Amoxicillin and potassium clavulafiate oil suspension and preparation method thereof

A technology of potassium clavulanate and oil suspension, applied in the field of medicine, can solve the problems of poor redispersibility, easy agglomeration, unusable medicines and the like

Inactive Publication Date: 2017-01-04
CHENGDU QIANKUN VETERINARY PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the experiment, it was found that the above-mentioned oil suspension was easy to agglomerate after centrifugation or long-term storage, and the redispersibility was poor, which made the medicine unusable

Method used

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  • Amoxicillin and potassium clavulafiate oil suspension and preparation method thereof
  • Amoxicillin and potassium clavulafiate oil suspension and preparation method thereof
  • Amoxicillin and potassium clavulafiate oil suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1 The preparation of amoxicillin-clavulanate potassium oil suspension of the present invention

[0024] Take 40ml of soybean oil, add 30ml of benzyl benzoate (or 30ml of isopropyl myristate), heat (60°C-70°C) and mix well, then add colloidal protective agent (magnesium aluminum silicate magnesium stearate 1:1 Mixture 1.0g), then add suspending agent (poloxamer 188 5.0g, polyethylene glycol 6000 2.5g) after melting, stir evenly, add surfactant (soybean lecithin 0.3g, Tween-80 0.3g and Ban-80 0.3g), after cooling to room temperature (15~25℃), add suspending agent (5.0g sodium carboxymethylcellulose), stir evenly, add 14g amoxicillin and 3.5g potassium clavulanate, stir evenly Afterwards, set the volume to 100ml with soybean oil and homogenize to obtain the amoxicillin sulfate colistin sulfate oil suspension of the present invention.

[0025] The beneficial effects of the present invention are demonstrated through experimental examples below.

[0026] 1 materi...

experiment example 1

[0040] The influence of experimental example 1 oil phase type on the quality of amoxicillin clavulanate potassium suspension

[0041] Soybean oil, rapeseed oil, peanut oil, corn oil, white oil, ethyl oleate, benzyl benzoate, isopropyl myristate, soybean oil-benzyl benzoate (volume ratio 50%: 50%) , soybean oil-isopropyl myristate (volume ratio 50%: 50%), soybean oil-ethyl oleate (volume ratio 50%: 50%) are used as the oil phase, and the surfactant Span-80 ( 5% w / v), antioxidant p-hydroxytert-butyl anisole (BHA) (0.02% w / v), thickener aluminum stearate (1% w / v) and main drug amoxicillin (14% w / v), potassium clavulanate (3.5% w / v) to prepare different suspensions, and investigate their sedimentation volume ratio, needle penetration, and dispersion after centrifugation. The results are shown in Table 1.

[0042] Table 1 adopts different kinds of oil phases to prepare the quality evaluation result of suspension

[0043]

[0044] It can be concluded from Table 1 that the amoxi...

experiment example 2

[0045]The influence of the composition ratio of experimental example 2 composite oil phase on the quality of amoxicillin clavulanate potassium suspension

[0046] Composite oil phases were prepared according to the ratio shown in Table 2, and combined with surfactant Span-80 (5% w / v), antioxidant p-hydroxytert-butyl anisole (BHA) (0.02% w / v), Thickener aluminum stearate (1% w / v) and the main drug amoxicillin (14% w / v), potassium clavulanate (3.5% w / v) to prepare different suspensions, and investigate their sedimentation volume See Table 2 for the results of ratio, puncture, and dispersion after centrifugation.

[0047] Table 2 prepares the quality evaluation results of the suspension according to the composition ratio of different composite oil phases

[0048]

[0049] Can draw in conjunction with the test result of table 1 and table 2, when benzyl benzoate, isopropyl myristate and soybean oil prepare composite oil phase respectively, benzyl benzoate ratio is 30%-50%v / v, ...

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Abstract

The invention discloses an oil suspension. Per 100mL of the oil suspension is prepared from the following raw auxiliary materials: 14g of amoxicillin, 3.5g of potassium clavulafiate, 0.9-1.0g of a surfactant, 1.0-4.0g of a colloid protective agent, 3.0-15.0g of a suspending agent and the balance of an oil phase. Under the conditions of specific varieties and dosage proportion of auxiliary materials, the suspension prepared by the preparation method is favorable in physical stability, warming promotion property and redispersion property, and has no quality reduction situation even if being stored in an environment at a temperature of 4-60 DEG C for three months, which indicates that the quality is stable.

Description

technical field [0001] The invention relates to amoxicillin-clavulanate potassium oil suspension and a preparation method thereof, belonging to the field of medicine. Background technique [0002] Amoxicillin, also known as amoxycillin or amoxycillin, is a white powder with a half-life of about 61.3 minutes, stable under acidic conditions, and a gastrointestinal absorption rate of 90%. Amoxicillin has a strong bactericidal effect and a strong ability to penetrate cell membranes. It is one of the most commonly used broad-spectrum β-lactam antibiotics, but it is unstable to β-lactamase. Clavulanic acid is an irreversible β-lactamase inhibitor. When used in combination with amoxicillin, it can protect amoxicillin from β-lactamase hydrolysis, and significantly enhance the antibacterial effect and broaden the antibacterial spectrum of amoxicillin. [0003] Amoxicillin and potassium clavulanate are often prepared into a compound according to the ratio of 14:3.5, which is mainly u...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/43A61K31/424A61K47/44A61K47/34A61K47/38A61K47/26A61K47/14
CPCA61K9/0019A61K9/10A61K31/424A61K31/43A61K47/10A61K47/14A61K47/26A61K47/38A61K47/44A61K2300/00
Inventor 杨海涵唐华侨吴学渊李超胡婷婷
Owner CHENGDU QIANKUN VETERINARY PHARMA
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