The application belongs to the technical field of pharmaceutical preparations, and discloses a soft
capsule preparation containing
alfacalcidol and a preparation method thereof. The soft
capsule preparation comprises a soft
capsule shell and content filled in the soft capsule shell, and the content is composed of a
drug-containing
oil phase and
alfacalcidol sustained-release
pellets dispersed in the
oil phase. The
drug-containing
oil phase comprises immediate-release
alfacalcidol dissolved in an oily base. The sustained-release
pellets comprise a blank pellet core, a
drug-loaded layer and a separation layer, and the separation layer comprises a combined
coating material of Eudragit RS30D and Eudragit RL30D. After
oral administration, the alfacalcidol in the oil phase is rapidly released to achieve immediate effect, and the alfacalcidol in the sustained-release
pellets is slowly released to maintain the
steady state of
blood drug concentration. The soft capsule preparation of the application realizes the dual-phase
drug release behavior of
immediate release and sustained release in the same soft capsule, so that the
blood drug concentration is smooth and controllable within 24 hours, the
steady state of
blood drug concentration is maintained, the frequency of
drug administration is reduced, and the risk of side effects such as hypercalcemia is reduced.