| 摘要 |
A controlled release formulation, particularly a controlled release formulation with zero-order release, comprising: (1) a core containing at least one drug; (2) a controlled release coating membrane coated outside of the core. The controlled release coating membrane comprises at least one polymer insoluble in water and gastrointestinal digestive fluid and a cyclodextrin derivative, wherein the cyclodextrin derivative is a water-soluble cyclodextrin derivative with an average substitution value (or DS) of no less than 5 of the hydroxyl group on each glucose unit, and disperses in the controlled release coating membrane in single molecular form and/or in micellar form. The drug release from the controlled release formulation is relatively less affected in vivo and in vitro and is relatively faster with a relatively smaller time lag. The bioavailability of the drug is higher, the stability of the drug release is increased, and the mechanical strength of the controlled release coating membrane of the formulation is also increased.
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