CN103655496A - Azithromycin dispersible tablet and preparation process thereof - Google Patents
Azithromycin dispersible tablet and preparation process thereof Download PDFInfo
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- CN103655496A CN103655496A CN201310667302.XA CN201310667302A CN103655496A CN 103655496 A CN103655496 A CN 103655496A CN 201310667302 A CN201310667302 A CN 201310667302A CN 103655496 A CN103655496 A CN 103655496A
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- dispersible tablet
- azithromycin
- covering
- bitterness
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Abstract
The invention relates to an azithromycin dispersible tablet, and in particular relates to an azithromycin dispersible tablet and a preparation process thereof. The dispersible tablet comprises the following components in parts by weight: 1 part of azithromycin, 0.7-3 parts of a filler, 0.05-0.2 part of a disintegrating agent, 0.2-1 part of disodium hydrogen phosphate, 0.05-0.1 part of a sweetening agent, 0.001-0.005 part of a bitter covering agent essence, 0.02-0.1 part of a glidant, 0.02-0.05 part of a lubricant, 0.02-0.05 part of lauryl sodium sulfate. According to the dispersible tablet and the process, the dissolution rate of the azithromycin dispersible tablet can be improved, a direct tableting process is adopted, the production process is simplified, the production cycle is shortened, and energy is saved; the flavor is regulated by the sweetening agent, the bitter covering agent essence, the lauryl sodium sulfate and the like, and the medication compliance of patients can be improved.
Description
Technical field
The present invention relates to a kind of Azithromycin dispersible tablet, be specifically related to a kind of Azithromycin dispersible tablet and preparation technology thereof.
Background technology
Azithromycin is macrolide antibiotics, and bitter in the mouth is water-soluble hardly.The mechanism of action is to be combined by the ribosomal subunit of the 50s with sensitive microbial, thereby disturbs synthetic (not the affecting the synthetic of nucleic acid) of its protein.
Azithromycin is because being insoluble in water, make dispersible tablet, with respect to solid preparations such as conventional tablet, capsules, have taking convenience, disintegrate rapidly, absorb fast and bioavailability high, can add after aqueous dispersion orally, also dispersible tablet can be contained in and in mouth, suck clothes or swallow.Especially inconvenience is swallowed infant, old man colony, taking convenience, but because it has larger bitterness, patient takes poor compliance.
Traditional dispersible tablet preparation technology is generally supplementary material and mixes rear wet granulation, and the present invention adopts technique of direct powder compression, summary of the invention
The object of this invention is to provide a kind of Azithromycin dispersible tablet and preparation technology thereof, simplified production process, shortened the production cycle, saved the energy.Regulate taste, improved patient's Compliance.Preparation method has that production efficiency is high, energy resource consumption is low, constant product quality.
Azithromycin dispersible tablet of the present invention, in parts by weight, raw material and composition umber thereof are as follows:
Azithromycin: 1 part, filler: 0.7-3 part, disintegrating agent: 0.05-0.2 part, sodium hydrogen phosphate: 0.2-1 part, sweeting agent: 0.05-0.1 part, bitterness masking agent essence: 0.001-0.005 part; Fluidizer 0.02-0.1 part, lubricant 0.02-0.05 part, sodium lauryl sulphate 0.02-0.05 part.
Wherein, azithromycin is active component.
Disintegrating agent is cross-linking sodium carboxymethyl cellulose.
Filler is microcrystalline Cellulose and sorbitol.
In mass fraction, sorbitol: 0.2-1 part, microcrystalline Cellulose: 0.5-2 part.
Preferably microcrystalline cellulose is PH-102, and manufacturer is U.S. FMC Corp..
Sweeting agent is aspartame.
Fluidizer is silicon dioxide.
Lubricant is magnesium stearate.
Sodium hydrogen phosphate, sweeting agent, bitterness masking agent essence act as taste and regulate.
Cover the preparation method of the Azithromycin dispersible tablet of bitterness:
Sodium hydrogen phosphate, sweeting agent, bitterness masking agent essence are crossed to 40-60 mesh sieve, and mix 10-20 minute, join in filler, disintegrating agent, fluidizer, lubricant, sodium lauryl sulphate and Azithromycin Raw Material and mix 20-30 minute, then direct pressed powder.
Tablet Hardness Control is at 50-100N.
Compared with prior art, the present invention has following beneficial effect:
1. this prescription and technique have improved the dissolution of Azithromycin dispersible tablet.
2. adopt direct compression technique, simplified production process, shortened the production cycle, saved the energy.
3. sweeting agent, bitterness masking agent essence, sodium hydrogen phosphate etc. have regulated taste, have improved patient's Compliance.
The specific embodiment
Below in conjunction with embodiment, the present invention is described further.
Embodiment 1
Prepare 1000 of Azithromycin dispersible tablets, raw material is counted with parts by weight:
Azithromycin: 1 part, magnesium stearate: 0.02 part, 0.5 part of microcrystalline Cellulose (PH-102), cross-linking sodium carboxymethyl cellulose: 0.05 part, silicon dioxide: 0.02 part, sodium lauryl sulphate: 0.02 part, sorbitol: 0.2 part, sodium hydrogen phosphate: 0.2 part, aspartame: 0.05 part, bitterness masking agent essence: 0.001 part.
Sodium hydrogen phosphate, aspartame, bitterness masking agent essence are crossed to 60 mesh sieves, and mix 10 minutes, join in microcrystalline Cellulose, sorbitol, cross-linking sodium carboxymethyl cellulose, silicon dioxide, magnesium stearate, sodium lauryl sulphate and Azithromycin Raw Material and mix 20 minutes, with the direct pressed powder of high speed rotating tablet machine, tablet Hardness Control is at 50-100N.
The present embodiment has been done the dissolution result of 6 groups of embodiment products as table 1.
The dissolution of table 16 group embodiment product
| Tablet | 1 | 2 | 3 | 4 | 5 | 6 |
| Dissolution | 98.5% | 95.6% | 99.2% | 98.9% | 97.6% | 99.8% |
Embodiment 2
Prepare 1000 of Azithromycin dispersible tablets, raw material is counted with parts by weight:
Azithromycin: 1 part, magnesium stearate: 0.05 part, 2 parts of microcrystalline Cellulose (PH-102), cross-linking sodium carboxymethyl cellulose: 0.2 part, silicon dioxide: 0.1 part, sodium lauryl sulphate: 0.05 part, sorbitol: 1 part, sodium hydrogen phosphate: 1 part, aspartame: 0.1 part, bitterness masking agent essence: 0.005 part.
Sodium hydrogen phosphate, sweeting agent, bitterness masking agent essence were waited to 40 mesh sieves, and mix 20 minutes, join in microcrystalline Cellulose, sorbitol, cross-linking sodium carboxymethyl cellulose, silicon dioxide, magnesium stearate, sodium lauryl sulphate and Azithromycin Raw Material and mix 25 minutes, with the direct pressed powder of high speed rotating tablet machine, tablet Hardness Control is at 50-100N.
The present embodiment has been done the dissolution result of 6 groups of embodiment products as table 2.
The dissolution of table 26 group embodiment product
| Tablet | 1 | 2 | 3 | 4 | 5 | 6 |
| Dissolution | 99.5% | 97.6% | 96.2% | 97.9% | 99.6% | 97.8% |
Embodiment 3
Prepare 1000 of Azithromycin dispersible tablets, raw material is counted with parts by weight:
Azithromycin: 1 part, magnesium stearate: 0.04 part, 1 part of microcrystalline Cellulose (PH-102), cross-linking sodium carboxymethyl cellulose: 0.12 part, silicon dioxide: 0.07 part, sodium lauryl sulphate: 0.03 part, sorbitol: 0.6 part, sodium hydrogen phosphate: 0.6 part, aspartame: 0.08 part, bitterness masking agent essence: 0.003 part.
Sodium hydrogen phosphate, sweeting agent, bitterness masking agent essence were waited to 50 mesh sieves, and mix 15 minutes, join in microcrystalline Cellulose, sorbitol, cross-linking sodium carboxymethyl cellulose, silicon dioxide, magnesium stearate, sodium lauryl sulphate and Azithromycin Raw Material and mix 30 minutes, with the direct pressed powder of high speed rotating tablet machine, tablet Hardness Control is at 50-100N.
The present embodiment has been done the dissolution result of 6 groups of embodiment products as table 3.
The dissolution of table 36 group embodiment product
| Tablet | 1 | 2 | 3 | 4 | 5 | 6 |
| Dissolution | 99.5% | 99.6% | 97.2% | 97.9% | 97.5% | 99.3% |
Claims (9)
1. an Azithromycin dispersible tablet of covering bitterness, is characterized in that, in mass fraction, the umber of raw material is as follows:
Azithromycin: 1 part, filler: 0.7-3 part, disintegrating agent: 0.05-0.2 part, sodium hydrogen phosphate: 0.2-1 part, sweeting agent: 0.05-0.1 part, bitterness masking agent essence: 0.001-0.005 part; Fluidizer 0.02-0.1 part, lubricant 0.02-0.05 part, sodium lauryl sulphate 0.02-0.05 part.
2. the Azithromycin dispersible tablet of covering bitterness according to claim 1, is characterized in that, disintegrating agent is cross-linking sodium carboxymethyl cellulose.
3. the Azithromycin dispersible tablet of covering bitterness according to claim 1, is characterized in that, filler is microcrystalline Cellulose and sorbitol.
4. the Azithromycin dispersible tablet of covering bitterness according to claim 3, is characterized in that, in mass fraction, and sorbitol: 0.2-1 part, microcrystalline Cellulose: 0.5-2 part.
5. the Azithromycin dispersible tablet of covering bitterness according to claim 1, is characterized in that, sweeting agent is aspartame.
6. the Azithromycin dispersible tablet of covering bitterness according to claim 1, is characterized in that, fluidizer is silicon dioxide.
7. the Azithromycin dispersible tablet of covering bitterness according to claim 1, is characterized in that, lubricant is magnesium stearate.
8. a preparation method of covering the Azithromycin dispersible tablet of bitterness claimed in claim 1, it is characterized in that, sodium hydrogen phosphate, sweeting agent, bitterness masking agent essence are crossed to 50-80 mesh sieve, and mix 10-20 minute, join in filler, disintegrating agent, fluidizer, lubricant, sodium lauryl sulphate and Azithromycin Raw Material and mix 20-30 minute, then direct pressed powder.
9. the preparation method of covering the Azithromycin dispersible tablet of bitterness according to claim 8, is characterized in that, tablet Hardness Control is at 50-100N.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310667302.XA CN103655496A (en) | 2013-12-10 | 2013-12-10 | Azithromycin dispersible tablet and preparation process thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201310667302.XA CN103655496A (en) | 2013-12-10 | 2013-12-10 | Azithromycin dispersible tablet and preparation process thereof |
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| CN103655496A true CN103655496A (en) | 2014-03-26 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104622825A (en) * | 2015-02-09 | 2015-05-20 | 鲁南贝特制药有限公司 | Azithromycin dispersible tablet |
| CN105012262A (en) * | 2015-08-20 | 2015-11-04 | 广东安诺药业股份有限公司 | Azithromycin dispersible tablets with bitterness covering function and preparation method of azithromycin dispersible tablets |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103040778A (en) * | 2012-12-31 | 2013-04-17 | 四川科伦药业股份有限公司 | Azithromycin dispersible tablet, as well as preparation method and application thereof |
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- 2013-12-10 CN CN201310667302.XA patent/CN103655496A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103040778A (en) * | 2012-12-31 | 2013-04-17 | 四川科伦药业股份有限公司 | Azithromycin dispersible tablet, as well as preparation method and application thereof |
Non-Patent Citations (1)
| Title |
|---|
| 叶虹等: "分散片的处方设计", 《齐鲁药事》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104622825A (en) * | 2015-02-09 | 2015-05-20 | 鲁南贝特制药有限公司 | Azithromycin dispersible tablet |
| CN105012262A (en) * | 2015-08-20 | 2015-11-04 | 广东安诺药业股份有限公司 | Azithromycin dispersible tablets with bitterness covering function and preparation method of azithromycin dispersible tablets |
| CN105012262B (en) * | 2015-08-20 | 2018-04-13 | 广东安诺药业股份有限公司 | Cover Azithromycin dispersible tablet of bitter taste and preparation method thereof |
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Application publication date: 20140326 |