CN104490803A - Improved production process of cefixime tablets - Google Patents

Improved production process of cefixime tablets Download PDF

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Publication number
CN104490803A
CN104490803A CN201410727299.0A CN201410727299A CN104490803A CN 104490803 A CN104490803 A CN 104490803A CN 201410727299 A CN201410727299 A CN 201410727299A CN 104490803 A CN104490803 A CN 104490803A
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CN
China
Prior art keywords
cefixime
tablets
lactose
sticking
cefixime tablets
Prior art date
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Pending
Application number
CN201410727299.0A
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Chinese (zh)
Inventor
赵洪霞
廖飞
魏晨曦
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TIANJIN PHARMACEUTICAL GROUP GENCOM PHARMACEUTICAL CO Ltd
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TIANJIN PHARMACEUTICAL GROUP GENCOM PHARMACEUTICAL CO Ltd
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Priority to CN201410727299.0A priority Critical patent/CN104490803A/en
Publication of CN104490803A publication Critical patent/CN104490803A/en
Pending legal-status Critical Current

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Abstract

The invention provides an improved production process of cefixime tablets. The problem on sticking of cefixime tablets can be solved effectively by replacing the frequently-used lactose with spray particle lactose with excellent flowability and compressibility, wherein the spray particle lactose is lactose monohydrate which is prepared by spray drying. Multiple research tests show that a significant effect of resisting the sticking of cefixime tablets can be achieved by replacing the 200-mesh lactose in a formula with the spray particle lactose. The cefixime tablets formed by pressing are smooth and attractive in surface and can release medicines rapidly, and the sticking defect rate of the cefixime tablets is reduced to 0.0% from 25.9%. The improved production process of the cefixime tables is simple and convenient. By adopting the improved production process of the cefixime tables, the problems on sticking of cefixime tablets can be solved effectively, and the time and labor utilization rate can be increased.

Description

A kind of improving technique producing Cefixime tablets
Technical field
The present invention relates to a kind of Cefixime tablets and production technology, belong to medical art.
Background technology
Cefixime (cefixime) is oral third generation cephalosporins, is developed by Japanese Teng Ze company, and is first gone on the market in Japan in 1987 by Japanese Fujisawa Pharmaceutical Co., Ltd, and commodity are called Cefspan.Cefixime has following several feature: has a broad antifungal spectrum, all has spectrum antibacterial effect to gram positive bacteria and negative bacterium; Long half time, daily 1 ~ 2 time, easy to use; Cross resistance is less, extremely stable to various bacteriogenic beta-lactamase, can effectively suppress or kill clinically to the Serratieae, enterobacteria, Bacillus proteus etc. of other cephalosporins drug resistances; Dosage is few, and distribution in vivo is wide, and curative effect is high, and use cost is low, and the market competitiveness is strong; Good penetrability, penetration into tissue is strong, all exists, therefore can treat inflammation in multiple body fluid, mucosa and system.
Because cefixime is to damp and hot instability, if use conventional wet lay pelletizing press sheet, all can cause the content of cefixime and the decline of tiring that degradation problem under variable color, content easily occurs.For this reason, adopt direct powder compression technology, cefixime can be avoided to be subject to damp and hot impact, so not only ensure that the stability of cefixime, and simplify technique, shorten the production cycle, reduce cost.But the selection of adjuvant is vital in direct powder compression, to the requirement of adjuvant except possessing the performance of general additive of tablet, wherein most importantly adjuvant will have good mobility and compressibility.Because this product drug powder does not have good mobility, compressibility and lubricity, therefore easy sticking, easily block, had a strong impact on manufacturing schedule.
Summary of the invention
For Cefixime tablets sticking problem, in order to solve the problem, the invention provides a kind of improving technique producing Cefixime tablets.The technical scheme that the present invention can realize is as described below:
A kind of Cefixime tablets, is characterized in that, containing cefixime 50 ~ 100mg in unit dose Cefixime tablets, and spraying granule lactose 30 ~ 90mg, microcrystalline Cellulose 50 ~ 100mg, cross-linking sodium carboxymethyl cellulose 15 ~ 20mg, magnesium stearate 1 ~ 2mg.
In the present invention Cefixime tablets production technology, it is characterized in that,
The first step takes the cefixime of recipe quantity, spraying granule lactose, microcrystalline Cellulose, crosses 100 mesh sieves;
Second step takes the cross-linking sodium carboxymethyl cellulose of recipe quantity, magnesium stearate, crosses 60 mesh sieves;
Above principal agent and adjuvant are placed in dry granulating machine by the 3rd step, dry granulation, tabletting.
Advantage of the present invention is: because spraying granule lactose is a kind of through spray-dired lactose monohydrate, there is remarkable mobility and excellent compressibility, spraying granule lactose is adopted to replace conventional lactose, effectively solve Cefixime tablets sticking problem, and through repeatedly development test, 200 order lactose in prescription are replaced with spraying granule lactose, effect clearly, the tablet surface be pressed into is bright and clean, attractive in appearance, release medicine is fast, sticking ratio of defects drops to 0.0% from 25.9%, improves the rate of utilization of work hour.
Detailed description of the invention
Following Application Example is described further it, and the simple replacement or improvement etc. done the present invention those skilled in the art all belong within the technical scheme that the present invention protects.
1. prepare Cefixime tablets, take the cefixime 100mg of recipe quantity, spraying granule lactose 60mg, microcrystalline Cellulose 50mg, cross 100 mesh sieves; Take the cross-linking sodium carboxymethyl cellulose 15mg of recipe quantity again, magnesium stearate 2mg, cross 60 mesh sieves; Above principal agent and adjuvant are placed in dry granulating machine, dry granulation, tabletting, obtained Cefixime tablets A1.The same method simultaneously adopted and dosage, change prescription 200 order lactose into by spraying granule lactose, the Cefixime tablets A2 that the obtained test contrasted is used.
1. first apply Cefixime tablets A2, carried out Cefixime tablets trial test, find to occur sticking phenomenon in tableting processes in process of the test, and carried out relative recording, above result of the test shows, Cefixime tablets sticking cumulative percent is 25.9%.Result is as follows:
Table one Cefixime tablets sticking is tested
2, in order to find out Cefixime tablets sticking reason, getting the mixed powder of three batch samples, measuring mixed powder moisture and the results are shown in following table.Result of the test moisture content is all less than inner quality standard, shows that mixed powder moisture content is not the main cause causing sticking.
Table two Cefixime tablets mixes powder moisture result
3, get three crowdes of mixed powder 200g, measure angle of repose respectively, result of the test is mixed powder and is all greater than 30 ° angle of repose, shows that mobility is defective, show mixed powder mobility bad be the main cause causing sticking.Data are as following table.
Table three mixes the mensuration of powder angle of repose
4,200 order lactose in prescription are replaced with spraying granule lactose, obtained Cefixime tablets A1 result of the test is mixed powder and is all less than 30 ° angle of repose, and the tablet surface be pressed into is bright and clean, attractive in appearance, and release medicine is fast, and sticking ratio of defects drops to 0.0% from 25.9%.The results are shown in following table.
Table four mixes the mensuration of powder angle of repose

Claims (3)

1. a Cefixime tablets, is characterized in that, containing cefixime 50 ~ 100mg in unit dose Cefixime tablets, and spraying granule lactose 30 ~ 90mg, microcrystalline Cellulose 50 ~ 100mg, cross-linking sodium carboxymethyl cellulose 15 ~ 20mg, magnesium stearate 1 ~ 2mg.
2. a kind of Cefixime tablets according to claim 1, is characterized in that, containing cefixime 100mg in unit dose Cefixime tablets, and spraying granule lactose 60mg, microcrystalline Cellulose 50mg, cross-linking sodium carboxymethyl cellulose 15mg, magnesium stearate 2mg.
3. produce an improving technique for Cefixime tablets, it is characterized in that, its concrete step is as described below:
The first step takes the cefixime of recipe quantity, spraying granule lactose, microcrystalline Cellulose, crosses 100 mesh sieves;
Second step takes the cross-linking sodium carboxymethyl cellulose of recipe quantity, magnesium stearate, crosses 60 mesh sieves;
Above principal agent and adjuvant are placed in dry granulating machine by the 3rd step, dry granulation, and tabletting, obtains Cefixime tablets.
CN201410727299.0A 2014-12-03 2014-12-03 Improved production process of cefixime tablets Pending CN104490803A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201410727299.0A CN104490803A (en) 2014-12-03 2014-12-03 Improved production process of cefixime tablets

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201410727299.0A CN104490803A (en) 2014-12-03 2014-12-03 Improved production process of cefixime tablets

Publications (1)

Publication Number Publication Date
CN104490803A true CN104490803A (en) 2015-04-08

Family

ID=52932321

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201410727299.0A Pending CN104490803A (en) 2014-12-03 2014-12-03 Improved production process of cefixime tablets

Country Status (1)

Country Link
CN (1) CN104490803A (en)

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Application publication date: 20150408

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