A pharmaceutical composition of lornoxicam for injection and a preparation method thereof

By using sodium carbonate to adjust the pH and form a crystalline complex in lornoxicam injection, the stability and reconstitution issues of lornoxicam injection were solved, resulting in highly stable and low-irritation lyophilized lornoxicam powder injection suitable for large-scale production.

CN117224494BActive Publication Date: 2026-07-14XIAN LICAI PHARM R&D CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
XIAN LICAI PHARM R&D CO LTD
Filing Date
2023-10-21
Publication Date
2026-07-14

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Abstract

The application provides a lornoxicam pharmaceutical composition for injection and a preparation method thereof, the pharmaceutical composition comprising lornoxicam, sodium carbonate and water for injection, pH 9.5-11, and the specific crystalline compound of lornoxicam and sodium carbonate is formed by repeatedly annealing the lornoxicam solution in the pre-freezing step of the freeze-drying process, and the lornoxicam freeze-dried powder injection has the advantages of high stability, good reconstitution, high clarity after reconstitution and the like.
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