Proponents Implemented for Quality Standardization and Toxicity Evaluation of Classical Ayurvedic Formulation: Dhatupaushtik Churna

Abstract

Dhatupaushtik Churna is a polyherbal powdered formulation that contains equal amounts of Gokhru (Tribulus terrestris L.; Family: Zygophyllaceae), Ashwagandha (Withania somnifera L.; family: Solanaceae), and Safed musli (Chlorophytum borivilianum L.; Family: Asparagaceae) and is used to treat a myriad of ailments, including premature ejaculation, weakness, rejuvenation of the male reproductive system, and anti-aging. The fundamental aspiration of this investigation is to document Dhatupaushtik Churna's distinctive characteristics in order to legitimise its identification, quality, and purity. The innumerable specifications explored included organoleptic characteristics, physicochemical parameters, physical characteristics of Churna, preliminary phytochemical, heavy metal, and microbial analysis, metabolomic tracking with gas chromatography/mass spectrometry, and high-performance thin layer chromatography assessment. The parameters established have been shown to be informative tools for assisting regulatory authorities, scientific organisations, and manufacturers in developing high-efficacy standard formulations, and they can be used as reference standards in a pharmaceutical startup's quality control/quality assurance laboratory. As a consequence of this investigation, each and every ingredient in Dhatupaushtik Churna might be identified. The characterisation parameters documented in this dissertation might be used as a standard benchmark for Dhatupaushtik Churna quality control analysis. To uphold batch-to-batch consistency, the criteria given in this study might be utilised to prepare a monograph on quality standards for Dhatupaushtik Churna. Furthermore, the study evaluated the acute and subacute oral toxicity of Dhatupaushtik Churna aqueous extract in Swiss albino mice and Wistar albino rats. Acute toxicity assessment was studied using male Swiss albino mice weighing 20-25 gm and the subacute toxicity testing was using male Wistar albino rats weighing 150-200 gm. The acute toxicity study was carried out according to OECD (Organisation for Economic Co-operation and Development) guidelines 423, at the dose of 2000 mg/kg, p.o., with no fatalities. In a subacute toxicity investigation, the extract-treated rats (200 and 400 mg/kg, p.o.) showed no significant differences compared to the control group. Haematological and biochemical markers were constant, whereas the weights of the liver, kidney, pancreas, and testicles did not alter. The results showed that Dhatupaushtik Churna had no appreciable impact on the parameters assessed at the doses used in the study. However, further study is required to investigate and confirm its safety.