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Sanjay Khedekar ¹, Swapnil Chaudhari ², R. Galib ³, P. K. Prajapati ⁴

Affiliations
1 Dept. of RS & BK, SSAM & H, MUHS, Nashik, IN
2 Central Ayurveda Drug Research Institute for Drug Development, Kolkata, IN
3 Dept. of RS & BK, All India Institute of Ayurveda, New Delhi, IN
4 Dean, All India Institute of Ayurveda, New Delhi, IN

Abstract

Use of metallic preparations has raised safety concerns and debate in scientific community for containing considerable levels of heavy metals like lead, mercury and/or arsenic etc. Such controversies have tried to malign the reputation of Ayurveda at global levels. Makaradhwaja, one such metallic preparation is frequently being used in many conditions. But, its safety at the levels of ponderal and biochemical parameters is not reported. Considering this, the present study is planned to evaluate safety effect of Triguna Balijarita Makaradhwaja (TBM) and Shadguna Balijarita Makaradhwaja (SBM) in wistar strain albino rats. TBM and SBM were prepared by following classical guidelines. Animals were divided into four groups. TBM and SBM were administered to rats at the doses of 2.63mg/kg along with Guduchi Ghana and honey for 21 days. Blood samples were collected and animals were sacrificed on 22nd day. Ponderal and biochemical parameters were studied. The results showed insignificant changes in the body weight, Serum creatinine, Cholesterol, Triglyceride and HDL; while SGOT, SGPT and Blood urea were decreased significantly by the treatment of TBM and SBM. The findings of the present study suggests that Makaradhwaja in therapeutic doses along with Honey administered to rats for 21 days does not have appreciable toxicological effects on ponderal and biochemical parameters.

Keywords

Makaradhwaja, Mercuric Sulphide, Metallic Preparations, Safety, Toxicity.

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Chandrashekhar Y. Jagtap ¹, Swapnil Y. Chaudhari ², Jalaram H. Thakkar ³, R. Galib ², P. K. Prajapati ²

Affiliations
1 Departments of Rasashastra and Bhaishajya Kalpana, Parul Institute of Ayurveda, Limda, Vadodara, IN
2 Rasashastra and Bhaishajya Kalpana, Institute of Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, IN
3 Department of Pharmacology, Swargiy Sanjibhai Roopajibhai College of Pharmacy, Silvassa, Union Territory of Dadra and Nagar Haveli, IN

Abstract

Objectives: Herbo‑mineral formulations are being successfully used in therapeutics since centuries. But recently, they came under the scanner for their metallic contents especially the presence of heavy metals. Hence it is the need of the hour to assess and establish the safety of these formulations through toxicity studies. In line with the various toxicity studies that are being carried out, Government of India expressed the need for conducting genotoxicity studies of different metal‑ or mineral‑based drugs. Till date very few Ayurvedic herbo‑mineral formulations have been studied for their genotoxic potential. The present study is aimed to evaluate the genotoxic potential of Hridayarnava Rasa. Materials and Methods: It was prepared as per classical guidelines and administered to Swiss albino mice for 14 consecutive days. Chromosomal aberration and sperm abnormality assay were done to evaluate the genotoxic potential of the test drugs. Cyclophosphamide (CP) was taken as positive group and results were compared. Results: All treated groups exhibited significant body weight gain in comparison to CP group. Results revealed no structural deformity in the above parameters in comparison to the CP‑treated group. Conclusion: Reported data showed that both tested samples of Hridayarnava Rasa does not possess genotoxic potential under the experimental conditions and can be safely used.

Keywords

Colchicine, cyclophosphamide, genotoxicity, herbo‑mineral formulations, Tamra bhasma

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Ankesh Agrawal ¹, Swapnil Chaudhari ², Mukesh Nariya ³, R. Galib ⁴, Pradeep Kumar Prajapati ⁴

Affiliations
1 Ayush Wing, Guna – 473001, Madhya Pradesh, IN
2 Department of Rasashastra and Bhaishajya Kalpana, ITRA, Jamnagar – 361008, Gujarat,, IN
3 Pharmacology Laboratory, ITRA, Jamnagar – 361008, Gujarat,, IN
4 4Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi – 110076,, IN

Abstract

Rasa parpati is a unique Ayurvedic mercurial formulation extensively prescribed by Ayurvedic physicians to treat different ailments. Considering toxicity concerns of traditional formulations for containing heavy metals like Mercury, Arsenic, Lead etc.; it becomes, imperative to evaluate safety aspects of such formulations. In Ayurveda, metals and minerals are advocated to be processed through the specified guidelines before their therapeutic application. An attempt has been made to evaluate the impact of Shodhana on safety aspects of Rasa parpati through acute and 90 days repeated dose toxicity of Rasa parpati that was prepared by two different samples of raw materials. One by using Hingulottha parada and Shuddha gandhaka (HRP) while, another with Ashuddha parada and Ashuddha gandhaka (ARP). Oral acute toxicity of test drugs was carried out at limit dose of 2000 mg/kg orally along with adjuvant in Charles foster female rats. In 90 days repeated dose toxicity, both ARP and HRP were orally administered at therapeutically equivalent dose (22.5 mg/kg), TEDx5 (112.5 mg/kg), TEDx10 (225 mg/kg) levels along with adjuvant for 90 days. Two recovery groups were also studied in the experiment. Acute toxicity revealed that, both the test drugs did not produce any signs and symptoms of toxicity and mortality up to oral dose of 2000 mg/kg in rats. Administration of HRP for 90 days revealed that, the drug at higher dose has potential to produce liver and kidney toxicity however, can be relatively safe at therapeutic dose level. ARP has potential for liver, kidney and GI tract toxicity with deposition in other organs. The recovery study suggests that, after discontinuation of HRP the observed changes are reversible in nature while, in ARP some of the observed changes are irreversible in nature. From present study, it is concluded that HRP was found to be safer than ARP at different dose levels in rats suggesting safe use at therapeutic dose level. It proves that classical procedures like Shodhana are mandatorily to be followed in the pharmaceutical processing of these formulations.

Keywords

Ayurveda, Mercury, Parada, Rasa parpati, Safety, Toxicity.

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