Unlock instant, AI-driven research and patent intelligence for your innovation.

Amoxicillin and potassium clavulanate capsule drug composition

A technology of amoxicillin sodium and clavulanate potassium and clavulanate potassium, which is applied in the field of amoxicillin sodium and clavulanate potassium capsule pharmaceutical composition, and can solve the problems of high content, unfavorable clinical use stability and drug efficacy stability and other problems, to achieve the effect of uniform particle size distribution, simple and comprehensive matching, and reduce the amount of related substances

Inactive Publication Date: 2014-12-24
SICHUAN PHARMA
View PDF1 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, the existing amoxicillin and clavulanate potassium preparations contain relatively high levels of impurities in related substances, which is not conducive to the stability of clinical use and the stability of drug efficacy

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Amoxicillin sodium clavulanate potassium capsule pharmaceutical composition comprises following components by weight:

[0025] Amoxicillin 12.0

[0026] Potassium clavulanate 3.0

[0027] Microcrystalline cellulose 11.5

[0028] Magnesium stearate 0.2.

[0029] The specific rotation of amoxicillin is +290°.

Embodiment 2

[0031] Amoxicillin sodium clavulanate potassium capsule pharmaceutical composition comprises following components by weight:

[0032] Amoxicillin 12.48

[0033] Potassium clavulanate 3.12

[0034] Microcrystalline Cellulose 12.0

[0035] Magnesium stearate 0.4.

[0036] The specific rotation of amoxicillin is +306°.

Embodiment 3

[0038] Amoxicillin sodium clavulanate potassium capsule pharmaceutical composition comprises following components by weight:

[0039] Amoxicillin 14.6

[0040] Potassium clavulanate 3.65

[0041] Microcrystalline Cellulose 12.0

[0042] Magnesium stearate 0.6.

[0043] The specific rotation of amoxicillin is +295°.

[0044] Above embodiment all can adopt following preparation method, comprise the following steps:

[0045] (1) Preparation of potassium clavulanate: Slowly add the crude potassium clavulanate dropwise into the lower alcohol that has been dissolved in a small amount of potassium clavulanate crystals in advance, and keep stirring. When precipitation occurs, let it stand for 1-2 hours Then add the same amount of clavulanic acid potassium crystals as before, continue to stir for 5-10min, and then let it stand for 0.5-1h, control the entire ambient temperature during this process to 10-18°C, and then vacuum vacuum and dry to obtain clavulanic acid The pure potassi...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
Specific rotationaaaaaaaaaa
Specific rotationaaaaaaaaaa
Login to View More

Abstract

The invention discloses an amoxicillin and potassium clavulanate capsule drug composition which contains a few of auxiliary materials. A medicament is prepared by selecting amoxicillin powder and potassium clavulanate powder which have certain specific rotation as main materials, so that a preparation with dissolution rate of over 85% can be obtained; the impurity content of related substances of amoxicillin and potassium clavulanate in production and storage processes is reduced, so that the stability and drug effect persistence of the amoxicillin are ensured.

Description

technical field [0001] The invention relates to the field of pharmaceutical production, in particular to a pharmaceutical composition of amoxicillin sodium clavulanate potassium capsules. Background technique [0002] Amoxicillin and Clavulanate Potassium is a compound preparation composed of the β-lactam inhibitor Clavulanate Potassium and the semi-synthetic penicillin Amoxicillin. Amoxicillin is a bactericidal broad-spectrum antibiotic, and potassium clavulanate is an irreversible broad-spectrum β-lactamase inhibitor, which can effectively inhibit the β-lactamase produced by drug-resistant bacteria. Satisfactory curative effect has been achieved clinically. [0003] However, the existing amoxicillin and clavulanate potassium preparations contain relatively high levels of impurities in related substances, which is unfavorable for the stability of clinical use and the stability of drug efficacy. In the actual application process, there is an urgent need for an amoxicillin...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): A61K31/43A61K9/48A61K47/38A61K47/12A61K31/424
Inventor 王强张静文刘萍
Owner SICHUAN PHARMA