The present application relates to the technical field of
medicine preparation, and more particularly to a preparation method of high-purity furanazole.S1 filters a
solvent;S2 adds crude furanazole and the filtered
solvent in S1 into a reaction tank, heats and stirs until completely dissolved, sequentially performs three times of cooling and stirring for
crystallization, three times of
centrifugation, collects filter cakes, dries, sieves and weighs to obtain finished furanazole.The finished product has high purity, the average value is greater than or equal to 99.9%, the purity is much higher than the purity of furanazole regulated by authoritative pharmacopoeias such as
Chinese Pharmacopoeia and BP, the content of genotoxic
impurity 5-nitro
furfural is low, and the content is less than or equal to 10 ppm, which completely meets the limit requirement (less than or equal to 50 ppm) of ICH M7 (R1), greatly improves the purity standard of furanazole
bulk drug, and is beneficial to
drug safety.The present application has high yield, less waste, does not cause the burden of environmental
pollution, is simple to operate, has few steps, has short
production cycle, and is suitable for industrial large-scale production.