Compound amoxicillin and clavulanate potassium tablet and preparation method thereof

Abstract

The invention relates to a compound amoxicillin and clavulanate potassium tablet and a preparation method thereof. The tablet consists of the following components in percentage by weight: 15 to 30 percent of amoxicillin, 5 to 15 percent of a clavulanate potassium mixture, 30 to 65 percent of a filler, 1.5 to 8 percent of crosslinked povidone, 0.6 to 3 percent of povidone K30, 1 to 3 percent of silica and 1 to 5 percent of glyceryl behenate. The preparation method comprises the following steps: adding the amoxicillin, the filler and the crosslinked povidone into a pelletizer, mixing and adding an adhesive in a mixing process; and adding the prepared amoxicillin granules and clavulanate potassium mixture, the silica and the glyceryl behenate into a mixing machine, mixing, discharging and tabletting. Although the compound amoxicillin and clavulanate potassium tablet adopts a half-wet method to pelletize, the clavulanate potassium is unlikely to degrade, so that the stability of a medicine is guaranteed effectively.

Description

technical field [0001] The invention relates to a medicine and a preparation process of the medicine, especially a tablet, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Amoxicillin and Clavulanate Potassium Tablets are compound preparations composed of Amoxicillin and Clavulanate Potassium, in which Amoxicillin is a spectrum penicillin antibiotic, and Clavulanate Potassium itself has only weak antibacterial activity, but has a strong spectrum β-lactamase hydrolysis. In vitro antibacterial studies have shown that clavulanic acid can increase the antibacterial activity of amoxicillin against Klebsiella vulgaris Proteus and a small number of intestinal enzyme-producing bacteria by 4 to 32 times, and increase the antibacterial activity against Haemophilus influenzae by 32 times. Amoxicillin has 4 to 32 times the antibacterial activity against Canamola. Clinical application also shows that the amoxicillin-clavulanate potassiu...

AI Technical Summary

Problems solved by technology

In this preparation method, after mixing amoxicillin granules and potassium clavulanate, all auxiliary materials are added by an equal amount incremental method for mixing. The mixing time is relatively long, the requirements for adding materials are relatively strict, and it is difficult to control the stability of the process.

[0006] Both of the above are typical dry granulation tableting methods, which are widely used in the preparation of compound amoxicillin-clavulanate potassium tablets, but the tablets produced by the dry granulation tableting method will cause crystal transformation and The activity is reduced, which affects the stability of the tablet. In addition, it is particularly prone to phenomena such as capping and sticking, and the appearance of the tablet is not ideal.

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