Compound amoxicillin powder and production process thereof

Abstract

The invention belongs to the technical field of veterinary drugs and relates to compound amoxicillin powder and a production process thereof. The compound amoxicillin powder comprises the following components in percentage by weight: 15-18 percent of mixed powder with a ratio of 4:1 of amoxicillin to potassium clavulanate, 30-40 percent of mannitol, 0.5-1 percent of superfine silica powder and the balance of glucosum anhydricum. The production process comprises the following steps: controlling the temperature of a production environment to be 25 DEG C or below, controlling the relative humidity to be 20 percent or below, and performing the following operations: (1) respectively grinding mannitol, superfine silica powder and glucosum anhydricum, allowing the powder to pass through a sieve with the granularity of 80 meshes, mixing in a drying mixer at the temperature of 80+ / -5 DEG C for 1-2 hours, and naturally cooling to room temperature; (2) adding the mixed powder with the ratio of 4:1 of amoxicillin to potassium clavulanate into the drying mixer, and continuously mixing for 20-30 minutes; and (3) performing vacuum packaging by using an aluminum foil bag, and packaging by using a plastic aluminum composite bag. According to the invention, auxiliary materials are carefully selected, a relatively stable product is obtained through fewer auxiliary materials with high safety, and the prepared product is high in liquidity, low in moisture content and difficult in moisture absorption, can completely meet pharmacopoeia detection and accords with the national drug administration policy.

Description

technical field [0001] The invention belongs to the technical field of veterinary medicine, and in particular relates to a compound amoxicillin fraction, and also relates to a production process thereof. Background technique [0002] With the rapid development of my country's aquaculture industry and the irrational use of antibiotics, drug-resistant strains are gradually increasing. Bacteria develop resistance to antibiotics through a variety of pathways, among which the production of β-lactamase to hydrolyze the β-lactam ring in drugs (such as penicillins, cephalosporins, etc.) is the main method. Potassium clavulanate has a strong and broad-spectrum inhibitory effect on β-lactamase, and when used in conjunction with amoxicillin, it can inhibit β-lactamase to prevent amoxicillin from being destroyed, thus expanding the antibacterial spectrum of amoxicillin and enhancing Its antibacterial strength has the advantages of good curative effect and low incidence of side effects,...

AI Technical Summary

Problems solved by technology

[0003] However, potassium clavulanate has strong hygroscopicity and extremely poor stability. It is easy to change color, agglomerate, and reduce content in the form of powder.

At present, although some amoxicillin compound preparations are disclosed in the Chinese patent database, most of them are tablets or capsules, which have certain advantages for human use, but are very inconvenient for veterinary medicine

Patents such as CN103127099A and CN102614174A respectively provide dry suspensions of potassium amoxicillin and clavulanate. The production process of these preparations is cumbersome and there are too many auxiliary materials, and the water solubility is not very ideal, so it is not suitable for large-scale promotion

[0004] In addition, the transportation and storage environment of veterinary drugs is often relatively harsh, and factors such as rough loading and unloading and humid environment are inevitable

Therefore, the production of veterinary drugs with reference to the production methods of human drugs often cannot meet the demand

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