin etmektir.
Curcumin, which is obtained from the rhizomes of "Curcuma longa L." (Turmeric), popularly known as 'Turmeric', is the homeland of South Asia and is widely used in Ayurveda medicine. It is also an important member of the Zingiberaceae family, which has been used since ancient times. In addition to being widely used as a spice in the food industry, recent studies in the pharmaceutical industry have shown that curcumin has various healthy physiological activities based on antioxidant effects, including antioxidant and antibacterial activities, anti-inflammatory effects, and the ability to highly inhibit the proliferation of cancer cells. Curcumin has gained popularity with the understanding of its medicinal uses. Many dietary supplements containing curcumin are currently available in various forms on the market. However, these products, which are in the food supplement category, are generally approved by the Ministry of Agriculture and Forestry, and quality control tests are not carried out in the development and obtaining license, as in traditional Herbal Medicinal Products such as medicines. The most important of these quality control parameters is the quantification of the active substance. When procuring raw materials containing active substances in food supplements, the product is developed by accepting the active substance potency specified in the requested analysis certificate as correct. Meanwhile, the analysis certificates obtained from the suppliers may not always contain the full and real value. The objective of this research is to create a hard capsule dosage form that contains curcumin and perform various tests to evaluate its quality. The tests include determining the flowability, tapped density, homogenization, and dispersion properties of the capsule. Additionally, an HPLC method will be developed to measure the active ingredient concentration, and the physicochemical properties of the formulation will be examined in order to determine the content of the formulation. Overall, this study aims to develop a high-quality and effective curcumin-containing capsule that can be reliably produced and used for a variety of health purposes.
Curcumin, which is obtained from the rhizomes of "Curcuma longa L." (Turmeric), popularly known as 'Turmeric', is the homeland of South Asia and is widely used in Ayurveda medicine. It is also an important member of the Zingiberaceae family, which has been used since ancient times. In addition to being widely used as a spice in the food industry, recent studies in the pharmaceutical industry have shown that curcumin has various healthy physiological activities based on antioxidant effects, including antioxidant and antibacterial activities, anti-inflammatory effects, and the ability to highly inhibit the proliferation of cancer cells. Curcumin has gained popularity with the understanding of its medicinal uses. Many dietary supplements containing curcumin are currently available in various forms on the market. However, these products, which are in the food supplement category, are generally approved by the Ministry of Agriculture and Forestry, and quality control tests are not carried out in the development and obtaining license, as in traditional Herbal Medicinal Products such as medicines. The most important of these quality control parameters is the quantification of the active substance. When procuring raw materials containing active substances in food supplements, the product is developed by accepting the active substance potency specified in the requested analysis certificate as correct. Meanwhile, the analysis certificates obtained from the suppliers may not always contain the full and real value. The objective of this research is to create a hard capsule dosage form that contains curcumin and perform various tests to evaluate its quality. The tests include determining the flowability, tapped density, homogenization, and dispersion properties of the capsule. Additionally, an HPLC method will be developed to measure the active ingredient concentration, and the physicochemical properties of the formulation will be examined in order to determine the content of the formulation. Overall, this study aims to develop a high-quality and effective curcumin-containing capsule that can be reliably produced and used for a variety of health purposes.
Açıklama
Anahtar Kelimeler
Eczacılık ve Farmakoloji, Pharmacy and Pharmacology
