CN102973529A - Azithromycin dispersible tablet and preparation method thereof - Google Patents
Azithromycin dispersible tablet and preparation method thereof Download PDFInfo
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- CN102973529A CN102973529A CN2012104941151A CN201210494115A CN102973529A CN 102973529 A CN102973529 A CN 102973529A CN 2012104941151 A CN2012104941151 A CN 2012104941151A CN 201210494115 A CN201210494115 A CN 201210494115A CN 102973529 A CN102973529 A CN 102973529A
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Abstract
The invention provides an azithromycin dispersible tablet and a preparation method thereof. The dispersible tablet consists of the following components in percentage by weight: 56 to 75 percent of azithromycin, 9 to 12 percent of microcrystalline cellulose, 8 to 12 percent of sodium carboxymethyl starch, 8 to 12 percent of croscarmellose sodium, 2 to 5 percent of silicon dioxide, and 1 to 2 percent of magnesium stearate. The method has an easily operated production process, does not have high requirement on equipment; and the prepared azithromycin dispersible tablet has the advantages of quick disintegration, uniform dispersibility, high bioavailability, convenient administration and good medicine compliance for patients.
Description
Technical field
The invention belongs to field of medicine preparations, be specifically related to a kind of Azithromycin dispersible tablet and preparation method thereof.
Background technology
Azithromycin is the macrolide antibiotics of Development and Production in recent years, is a kind of broad ectrum antibiotic that obtains after the erythromycin chemical constitution is modified.Its chemical name is: (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[(2, the pyrans glycosyl of 6-dideoxy-3-C-methyl-3-O-methyl-α-L-nuclear-) oxygen]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-seven methyl isophthalic acid 1-[[3,4,6-, three deoxidations-3-(dimethylamino)-and the pyrans glycosyl of β-D-wood-] oxygen]-1-oxa--6-azacyclo-pentadecane-15-ketone.The disease that causes for treatment micrococcus scarlatinae, sensitive bacterial, streptococcus pneumoniae, hemophilus influenza and mycoplasma pneumoniae, chlamydia trachomatis and non-several drug resistance Diplococcus gonorrhoeae etc. has fabulous curative effect.
By going on the market at first in this state after the research and development of Yugoslavia SourPliva company, Pfizer Inc. pushes it against the world market after awarding and having allowed global development weigh to azithromycin at first.Nineteen ninety, this product of JIUYUE went on the market in Britain, obtained the FDA approval end of the year 1991 in U.S.'s listing, and commodity be called the Zithromax(Zithromax), these product in October, 2005 patent expire.Because this product is easily molten in methanol, acetone, chlorine wound, dehydrated alcohol or dilute hydrochloric acid, and is almost insoluble in water.At present, the Technology of azithromycin moves to maturity gradually, and through development in recent years, its crude drug output steadily rises, but the commercially available conventional tablet of these product exists bioavailability low, the shortcoming that treatment cycle is long.It is high how to study a kind of bioavailability, and the fast azithromycin preparation of absorption of human body is the main direction of studying in this year.
Chinese patent CN200710055157.4 discloses a kind of Azithromycin dispersible tablet and preparation method thereof, and its concrete grammar is: get the miramycin of pulverizing and cross respectively 120 mesh sieves and medical starch, the abundant mix homogeneously of pregelatinized Starch again take 60% ethanol as the wetting agent wet granulation.The method prepares the bioavailability that Azithromycin dispersible tablet has improved azithromycin to a certain extent, but its main content is unstable, uses ethanol to make wetting agent so that the drug effect of medicine has certain influence.
Summary of the invention
The present invention aims to provide a kind of Azithromycin dispersible tablet and preparation method thereof, and this invention production technology is easy to operate, equipment requirements is not high, and the Azithromycin dispersible tablet disintegrate of preparation is rapid, be uniformly dispersed, bioavailability is high, taking convenience, have no side effect, patient's medicine compliance is good.
For achieving the above object, a kind of Azithromycin dispersible tablet of the present invention and preparation method thereof, its specific embodiments is:
A kind of Azithromycin dispersible tablet of the present invention and preparation method thereof, the Azithromycin dispersible tablet that it is characterized in that the method preparation by azithromycin, microcrystalline Cellulose, carboxymethyl starch receive, cross-linking sodium carboxymethyl cellulose, silicon dioxide, magnesium stearate form.
A kind of Azithromycin dispersible tablet of the present invention and preparation method thereof is characterized in that each weight percentages of components counts:
Azithromycin 56-75% microcrystalline Cellulose 9-12% carboxymethyl starch sodium 8-12%
Cross-linking sodium carboxymethyl cellulose 8-12% silicon dioxide 2-5% magnesium stearate 1-2%
A kind of Azithromycin dispersible tablet of the present invention and preparation method thereof is characterized in that the method concrete steps are:
1) supplementary material is processed: azithromycin is crossed 40 mesh sieves, and adjuvant directly sieves with 100 eye mesh screens;
2) take by weighing azithromycin by recipe quantity, add cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose and carboxymethylstach sodium, fully mix, the purified water that adds the about 40-50% of main ingredient weight, make soft material, check soft material quality: make it hands and pinch agglomeratingly, namely faling apart of strandinging is advisable;
3) the wet grain of system: get above-mentioned soft material and place oscillating granulator to granulate by 20 order nylon mesh;
4) drying: wet grain drying makes dried granule water content reach prescribed limit;
5) granulate: place spin vibration sieve with 20 eye mesh screen granulate dried particles;
6) total mixed: the granulate granule places V-Mixer, adds magnesium stearate and the silicon dioxide of surplus carboxymethylstach sodium and recipe quantity, mixing, tabletting after the intermediate check;
7) after the check of bag product is qualified, pack.
A kind of Azithromycin dispersible tablet of the present invention and preparation method thereof is characterized in that step 2) dosage is 3/4 of recipe quantity in the carboxymethylstach sodium, and residue 1/4 is used for total mixed adding, and the incorporation time of main ingredient is 5 minutes.
A kind of Azithromycin dispersible tablet of the present invention and preparation method thereof is characterized in that 60-65 ℃ of step 4) inlet temperature, material temperature: 55 ~ 60 ℃, temperature is 30-35 ℃ during discharging.
A kind of Azithromycin dispersible tablet of the present invention and preparation method thereof is characterized in that the always dark time of closing of step 6) is 30 minutes, and intermediate adopts special-shaped punch die tabletting, and thickness is 5.2mm.
The present invention has the following advantages:
1. the used major-minor raw material of the present invention source is wide, and cost is low.
2. technique of the present invention is simple, is convenient to large-scale production.
3. dispersible tablet disintegrate of the present invention is rapid, and drug content is stable, and bioavailability is high.
4. dispersible tablet treatment cycle weak point of the present invention, instant effect, patient's medicine compliance are good.
The specific embodiment
Below enforcement only for more detailed description the present invention, but do not limit in any form the present invention.
Embodiment 1
Prescription:
Azithromycin 2500g
Microcrystalline Cellulose 420g
Carboxymethyl starch sodium (import) 380g
Cross-linking sodium carboxymethyl cellulose 380g
Silica 1 26g
Magnesium stearate 42g
__________________________________________
Make altogether 10000
Preparation method:
At first azithromycin is crossed 40 mesh sieves, adjuvant directly sieves with 100 eye mesh screens.Then take by weighing azithromycin by recipe quantity, add the carboxymethylstach sodium of cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose and 3/4 amount, fully mixed 5 minutes, add the purified water of main ingredient weight about 40%, make soft material.Check soft material quality: make it hands and pinch agglomeratingly, namely faling apart of strandinging is advisable.Getting above-mentioned soft material places oscillating granulator to granulate by 20 order nylon mesh.Wet grain drying makes dried granule water content reach prescribed limit.General baking temperature: 60-65 ℃ of inlet temperature, material temperature: 55 ~ 60 ℃, temperature is 30-35 ℃ during discharging.Place spin vibration sieve with 20 eye mesh screen granulate dried particles.The granulate granule places V-Mixer at last, adds magnesium stearate and the silicon dioxide of residue 1/4 amount carboxymethylstach sodium and recipe quantity, mixing, and incorporation time is 30 minutes.With special-shaped punch die tabletting, THICKNESS CONTROL is at 5.2mm after the intermediate check, pressure.After the check of bag product is qualified, pack.
Claims (5)
1. Azithromycin dispersible tablet and preparation method thereof, it is characterized in that this pharmaceutical preparation by azithromycin, microcrystalline Cellulose, carboxymethyl starch receive, cross-linking sodium carboxymethyl cellulose, silicon dioxide, magnesium stearate form, its preparation method is as follows:
1) supplementary material is processed: azithromycin is crossed 40 mesh sieves, and adjuvant directly sieves with 100 eye mesh screens;
2) take by weighing azithromycin by recipe quantity, add cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose and carboxymethylstach sodium, fully mix, add the purified water of main ingredient weight 40-50%, make soft material;
3) the wet grain of system: get above-mentioned soft material and place oscillating granulator to granulate by 20 order nylon mesh;
4) drying: wet grain drying makes dried granule water content reach prescribed limit;
5) granulate: place spin vibration sieve with 20 eye mesh screen granulate dried particles;
6) total mixed: the granulate granule places V-Mixer, adds magnesium stearate and the silicon dioxide of surplus carboxymethylstach sodium and recipe quantity, mixing, tabletting after the intermediate check;
7) after the check of bag product is qualified, pack.
2. method according to claim 1 is characterized in that each weight percentages of components counts:
Azithromycin 56-75% microcrystalline Cellulose 9-12% carboxymethyl starch sodium 8-12%
Cross-linking sodium carboxymethyl cellulose 8-12% silicon dioxide 2-5% magnesium stearate 1-2%.
3. method according to claim 1 and 2 is characterized in that step 2) dosage is 3/4 of recipe quantity in the carboxymethylstach sodium, and residue 1/4 is used for total mixed adding, and the incorporation time of main ingredient is 5 minutes.
4. method according to claim 1, it is characterized in that 60-65 ℃ of step 4) inlet temperature, material temperature: 55 ~ 60 ℃, temperature is 30-35 ℃ during discharging.
5. method according to claim 1 is characterized in that the always dark time of closing of step 6) is 30 minutes, and intermediate adopts special-shaped punch die tabletting, and thickness is 5.2mm.
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| CN2012104941151A CN102973529A (en) | 2012-11-28 | 2012-11-28 | Azithromycin dispersible tablet and preparation method thereof |
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| CN2012104941151A CN102973529A (en) | 2012-11-28 | 2012-11-28 | Azithromycin dispersible tablet and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103494783A (en) * | 2013-09-25 | 2014-01-08 | 南京正宽医药科技有限公司 | Azithromycin dispersible tablet and preparation method thereof |
| CN103784415A (en) * | 2014-01-23 | 2014-05-14 | 刘燕 | Azithromycin chewable tablet and preparation method thereof |
| CN104606160A (en) * | 2015-01-28 | 2015-05-13 | 康普药业股份有限公司 | Drug composition containing fenoprofen calcium |
| CN105193753A (en) * | 2015-10-30 | 2015-12-30 | 成都通德药业有限公司 | Preparation method of azithromycin dispersible tablets |
| CN104606160B (en) * | 2015-01-28 | 2018-06-01 | 康普药业股份有限公司 | A kind of fenoprofen calcium medicine compound |
| CN113559073A (en) * | 2021-07-20 | 2021-10-29 | 海南海神同洲制药有限公司 | Azithromycin tablet and preparation method thereof |
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| WO2005002592A2 (en) * | 2003-07-01 | 2005-01-13 | Ranbaxy Laboratories Limited | Stable oral compositions of azithromycin monohydrate |
| CN102018679A (en) * | 2009-09-11 | 2011-04-20 | 上海天龙药业有限公司 | Azithromycin dispersing tablet with improved mouthfeel and preparation method of same |
| CN102648898A (en) * | 2011-02-25 | 2012-08-29 | 上海天龙药业有限公司 | Method for preventing azithromycin from adhering during tabletting |
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2012
- 2012-11-28 CN CN2012104941151A patent/CN102973529A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005002592A2 (en) * | 2003-07-01 | 2005-01-13 | Ranbaxy Laboratories Limited | Stable oral compositions of azithromycin monohydrate |
| CN102018679A (en) * | 2009-09-11 | 2011-04-20 | 上海天龙药业有限公司 | Azithromycin dispersing tablet with improved mouthfeel and preparation method of same |
| CN102648898A (en) * | 2011-02-25 | 2012-08-29 | 上海天龙药业有限公司 | Method for preventing azithromycin from adhering during tabletting |
Non-Patent Citations (2)
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| 刘素领等: "阿奇霉素分散片制备工艺研究", 《现代中西医结合杂志》, vol. 16, no. 25, 30 September 2007 (2007-09-30), pages 3639 - 3640 * |
| 张丽娥等: "阿奇霉素分散片的制备与溶出度测定", 《医药导报》, vol. 27, no. 4, 30 April 2008 (2008-04-30), pages 438 - 440 * |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103494783A (en) * | 2013-09-25 | 2014-01-08 | 南京正宽医药科技有限公司 | Azithromycin dispersible tablet and preparation method thereof |
| CN103784415A (en) * | 2014-01-23 | 2014-05-14 | 刘燕 | Azithromycin chewable tablet and preparation method thereof |
| CN104606160A (en) * | 2015-01-28 | 2015-05-13 | 康普药业股份有限公司 | Drug composition containing fenoprofen calcium |
| CN104606160B (en) * | 2015-01-28 | 2018-06-01 | 康普药业股份有限公司 | A kind of fenoprofen calcium medicine compound |
| CN105193753A (en) * | 2015-10-30 | 2015-12-30 | 成都通德药业有限公司 | Preparation method of azithromycin dispersible tablets |
| CN113559073A (en) * | 2021-07-20 | 2021-10-29 | 海南海神同洲制药有限公司 | Azithromycin tablet and preparation method thereof |
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Application publication date: 20130320 |