CN104415054A - Preparation method of quickly-releasing compounded paracetamol and amantadine hydrochloride tablet - Google Patents
Preparation method of quickly-releasing compounded paracetamol and amantadine hydrochloride tablet Download PDFInfo
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- CN104415054A CN104415054A CN201310363024.9A CN201310363024A CN104415054A CN 104415054 A CN104415054 A CN 104415054A CN 201310363024 A CN201310363024 A CN 201310363024A CN 104415054 A CN104415054 A CN 104415054A
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Abstract
The invention provides a preparation method of a quickly-releasing compounded paracetamol and amantadine hydrochloride tablet. The preparation method mainly comprises following steps: pulverization, mixing, granulation, granule drying, granule shaping, totally blending and tablet pressing. In the steps of the pulverization, the mixing and the granulation, a preparation technology of a solid dispersing body is employed, wherein a carrier is an indissolvable hydrophilic material. After pulverizing the raw materials and the auxiliary materials into a certain degree, the raw materials and the auxiliary materials are dispersed with the carrier uniformly to prepare the solid dispersing body, and then the solid dispersing body is subjected to other processes and finally is subjected to the tablet pressing to obtain the tablet, which can achieve a good quickly-releasing effect with a dissolution rate being not less than 82% which is indicated. The invention has significant clinical significance in treatment of cold patients.
Description
Technical field
What the present invention relates to is a kind of preparation method of tablet medicament, particularly a kind of preparation method of quick effect compounded paracetamol and amantadine hydrochloride sheet.
Background technology
Solid preparation particularly tablet has very many advantages for other preparation formulations.These advantages comprise physical and chemical properties of drugs and stablize, and can ensure patient medication safety; Volume is little to be easy to carry, taking convenience etc., and this dosage form uses the widest model now.Along with the development of medicine trade, the attention degree of people to drug safety continues to increase, develop can be larger with risk the demand of quick-release tablet that compares favourably of ejection preparation constantly increase.Main the concentrating on of present solution to this problem changes on disintegrating agent kind, consumption and adding method, but the effect played is very limited.
Solid dispersion is exactly with molecule, colloid, amorphous, the dispersed a kind of disperse system on a solid support of microcrystalline state by medicine.In solid dispersion, active medicine is attracted to carrier surface, medicine is with very little particulate form high degree of dispersion, surface free energy is also very large simultaneously, and when there being solvent to exist, drug particle can contact solvent fully, and medicine is distributed in solvent rapidly.As long as select suitable carrier auxiliary material, just rapid release effect can be reached.In Paracetamol and Amantadine Compound sheet, principal agent acetaminophen belongs to insoluble drug, is selecting suitable water solublity or hydrophilicity condiment as solid dispersion, coordinates suitable disintegrating agent to can be good at solving it simultaneously and discharges problem slowly.
Summary of the invention
The object of the present invention is to provide a kind of method preparing rapid release Paracetamol and Amantadine Compound sheet, good rapid release effect can be reached, improve the curative effect of product.
The object of the present invention is achieved like this:
Prepare rapid release Paracetamol and Amantadine Compound sheet containing following steps:
(1) supplementary material is got ready according to the ratio of the pharmaceutical excipients of acetaminophen 100 weight portion, amantadine hydrochloride 250 weight portion, caffeine 15 weight portion, chlorphenamine maleate 2 weight portion, artificial Calculus Bovis 10 weight portion and necessity, supplementary material is pulverized, crosses 50 ~ 200 mesh sieves; Described pharmaceutical excipients comprises disintegrating agent, binding agent and other adjuvant;
(2) first carry out caffeine, chlorphenamine maleate and artificial Calculus Bovis being mixed to get just batch mixing, in mixed process, material needed 50 ~ 100 mesh sieve 3 times;
(3) disintegrating agent of acetaminophen, amantadine hydrochloride, first batch mixing and solid dispersion carrier and 20 ~ 50 weight portions is dropped in wet-mixed machine, mix 5 minutes, then add binding agent, mix 1 ~ 3 minute, granulation;
(4) granule moves in boiling drier, temperature of charge is controlled at 30 ~ 80 DEG C, aeration-drying 20 ~ 60 minutes, granule is cooled to room temperature, carries out granulate, and then moves in hybrid machine by granule, add disintegrating agent and other adjuvant of 1 ~ 10 weight portion, mix 10 ~ 60 minutes, the inspection of semifinished product is qualified, and tabletting obtains product.
Described disintegrating agent comprises: carboxymethyl starch sodium, cross-linked pvp, starch one or more mixture wherein.
Described binding agent comprises: starch, carboxymethyl cellulose, hydroxypropyl methylcellulose one or more mixture wherein.
Other adjuvant described comprises: one or more the mixture in microcrystalline Cellulose, calcium phosphate, silicon dioxide, magnesium stearate, Pulvis Talci.
The present invention improves by series of process to comprise the particle diameter controlling starting material, requires that starting material at least crosses 100 sieves; In mixed process, have employed equivalent to progressively increase method.After process modification, adopt solid dispersions technique especially simultaneously.After finding to adopt solid dispersions technique by comparison, Paracetamol and Amantadine Compound sheet at least shortens 10% disintegration after testing, and the dissolution of acetaminophen improves 10% simultaneously.Illustrate and adopt solid dispersion body technique well to solve the slow problem of the release of quick effect compounded paracetamol and amantadine hydrochloride sheet, and whole production Technology cost is also very low, is convenient to the large production of industrialization.
In the preparation technology of this solid dispersion, have employed the preparation method different from traditional method---mixing dispersion method.The method needs crude drug to be crushed to certain particle diameter, then carrier is crushed to a slightly large granularity, then both is fully mixed and makes medicine well be dispersed in solid dispersion carrier surface.Can ensure that active medicine is not assembled like this, drug particle has higher surface free energy simultaneously, when medicament contact is to solvent, can is distributed in solvent rapidly and uniformly, reaches rapid release effect.
The finished product adopting method of the present invention to obtain can reach good rapid release effect, and wherein the Dissolution Value of acetaminophen is all not less than 82% of sign, and the disintegration of tablet is all not more than 9 minutes.Rehabilitation for cold patients has very large clinical meaning.
Detailed description of the invention
Example 1
1, pulverized by all supplementary materials, cross 100 mesh sieves, wherein silicon dioxide crosses 50 mesh sieves;
2, get 15 weight portion caffeine, 2 parts by weight of maleic chlorphenamines and 10 weight portion artificial Calculus Boviss to mix, in mixed process, material needed 50 mesh sieve 3 times;
3, the carboxymethylstach sodium of 100 weight portion acetaminophen, 250 weight portion amantadine hydrochlorides, the material be pre-mixed and 40 parts by weight of silica and 20 weight portions is dropped in wet-mixed machine, mix 5 minutes, add binding agent again, mix 3 minutes, granulate.
4, granule moves in boiling drier, is controlled by temperature of charge at 30 ~ 80 DEG C, aeration-drying 20 ~ 60 minutes, granule is cooled to room temperature, carries out granulate, and then moves in hybrid machine by granule, add the carboxymethylstach sodium of 3 weight portions and other adjuvants, mix 10 ~ 60 minutes, tabletting and get final product.
The partial data testing result of three batch samples adopting this legal system standby is as table one
Table one
Example 2
1, pulverized by all supplementary materials, cross 120 mesh sieves, wherein calcium phosphate crosses 80 mesh sieves.
2, get 15 weight portion caffeine, 2 parts by weight of maleic chlorphenamines and 10 weight portion artificial Calculus Boviss to mix, in mixed process, material needed 80 mesh sieve 3 times;
3, the carboxymethylstach sodium of the calcium phosphate of 100 weight portion acetaminophen, 250 weight portion amantadine hydrochlorides, the material be pre-mixed and 40 weight portions and 30 weight portions is dropped in wet-mixed machine, mix 5 minutes, add binding agent again, mix 3 minutes, granulate.
4, granule moves in boiling drier, is controlled by temperature of charge at 30 ~ 80 DEG C, aeration-drying 20 ~ 60 minutes, granule is cooled to room temperature, carries out granulate, and then moves in hybrid machine by granule, add the carboxymethylstach sodium of 3 weight portions and other adjuvants, mix 10 ~ 60 minutes, tabletting and get final product.
The partial data testing result of three batch samples adopting this legal system standby is as table two
Table two
Example 3
1, pulverized by all supplementary materials, cross 120 mesh sieves, wherein silicon dioxide crosses 80 mesh sieves.
2, get 15 weight portion caffeine, 2 parts by weight of maleic chlorphenamines and 10 weight portion artificial Calculus Boviss to mix, in mixed process, material needed 100 mesh sieve 3 times;
3, the carboxymethylstach sodium of the silicon dioxide of 100 weight portion acetaminophen, 250 weight portion amantadine hydrochlorides, the material be pre-mixed and 50 weight portions and 50 weight portions is dropped in wet-mixed machine, mix 5 minutes, add binding agent again, mix 3 minutes, granulate.
4, granule moves in boiling drier, is controlled by temperature of charge at 70 DEG C, aeration-drying 20 ~ 60 minutes, granule is cooled to room temperature, carries out granulate, and then moves in hybrid machine by granule, add the carboxymethylstach sodium of 7 weight portions and other adjuvants, mix 10 ~ 60 minutes, tabletting and get final product.
The partial data testing result of three batch samples adopting this legal system standby is as table three
Table three
Claims (6)
1. a preparation method for rapid release Paracetamol and Amantadine Compound sheet, is characterized in that:
(1) supplementary material is got ready according to the ratio of the pharmaceutical excipients of acetaminophen 100 weight portion, amantadine hydrochloride 250 weight portion, caffeine 15 weight portion, chlorphenamine maleate 2 weight portion, artificial Calculus Bovis 10 weight portion and necessity, supplementary material is pulverized, crosses 50 ~ 200 mesh sieves; Described pharmaceutical excipients comprises disintegrating agent, binding agent and other adjuvant;
(2) first carry out caffeine, chlorphenamine maleate and artificial Calculus Bovis being mixed to get just batch mixing, in mixed process, material needed 50 ~ 100 mesh sieve 3 times;
(3) disintegrating agent of acetaminophen, amantadine hydrochloride, first batch mixing and solid dispersion carrier and 20 ~ 50 weight portions is dropped in wet-mixed machine, mix 5 minutes, then add binding agent, mix 1 ~ 3 minute, granulation;
(4) granule moves in boiling drier, temperature of charge is controlled at 30 ~ 80 DEG C, aeration-drying 20 ~ 60 minutes, granule is cooled to room temperature, carries out granulate, and then moves in hybrid machine by granule, add disintegrating agent and other adjuvant of 1 ~ 10 weight portion, mix 10 ~ 60 minutes, the inspection of semifinished product is qualified, and tabletting obtains product.
2. the preparation method of rapid release Paracetamol and Amantadine Compound sheet according to claim 1, is characterized in that: in the mixed process of the first batch mixing of preparation, material needed 100 ~ 200 mesh sieve 3 times.
3. the preparation method of rapid release Paracetamol and Amantadine Compound sheet according to claim 1, is characterized in that described disintegrating agent comprises: carboxymethyl starch sodium, cross-linked pvp, starch one or more mixture wherein.
4. the preparation method of the rapid release Paracetamol and Amantadine Compound sheet according to claim 1 or 3, is characterized in that: disintegrating agent adding method is inside and outside addition.
5. the preparation method of rapid release Paracetamol and Amantadine Compound sheet according to claim 1, is characterized in that described binding agent comprises: starch, carboxymethyl cellulose, hydroxypropyl methylcellulose one or more mixture wherein.
6. the preparation method of rapid release Paracetamol and Amantadine Compound sheet according to claim 1, is characterized in that other adjuvant described comprises: one or more the mixture in microcrystalline Cellulose, calcium phosphate, silicon dioxide, magnesium stearate, Pulvis Talci.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201310363024.9A CN104415054A (en) | 2013-08-20 | 2013-08-20 | Preparation method of quickly-releasing compounded paracetamol and amantadine hydrochloride tablet |
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| CN201310363024.9A CN104415054A (en) | 2013-08-20 | 2013-08-20 | Preparation method of quickly-releasing compounded paracetamol and amantadine hydrochloride tablet |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105920043A (en) * | 2016-06-23 | 2016-09-07 | 吉林省吴太感康药业有限公司 | Compound paracetamol and amantadine hydrochloride tablet and preparation method thereof |
| CN112076174A (en) * | 2020-09-04 | 2020-12-15 | 四川省百草生物药业有限公司 | Rimantadine hydrochloride tablet and preparation method thereof |
| CN114042045A (en) * | 2021-12-07 | 2022-02-15 | 葵花药业集团(唐山)生物制药有限公司 | Granulating method adopting equivalent progressive method |
| CN114191395A (en) * | 2021-12-07 | 2022-03-18 | 葵花药业集团(唐山)生物制药有限公司 | Granulating method with uniform granules |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1819817A (en) * | 2003-07-09 | 2006-08-16 | 株式会社钟根堂 | The solid dispersion of tacrolimus |
| CN102488711A (en) * | 2011-12-28 | 2012-06-13 | 吉林省吴太感康药业有限公司 | Method for preparing compound paracetamol and amantadine hydrochloride tablet |
-
2013
- 2013-08-20 CN CN201310363024.9A patent/CN104415054A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1819817A (en) * | 2003-07-09 | 2006-08-16 | 株式会社钟根堂 | The solid dispersion of tacrolimus |
| CN102488711A (en) * | 2011-12-28 | 2012-06-13 | 吉林省吴太感康药业有限公司 | Method for preparing compound paracetamol and amantadine hydrochloride tablet |
Non-Patent Citations (3)
| Title |
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| 国家食品药品监督管理局药品审评中心: "《药品技术评价文集第2辑》", 30 November 2007 * |
| 李安良: "《生物利用度控制——药物化学原理、方法和应用》", 30 June 2004 * |
| 李岚凤等: ""优化复方氨酚烷胺片工艺崩解度的研究"", 《中小企业管理与科技(下旬刊)》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105920043A (en) * | 2016-06-23 | 2016-09-07 | 吉林省吴太感康药业有限公司 | Compound paracetamol and amantadine hydrochloride tablet and preparation method thereof |
| CN112076174A (en) * | 2020-09-04 | 2020-12-15 | 四川省百草生物药业有限公司 | Rimantadine hydrochloride tablet and preparation method thereof |
| CN114042045A (en) * | 2021-12-07 | 2022-02-15 | 葵花药业集团(唐山)生物制药有限公司 | Granulating method adopting equivalent progressive method |
| CN114191395A (en) * | 2021-12-07 | 2022-03-18 | 葵花药业集团(唐山)生物制药有限公司 | Granulating method with uniform granules |
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Application publication date: 20150318 |