The invention discloses an oral PEGylated
insulin pH-sensitive naonparticle and a preparation method thereof. The naonparticle is prepared from PEGylated
insulin, pH-sensitive
polymer, carrier, additives and stabilizer. The preparation method of the naonparticle comprises the following steps: preparing a PEGylated
insulin / pH-sensitive
polymer / carrier W / O primary
emulsion, dispersing the W / O primary
emulsion in a stabilizer solution to form a W / O / W multiple
emulsion, obtaining a crude product after the
solvent volatilizes, purifying the crude product, and carrying out freeze-
drying to obtain the naonparticle. The PEGylated insulin pH-sensitive naonparticle disclosed by the invention has the advantages of uniform dispersion and high
medicine enveloping rate; the insulin modified by
polyethylene glycol can reduce the aggregation of insulin molecules, prolong the
half life in vivo, and prolong the time of
blood sugar reduction effect; and the release rate of the insulin in the
gastric acid environment is reduced, the release rate of the insulin in the intestinal tract environment is enhanced since the naonparticle swells, and thus, the oral PEGylated insulin pH-sensitive naonparticle has an
oral application value.