The First New Botanical Drug Approved in Taiwan--PG2 Injection

Abstract

PG2, different from single-ingredient chemically synthetic drugs, is a novel lyophilized injection containing complicated mixture of plant-derived ingredients. PG2's raw materials, Astragalus membranaceus, were cultivated in the specific region of Inner Mongolia, China. Based on the GAP (Good Agricultural Practice) protocols, Astragalus were grown via breeding, nurturing seedlings, field growing, harvesting to monitor soil, water, fertilizer in order to control their qualities and batch-to-batch uniformity. After harvesting, Astragalus underwent step-by-step SOP such as screening, washing, drying, slicing before shipping to Taiwan. Every batch of Astragalus raw material must go through DNA appraisal to confirm it was Astragalus membranaceus by Industrial Technology Research Institute (ITRI), Hsinchu, Taiwan. Astragalus were subsequently manufactured through a series of proprietary processes: extraction, condensation, filtration, purification and spray drying to obtain the highly-purified polysaccharides as the PG2 active pharmaceutical ingredients (API). The entire process from raw material to finished product comprised of 68 steps and 141 inspection items to ensure product quality and uniformity.