一种维生素B2注射液组合物及其制备方法

By mixing a eutectic solvent formed from malic acid, citric acid, and propylene glycol with zein, the photodegradation problem of vitamin B2 injection was solved, achieving high photostability and efficacy retention.

CN121287616BActive Publication Date: 2026-07-17山西晟泽元生物科技有限公司

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
山西晟泽元生物科技有限公司
Filing Date
2025-12-03
Publication Date
2026-07-17

AI Technical Summary

Technical Problem

Vitamin B2 injection is easily degraded under light conditions, and existing technologies cannot effectively improve its photostability at the molecular level, leading to loss of efficacy and safety risks during production, storage, and clinical use.

Method used

A eutectic solvent was prepared using malic acid, citric acid, and propylene glycol. This solvent was used to mix zein and sodium riboflavin phosphate to form a vitamin B2 injection composition. The photostabilizing effect of zein protected the sodium riboflavin phosphate molecules.

Benefits of technology

It significantly improves the photostability of vitamin B2 injection, reducing the degradation rate to 2.18%, effectively avoiding photochemical reactions and ensuring efficacy and safety.

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Abstract

本发明属于药物制剂技术领域,涉及一种维生素B2注射液组合物及其制备方法。本发明提供了一种维生素B2注射液组合物的制备方法,其包括:将苹果酸、柠檬酸和丙二醇混合,加热至80~90℃并不断搅拌直至形成透明液体;在避光条件下向所述透明液体中加入玉米醇溶蛋白和核黄素磷酸钠,在25~30℃下保温反应至少30s制得原液;将所述原液、助剂和水混合,制得pH值为4.5~6.5的维生素B2注射液组合物。本发明采用苹果酸、柠檬酸和丙二醇制得低共熔溶剂,实现玉米醇溶蛋白和核黄素磷酸钠混合均一,制得维生素B2注射液组合物具有较好的光稳定性。
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