Acute and sub-chronic toxicity study of traditional Indian medicine Manahshila (realgar)

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ORIGINAL ARTICLE

Acute and sub‑chronic toxicity study of traditional Indian medicine Manahshila (realgar) Vineet Sharma1 · Dev Nath S. Gautam1   · Himanshu Rai2 · Narendra K. Singh3 Accepted: 3 February 2020 © Korean Society of Environmental Risk Assessment and Health Science 2020

Abstract Objective  In the present scenario, interest and concerns are projected about arsenic and other heavy metal-containing formulations for their safety aspects. Although arsenical Ayurvedic formulations were used safely, on the other hand, it is not used as a single compound in the clinical practices that is why there is an importance to produce research-based confirmation that these compounds are safe. Manahshila (realgar) is one of the arsenical compounds which is widely used in preparation and practice of Ayurvedic medicine. The aim of the present study was to assess the safety profile of crude realgar (CR) and purified realgar (PR) in rats. Methods  The CR and PR were given to overnight starved animals at sorted doses by following the ‘Up and Down method’ with 2 g/kg for acute toxicity. In the sub-chronic toxicity, the CR and PR were given at the doses of 0.7, 3.5 and 7 mg/kg to rats for 28 days. Rats were slaughter after anaesthetized with an overdose of carbon dioxide on 29th day. The effects of both drugs were evaluated on body weight changes, food–water intake, changes in biochemical, haematological and histopathological parameters. Results  The PR-treated rats did not show any differences in gross behaviour up to 14 days, while CR-treated rats showed signs of toxicity like sedentary, trembling, piloerection, fore-limbs and body stretching through 14 days at the dose level of 2 g/kg. In the sub-chronic study, changes in weight, food–water intake, biochemical and cytoarchitecture in organs of CR and tenfold of a therapeutic dose of PR-treated rats were found. Conclusion  The obtained results showed that PR is safe at its effective dose for clinical practice. Keywords  Realgar · Arsenic · Acute · Sub-chronic · Toxicity

Introduction In Rasa Shastra (an Indian classical alchemical treatise), Manahshila (Realgar) is grouped in mineral drug of Uparasa Varga (the group of minerals) [1]. Over 40 compound formulations for internal and external administration have been mentioned in the Ayurvedic formulary of India (AFI), in which purified realgar (PR) is used as a * Dev Nath S. Gautam [email protected] 1



Department of Rasa Shastra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh 221005, India

2



Department of Science and Technology‑CIMS, Institute of Science, Banaras Hindu University, Varanasi, India

3

School of Pharmacy, Babu Banarasi Das University, Lucknow, Uttar Pradesh 226028, India



main ingredient. Commonly, crude realgar (CR) is highly toxic and causes disease like Ashmari (urinary stones), Mutrakrichra (dysuria), Mandagni (digestive fire is too low) and Malabandha (constipation) [2]. But Ayurveda has asserted that a strong poison may be changed into a s