The present invention relates to the technical field of pharmaceutical preparations, and discloses a
menadione soft
capsule and a preparation method thereof, the
capsule comprises a
capsule shell and a content filled in the capsule shell, the content comprises the following substances by weight: 12%-20% of
menadione, 25%-38% of a surfactant, and the balance of an oily
solvent; the capsule shell comprises the following substances in percentage by weight: 30%-35% of a film-forming agent, 12.75%-17% of a
plasticizer, 15%-18% of an enteric-coated material, 2%-4% of a
metal ion chelating agent, 0.1%-1.0% of a pH
regulator, 0.2%-0.8% of an opacifying agent, 0.05%-0.1% of a coloring agent and the balance of
purified water; the
metal ion chelating agent is
aspartic acid; the film-forming agent is a composition of
sodium alginate and
gelatin. According to the scheme, the
menadione enteric soft capsule has enteric
solubility and
excellent preparation property, can be dissolved in acid under the condition that the menadione enteric soft capsule is not dissolved in
weak base, and is beneficial to improving absorption of menadione in small intestines, so that the
bioavailability is improved; and the crosslinking phenomenon in the long-term storage process can be reduced, so that the long-term storage of the product is facilitated.