CN105310990B - It is a kind of prevent sticking and sliver to acetyl ammonia phenol piece and preparation method thereof - Google Patents
It is a kind of prevent sticking and sliver to acetyl ammonia phenol piece and preparation method thereof Download PDFInfo
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- CN105310990B CN105310990B CN201410735866.7A CN201410735866A CN105310990B CN 105310990 B CN105310990 B CN 105310990B CN 201410735866 A CN201410735866 A CN 201410735866A CN 105310990 B CN105310990 B CN 105310990B
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- starch
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- sliver
- paracetamol
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Abstract
The invention provides it is a kind of prevent sticking and sliver to acetyl ammonia phenol piece, including paracetamol, pregelatinized starch, sodium carboxymethyl starch, adhesive and glidant；Described adhesive presses 12 by starch, polyvinylpyrrolidone and water:0.1‑0.2:17.8 mass ratio, which is mixed with, to be formed.The present invention is had unilateral bright and clean attractive in appearance using tablet made from above-mentioned formula, the advantages of hardness height, impact resistance, fast disintegration, solve the problems, such as tabletting sticking, sliver, knock the influence such as side tablet integrity degree, the tablet can fater disintegration release, drastically increase dissolution rate and release, the stability of product is significantly improved, also efficiently solve because in product multiple-unit container and transportation medicine hit and caused by medicine lack side the problems such as.
Description
Technical field
The present invention relates to medicinal chemistry art, specifically, be related to it is a kind of prevent sticking and sliver to acetyl ammonia phenol piece
And preparation method thereof.
Background technology
Paracetamol is phenyl amines ntipyretic analgesic medicine, generally plays the clinical practice of the therapeutic actions such as antipyretic-antalgic
Dosage is larger, typically up to 500mg.Paracetamol clinical practice is mainly based on tablet and granule.Paracetamol
Using bead dosage form need dissolve after take, and because the bitter taste of paracetamol in itself it is heavier, it is necessary to be subject to sweetener and
Aromatic flavoring, manufacturing cost is added, therefore product price is higher, patient's medication cost is big.Big specification (heavy dose)
Paracetamol design piece agent, if tablet design it is excessive easily cause patient swallow difficulty, drug compliance decline,
If tablet design is smaller, it is difficult to solve the problems such as sticking, sliver again.The big specification paracetamol tabletses of domestic many enterprises
The problem of because of generally existing tabletting sticking, sliver, big friability, can not industrialization production and high-volume supply market.Many lifes
Production producer attempts solve the problems, such as sticking and sliver by controlling the moisture of particle and the granularity of particle, but due to scale batch
The moisture of particle is difficult control in industrialization production, the particle diameter and moisture of particle also heterogeneity, solves the effect of sticking and sliver
It is very little.
The content of the invention
In order to solve problems of the prior art, it is an object of the invention to provide a kind of pair for preventing sticking and sliver
Acetyl ammonia phenol piece and preparation method thereof.
In order to realize the object of the invention, present invention firstly provides it is a kind of prevent sticking and sliver to acetyl ammonia phenol piece, institute
State includes paracetamol, pregelatinized starch, sodium carboxymethyl starch, adhesive and glidant to acetyl ammonia phenol piece；It is described viscous
Mixture presses 10 by starch and polyvinylpyrrolidone:1-2 mass ratio, which is mixed with, to be formed.
Preferably, described be made up of to acetyl ammonia phenol piece the raw material of following parts by weight：It is 100 parts of paracetamol, pre-
Gelling starch 4-12 parts, sodium carboxymethyl starch 0.5-5 parts, adhesive 30-50 parts and glidant 0.05-0.2 parts.
More preferably, described be made up of to acetyl ammonia phenol piece the raw material of following parts by weight：It is 100 parts of paracetamol, pre-
Gelling starch 8-10 parts, sodium carboxymethyl starch 2-5 parts, adhesive 30-50 parts and glidant 0.1-0.2 parts.
Further, the preparation method of described adhesive is：By 10:1-2 mass ratio weighs starch and polyethylene respectively
Pyrrolidones, the starch slurry that starch is configured to 8-10% using slurry processes are rushed, the dissolving of polyvinylpyrrolidone purified water is matched somebody with somebody
8-10% polyvinylpyrrolidonesolution solution is made, starch slurry and polyvinylpyrrolidonesolution solution are mixed and produced.
Further, the glidant is stearic acid or magnesium stearate.
Further, the preparation method to acetyl ammonia phenol piece comprises the following steps：
1) each raw material is weighed by formula ratio；
2) paracetamol, pregelatinized starch, sodium carboxymethyl starch are mixed；
3) add adhesive and softwood is made, pelletize, dry；
4) tabletting after glidant mixes is added.
Present invention also offers a kind of pharmaceutical purpose adhesive for preventing sticking and sliver, described adhesive is by starch and poly- second
Alkene pyrrolidone presses 10:1-2 mass ratio, which is mixed with, to be formed.
Further, the preparation method of described adhesive is：By 10:1-2 mass ratio weighs starch and polyethylene respectively
Pyrrolidones, the starch slurry that starch is configured to 8-10% using slurry processes are rushed, the dissolving of polyvinylpyrrolidone purified water is matched somebody with somebody
8-10% polyvinylpyrrolidonesolution solution is made, starch slurry and polyvinylpyrrolidonesolution solution are mixed and produced.
Present invention also offers application of the foregoing pharmaceutical purpose adhesive in tablet medicament is prepared.
The beneficial effects of the present invention are：
The present invention will determine the mouldability of tablet to acetyl ammonia phenol using the filling class auxiliary material pregelatinized starch of routine, adopt
The disintegration for ensureing tablet with disintegration class auxiliary material sodium carboxymethyl starch discharges.Adhesive changes conventional list by improving and innovating
One adhesive composition, is combined with starch and polyvinylpyrrolidone, the granularity of particle can be allowed to pass through starch slurry
To control, and can ensures that the roundness of particle and moisture control by polyvinylpyrrolidone, by using combination adhesive,
So that the particle used in paracetamol tabletses has preferable integrity degree.The tablet extruded using above-mentioned formula has unilateral bright and clean
It is attractive in appearance, hardness height, impact resistance, the advantages of fast is disintegrated, solves tabletting sticking, sliver, knock asking for the influence tablet integrity degree such as side
Topic, the tablet can fater disintegration release, drastically increase dissolution rate and release, the stability of product is significantly carried
Height, also efficiently solve because in product multiple-unit container and transportation medicine hit and caused by medicine lack side the problems such as.
Embodiment
Following examples are used to illustrate the present invention, but are not limited to the scope of the present invention.
Paracetamol specification in the embodiment of the present invention is in terms of 0.5g/ pieces.
Embodiment 1
1st, raw material and formula
Paracetamol 0.5g；
Pregelatinized starch 0.05g；
Sodium carboxymethyl starch 0.01g；
Polyvinylpyrrolidone 0.0028g；
Starch 0.028g；
Stearic acid 0.004g.
2nd, preparation method
It is made up of the following steps：
(1) each supplementary material is weighed standby；
(2) paracetamol, pregelatinized starch, sodium carboxymethyl starch are well mixed；
(3) softwood is made in the adhesive that composition is mixed with 10% starch slurry and 10% polyvinylpyrrolidone, pelletizes, 50 DEG C
Dry；
Adhesive is formulated as follows：The dissolving of polyvinylpyrrolidone purified water is configured to 10% solution, starch is adopted
10% starch slurry is prepared with slurry processes are rushed, the liquid of above-mentioned preparation is mixed.
(4) tabletting after stearic acid mixes is added.
Embodiment 2
1st, raw material and formula
Paracetamol 0.5g；
Pregelatinized starch 0.06g；
Sodium carboxymethyl starch 0.02g；
Polyvinylpyrrolidone 0.0028g；
Starch 0.028g；
Stearic acid 0.0012g.
2nd, preparation method
It is made up of the following steps：
(1) each supplementary material is weighed standby；
(2) paracetamol, pregelatinized starch, sodium carboxymethyl starch are well mixed；
(3) softwood is made in the adhesive that composition is mixed with 10% starch slurry and 10% polyvinylpyrrolidone, pelletizes, 50 DEG C
Dry；
Adhesive is formulated as follows：The dissolving of polyvinylpyrrolidone purified water is configured to 10% solution, starch is adopted
10% starch slurry is prepared with slurry processes are rushed, the liquid of above-mentioned preparation is mixed.
(4) tabletting after stearic acid mixes is added.
Embodiment 3
1st, raw material and formula
Paracetamol 0.5g；
Pregelatinized starch 0.02g；
Sodium carboxymethyl starch 0.02g；
Polyvinylpyrrolidone 0.0028g；
Starch 0.028g；
Stearic acid 0.0012g.
2nd, preparation method
It is made up of the following steps：
(1) each supplementary material is weighed standby；
(2) paracetamol, pregelatinized starch, sodium carboxymethyl starch are well mixed；
(3) softwood is made in the adhesive that composition is mixed with 10% starch slurry and 10% polyvinylpyrrolidone, pelletizes, 50 DEG C
Dry；
Adhesive is formulated as follows：The dissolving of polyvinylpyrrolidone purified water is configured to 10% solution, starch is adopted
10% starch slurry is prepared with slurry processes are rushed, the liquid of above-mentioned preparation is mixed.
(4) tabletting after stearic acid mixes is added.
Embodiment 4
1st, raw material and formula
Paracetamol 0.5g；
Pregelatinized starch 0.03g；
Sodium carboxymethyl starch 0.01g；
Polyvinylpyrrolidone 0.0028g；
Starch 0.025g；
Stearic acid 0.0006g.
2nd, preparation method
It is made up of the following steps：
(1) each supplementary material is weighed standby；
(2) paracetamol, pregelatinized starch, sodium carboxymethyl starch are well mixed；
(3) softwood is made in the adhesive that composition is mixed with 8% starch slurry and 10% polyvinylpyrrolidone, pelletizes, 50 DEG C
Dry；
Adhesive is formulated as follows：The dissolving of polyvinylpyrrolidone purified water is configured to 10% solution, starch is adopted
8% starch slurry is prepared with slurry processes are rushed, the liquid of above-mentioned preparation is mixed.
(4) tabletting after stearic acid mixes is added.
Embodiment 5
1st, raw material and formula
Paracetamol 0.5g；
Pregelatinized starch 0.05g (10%)；
Sodium carboxymethyl starch 0.02g (2%)；
Polyvinylpyrrolidone 0.0025g；
Starch 0.028g；
Stearic acid 0.0006g (0.1%).
2nd, preparation method
It is made up of the following steps：
(1) each supplementary material is weighed standby；
(2) paracetamol, pregelatinized starch, sodium carboxymethyl starch are well mixed；
(3) softwood is made in the adhesive that composition is mixed with 10% starch slurry and 8% polyvinylpyrrolidone, pelletizes, 50 DEG C
Dry；
Adhesive is formulated as follows：The dissolving of polyvinylpyrrolidone purified water is configured to 8% solution, starch is used
Rush slurry processes and prepare 10% starch slurry, the liquid of above-mentioned preparation is mixed.
(4) tabletting after stearic acid mixes is added.
Embodiment 6
1st, raw material and formula
Paracetamol 0.5g；
Pregelatinized starch 0.04g (8%)；
Sodium carboxymethyl starch 0.02g (4%)；
Polyvinylpyrrolidone 0.0028g；
Starch 0.028g；
Stearic acid 0.0012g.
2nd, preparation method
It is made up of the following steps：
(1) each supplementary material is weighed standby；
(2) paracetamol, pregelatinized starch, sodium carboxymethyl starch are well mixed；
(3) softwood is made in the adhesive that composition is mixed with 10% starch slurry and 10% polyvinylpyrrolidone, pelletizes, 50 DEG C
Dry；
Adhesive is formulated as follows：The dissolving of polyvinylpyrrolidone purified water is configured to 10% solution, starch is adopted
10% starch slurry is prepared with slurry processes are rushed, the liquid of above-mentioned preparation is mixed.
(4) tabletting after stearic acid mixes is added.
Test example
1st, based on main ingredient paracetamol 0.5g/ pieces, the compressibility of tablet, hardness, friability, molten is investigated respectively
The indexs such as out-degree.
Table 1 investigates the indices of paracetamol tablet in embodiment 1-6
2nd, the study on the stability of product
Table 2 investigates paracetamol tablet study on the stability situation in embodiment 1-6
3rd, the contrast experiment to acetyl ammonia phenol piece prepared using different adhesives
Prepared below using different adhesives to acetyl ammonia phenol piece and carry out contrast test, analyzed according to data result
Go out, using made from adhesive of the present invention to acetyl ammonia phenol piece, than using made from single adhesive to acetyl ammonia phenol
Piece has obvious advantage, and specific experiment data are shown in Table 3：
The contrast to acetyl ammonia phenol piece that table 3 is prepared using different adhesives
Although above the present invention is described in detail with a general description of the specific embodiments,
On the basis of the present invention, it can be made some modifications or improvements, this will be apparent to those skilled in the art.Cause
This, these modifications or improvements, belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (1)
1. it is a kind of prevent sticking and sliver to acetyl ammonia phenol piece, it is characterised in that
Its raw material is：Paracetamol 0.5g；Pregelatinized starch 0.05g；Sodium carboxymethyl starch 0.01g；Polyvinylpyrrolidine
Ketone 0.0028g；Starch 0.028g；Stearic acid 0.004g；
Its preparation method is as follows：
(1) each supplementary material is weighed standby；
(2) paracetamol, pregelatinized starch, sodium carboxymethyl starch are well mixed；
(3) softwood is made in the adhesive that composition is mixed with 10% starch slurry and 10% polyvinylpyrrolidone, pelletizes, and 50 DEG C dry
It is dry；
Adhesive is formulated as follows：The dissolving of polyvinylpyrrolidone purified water is configured to 10% solution, by starch using punching
Slurry processes prepare 10% starch slurry, and the liquid of above-mentioned preparation is mixed；
(4) tabletting after stearic acid mixes is added.
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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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|---|---|---|---|
| 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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| Publication Number | Publication Date |
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| CN105310990A CN105310990A (en) | 2016-02-10 |
| CN105310990B true CN105310990B (en) | 2018-01-19 |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1374862A (en) * | 1999-09-16 | 2002-10-16 | 罗狄亚公司 | Directly compressible, ultra fine acetaminophen compositions and process for producing same |
| CN1575164A (en) * | 2001-08-29 | 2005-02-02 | 兰贝克赛实验室有限公司 | Controlled release preparation of clarithromycin or tinidazole |
| CN101466359A (en) * | 2006-04-07 | 2009-06-24 | 史密丝克莱恩比彻姆公司 | Fast release paracetamol tablets |
| CN102988993A (en) * | 2011-09-13 | 2013-03-27 | 广东九明制药有限公司 | Screening and composition of main auxiliary materials of compound acetaminophen tablet, and preparation method of compound acetaminophen tablet |
-
2014
- 2014-12-04 CN CN201410735866.7A patent/CN105310990B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1374862A (en) * | 1999-09-16 | 2002-10-16 | 罗狄亚公司 | Directly compressible, ultra fine acetaminophen compositions and process for producing same |
| CN1575164A (en) * | 2001-08-29 | 2005-02-02 | 兰贝克赛实验室有限公司 | Controlled release preparation of clarithromycin or tinidazole |
| CN101466359A (en) * | 2006-04-07 | 2009-06-24 | 史密丝克莱恩比彻姆公司 | Fast release paracetamol tablets |
| CN102988993A (en) * | 2011-09-13 | 2013-03-27 | 广东九明制药有限公司 | Screening and composition of main auxiliary materials of compound acetaminophen tablet, and preparation method of compound acetaminophen tablet |
Non-Patent Citations (2)
| Title |
|---|
| "对乙酰氨基酚片剂裂片的倾向性预测";王洪光等;《中国医药工业杂志》;20001231;第31卷(第2期);第61-64页 * |
| "新辅料及新工艺在对乙酞氨基酚片中的应用";梁勇坤等;《广东药学》;20041231;第14卷(第4期);第40-43页 * |
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