CN102872173A - Compound acetaminophen orally disintegrating tablet for beasts and birds and preparation method for compound acetaminophen orally disintegrating tablet - Google Patents
Compound acetaminophen orally disintegrating tablet for beasts and birds and preparation method for compound acetaminophen orally disintegrating tablet Download PDFInfo
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- CN102872173A CN102872173A CN2012104023272A CN201210402327A CN102872173A CN 102872173 A CN102872173 A CN 102872173A CN 2012104023272 A CN2012104023272 A CN 2012104023272A CN 201210402327 A CN201210402327 A CN 201210402327A CN 102872173 A CN102872173 A CN 102872173A
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Abstract
The invention relates to a compound acetaminophen orally disintegrating tablet for beasts and birds. The compound acetaminophen orally disintegrating tablet for the beasts and birds consists of the following components in parts by weight: 80-100 parts of acetaminophen, 8-12 parts of Bupleurum sinensis extract, 10-40 parts of polyacrylic resin, 20-60 parts of microcrystalline cellulose, 30-60 parts of polyvinylpolypyrrolidone, 10-30 parts of lactose, 40-60 parts of mannitol, 0.5-2.0 parts of acesulfame and 0.5-2.0 parts of magnesium stearate. The acetaminophen and the Bupleurum sinensis extract are scientifically formulated to prepare the orally disintegrating tablet, and the orally disintegrating tablet can be widely used for treating fever, courbature and rheumatism of horses, cattle, sheep and pigs. The acetaminophen with a bitter taste is treated by the polyacrylic resin by adopting the powder coating technique to better achieve the goal of covering the bitter taste. The compound acetaminophen orally disintegrating tablet for the beasts and birds is rapid in absorption, high in bioavailability, simple in production equipment and low in cost, and a new way is opened for domestic veterinary drug markets to treat acute diseases.
Description
Technical field
The present invention relates to a kind of medicine for animal, particularly a kind of oral disintegrant of compound paracetamol and preparation method thereof.
Background technology
Along with developing rapidly of China's livestock and poultry breeding industry and deepening continuously of veterinary drug research, the application of antipyretic-antalgic on poultry various diseases treatment of infection formed generally, and the survival rates of raising poultry and health level and disease treatment have all been played positive role.Acetaminophen is the phenyl amines antipyretic analgesic, can make the poultry of infection and severe infections analgesic rapidly, and it is constant that body temperature is kept.As domestic and international large kind, use clinically safety, effective, be one for the treatment of heating, analgesic choice drug, obtained generally acknowledging of the whole world, have the history in more than 50 year.
Oral cavity disintegration tablet can affect the rate of dissolution of medicine, discharge fast and also arrive action target spot, reach fast CSS, in prevention with reduce aspect the sensitivity of central pain passage extremely important, thereby reduce the acute attack of heating, so make the bioavailability that oral cavity disintegration tablet can improve medicine.Oral cavity disintegration tablet needn't be used water delivery service, and saliva can make its disintegrate or dissolving, can swallow by common dose, can be placed in the water again to take after the disintegrate, can also not need to take medicine with water swallow.Rapidly disintegrate and be dispersed into trickle granule causes medicine to distribute in the gastrointestinal tract large tracts of land before medicine arrives gastrointestinal tract, and absorption point increases, thereby has reduced medicine to the gastrointestinal local excitation.Because oral cavity disintegration tablet is rapidly disintegrate in mouth, except major part enters the gastrointestinal tract with swallowing act, also there is the considerable part direct oral cavity to absorb, thereby rapid-action, first pass effect is little, the poultry that are particularly useful for serious disease, dysphagia and water intaking inconvenience, greatly improve drug compliance, solve the hard problem of taking medicine.
Second phthalein amino phenols oral cavity disintegration tablet is gone on the market in the U.S. first, Chinese people is being developed with existing part unit, but not yet there are this dosage form and the compound recipe development and the exploitation that contain this product in the veterinary drug market of China at present, therefore domestic urgent need is developed a kind of and a series of convenient drug administration, need not feed water, absorb fast, bioavailability is high, instructions of taking, mouthfeel is good, intestinal is residual few, side effect is low, the veterinary drug product of avoiding the first pass effect of liver or only needing a small amount of water and need not to chew, to remedy the blank of domestic veterinary drug market on dosage form, for treatment poultry special-purpose medicaments is opened up new way.
Summary of the invention
The objective of the invention is to propose a kind of absorb the poultry fast, that bioavailability is high with compound recipe to second phthalein amino phenols oral cavity disintegration tablet and preparation method thereof.
The present invention is achieved through the following technical solutions:
A kind of poultry oral disintegrant of compound paracetamol is characterized in that its component by following parts by weight forms: acetaminophen 80-100 part, Radix Bupleuri extract 8-12 part, polyacrylic resin 10-40 part, microcrystalline Cellulose 20-60 part, polyvinylpolypyrrolidone 20-60 part, lactose 10-30 part, mannitol 40-60 part, acesulfame-K 0.5-2.0 part, magnesium stearate 0.5-2.0 part.
Preferably, its component by following parts by weight forms: 90 parts of acetaminophen, 10 parts of Radix Bupleuri extracts, 30 parts of polyacrylic resins, 40 parts of microcrystalline Cellulose, 40 parts of polyvinylpolypyrrolidone, 20 parts of lactose, 50 parts in mannitol, 1 part of acesulfame-K, 1 part of magnesium stearate.
Described polyacrylic resin is preferably polyacrylic resin Ⅳ; Described lactose is the granulation lactose.
The described poultry preparation method of oral disintegrant of compound paracetamol is characterized in that may further comprise the steps: polyacrylic resin is dissolved in the ethanol, and spray technique at the bottom of the employing fluid bed carries out coating with acetaminophen, crosses 60 mesh sieves, and is for subsequent use; Add Radix Bupleuri extract, microcrystalline Cellulose, mannitol, lactose and 1/2 part of polyvinylpolypyrrolidone, take 30% ethanol as adhesive, the fluid bed top spray is granulated, and adds remaining polyvinylpolypyrrolidone mix homogeneously behind the granulate, after adding again acesulfame-K, magnesium stearate mixing, tabletting.
The fluidized bed granulation technological parameter is: inlet temperature 55-65 ℃, and intake 24-30m
3/ h, temperature of charge 30-40 ℃, leaving air temp 35-45 ℃, atomization air pressure 1.8-2.2 * 10
5Pa, hydrojet speed 9-13g/min.
Acetaminophen is antipyretic analgesic, is used for heating, myalgia and rheumatism etc.Radix Bupleuri is Umbelliferae Bupleurum plant, and tool induces sweat, brings down a fever, the dispersing the stagnated live-QI to relieve the stagnation of QI function, cures mainly cold, fever, alternate attack of chill and fever, and the diseases such as costa sternales stomachache, the main effective ingredient of Radix Bupleuri is volatile oil and saikoside etc.What the present invention innovated forms compound preparation with acetaminophen and Radix Bupleuri extract, western medicine composition has the analgesic activity of bringing down a fever to second phthalein amino phenols, the pain valve reaches the pain relieving purpose by raising, by hypothalamus thermotaxic centre generation effect being reached the purpose of bringing down a fever, effectively alleviating pain and heating; Join diaphoretic medicine Radix Bupleuri reconciling superficies and interior, expelling pathogenic factors from muscles for reducing heat is used for the treatment of alternate attack of chill and fever, cold, fever; Integrative Chinese-Western is used in this invention, is used for cold, fever, myalgia and rheumatism etc., the heating, myalgia and the rheumatism that are used for the treatment of horse, cattle, sheep, pig, chicken, duck, goose etc. through testing it, and effective percentage is up to more than 93%.
Advantage of the present invention and beneficial effect are: (1) the present invention be evenly distributed at gastric at dissolved in oral cavity, and side effect is low, and absorption is fast, bioavailability is high, can avoid corroding medicine at gastric acid, is conducive to increase the stability of medicine; Production equipment of the present invention is simple, processing ease, and cost is low, adopts general powder granule pressed-disc technique processed can produce oral cavity disintegration tablet, is the important breakthrough of domestic oral formulations process technology, for domestic veterinary drug market treatment emergency case has been opened up new way; (2) the present invention adopts the fluidized bed powder packaging technique with polyacrylic resin the acetaminophen with bitterness to be processed, its coating effect is good, can reach preferably the purpose of covering bitterness, and with extract and the granulation of adjuvant employing fluid bed top spray, carry out direct powder compression and prepare oral cavity disintegration tablet, the oral cavity disintegration tablet that makes has the advantages such as disintegrate is fast, onset is rapid; (3) among the present invention to second phthalein amino phenols oral cavity disintegration tablet and Radix Bupleuri extract science collocation prescription, can be widely used in heating, myalgia and the rheumatism for the treatment of horse, cattle, sheep, pig, also can use simultaneously with other medicines.
The specific embodiment
The invention will be further described below by specific embodiment, and following examples are descriptive, is not determinate, can not limit protection scope of the present invention with this.
EXAMPLE l:
Batching: acetaminophen 900g, Radix Bupleuri extract 100g, polyacrylic resin Ⅳ 300g, microcrystalline Cellulose 400g, polyvinylpolypyrrolidone 400g, lactose 200g, mannitol 500g, acesulfame-K 10g, magnesium stearate 1 0g.
The preparation of Radix Bupleuri extract: Radix Bupleuri is added 8 times of water gagings decoct twice, each 2 hours, collecting decoction, concentrated, drying is pulverized, and be get final product.
Preparation technology: polyacrylic resin is dissolved in the ethanol, and spray technique at the bottom of the employing fluid bed carries out coating with acetaminophen, crosses 60 mesh sieves, and is for subsequent use; Add Radix Bupleuri extract, microcrystalline Cellulose, mannitol, lactose and 1/2 part of polyvinylpolypyrrolidone, take 30% ethanol as adhesive, the fluid bed top spray is granulated, and adds remaining polyvinylpolypyrrolidone mix homogeneously behind the granulate, after adding again acesulfame-K, magnesium stearate mixing, tabletting.
The fluidized bed granulation technological parameter is: inlet temperature 55-65 ℃, and intake 24-30m
3/ h, temperature of charge 30-40 ℃, leaving air temp 35-45 ℃, atomization air pressure 1.8-2.2 * 10
5Pa, hydrojet speed 9-13g/min.
Embodiment 2:
Batching: acetaminophen 900g, Radix Bupleuri extract 100g, polyacrylic resin Ⅳ 200g, microcrystalline Cellulose 200g, polyvinylpolypyrrolidone 600g, lactose 100g, mannitol 400g, acesulfame-K 10g, magnesium stearate 1 0g.
The preparation of Radix Bupleuri extract: Radix Bupleuri is added 10 times of water gagings decoct twice, each 1 hour, collecting decoction, concentrated, drying is pulverized, and be get final product.
Preparation technology: the step of the preparation method of present embodiment is same as embodiment 1.
Embodiment 3:
Batching: acetaminophen 900g, Radix Bupleuri extract 120g, polyacrylic resin Ⅳ 350g, microcrystalline Cellulose 500g, polyvinylpolypyrrolidone 300g, granulation lactose 200g, mannitol 600g, acesulfame-K 20g, magnesium stearate 10g.
The preparation of Radix Bupleuri extract: Radix Bupleuri is added 10 times of amount 50% alcohol heating reflux twice, each 1 hour, merge extractive liquid,, Recycled ethanol, concentrated, drying is pulverized, and be get final product.
Preparation technology: the step of the preparation method of present embodiment is same as embodiment 1.
Embodiment 4:
Batching: acetaminophen 1000g, Radix Bupleuri extract 80g, polyacrylic resin Ⅳ 400g, microcrystalline Cellulose 300g, polyvinylpolypyrrolidone 500g, lactose 300g, mannitol 400g, acesulfame-K 10g, magnesium stearate 2 0g.
The preparation of Radix Bupleuri extract: Radix Bupleuri is added 8 times of amount 80% alcohol heating reflux twice, each 1 hour, merge extractive liquid,, Recycled ethanol, concentrated, drying is pulverized, and be get final product.
Preparation technology: the step of the preparation method of present embodiment is same as embodiment 1.
Embodiment 5:
Batching: acetaminophen 800g, Radix Bupleuri extract 80g, polyacrylic resin Ⅳ 100g, microcrystalline Cellulose 200g, polyvinylpolypyrrolidone 400g, granulation lactose 300g, mannitol 500g, acesulfame-K 20g, magnesium stearate 5g.
The preparation of Radix Bupleuri extract: Radix Bupleuri is added first 6 times of water gaging vapor extraction volatile oil, and volatile oil is prepared into clathrate with beta-schardinger dextrin-, and water liquid filters for subsequent use; Medicinal residues are with water extraction twice, and each 1 hour, merge above-mentioned water liquid and extracted twice liquid, concentrated, drying is pulverized, with the clathrate merging, mixing and get final product.
Preparation technology: the step of the preparation method of present embodiment is same as embodiment 1.
Embodiment 6:
Batching: acetaminophen 900g, Radix Bupleuri extract 100g, polyacrylic resin Ⅳ 350g, microcrystalline Cellulose 300g, polyvinylpolypyrrolidone 400g, granulation lactose 300g, mannitol 400g, acesulfame-K 8g, magnesium stearate 15g.
The preparation of Radix Bupleuri extract: Radix Bupleuri is added first water or supercritical CO
2Extract volatile oil, volatile oil is prepared into clathrate with beta-schardinger dextrin-, and water liquid filters for subsequent use; Medicinal residues are with 80% alcohol reflux twice, and each 1 hour, merge extracted twice liquid, Recycled ethanol merges concentratedly with above-mentioned water liquid, and drying is pulverized, and merges mixing and get final product with clathrate.
Preparation technology: the step of the preparation method of present embodiment is same as embodiment 1.
Claims (5)
1. a poultry oral disintegrant of compound paracetamol is characterized in that its component by following parts by weight forms: acetaminophen 80-100 part, Radix Bupleuri extract 8-12 part, polyacrylic resin 10-40 part, microcrystalline Cellulose 20-60 part, polyvinylpolypyrrolidone 30-60 part, lactose 10-30 part, mannitol 40-60 part, acesulfame-K 0.5-2.0 part, magnesium stearate 0.5-2.0 part.
2. poultry oral disintegrant of compound paracetamol according to claim 1 is characterized in that its component by following parts by weight forms: 90 parts of acetaminophen, 10 parts of Radix Bupleuri extracts, 30 parts of polyacrylic resins, 40 parts of microcrystalline Cellulose, 40 parts of polyvinylpolypyrrolidone, 20 parts of lactose, 50 parts in mannitol, 1 part of acesulfame-K, 1 part of magnesium stearate.
3. poultry oral disintegrant of compound paracetamol according to claim 1 and 2, it is characterized in that: described polyacrylic resin is polyacrylic resin Ⅳ; Described lactose is the granulation lactose; Described Radix Bupleuri extract is a kind of or its mixture of Radix Bupleuri water extract, ethanol extract and supercritical extraction extract.
4. described poultry are with the preparation method of oral disintegrant of compound paracetamol according to claim 1-3, it is characterized in that may further comprise the steps: polyacrylic resin is dissolved in the ethanol, and spray technique at the bottom of the employing fluid bed carries out coating with acetaminophen, cross 60 mesh sieves, for subsequent use; Add Radix Bupleuri extract, microcrystalline Cellulose, mannitol, lactose and 1/2 part of polyvinylpolypyrrolidone, take 30% ethanol as adhesive, the fluid bed top spray is granulated, and adds remaining polyvinylpolypyrrolidone mix homogeneously behind the granulate, after adding again acesulfame-K, magnesium stearate mixing, tabletting.
5. poultry according to claim 4 are with the preparation method of oral disintegrant of compound paracetamol, and it is characterized in that: the fluidized bed granulation technological parameter is: inlet temperature 55-65 ℃, and intake 24-30m
3/ h, temperature of charge 30-40 ℃, leaving air temp 35-45 ℃, atomization air pressure 1.8-2.2 * 10
5Pa, hydrojet speed 9-13g/min.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104023272A CN102872173A (en) | 2012-10-22 | 2012-10-22 | Compound acetaminophen orally disintegrating tablet for beasts and birds and preparation method for compound acetaminophen orally disintegrating tablet |
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| CN2012104023272A CN102872173A (en) | 2012-10-22 | 2012-10-22 | Compound acetaminophen orally disintegrating tablet for beasts and birds and preparation method for compound acetaminophen orally disintegrating tablet |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107595905A (en) * | 2017-09-26 | 2018-01-19 | 佛山市盛世泰康医药科技有限公司 | The defervescence plaster used and preparation method prepared is combined by paracetamol and bupleurum Chinense volatile oil |
| CN111374953A (en) * | 2018-12-31 | 2020-07-07 | 上海鼎雅药物化学科技有限公司 | Paracetamol tablet and preparation process thereof |
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| CN1559390A (en) * | 2004-02-27 | 2005-01-05 | 中奇制药技术（石家庄）有限公司 | Oral disintegration tablets contg. p-acetaminophenol, and prepn. method therefor |
| CN101524335A (en) * | 2009-04-22 | 2009-09-09 | 天津必佳药业集团有限公司 | Paracetanol orally-disintegrating tablet for beasts and birds and preparation method thereof |
| CN101548953A (en) * | 2008-04-03 | 2009-10-07 | 上海医药工业研究院 | Medicine granule, preparation method thereof, and preparation containing same |
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2012
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1559390A (en) * | 2004-02-27 | 2005-01-05 | 中奇制药技术（石家庄）有限公司 | Oral disintegration tablets contg. p-acetaminophenol, and prepn. method therefor |
| CN101548953A (en) * | 2008-04-03 | 2009-10-07 | 上海医药工业研究院 | Medicine granule, preparation method thereof, and preparation containing same |
| CN101524335A (en) * | 2009-04-22 | 2009-09-09 | 天津必佳药业集团有限公司 | Paracetanol orally-disintegrating tablet for beasts and birds and preparation method thereof |
Non-Patent Citations (2)
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| 叶磊等: "混料均匀设计法优化对乙酰氨基酚口腔崩解片处方", 《中国医药工业杂志》, vol. 36, no. 1, 31 December 2005 (2005-12-31), pages 24 - 26 * |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107595905A (en) * | 2017-09-26 | 2018-01-19 | 佛山市盛世泰康医药科技有限公司 | The defervescence plaster used and preparation method prepared is combined by paracetamol and bupleurum Chinense volatile oil |
| CN111374953A (en) * | 2018-12-31 | 2020-07-07 | 上海鼎雅药物化学科技有限公司 | Paracetamol tablet and preparation process thereof |
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Application publication date: 20130116 |