CN102861040A - Medicine composition containing aspirin, acetaminophen and caffeine and preparation method thereof - Google Patents
Medicine composition containing aspirin, acetaminophen and caffeine and preparation method thereof Download PDFInfo
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- CN102861040A CN102861040A CN2012103855303A CN201210385530A CN102861040A CN 102861040 A CN102861040 A CN 102861040A CN 2012103855303 A CN2012103855303 A CN 2012103855303A CN 201210385530 A CN201210385530 A CN 201210385530A CN 102861040 A CN102861040 A CN 102861040A
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Abstract
The invention discloses a medicine composition containing aspirin, acetaminophen and caffeine and a preparation method thereof. The medicine composition includes aspirin particles and acetaminophen-caffeine particles, wherein the aspirin particles are prepared by the following compositions by parts of weight: 25 parts of aspirin, 1.8-2.2 parts of microcrystalline cellulose, 0.8-1.2 parts of polyvinylpolypyrrolidone and 0.13-0.15 part of silica; and the acetaminophen-caffeine particles are prepared by the follow compositions by parts of weight: 25 parts of acetaminophen, 6.5 parts of caffeine, 2.3-2.7 parts of microcrystalline cellulose, 0.3-0.7 part of polyvinylpolypyrrolidone and 0.12-0.16 part of silica. The preparation method respectively performs dry palletizing on the aspirin, the acetaminophen and the caffeine and proper accessories, effectively prevents the aspirin from directly contacting with moisture in the air, prevents the acetaminophen from quickening degradation of the aspirin and obviously improves stability of the aspirin contained in the prepared medicine composition.
Description
Technical field
The present invention relates to field of medicaments, be specially a kind of pharmaceutical composition that contains aspirin, acetaminophen and caffeine and preparation method thereof.
Background technology
The compositions that the present invention relates to contains aspirin, acetaminophen and three kinds of compositions of caffeine.
Present Afenca tablets (Aspirin, Acetaminophen and Caffeine Tablets, every contains aspirin 0.25g, acetaminophen 0.25g and caffeine 65mg) wide clinical application in the slight persistence dull pain for the treatment of migraine and respite and headache, sinusitis, flu, myalgia, through front with menstrual period pain, toothache institute with pain and mild osteoarthritis bitterly.This mechanism of drug action is comprehensive, reaches the analgesic effect by number of mechanisms.
Aspirin mainly is can make synthetic to the material (such as Kallidin I, histamine) of mechanicalness or chemical irritation sensitivity of the pain sensation by suppressing prostaglandin and other, belongs to the periphery analgesic.But the probability that can not get rid of central analgesia (may act on hypothalamus); This product acts on the inflammation tissue, the material (such as histamine) by suppressing prostaglandin and other reaction that can cause inflammation synthesized antiinflammatory action.
The impulsion of acetaminophen by suppressing the synthetic and blocking-up pain nerve tip of prostaglandin among the central nervous system (may with suppress prostaglandin or other can make the material of pain receptor sensitivity, synthetic relevant such as 5-hydroxy tryptamine, Kallidin I etc.) and generation analgesic activity.
Coffee can strengthen the antipyretic effect of aspirin and acetaminophen because of central stimulants.
This medicine analgesic effect is remarkable, and clinical practice is extensive.But regrettably, aspirin is extremely unstable, adopts general adjuvant and preparation store method, unavoidably causes aspirin to degrade in a large number, and catabolite is salicylic acid.And salicylic acid has stronger GI irritation, is unfavorable for patient's use, also so has greatly limited the clinical practice of this medicine.
Summary of the invention
The purpose of this invention is to provide a kind of pharmaceutical composition that contains aspirin, acetaminophen and caffeine, the good stability of aspirin in this pharmaceutical composition.
The technical scheme that realizes above-mentioned purpose is as follows:
A kind of pharmaceutical composition that contains aspirin, acetaminophen and caffeine, include the aspirin coated granule that coated aspirin granule is prepared into, with will to the coffee granule coating be prepared into to the coffee coated granule, aspirin granule is prepared from by the component of following weight portion: 25 parts of aspirin, microcrystalline Cellulose 1.8-2.2 part, polyvinylpolypyrrolidone 0.8-1.2 part, silicon dioxide 0.13-0.15 part; The coffee granule is prepared from by the component of following weight portion is 25 parts of acetaminophen, 6.5 parts of caffeine, microcrystalline Cellulose 2.3-2.7 part, polyvinylpolypyrrolidone 0.3-0.7 part, silicon dioxide 0.12-0.16 part.
Among the embodiment, aspirin granule is prepared from by the component of following weight portion therein: 25 parts of aspirin, 2 parts of microcrystalline Cellulose, 1 part of polyvinylpolypyrrolidone, 0.14 part of silicon dioxide.
Among the embodiment, the component of coffee granule by following weight portion is prepared from therein: 25 parts of acetaminophen, 6.5 parts of caffeine, 2.5 parts of microcrystalline Cellulose, 0.5 part of polyvinylpolypyrrolidone, 0.14 part of silicon dioxide.
Among the embodiment, the coating solution in the coating preparation is: the ethanol water that contains the hypromellose of 4.5-5.5wt% therein.
Among the embodiment, in the described aspirin coated granule, the amount of hypromellose is the 1.9-2.1wt% of aspirin granule therein; Described in the coffee coated granule, the amount of hypromellose is the 1.9-2.1wt% to the coffee granule.
Another object of the present invention provides the above-mentioned preparation method that contains the pharmaceutical composition of aspirin, acetaminophen and caffeine.
The technical scheme that realizes above-mentioned purpose is as follows.
A kind of above-mentioned preparation method that contains the pharmaceutical composition of aspirin, acetaminophen and caffeine is characterized in that, comprises the steps:
A) aspirin, acetaminophen, caffeine, microcrystalline Cellulose, polyvinylpolypyrrolidone are crossed 80 mesh sieves through pulverization process;
B) aspirin, microcrystalline Cellulose, polyvinylpolypyrrolidone and silicon dioxide take by weighing according to recipe quantity, and then mix homogeneously gets compound 1, and dry granulation makes respectively aspirin granule;
C) acetaminophen, caffeine, microcrystalline Cellulose, polyvinylpolypyrrolidone and silicon dioxide take by weighing according to recipe quantity, and then mix homogeneously gets compound 2, and dry granulation makes the coffee granule;
D) aspirin granule is carried out coating, obtain the aspirin coated granule; To the coffee granule is carried out coating, obtain the coffee coated granule; Mix, and get final product.
Therein among embodiment, the d of step) being prepared as of the coating solution in the coating: at hypromellose, adding concentration is the alcoholic solution of 30-40wt%, stirs dissolving is disperseed, and is made into to contain the coating solution that hypromellose is 4.5-5.5wt%.
In the described aspirin coated granule, the amount of hypromellose is the 1.9-2.1wt% of aspirin granule; Described in the coffee coated granule, the amount of hypromellose is the 1.9-2.1wt% to the coffee granule.
Among embodiment, also comprise therein, with mixed aspirin coated granule with to the coffee coated granule, make capsule or tablet.
The present invention is degraded into this difficult problem of salicylic acid for solving aspirin, has carried out a large amount of research work.At first with aspirin and suitable adjuvant dry granulation, granule coating; Acetaminophen and caffeine and appropriate amount of auxiliary materials dry granulation, granule coating.Again two kinds of coated granules are filled aluminum-plastic composite membrane bags or capsule or tabletting, plain coating tablets.
The present invention adopts dry granulation, avoids aspirin directly to contact with moisture, can suppress the degraded of aspirin.The present invention has also adopted packaging technique, can effectively stop aspirin to contact with the direct of moisture in air, and has avoided the accelerated degradation of acetyl aminophenol to aspirin.
The stability of aspirin significantly improves in the pharmaceutical composition of the present invention preparation, understands beneficial effect of the present invention for better, and now this pharmaceutical composition the results list explanation of the preparation method gained that general preparation method and the present invention is used sees Table 1.
The general preparation method of table 1 and preparation method of the present invention contrast detail list
The specific embodiment
Embodiment 1:
The described pharmaceutical composition that contains aspirin, acetaminophen and caffeine of present embodiment is granule.Concrete prescription is as follows:
Prescription:
Granule packing prescription
The aspirin coated granule is pressed the content conversion
The coffee coated granule is pressed the content conversion
Preparation method:
A, aspirin, acetaminophen, caffeine, microcrystalline Cellulose, polyvinylpolypyrrolidone are crossed 80 mesh sieves through pulverization process;
B, aspirin, microcrystalline Cellulose, polyvinylpolypyrrolidone and silicon dioxide take by weighing according to recipe quantity, then mix 30 minutes, get compound 1, and according to conventional method, dry granulation makes aspirin granule;
C, acetaminophen, caffeine, microcrystalline Cellulose, polyvinylpolypyrrolidone and silicon dioxide take by weighing according to recipe quantity, then mix 30 minutes, get compound 2; According to conventional method, dry granulation makes the coffee granule;
D, take by weighing the hypromellose of aequum, adding concentration is the ethanol water of 35wt%, stirs dissolving is disperseed, and is made into to contain the solution that hypromellose is 5wt%, as coating solution; In the described aspirin coated granule, the amount of hypromellose is the 2wt% of aspirin granule; Described in the coffee coated granule, the amount of hypromellose is the 2wt% to the coffee granule;
E, carry out granule coating to aspirin granule with to the coffee granule, make respectively the aspirin coated granule and to the coffee coated granule;
F, coated granule are pressed the content conversion, directly pack in the aluminum-plastic composite membrane bag, get granule.
Embodiment 2:
The described pharmaceutical composition that contains aspirin, acetaminophen and caffeine of present embodiment is capsule.Concrete prescription is as follows:
Prescription:
The capsule subpackage prescription
The aspirin coated granule is pressed the content conversion
The coffee coated granule is pressed the content conversion
Preparation method:
A, aspirin, acetaminophen, caffeine, microcrystalline Cellulose, polyvinylpolypyrrolidone are crossed 80 mesh sieves through pulverization process;
B, aspirin, microcrystalline Cellulose, polyvinylpolypyrrolidone and silicon dioxide take by weighing according to recipe quantity, then mix 30 minutes, get compound 1; According to conventional method, dry granulation makes aspirin granule;
C, acetaminophen, caffeine, microcrystalline Cellulose, polyvinylpolypyrrolidone and silicon dioxide take by weighing according to recipe quantity, then mix 30 minutes, get compound 2; According to conventional method, dry granulation makes the coffee granule;
D, (amount of the hypromellose of preparation aspirin coated granule is the 2wt% of aspirin granule to take by weighing the hypromellose of aequum, preparation is 2wt% to the coffee granule to the amount of the hypromellose of coffee coated granule granule) add a certain amount of 35% alcoholic solution, stirring disperses dissolving, be made into hypromellose content and be 5% alcoholic solution, as coating solution;
E, carry out granule coating, make respectively the aspirin coated granule and to the coffee coated granule;
F, coated granule are pressed the content conversion, in directly incapsulating, get capsule; Capsule high-density polyethylene bottle packing adds desiccant in the bottle.
Embodiment 3:
The described pharmaceutical composition that contains aspirin, acetaminophen and caffeine of present embodiment is tablet.Concrete prescription is as follows:
Prescription:
Preparation method:
A, aspirin, acetaminophen, caffeine, microcrystalline Cellulose, polyvinylpolypyrrolidone are crossed 80 mesh sieves through pulverization process;
B, aspirin, microcrystalline Cellulose, polyvinylpolypyrrolidone and silicon dioxide take by weighing according to recipe quantity, then mix 30 minutes, get compound 1; According to conventional method, dry granulation makes aspirin granule;
C, acetaminophen, caffeine, microcrystalline Cellulose, polyvinylpolypyrrolidone and silicon dioxide take by weighing according to recipe quantity, then mix 30 minutes, get compound 2; According to conventional method, dry granulation makes the coffee granule;
D, according to above-mentioned prescription, take by weighing the hypromellose of aequum, add 35% alcoholic solution, stir dissolving disperseed, be made into the solution of hypromellose 5%, as coating solution;
E, carry out granule coating, make respectively the aspirin coated granule and to the coffee coated granule.
F, according to above-mentioned prescription, add lubricant, according to conventional method, tabletting gets Ah phenol's coffee element sheet; The element coating tablets gets Ah phenol's coffee coated tablet; Coated tablet high-density polyethylene bottle packing adds desiccant in the bottle.
Embodiment 4: pharmaceutical composition aspirin stability contrast test data
We get the prepared pharmaceutical composition (referring to embodiment 2 and embodiment 3) that contains aspirin, acetaminophen and caffeine of dry granulation preparation method of the present invention, the pharmaceutical composition that makes with wet granulation system (consumption of aspirin is identical) Preparation Method with prior art, the stability of its aspirin of contrast test, take the salicylic amount of aspirin catabolite as index, (HPLC) tests with the high performance liquid chromatography chromatography, and corresponding test data sees Table 2.
Table 2 aspirin stability contrast test data
From table 2 data as can be known, adopt the prepared pharmaceutical composition that contains aspirin, acetaminophen and caffeine of preparation method of the present invention, the salicylic content of aspirin catabolite in its compositions, obviously low with respect to the salicylic content of aspirin catabolite in the pharmaceutical composition of existing wet granulation, prove that the aspirin in the pharmaceutical composition that contains aspirin, acetaminophen and caffeine that dry powder granulation preparation method of the present invention makes is stablized.
The above embodiment has only expressed several embodiment of the present invention, and it describes comparatively concrete and detailed, but can not therefore be interpreted as the restriction to claim of the present invention.Should be pointed out that for the person of ordinary skill of the art without departing from the inventive concept of the premise, can also make some distortion and improvement, these all belong to protection scope of the present invention.Therefore, the protection domain of patent of the present invention should be as the criterion with claims.
Claims (9)
1. pharmaceutical composition that contains aspirin, acetaminophen and caffeine, it is characterized in that, include the aspirin coated granule that coated aspirin granule is prepared into, with will to the coffee granule coating be prepared into to the coffee coated granule, aspirin granule is prepared from by the component of following weight portion: 25 parts of aspirin, microcrystalline Cellulose 1.8-2.2 part, polyvinylpolypyrrolidone 0.8-1.2 part, silicon dioxide 0.13-0.15 part; The coffee granule is prepared from by the component of following weight portion is 25 parts of acetaminophen, 6.5 parts of caffeine, microcrystalline Cellulose 2.3-2.7 part, polyvinylpolypyrrolidone 0.3-0.7 part, silicon dioxide 0.12-0.16 part.
2. the pharmaceutical composition that contains aspirin, acetaminophen and caffeine according to claim 1, it is characterized in that, described aspirin granule is prepared from by the component of following weight portion: 25 parts of aspirin, 2 parts of microcrystalline Cellulose, 1 part of polyvinylpolypyrrolidone, 0.14 part of silicon dioxide.
3. according to claim 1 the pharmaceutical composition that contains aspirin, acetaminophen and caffeine, it is characterized in that, described the component of coffee granule by following weight portion is prepared from: 25 parts of acetaminophen, 6.5 parts of caffeine, 2.5 parts of microcrystalline Cellulose, 0.5 part of polyvinylpolypyrrolidone, 0.14 part of silicon dioxide.
4. each described pharmaceutical composition that contains aspirin, acetaminophen and caffeine is characterized in that according to claim 1-3, and the coating solution in the coating preparation is: the ethanol water of the hypromellose of 4.5-5.5wt%.
5. the pharmaceutical composition that contains aspirin, acetaminophen and caffeine according to claim 4 is characterized in that, in the described aspirin coated granule, the amount of described hypromellose is the 1.9-2.1wt% of aspirin granule; Described in the coffee coated granule, the amount of hypromellose is the 1.9-2.1wt% to the coffee granule.
6. a preparation method that contains the pharmaceutical composition of aspirin, acetaminophen and caffeine claimed in claim 1 is characterized in that, comprises the steps:
A) aspirin, acetaminophen, caffeine, microcrystalline Cellulose, polyvinylpolypyrrolidone sieve through pulverization process;
B) aspirin, microcrystalline Cellulose, polyvinylpolypyrrolidone and silicon dioxide take by weighing according to recipe quantity, and then mix homogeneously gets compound 1, and dry granulation makes aspirin granule;
C) acetaminophen, caffeine, microcrystalline Cellulose, polyvinylpolypyrrolidone and silicon dioxide take by weighing according to recipe quantity, and then mix homogeneously gets compound 2, and dry granulation makes the coffee granule;
D) aspirin granule is carried out coating, obtain the aspirin coated granule; To carry out coating to the coffee granule, obtain the coffee coated granule; Mix, and get final product.
7. preparation method according to claim 6, it is characterized in that the d of step) being prepared as of coating solution in the coating: at hypromellose, add the alcoholic solution of 30-40wt%, stirring disperses dissolving, is made into to contain the coating solution that hypromellose is 4.5-5.5wt%.
8. preparation method according to claim 7 is characterized in that, in the described aspirin coated granule, the amount of hypromellose is the 1.9-2.1wt% of aspirin granule; Described in the coffee coated granule, the amount of hypromellose is the 1.9-2.1wt% to the coffee granule.
9. each described preparation method is characterized in that according to claim 6-8, also comprises, with mixed aspirin coated granule with to the coffee coated granule, makes capsule or tablet.
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| CN201210385530.3A CN102861040B (en) | 2012-08-02 | 2012-10-11 | Medicine composition containing aspirin, acetaminophen and caffeine and preparation method thereof |
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| CN201210385530.3A CN102861040B (en) | 2012-08-02 | 2012-10-11 | Medicine composition containing aspirin, acetaminophen and caffeine and preparation method thereof |
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Cited By (8)
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| CN103110637A (en) * | 2013-02-19 | 2013-05-22 | 青岛正大海尔制药有限公司 | Paracetamol capsules and preparation method thereof |
| CN105213344A (en) * | 2015-11-12 | 2016-01-06 | 四川巴中普瑞制药有限公司 | A kind of method solving sticking in compound paracetamol tablets tabletting |
| CN108272761A (en) * | 2018-02-28 | 2018-07-13 | 重庆希尔安药业有限公司 | Compound Paracetamol Tablets and preparation method thereof |
| 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 |
| CN109381430A (en) * | 2018-10-17 | 2019-02-26 | 广州白云山医药集团股份有限公司白云山何济公制药厂 | A kind of antipyretic-antalgic powder and preparation method thereof |
| CN110711197A (en) * | 2018-07-12 | 2020-01-21 | 北京恒润泰生医药科技有限公司 | Molecular complex of aspirin and acetaminophen with caffeine, preparation, activity and uses thereof |
| CN112494640A (en) * | 2020-12-23 | 2021-03-16 | 杨勇 | Medicine for treating burn and scald and its preparing method |
| CN115715188A (en) * | 2020-05-22 | 2023-02-24 | 葛兰素史克消费者健康控股(美国)有限责任公司 | Pharmaceutical composition |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103110637A (en) * | 2013-02-19 | 2013-05-22 | 青岛正大海尔制药有限公司 | Paracetamol capsules and preparation method thereof |
| CN103110637B (en) * | 2013-02-19 | 2014-07-30 | 青岛正大海尔制药有限公司 | Paracetamol capsules and preparation method thereof |
| CN105213344A (en) * | 2015-11-12 | 2016-01-06 | 四川巴中普瑞制药有限公司 | A kind of method solving sticking in compound paracetamol tablets tabletting |
| CN108272761A (en) * | 2018-02-28 | 2018-07-13 | 重庆希尔安药业有限公司 | Compound Paracetamol Tablets and preparation method thereof |
| CN110711197A (en) * | 2018-07-12 | 2020-01-21 | 北京恒润泰生医药科技有限公司 | Molecular complex of aspirin and acetaminophen with caffeine, preparation, activity and uses thereof |
| CN110711197B (en) * | 2018-07-12 | 2023-11-24 | 北京恒润泰生医药科技有限公司 | Molecular complex of aspirin and acetaminophen with caffeine, and preparation, activity and application thereof |
| 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 |
| CN109381430A (en) * | 2018-10-17 | 2019-02-26 | 广州白云山医药集团股份有限公司白云山何济公制药厂 | A kind of antipyretic-antalgic powder and preparation method thereof |
| CN115715188A (en) * | 2020-05-22 | 2023-02-24 | 葛兰素史克消费者健康控股(美国)有限责任公司 | Pharmaceutical composition |
| CN112494640A (en) * | 2020-12-23 | 2021-03-16 | 杨勇 | Medicine for treating burn and scald and its preparing method |
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| CN102861040B (en) | 2014-04-23 |
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Address after: Three road 528303 in Guangdong province Foshan city Shunde District of Ronggui high tech Park Keyuan cross No. 2 Patentee after: SINOPHARM GUANGDONG GLOBAL PHARMACEUTICAL CO., LTD. Address before: 528303 West Guangdong province Foshan city Shunde District Ronggui Bridge No. 2 Patentee before: Huanqiu Pharmaceutical Co., Ltd., Guangdong |