CN102846568A - Preparation method of cephalexin layering digestion tablet - Google Patents
Preparation method of cephalexin layering digestion tablet Download PDFInfo
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- CN102846568A CN102846568A CN2012103074277A CN201210307427A CN102846568A CN 102846568 A CN102846568 A CN 102846568A CN 2012103074277 A CN2012103074277 A CN 2012103074277A CN 201210307427 A CN201210307427 A CN 201210307427A CN 102846568 A CN102846568 A CN 102846568A
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- cefalexin
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- starch
- layering
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Abstract
A preparation method of a cephalexin layering digestion tablet comprises the steps of: taking 1.5kg from 13kg of starch to prepare a starch paste with concentration of 12% as a binder; mixing the remaining starch with the binder, and pressing a substrate with weight of 0.13g and diameter of 6.5-7mm; mixing a bulk medicine cefalexin powder with a lubricant to obtain a mixed powder; placing the prepared substrate in a sugar-coating pot, spraying 12kg of mixed powder on the substrate layer by layer by a spray gun with a sodium carboxymethyl cellulose solution as a spray, drying, and airing the tablet, so as to obtain the cephalexin layering digestion tablet. The invention has the advantages that starch is used to suppress substrate, and the bulk medicine is sprayed on the substrate, so as to facilitate drug disintegration, and avoid impediment on digestion speed of the bulk medicine by adjuvant materials for mixing tabletting; and the drug has good digestion speed, can digest more than 90% of the total drug in 15 seconds, and quickly reach blood drug level threshold required by treatment in the human body, and has good treatment effect.
Description
Technical field
The present invention relates to a kind of preparation method of cefalexin layering stripping sheet.
Background technology
Cefalexin has another name called Cefalexin, cephalexin, and the acetoxyl group cephalosporinic acid is semi-synthetic to be made by going, and by suppressing the synthetic of cell wall, cellular content is expanded to break dissolving, thereby reaches bactericidal action, is broad ectrum antibiotic.Cefalexin belongs to first generation cephalosporin, neisseria there is preferably antibacterial action, part escherichia coli, proteus mirabilis, sramana's formula bacterium and dysentery bacterium there are certain antibacterial action, are mainly used in clinically treating respiratory tract infection and urinary tract infection due to the sensitive bacterial.
At present, during preparation cefalexin tablet, need to add adjuvant, be about to cefalexin and binding agent, filler, disintegrating agent, mix lubricant, tabletting.Because cefalexin directly mixes film-making with adjuvant, and cefalexin slightly soluble in water when oral can hinder medicine disintegrate dissolution rate, makes blood drug level not reach threshold value, and therapeutic effect is undesirable.
Summary of the invention
The technical problem to be solved in the present invention provides the preparation method of the cefalexin layering stripping sheet that a kind of drug-eluting speed is fast, therapeutic effect is good.
Technical solution of the present invention is:
A kind of preparation method of cefalexin layering stripping sheet, its concrete steps are:
1, the preparation of substrate
Get 1.5kg starch preparation quality concentration and be 12% gelatinized corn starch in 13kg starch and make binding agent, the starch of surplus is mixed the compacting quality with binding agent be that 0.13g, diameter are the substrate of 6.5mm-7mm;
2, spray packs sheet
Be that the 1:0.01-1:0.02 mix homogeneously gets mixed powder with crude drug cefalexin powder body and lubricant according to mass ratio, the substrate that makes is put into coating pan, getting the 12kg mixed powder, to adopt spray gun concentration be that the 1%-1.5% carboxymethylcellulose sodium solution is made spray and mixed powder is successively sprayed wrapped on the substrate, at 35 ℃-40 ℃ lower oven dry 20min-30min, the sheet 10h-12h that dries in the air under 50 ℃-60 ℃ gets cefalexin layering stripping sheet.
The particle diameter of described cefalexin powder body is 125 orders-150 orders.
Described lubricant is Pulvis Talci.
During the spray bag, temperature of charge is room temperature, and the coating pan revolution is 52 rev/mins, and inlet temperature is 30 ℃-35 ℃, and spray gun pressure is 0.3MPa.
The number of plies of described successively spray bag is the 80-90 layer.
The present invention suppresses substrate with starch, and at substrate spray bag crude drug, be conducive to the disintegrate stripping of medicine, avoided mixing the film-making adjuvant to the obstruction of crude drug dissolution rate, drug-eluting speed is good, the blood drug level that needs that reaches rapidly treatment in body was threshold value with regard to more than 90% of the total dose of energy stripping in 15 seconds, and medication effect is good.
The specific embodiment
Embodiment 1
1, the preparation of substrate
Get 1.5kg starch preparation quality concentration and be 12% gelatinized corn starch in 13kg starch and make binding agent, the starch of surplus is mixed the compacting quality with binding agent be that 0.13g, diameter are the substrate of 6.5mm-7mm;
2, spray packs sheet
Be that 125 order crude drug cefalexin powder body and lubricant Pulvis Talci are that the 1:0.01 mix homogeneously gets mixed powder according to mass ratio with particle diameter, the 13kg substrate is put into coating pan, adopting spray gun concentration is that 1% carboxymethylcellulose sodium solution is made spray and the 12kg mixed powder is successively sprayed wrapped on the substrate, during the spray bag, temperature of charge is room temperature, the coating pan revolution is 52 rev/mins, inlet temperature is 30 ℃, spray gun pressure is 0.3MPa, the number of plies of spray bag is 80 layers, at 35 ℃ of lower oven dry 20min, the sheet 10h that dries in the air under 50 ℃ gets cefalexin layering stripping sheet.
Embodiment 2
1, the preparation of substrate
Get 1.5kg starch preparation quality concentration and be 12% gelatinized corn starch in 13kg starch and make binding agent, the starch of surplus is mixed the compacting quality with binding agent be that 0.13g, diameter are the substrate of 6.5mm-7mm;
2, spray packs sheet
Be that 150 order crude drug cefalexin powder body and lubricant Pulvis Talci are that the 1:0.02 mix homogeneously gets mixed powder according to mass ratio with particle diameter, the 13kg substrate is put into coating pan, adopting spray gun concentration is that 1.5% carboxymethylcellulose sodium solution is made spray and the 12kg mixed powder is successively sprayed wrapped on the substrate, during the spray bag, temperature of charge is room temperature, the coating pan revolution is 52 rev/mins, inlet temperature is 35 ℃, spray gun pressure is 0.3MPa, the number of plies of spray bag is 90 layers, at 40 ℃ of lower oven dry 30min, the sheet 12h that dries in the air under 60 ℃ gets cefalexin layering stripping sheet.
Embodiment 3
1, the preparation of substrate
Get 1.5kg starch preparation quality concentration and be 12% gelatinized corn starch in 13kg starch and make binding agent, the starch of surplus is mixed the compacting quality with binding agent be that 0.13g, diameter are the substrate of 6.5mm-7mm;
2, spray packs sheet
Be that 150 order crude drug cefalexin powder body and lubricant Pulvis Talci are that the 1:0.015 mix homogeneously gets mixed powder according to mass ratio with particle diameter, the 13kg substrate is put into coating pan, adopting spray gun concentration is that the 1.2%-carboxymethylcellulose sodium solution is made spray and the 12kg mixed powder is successively sprayed wrapped on the substrate, during the spray bag, temperature of charge is room temperature, the coating pan revolution is 52 rev/mins, inlet temperature is 32 ℃, spray gun pressure is 0.3MPa, the number of plies of spray bag is 84 layers, at 37 ℃ of lower oven dry 25min, the sheet 11 that dries in the air under 55 ℃ gets cefalexin layering stripping sheet.
Comparative Examples
According to the method for the cefalexin tablet of selling in the market, according to the mass fraction, with 125 parts of cefalexin and 25 parts of adjuvants (binding agent, filler, disintegrating agent, lubricant) mix homogeneously, tabletting, oven dry, the sheet that dries in the air gets cefalexin Tablet.
The dissolution of cefalexin Tablet and cefalexin layering stripping sheet detects:
The Comparative Examples cefalexin Tablet is got this product take water as solvent according to dissolution method, and rotating speed is that per minute 100 turns, and operation in the time of 45 minutes, is got solution an amount of in accordance with the law, filters, and it is an amount of that precision measures subsequent filtrate, is diluted with water to the solution that approximately contains 25 μ g among every 1ml; Other gets 10 of this product, and is accurately weighed, and porphyrize, precision takes by weighing that approximately to be equivalent in right amount average sheet heavy), be dissolved in water and be diluted to the solution that approximately contains 1mg among every 1ml by labelled amount, filter, precision measures subsequent filtrate, is diluted with water to the solution that approximately contains 25 μ g among every 1ml.Get above-mentioned two kinds of solution, according to spectrophotography (appendix IV A), measure respectively trap at the wavelength place of 262nm, calculate every stripping quantity by the ratio meter of the two trap.Measurement result is as shown in table 1:
Table 1 cefalexin Tablet dissolution measurement result table
| ? | Comparative Examples 45min dissolution determination value % |
| ? | 87.69 |
| 2 | 86.62 |
| 3 | 83.19 |
| 4 | 84.41 |
| 5 | 85.11 |
| Meansigma methods | 85.40 |
Embodiment 1-embodiment 3 cefalexin layering stripping sheets are pressed dissolution method (appendix XC first method) measure, dissolution time shortens to 45s, measures dissolution.Measurement result is as shown in table 2:
Table 2 cefalexin layering stripping sheet dissolution measurement result table
| ? | Embodiment 1 | Embodiment 2 | Embodiment 3 |
| 15s dissolution determination value % | 91.25 | 92.51 | 95.22 |
By table 1 and table 2 as can be known, the dissolution rate of the cefalexin layering stripping sheet that the present invention makes is than fast 3000 times of the cefalexin Tablet dissolution rate of selling in the market.
Claims (5)
1. the preparation method of a cefalexin layering stripping sheet is characterized in that:
1.1, the preparation of substrate
Get 1.5kg starch preparation quality concentration and be 12% gelatinized corn starch in 13kg starch and make binding agent, the starch of surplus is mixed the compacting quality with binding agent be that 0.13g, diameter are the substrate of 6.5mm-7mm;
1.2, spray packs sheet
Be that the 1:0.01-1:0.02 mix homogeneously gets mixed powder with crude drug cefalexin powder body and lubricant according to mass ratio, the substrate that makes is put into coating pan, getting the 12kg mixed powder, to adopt spray gun concentration be that the 1%-1.5% carboxymethylcellulose sodium solution is made spray and mixed powder is successively sprayed wrapped on the substrate, at 35 ℃-40 ℃ lower oven dry 20min-30min, the sheet 10h-12h that dries in the air under 50 ℃-60 ℃ gets cefalexin layering stripping sheet.
2. the preparation method of cefalexin layering stripping sheet according to claim 1, it is characterized in that: the particle diameter of described cefalexin powder body is 125 orders-150 orders.
3. the preparation method of cefalexin layering stripping sheet according to claim 1, it is characterized in that: described lubricant is Pulvis Talci.
4. the preparation method of cefalexin layering stripping sheet according to claim 1 is characterized in that: during the spray bag, temperature of charge is room temperature, and the coating pan revolution is 52 rev/mins, and inlet temperature is 30 ℃-35 ℃, and spray gun pressure is 0.3MPa.
5. the preparation method of cefalexin layering stripping sheet according to claim 1 is characterized in that: the number of plies of described successively spray bag is the 80-90 layer.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012103074277A CN102846568B (en) | 2012-08-27 | 2012-08-27 | Preparation method of cephalexin layering digestion tablet |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012103074277A CN102846568B (en) | 2012-08-27 | 2012-08-27 | Preparation method of cephalexin layering digestion tablet |
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| CN102846568B CN102846568B (en) | 2013-11-20 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1939262A (en) * | 2005-09-26 | 2007-04-04 | 刘凤鸣 | Oral preparation containing cephaampi and its making method |
| CN1946376A (en) * | 2004-03-25 | 2007-04-11 | 布里斯托尔-迈尔斯·斯奎布公司 | Coated tablet composition and method of manufacturing the same |
| CN101269000A (en) * | 2007-03-21 | 2008-09-24 | 北京亿利高科生物工程技术研究所有限公司 | Oral preparation containing cefa-iskia, preparation method and application thereof |
-
2012
- 2012-08-27 CN CN2012103074277A patent/CN102846568B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1946376A (en) * | 2004-03-25 | 2007-04-11 | 布里斯托尔-迈尔斯·斯奎布公司 | Coated tablet composition and method of manufacturing the same |
| CN1939262A (en) * | 2005-09-26 | 2007-04-04 | 刘凤鸣 | Oral preparation containing cephaampi and its making method |
| CN101269000A (en) * | 2007-03-21 | 2008-09-24 | 北京亿利高科生物工程技术研究所有限公司 | Oral preparation containing cefa-iskia, preparation method and application thereof |
Non-Patent Citations (2)
| Title |
|---|
| 张军等: "头孢氨苄分散片的研制", 《山东医药工业》 * |
| 韩玉玲等: "用正交法探讨头孢氨苄片的最佳生产工艺", 《黑龙江医药》 * |
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