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Stable amoxicillin and clavulanate potassium sustained release preparation and preparation technology

A technology of potassium clavulanate and slow-release preparations, which is applied to medical preparations containing active ingredients, pill delivery, antibacterial drugs, etc. It can solve the problems of increased incidence and loss of efficacy of antibiotics, and reduce the number of medications. Constant release rate and good stability

Active Publication Date: 2013-01-09
北京乐维生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Clinically, antibiotics such as penicillin are usually used to treat respiratory tract infections. However, due to the frequent and inappropriate use of antibiotics in recent years, the incidence of Streptococcus pneumoniae resistance to penicillin (the resistance mechanism is the change of penicillin-binding protein PBP) has increased. Antibiotics are gradually losing their effectiveness

Method used

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  • Stable amoxicillin and clavulanate potassium sustained release preparation and preparation technology
  • Stable amoxicillin and clavulanate potassium sustained release preparation and preparation technology
  • Stable amoxicillin and clavulanate potassium sustained release preparation and preparation technology

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Slow release layer:

[0027]

[0028]

[0029] Immediate release layer:

[0030]

[0031] The preparation method of the amoxicillin delayed-release preparation of the present invention is as follows, comprising: the quick-release layer amoxicillin and all potassium clavulanate and auxiliary materials are granulated by a dry method, and the slow-release layer amoxicillin and the sustained-release materials are prepared by a wet method. Granules, and finally use a double-layer tablet press for tableting and coating.

[0032] The preparation method of the preparation is as follows: the slow-release layer is granulated by wet method, the main drug amoxicillin and the slow-release material are mixed evenly, and then the adhesive is added, wet granulated, dried, and granulated to obtain the sustained-release layer granules for later use; Release layer: Mix the main drug amoxicillin and potassium clavulanate with auxiliary materials evenly, dry granulate, and dry und...

Embodiment 2

[0036] Slow release layer:

[0037]

[0038] Immediate release layer:

[0039]

[0040]

[0041] The preparation method is the same as in Example 1.

Embodiment 3

[0043] Slow release layer:

[0044]

[0045] Immediate release layer:

[0046]

[0047] The preparation method is the same as in Example 1.

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Abstract

The invention provides a stable amoxicillin and clavulanate potassium sustained release preparation, which is composed of a rapid-release layer and a slow-release layer. The weight ratio of amoxicillin to clavulanate potassium is 1000:62.5, the proportion of amoxicillin in the rapid-release layer and the slow-release layer is 1:1, all of clavulanate potassium is placed in the rapid-release layer, wherein the pharmaceutic auxiliary material comprises the following ingredients by weight: the ratio of amoxicillin to slow release material to lubricant to adhesive in the slow release layer is 500:140-150:5-10:16:23, the ratio of amoxicillin to clavulanate potassium to disintegrating agent to lubricant to coating powder in the rapid-release layer is 62.5:30-60:6-10:40-80. The amoxicillin and clavulanate potassium sustained release preparation has the characteristics of good stability, high curative effect, low side-effect incidence rate and reduced drug usage frequency.

Description

technical field [0001] The invention relates to a stable slow-release preparation of amoxicillin-clavulanate potassium, which can be made more effective and stable by adopting a double-layer tableting process. Background technique [0002] Respiratory tract infection is one of the most common infectious diseases, and acute sinusitis is one of upper respiratory tract infection diseases. According to statistics, more than 90% of all upper respiratory tract infection patients are accompanied by sinusitis symptoms of varying degrees. Foreign statistics show that the average number of acute sinusitis per person per year is 2 to 3 times, and the incidence rate is higher in urban areas with heavy air pollution. Adult community-acquired pneumonia is one of the lower respiratory tract infection diseases. As a common respiratory disease, it is very harmful. [0003] Clinically, antibiotics such as penicillin are usually used to treat respiratory tract infections. However, due to the ...

Claims

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Application Information

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IPC IPC(8): A61K31/43A61K31/424A61K9/24A61P31/04
Inventor 胡晶晶钟雪彬李新杰余丽丽薛泉
Owner 北京乐维生物技术有限公司
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