Norepinephrine bitartrate injection and preparation method thereof

By using amino acid antioxidants and N-(2-hydroxyethyl)-ethylenediamine triacetic acid trisodium salt in the injection, the high content of S-isomers, oxide impurities and sulfonates in the injection was solved, and the stability of the preparation and the safety of the drug were improved.

CN119367287BActive Publication Date: 2025-03-28成都硕德药业有限公司
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Patent Information

Application Number
CN202411943437.9
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-12-27
Publication Date
2025-03-28
Estimated Expiration
2044-12-27

AI Technical Summary

Technical Problem

The existing norepinephrine heavy tartaric acid injection has high content of S-isomer impurities, and the sulfonate impurities brought by sodium metabisulfite antioxidants are also high, resulting in changes in the color of the preparation and drug safety issues.

Method used

The amino acid antioxidants and N-(2-hydroxyethyl)-ethylenediamine triacetic acid trisodium salt are used as auxiliary materials to control the pH value of the injection solution to the range of 3.0 to 5.0, and avoid the use of sodium metabisulfite, thereby reducing the content of S-isomers, oxide impurities and sulfonate impurities.

Benefits of technology

The content of norepinephrine S-isomer impurities of heavy tartaric acid is effectively controlled, the production of oxidized impurities and sulfonated impurities is reduced, the color changes of the preparation and the risk of allergic reactions is avoided, and the stability of the injection and the safety of the medication are improved.

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Abstract

The invention belongs to the field of pharmaceutical preparations, and specifically relates to a norepinephrine bitartrate injection and a preparation method thereof. The injection comprises the following components: norepinephrine bitartrate, an amino acid antioxidant, N-(2-hydroxyethyl)-ethylenediaminetriacetic acid trisodium salt, sodium chloride and a remainder of water for injection. The invention solves the technical problems of high impurity content of S-isomer of norepinephrine bitartrate and high impurity content of sulfonate caused by sodium pyrosulfite antioxidant in the prior art, and achieves the technical effect of simultaneously controlling S-isomer impurities, oxide impurities and sulfonate impurities of norepinephrine bitartrate injection, while avoiding the allergic risk caused by the use of sodium pyrosulfite, thereby increasing the safety of medication.
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