Preparation method of amoxicillin and clavulanate potassium tablets

Abstract

The invention discloses a preparation method of amoxicillin and clavulanate potassium tablets. The method comprises the following steps of mixing and drying amoxicillin compacted powder, microcrystalline cellulose and colloidal silicon dioxide, and stopping until the water activity of mixed powder is less than 0.05 aW to obtain mixed powder I; adding a mixed raw material of clavulanate potassium and the microcrystalline cellulose, sodium carboxymethyl starch, the colloidal silicon dioxide and the microcrystalline cellulose into the mixed powder I, and performing mixing to obtain mixed powder II; adding magnesium stearate into the mixed powder II and performing mixing to obtain mixed powder III; directly tabletting the mixed powder III to obtain amoxicillin and clavulanate potassium tablets; and taking the pressed amoxicillin and clavulanate potassium tablets as tablet core coatings to obtain the finished amoxicillin and clavulanate potassium tablets, wherein the mass ratio of amoxicillin to clavulanic acid is 7:1, and a coating solvent adopts a mixed solution of isopropanol and dichloromethane. According to the invention, the amoxicillin and clavulanate potassium tablet product with good stability and dissolution rate is obtained by improving a component combination relationship and the preparation process.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a preparation method of amoxicillin-clavulanate potassium tablet. Background technique [0002] Amoxicillin and clavulanate potassium are suitable for lower respiratory tract infection, otitis media, and sinusitis caused by β-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis; β-lactamase-producing Staphylococcus aureus and enzyme-producing intestinal Bacteriaceae bacteria such as Escherichia coli, Klebsiella caused by urinary tract and skin and soft tissue infections; it can also be used for mild and moderate infections caused by Enterococcus. This product can also be used for the above-mentioned various infections caused by non-enzyme-producing strains of the above-mentioned bacteria. [0003] The dry granulation tableting method is widely used in the preparation of compound amoxicillin-clavulanate potassium tablets, but the tablet produced by the dry granul...

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Problems solved by technology

[0003] The dry granulation tableting method is widely used in the preparation of compound amoxicillin-clavulanate potassium tablets, but the tablet produced by the dry granulation tableting method will cause crystal transformation and activity reduction due to high pressure and high temperature, which is harmful to the tablet. Improving the stability of tablets has always been the key work of various research breakthroughs; and the dry granulation and tabletting method has many overall processes and the operation is relatively cumbersome

[0004] Although the powder direct compression method avoids the granulation process, it can save time and energy, the process is simple, the process is less, and it is suitable for drugs with unstable moisture and heat. Tablets are prone to cracks and other weaknesses, and the appearance of the tablet is not ideal, which limits the application of this process; in addition, the tablet amoxicillin and clavulanate potassium obtained by conventional powder direct compression has poor stability and slow dissolution. Insufficient to reference preparations etc.

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