Amoxicillin capsule and preparation method thereof

Abstract

The invention provides an amoxicillin capsule and a preparation method thereof, and belongs to the technical field of medicine preparation. 10 to 35 wt% of amoxicillin calomel with the particle size being smaller than 0.180 mm, 10 to 40 wt% of amoxicillin heavy powder with the particle size being 0.600 to 0.850 mm and the balance of amoxicillin heavy powder with the particle size being 0.180 to 0.600 mm are taken and subjected to heavy powder mixing, then the mixture and magnesium stearate are alternately fed and mixed, then filling and polishing are conducted, and the amoxicillin capsule is obtained. The amoxicillin capsule with high stability and good dissolution rate is obtained by adjusting the particle size ratio of the amoxicillin powder and increasing the dosage of the amoxicillin calomel without limiting the minimum particle size of the calomel, but limiting the maximum particle size of the heavy powder.

Description

technical field [0001] The invention relates to the preparation of capsules, in particular to an amoxicillin capsule and a preparation method thereof. Background technique [0002] Amoxicillin, also known as amoxycillin or amoxycillin, is the most commonly used semi-synthetic penicillin broad-spectrum β-lactam antibiotics, clinically used to treat tonsillitis, laryngitis, pneumonia, chronic bronchitis, urinary Systemic infection, skin and soft tissue infection, suppurative pleurisy, hepatobiliary system infection, sepsis, typhoid fever, dysentery, etc. At present, oral dosage forms of amoxicillin mainly include tablets, capsules, granules, etc., and amoxicillin capsules are mainly used clinically as a therapeutic drug. [0003] Due to the poor solubility of amoxicillin, which is slightly soluble in water and insoluble in ethanol, the amoxicillin capsules made have the problem of poor dissolution. The poor dissolution rate further limits the in vivo absorption of amoxicilli...

AI Technical Summary

Problems solved by technology

However, in order to ensure the stability of the drug, this technical solution uses amoxicillin heavy powder to prepare capsules, but due to the relatively large particle size of amoxicillin heavy powder, there is a phenomenon of uneven mixing, and this technical solution lacks disintegrants, etc. Excipients, resulting in poor dissolution rate of prepared amoxicillin capsules

[0005] A Chinese invention patent application with publication number CN109172539 A discloses a kind of amoxicillin capsule and its production method and application. In order to improve the dissolution rate of amoxicillin, the technical scheme adjusts the ratio of amoxicillin heavy powder and light powder , increased the amount of light powder, but clearly restricted the amount of light powder and the minimum particle size. It is difficult to mix, and the increase in the amount of light powder will make it more difficult to mix light powder and heavy powder. The light powder aggregates, and the specific surface area of ​​the aggregated part of the light powder is large, and the increase in the specific surface area will cause it to contact with water. The probability increases, thereby increasing the impurities, and the stability of the amoxicillin capsules produced is poor

[0006] Publication No. CN109953971 A Chinese invention patent application discloses a preparation method of amoxicillin capsules, which uses amoxicillin heavy powder of 20 to 60 mesh and amoxicillin light powder of more than 60 mesh to mix. The amount of amoxicillin light powder above 60 mesh is specified and the minimum particle size is not limited, but it defines amoxicillin powder above 60 mesh as light powder, and 20 and 60 mesh sieves are used as rotary vibrating sieves during the granulation process The number of sieve meshes, the amount of light powder above 80 meshes contained in the amoxicillin light powder prepared in this way will be significantly reduced in essence. In this way, the technical scheme reduces the difficulty of mixing heavy powder and light powder, thereby improving The stability of amoxicillin capsules, but its dissolution rate needs to be improved

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