An alfacalcidol soft capsule composition and a method for preparing the same

By combining alfacalcidol eutectic with an oily matrix and using gelatin and compound plasticizers as the soft capsule shell material, the problems of shell aging and delayed dissolution of alfacalcidol soft capsules during long-term storage have been solved, achieving improved stability and solubility, making it suitable for industrial production.

CN120983375BActive Publication Date: 2026-03-17QINGDAO DOUBLE WHALE PHARMA
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Patent Information

Application Number
CN202511106884.3
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-08-08
Publication Date
2026-03-17
Estimated Expiration
2045-08-08

AI Technical Summary

Technical Problem

Existing alfacalcidol soft capsules suffer from disintegration and delayed dissolution due to cross-linking and aging of the capsule shell during long-term storage, which affects the efficacy of the drug. Furthermore, existing technologies have not been able to effectively solve this problem.

Method used

Alfacalcidol eutectic is combined with an oily matrix, and gelatin and plasticizer (a combination of glycerol, erythritol and glycine) are used as the shell material. A stable eutectic structure is formed through hydrogen bonds and non-covalent bonds, which enhances the barrier properties and antioxidant properties of the shell and inhibits the aging of the shell.

Benefits of technology

It improves the stability and solubility of alfacalcidol soft capsules, delays shell aging, ensures long-term stability of efficacy and dissolution rate, and is suitable for industrial production.

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Abstract

The present application relates to the field of new drug preparations, and specifically discloses a kind of alfacalcidol soft capsule composition and preparation method thereof, the alfacalcidol soft capsule composition is prepared from alfacalcidol content drug liquid and soft capsule shell, wherein the soft capsule content drug liquid includes alfacalcidol co-crystal, oily base, the soft capsule shell is made of gelatin, plasticizer, purified water and light shielding agent;The alfacalcidol soft capsule composition prepared by the present application has high stability, and improves the problems of low solubility of raw material, easy oxidation and poor water solubility, the preparation method of the alfacalcidol soft capsule composition is simple and easy to operate, low in cost, and easy to mass production.
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