ABSTRACT:
More individuals are turning to the conventional medical system as they become more conscious of safety and health issues. There is significant export potential for the traditional medicine sectors. Strict quality standards, quality control, safety and efficacy are necessary for export to a number of nations. To create a testing protocol, the Department of Ayush tasked Pharmacopoeial Laboratory for Indian Medicine (PLIM). Among the 32 internal medications in Siddha, Theeneer (distillate) is one of them. Sombu Theeneer is one of the herbal distillate formulations stated in the Siddha literature was taken for analysis. Objective: The current study's primary goal is to standardize the formulation Sombu Theeneer as per Ayush guideline and to disclose the property of the formulation to the scientific community for better understanding about the standards of the formulation. Methods: The sample was purchased from GMP certified company and used for analysis. Numerous parameters, including pesticide residue, microbial load, heavy metal limits, aflatoxins, safety and quality parameters were tested. These requirements were extracted from the PLIM guidelines. Results: The results obtained from the HPTLC analysis of the sample shows the presence of four versatile phytocomponents. The phytochemical analysis of the sample reveals the existence of carbonate, ammonium, iron and alkaloid. Analysis of heavy metals demonstrates unequivocally that lead is present in the sample at 1.180 PPM level. Outcome of specific pathogen test indicates the absence of pathogenic microbes. There were no traces found, according to the pesticide residue analysis results. Additionally, there were no aflatoxin B1, aflatoxin B2, aflatoxin G1, and aflatoxin G2 in the formulation. Conclusion: The present investigation results reveals that the formulation Sombu Theeneer follow the standard outlines in the Ayush guideline.