پديد آورندگان :
Rezghi ، Maedeh Shahid Beheshti University of Medical Sciences - Student Research Committee,Traditional Medicine and Materia Medica Research Center,School of Traditional Medicine - Department of Traditional Pharmacy , Mortazavi ، Alireza Shahid Beheshti University of Medical Sciences - School of Pharmacy - Department of Pharmaceutics , Fahimi ، Shirin Shahid Beheshti University of Medical Sciences - Traditional Medicine and Materia Medica Research Center, School of Traditional Medicine - Department of Traditional Pharmacy , Choopani ، Rasool Shahid Beheshti University of Medical Sciences - School of Traditional Medicine - Department of Traditional Medicine , Sheikholeslam ، Abbas Shahid Beheshti University of Medical Sciences - School of Medicine - Department of Pharmacology , Hamzeloo-Moghadam ، Maryam Shahid Beheshti University of Medical Sciences - Traditional Medicine and Materia Medica Research Center , School of Traditional Medicine - Department of Traditional Pharmacy
كليدواژه :
Monzej , e , balgham , Quality control , Tablet , Total phenol content , Iranian traditional medicine
چكيده فارسي :
Background: Medicinal plants have important role for prevention and treatment of diseases regarding their traditional uses. In Iranian traditional medicine (ITM), herbal medicines have been considered as the key agents in the treatment of wide ranges of disorders. Traditional preparations can be reformulated to achieve pharmacopoeia standards as modern medicines. Objective: In this research, a polyherbal tablet namely ldquo;Monzejebalgham rdquo;, which is widely used for treating different diseases, has been formulated and quality control assessments have been done to present a proper formulation. Methods: Glycyrrhiza glabra L., Rosa x damascena Herrm., Adiantum capillusveneris L., Onopordum acanthium L., Vitis vinifera L., Ficus carica L. and Foeniculum vulgare Mill. were extracted with water, filtered, concentrated and dried with spray drying method. Thirteen tablets formulations by direct compression and pre and post formulation analyses were prepared. Finally, the most proper formulation was selected and evaluated physicochemically and microbiologically according to standard protocols. The total phenol content as marker of the tablets was determined and accelerated stability tests were conducted (40 °C/75 % RH) as per ICH guidelines for six months. Results: For the selected formulation (F2), the hardness, weight variation, friability, disintegration time and drug release were determined as 6.78 ± 0.28 kg/cm2, 714.36 ± 1.71 mg, 0.79 ± 0.05 %, 10.18 ± 0.39 min and 97.67 ± 0.16% in one hour, respectively. The amount of total phenol was found to be 25.15 ± 0.13 mg/tablet. Microbial levels were in agreement with requirements. In the accelerated stability tests, no significant changes were observed. Total phenol content decreased 1.03 % during 6 months. Conclusion: After completing complementary tests such as in vivo and clinical trials, the formulated tablet (F2) could be presented for mass production.
