SUB-ACUTE TOXICITY STUDY OF DIABECINE RECONSTITUTE IN SPRAGUE-DAWLEY RATS: A PRELIMINARY STUDY IN THE EVALUATION AS AN ANTIHYPERGLYCEMIA AGENT
DOI:
https://doi.org/10.11113/jurnalteknologi.v85.19023Keywords:
Diabecine reconstitute, Sprague Dawley rats, 14 days sub-acute toxicity, histopathology, polyherbalAbstract
Diabecine reconstitute is a combination of well-known herbs such as Cinnamomum zeylanicum, Eugenia polyantha, Curcuma xanthorizza, Orthosiphon stamineus and Andrographis paniculata which are believed to give promising finding especially in the treatment of diabetes mellitus. However, no scientific studies have been performed to investigate its toxicological effect. Therefore, this study aimed to evaluate its safety profile using sub-acute toxicity (14 days repeated doses) in rat model. The sub-acute toxicity study was evaluated by daily administration of different doses (250, 600 and 2000 mg/kg) of diabecine reconstitute for 14 days. Clinical signs, body weight changes, food and water intake, white blood count and relative organ weight were recorded. While the liver and kidney were removed for histological analysis. The result indicated that administration of diabecine reconstitute did not show significant differences in food consumption, water intake and white blood count (p>0.05) as compared to the control. However, there is significant difference observed in body weight and relative organ weight (p<0.05). Diabecine reconstitute at 600 and 2000 mg/kg proved to be toxic to kidney and liver in histopathology studies. However, the diabecine reconstitute at concentration of 250 mg/kg is safe to be used and showed no toxicity effect. Therefore, diabecine reconstitute at dose of 250 mg/kg was found to be toxicologically safe and it may be a good potential polyherbal formula to be incorporated in the diabetes mellitus treatment.
References
Ezeja, M. I., Anaga, A. O., Asuzu, I. U. 2014. Acute and Sub-Chronic Toxicity Profile of Methanol Leaf Extract of Gouania Longipetala in Rats. Journal of Ethnopharmacology. 151: 1155-1164.
Ghorbani, A., Shafiee-Nick, R., Rakhshandeh, H., & Borji, A. 2013. Antihyperlipidemic Effect of a Polyherbal Mixture in Streptozotocin-Induced Diabetic Rats. Journal of Lipids. 1-6. https://doi.org/10.1155/2013/675759.
Samani, N. B., Jokar, A., Soveid, M., Heydari, M., & Mosavat, S. H. 2016. Efficacy of the Hydroalcoholic Extract of Tribulus terrestris on the Serum Glucose and Lipid Profile of Women With Diabetes Mellitus. Journal of Evidence-Based Complementary & Alternative Medicine. 21(4): 91-97. https://doi.org/10.1177/2156587216650775.
Park, C., & Lee, J. S. 2013. Mini Review: Natural Ingredients for Diabetes which are Approved by Korean FDA. Biomedical Research. 24(1): 164-169.
Gauttam, V. K. (2013). Development of Polyherbal Antidiabetic Formulation Encapsulated in the Phospholipids Vesicle System. Journal of Advanced Pharmaceutical Technology & Research. 4(2): 108–117. https://doi.org/10.4103/2231-4040.111527.
Yadav, D., Chaudhary, A. A., Garg, V., Anwar, M. F., Rahman, M. M. ur, Jamil, S. S., Asif, M. 2013. In vitro Toxicity and Antidiabetic Activity of a Newly Developed Polyherbal Formulation (MAC-ST/001) in Streptozotocin-Induced Diabetic Wistar rats. Protoplasma. 250(3): 741-749. https://doi.org/10.1007/s00709-012-0458-7.
Azeez, A., Tomy, S., Ali Abdalla, F. M., Suresh, R., & Johnson, B. 2016. Antidiabetic Effect of Polyherbal Formulation “Kathakakhadiradi Kashyam” in Streptozotocin Induced Diabetic rats. Journal of Young Pharmacists. 8(4): 496-499. https://doi.org/10.5530/jyp.2016.4.30.
Saifi, A., Chauhan, R., & Dwivedi, J. 2017. Development of a Polyherbal Formulation FMST and Evaluation for Antidiabetic Activity in Alloxan Induced Diabetic Rats. Asian Journal of Pharmaceutical Research. 7(1): 4-7.
Tang, W., Li, S., Liu, Y., Huang, M. & Ho, C. (2013). Anti-Diabetic Activity of Chemically Profiled Green Tea and Black Tea Extracts in A Type 2 Diabetes Mice Model Via Different Mechanisms. Journal of Functional Food. 5: 1784-1793.
Anderson, R. A., Zhan, Z., Luo, R., Guo, X., Guo, Q., Zhou, J., Stoecker, B. J. 2016. Cinnamon Extract Lowers Gucose, Insulin and Cholesterol in People with Elevated Serum Glucose. Journal of Traditional and Complementary Medicine. 6(4): 332-336. https://doi.org/10.1016/j.jtcme.2015.03.005.
Sutrisna, E. M. (2016). Antidiabetic Activity of Ethanolic Extract of Eugenia Polyantha Wight Leaf from Indonesia in Diabetic Rat Wistar Strain Induced by Alloxan. Asian Journal of Pharmaceutical and Clinical Research. 9(1): 374-376.
Nughoro, A. E., Andrie, M., Warditiani, N. K., Siswanto, E., Pramono, S., & Lukitaningsih, E. 2012. Antidiabetic and Antihiperlipidemic Effect of Andrographis paniculata (Burm.f.) Nees and Andrographolide in high -fructose –fat- fed- rats. Indian Journal of Pharmacology. 44(3): 377-381.
Nabavi, S. F., Thigarajan, R., Rastrelli, L., Daglia, M., Sobarzo-Sanchez, E., Alinezhad, H., & Nabavi, S. M. (2015). Curcumin: A Natural Product for Diabetes Mellitus and Its Complication. Current Topical Medical Chemistry. 15(23): 2445-55.
Jayanthy, G., & Subramaniam, S. 2014. Rosmarinic Acid, a Polyphenol, Ameriolates Hyperglycemia by Regulating Key Enzymes of Carbohydrates Metabolism in High Fat Diet-STZ Induced Experimental Diabetes Mellitus. Biomedicine & Preventive Nutrition. 4(3): 431-437.
Patrick-Iwuanyanwu, K. C., Amadi, U., Charles, A., & Ayalogu, E. O. 2012. Evaluation of Acute and Sub-Chronic Oral Toxicity Study of Baker Cleansers Bitters -A Polyherbal Drug on Experimental Rats. EXCLI Journal. 11: 632-640.
Wong, T. T., Hashim, Z., Zulkifli. R. M., Zainol, N., Md Rajib, N. S., The, L. C., & Majid, F. A. A. 2017. LD50 Estimations for DiabecineTM Polyherbal Extracts Based on In Vitro Diabetic Models of 3T3-L1, WRL-68 and 1.1B4 Cell Lines. Chemical Engineering Transactions. 56.
Kandhare, A. D., Bondhankar, S. L., Mohan, V., & Thakurdesai, P. A. 2015. Acute and Repeated Doses (28 days) Oral Toxicity Study of Glycosides Based Standardized Fenugreek Seed Extract in Laboratory Mice. Regulatory Toxicology and Pharmacology. 72: 323-334.
Attanayake, A. P., Jayatilaka, K. A. P. W., Pathirana, C., Kumari, L., and Mudduwa, B. 2013. Efficacy and Toxicological Evaluation of Coccinia grandis (Cucurbitaceae) Extract in Male Wistar Rats. Asian Pacific Journal of Tropical Disease. 3(6): 460-466.
Ahmad, R. A., Serati-Nouri, H., Abdul Majid, F. A., Sarmidi, M. R., & Abdul Aziz, R. 2015. Assessment of Potential Toxicological Effects of Cinnamon Bark Aqueous Extract in Rats. Research Journal of Chemistry and Environment. 19(2): 50-56.
Ogunlala, O. O., Ogunlana, O. E., Adeneye, A. A., Udo-Chijoke, O. A. C., Dare-Olipede, T. I., Olagunju, J. A., & Akindahunsi, A. A. 2013. Evaluation of the Toxicological Profile of the Leaves and Young Twigs of Caesalpinia Bonduc (Linn) Roxb. African Journal Traditional Complement Alternative Medicine. 10(6): 504-512.
Effendy, A. W. M., Siti-NurTahirah, J., Husin, Z. M. 2006. The Side Effects of Kacip Fatimah Extract on Liver and Kidney of White Rats. Journal of Sustainability Science and Managements. 1(1): 40-46.
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