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Journal of Pharmaceutical Research

Article

Journal of Pharmaceutical Research

Year: 2023, Volume: 22, Issue: 1, Pages: 50-54

Original Article

Acute and Subchronic Toxicity and LC-MS Fingerprinting of a Polyherbal Formulation (KNDBHU) used for COVID-19 Management

Abstract

A polyherbal formulation consisting of Withania somnifera, Tinospora cordifolia, Moringa oleifera, Adhatoda vasica, Pipper longum, Glycyrrhiza glabra, Ocimum sanctum and Curcuma longa has been used for Covid-19 treatment empirically, which was found effective. However, toxicity data were not available for this polyherbal formulation. This study aims to assess the polyherbal formulation's oral acute and subchronic toxicity in rats. The fixed-dose approach was used to conduct the acute toxicity investigation on 6 female Wistar rats for the treatment group and 5 female Wistar rats for the control group. A single dosage of this polyherbal formulation weighing 2,000 mg/kg was administered orally to the test group. At the end of the investigation, no fatalities or major toxic effects were noted, and it was determined that the lethal dose 50% (LD50) of the polyherbal formulation was greater than 2,000 mg/kg. Vital organs underwent macroscopic and microscopic inspection, neither of which revealed any toxicity signs. The polyherbal formulation was given orally for 91 days during the subchronic toxicity research in dose variations: 250 mg/kg, 500 mg/kg, 1,000 mg/kg, 2,000 mg/kg, and 4,000 mg/kg. The daily dose for a human is the same at the lowest level of 250 mg/kg. On physical signs and symptoms, weight growth, food intake, haematological parameters, biochemical parameters, and macroscopic and microscopic examination of organs, no major harmful effects were seen at any of these doses. These results demonstrated that the oral administration of this polyherbal formulation over the short- and long-term is safe when taken as suggested.

Keywords: Ayurvedic, Polyherbal, COVID­19, Acute toxicity, Sub­chronic Oral Toxicity

References

  1. V’kovski P, Kratzel A, Steiner S, Stalder H, Thiel V. Coronavirus biology and replication: implications for SARS-CoV-2Nature Reviews Microbiology2021;19(3):155170.
  2. Kanchibhotla D, Subramanian S, Kumar RMR, Hari KRV, Pathania MR. An In-vitro evaluation of a polyherbal formulation, against SARS-Cov-2Journal of Ayurveda and Integrative Medicine2022;13(3):100581100585. Available from: https //doi.org/10.1016/j.jaim.2022.100581
  3. Ben-Shabat S, Yarmolinsky L, Porat D, Dahan A. Antiviral effect of phytochemicals from medicinal plants: Applications and drug delivery strategiesDrug Delivery and Translational Research2020;10(2):354367. Available from: https://doi.org/10.1007/s13346-019-00691-6
  4. Singh M, Jayant K, Singh D, Bhutani S, Poddar NK, Chaudhary AA, et al. Withania somnifera (L.) Dunal (Ashwagandha) for the possible therapeutics and clinical management of SARS-CoV-2 infection: Plant-based drug discovery and targeted therapyFrontiers in Cellular and Infection Microbiology2022;12:0123. Available from: https://doi.org/10.3389/fcimb.2022.933824
  5. Sreelatha S, Jeyachitra A, Padma PR. Antiproliferation and induction of apoptosis by Moringa oleifera leaf extract on human cancer cellsFood and Chemical Toxicology2011;49(6):12701275. Available from: https://doi.org/10.1016/j.fct.2011.03.006
  6. Bisht D, Rashid M, Arya RKK, Kumar D, Chaudhary SK, Rana VS, et al. Revisiting liquorice (Glycyrrhiza glabra L.) as anti-inflammatory, antivirals and immunomodulators: Potential pharmacological applications with mechanistic insight. Phytomedicine Plus2022;2(1):100206. Available from: https://doi.org/10.1016/j.phyplu.2021.100206
  7. Baliga MS, Jimmy R, Thilakchand KR, Sunitha V, Bhat NR, Saldanha E, et al. Ocimum sanctum L (Holy Basil or Tulsi) and its phytochemicals in the prevention and treatment of cancerNutrition and Cancer2013;65(sup1):2635. Available from: https://doi.org/10.1080/01635581.2013.785010
  8. Sharifi-Rad J, Rayess YE, Rizk AA, Sadaka C, Zgheib R, Zam W, et al. Turmeric and Its Major Compound Curcumin on Health: Bioactive Effects and Safety Profiles for Food, Pharmaceutical, Biotechnological and Medicinal ApplicationsFrontiers in Pharmacology2020;11:123. Available from: https://doi.org/10.3389%2Ffphar.2020.01021
  9. Xiaohui F, Yi W, Yiyu C. LC/MS fingerprinting of Shenmai injection: A novel approach to quality control of herbal medicinesJournal of Pharmaceutical and Biomedical Analysis2006;40(3):591597. Available from: https://doi.org/10.1016/j.jpba.2005.10.036
  10. Ishtiaq S, Akram M, Kamran SH, Hanif U, Afridi MSK, Sajid-Ur-Rehmanet al. Acute and sub-acute toxicity study of a Pakistani polyherbal formulationBMC Complementary and Alternative Medicine2017;17(1):113. Available from: https://doi.org/10.1186/s12906-017-1889-7
  11. Sushruta K, Satyanarayana S, Srinivas S, Sekhar JR. Evaluation of the Blood-Glucose Reducing Effects of Aqueous Extracts of the Selected Umbelliferous Fruits Used in Culinary PracticesTropical Journal of Pharmaceutical Research2007;5(2):613617. Available from: https://doi.org/10.4314/tjpr.v5i2.14639
  12. Kim SHH, Jun CDD, Suk K, Choi BJ, Lim H, Park S, et al. Gallic Acid Inhibits Histamine Release and Pro-inflammatory Cytokine Production in Mast CellsToxicological Sciences2006;91(1):123131. Available from: https://doi.org/10.1093/toxsci/kfj063

Copyright

© 2023 Published by Krupanidhi College of Pharmacy. This is an open-access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/

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