CN103191135B - The compositions of aspirin, phenacetin and caffeine tablet and preparation technology thereof - Google Patents
The compositions of aspirin, phenacetin and caffeine tablet and preparation technology thereof Download PDFInfo
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- CN103191135B CN103191135B CN201210369281.9A CN201210369281A CN103191135B CN 103191135 B CN103191135 B CN 103191135B CN 201210369281 A CN201210369281 A CN 201210369281A CN 103191135 B CN103191135 B CN 103191135B
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- sodium lauryl
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Abstract
The invention discloses the compositions of a kind of aspirin, phenacetin and caffeine tablet and preparation technology thereof, preparation technology includes step: aspirin, phenacetin and caffeine, citric acid, microcrystalline Cellulose, starch, sodium lauryl sulphate, hypromellose, PVP K30 are crossed 80 orders, standby；By crossing the aspirin of 80 orders, partial starch and part sodium lauryl sulphate, prepare acetysalicylic independent microsphere particle by fluidized drying pelletizer；By crossing the phenacetin of 80 orders, caffeine, partial starch and sodium lauryl sulphate, prepared the mixing microsphere particle of phenacetin and caffeine by fluidized drying pelletizer；The mixing microsphere particle of prepared acetysalicylic independent microsphere particle and described phenacetin and caffeine is mixed homogeneously with microcrystalline Cellulose, tabletting。Adopting scheme disclosed in this invention, improve the stability of obtained combination of Chinese medicine thing, reducing the content of free salicylic acid in obtained compositions, thus ensure that the stability of product quality。
Description
Technical field
The present invention relates to pharmaceutical engineering field, be related specifically to compositions and the preparation technology thereof of a kind of aspirin, phenacetin and Tirend。
Background technology
Aspirin, phenacetin and caffeine tablet are acetophenone amine antipyretic analgesic。By suppressing Cycloxygenase, the synthesis of Selective depression hypothalamus thermotaxic centre prostaglandin, causing peripheral blood vessel expansion, perspire and reach antipyretic effect, its refrigeration function intensity is similar to aspirin；By suppressing synthesis and the release of prostaglandin etc., improve the threshold of pain and play analgesic activity, belong to periphery property analgesic, act on weak compared with aspirin, only to light, moderate pain is effective。The technique of the aspirin of tradition preparation, phenacetin and caffeine tablet is to take wet granulation, namely adds water and makes wet granular, and heating, drying granule, tabletting forms。
But, owing to free salicylic acid is not readily reachable by the requirement of quality standard, easily occur that free salicylic acid exceeds standard, simultaneously in technical process, glutinous punching, fragment, produce and tend not to be smoothed out。And, in the prescription of this kind, aspirin is unstable, meet water capacity facile hydrolysis and go out free salicylic acid, particularly it is easier to hydrolysis in the case of a high temperature, have again due to aspirin, eutectic phenomenon can be produced after phenacetin and caffeine three mixing, although taking aspirin individually to granulate when granulating, phenacetin and caffeine are mixed together the way of granulation, but after the independent granule of the aspirin that the adjuvant of employing routine prepares mixes with the hybrid particles of phenacetin and caffeine again, still can produce to stick when tabletting to rush phenomenon, cause that tablet appearance is defective, and product friability is often defective；Also having the APC (Aspirin Phenacetin and Caffeine) quality prepared unstable, the friability of product is bad, and during storage, beyond standard regulation, free salicylic acid causes that product is defective。In the granule that wet method is made, owing to there is countless air bag, during tabletting, during drift pressure, air is compressed, but when pressure terminates suddenly, compress air expansion, it is easy to produce fragment。
Summary of the invention
The main purpose of the present invention is for providing compositions and the preparation technology thereof of a kind of aspirin, phenacetin and Tirend, it is intended to improve the salicylic stability in said composition, thus ensureing the stability of product quality；And in the technical process of preparation, it is to avoid the phenomenons such as glutinous punching, fragment occur, thus ensureing that what produce is smoothed out。
The present invention provides the compositions of a kind of aspirin, phenacetin and caffeine tablet, including following composition:
Preferably, the compositions of aspirin, phenacetin and caffeine tablet also includes appropriate PVP K30 and hypromellose。
Preferably, described sodium lauryl sulphate is disintegrating agent and lubricant；
Described hypromellose is binding agent；
Described microcrystalline Cellulose is disintegrating agent and filler；
Described PVP K30 is binding agent and disintegrating agent；
Described citric acid is PH regulator。
Preferably, PVP K30 with 5%～15% and the alcoholic solution of 30%～70%, acetysalicylic independent granule is prepared as adhesive, hypromellose aqueous solution with 5%～15% prepares the hybrid particles of phenacetin and caffeine as adhesive, inside adding the sodium lauryl sulphate that total amount is 1%～5% and make lubricant and disintegrate, dissolution accelerator, additional total amount is 4%～12% microcrystalline Cellulose。
The present invention also provides for the preparation technology of the compositions of a kind of aspirin, phenacetin and caffeine tablet, comprises the steps:
The first step: aspirin, phenacetin and caffeine, citric acid, microcrystalline Cellulose, starch, sodium lauryl sulphate, hypromellose, PVP K30 are crossed 80 orders, standby；
Second step: by aspirin, partial starch and part sodium lauryl sulphate described in 80 purposes; adhesive is made with the PVP K30 of 10% and the alcoholic solution of 50%; by fluidized drying pelletizer, prepare acetysalicylic independent granule when 50 DEG C；
3rd step: by phenacetin, caffeine, another part starch and another sodium lauryl sulphate described in 80 purposes; adhesive is made with the hypromellose aqueous solution of 10%; by fluidized drying pelletizer, prepare the hybrid particles of phenacetin and caffeine when 60 DEG C；
4th step: the hybrid particles of prepared described acetysalicylic independent granule and described phenacetin and caffeine is put into three-dimensional motion mixer with microcrystalline Cellulose and mixes 40 minutes, mix homogeneously, tabletting。
The present invention is by adjusting supplementary product kind and the proportioning of aspirin, phenacetin and caffeine tablet, conventional wet is granulated and changes dry granulation into, and the selection of technological parameter, make by the compositions prepared by this adjustment, improve the stability of free salicylic acid in said composition, thus ensure that the stability of product quality。
Detailed description of the invention
Should be appreciated that specific embodiment described herein is only in order to explain the present invention, is not intended to limit the present invention。
The present invention provides the compositions of a kind of aspirin, phenacetin and caffeine tablet。
In the compositions first embodiment of aspirin of the present invention, phenacetin and caffeine tablet, according to ratio of weight and number, its recipe ratio is:
In compositions second embodiment of aspirin of the present invention, phenacetin and caffeine tablet, according to ratio of weight and number, its recipe ratio is:
In compositions second embodiment of aspirin of the present invention, phenacetin and caffeine tablet, according to ratio of weight and number, its recipe ratio is:
In the first to the 3rd embodiment of the compositions of the invention described above aspirin, phenacetin and caffeine tablet, aspirin, phenacetin and Tirend specification be: aspirin 220mg, phenacetin 150mg, caffeine 35mg。
In the first to the 3rd embodiment of the compositions of the invention described above aspirin, phenacetin and caffeine tablet, sodium lauryl sulphate is disintegrating agent and lubricant, can play good disintegrate and lubrication；Hypromellose is binding agent, joins in phenacetin and caffeine, it can be made to bond, can play good adhesive effect；Microcrystalline Cellulose is disintegrating agent and filler, can play good disintegration；PVP K30 is binding agent and disintegrating agent, easily compressing, particularly not easy-formation, plasticity and the big slice, thin piece of fragility, add PVP K30 and just can improve the hardness of tablet and the brightness of outward appearance, disintegration of tablet can also be made rapid, improve slice, thin piece inherent quality, and improve curative effect；It is unaffected that the tablet prepared with PVP K30 preserves disintegration for a long time, can play well bonding and disintegration；Citric acid, as PH regulator, makes whole prescription show certain alkalescence, the micro-acidity of citric acid, and aspirin has esters structure, under soda acid exists, has catalyzing hydrolysis effect, adjusts PH in neutrality with citric acid, is conducive to stablizing of mentioned component。
In the above-described embodiments, PVP K30 with 5%～15% and the alcoholic solution of 30%～70%, acetysalicylic independent granule is prepared as adhesive, hypromellose aqueous solution with 5%～15% prepares the hybrid particles of phenacetin and caffeine as adhesive, inside add the sodium lauryl sulphate that total amount is 1%～5% and make lubricant and disintegrate, dissolution accelerator, additional 4%～12% microcrystalline Cellulose。
In the present embodiment, preferably employ the PVP K30 of 10% and the alcoholic solution of 50% and prepare acetysalicylic independent granule as adhesive, acetyl salicylic acid surfaces parcel layer of polyethylene ketopyrrolidine can be made, form microsphere particle, add acetysalicylic stability, contribute to again medicine disintegration and dissolution simultaneously；Preferably employ the hypromellose aqueous solution of 10% simultaneously and prepare the hybrid particles of phenacetin and caffeine as adhesive, phenacetin and caffeine surface one layer of hypromellose of parcel can be made, form microsphere particle, it is to avoid the eutectic phenomenon that aspirin directly contacts with phenacetin, caffeine three and causes。The granule so prepared is tiny, neat, is conducive to tabletting, contributes to again medicine disintegration and dissolution simultaneously。Add sodium lauryl sulphate and can promote disintegrate and drug-eluting, and play lubrication fluidizer effect, it is prevented that glutinous punching。Adopt microcrystalline Cellulose can increase compressibility, and have fluidizer effect, make the slice, thin piece smooth surface pressed attractive in appearance。
Adopt the compositions first embodiment of aspirin of the present invention, phenacetin and caffeine tablet to the recipe ratio in the 3rd embodiment, by adjusting supplementary product kind and the proportioning of aspirin, phenacetin and caffeine tablet, conventional wet is granulated and changes dry granulation into, and the selection of technological parameter, make by the compositions prepared by this adjustment, improve the stability of free salicylic acid in said composition, thus ensure that the stability of product quality。
The present invention also provides for the preparation technology of the compositions of a kind of aspirin, phenacetin and caffeine tablet。
In the preparation technology first embodiment of the compositions of aspirin of the present invention, phenacetin and caffeine tablet, this technique comprises the following steps:
The first step: aspirin, phenacetin and caffeine, citric acid, microcrystalline Cellulose, starch, sodium lauryl sulphate, hypromellose, PVP K30 are crossed 80 orders, standby；
Second step: the aspirin of 80 orders, partial starch and part sodium lauryl sulphate will be crossed; adhesive is made with the PVP K30 of 10% and the alcoholic solution of 50%; by fluidized drying pelletizer, prepare acetysalicylic independent granule when 50 DEG C；
3rd step: the phenacetin of 80 orders, caffeine, another part starch and another part sodium lauryl sulphate will be crossed; adhesive is made with the hypromellose aqueous solution of 10%; by fluidized drying pelletizer, prepare the hybrid particles of phenacetin and caffeine when 60 DEG C；
4th step: the hybrid particles of prepared acetysalicylic independent granule and described phenacetin and caffeine is put into microcrystalline Cellulose three-dimensional motion mixer and mixes 40 minutes, mix homogeneously, tabletting。
In the present embodiment; preferably employ the PVP K30 of 10% and the alcoholic solution of 50% and prepare acetysalicylic independent granule as adhesive through fluidized drying pelletizer one step; acetyl salicylic acid surfaces parcel layer of polyethylene ketopyrrolidine can be made; form microsphere particle; add acetysalicylic stability, contribute to again medicine disintegration and dissolution simultaneously；Preferably employ the hypromellose aqueous solution of 10% simultaneously and prepare the hybrid particles of phenacetin and caffeine as adhesive through fluidized drying pelletizer one step; phenacetin and caffeine surface one layer of hypromellose of parcel can be made; form microsphere particle, it is to avoid the eutectic phenomenon that aspirin directly contacts with phenacetin, caffeine three and causes。The granule so prepared is tiny, neat, is conducive to tabletting, contributes to again medicine disintegration and dissolution simultaneously。Add sodium lauryl sulphate and can promote disintegrate and drug-eluting, and play lubrication fluidizer effect, it is prevented that glutinous punching。Adopt microcrystalline Cellulose can increase compressibility, and have fluidizer effect, make the slice, thin piece smooth surface pressed attractive in appearance。
The preparation technology of the compositions of aspirin of the present invention, phenacetin and caffeine tablet, adopts airpillow-dry one-step-granulating method to prepare granule, and during by material microsphere state, temperature controls to be dried between 50～60 degrees Celsius, and Boiler pressure control is in middle file location。Under above-mentioned prescription and process conditions, can there is certain hydrolysis in phenacetin and aspirin, discharge free salicylic acid, but do not exceed standard。Adopt airpillow-dry one-step-granulating method prepare granule, when material is pressed into chip-type solid state, maximum system pressure at 20Mpa～25Mpa, maximum roll gap pressure 25T～30T。When this technological parameter, material due to high-pressure extrusion, high temperature can be produced, hydrolysis can be controlled, and the hardness of material is moderate, provides the compressibility of material for later sheeting process。
The foregoing is only the preferred embodiments of the present invention; not thereby the scope of the claims of the present invention is limited; every equivalent structure utilizing description of the present invention and accompanying drawing content to make or equivalence flow process conversion; or directly or indirectly it is used in other relevant technical fields, all in like manner include the scope of patent protection in the present invention。
Claims (2)
1. the compositions of an aspirin, phenacetin and caffeine tablet, it is characterised in that include following composition:
And also include appropriate PVP K30 and hypromellose；
Described sodium lauryl sulphate is disintegrating agent and lubricant；Hypromellose is binding agent；Microcrystalline Cellulose is disintegrating agent and filler；PVP K30 is binding agent and disintegrating agent；Citric acid is pH adjusting agent；
PVP K30 with 5%～15% and the alcoholic solution of 30%～70%, acetysalicylic independent granule is prepared as adhesive, hypromellose aqueous solution with 5%～15% prepares the hybrid particles of phenacetin and caffeine as adhesive, inside adding the sodium lauryl sulphate that total amount is 1%～5% and make lubricant and disintegrate, dissolution accelerator, additional total amount is 4%～12% microcrystalline Cellulose。
2. the preparation technology of the compositions of an aspirin as claimed in claim 1, phenacetin and caffeine tablet, it is characterised in that comprise the steps:
The first step: aspirin, phenacetin and caffeine, citric acid, microcrystalline Cellulose, starch, sodium lauryl sulphate, hypromellose, PVP K30 are crossed 80 orders, standby；
Second step: by aspirin, partial starch and part sodium lauryl sulphate described in 80 purposes; adhesive is made with the PVP K30 of 10% and the alcoholic solution of 50%; by fluidized drying pelletizer, prepare acetysalicylic independent microsphere particle when 50 DEG C；
3rd step: by phenacetin, caffeine, another part starch and another part sodium lauryl sulphate described in 80 purposes; adhesive is made with the hypromellose aqueous solution of 10%; by fluidized drying pelletizer, prepare the mixing microsphere particle of phenacetin and caffeine when 60 DEG C；
4th step: the mixing microsphere particle of prepared described acetysalicylic independent microsphere particle and described phenacetin and caffeine is put into three-dimensional motion mixer with microcrystalline Cellulose and mixes 40 minutes, mix homogeneously, tabletting。
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| Application Number | Priority Date | Filing Date | Title |
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| CN201210369281.9A CN103191135B (en) | 2012-09-28 | 2012-09-28 | The compositions of aspirin, phenacetin and caffeine tablet and preparation technology thereof |
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| CN201210369281.9A CN103191135B (en) | 2012-09-28 | 2012-09-28 | The compositions of aspirin, phenacetin and caffeine tablet and preparation technology thereof |
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| CN103191135A CN103191135A (en) | 2013-07-10 |
| CN103191135B true CN103191135B (en) | 2016-06-22 |
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| CN104922124B (en) * | 2015-05-28 | 2017-06-30 | 华润三九医药股份有限公司 | A kind of feritin that quick and preparation method thereof |
| CN114609277B (en) * | 2022-03-07 | 2024-03-08 | 乐山市食品药品检验检测中心(乐山市药品不良反应监测中心) | Method for measuring content of compound acetylsalicylic acid tablet |
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| CN102988372A (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 aspirin tablet, and preparation method of compound aspirin sheet |
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| CN102988372A (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 aspirin tablet, and preparation method of compound aspirin sheet |
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