Industrial approach of process validation of Bharjana (frying) process WSR to Eranda Bhrishta Haritaki: An experimental observation

Abstract

Eranda Bhrishta Haritaki (EBH) is popularly used Ayurvedic medicine indicate in the management of Vatavyadhi, Amavata (rheumatoid arthritis), Grudhrasi (sciatica) which lacks of documentation of parameters of standardization, especially in process standardization. In the present study, few economic, desirable parameters of its Standard Manufacturing Process at industrial level are identified and observed. Randomized observations of two major (½ quintal each referring to large scale) and 18 sub-batches of EBH of pharmacy department, Gujarat Ayurved University, Jamnagar, Gujarat were made. Immature Haritaki was classified as per parameters quoted in Bhavaprakasha and formulation EBH prepared from it was divided into 2 groups as per heating pattern (increasing degree of heating from Group A and B) and subdivided into three subgroup on the basis of its size and studied their quality parameters. Percentage of yield in weight in two batch and three sub-batches 74%, 83.62%, 82.05%, and 71.20%, 83.80%, and 78.40%, respectively. The maximum yield is found in medium size Haritaki. In physiochemical parameter, there was no major changes was observed except Ash value. The study concludes if proportion of standard ingredients, batch size, equipment, duration and pattern of frying and frequency of stirring is kept constant the procedure can be validated by proper regulation of heat.