CN102349915A - Acetaminophen, caffeine, chlorphenamine maleate, and vitamin C preparation and preparation method thereof - Google Patents
Acetaminophen, caffeine, chlorphenamine maleate, and vitamin C preparation and preparation method thereof Download PDFInfo
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Abstract
The invention discloses an acetaminophen, caffeine, chlorphenamine maleate, vitamin C preparation and a preparation method thereof, wherein the preparation is double-layer tablets which are respectively an acetaminophen granular layer embedded by beta-cyclodextrin, and a caffeine, chlorphenamine maleate and vitamin C granular layer, which are moulded by a tablet press. The preparation uses the beta-cyclodextrin to embed the acetaminophen so as to remarkably improve the stability and dissolution rate of the acetaminophen and reduce the stimulation and toxic side effects of medicaments; the beta-cyclodextrin can further reduce the offensive odour of the medicaments; moreover, the invention adopts the synergistic effect of the acetaminophen and the vitamin C so as to shorten the treatment course for curing the cold and make the cold be not easy to relapse; and the double-layer tablet structure achieves the purposes of isolating the acetaminophen and the caffeine, the chlorphenamine maleate and the vitamin C and solves the problems of metamorphic degradation, poor stability, short period of efficacy and the like caused by the interaction of the medicaments. The preparation is not easy to split, and is excellent in quality. The method is used for preparing the acetaminophen caffeine chlorphenamine maleate vitamin C double-layer tablet, and the preparation is mainly used for treating disease such as cold.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of coldrex preparation, quick vitamin C preparation of specifically a kind of ammonia phenol coffee and preparation method thereof.
Background technology
Flu is a kind of common disease, has a strong impact on daily work of people and life.The medicine that is used to treat flu has a variety of; The medicine that wherein contains components such as acetaminophen, chlorphenamine maleate, caffeine is common cold-treating preparation; But, cause solid preparation oral administration bioavailability lower because the acetaminophen water solublity is relatively poor.
Cyclodextrin can increase dissolubility and the dissolution velocity of the bad medicine of some water solublity in water effectively, and it can also improve stability of drug and bioavailability; Reduce the bad smell or the bitterness of medicine; Reduce the stimulation and the toxic and side effects of medicine; And make medicament slow release and improve effect such as dosage form.
Houston JB in 1976; Levy G. publish an article at J Pharm Sci. magazine (Drug biotransformation interactions in man VI:acetaminophen and ascorbic acid.) point out that vitamin C can reduce acetaminophen and eliminate speed; (mean ± SD) extend to 3.1 ± 0.5 hr demonstrates synergistic therapeutic action in acetaminophen, the vitamin C therapeutic alliance flu from 2.3 ± 0.2 to make the half-life.
Summary of the invention
The technical problem that the present invention will solve; Just provide quick vitamin C preparation of a kind of ammonia phenol coffee and preparation method thereof; Said preparation is acetaminophen, caffeine, chlorphenamine maleate, the ascorbic composition of medicine that comprises the beta-schardinger dextrin-parcel, and this medicine has enough stability.
Said preparation is to the acetaminophen poorly water-soluble; Solid preparation oral administration bioavailability is low etc.; Adopt acetaminophen--preparation of Benexate Hydrochloride addresses this problem; Because of containing four principal agent compositions in the prescription; Stability for each composition of guaranteeing product; Containing the problems referred to above relevant with conventional method in the fixed dosage composition of medicine of above composition in preparation can overcome through double-layer tablet; This biplate layer comprises the ground floor of the acetaminophen of beta-schardinger dextrin-embedding; And contain chlorphenamine maleate; Caffeine; The ascorbic second layer; Acetaminophen significantly improves its stability after processing Benexate Hydrochloride; Dissolution rate; Zhi Bei double-layer tablet is difficult for sliver like this, and quality is better.
Another object of the present invention has provided preparing such formulations.
The present invention will solve above-mentioned technical problem, is achieved through following technical scheme:
The quick vitamin C preparation of a kind of ammonia phenol coffee is bilayer tablet, and said first lamella is compressed beta-schardinger dextrin-embedding acetaminophen particles layer, and said second lamella is compressed caffeine, chlorphenamine maleate and vitamin C granules layer; Wherein, the raw material of processing said preparation comprise following parts by weight each form:
200 parts of acetaminophen,
700～1000 parts of beta-schardinger dextrin-s,
25 parts of caffeine,
150 parts of dimension C,
2.5 parts of chlorphenamine maleate,
350～1600 parts of filleies,
13.5～55 parts of lubricants,
120～200 parts of binding agents.
As a kind of qualification of the present invention,
1. the parts by weight of each composition are in said first lamella:
200 parts of acetaminophen,
700～1000 parts of beta-schardinger dextrin-s,
200～1300 parts of the first lamella filleies,
10～15 parts of the first lamella lubricants,
80～150 parts of the first lamella binding agents;
2. the parts by weight of each composition are in said second lamella:
25 parts of caffeine,
2.5 parts of chlorphenamine maleate,
150 parts of vitamin Cs,
150～300 parts of the second lamella filleies,
3.5～40 parts of the second lamella lubricants,
40～50 parts of the second lamella binding agents.
As further qualification of the present invention,
(1) filler of said first lamella is any two kinds in lactose, Lactis Anhydrous, starch, vertical compression starch, amylum pregelatinisatum, sorbitol, mannitol, the microcrystalline Cellulose;
(2) filler of said second lamella is a kind of in cellulose powder and microcrystalline Cellulose, cellulose derivative, lactose, calcium hydrogen phosphate, starch, the amylum pregelatinisatum;
(3) lubricant of said first and second lamella is a kind of in stearic acid, magnesium stearate, calcium stearate, the Pulvis Talci, preferred magnesium stearate (because the stable in properties of magnesium stearate, specific surface area is big, is easy to distribute good fluidity);
(4) binding agent of said first lamella is a kind of in hydroxypropyl emthylcellulose, polyvidone, the starch;
(5) binding agent of said second lamella is a kind of in corn starch, polyvidone, copolyvidone and the cellulose derivative (like hydroxypropyl emthylcellulose, hydroxyl methylcellulose, hyprolose).
The present invention also provides the method for preparing of the quick vitamin C preparation of above-mentioned a kind of ammonia phenol coffee, carries out according to the following step order:
1. the particulate preparation of first lamella:
(1) take by weighing acetaminophen, stirring adds dehydrated alcohol down makes dissolving fully, makes solution A, subsequent use;
(2) in agitator tank, add purified water, be heated to 57～63 ℃, stop heating, behind filtering tank, 1 μ m micropore membrane filter, 0.45 μ m micropore membrane filter three-stage filtration, to the enclose jar;
Add beta-schardinger dextrin-, stir and make it dissolving, stop heating, be cooled to 37～43 ℃ of insulations, obtain solution B;
(3) solution A is at the uniform velocity dropped in the solution B, dropwise in 1.8～2.1h, behind continuation stirring reaction 3.5～5h, reduce to room temperature, leave standstill 12h, get enclose liquid C;
(4) enclose liquid C is transferred in the sucking filtration jar, sucking filtration 2～3h, and filter cake washs with pure water;
(5) filter cake after the washing places baking oven to dry 3～5h down for 35～45 ℃, gets acetaminophen-Benexate Hydrochloride dry product D;
(6) filler is crossed 80 mesh sieves respectively, get 1000 tablet recipe amounts; Then
(7) with the D mix homogeneously of formula ratio; Binding agent after will in suitable quantity of water, dissolving joins in the said mixture, is mixed with soft material, crosses 16 mesh sieves and granulates; Then
(8) granule is in 40～50 ℃ of dryings, and take out dried back, adds the magnesium stearate mix homogeneously, crosses 18 mesh sieve granulate, gets acetaminophen layer granule;
2. the particulate preparation of second lamella:
Other gets caffeine, chlorphenamine maleate, vitamin C, filler, the binding agent mix homogeneously of recipe quantity; Be pressed into large stretch of 18 mesh sieve granulate dry granulations of crossing; Take out back and magnesium stearate mix homogeneously, get caffeine, vitamin C, chlorphenamine maleate layer granule;
3. the preparation of double-layer tablet:
Two kinds of granules are inserted in the different hoppers of tablet machine, and compression ground floor granule forms lamella I, and back another lamella granule of compression forms lamella II, and the applications as laminates of compression lamella I and lamella II forms layer tablets, is the applications as laminates of first lamella and second lamella.
As a kind of optimization of the above-mentioned method for preparing of the present invention, institute's applied pressure is 1:2～10 with the ratio of institute's applied pressure in the applications as laminates layer compression process of lamella I and lamella II in the said lamella I compression process.
Preparation prescription provided by the present invention also can be prepared into the small pieces that are fit to size and shape and form capsule preparations in the capsule to be filled into, but because main component is many and dosage is big, will use 0 during filled capsules
#The lengthening capsule is considered compliance of patients, and long capsule is dangerous when taking.
Owing to adopted above-mentioned technical scheme, the present invention compared with prior art, the technological progress that is obtained is:
It utilizes beta-schardinger dextrin-parcel acetaminophen, has significantly improved the stimulation and the toxic and side effects of its stability, dissolution rate, reduction medicine, and beta-schardinger dextrin-can also play the bad smell that reduces medicine or the effect of bitterness; In addition, this preparation that has adopts acetaminophen, vitamin C synergism, makes that shortened the course of treatment when said preparation was used for the treatment flu, is difficult for recurrence; Said preparation is prepared into bilayer tablet configuration; Realized purpose isolated between acetaminophen and caffeine, chlorphenamine maleate and the vitamin C; The rotten degraded that can prevent to interact between the medicine and cause; Problems such as poor stability and effect duration are short; And the medicine of this structure is difficult for sliver, and quality is better.
The present invention is used to prepare the quick dimension of ammonia phenol coffee C bilayer tablet, and this medicine is mainly used in treatment flu type disease.
Below in conjunction with Figure of description and specific embodiment the present invention is done further explain.
Description of drawings
Fig. 1-Fig. 4 is respectively the stripping curve of embodiment 1-3, Comparative Examples.
The specific embodiment
Following examples only are used to illustrate the present invention, and do not limit the present invention.
Annotate: upward cellulose derivative is hydroxypropyl emthylcellulose, hydroxyl methylcellulose or hyprolose in the table.
Embodiment 1-7 is respectively the quick vitamin C preparation of a kind of ammonia phenol coffee, is bilayer tablet configuration, comprises acetaminophen, caffeine, dimension C, chlorphenamine maleate in the effective ingredient.Process the supplementary material prescription of 1000 of said medicine and see upward table, their method for preparing is carried out according to the following steps order respectively:
1. the particulate preparation of first lamella:
(1) take by weighing acetaminophen, stirring adds dehydrated alcohol down makes dissolving fully, makes solution A, subsequent use;
(2) in agitator tank, add purified water, be heated to 57～63 ℃, stop heating, behind filtering tank, 1 μ m micropore membrane filter, 0.45 μ m micropore membrane filter three-stage filtration, to the enclose jar;
Add beta-schardinger dextrin-, stir and make it dissolving, stop heating, be cooled to 37～43 ℃ of insulations, obtain solution B;
(3) solution A is at the uniform velocity dropped in the solution B, dropwise in 1.8～2.1h, behind continuation stirring reaction 3.5～5h, reduce to room temperature, leave standstill 12h, get enclose liquid C;
(4) enclose liquid C is transferred in the sucking filtration jar, sucking filtration 2～3h, and filter cake washs with pure water;
(5) filter cake after the washing places baking oven to dry 3～5h down for 35～45 ℃, gets acetaminophen-Benexate Hydrochloride dry product D;
(6) filler is crossed 80 mesh sieves respectively, get 1000 tablet recipe amounts; Then
(7) with the D mix homogeneously of formula ratio; Binding agent after will in suitable quantity of water, dissolving joins in the said mixture, is mixed with soft material, crosses 16 mesh sieves and granulates; Then
(8) granule is in 40～50 ℃ of dryings, does the back and takes out, and it is even to add the first lamella mix lubricant, crosses 18 mesh sieve granulate, acetaminophen layer granule;
2. the particulate preparation of second lamella:
Other gets caffeine, chlorphenamine maleate, vitamin C, filler, the binding agent mix homogeneously of recipe quantity; Be pressed into large stretch of 18 mesh sieve granulate dry granulations of crossing; It is even with the second lamella mix lubricant to take out the back, gets caffeine, vitamin C, chlorphenamine maleate layer granule;
3. the preparation of double-layer tablet:
Two kinds of granules are inserted in the different hoppers of tablet machine, and compression ground floor granule forms lamella I, and back another lamella granule of compression forms lamella II, and the applications as laminates of compression lamella I and lamella II forms layer tablets, is the applications as laminates of first lamella and second lamella.
In the above-mentioned compression process: institute's applied pressure is 1:2～10 with the ratio of institute's applied pressure in the applications as laminates compression process of lamella I and lamella II in the lamella I compression process.
The present invention has carried out practical measurement (and embodiment 4-7 measures) to dissolution, the component content of embodiment 1-3, and contrasts with Comparative Examples, and concrete outcome is seen Table I and Table II.
The principal agent composition of Comparative Examples does not have beta-schardinger dextrin-and coats, and it is write out a prescription as follows:
A. acetaminophen layer component and content are:
Acetaminophen 200 mg
Lactose 1000mg
Vertical compression starch 300mg
Hydroxypropyl emthylcellulose 100mg
Magnesium stearate 15mg
B. caffeine, chlorphenamine maleate, VITAMIN C TABLET layer component and content are:
Caffeine 25 mg
Chlorphenamine maleate 2.5 mg
Vitamin C 150 mg
Vertical compression starch 150mg
Hydroxypropyl emthylcellulose 50mg
Magnesium stearate 40mg.
The method for preparing of Comparative Examples: acetaminophen, lactose, vertical compression starch mix homogeneously; With the hydroxypropyl emthylcellulose that is dissolved in the suitable quantity of water is adhesive; Join in the said mixture; Be mixed with soft material; Cross 16 mesh sieves and granulate, 50 ℃ of granules are dry down, take out after doing to add the magnesium stearate mix homogeneously; Cross 18 mesh sieve granulate, get acetaminophen layer granule; Other gets caffeine, chlorphenamine maleate, vitamin C, lactose, the vertical compression starch mix homogeneously of recipe quantity; With the hydroxypropyl emthylcellulose that is dissolved in the water is adhesive; Join in the said mixture; Be mixed with soft material; Crossing 16 mesh sieves granulates; Granule is dry down at 50 ℃; Take out and the magnesium stearate mix homogeneously; Cross 18 mesh sieve granulate; Get caffeine, vitamin C, chlorphenamine maleate layer granule, two kinds of granules are pressed into double-layer tablet up and down, wherein one deck is the paracetamol tablets layer; Another layer is the caffeine lamella, promptly gets.
Table I drug dissolution measured data contrast table
Visible by Table I: in acceleration and long-term experiment; Embodiment 1-3 prepared preparation product; Owing to add beta-schardinger dextrin-acetaminophen is carried out enclose; Compare with Comparative Examples; The dissolution of acetaminophen is significantly improved; Thereby improved bioavailability of medicament, made drug effect abundant.Wherein:
The condition of accelerated test is 38～42 ℃ of temperature, humidity 70～80%;
The condition of long term test is 23～27 ℃ of temperature, humidity 50～70%.
Medicine effective component content measured data is as shown in Tble II:
Table II medicine effective component content
Visible by Table II: in acceleration and long-term experiment, embodiment 1-3 prepared preparation products are compared with Comparative Examples, and the content of acetaminophen is improved significantly.Mainly be acetaminophen to be carried out enclose owing to respectively add beta-schardinger dextrin-among the embodiment 1-3; And utilize the mode of double-layer tablet that acetaminophen and caffeine, chlorphenamine maleate and vitamin C are isolated; Solved between the medicine the rotten degraded that interacts and cause, poor stability and effect duration such as lack at problem.
The dissolution curve of embodiment 1-3 and Comparative Examples is respectively referring to Fig. 1-Fig. 4.Can find out by the dissolution curve chart: respectively add beta-schardinger dextrin-among the embodiment 1-3 acetaminophen is carried out enclose, do not wrap up the dissolution of acetparaminosalol phenol agents with the acetaminophen dissolution of beta-schardinger dextrin-parcel in the Comparative Examples.
Claims (5)
1. quick vitamin C preparation of ammonia phenol coffee; It is characterized in that said preparation is a bilayer tablet; It is characterized in that: said first lamella is compressed beta-schardinger dextrin-embedding acetaminophen particles layer, and said second lamella is compressed caffeine, chlorphenamine maleate and vitamin C granules layer;
Wherein, each that process said preparation is below the raw materials in part by weight:
200 parts of acetaminophen,
700～1000 parts of beta-schardinger dextrin-s,
25 parts of caffeine,
150 parts of dimension C,
2.5 parts of chlorphenamine maleate,
350～1600 parts of filleies,
13.5～55 parts of lubricants,
120～200 parts of binding agents.
2. the quick vitamin C preparation of a kind of ammonia phenol coffee according to claim 1 is characterized in that:
1. the parts by weight of each composition are in said first lamella:
200 parts of acetaminophen,
700～1000 parts of beta-schardinger dextrin-s,
200～1300 parts of the first lamella filleies,
10～15 parts of the first lamella lubricants,
80～150 parts of the first lamella binding agents;
2. the parts by weight of each composition are in said second lamella:
25 parts of caffeine,
2.5 parts of chlorphenamine maleate,
150 parts of vitamin Cs,
150～300 parts of the second lamella filleies,
3.5～40 parts of the second lamella lubricants,
40～50 parts of the second lamella binding agents.
3. the quick vitamin C preparation of a kind of ammonia phenol coffee according to claim 2 is characterized in that:
(1) filler of said first lamella is any two kinds in lactose, Lactis Anhydrous, starch, vertical compression starch, amylum pregelatinisatum, sorbitol, mannitol, the microcrystalline Cellulose;
(2) filler of said second lamella is a kind of in cellulose powder and microcrystalline Cellulose, cellulose derivative, lactose, calcium hydrogen phosphate, starch, the amylum pregelatinisatum;
(3) lubricant of said first and second lamella is a kind of in stearic acid, magnesium stearate, calcium stearate, the Pulvis Talci;
(4) binding agent of said first lamella is a kind of in hydroxypropyl emthylcellulose, polyvidone, the starch;
(5) binding agent of said second lamella is a kind of in corn starch, polyvidone, copolyvidone and the cellulose derivative.
4. like the method for preparing of the quick vitamin C preparation of each described a kind of ammonia phenol coffee in claims 1-3, carry out according to the following step order:
1. the particulate preparation of first lamella:
(1) take by weighing acetaminophen, stirring adds dehydrated alcohol down makes dissolving fully, makes solution A, subsequent use;
(2) in agitator tank, add purified water, be heated to 57～63 ℃, stop heating, behind filtering tank, 1 μ m micropore membrane filter, 0.45 μ m micropore membrane filter three-stage filtration, to the enclose jar;
Add beta-schardinger dextrin-, stir and make it dissolving, stop heating, be cooled to 37～43 ℃ of insulations, obtain solution B;
(3) solution A is at the uniform velocity dropped in the solution B, dropwise in 1.8～2.1h, behind continuation stirring reaction 3.5～5h, reduce to room temperature, leave standstill 12h, get enclose liquid C;
(4) enclose liquid C is transferred in the sucking filtration jar, sucking filtration 2～3h, and filter cake washs with pure water;
(5) filter cake after the washing places baking oven to dry 3～5h down for 35～45 ℃, gets acetaminophen-Benexate Hydrochloride dry product D;
(6) filler is crossed 80 mesh sieves respectively, get 1000 tablet recipe amounts; Then
(7) with the D mix homogeneously of formula ratio; Binding agent after will in suitable quantity of water, dissolving joins in the said mixture, is mixed with soft material, crosses 16 mesh sieves and granulates; Then
(8) granule is in 40～50 ℃ of dryings, and take out dried back, adds the magnesium stearate mix homogeneously, crosses 18 mesh sieve granulate, gets acetaminophen layer granule;
2. the particulate preparation of second lamella:
Other gets caffeine, chlorphenamine maleate, vitamin C, filler, the binding agent mix homogeneously of recipe quantity; Be pressed into large stretch of 18 mesh sieve granulate dry granulations of crossing; Take out back and magnesium stearate mix homogeneously, get caffeine, vitamin C, chlorphenamine maleate layer granule;
3. the preparation of double-layer tablet:
Two kinds of granules are inserted in the different hoppers of tablet machine, and compression ground floor granule forms lamella I, and back another lamella granule of compression forms lamella II, and the applications as laminates of compression lamella I and lamella II forms layer tablets, is the applications as laminates of first lamella and second lamella.
5. the method for preparing of the quick vitamin C preparation of a kind of ammonia phenol coffee according to claim 4 is characterized in that: institute's applied pressure is 1:2～10 with the ratio of institute's applied pressure in the applications as laminates layer compression process of lamella I and lamella II in the said lamella I compression process.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104127417A (en) * | 2014-08-05 | 2014-11-05 | 辽宁格林生物药业集团有限公司 | Paracetamol, caffeine and chlorpheniramine maleate tablet and preparation method thereof |
| WO2016066851A1 (en) * | 2014-10-31 | 2016-05-06 | Spherium Biomed S.L. | Combination for the treatment of conditions involving muscular pain |
| CN108452673A (en) * | 2018-03-22 | 2018-08-28 | 淮北智淮科技有限公司 | A kind of preparation method of antibacterial type air purifying preparation |
| CN108853124A (en) * | 2018-08-15 | 2018-11-23 | 康美保宁（四川）制药有限公司 | A kind of Ah coffee's phenol preparation and its formulation method |
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| CN101721380A (en) * | 2008-10-17 | 2010-06-09 | 广东环球制药有限公司 | Method for preparing sustained-release preparation |
| CN101816753A (en) * | 2010-03-15 | 2010-09-01 | 江西新赣江药业有限公司 | Method for detecting quality of compound preparation for treating cold |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101721380A (en) * | 2008-10-17 | 2010-06-09 | 广东环球制药有限公司 | Method for preparing sustained-release preparation |
| CN101816753A (en) * | 2010-03-15 | 2010-09-01 | 江西新赣江药业有限公司 | Method for detecting quality of compound preparation for treating cold |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104127417A (en) * | 2014-08-05 | 2014-11-05 | 辽宁格林生物药业集团有限公司 | Paracetamol, caffeine and chlorpheniramine maleate tablet and preparation method thereof |
| CN104127417B (en) * | 2014-08-05 | 2016-04-20 | 辽宁格林生物药业集团股份有限公司 | A kind of ammonia phenol coffee that quick and preparation method thereof |
| WO2016066851A1 (en) * | 2014-10-31 | 2016-05-06 | Spherium Biomed S.L. | Combination for the treatment of conditions involving muscular pain |
| CN108452673A (en) * | 2018-03-22 | 2018-08-28 | 淮北智淮科技有限公司 | A kind of preparation method of antibacterial type air purifying preparation |
| CN108853124A (en) * | 2018-08-15 | 2018-11-23 | 康美保宁（四川）制药有限公司 | A kind of Ah coffee's phenol preparation and its formulation method |
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| CN102349915B (en) | 2014-02-26 |
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