FORMULATION AND EVALUATION OF TOPICAL ANTI-INFLAMMATORY HERBAL GEL
Objective: The present investigation aims at development and evaluation of herbal anti-inflammatory gel using of methanolic extract from Emblica officinalis fruits (MEEOF) and Aegle marmelos fruits (MEAMF).
Methods: The gels were prepared using Carbopol 934, various concentrations of MEEOF, MEAMF, propylene glycol 400, methylparaben, propylparaben, and required amount of distilled water. Then, skin pH (6.8-7) was maintained by dropwise addition of triethanolamine. Prepared formulations were evaluated for physical appearance, pH, spreadability, viscosity and homogeneity, skin irritation on animal model (rabbit), and anti-inflammatory activity using carrageenan-induced rat paw edema model on albino Wistar rats of either sex (150–200 g). Change in edema volume of the rat hind paw was measured, and percent inhibition was calculated. ICH guidelines have followed for stability studies.
Results: Results reveal that gel showed good appearance, homogeneity, and spreadability. Viscosity is ranging between 4200 and 4500 centipoises. All formulations have shown no skin irritation to animals. Formulations F4 and F5 significantly inhibited the inflammation to the extent of 56.66%, 61.66% at 3 h and 59.21%, 63.15% at 4 h, respectively, while the reference drug reduced the inflammation by 66.66% at 3 h and 76.31% at 4 h. The preparation was stable under normal storage conditions and did not produce any skin irritation, i.e., erythema and edema when applied over the skin on storage.
Conclusion: It was concluded that anti-inflammatory effect of F4 and F5 was comparable to standard.
2. Lambole VB, Murti K, Kumar U, Sandipkumar BP, Gajera V. Phytopharmacological properties of Aegle marmelos as a potential medicinal tree: An overview. Int J Pharm Sci Rev Res 2010;5:67-72.
3. Ghasemian M, Owlia MB. A different look at pulsed glucocorticoid protocols; is high dose oral prednisolone really necessary just after initiation of pulse therapy? J Case Rep Pract 1994;3:1-3.
4. Sharma PC, Bhatia V. A review on bael tree. Nat Prod Rad 2007;6:171-8.
5. Dhankhar S, Ruhil S, Balhara M, Dhankhar S, Chhillar AK. Aegle marmelos correa: A potential source of phytomedicine. J Med Plants Res 2011;5:1497-507.
6. Arul V, Miyazaki S, Dhananjayan R. Studies on the anti-inflammatory, antipyretic and analgesic properties of the leaves of Aegle marmelos corr. J Ethnopharmacol 2005;96:159-63.
7. Takase H, Yamamoto K, Hirano H, Saito Y, Yamashita A. Pharmacological profile of gastric mucosal protection by marmin and nobiletin from a traditional herbal medicine, aurantii fructus immaturus. Jpn J Pharmacol 1994;66:139-47.
8. Mazumder R, Bhattacharya S, Mazumder A, Pattnaik AK, Tiwary PM, Chaudhary S. Antidiarrhoeal evaluation of Aegle marmelos (Correa) linn. Root extract. Phytother Res 2006;20:82-4.
9. Gurulningappa S, Hallur MS. Anti-inflammatory assays of extracts of medicinal plants. Indian J Pharm Sci 2002;64:498-500.
10. Benni JM, Jayanthi MK, Suresha RN. Evaluation of the anti- inflammatory activity of Aegle marmelos (Bilwa) root. Indian J Pharmacol 2011;43:393-7.
11. Nadkarni KM, editor. Indian Meteria Medica. Bombay, India: The Karnataka Printing Press and the Popular Press Ltd.; 1976. p. 480-4.
12. Kirtikar KR, Basu BD. Indian Medicinal Plants. Allahabad: Basu Ltd.; 1935. p. 488.
13. Rehman H, Yasin KA, Choudhary MA, Khaliq N, Rahman A, Choudhary MI, et al. Studies on the chemical constituents of Phyllanthus emblica. Nat Prod Res 2007;21:775-81.
14. Charaka SC. Kavyamala Series of Books. Bombay, India: Nirnaya Sagar Press; 1941. p. 114-5.
15. Liu X, Cui C, Zhao M, Wang J, Luo W, Yang B, et al. Identification of phenolics in the fruit of emblica (Phyllanthus emblica L.) and their antioxidant activities. Food Chem 2008;109:909-15.
16. Thilakchand KR, Mathai RT, Simon P, Ravi RT, Baliga-Rao MP, Baliga MS. Hepatoprotective properties of the Indian gooseberry (Emblica officinalis gaertn): A review. Food Funct 2013;4:1431-41.
17. Baliga MS, Dsouza JJ. Amla (Emblica officinalis gaertn), a wonder berry in the treatment and prevention of cancer. Eur J Cancer Prev 2011;20:225-39.
18. Baliga MS, Meera S, Mathai B, Rai MP, Pawar V, Palatty PL. Scientific validation of the ethnomedicinal properties of the ayurvedic drug triphala: A review. Chin J Integr Med 2012;18:946-54.
19. Kumar A, Singh A, Dora J. Essential perspectives for Emblica offcinalis. Int J Pharma Chem Sci 2012;1:11-8.
20. Khan KH. Roles of Emblica officinalis in medicine – A review. Bot Res Int 2009;2:218-28.
21. Zhang LZ, Zhao WH, Guo YJ, Tu GZ, Lin S, Xin LG. Studies on chemical constituents in fruits of tibetan medicine Phyllanthus emblica. Zhongguo Zhong Yao Za Zhi 2003;28:940-3.
22. Rehman H, Yasin KA, Choudhary MA, Khaliq N, Rahman A, Choudhary MI, et al. Studies on the chemical constituents of Phyllanthus emblica. Nat Prod Res 2007;21:775-81.
23. El-Desouky SK, Ryu SY, Kim YK. A new cytotoxic acylated apigenin glucoside from phyllanthus emblica L. Nat Prod Res 2008;22:91-5.
24. Sudipta D, Haldar PK, Pramanik G. Formulation and evaluation of herbal gel containing Clerodendrum infortunatum leaves extract. Int J Pharmtech Res 2011;3:140-3.
25. Wood JH, Catacalos G, Liberman SV. Adaptation of commercial viscometers for special applications in pharmaceutical rheology – Severs extrusion rheometer. J Pharm Sci 1963;52:375-8.
26. Goyal S, Sharma P, Ramchandani V, Shrivastava SK, Dubey PK. Novel anti-inflammatory topical herbal gels containing Withania somnifera and Boswellia serrata. Int J Pharm Biol Sci Arch 2011;2:1087-94.
27. Mishra US, Murthey PN, Mishra D, Sahu K. Formulation and standerdisation of herbal gel containing methanolic extract of Calophyllum inophyllum. Am J Pharmtech Res 2011;1:276-89.
28. Jyothi D, Koland M, Priya S. Investigation of anti-inflammatory activity of ointments containing fenugreek extract. Asian J Pharm Clin Res 2014;7:66-9.
29. Dixit G, Misal G, Gulkari V, Upadhye K. Formulation and evaluation of polyherbal gel for anti-inflammatory activity. Int J Pharm Sci Res 2013;4:1186-91.
30. ICH Guidelines. Stability Testing of New Drug Substances and Products; 27 October, 1993.
31. Singh M, Mittal V. Formulation and evaluation of herbal gel containing ethanolic extract of ipomoea fistulosa. Int J Sci Res 2014;3:25-9.
32. Misal G, Dixit G, Gilkari V. Formulation and evaluation of herbal gel. Indian J Nat Prod Res 2012;3:501-5.
33. Bhalke RD, Pal SC. Anti-inflammatory and antinociceptive activity of Pterospermum acerifolium leaves. Asian J Pharm Clin Res 2012;5:23 6.
34. Helal DA, El-Rhman DA, Abdel-Halim SA, El-Nabarawi MA. Formulation and evaluation of fluconazole topical gel. Int J Pharm Pharm Sci 2012;4:176-83.
35. Jyothi D, Koland M. Formulation and evaluation of an herbal anti-inflammatory gel containing Trigonella foenum greacum seed extract. Int J Pharm Pharm Sci 2016;8:41-4.
36. Patkar AN, Desai NV, Ranage AA, Kalekar KS. A review on Agel marmelos: A potential medicinal tree. Int Res J Pharm 2012;3:86-91.
37. González-Ponce HA, Rincón-Sánchez AR, Jaramillo-Juárez F, Moshage H. Natural dietary pigments: Potential mediators against hepatic damage induced by over-the-counter non-steroidal anti-inflammatory and analgesic drugs. Nutrients 2018;10. pii: E117.
38. de Queiroz AC, de Lira DP, Dias Tde L, de Souza ET, da Matta CB, de Aquino AB, et al. The antinociceptive and anti-inflammatory activities of Piptadenia stipulacea benth. (Fabaceae). J Ethnopharmacol 2010;128:377-83.
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