Polypeptide drug preparation and preparation method thereof

Abstract

The invention discloses a polypeptide drug preparation with a mixture of citric acid and carbonate as a buffer salt system. The preparation comprises a GLP-1 analog, a buffer agent, an isotonic adjusting agent or a stabilizer and a preservative. The polypeptide drug preparation has the advantages that the pH (potential of hydrogen) of the polypeptide drug preparation is stabilized at a high level with a little amount of buffer salt, meanwhile, the buffer salt can reduce aggregation, degradation, oxidation and sedimentation of the GLP-1 analog, and the stability of the drug preparation is guaranteed in the transportation and storage processes. The invention further discloses a method for preparing the polypeptide drug preparation.

Description

technical field [0001] The present invention belongs to the field of GLP-1 analog pharmaceutical preparations, in particular to GLP-1 analog pharmaceutical preparations prepared in a buffer salt system composed of citrate and carbonate, more specifically to liraglutide pharmaceutical preparations and its preparation method. Background technique [0002] Glucagon-like peptide-1 (GLP-1) is a glucose-dependent incretin hormone secreted by L cells of the terminal jejunum, ileum, and colon. GLP-1 has multiple physiological effects on the human body: first, GLP-1 can act on the β cells of the pancreas, induce insulin secretion in a glucose concentration-dependent manner, improve the sensitivity of β cells, and promote the synthesis of insulin; it has also been found by animal experiments GLP-1 can increase the amount of β cells; GLP-1 can also act on α cells and inhibit the secretion of glucagon. Therefore, GLP-1 can effectively reduce blood sugar without increasing the occurrenc...

AI Technical Summary

Problems solved by technology

However, in the transportation and storage environment, the preservation of drugs cannot meet the above requirements. Drugs are easily affected by the environment, such as adsorption, degradation, aggregation, oxidation and other changes that affect drug stability, resulting in drug impurities and reducing drug purity.

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