Safety Profile of Manahshila and its Formulations: An Evidence-Based Study

Sarika Makwana; Rahul Kanjibhai Shingadiya; Prashant Bedarkar; Biswajyoti J Patgiri

doi:10.4103/AYUHOM.AYUHOM_10_21

REVIEW ARTICLE

Year : 2019 | Volume : 6 | Issue : 2 | Page : 60-64

Safety Profile of Manahshila and its Formulations: An Evidence-Based Study

Sarika Makwana¹, Rahul Kanjibhai Shingadiya², Prashant Bedarkar¹, Biswajyoti J Patgiri¹
¹ Department of Rasa Shashtra and Bhaishajya Kalpana, I.P.G.T. and R.A, Gujarat Ayurved University, Jamnagar, Gujarat, India
² Departmet of Rasashashtra and Bhaishajya Kalpana, Government Ayurveda College, Junagadh, Gujarat, India

Date of Submission	04-Jan-2021
Date of Acceptance	20-Jan-2021
Date of Web Publication	05-Mar-2021

Correspondence Address:
Dr. Sarika Makwana
Department of Rasa Shashtra and Bhaishajya Kalpana, I.P.G.T. and R.A, Gujarat Ayurved University, Jamnagar - 361 008, Gujarat
India

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/AYUHOM.AYUHOM_10_21

Abstract

Manahshila (Realgar, As₂S₃) is a widely utilized drug in Ayurvedic therapeutics since the Samhita period. It is one of the mineral drugs, on few researches have been conducted which cover the area of quality control and safety profile. Therefore, the present work was conducted to review published researches of Manahshila and its containing formulations which related to pharmaceutico–analytical studies and safety concern. Published articles on toxicity studies and pharmacological studies of Manahshila and its formulations were reviewed through various search engines and databases such as Google, Google Scholar, Yahoo, Springer, Omics, Medknow, PubMed, and J gate. Results: A total of 12 published research articles were summarized. Among them, three were on pharmaceutico–analytical study; four on pharmacological study and toxicity study of Manahshila; three on pharmaceutico–analytical study; and two on pharmacological study and toxicity study of Manahshila and formulations containing Manahshila. Above mentioned published researches on Manahshila evidently conclude that Manahshila and its formulations are safe to be used in human to treat different diseases conditions.

Keywords: Arsenicals, Ayurveda, critical review, safety, toxicity

How to cite this article:
Makwana S, Shingadiya RK, Bedarkar P, Patgiri BJ. Safety Profile of Manahshila and its Formulations: An Evidence-Based Study. AYUHOM 2019;6:60-4

How to cite this URL:
Makwana S, Shingadiya RK, Bedarkar P, Patgiri BJ. Safety Profile of Manahshila and its Formulations: An Evidence-Based Study. AYUHOM [serial online] 2019 [cited 2023 Mar 31];6:60-4. Available from: http://www.ayuhom.com/text.asp?2019/6/2/60/310850

Introduction

In Rasashastra, Manahshila has been illustrated under Uparasa Varga.^[1] Charaka Samhita^[2] and Sushruta Samhita^[3] explained Manahshila under Parthiva Dravya Varga, whereas in Sharangadhara Samhita,^[4] it is classified under Upadhatu as well as Uparasa Varga. However, Ayurveda has emphasized that a strong poison may be converted into a safe and potent therapeutic drug by applying specific pharmaceutical processes (Samskara) such as Shodhana and Marana. The drug Manahshila, one of the arsenicals, has been identified as Realgar due to its similar chemical and physical properties. Most authors have identified three varieties of Manahshila, viz., Shyamangi, Kanaviraka, and Khandakhya; each has its own specific physical properties. The last two varieties display properties of shining red-cultured crystals, devoid of external impurity, heavy in weight, and more fragility to turn to powder. Therapeutically, it is always recommended to be used only after purification process (Shodhana). On the other hand, in contemporary science, three polymorphs (having similar chemical structure with different crystalline bonds of the atoms) of Realgar (As₄S₄) have been identified, which match with the description of Manahshila described in the ancient texts on Rasashastra.^[5]

Hence, safety of Manahshila and its formulations should be tested by using contemporary toxicological, pharmacological, and pharmaceutico–analytical studies. Various researches on Manahshila and its formulations are also found published. Here, it was planned to compile the evidence and critically review them to confirm the safety profile of Manahshila and its formulations.

Materials and Methods

In the present review, published articles on pharmaceutico–analytical studies, pharmacological studies, and toxicity studies of Manahshila and its containing formulations were reviewed and relevant data of safety were critically analyzed. Articles were searched through various search engines such as Google India, Google, Google Scholar, PubMed, Scopus, J Gate, Yahoo, Omics, Springer, Medknow, Ovid, Wikipedia, and Biomed Central websites by searching the words “Toxicity of Manahshila,” “Pharmacological study of Manahshila,” and “Researches on Manahshila.”

Inclusion and exclusion

Articles on pharmacological, pharmaceutico–analytical, and toxicity studies on Manahshila and its formulations were included. Articles published in peer-reviewed reputed journals were included. Pharmaceutical standardization and review articles were excluded. Article published in souvenir and newsletter were excluded.

Observations and Results

In this review, a total of 12 published research articles are summarized. Among them on Manahshila, a total of seven published articles are noted and five published articles are relevant to formulations which contain Manahshila as an ingredient and are categorized in pharmaceutico–analytical, pharmacological, and toxicity study as follows [Figure 1]:

Figure 1: Methodology and selection chart

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Original research published articles on Manahshila and its containing formulations:

Published articles on pharmaceutico–analytical study of Manahshila [Table 1]
Published articles on pharmaceutico–analytical study of Manahshila containing formulation [Table 2]
Published articles on toxicity and pharmacological study of Manahshila [Table 3]
Published articles on toxicity and pharmacological study of Manahshila containing formulations [Table 4].

Table 1: Published articles on pharmaceutico-analytical study of Manahshila

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Table 2: Published articles on pharmaceutico-analytical study of Manahshila containing formulation

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Table 3: Published articles on toxicity and pharmacological study of Manahshila

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Table 4: Published articles on toxicity and pharmacological study of Manahshila containing formulations

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Discussion

Manahshila (Realgar) is one of the mineral drugs which are used in the treatment of various diseases. In Ayurveda, Shodhana Samskara (detoxification process) is done on Manahshila before using as a medicine to remove toxic effects. 12.4% of increase in weight of Manahshila in Ardraka shodhita Manahshila. No change were found in the chemical composition, both Ashudhdha Manahshila and Ardraka Shodhita Manahshila remained as arsenic disulfide. Particles size distribution of Ardraka Shodhita Manahshila was found to be 15.55 μm as that of Ashudhdha Manahshila (54.18 μm). Sophisticated analytical parameters revealed Kanavirak as alacranite and Khandakhya (Realgar) as in X-ray diffraction study and 51.33% and 68.14% of arsenicin alacranite and Realgar samples, respectively, as in energy dispersive X-ray analysis study. Quantitative analysis of Talasindoora and Shilasindoora suggests that difference in lattice structure, though chemically same, like cinnabar. Swashkuthara rasa prepared by classical method (adding Maricha one by one) showed better results in microscopic study and quantity of piperine (126.89mg/gm ext) too.

According to pharmacology studies of Manahshila, there were no toxic effects on behavior of rats and no signs of toxicity observed in gross necropsy up to 5000 mg/kg body weight for single dose. It indicates LD₅₀ is >5000 mg/kg of rat. The signs listed in texts may be for long-term dose administration and not for a single dose. Pharmacology study supports the basis for the use of Manahshila in the formulation intended-to-treat psychological diseases and insomnia. Nidrajanana drugs are one of the choices of medication in the management of psychological disorders. It is basically a Vata-Kapha-Hara drug possessing qualities such as Snigdha, Guru, Ushna, and Sara. Because of these qualities, it can subside Vata. Hence, by maintaining the normalcy of Vata, it might have exhibited a sedative hypnotic effect. The result may also attribute to central sedating or hypnotic action, resulting in the suppression of cough reflex which has been demonstrated in SO₂-induced cough reflex rat model with Shwasakuthara Rasa and Sameerapannaga rasa. Among all the groups which were purified by seven levigations of Ardraka Swarasa, Jayanti Swarasa, Nimbu Swarasa, and Churnadrava, the ginger juice-treated Manahshila (56.60%) was found to be the best to alleviate rat's response to egg albumin-induced inflammation. Ardraka Shodhita Manahshila possessed marked in vitro anti-inflammatory effect against the denaturation of the protein and heat-induced hemolysis of the erythrocyte. Significant antiepileptic activity of Unmadagajakesari rasa was observed in MES and pentylenetetrazole-induced seizures on the 8^th day. Swashkuthara rasa and Unmadagajakesari rasa were found to be safe at limit dose of 2000 mg/kg in its acute toxicity study. Swashkuthara rasa with Kajjali showed a significant improvement in antitussive activity (75%) as that of Swashkuthara rasa without Kajjali. The minerals and herbs together probably balance the excitatory and inhibitory neurotransmitters in the central nervous system, the main action being GABAergic action and additional antioxidant activity of herbs. This work is expected to be helpful and reduces the strenuous efforts of researchers to gather information.

Conclusion

LD₅₀ of Swedita Shuddha Manahshila is >5000 mg/kg of rat in oral, acute toxicity study in a single dose. Shuddha Manahshila possesses sedative effects at the dose of 36 mg/kg and Kasahara effect at the dose of 10–25 mg, three times a day for 4 weeks, with the adjuvant of honey in animal rat model. Swashkuthara Rasa and Unmadagajakesari Rasa were found to be safe at limit dose of 2000 mg/kg in Wistar female rat model. Unmadagajakesari Rasa may be useful addition to antiepileptic agents which probably may be effective in all types of seizures. In Swashkuthara Rasa, the presence of Kajjali is safe and further potentiates therapeutic efficacy as an anti-tussive agent by its Yogavahi (catalytic) activity. Various published reports revealed that when these minerals are transformed into medicines sternly adhering to the classical guidelines specified in ancient texts, they are devoid of any toxicity. The present research work evidently reflects that Manahshila and its formulations are safely used in human to treat different disease conditions.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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