Butorphanol Tartrate Injection and Its Preparation Method

By using colorless glass bottle packaging, passivation treatment and addition of antioxidant thiourea, the degradation problem of Butorphinol tartaric acid injection under light and oxidation conditions is solved, and the product is high stability and safety is achieved.

CN119770423BActive Publication Date: 2025-08-05CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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Patent Information

Application Number
CN202411967303.0
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-12-30
Publication Date
2025-08-05
Estimated Expiration
2044-12-30

AI Technical Summary

Technical Problem

The existing Butorphinol tartaric acid injection is prone to degradation under light and oxidation conditions, resulting in excess of impurities, affecting product quality stability and clinical use safety, and the leaching of metal ions in brown bottles cannot be completely avoided.

Method used

The stainless steel liquid dispensing tank and pipeline are packaged in the preparation process, the antioxidant thiourea is added, and sodium chloride and sodium tartrate buffer are used to control the pH between 3.0-5.0 to ensure the stability of the product under light.

Benefits of technology

It significantly reduces the generation of impurities under light, meets the single and total miscellaneous limits stipulated in the pharmacopoeia, avoids the instability of metal ions to the product, and improves the stability and safety of the product.

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Abstract

The present invention belongs to the field of pharmaceutical preparations, and particularly relates to a butorphanol tartrate injection and a preparation method thereof. Each milliliter of the butorphanol tartrate injection comprises: 2 mg of butorphanol tartrate, 0.18 - 2.2 mg of tartaric acid, 2.9 - 3.32 mg of sodium tartrate, 0.01 - 0.5 mg of antioxidant, 6.4 mg of sodium chloride and water for injection, and the pH is 3.0 - 5.0. The butorphanol tartrate injection prepared by the present invention solves the influence of light on the product quality through the synergistic effect of tartaric acid and a specific antioxidant, has good light stability, and at the same time avoids the influence of the leaching of metal ions in the brown glass bottle on the product quality during long-term storage of the product, significantly improves the stability of the product, and thus ensures the effectiveness and safety of the product.
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