Novel amoxicillin sodium compound and composition of amoxicillin sodium compound and sulbactam sodium compound

Abstract

The invention discloses a novel amoxicillin sodium compound. The purity of the amoxicillin sodium compound is more than 99%, the specific rotation of the amoxicillin sodium compound is between +260 degrees and +280 degrees. The invention also discloses a composition of the amoxicillin sodium compound and the sulbactam sodium compound, which comprises the following components in parts by weight: 50-100 parts of amoxicillin sodium, 25-50 parts of sulbactam sodium, 3-9 parts of vitamin C, 1-6 parts of proline, and 2-8 parts of nicotinamide. According to the composition of the amoxicillin sodium compound and the sulbactam sodium compound, the vitamin C, the proline and the nicotinamide are taken as stabilizers and play synergistic effect so as to improve the stability of the composition of the amoxicillin sodium compound and the sulbactam sodium compound effectively, the composition can be prepared into stable injection which is not easy to deteriorate due to oxygenolysis after being laid for a period, and the injection does not need to be prepared when being used, thus being convenient to use.

Description

technical field [0001] The invention relates to an amoxicillin sodium compound and a pharmaceutical composition thereof, in particular to a composition of an amoxicillin sodium compound and a sulbactam sodium compound. Background technique [0002] Amoxicillin sodium is a bactericidal broad-spectrum antibiotic, and sulbactam sodium is an irreversible broad-spectrum β-lactamase inhibitor, which can effectively inhibit the β-lactamase produced by drug-resistant bacteria. Clinically, many Gram-positive and Gram-negative bacteria produce β-lactamase, which can make amoxicillin lose its antibacterial activity. Due to the presence of sulbactam sodium, amoxicillin can be protected from the destruction of β-lactamase, so that the bacteria that have been resistant to amoxicillin and produce β-lactamase are still sensitive to amoxicillin. This product is a bactericidal antibiotic, which can kill a variety of Gram-positive and Gram-negative bacteria in clinical practice, especially fo...

AI Technical Summary

Problems solved by technology

[0003] Amoxicillin sodium sulbactam sodium pharmaceutical composition compound preparation has a large amount of clinical use, definite curative effect, and very good market prospect. Like most cephalosporin antibiotics, it is composed of amoxicillin sodium and sulbactam sodium aseptic raw materials. Subpackaged or freeze-dried, it has a common defect that the stability of the preparation is poor, and it cannot meet the quality requirements of the expiration date

Existing amoxicillin sodium sulbactam sodium compositions are generally lyophilized powder injections, which are mixed and dissolved in sterile powders and used in injection solvents during use, which not only causes the possibility of secondary infection and inaccurate dosage, but also It needs to be prepared at the same time as it is used. If it is left for a long time, the active ingredients will be oxidized and decomposed, which will affect the use of patients.

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