CN101129398B - Azithromycin dispersible tablet and method of preparing the same - Google Patents
Azithromycin dispersible tablet and method of preparing the same Download PDFInfo
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- CN101129398B CN101129398B CN2007100551574A CN200710055157A CN101129398B CN 101129398 B CN101129398 B CN 101129398B CN 2007100551574 A CN2007100551574 A CN 2007100551574A CN 200710055157 A CN200710055157 A CN 200710055157A CN 101129398 B CN101129398 B CN 101129398B
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Abstract
The invention relates to an Azithromycin dispersible tablet and its preparing process, wherein the constituents include (by weight percent) Azithromycin 45-50%, medicinal starch 24-25%, pre-gelatinized starch 18-20%, micro-powdered silica gel 4-5% and methylcellulose propylene glycol ether. The preparing process consists of disintegrating, sieving, mixing homogeneously, granulating, drying and tabletting. .
Description
Technical field
The invention belongs to the medicinal preparation technical field, particularly a kind of Azithromycin dispersible tablet and production method thereof.
Background technology
(English name: Azithromycin Dispersible Tablets) Main Ingredients and Appearance is an azithromycin to Azithromycin dispersible tablet, and its chemical name is (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-and 13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-nuclear-own pyrans glycosyl) 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)-β-D-wood-own pyrans glycosyl] oxygen]-1-oxa--6-azacyclo-pentadecane-15-ketone, be a kind of novel macrolide antibiotics.In vitro tests proof azithromycin has antibacterial action to multiple common pathogen clinically.The Zitromax prime system passes through the obstruction antibacterial and changes the peptide process, thereby suppresses the synthetic of bacterioprotein, and its mechanism of action is identical with erythromycin, mainly combines with the 50S subunit of bacterial ribosome, and the albumen that inhibition depends on RNA synthesizes.
The oral solid formulation of original commercially available azithromycin mainly is a conventional tablet; Dispersible tablet is the novel pharmaceutical formulation that recent studies in recent years grows up, and this dosage form is compared with conventional tablet, and it is rapid to have a disintegrate, and absorption of human body is fast, characteristics such as bioavailability height; Therefore, more and more be subjected to numerous doctors patient's welcome.
Summary of the invention
The Azithromycin dispersible tablet that provides a kind of capability and performance stable is provided the object of the invention.
In addition, the present invention also aims to provide a kind of production method of Azithromycin dispersible tablet.
In order to reach above-mentioned purpose, the present invention adopts following technical scheme: Azithromycin dispersible tablet, form by azithromycin and the medical starch of 24%-25%, the pregelatinized Starch of 18%-20%, the micropowder silica gel of 4%-5%, the hydroxypropyl cellulose powder of 4%-5% of percentage by weight 50-55%.
The Azithromycin dispersible tablet production method is: get the azithromycin of pulverizing and cross respectively 120 mesh sieves and medical starch, the abundant mix homogeneously of pregelatinized Starch, with 60% ethanol is wetting agent, system granule, airpillow-dry, granulate, add hydroxypropyl cellulose and micropowder silica gel, behind the mix homogeneously, the chemical examination stator is heavy, tabletting, be up to the standards packing, full inspection.
Utilize method well known to those skilled in the art to detect and show, production dosage form of the present invention is compared with former commercially available conventional tablet has the absorption rapidly of oral back, characteristics such as bioavailability height.Behind the oral 0.5g of single agent, peak time is 2.5-2.6 hour, blood peak concentration of drug (C
Max) be 0.4-0.45mg/L.This product is widely distributed in vivo, and concentration can reach the 10-100 times of the blood concentration same period in each tissue, concentration height in macrophage and fibroblast, and the former can be transported to inflammation part with azithromycin.Blood after the single agent administration of the present invention is eliminated half-life (T
1/2 β) be 35-48 hour, the discharging through biliary tract with original shape more than 50% of dosage about 4.5% discharged through urine with original shape in 72 hours after the administration.Serum albumin combination rate of the present invention lowers with the increase of blood drug level, and when blood drug level was 0.02 μ g/ml, the serum albumin combination rate was 15%; When blood drug level was 2 μ g/ml, the serum albumin combination rate was 7%.
Preparation of the present invention is applicable to the caused following infection of sensitive bacterial: upper respiratory tract infection such as otitis media, sinusitis, pharyngitis, tonsillitis, lower respiratory infections such as bronchitis, pneumonia.Skin and soft tissue infection; Simple sexual reproduction device infects due to the chlamydia trachomatis; Simple sexual reproduction device due to the non-multidrug resistant gonococcus infects (concurrent infection that needs to get rid of treponema pallidum).
Show through the tests in 2 years and the stable stability test that keeps sample: the said preparation steady quality.Prescription and production method that this product is described are feasible; Through accelerated tests and secular reserved sample observing, product quality meets the regulation under two " Azithromycin dispersible tablet " normal terms of Chinese Pharmacopoeia version in 2005, stable and reliable product quality.
The specific embodiment
Embodiment 1, Azithromycin dispersible tablet are made up of azithromycin and 25% medical starch, 20% pregelatinized Starch, 5% micropowder silica gel, 5% the hydroxypropyl cellulose powder of percentage by weight 45%.
The Azithromycin dispersible tablet production method is: get the azithromycin of pulverizing and cross respectively 120 mesh sieves and medical starch, the abundant mix homogeneously of pregelatinized Starch, with 60% ethanol is wetting agent, system granule, airpillow-dry, granulate, add hydroxypropyl cellulose and micropowder silica gel, behind the mix homogeneously, the chemical examination stator is heavy, tabletting, be up to the standards packing, full inspection.The preparation specification is 0.25 gram.
In embodiment 2, the present embodiment, Azithromycin dispersible tablet is made up of azithromycin and 24% medical starch, 18% pregelatinized Starch, 4% micropowder silica gel, 4% the hydroxypropyl cellulose powder of percentage by weight 50%.Other are with embodiment 1.
In embodiment 3, the present embodiment, Azithromycin dispersible tablet is made up of azithromycin and 24.5% medical starch, 19% pregelatinized Starch, 4.5% micropowder silica gel, 4.5% the hydroxypropyl cellulose powder of percentage by weight 47.5%.Other are with embodiment 1.
Claims (2)
1. Azithromycin dispersible tablet is characterized in that, is made up of azithromycin and the medical starch of 24%-25%, the pregelatinized Starch of 18%-20%, the micropowder silica gel of 4%-5%, the hydroxypropyl cellulose powder of 4%-5% of percentage by weight 45-50%.
2. Azithromycin dispersible tablet production method, it is characterized in that, get the azithromycin of the percentage by weight 45-50% that pulverizes and cross respectively 120 mesh sieves and the medical starch of 24%-25%, the abundant mix homogeneously of pregelatinized Starch of 18%-20%, is wetting agent with 60% ethanol, system granule, airpillow-dry, granulate, add the micropowder silica gel of 4%-5% and the hydroxypropyl cellulose powder of 4%-5%, behind the mix homogeneously, the chemical examination stator is heavy, tabletting, be up to the standards packing, full inspection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2007100551574A CN101129398B (en) | 2007-09-13 | 2007-09-13 | Azithromycin dispersible tablet and method of preparing the same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2007100551574A CN101129398B (en) | 2007-09-13 | 2007-09-13 | Azithromycin dispersible tablet and method of preparing the same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101129398A CN101129398A (en) | 2008-02-27 |
| CN101129398B true CN101129398B (en) | 2010-12-08 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN2007100551574A Active CN101129398B (en) | 2007-09-13 | 2007-09-13 | Azithromycin dispersible tablet and method of preparing the same |
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Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104825408A (en) * | 2012-12-31 | 2015-08-12 | 四川科伦药业股份有限公司 | Azithromycin dispersible tablet and preparation method and use thereof |
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Owner name: SUICHENG PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME: TIANJIN PHARMACEUTICAL GROUP XINZHENG CO., LTD. |
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| CP01 | Change in the name or title of a patent holder |
Address after: 451150 No. 6 Renmin Middle Road, Henan, Xinzheng Patentee after: Suicheng Pharmaceutical Co., Ltd. Address before: 451150 No. 6 Renmin Middle Road, Henan, Xinzheng Patentee before: Tianjin Pharmaceutical Group Xinzheng Co., Ltd. |