A hyaluronidase freeze-dried preparation and preparation method thereof

By using citric acid-sodium citrate buffer system, trehalose protector, Tween-80 surfactant, polyvinylpyrrolidone, calcium chloride stabilizer in hyaluronidase lyophilized preparations, and using annealing procedure during lyophilization, the problem of hyaluronidase is easily deactivated in long-term storage is solved, and the high activity and stability of the preparation is achieved.

CN119746046APending Publication Date: 2025-04-04HEFEI KNATURE BIO PHARM CO LTD
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Patent Information

Application Number
CN202411990339.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-31
Publication Date
2025-04-04

AI Technical Summary

Technical Problem

Hydrotriidase is prone to inactivate in long-term storage, resulting in a decrease in the stability and activity of the formulation, which is difficult to meet clinical needs.

Method used

Citric acid-sodium citrate is used as the buffer system, trehalose is used as the lyophilized protective agent, Tween-80 is used as the surfactant, polyvinylpyrrolidone and calcium chloride are used as the stabilizer, and the annealing temperature is optimized during the lyophilization process, and the annealing procedure is used in the prefreezing process.

Benefits of technology

The activity and stability of hyaluronidase lyophilized preparations are improved, ensuring that the preparations maintain high activity and quality stability in long-term storage, and the production process is controllable and expandable.

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Abstract

The invention belongs to the field of pharmaceutical preparations, and specifically relates to a hyaluronidase freeze-dried preparation and a preparation method thereof. The hyaluronidase freeze-dried preparation uses citric acid-sodium citrate as a buffer system, trehalose as a freeze-drying protective agent, Tween-80 as a surfactant, polyvinyl pyrrolidone and calcium chloride as stabilizers, and an annealing procedure is adopted in a pre-freezing process during the freeze-drying process to optimize the annealing temperature, thereby solving the stability problem of hyaluronidase being easily inactivated during long-term storage. The prepared hyaluronidase freeze-dried preparation has high activity, stable quality, can be stored for a long time, and is controllable in production and can be scaled up for production.
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