CN105310990A - Sticking-resistant and cracking-resistant paracetamol tablet and preparation method thereof - Google Patents
Sticking-resistant and cracking-resistant paracetamol tablet and preparation method thereof Download PDFInfo
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- CN105310990A CN105310990A CN201410735866.7A CN201410735866A CN105310990A CN 105310990 A CN105310990 A CN 105310990A CN 201410735866 A CN201410735866 A CN 201410735866A CN 105310990 A CN105310990 A CN 105310990A
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Abstract
The invention provides a sticking-resistant and cracking-resistant paracetamol tablet. The sticking-resistant and cracking-resistant paracetamol tablet comprises paracetamol, pregelatinized starch, sodium carboxymethyl starch, adhesive and glidant; and the adhesive is prepared by mixing starch, polyvinylpyrrolidone and water according to the mass ratio of 1-2:0.1-0.2-17.8. The tablet prepared from the formula has the advantages of smooth and attractive table surfaces, high hardness, impact resistance and quick disintegration. The problem that integrity of the tablet is affected by tabletting sticking, cracking, edge damage and the like is solved. The tablet can be quickly disintegrated and released, dissolution rate and releasing rate are greatly improved, stability of the product is obviously improved, and the problem that edges of medicines are damaged due to collision of the medicines in multi-dose packaging and conveying processes of the product is also solved effectively.
Description
Technical field
The present invention relates to medicinal chemistry art, specifically, relate to a kind of prevent sticking and sliver to acetyl ammonia phenol sheet and preparation method thereof.
Background technology
Acetaminophen is phenyl amines ntipyretic analgesic medicine, and the clinical practice dosage usually playing the therapeutical effect such as antipyretic-antalgic is comparatively large, generally reaches 500mg.Acetaminophen clinical practice is mainly based on tablet and granule.Acetaminophen is taken after adopting bead dosage form to need to dissolve, and because the bitterness of acetaminophen itself is heavier, and need in addition sweeting agent and aromatic taste masking, add manufacturing cost, therefore product price is higher, and patient consumes's cost is large.The acetaminophen of large gauge (heavy dose) is designed to tablet, if tablet designs and excessively easily causes patient swallow's difficulty, drug compliance declines, if tablet design is less, is difficult to again solve the problem such as sticking, sliver.The large gauge paracetamol tablets of domestic many enterprises, because of ubiquity tabletting sticking, sliver, problem that friability is large, industrialization cannot be produced and supply market in enormous quantities.Many manufacturers attempt solving sticking and sliver problem by the control moisture of granule and the granularity of granule, but because in scale batch industrialization production, the moisture of granule is difficult to control, the particle diameter of granule and moisture also heterogeneity, the effect solving sticking and sliver is very little.
Summary of the invention
In order to solve problems of the prior art, the object of this invention is to provide a kind of prevent sticking and sliver to acetyl ammonia phenol sheet and preparation method thereof.
In order to realize the object of the invention, the present invention first provide a kind of prevent sticking and sliver to acetyl ammonia phenol sheet, described acetaminophen, pregelatinized Starch, carboxymethyl starch sodium, binding agent and fluidizer are comprised to acetyl ammonia phenol sheet; Described binding agent to be mixed with by the mass ratio of 10:1-2 by starch and polyvinylpyrrolidone and to form.
As preferably, described acetyl ammonia phenol sheet to be made up of the raw material of following weight portion: acetaminophen 100 parts, pregelatinized Starch 4-12 part, carboxymethyl starch sodium 0.5-5 part, binding agent 30-50 part and fluidizer 0.05-0.2 part.
More preferred, described acetyl ammonia phenol sheet to be made up of the raw material of following weight portion: acetaminophen 100 parts, pregelatinized Starch 8-10 part, carboxymethyl starch sodium 2-5 part, binding agent 30-50 part and fluidizer 0.1-0.2 part.
Further, the preparation method of described binding agent is: weigh starch and polyvinylpyrrolidone respectively by the mass ratio of 10:1-2, starch is adopted and rushes the starch slurry that slurry processes is mixed with 8-10%, polyvinylpyrrolidone purified water is dissolved the polyvinylpyrrolidonesolution solution being mixed with 8-10%, starch slurry and polyvinylpyrrolidonesolution solution are mixed and get final product.
Further, described fluidizer is stearic acid or magnesium stearate.
Further, the described preparation method to acetyl ammonia phenol sheet comprises the steps:
1) each raw material is weighed by formula ratio;
2) by acetaminophen, pregelatinized Starch, carboxymethyl starch sodium mixing;
3) add binding agent and make soft material, granulate, dry;
4) the rear tabletting of fluidizer mixing is added.
Present invention also offers a kind of pharmaceutical purpose binding agent preventing sticking and sliver, described binding agent to be mixed with by the mass ratio of 10:1-2 by starch and polyvinylpyrrolidone and to form.
Further, the preparation method of described binding agent is: weigh starch and polyvinylpyrrolidone respectively by the mass ratio of 10:1-2, starch is adopted and rushes the starch slurry that slurry processes is mixed with 8-10%, polyvinylpyrrolidone purified water is dissolved the polyvinylpyrrolidonesolution solution being mixed with 8-10%, starch slurry and polyvinylpyrrolidonesolution solution are mixed and get final product.
Present invention also offers aforementioned pharmaceutical purpose binding agent and prepare the application in tablet medicament.
Beneficial effect of the present invention is:
The present invention adopts conventional filling class adjuvant pregelatinized Starch to determine the mouldability of tablet by acetyl ammonia phenol, adopts disintegrate class adjuvant carboxymethyl starch sodium to ensure the disintegrate release of tablet.Binding agent passes through improvement and bring new ideas, change in the past single binding agent composition, combine with starch and polyvinylpyrrolidone, the granularity of granule can be allowed can be controlled by starch slurry, roundness and the moisture Control of granule is ensured again by polyvinylpyrrolidone, by adopting combination adhesive, the granule making paracetamol tablets used has good integrity degree.The tablet adopting above-mentioned formula to extrude has unilateral bright and clean attractive in appearance, hardness is high, impact resistance, advantage that disintegrate is fast, solve tabletting sticking, sliver, knock the problem that limit etc. affects tablet integrity degree, this tablet can discharge by fater disintegration, drastically increase dissolution and release, the stability of product is significantly improved, and also efficiently solves the medicine caused because the medicine in product multiple-unit container and transportation clashes into and lacks the problems such as limit.
Detailed description of the invention
Following examples for illustration of the present invention, but are not used for limiting the scope of the invention.
Acetaminophen specification in the embodiment of the present invention is in 0.5g/ sheet.
Embodiment 1
1, raw material and formula
Acetaminophen 0.5g;
Pregelatinized Starch 0.05g;
Carboxymethyl starch sodium 0.01g;
Polyvinylpyrrolidone 0.0028g;
Starch 0.028g;
Stearic acid 0.004g.
2, preparation method
Be made up of the following step:
(1) each supplementary material is weighed for subsequent use;
(2) by acetaminophen, pregelatinized Starch, carboxymethyl starch sodium mix homogeneously;
(3) make soft material with the binding agent of 10% starch slurry and 10% polyvinylpyrrolidone mixing composition, granulate, 50 DEG C of dryings;
Binding agent is formulated as follows: polyvinylpyrrolidone purified water is dissolved the solution being mixed with 10%, slurry processes is rushed in starch employing and prepares 10% starch slurry, by the liquid mixing of above-mentioned preparation.
(4) the rear tabletting of stearic acid mixing is added.
Embodiment 2
1, raw material and formula
Acetaminophen 0.5g;
Pregelatinized Starch 0.06g;
Carboxymethyl starch sodium 0.02g;
Polyvinylpyrrolidone 0.0028g;
Starch 0.028g;
Stearic acid 0.0012g.
2, preparation method
Be made up of the following step:
(1) each supplementary material is weighed for subsequent use;
(2) by acetaminophen, pregelatinized Starch, carboxymethyl starch sodium mix homogeneously;
(3) make soft material with the binding agent of 10% starch slurry and 10% polyvinylpyrrolidone mixing composition, granulate, 50 DEG C of dryings;
Binding agent is formulated as follows: polyvinylpyrrolidone purified water is dissolved the solution being mixed with 10%, slurry processes is rushed in starch employing and prepares 10% starch slurry, by the liquid mixing of above-mentioned preparation.
(4) the rear tabletting of stearic acid mixing is added.
Embodiment 3
1, raw material and formula
Acetaminophen 0.5g;
Pregelatinized Starch 0.02g;
Carboxymethyl starch sodium 0.02g;
Polyvinylpyrrolidone 0.0028g;
Starch 0.028g;
Stearic acid 0.0012g.
2, preparation method
Be made up of the following step:
(1) each supplementary material is weighed for subsequent use;
(2) by acetaminophen, pregelatinized Starch, carboxymethyl starch sodium mix homogeneously;
(3) make soft material with the binding agent of 10% starch slurry and 10% polyvinylpyrrolidone mixing composition, granulate, 50 DEG C of dryings;
Binding agent is formulated as follows: polyvinylpyrrolidone purified water is dissolved the solution being mixed with 10%, slurry processes is rushed in starch employing and prepares 10% starch slurry, by the liquid mixing of above-mentioned preparation.
(4) the rear tabletting of stearic acid mixing is added.
Embodiment 4
1, raw material and formula
Acetaminophen 0.5g;
Pregelatinized Starch 0.03g;
Carboxymethyl starch sodium 0.01g;
Polyvinylpyrrolidone 0.0028g;
Starch 0.025g;
Stearic acid 0.0006g.
2, preparation method
Be made up of the following step:
(1) each supplementary material is weighed for subsequent use;
(2) by acetaminophen, pregelatinized Starch, carboxymethyl starch sodium mix homogeneously;
(3) make soft material with the binding agent of 8% starch slurry and 10% polyvinylpyrrolidone mixing composition, granulate, 50 DEG C of dryings;
Binding agent is formulated as follows: polyvinylpyrrolidone purified water is dissolved the solution being mixed with 10%, slurry processes is rushed in starch employing and prepares 8% starch slurry, by the liquid mixing of above-mentioned preparation.
(4) the rear tabletting of stearic acid mixing is added.
Embodiment 5
1, raw material and formula
Acetaminophen 0.5g;
Pregelatinized Starch 0.05g (10%);
Carboxymethyl starch sodium 0.02g (2%);
Polyvinylpyrrolidone 0.0025g;
Starch 0.028g;
Stearic acid 0.0006g (0.1%).
2, preparation method
Be made up of the following step:
(1) each supplementary material is weighed for subsequent use;
(2) by acetaminophen, pregelatinized Starch, carboxymethyl starch sodium mix homogeneously;
(3) make soft material with the binding agent of 10% starch slurry and 8% polyvinylpyrrolidone mixing composition, granulate, 50 DEG C of dryings;
Binding agent is formulated as follows: polyvinylpyrrolidone purified water is dissolved the solution being mixed with 8%, slurry processes is rushed in starch employing and prepares 10% starch slurry, by the liquid mixing of above-mentioned preparation.
(4) the rear tabletting of stearic acid mixing is added.
Embodiment 6
1, raw material and formula
Acetaminophen 0.5g;
Pregelatinized Starch 0.04g (8%);
Carboxymethyl starch sodium 0.02g (4%);
Polyvinylpyrrolidone 0.0028g;
Starch 0.028g;
Stearic acid 0.0012g.
2, preparation method
Be made up of the following step:
(1) each supplementary material is weighed for subsequent use;
(2) by acetaminophen, pregelatinized Starch, carboxymethyl starch sodium mix homogeneously;
(3) make soft material with the binding agent of 10% starch slurry and 10% polyvinylpyrrolidone mixing composition, granulate, 50 DEG C of dryings;
Binding agent is formulated as follows: polyvinylpyrrolidone purified water is dissolved the solution being mixed with 10%, slurry processes is rushed in starch employing and prepares 10% starch slurry, by the liquid mixing of above-mentioned preparation.
(4) the rear tabletting of stearic acid mixing is added.
Test example
1, based on principal agent acetaminophen 0.5g/ sheet, the indexs such as the compressibility of tablet, hardness, friability, dissolution are investigated respectively.
The indices of acetaminophen tablet in embodiment 1-6 investigated by table 1
2, the study on the stability of product
Acetaminophen tablet study on the stability situation in embodiment 1-6 investigated by table 2
3, the contrast experiment to acetyl ammonia phenol sheet adopting different binding agent to prepare
Different binding agent is below adopted to prepare acetyl ammonia phenol sheet and carry out contrast test, draw according to data result analysis, adopt binding agent of the present invention obtained to acetyl ammonia phenol sheet, than adopt single binding agent obtained to acetyl ammonia phenol sheet, there is obvious advantage, specific experiment data are in table 3:
The contrast to acetyl ammonia phenol sheet that table 3 adopts different binding agent to prepare
Although above the present invention is described in detail with a general description of the specific embodiments, on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.
Claims (9)
1. prevent sticking and sliver to an acetyl ammonia phenol sheet, it is characterized in that, described acetaminophen, pregelatinized Starch, carboxymethyl starch sodium, binding agent and fluidizer are comprised to acetyl ammonia phenol sheet; Described binding agent to be mixed with by the mass ratio of 10:1-2 by starch and polyvinylpyrrolidone and to form.
2. according to claim 1 to acetyl ammonia phenol sheet, it is characterized in that, described acetyl ammonia phenol sheet to be made up of the raw material of following weight portion: acetaminophen 100 parts, pregelatinized Starch 4-12 part, carboxymethyl starch sodium 0.5-5 part, binding agent 30-50 part and fluidizer 0.05-0.2 part.
3. according to claim 2 to acetyl ammonia phenol sheet, it is characterized in that, described acetyl ammonia phenol sheet to be made up of the raw material of following weight portion: acetaminophen 100 parts, pregelatinized Starch 8-10 part, carboxymethyl starch sodium 2-5 part, binding agent 30-50 part and fluidizer 0.1-0.2 part.
4. according to any one of claim 1-3 to acetyl ammonia phenol sheet, it is characterized in that, the preparation method of described binding agent is: weigh starch and polyvinylpyrrolidone respectively by the mass ratio of 10:1-2, starch is adopted and rushes the starch slurry that slurry processes is mixed with 8-10%, polyvinylpyrrolidone purified water is dissolved the polyvinylpyrrolidonesolution solution being mixed with 8-10%, starch slurry and polyvinylpyrrolidonesolution solution are mixed and get final product.
5. according to claim 4ly it is characterized in that acetyl ammonia phenol sheet, described fluidizer is stearic acid or magnesium stearate.
6. according to claim 5 to acetyl ammonia phenol sheet, it is characterized in that, its preparation method comprises the steps:
1) each raw material is weighed by formula ratio;
2) by acetaminophen, pregelatinized Starch, carboxymethyl starch sodium mixing;
3) add binding agent and make soft material, granulate, dry;
4) the rear tabletting of fluidizer mixing is added.
7. prevent a pharmaceutical purpose binding agent for sticking and sliver, it is characterized in that, described binding agent to be mixed with by the mass ratio of 10:1-2 by starch and polyvinylpyrrolidone and to form.
8. binding agent according to claim 7, it is characterized in that, the preparation method of described binding agent is: weigh starch and polyvinylpyrrolidone respectively by the mass ratio of 10:1-2, starch is adopted and rushes the starch slurry that slurry processes is mixed with 8-10%, polyvinylpyrrolidone purified water is dissolved the polyvinylpyrrolidonesolution solution being mixed with 8-10%, starch slurry and polyvinylpyrrolidonesolution solution are mixed and get final product.
9. the pharmaceutical purpose binding agent described in claim 7 or 8 is preparing the application in tablet medicament.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201410735866.7A CN105310990B (en) | 2014-12-04 | 2014-12-04 | It is a kind of prevent sticking and sliver to acetyl ammonia phenol piece and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410735866.7A CN105310990B (en) | 2014-12-04 | 2014-12-04 | It is a kind of prevent sticking and sliver to acetyl ammonia phenol piece and preparation method thereof |
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| CN105310990B CN105310990B (en) | 2018-01-19 |
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Cited By (3)
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|---|---|---|---|---|
| CN111920774A (en) * | 2020-08-06 | 2020-11-13 | 河北君临药业有限公司 | Paracetamol tablet and preparation method thereof |
| CN112641854A (en) * | 2020-12-14 | 2021-04-13 | 蚌埠丰原涂山制药有限公司 | Traditional Chinese medicine composition for clearing heat and reducing internal heat and preparation method thereof |
| CN114432256A (en) * | 2021-12-31 | 2022-05-06 | 陕西必康制药集团控股有限公司 | Paracetamol coated tablet and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111920774A (en) * | 2020-08-06 | 2020-11-13 | 河北君临药业有限公司 | Paracetamol tablet and preparation method thereof |
| CN111920774B (en) * | 2020-08-06 | 2022-08-12 | 河北君临药业有限公司 | Paracetamol tablet and preparation method thereof |
| CN112641854A (en) * | 2020-12-14 | 2021-04-13 | 蚌埠丰原涂山制药有限公司 | Traditional Chinese medicine composition for clearing heat and reducing internal heat and preparation method thereof |
| CN114432256A (en) * | 2021-12-31 | 2022-05-06 | 陕西必康制药集团控股有限公司 | Paracetamol coated tablet and preparation method thereof |
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| CN105310990B (en) | 2018-01-19 |
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