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Sultamicittin composition and preparation method thereof

A technology for sutacillin and composition, which is applied in the field of sutacillin composition and its preparation, can solve the problems of no tablet stability data, no sutacillin tablet, etc., and is suitable for wide popularization and application and easy to operate. , the effect of fast disintegration

Active Publication Date: 2012-06-27
广东奇灵制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no experimental data on the preparation of sultacillin tablets, and there is no detailed stability data of the tablets

Method used

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  • Sultamicittin composition and preparation method thereof
  • Sultamicittin composition and preparation method thereof

Examples

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Comparison scheme
Effect test

Embodiment 1

[0031] A sultacillin composition, comprising the following components by weight: 73.53 parts of sultacillin (particle size: 100-150 μm), 2.64 parts of crospovidone, 7.35 parts of croscarmellose sodium, poly 7.35 parts of vitamin ketone, 7.35 parts of lactose, 0.74 parts of magnesium stearate, 0.37 parts of steviol glycosides, and 0.37 parts of strawberry powder essence.

[0032] The preparation method of above-mentioned sultacillin composition, comprises the following steps:

[0033] 1) After drying the raw materials except sultacillin to a water content of ≤1%, mix them with sultacillin in a mixer for 30 minutes to obtain a mixture;

[0034] 2) The mixture is made into 40 mesh granules with a dry granulator;

[0035] 3) Put the granules in a tablet machine and compress into tablets with a tablet weight of 0.323-0.357g / tablet to obtain sultacillin tablets.

Embodiment 2

[0037] A sultacillin composition, comprising the following components by weight: 55.37 parts of sultacillin (with a particle size of 180-200 μm), 9.97 parts of crospovidone, 5.54 parts of povidone, and 13.84 parts of microcrystalline cellulose , 3 parts of lactose, 0.55 parts of magnesium stearate, 0.3 parts of steviol glycosides, 0.2 parts of aspartame, 0.5 parts of strawberry powder flavor.

[0038] The preparation method of above-mentioned sultacillin composition, comprises the following steps:

[0039] 1) After drying the raw materials except sultacillin to a water content of ≤1%, mix them with sultacillin in a mixer for 30 minutes to obtain a mixture;

[0040] 2) Place the mixture in a tablet press, press the tablet with a die with a diameter of 25mm, and then crush it into 50 mesh particles;

[0041] 3) Divide the granules into aluminum bags with a loading range of 0.429 to 0.474g / bag to make sultacillin granules.

Embodiment 3

[0043] A sultacillin composition, comprising the following components by weight: 45 parts of sultacillin (particle size: 25-80 μm), 7 parts of crospovidone, 7 parts of croscarmellose sodium, lactose 27.45 parts, 8.55 parts of mannitol, 7.32 parts of povidone, 0.4 parts of magnesium stearate, 0.2 parts of aspartame, and 0.2 parts of apple powder essence.

[0044] The preparation method of above-mentioned sultacillin composition, comprises the following steps:

[0045] 1) After drying the raw materials except sultacillin to a water content of ≤1%, mix them with sultacillin in a mixer for 30 minutes to obtain a mixture;

[0046] 2) Place the mixture in a tablet press, press the tablet with a die with a diameter of 25mm, and then crush it into 80 mesh particles;

[0047] 3) Divide the granules into aluminum bags with a filling volume ranging from 0.519 to 0.573 g to make sultacillin granules.

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Abstract

The invention discloses a sultamicillin composition. Raw materials of the composition contain sultamicillin, a disintegrating agent, an adhesive, a filler, a lubricant and a flavoring agent; and the preparation method comprises the following steps of: drying the raw materials apart from the sultamicillin until water content is less than or equal to 1 percent and uniformly mixing with the sultamicillin; directly tabletting; crushing into 30-mesh to 80-mesh particles, or preparing 30-mesh to 80-mesh particles through dry granulation; and preparing the particles into granules, capsules and tablets. The sultamicillin composition has high stability and good mouthfeel, is convenient to use, safe and practical; dry tabletting is selected by the preparation method; the sultamicillin is prevented from being decomposed in a preparation process; and the method has the characteristics of easiness in operation, easy and convenient process, suitability for industrial production, suitability for wide promotion and application and the like.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a sultacillin composition and a preparation method thereof. Background technique [0002] Sultacillin is a diester formed by connecting equimolar sulbactam and ampicillin with a methylene bridge, that is, a tosylate formed by covalent bonding. Ampicillin has become a broad-spectrum antibiotic widely used clinically, but many bacteria or strains produce β-lactamase and develop resistance to ampicillin, which reduces the efficacy or even fails, and sulbactam is a β-lactamase Inhibitors of sulbactam can protect ampicillin from destruction, thereby improving its antibacterial activity. In recent years, due to the increasing number of bacteria producing β-lactamase, the resistance to ampicillin has increased, and sultacillin not only has a broad-spectrum anti-gram-negative bacteria similar to ampicillin, but also has an effect on enzyme-producing bacteria. Bacteria also have strong antibacteri...

Claims

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Application Information

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IPC IPC(8): A61K31/431A61K9/20A61K9/16A61K9/48A61P31/04
Inventor 陈泽选陈琼丽麦耀权赖松然曾万溪杨航
Owner 广东奇灵制药有限公司
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