A kind of amoxicillin tablet and preparation method thereof

Abstract

The invention relates to an amoxicillin tablet with reliable quality and a preparation method thereof, and belongs to the technical field of medicine. The preparation is prepared from amoxicillin, internal adjuvant materials and external adjuvant materials; the internal adjuvant materials include croscarmellose sodium, sucrose and hydroxypropyl cellulose (L); the external adjuvant materials include the external adjuvant material A, the external adjuvant material B and the external adjuvant material C, wherein the external adjuvant material A is croscarmellose sodium, the external adjuvant material B is magnesium stearate, and the external adjuvant material C is one of optional cellulose acetate, microcrystalline cellulose and sodium lauryl sulfate. The preparation has excellent dissolutioncharacteristics, the stability of the preparation is also well improved, and thus the effectiveness and safety of medication are guaranteed.

Description

technical field [0001] The invention relates to a tablet preparation, in particular to an amoxicillin tablet with reliable 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 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 tablets are suitable for respiratory tract infections, urogenital tract infections, and skin and soft tissue infections caused by sensitive bacteria. When the existing amoxicillin tablet product is subjected to an in vitro dissolut...

AI Technical Summary

Problems solved by technology

When the existing amoxicillin tablet products are subjected to in vitro dissolution tests, flocculent precipitation will occur, which directly affects the dissolution effect of the active ingredient amoxicillin, thereby affecting the effective absorption and utilization of the drug in the human body

In addition, the quality standards for amoxicillin tablets are not currently included in the Japanese Pharmacopoeia; the quality standards for amoxicillin tablets are included in the Chinese Pharmacopoeia, and the dissolution test method uses the paddle method, 900mL water medium, 100 rpm, ultraviolet light - Determination by visible spectrophotometry; the United States Pharmacopoeia has also included the quality standards of amoxicillin tablets, wherein the detection method of dissolution adopts paddle method, 900mL water medium, 75 rpm, UV-visible spectrophotometry, but These dissolution test conditions cannot accurately and truly reflect the in vitro release behavior of amoxicillin tablets, and the influence of formulation or process variables on in vitro release cannot be effectively distinguished

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