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polyherbal tablet based on iranian traditional medicine
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نویسنده
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rezghi maedeh ,mortazavi alireza ,fahimi shirin ,choopani rasool ,sheikholeslam abbas ,hamzeloo-moghadam maryam
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منبع
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journal of medicinal plants - 2021 - دوره : 20 - شماره : 77 - صفحه:15 -25
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چکیده
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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.
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کلیدواژه
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monzej-e-balgham ,quality control ,tablet ,total phenol content ,iranian traditional medicine
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آدرس
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shahid beheshti university of medical sciences, student research committee,traditional medicine and materia medica research center,school of traditional medicine, department of traditional pharmacy, iran, shahid beheshti university of medical sciences, school of pharmacy, department of pharmaceutics, iran, shahid beheshti university of medical sciences, traditional medicine and materia medica research center, school of traditional medicine, department of traditional pharmacy, iran, shahid beheshti university of medical sciences, school of traditional medicine, department of traditional medicine, iran, shahid beheshti university of medical sciences, school of medicine, department of pharmacology, iran, shahid beheshti university of medical sciences, traditional medicine and materia medica research center , school of traditional medicine, department of traditional pharmacy, iran
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پست الکترونیکی
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mhmoghadam@sbmu.ac.ir
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Polyherbal tablet based on Iranian traditional medicine
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Authors
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Rezghi Maedeh ,Mortazavi Seyed Alireza ,Fahimi Shirin ,Choopani Rasool ,Sheikholeslam Abbas ,Hamzeloo-Moghadam Maryam
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Abstract
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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.
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Keywords
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Monzej-e-balgham ,Quality control ,Tablet ,Total phenol content ,Iranian traditional medicine
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