The application belongs to the technical field of pharmaceutical preparations, and particularly relates to a mononitrate
isosorbide oral dissolving film and a preparation method thereof. The mononitrate
isosorbide oral dissolving film preparation is composed of a
drug-containing layer and isolation
layers which are compounded on the upper and lower surfaces of the
drug-containing layer. The
drug-containing layer comprises the following raw materials in percentage by
mass:
cyclodextrin-encapsulated mononitrate
isosorbide 10-60%, film-forming material 20-80%,
plasticizer 0-20% and auxiliary material 0-10%. The
isolation layer comprises the following raw materials in percentage by
mass: film-forming material 70-100%,
plasticizer 0-30% and auxiliary material 0-10%. The mononitrate isosorbide oral dissolving film prepared by the application has the advantages of smooth appearance, good taste, uniform
drug content, rapid
dissolution under the action of
saliva after entering the mouth, and further release and absorption, which greatly improves the
drug administration compliance and solves the problem of surface
crystallization of mononitrate isosorbide after long-term storage.