Preparation method of amoxicillin sodium and clavulanate potassium for injection

Abstract

The invention provides a preparation method of amoxicillin sodium and clavulanate potassium for injection. An amoxicillin sodium and clavulanate potassium powder-injection manufactured by using the method disclosed by the invention is simple in production process, safe and reliable, and stable in product quality, and the period of validity is up to 24 months, therefore, the amoxicillin sodium and clavulanate potassium powder-injection is applicable to mass industrial production.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a preparation method of a penicillin pharmaceutical composition, in particular to a preparation method of amoxicillin sodium clavulanate potassium for injection. Background technique [0002] Amoxicillin (Amoxicillin), also known as amoxycillin or amoxycillin, is a semi-synthetic broad-spectrum penicillin antibiotic. The chemical name of amoxicillin is (2S,5R,6R)-3,3-dimethyl-6-[(R)-(-)-2-amino-2-(4-hydroxyphenyl)etheramino] -7-Oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate, molecular formula C 16 h 19 N 3 o 5 S·3H 2 O, molecular weight 419.46. Its chemical structural formula is as follows: [0003] [0004] Amoxicillin (or its sodium salt) is a β-lactam antibiotic, a white powder with a half-life of about 61.3 minutes. Amoxicillin has the characteristics of wide antibacterial spectrum, strong bactericidal ability in vivo, good absorption (75-90%), and short p...

AI Technical Summary

Problems solved by technology

The disadvantage of the solid-phase mixing method is that it is difficult to really mix the amoxicillin sodium and clavulanate potassium evenly, resulting in uneven packaging and difficulty in unifying the quality standards

In addition, solid-phase mixing has high requirements on raw materials and the environment, and the organic solvent residues in the raw material preparation process are also difficult to remove

CN100464750C discloses a method for preparing a drug mixture containing amoxicillin sodium and potassium clavulanate. The method adopts supercritical fluid technology to prepare micropowder. It needs water or methanol as a solvent in the preparation process. Because potassium clavulanate It has hygroscopicity and poor stability. During the preparation process, there will be a certain amount of water residue or organic solvent residue. In addition, the supercritical method has a sharp change in the physical properties of the fluid, which affects its stability and safety.

Freeze-drying is a commonly used method for preparing powder injections, but it is generally believed that the use of amoxicillin sodium clavulanate potassium is difficult to effectively remove water, poor stability, easy to produce insoluble particles, and the content of related substances exceeds the standard

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