Amoxicillin granule with stable quality

Abstract

The invention relates to an amoxicillin granule with stable quality and a preparation method thereof and belongs to the technical field of medicine. The preparation is prepared from amoxicillin and auxiliary materials through a wet granulation technology; the amoxicillin granule contains a diluent, an adhesive, a disintegrating agent, a colorant and a smell masking agent and does not contain ethylalcohol; after a long-term stability test for 36 months, the content of each specific impurity is not higher than 0.07%, and stability of the medicine in a storage period is ensured. According to a preparation technology, a low-temperature drying technology is utilized; thus, stability of the amoxicillin granule in a production process is ensured.

Description

technical field [0001] The invention relates to a granule preparation, in particular to an amoxicillin granule with stable quality and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Amoxicillin was developed by British Beecham Company (now GSK) in 1968. The basic compound patent is GB978178A (application date 1962.11.2), and it was first listed in the UK in 1972 and listed in the United States in 1974. Because of its good absorption and curative effect, and generally not easy to relapse after treatment, the World Health Organization recommends amoxicillin as the first choice of β-lactam oral antibiotics, and it still occupies an important position in oral antibiotics so far. [0003] Amoxicillin granules have the advantages of convenient administration and good patient compliance, and are widely used in children's respiratory system, urogenital system, and digestive system infections. Granules are only marketed in C...

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to solve the problems of poor stability of amoxicillin granules in storage and easy generation of degraded impurities. By controlling the amount of sugar in the prescription, adding a specific amount of dextrin and guar gum, and using low-temperature and long-term drying techniques , so as to provide an amoxicillin granule preparation, which can reduce the content of specific impurities, and can keep the content of specific impurities increasing slowly after the drug is placed for a long time, which is conducive to the long-term stability of the preparation, thereby ensuring the safety of the drug

Images