Formulation and Finger Printing of a Poly Herbal Film-Coated Tablet for Treatment of Hemorrhoids

Document Type : Original paper

Authors

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

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

3 Department of Pharmaceutics, School of Pharmacy, 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.

Abstract

Background and objectives: Hemorrhoids is the most prevalent rectal disease. Despite different medical efforts, its complications are not managed well. In the present research, a popular prescription for treatment of hemorrhoids was formulated as tablet dosage form and, its HPTLC fingerprint prepared. Methods: Commiphora mukul was dissolved in Allium ampeloprasum juice (1:3). Then, this solution was blended with Terminalia chebula, Phyllantus emblica and Terminalia bellirica (1:1:1) powder. Different formulations were prepared from the mixture and the best one was selected for tablet preparation. Subsequently, the tablets were coated and their physicochemical characteristics and fingerprint pattern were obtained using silica gel plate, NP/PEG reagent and toluene: ethyl acetate: formic acid (70:15:15) as mobile phase. Laboratory stability studies were carried out as well. Results: Formulation C revealed excellent results in flowability studies (angle of repose: 26, carr’s index: 6, hausner ratio: 1.00). It was also demonstrated acceptable results in different tests including weight variation (500 mg), hardness (8.04 kg/cm2), disintegration time (28.50 min), friability (0.6%), dissolution (97.6% phenolics and 96.1% tannins, respectively) and the coating process. Total phenolics and tannins contents were determined as 125.8 mg/tab and 89.2 mg/tab, respectively. In fingerprinting study, characteristic spots of each species were distinguished. The film-coated tablets were stable in laboratory stability test. Conclusion: With reference to anti-inflammatory, astringent and wound healing roles of phenolics and tannins in hemorrhoids, the present tablets could be an appropriate candidate for hemorrhoids regarding its historical backgrounds.

Keywords

Main Subjects

References

[1] Moult HP, Aubert M, Parades VD. Classical treatment of hemorrhoids. J Visc Surg. 2014; 7(2): 1-7.
[2] Lohsiriwat V. Approach to hemorrhoids. Curr Gastroenterol Rep. 2013; 15(3): 13-16.
[3] Abramowitz L, Godeberge P, Staumont G, Soudan D. Clinical practice guidelines for the treatment of hemorrhoid diseases. Gastroen Clin Biol. 2001; 25(6-7): 674-702.
[4] Lohsiriwat V. Hemorrhoids: from basic pathophysiology to clinical management. World J Gastroenterol. 2012; 18(17): 2009-2017.
[5] Riss S, Weiser FA, Schwameis K, Riss T, Mittlböck M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012; 27(2): 215-220.
[6] Jeffrey L, Barnett MD, Peter C, Gary R, Lichtenstein H. Technical review on the diagnosis and treatment of hemorrhoids. Gastroenterology. 2004; 5085(04): 1463-1473.
[7] Lohsiriwat V. Treatment of hemorrhoids : a coloproctologist’s view. World J gastroenterol. 2015; 21(31): 9245-9252.
[8] Rahimi R, Abdollahi M. Evidence-based review of medicinal plants used for the treatment of hemorrhoids. Int J Pharmacol. 2013; 9(1): 1-11.
[9] van Andel T, Carvalheiro LG. Why urban citizens in developing countries use traditional medicines: the case of suriname. Evid Based Complement Altern Med.  2013; Article ID 687197.
[10] Zargaran A, Mehdizadeh A. Avicenna (980–1037 AD). J Neurol. 2012; 259(2): 389-390.
[11] Zarshenas MM, Mehdizadeh A, Zargaran A, Mohagheghzadeh A. Rhazes (865-925 AD). J Neurol. 2012; 259(5): 1001-1002.
[12] Nazem Jahan MA. Qarabadin-e Azam. Tehran: Iran University of Medical Sciences, 2004.
[13] Shafaee Esfehani MM. Qarabadin-e Shafaie. Tehran: Iran University of Medical Sciences, Research Institute for Islamic and Complementary Medicine, 2004.
[14] Aghili Khorasani MH. Qarabadin-e kabir. Tehran: Ostad Allah Qoli Khan Qajar publisher, 1855.
[15] Bag A, Kumar Bhattacharyya S, Kumar Pal N, Ranjan Chattopadhyay R. Anti-inflammatory, anti-lipid peroxidative, antioxidant and membrane stabilizing activities of hydroalcoholic extract of Terminalia chebula fruits. Pharm Biol. 2013; 51(12): 1515-1520.
[16] Evangeline S, Sundaram V, Manian RP, Kulanthaivelu K, Balasundaram S. Antioxidant, antibacterial and anti-inflammatory activity of Acalypha indica and Terminalia chebula: an in-vitro analysis. Res J Pharm Biol Chem Sci. 2015; 6(3): 388-396.
[17] Jami SI, Sultana Z, Ali E, Begum MM, Haque M. Evaluation of analgesic and anti-inflammatory activities on ethanolic extract of Terminalia chebula fruits in experimental animal models. Am J Plant Sci. 2014; 5(1): 63-69.
[18] Reddy TC, Aparoy P, Babu NK, Kumar KA, Kalangi SK. Kinetics and docking studies of a COX-2 inhibitor isolated from Terminalia bellerica fruits. Protein Peptide Lett. 2010; 17(10): 1251-1257.
[19] Ihantola-Vormisto A, Summanen J, Kankaanranta H, Vuorela H, Asmawi ZM, Moilanen E. Anti-inflammatory activity of extracts from leaves of Phyllanthus emblica. Planta Med. 1997; 63(6): 518-524.
[20] Francis JA, Raja SN, Nair MG. Bioactive terpenoids and guggulusteroids from Commiphora mukul gum resin of potential anti-inflammatory interest. Chem Biodivers. 2004; 1(11): 1842-1853.
[21] Adao CR, Da Silva BP, Parente JP. A new steroidal saponin with antiinflammatory and antiulcerogenic properties from the bulbs of Allium ampeloprasum var. porrum Fitoterapia. 2011; 82(8): 1175-1180.
[22] Kumar CU. Evaluation of the analgesic activity of standardized aqueous extract of Terminalia chebula in healthy humaan participants using hot air pain model. J Clin Diagn Res. 2015; 9(5): 1-4.
[23] Jong BS, Jae YJ, Jae YP, Eun MJ, Sang IL, Sung SC, Do YP, Eun WC, Dong SS, Jong SL, Tae GLee. Anti-arthritic and analgesic effect of NDI10218, a standardized extract of Terminalia chebula, on arthritis and pain model. Biomol Ther. 2012; 20(1): 104-112.
[24] Sireeratawong S, Jaijoy K, Khonsung P, Soonthornchareonnon N. Analgesic and anti-inflammatory activities of the water extract from Terminalia chebula Rezt. Afr J Trad Complement Altern Med. 2015; 11(6): 77-82.
[25] Khan AU, Gilani AH. Antisecretory and analgesic activities of Terminalia bellerica. Afr J Biotechnol. 2010; 9(18): 2717-2719.
[26] Suguna L, Singh S, Sivakumar P, Sampath P, Chandrakasan G. Influence of Terminalia chebula on dermal wound healing in rats. Phytother Res. 2002; 16(3): 227-231.
[27] Chularojmontri L, Suwatronnakorn M, Wattanapitayakul SK. Phyllanthus emblica L. enhances human umbilical vein endothelial wound healing and sprouting. Evid Based Complement Altern Med. 2013; Article ID 720728 .
[28] Mosavat SH, Ghahramani L, Sobhani Z, Haghighi ER, Heydari M. Topical Allium ampeloprasum subsp iranicum (leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial. J Evid Based Complement Altern Med. 2015; 20(2): 132-136.
[29] Altomare DF, Giannini I. Pharmacological treatment of hemorrhoids : a narrative review. Expert Opin Pharmacother. 2013; 14(17): 1-7.
[30] Editorial Board. British Pharmacopoeia. London: The Stationary Office, 2015.
[31] Editorial Board. United States Pharmacopeia 39, National Formulary 34. Rockville: USP Convention, 2016.
[32] Ibn Sina HAA. Al Qanun Fi al-Tibb (Canon of medicine). Beirut: Alamy Le- Al-Matbooat Institute, 2005.
[33] Rhazes. Al Havi (Liber Continent). Tehran: Academy of Medical Sciences, 2005.
[34] Patel S, Jayvadan K, Patel RK. To study proximate analysis & biological evaluation of Triphala guggulu formulation. Int J PharmTech Res. 2012; 4(4): 1520-1526.
[35] Savarikar SS, Barbhind MM, Halde UK, Kulkarni AP. Pharmaceutical and analytical evaluation of triphalaguggulkalpa tablets. J Ayurveda Integr Med. 2011; 2(1): 21-25.
[36] Kulkarni A, Chimangude P, Wagh V, Kolatkar A. Formulation and evaluation of triphalaguggulkalpa tablets for optimum disintegration time. Int J Pharm Sci Rev Res. 2015; 34(1): 270-275.
[37] Yousefi M, Mahdavi MRV, Hosseini SM, Bahrami A, Davati A, Kamalinejad M, Faghihzadeh S. Clinical evaluation of Commiphora mukul, a botanical resin, in the management of hemorrhoids: a randomized controlled trial. Pharmacogn Mag. 2013; 9(36): 350-356.
[38] Dehdari S, Hajimehdipoor H, Esmaeili S, Choopani R. Scientific Evaluation of the prescribed herbs by Avicenna for the management of post hemorrhoidectomy complications. Galen Med J. 2017; 6(3): 166-184.
[39] Zhong X, Shi Y, Chen J, Xu J, Wang L, Beier RC, Hou X, Liu F. Polyphenol extracts from Punica granatum and Terminalia chebula are anti-inflammatory and increase the survival rate of chickens challenged with Escherichia coli. Biol Pharm Bull. 2014; 37(10): 1575-1582.
[40] Lee HH, Paudel KR, Kim DW. Terminalia chebula fructus inhibits migration and proliferation of vascular smooth muscle cells and production of inflammatory mediators in RAW 264.7. Evid Based Complement Altern Med. 2015; Article ID 502182.
[41] Bandyopadhyay SK, Chatterjee A, Chattopadhyay S. Biphasic effect of Phyllanthus emblica L. extract on NSAID-induced ulcer: an antioxidative trail weaved with immunomodulatory effect. Evid Based Complement Altern Med. 2011; Article ID 146808.
[42] Hossen SMM, Sarkar R, Mahmud S, Aziz NMA. Medicinal potential of Phyllanthus emblica (Linn.) fruits extracts: biological and pharmacological activities. J Pharm Res Int. 2014; 4(12): 1486-1499.
[43] Nampoothiri SV, Prathapan A, Cherian OL, Raghu KG, Venugopalan VV, Sundaresan A.
 In vitro antioxidant and inhibitory potential of Terminalia bellerica and Emblica officinalis fruits against LDL oxidation and key enzymes linked to type 2 diabetes. Food Chem Toxicol. 2011; 49(1): 125-131.
[44] Li K, Diao Y, Zhang H, Wang S, Zhang Z, Yu B, Huang S, Yang H. Tannin extracts from immature fruits of Terminalia chebula Fructus Retz. promote cutaneous wound healing in rats. BMC complement Altern Med. 2011; 11(1): 86-90.
[45] Palit M, Hegde SK, Bhat SS. Effectiveness of mouthrinse formulated from aqueous extract of Terminalia chebula on salivary Streptococcus mutans count and pH among 8- to 12-year-old school children of karnataka : a randomized clinical trial. Int J Clin Pediatr Dent. 2016; 9(4): 349-354.
[46] Andarkhor P, Sadeghi A, Khodadoost M, Kamalinejad M, Gachkar L, Abdi S,  Zargaran A. Effects of Terminalia chebula Retz. in treatment of hemorrhoids: a double – blind randomized placebo – controlled clinical trial. Eur J Integr Med. 2019; 30: 100935.
[47] Andarkhor P, Khodadoost M, Kamalinejad M, Talaie R, Gachkar L, Zargaran A. Twelve vegetables used for prevention and treatment of hemorrhoids in Persian Medicine. J Tradit Chin Med. 2019; 39(4): 466-473.
 
Research Journal of Pharmacognosy
Volume 7, Issue 4
October 2020
Pages 39-47

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