Pharmaceutical composition
By using a combination of ascorbate palmitate and organic acids in the pharmaceutical composition, the problems of instability and impurity generation during long-term storage are solved, resulting in higher stability and lower impurity content, simplifying the production process and reducing costs.
Patent Information
- Application Number
- CN202510715248.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2024-06-03
- Filing Date
- 2025-05-30
- Publication Date
- 2025-12-05
AI Technical Summary
Existing drug compositions are unstable during long-term storage and are prone to impurities, which affect drug quality. Existing antioxidants such as tocopherol are inconvenient to use and costly, and it is difficult to guarantee long-term stability.
By combining ascorbate palmitate and organic acids such as citric acid hydrate or tartaric acid with active substance compound I or its monobenzene sulfonate, the stability of the drug composition is improved through a specific ratio and type of antioxidant combination, especially the inhibition of the formation of impurity Ia.
It significantly improves the long-term stability of the drug composition, reduces the content of impurity Ia, meets the pharmacopoeia quality control requirements, simplifies the production process, and reduces costs.