year 20, Issue 77 (1-2021)
J. Med. Plants 2021, 20(77): 15-25 |
Back to browse issues page
Maedeh Rezghi1 
, Seyed Alireza Mortazavi2 , Shirin Fahimi3 , Rasool Choopani4 , Mohammad Abbas Sheikholeslami5 , Maryam Hamzeloo-Moghadam * 6
, Seyed Alireza Mortazavi2 , Shirin Fahimi3 , Rasool Choopani4 , Mohammad Abbas Sheikholeslami5 , Maryam Hamzeloo-Moghadam * 6
1- Student Research Committee, Shahid Beheshti University of Medical Sciences, Tehran, Iran
2- Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
3- Traditional Medicine and Materia Medica Research Center and Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
4- Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
5- Department of Pharmacology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
6- Traditional Medicine and Materia Medica Research Center and Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran , mhmoghadam@sbmu.ac.ir
2- Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
3- Traditional Medicine and Materia Medica Research Center and Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
4- Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
5- Department of Pharmacology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
6- Traditional Medicine and Materia Medica Research Center and Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran , mhmoghadam@sbmu.ac.ir
Abstract: (7884 Views)
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 “Monzej-e-balgham”, 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 capillus-veneris 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.
Keywords: Monzej-e-balgham, Quality control, Tablet, Total phenol content, Iranian traditional medicine
Type of Study: Research |
Subject:
Pharmacognosy & Pharmaceutics
Received: 2020/02/19 | Accepted: 2020/09/9 | Published: 2021/01/4
Received: 2020/02/19 | Accepted: 2020/09/9 | Published: 2021/01/4
References
1. Calixto J. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents). Braz. J. Med. Biol. Res. 2000; 33(2): 179-189. [DOI:10.1590/S0100-879X2000000200004]
2. Davoodi A, Jouybari HB, Fathi H and Ebrahimnejad P. Formulation and physicochemical evaluation of medlar (mespilus germanica l.) and oak (quercus castaneifolia ca mey.) effervescent tablets. Int. J. Pharm. Sci. Res. 2018; 9(9): 3870-3875.
3. Suma TS, Ravikumar K, Somashekhar BS, Ved DK, Zaman R, Rajalakshmi G, Nair SNV and Kukkupuni SK. Documentation of 'Plant Drugs' dispensed via local weekly shanties of Madurai City, India. J. Ayurveda Integr. Med. 2018; 9(2): 104-112. [DOI:10.1016/j.jaim.2017.05.008]
4. Zargaran A, Daneshamouz S, Kordafshari G and Mohagheghzadeh A. Renovation of a traditional Ergh-al-Nassa pill (Hab) to a standard Pharmaceutical molded tablet. Pak. J. Pharm. Sci. 2016; 29(5): 1703-1709.
5. Moein E, Hajimehdipoor H, Toliyat T, Choopani R and Hamzeloo-Moghadam M. Formulation of an aloe-based product according to Iranian traditional medicine and development of its analysis method. DARU J. Pharm. Sci. 2017; 25(1): 19-27. [DOI:10.1186/s40199-017-0185-x]
6. Fahimi S, Mortazavi SA, Abdollahi M and Hajimehdipoor H. Formulation of a traditionally used polyherbal product for burn healing and HPTLC fingerprinting of its phenolic contents. Iran. J. Pharm. Res. 2016; 15(1): 95-105.
7. Zargaran A, Zarshenas MM, Karimi A, Yarmohammadi H and Borhani-Haghighi A. Management of stroke as described by Ibn Sina (Avicenna) in the Canon of Medicine. Int. J. Cardiol. 2013; 169(4): 233-237. [DOI:10.1016/j.ijcard.2013.08.115]
8. Yarmohammadi H and Dalfardi B. Al-Akhawayni's views on stroke. Int. J. Cardiol. 2014; 172(3): 598. [DOI:10.1016/j.ijcard.2014.01.061]
9. Ahmed A, Ansari AN, Ali SJ and Yasir M. Efficacy of Munzij wa Mushil-e-Balgham (poly herbal formulations) and massage with Roghan-e-Malkangani in Falij Nisfi (Hemiplegia): a randomised controlled clinical trial. Int. J. Pharm. Sci. Res. 2015; 6(1): 453-458.
10. Upur H, Dubrovin D and Amat N. Letter to the Editor: Avicenna's view on the prevention of thrombosis. Int. J. Cardiol. 2013; 168(1): 577-578. [DOI:10.1016/j.ijcard.2013.01.279]
11. Dabbaghmanesh MH and Gordon Ferns MD D. Effects of body electroacupuncture on plasma leptin concentrations in obese and overweight people in Iran: a randomized controlled trial. Altern. Ther. Health Med. 2013; 19(2): 24.
12. Xilifu D, Nurmuhammat A and Halmurat U. Abnormal Balgham Munziq, a Uighur herbal medicine formula, has been recently shown to possess extensive cardiovascular pharmacological activities. Atherosclerosis 2016; 252: 87. [DOI:10.1016/j.atherosclerosis.2016.07.523]
13. Yuemaier M, Tuerhong M, Keremu A, Kadeer N, Aimaiti A, Wushouer X, Yiming A and Yilike X. Research on establishment of abnormal phlegmatic syndrome with premature ovarian failure rat model and effects of Balgham Munziq treatment. Evid. Based. Complement. Alternat. Med. 2018. Article ID 3858209. [DOI:10.1155/2018/3858209]
14. Adilijiang Y, Liu F, Maowulan M and Zhang P. The study of erectile changes of abnormal balgam syndrome with impotence rats model and the gonad axial mechanism. Transl. Androl. Urol. 2015; 4(1): 105.
15. Quddus A, Siddiqui M, Siddiqui M and Aleem S. Clinical evaluation of the efficacy of Qurs Sartan Kafoori and Sharbat Zoofa Murakkab in chronic bronchitis. Indian J. Tradit. Know. 2009; 8(3): 417-420.
16. Aibai S, Anzhaer A, Aimaiti A, Islam R, Aimaiti G and Abuduaini A. Association analysis of traditional Uighur medicine differential syndrome typing with biochemical parameters in serum and lesional tissue fluid of vitiligo patients. Eur. J. Integr. Med. 2015; 7(6): 653-656. [DOI:10.1016/j.eujim.2015.10.010]
17. Aimaiti N and Wufuer H. Effect of abnormal Balgham Munziq aqueous extracts and ethanol extracts on proliferation, tyrosinase activity and melanogenesis of B16 Murine Melanoma. Planta Med. 2011; 77(12): 77. [DOI:10.1055/s-0031-1282835]
18. Shah Arzani MA. Mizan Al-teb. 1st ed. Sama Cultural Institute. Qom. 2002, pp: 23-4.
19. Iranian Herbal Pharmacopoeia Committee. Iranian Herbal Pharmacopoeia. 1st ed. Ministry of Health and Medical Education of Iran, Food and Drug Administration. Tehran. 2002, pp: 200-5.
20. The British Pharmacopoeia Commission. British pharmacopoeia. Vol 4. The Stationary Office. London. 2011, pp: 189-95, 264-8.
21. Pharmacopoeia Commission for Indian. The Unani Pharmacopoeia of India. Department of AYUSH, Ministry of Health & Family Welfare, Govt. of India. New Delhi. 2016, pp: 11-2, 31-3, 96-7.
22. The US Pharmacopoeial Committees. United States Pharmacopoeia XXXVII, National Formulary XXXII. Vol 1. United States Pharmacopoeial Convention. Rockville (MD). 2014, pp: 341-56.
23. Aulton ME and Taylor KM. Aulton's pharmaceutics: the design and manufacture of medicines. 5th ed. Elsevier Health Sciences. London. 2017, pp: 346-52.
24. Allen L and Ansel HC. Ansel's pharmaceutical dosage forms and drug delivery systems. 9th ed. Lippincott Williams & Wilkins. Philadelphia. 2013, pp: 184-92.
25. Cerciello A, Auriemma G, Del Gaudio P, Cantarini M and Aquino RP. Natural polysaccharides platforms for oral controlled release of ketoprofen lysine salt. Drug Dev. Ind. Pharm. 2016; 42(12): 2063-2069. [DOI:10.1080/03639045.2016.1195401]
26. Osei-Yeboah F and Sun CC. Validation and applications of an expedited tablet friability method. Int. J. Pharm. 2015; 484(1-2): 146-155. doi: 10.1016/j.ijpharm.2015. 02.061. [DOI:10.1016/j.ijpharm.2015.02.061]
27. United States Pharmacopeia (USP). Pharmacopeial Convention, Inc., Rockville, MD, 2015.
28. ICH Expert Working Group. Stability testing of new drug substances and products. Q1A (R2). Current Step 4. ICH Harmonised Tripartite Guideline. London. 2003.
29. Shivakumar A, Paramashivaiah S, Anjaneya RS, Hussain J and Ramachandran S. Pharmacognostic evaluation of triphala herbs and establishment of chemical stability of Triphala caplets. Int. J. Pharm. Sci. Res. 2016; 7(1): 244-251.
30. Pani N, Nath L and Acharya S. Compatibility studies of nateglinide with excipients in immediate release tablets. Acta Pharm. 2011; 61(2): 237-247. [DOI:10.2478/v10007-011-0016-4]
31. World Health Organization. Quality control methods for herbal materials. WHO Press. Geneva. 2011, pp: 75-83.
| Rights and permissions | |
 |
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |