The invention discloses a
chitosan composite temperature-sensitive gel
microsphere for vaginal administration and a preparation method thereof, and relates to the technical field of biological medicines.The preparation method comprises the steps that high-purity
chitosan and a temperature-sensitive
polymer are mixed, then a cross-linking agent is dropwise added in a gradient mode to form pre-gel, after
medicine is ultrasonically embedded, spraying or micro-fluidic forming is conducted, and the
chitosan composite temperature-sensitive gel
microsphere is obtained; carrying out
surface modification and
freeze drying by using a stabilizing aid to obtain microspheres; the
system is composed of a chitosan matrix, a poly N-isopropylacrylamide temperature-sensitive
polymer, a
sodium tripolyphosphate cross-linking agent, an
antifungal / antiviral /
hormone drug and a hydroxypropyl
methyl cellulose stabilizing aid, the particle size of microspheres is 50-300 [mu] m, the microspheres are rapidly gelatinized at 37 DEG C, the half-life period of the
drug is longer than 8 h, the
adhesive force is improved by 30% or above, and the
residence time is prolonged to 12 h or above. According to the invention, by constructing a temperature-sensitive interpenetrating
network structure and performing surface
functional modification, body temperature triggered in-situ gelation, long-acting slow release and strong adhesion synergism are realized, and the local
treatment effect and
patient compliance are remarkably improved.