Formulation of a Traditional Polyherbal Product to a Standard Pharmaceutical Syrup and Development of Its Quality Control Methods

Document Type : Original paper

Authors

1 Student Research Committee, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Traditional Medicine and Materia Medica Research Center and Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

2 Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

3 Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

4 Traditional Medicine and Materia Medica Research Center and Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

5 Department of Pharmacology and Toxicology, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Abstract

Background and objectives: People interest in traditional medicine has increased recently; however, traditional herbal medicines should be transformed into modern forms of medicine to increase patient acceptance. In this investigation, a polyherbal traditional combination “Monzej-e-balgham” has been based on according to Iranian traditional medicine (ITM) manuscripts and its quality control evaluations have been performed. Methods: The main ingredients of the formulation including Vitis venifera L., Ficus carica L., Foeniculum vulgare Mill., Glycyrrhiza glabra L., Adiantum capillus-veneris L., Rosa damascena Herrm. and Onopordum acanthium L. were crushed, mixed and extracted with distilled water by decoction method. The mixture was used to prepare formulations of the syrup. Physicochemical, microbiological properties and rheological behavior of the syrup were studied and total phenolics content of the formulation was determined. The syrup was evaluated in accelerated stability test during 6 months. Results: The product was light brown semitransparent syrup with appropriate taste and odor. There was no cap locking and precipitation. Dry residue, sedimentation, pH, viscosity, density and total phenolics were found to be 14.82%, 0.015%, 5.40, 4.6 cP, 1.076 g/mL and 127.34 mg/100 mL, respectively. Microbial evaluations of syrupwere consistent with the WHO protocol. The rheogram of the product represented the Newtonian behavior. In the accelerated stability tests, no significant changes were observed. Total phenolics content reduced to 2.50% within 6 months in 40 ºC. Conclusion: The outcome of this research was a pharmaceutical standardized formulation from the traditional “Monzej-e-balgham” which supports the idea of drug discovery based on traditional knowledge.

Keywords

Main Subjects


[1] Zargaran A, Daneshamouz S, Kordafshari G, 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.
[2] Hamzeloo-Moghadam M, Danaifar N, Mostafavi S, Hajimehdipoor H. Formulation and quality control of Prunus domestica syrup, prepared according to Iranian Traditional Medicine. Res J Pharmacogn. 2015; 2(2): 13-17.
[3] Moein E, Hajimehdipoor H, Toliyat T, Choopani R, 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.
[4] Zargaran A, Zarshenas MM, Karimi A, Yarmohammadi H, 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.
[5] Yarmohammadi H, Dalfardi B. Al-Akhawayni's views on stroke. Int J Cardiol. 2014; 172(3): 598.
[6] Ahmed A, Ansari AN, Ali SJ, 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.
[7] Upur H, Dubrovin D, Amat N. Avicenna's view on the prevention of thrombosis. Int J Cardiol. 2013; 168(1): 577-578.
[8] Dabbaghmanesh MH, Ferns G. 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): 24-31.
[9] Xilifu D, Nurmuhammat A, Halmurat U. Abnormal Balgham Munziq, a Uighur herbal medicine formula, has been recently shown to possess extensive cardiovascular pharmacological activities. Atherosclerosis. 2016; 252: 87.
[10] Aibai S, Anzhaer A, Aimaiti A, Islam R, Aimaiti G, 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.
[11] Aimaiti N, 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.
[12] Yiming A, Pan JC, Wufuer H, Ji ZH, Mutalifu Z. The changes of spermatogenic function in rat model with abnormal balgam syndrome and impotence disease of Uygur medicine. J Xinjiang Med Univ. 2012; 11: 5.
[13] Yiming A, Pan JC, Wufuer H, Ji ZH, Aihaiti N. Biological significances and change of reproductive hormones in rat model with abnormal balgam syndrome and impotence disease of Uygur medicine. J Xinjiang Med Univ. 2012; 11: 3.
[14] Adilijiang Y, Liu F, Maowulan M, 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] Firdose KF, Shameem I. An approach to the management of poly cystic ovarian disease in Unani system of medicine: a review. Int J Appl Res. 2016; 2(6): 585-590.
[16] Yuemaier M, Tuerhong M, Keremu A, Kadeer N, Aimaiti A, Wushouer X, Yiming A, 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.
[17] Salim S, Kalam MA, Yusuf A, Khanday S, Shafi S, Mohammad I. Asl-us-Sus (Glycyrrhiza glabra L.), a great munzij-i-balgham (concotive of phlegm) drug of Unani system of medicine: a review. Int J Unani Integ Med. 2018; 2(3): 16-19.
[18] Aibai S, Wufuer T, Abuduaini A. Syndrome differentiation of vitiligo and its munzich and mushil therapy based on traditional Uighur medicine theory. Int J Complement Alt Med. 2018; 11(4): 210-215.
[19] Shah Arzani MA. Mizan al-teb. 1st ed. Qom: Sama Cultural Institute, 2002.
[20] Rasheed A, Roja C, Reddy GAK, Reddy BS. Formulation, standardization and pharmacological evaluation of a poly herbal traditional remedy-Ashwagandharishtam. Orient Pharm Exp Med. 2012; 12(1): 51-58.
[21] The British Pharmacopoeia Commission. British pharmacopoeia. London: The Stationary Office, 2011.
[22] Iranian Herbal Pharmacopoeia Committee. Iranian Herbal Pharmacopoeia. 1st ed. Tehran: Ministry of Health and Medical Education of Iran, Food and Drug Administration, 2002.
[23] Pharmacopoeia Commission for Indian. The Unani Pharmacopoeia of India. New Delhi: Department of AYUSH, Ministry of Health & Family Welfare, Govt. of India, 2016.
[24] World Health Organization. Quality control methods for herbal materials. Geneva: WHO Press, 2011.
[25] ICH Expert Working Group. Stability testing of new drug substances and products. Q1A (R2), Current Step 4. London: ICH Harmonized Tripartite Guideline, 2003.
[26] 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.
[27] Shivakumar A, Paramashivaiah S, Anjaneya RS, Hussain J, 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.
[28] Allen L, Ansel HC. Ansel's pharmaceutical dosage forms and drug delivery systems. 10th ed. Philadelphia: Lippincott Williams & Wilkins, 2013.