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The current study explores the safety of Rasasindura (RS) , an Ayurvedic herbo-metallic preparation containing mercury, and its therapeutic potential against oligospermia. Based on global concerns due to the toxicity of mercury, this study was designed to evaluate the toxicology and pharmacology of RS . Wistar rats were administered therapeutic and high doses of RS intragastrically for the in vivo toxicology study. The toxicity tests showed no significant changes in the major functions of organs, hematological and biochemical functions except mild hyperactivity in a few animals in the high dose group. The study’s histopathological and biochemical analyses revealed no significant morphological or functional abnormalities in the brain, liver, kidneys, or testes of rats administered with high doses of RS , indicating normal neuronal and organ function. Additionally, biochemical and hematological evaluations showed no adverse effects, suggesting RS does not impair metabolic activities at the tested doses. A therapeutic study was carried out in oligospermia-induced Swiss Albino mice. RS caused a significant increase in sperm motility and count and reduced sperm abnormalities in mice treated with lead acetate-induced oligospermia. The elevated levels of the genes Catsper and Calpain revealed that the formulation activates the calcium channels which contribute to an increase in sperm count. Further, microarray studies revealed potential anti-inflammatory, anti-obesity, anti-diabetic, anti-cancer, and immunomodulatory activities of RS . However, RS treatment also resulted in gene expression linked to possible toxic effects. Purified mercury-containing Ayurvedic preparations are safe at therapeutic concentrations if administered using a suitable vehicle; this is of great significance in reducing toxicity and enhancing efficacy, though higher concentrations could cause toxic effects mainly neurological, and hence the use of such potent metal-based medications are advised to be prescribed under medical supervision. To conclude, Rasasindura appears to be non-toxic at therapeutic doses and has shown promise the in treatment of oligospermia. Further studies could explore additional therapeutic effects and associated mechanisms for other disorders.

This review aims to explore the toxicological aspects of mercury-based herbo - metallic preparations like cinnabar and “ Rasasindura ” that are primarily composed of mercuric sulfide (HgS). Cinnabar-containing preparations have been used extensively in Indian and Chinese systems of medicine for treatment of chronic ailments like syphilis, high fever, pneumonia, insomnia, nervous disorders, deafness, and paralysis of the tongue. Contrary to Western medicine, which does not promote the use of mercury due to its toxic effects, Indian and Chinese traditional practitioners believe that mercury - based formulations have potent therapeutic efficacy, while there is no toxicity due to the unique and repeated purification processes employed during preparation. However, lack of proper pharmacovigilance and widespread self-medication has resulted in undesirable effects to certain sections of the consumers of these preparations, which have contributed to the negative publicity for these forms of medicine. Variations in the quality of the preparations coupled with the lack of understanding of the differences in the recommended dosages and treatment strategies adopted by traditional medicine practitioners, further fuels concerns in the Western world on the safety and efficacy of traditional medicine. But in spite of these concerns, concerted efforts to understand the biological interactions and transformations of these preparations are yet to gain momentum. Although scattered reports on the toxicity of these preparations are available in literature, their mechanism of action has not been conclusively established. Long-term pharmacotherapeutic and in-depth toxicity studies are needed to address the apprehensions raised by these herbo - metallic preparations. This review highlights the lacunae in the studies conducted thus far, and assesses the need for further studies to provide significant data to establish the safety and efficacy of such preparations, as well as develop gold standards for stringent quality control of these preparations.

In recent years, iron oxide incorporated highly oriented mesoporous silica has evinced considerable interest for biomedical applications due to its amenability to chemical modification, ability to be visualized through non-invasive magnetic resonance imaging and simultaneously deliver therapeutic molecules at the site of interest. However, reports on the biocompatibility of mesoporous silica are contradictory and information on the response of the biological system to these materials is relatively unknown. In our previous study we had reported the use of spherically modified iron oxide incorporated mesoporous silica (Sp-IO-MPS) as a theranostic tool. The present work focuses on the evaluation of the in vivo biodistribution of the material in rodents along with the histopathological profile of the tissues in treated animals. Organ distribution results show that the intravenously administered Sp-IO-MPSs are mainly deposited in the spleen within an hour of administration when compared to other tissues. This suggests that the presence of iron oxide in the mesopores direct these particles to localize preferentially in the spleen. Histopathology studies revealed that both mesoporous silica and the iron oxide incorporated mesoporous silica caused minimal toxicity to lungs and spleen after 60 h after administration while the other tissues remained unaffected. Taken together, this study reveals that iron oxide incorporated mesoporous silica can be used only for short-term applications while prolonged circulation of these materials may cause adverse effects in the lungs and spleen.