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Entecavir oral instant film and preparation method thereof

1. A fast-dissolving oral entecavir film, characterized in that, based on its total weight, it includes each of the following mass fractions
Components: Entecavir 0.05-15%; polyvinyl alcohol/polyethylene glycol graft copolymer 55-90%; glycerin plasticizer 5-15%; sodium alginate disintegrant 0.5-15%.
2. The fast-dissolving oral film of entecavir according to claim 1, characterized in that it further comprises adjuvants, and the adjuvants are one or more of coloring agents, suspending agents and flavoring agents.
3. The instant oral entecavir film according to claim 2, characterized in that: the mass fraction of the colorant is 0.5-10%; the colorant is titanium dioxide and/or indigo.
4. The instant oral entecavir film of claim 2, wherein the mass fraction of the suspending agent is 0.5-10%; the suspending agent is microcrystalline cellulose and sodium carboxymethyl cellulose Mixture, gum arabic and tragacanth
One or more of them.
5. The instant oral entecavir film of claim 2, wherein the mass fraction of the corrective agent is 0.1-10%; the corrective agent is one of mannitol, sorbitol and stevioside Or several.
6. The entecavir oral instant film according to claim 2, characterized in that, based on its total weight, it comprises the following components in mass fraction: Entecavir 0.05-15%; polyvinyl alcohol/polyethylene glycol Branch copolymer 55-90%; Gan
Oil plasticizer 5-15%; Sodium alginate disintegrant 0.5-15%; Coloring agent 0.5-10%; Suspending agent 0.5-10%; Flavoring agent 0.1-10%.
7. The entecavir oral instant film according to claim 1, wherein the polyvinyl alcohol in the polyvinyl alcohol/polyethylene glycol graft copolymer accounts for 75% of the total weight of the graft copolymer, and polyethylene glycol The glycol accounts for 25% of the total weight of the graft copolymer.
8. The instant oral entecavir film of claim 1, wherein the polyvinyl alcohol/polyethylene glycol graft copolymer has a molecular weight of 45,000 Daltons.
9. A method for preparing entecavir oral instant film according to any one of claims 1-8, characterized in that it comprises the following steps:
(1) Mixing the polyvinyl alcohol/polyethylene glycol graft copolymer with water to obtain a polymer gel;
(2) Adding entecavir to the polymer gel, adding glycerin plasticizer and sodium alginate disintegrant to the polymer gel after mixing to obtain a drug-containing solution;
(3) The drug-containing solution is degassed and coated on a substrate, and dried at 40-60° C. to obtain the entecavir oral instant film.
10. The preparation method of entecavir oral instant film according to claim 9, characterized in that: before step (3), it further comprises the step of adding auxiliary materials, and the auxiliary materials are coloring agents, suspending agents and flavoring agents One or more of them.

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