The invention provides a
nicotine orally disintegrating tablet with a multi-layer composite sustained-release structure and a preparation method of the
nicotine orally disintegrating tablet. The
nicotine orally disintegrating tablet comprises an inner layer, a middle layer and an outer layer, wherein the middle layer and the outer layer sequentially coat the inner layer from inside to outside; the outer layer comprises nicotine, instant
starch and a
lubricant; the middle layer comprises nicotine,
ethyl cellulose,
polyethylene glycol and a flow aid; the inner layer comprises the following components: nicotine nanoparticles coated with
chitosan and
sodium tripolyphosphate, an oral microenvironment
regulator and a filling agent. According to the nicotine orally disintegrating tablet provided by the invention, due to the gradient
coating structure design of the inner layer, the middle layer and the outer layer, the multi-stage accurate release of nicotine, namely early-stage quick release, middle-stage stable release and later-stage slow release, is realized, the reactions of dizziness,
vomiting and the like caused by excessive release of nicotine are avoided, and the use comfort is improved. Meanwhile, the pH value of the
oral cavity is adjusted, micro-ecological balance of the
oral cavity is maintained, the content of volatile
sulfide in breath is reduced, and breath is refreshed.