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Cefixime dispersible tablets and preparation method thereof

A technology of cefixime and dispersible tablets, which is applied in the field of cefixime dispersible tablets and its preparation, can solve problems such as poor fluidity, difficulty in popularization and application, and strong hygroscopicity of granules, so as to achieve reduced procedures, low external pollution, and uniform particle size Effect

Active Publication Date: 2014-01-01
HAINAN HULUWA PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Chinese patent CN101401810A discloses cefixime dispersible tablets and a preparation method thereof, each tablet contains 25-250 mg of cefixime, 0-200 mg of starch, 0-200 mg of microcrystalline cellulose, 0-200 mg of low-substituted hydroxypropyl cellulose, cross-linked Polyvinylpyrrolidone 2-200mg, croscarmellose sodium 0-200mg, micropowder silica gel 0-15mg, magnesium stearate 0.1-20mg, sodium lauryl sulfate 0-15mg, stevia 0-15mg, the Methods During the preparation process, "dropping 5% polyvinylpyrrolidone K30 ethanol liquid to make soft materials", among which "dropping" is mostly used in laboratory operations, it is difficult to popularize and apply in large-scale production
The process adopts dry granulation, although dry granulation is relatively simple, but the granules have strong hygroscopicity and poor fluidity

Method used

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  • Cefixime dispersible tablets and preparation method thereof
  • Cefixime dispersible tablets and preparation method thereof
  • Cefixime dispersible tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Prescription: based on 1000 tablets

[0037]

[0038] Preparation:

[0039] 1) Adhesive: first add polyvinylpyrrolidone into hot water (80°C-90°C) of 1 / 5-1 / 3 of the total volume, fully disperse and hydrate, then stir continuously under cooling conditions, add Cool water to the total volume, make 2% polyvinylpyrrolidone aqueous solution, and put it in a spray tank for later use.

[0040] 2) Sieving: cefixime is passed through a 100-mesh sieve, and the auxiliary materials are respectively passed through a 80-mesh sieve for later use.

[0041]3) Granulation: Open the lid of the pot, put 50g of cefixime, 10g of pregelatinized starch starch1500, 15g of lactose, 6.5g of low-substituted hydroxypropyl cellulose, 2g of talc, and 1.25g of magnesium stearate into the pot. The one-step granulator is in the feeding car. Turn on the fan and heat it so that the material is evenly heated to 50°C in a fluidized state, turn on the spray button, spray the adhesive, the liquid inlet ...

Embodiment 2

[0045] Prescription: based on 1000 tablets

[0046]

[0047] Preparation:

[0048] 1) Adhesive: first add polyvinylpyrrolidone into hot water (80°C-90°C) of 1 / 5-1 / 3 of the total volume, fully disperse and hydrate, then stir continuously under cooling conditions, add Cool water to the total volume, make 2% polyvinylpyrrolidone aqueous solution, and put it in a spray tank for later use.

[0049] 2) Sieving: cefixime is passed through a 100-mesh sieve, and the auxiliary materials are respectively passed through a 80-mesh sieve for later use.

[0050] 3) Granulation: Open the lid of the pot, and put in the above-mentioned prescription amount of 60g of cefixime, 10g of pregelatinized starch starch1500, 10g of lactose, 6.5g of low-substituted hydroxypropyl cellulose, 2g of talcum powder, and 1.25g of magnesium stearate The one-step granulator is in the feeding car. Turn on the fan and heat it so that the material is evenly heated to 50°C in a fluidized state, turn on the spray...

Embodiment 3

[0054] Prescription: based on 1000 tablets

[0055]

[0056] Preparation:

[0057] 1) Adhesive: first add polyvinylpyrrolidone into hot water (80°C-90°C) of 1 / 5-1 / 3 of the total volume, fully disperse and hydrate, then stir continuously under cooling conditions, add Cool water to the total volume, make 2% polyvinylpyrrolidone aqueous solution, and put it in a spray tank for later use.

[0058] 2) Sieving: cefixime is passed through a 100-mesh sieve, and the auxiliary materials are respectively passed through a 80-mesh sieve for later use.

[0059] 3) Granulation: Open the lid of the pot, take the above prescription amount of cefixime 40g, pregelatinized starch 1500 20g, lactose 10g, low-substituted hydroxypropyl cellulose 6.5g, talcum powder 2g, magnesium stearate 1.25g Pour into pot. Turn on the fan and heat it so that the material is evenly heated to 50°C in a fluidized state, turn on the spray button, spray the adhesive, the liquid inlet speed is 25-32ml min, the atom...

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Abstract

The invention discloses cefixime dispersible tablets. 1000 cefixime dispersible tablets are prepared from the following raw materials in parts by weight: 40-70 g of cefixime, 5-20 g of pregelatinized starch, 5-20 g of lactose, 5-10 g of low-substituted hydroxypropyl cellulose, 1-5 g of lubricant and a proper amount of polyvinylpyrrolidone. The invention also provides a preparation method of the cefixime dispersible tablets. According to the preparation method, granulation is performed by using a one-step granulation method; the three steps of mixing, granulation and drying of the conventional wet granulation are finished in a closed container at one time; according to the process, the problems that the solvent is remained and discolored in the wet granulation process and the pharmaceutical ingredients are heated to be lost in the drying process are avoided, and the problems such as serious dust flying and high probability of cross contamination during tabletting in the dry granulation process are also avoided.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to cefixime dispersible tablets and a preparation method thereof. Background technique [0002] Cefixime (Cefixime) is the third-generation cephalosporin product developed by Fujisawa Pharmaceutical Co., Ltd. in Japan. It was launched in Japan in 1987. In 1998, among the five developed countries in Europe, cefixime surpassed cefuroxime axetil and cefaclor to become the oral cephalosporin with the highest market share. In 1999, more than 80 countries in the world had used cefixime clinically. [0003] my country began to import cefixime raw materials and preparations in 1994. The administrative protection of cefixime raw materials in China expired in early 2001, and because of its obvious clinical effect, definite curative effect and few side effects, its market demand has been on a fast-growing channel in recent years. Clinical verification shows that cefixi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/546A61P31/04
Inventor 刘全国陈克领林文君
Owner HAINAN HULUWA PHARMA GRP CO LTD
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