CN102641247A - Acid and alkali neutralization granulating method of effervescent - Google Patents
Acid and alkali neutralization granulating method of effervescent Download PDFInfo
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Abstract
The invention relates to an acid and alkali neutralization granulating method of an effervescent, belonging to the pharmaceutical field, comprising the following steps: adding main materials into a granulating kettle to stir; preparing a granulating agent; connecting a liquid tank; starting a spray pump to spray granulating agent liquid into materials at a stirring state in the kettle at constant speed; cutting, stirring; drying and cooling system; discharging and granulating. According to the invention, acid and alkali are not granulated independently in sub-steps so as to simplify process, increase production efficiency, save energy, and shorten granulating time by more than a quarter; and the method can effectively avoid potential safety hazards caused by overlarge concentration of ethanol, and can ensure production process is safe without special explosion-proof facilities.
Description
Technical field
The invention belongs to pharmaceutical field.
Background technology
Effervescent is meant and contains sodium bicarbonate and organic acid; Meet that water can produce gas and a kind of special form of being the effervescent shape is commonly called as dried liquid preparation, with the traditional classification method of pharmaceutical dosage form; Effervescent belongs to the special form in all kinds of dosage forms of traditional classification, divides to be listed in the middle of each dosage form.Mainly contain effervescent tablet, effervescent granule, pulvis aerophorus, type of effervescent suppository etc.Can be divided into oral administration effervescing agent and external effervescent by route of administration.Before oral administration effervescing agent is taken acid-base reaction takes place in water, disintegrate is rapid, helps improving drug bioavailability.Its predecessor's form is blistered soda pop, foaming sheet, pulvis aerophorus, effervescent preserved material etc.
This paper is example with the oral administration effervescing sheet, sets forth its acid-base neutralization method of granulating.
The embryo of effervescent tablet is created in 1672 the earliest, after the Soluble tartar. sodium salt is synthetic, produces foamy foaming powder and occurs, and afterwards, pulvis aerophorus, effervescent preserved material and external effervescent tablet produce in succession." big pharmacy encyclopedia " reported by sodium bicarbonate and tartaric acid and formed effervescent in 1904, adjuvants such as adding active ingredient and flavouring agent, be pressed into the tin plate drying after, wrap in the masking foil Here it is initial effervescent tablet.
The key component of effervescent tablet is made up of excipient such as principal agent and gas-producing disintegrant, correctives, lubricant, coloring agent.Its main technique flow process is that supplementary material just mixes, granulates, always mixes, tabletting, Nei Bao, outsourcing; Gas-producing disintegrant wherein is the key components of effervescent tablet; Play the effect of effervescent foaming; Comprise an acid source and an alkali source, acid source commonly used is mainly citric acid, tartaric acid etc., and alkali source commonly used is sodium bicarbonate, sodium carbonate or the mixture of the two.Meet the water afterreaction and produce great amount of bubbles and play rapid disintegration, its granulating process is the important step in the production process, can have influence on the molding of tablet and the homogeneity of quality.
At present, the existing method of granulating that is used for effervescent tablet production is broadly divided into five kinds, and the one, wet granulation; Adopt PEG6000 parcel granulation technique; Promptly melt with acid or with alkali and separately granulate separately with PEG6000, then with the two mixing, the 2nd, adopt non-water to granulate; Be about to acid and mix the granulation of back employing anhydrous solution with alkali, be generally dehydrated alcohol.The 3rd, direct compression process directly mixes the back tabletting with material.The 4th, dry granulation is granulated with roll extrusion or double compression.Above-mentioned three, four liang of methods require to need special adjuvant than higher to material fluidity and compressibility, and production cost is higher, and application is restricted.The 5th, control granulation water quantities is so that make the dissolving of part composition form granule.This method needs special installation, uses also extensive inadequately.Commonly used is above-mentioned first and second kinds of methods.
Find that in production practices above method also exists some shortcomings,, poor stability, production limitation low like complex manufacturing, production efficiency, the slice, thin piece molding is poor, disintegrate is inhomogeneous, shortcomings such as production cost height.
Summary of the invention
The present invention provides a kind of effervescent tablet acid-base neutralization method of granulating, and the complex manufacturing, the production efficiency that exist at present are low to solve, poor stability, production limitation, the slice, thin piece molding is poor, disintegrate is inhomogeneous, the problem that production cost is high.
The technical scheme that the present invention takes is: comprise the following steps:
One, major ingredient is added in the granulation still, stirred 8-10 minute, mixing speed is 60-80 rev/min, and said major ingredient is crude drug, acidizer and alkaline agent;
Two, take by weighing in the granulation agent 30 POVIDONE K 30 BP/USP 30 and put in the Agitation Tank, add 95% ethanol, or add purified water as required, begin to be stirred to whole dissolvings, 30 POVIDONE K 30 BP/USP 30 alcoholic solution, wherein: each raw materials quality part is in this granulation agent:
305～24 parts of 30 POVIDONE K 30 BP/USPs,
12～456 parts of 95% ethanol,
0～40 part of purified water;
Three, connect Agitation Tank, start the hydrojet air pump, granulation agent liquid is sprayed into evenly in the material of stirring in the still, hydrojet flow velocity 1.0L-1.2L/ minute, the mass parts of major ingredient and granulation agent is:
96.0～98.0 parts of major ingredients,
2.0～4.0 parts of granulation agents,
After treating that hydrojet finishes, continue to stir granulation 3-5 minute, stirring paddle speed is 60 rev/mins～80 rev/mins; Open the cutting of cross cutter, stir, the cutting knife speed setting is 800-1000 rev/min, makes formation than homogeneous granules after the cutting, and the operation room temperature is 18-26 ℃, and relative humidity is less than 30%;
Four, stop cutting, stirring, 80 ℃ of heat source temperatures are set, 75 ℃ of product temperatures start the automatic drying system, vacuum 60～100mbar; After dry 6～8 hours, behind mensuration pellet moisture≤0.10%, stop heating, start cooling system, be cooled to 20～30 ℃, close vacuum, cooling system, the discharging granulate.
According to the understanding of technology in the past, most of people think and the bronsted lowry acids and bases bronsted lowry granulation of can not putting together to avoid reaction; But constantly grope and study through us; And prove with production practices, completed successfully the method that soda acid is put together and granulated, and it has been applied in the middle of the production reality.This method The key factor is the consumption of granulation agent and the preference temperature of reaction, and the control of vacuum drying vacuum and final pellet moisture, accurately grasps above-mentioned key factor and just can produce the needed granule of effervescent tablet technology by this method of granulating.We confirm should technology be " effervescent acid-base neutralization method of granulating "; We adopt with the citric acid is acid source, is that alkali source is formed gas-producing disintegrant with the sodium bicarbonate, is granulation agent with water, ethanol, 30 POVIDONE K 30 BP/USP 30 mixed solutions; The neutralization reaction of utilizing citric acid and sodium bicarbonate to take place is main granulating mode; And be aided with granulating modes such as bonding, thawing, and form comprehensive granulating system, accomplish quick, efficient, complete pelletization.The novel substance sodium citrate that acid-base reaction generates; It has played the effect of solid bridge in whole material system; With most of soda acid formation granule that condenses together, again soda acid is effectively isolated simultaneously, bronsted lowry acids and bases bronsted lowry is no longer directly contacted; Remove moisture this moment rapidly, promptly gets metastable granule after the drying.
Chemical equation: 3NaHCO
3+ C
6H
8O
7=C
6H
5O
7Na
3+ 3H
2O+3CO
2↑
In above course of reaction, control well the reaction degree, can not be excessive or too small, according to different variety control yields between 90%-96%.Reacted conference and cause disintegrating agent to lose efficacy, disintegration time is defective, reacts too small meeting and causes the granule granulating bad, influences the tablet molding effect.
In pelletization, should guaranteeing to granulate, temperature of charge is controlled between 20 ℃-30 ℃ in the still, keeps basicly stable.PVPK30 in the granulation agent, 95% ethanol, purified water three's ratio can be adjusted according to different prescriptions.Granulator stirring paddle mixing time is 3-5 minute after the hydrojet, and this mixing time is different slightly variant because of kind, stirs the rapid vacuum that starts in end back the granulator internal pressure is reduced to below the 100mbar; Open the heat drying system, carry out drying, after the startup vacuum; Reduce the granulator internal pressure; The boiling point lowering of water simultaneously makes in the machine moisture evaporated rapidly and takes away, blocks the continuation reaction of soda acid rapidly.Continue drying and be lower than below 0.10% until moisture, soda acid reaches metastable state.
Adopt the present invention substep to be granulated separately by soda acid, simplified technology, enhance productivity, save the energy, the production time of granulating can shorten more than 1/4th.Solid bridge and buffer action that the sodium citrate that utilizes reaction to generate plays combine soda acid, form granule, make soda acid no longer continue to react after the drying rapidly, and product reaches steady statue.Soda acid fully mixes in the pelletization, is uniformly dispersed, and it is good to make mobility of particle; Angle of repose θ≤35 °, the granule of particle diameter between 180 μ m-2000 μ m accounts for more than 85% of total particle quantity, guarantees that the product gas release of producing is uniform and stable; Disintegrate is rapid, all can disintegrate in 4 minutes.The acidity difference is little, to detect pH value mean absolute deviation≤0.03 with batch multidraw.Acid-base neutralization is granulated and is compared with adopting dehydrated alcohol to granulate fully; Do not have a large amount of ethanol to participate in granulating, can effectively reduce cost, and can effectively avoid the excessive and potential safety hazard brought of concentration of alcohol; Need not to adopt special blasting protection facilities, guarantee production process safety.
Parameters such as the vacuum of the amount through control adjustment granulation agent, hydrojet initial temperature, equipment, pellet moisture are accomplished the process that acid-base neutralization is granulated.
Below be to be example, be set forth under the above-mentioned different condition influence effervescent tablet granulation yield, drying time, disintegration, tablet mouldability, product stability with the acetaminophen effervescent tablet:
1, different granulation agent additions are to the granulate influence of yield, disintegration, tablet mouldability of effervescent tablet:
| Granulation dosage Kg | 14 | 16 | 18 | 20 | 22 | 25 |
| Granulation yield % | 97.8 | 96.0 | 95.8 | 94.1 | 92.8 | 88.5 |
| Disintegration s | 145 | 150 | 168 | 170 | 190 | 255 |
| Mouldability | The sliver phenomenon is arranged | Plastic | Plastic | Plastic | Plastic | Plastic |
Can find out that through above data what of granulation agent addition directly influences the mouldability of granulation yield, disintegration, slice, thin piece, so control the addition of granulation agent that the size of may command acid-base reaction is one of key operation of acid-base neutralization granulation.
2, under the certain condition of spouting liquid, different hydrojet initial temperatures are to effervescent tablet yield, EFFECT OF CORK STOPPER:
| Initial temperature | 15℃ | 20℃ | 25℃ | 30℃ | 35℃ |
| Granulation yield % | 98.2 | 96.1 | 95.5 | 92.8 | 90.2 |
| Disintegration s | 140 | 151 | 165 | 185 | 243 |
Can find out that along with increasing of temperature, the degree of acid-base reaction increases, loss amount increases, and yield reduces, and prolong disintegration.
3, under the certain condition of spouting liquid, the influence that different vacuums are granulated yield, drying time to effervescent tablet:
| Vacuum | 60mbar | 80mbar | 100mbar | 120mbar | 140mbar |
| Granulation yield % | 95.8 | 94.3 | 92.2 | 90.5 | 88.2 |
| Drying time | 7h | 7.5h | 8.5h | 9.5 | 11h |
Vacuum up causes moisture removal slack-off, and the extent of reaction is big, and yield reduces, and prolong drying time.
The boiling point and the pressure of water are proportional, and along with the reduction of pressure in the granulation still, the boiling point of water also reduces, and has quickened particulate dry run, below are the boiling point of water and the mapping table of pressure:
| Solvent | 1013mbar | 100mbar | 80mbar | 60mbar | 40mbar | 20mbar |
| Water | 100℃ | 45.806℃ | 41.509℃ | 36.159℃ | 28.96℃ | 17.495℃ |
4, the granule of different in moisture is to the influence of finished product stability:
With the acetaminophen effervescent tablet is example, gets 5 different lot sample article of pellet moisture and carries out accelerated test observation 3 months, and the result is following:
| Sample number | Sample 1 | Sample 2 | Sample 3 | Sample 4 | Sample 5 |
| Pellet moisture | 0.06％ | 0.11％ | 0.15％ | 0.23％ | 0.27％ |
| The finished product outward appearance | Normally | Normally | Bag slightly rises | Bag slightly rises | Bag rises |
| Drug content | 98.8％ | 99.1％ | 98.3％ | 98.6％ | 97.7％ |
| Disintegration (S) | 150 | 152 | 161 | 188 | 230 |
Annotate: because of the final products inner packing adopts the composite membrane mmic package, the too high meeting of moisture directly causes soda acid to react, and aerogenesis, directly influences product appearance, bag phenomenon that occurs rising, therefore with the cosmetic variation situation of product inner packing as one of stability criterion.Should be controlled at below 0.10% through the above-mentioned test dried pellet moisture of can confirming to granulate, meet the requirements to guarantee product stability.
The specific embodiment
95% alcoholic acid relative density is 0.8129 among each embodiment.
Embodiment 1: the acetaminophen effervescent tablet
The granulation part:
Total part of mixing:
Production stage:
One, will be added in the granulation still acetamide amino phenols, anhydrous citric acid, sodium bicarbonate, stirring paddle speed is 60rpm, mixes 10 minutes;
Two, take by weighing in the granulation agent 30 POVIDONE K 30 BP/USP 30 and put in the Agitation Tank, process granulation agent after 95% ethanol and purified water are mixed and pour in the whitewashing jar, liquid is sprayed into evenly in the material of stirring in the still; Hydrojet flow velocity 1.2L/ minute, treat that liquid has sprayed after, stirring paddle speed is 80rpm; Stirred 5 minutes, and opened the cutting of cross cutter simultaneously, stir, the cutting knife speed setting is 1000 rev/mins; Make formation than homogeneous granules after the cutting, the operation room temperature is 18 ℃, and relative humidity is less than 30%;
Three, start vacuum, startup drying system, vacuum 60mbar is provided with 80 ℃ of heat source temperatures, 75 ℃ of product temperatures; Measure moisture after dry 7 hours,, close drying system, start cooling system less than 0.10% o'clock; Be cooled to 30 ℃, close vacuum, cooling system, discharging.
Four, granule be will make and tabletting, packing carried out after partial material is mixed with total mixing.
Embodiment 2: the carbocisteine effervescent tablet
The granulation part:
Total part of mixing:
Sweeting agent 6.00kg
Spice 3.00kg
Production stage:
One, anhydrous citric acid sodium, anhydrous citric acid, sodium bicarbonate, carbocisteine are added in the granulation still, stirring paddle speed is 60rpm, mixes 10 minutes;
Two, take by weighing in the granulation agent 30 POVIDONE K 30 BP/USP 30 and put in the Agitation Tank, process granulation agent after 95% ethanol and purified water are mixed and pour in the whitewashing jar, liquid is sprayed into evenly in the material of stirring in the still; Hydrojet flow velocity 1.0L/ minute, treat that liquid has sprayed after, stirring paddle speed is 70rpm; Stirred 4 minutes, and opened the cutting of cross cutter simultaneously, stir, the cutting knife speed setting is 900 rev/mins; Make formation than homogeneous granules after the cutting, the operation room temperature is 22 ℃, and relative humidity is less than 30%;
Three, start vacuum, startup drying system, vacuum 100mbar is provided with 80 ℃ of heat source temperatures, 75 ℃ of product temperatures; Measure moisture after dry 8 hours,, close drying system, start cooling system less than 0.10% o'clock; Be cooled to 35 ℃, close vacuum, cooling system, discharging.
Four, granule be will make and tabletting, packing carried out after partial material is mixed with total mixing.
Embodiment 3: the zinc gluconate effervescent tablet
The granulation part:
Total part of mixing:
Sweeting agent 14.00kg
Spice 4.00kg
Production stage:
One, anhydrous citric acid, sodium bicarbonate, anhydrous citric acid sodium, zinc gluconate are added in the granulation still, stirring paddle speed is 70rpm, mixes 9 minutes.
Two, pour in the whitewashing jar processing granulation agent behind 30 POVIDONE K 30 BP/USP 30, the 95% ethanol mixed dissolution, liquid is sprayed into evenly in the material of stirring in the still hydrojet flow velocity 1.1L/ minute; After treating that liquid has sprayed, stirring paddle speed is 60rpm, stirs 3 minutes; Open the cutting of cross cutter simultaneously, stir, the cutting knife speed setting is 800 rev/mins, makes formation than homogeneous granules after the cutting; The operation room temperature is 26 ℃, and relative humidity is less than 30%;
Three, start vacuum, startup drying system, vacuum 80mbar is provided with 80 ℃ of heat source temperatures, 75 ℃ of product temperatures; Measure moisture after dry 6 hours,, close drying system, start cooling system less than 0.10% o'clock; Be cooled to 20 ℃, close vacuum, cooling system, discharging.
Four, granule be will make and tabletting, packing carried out after partial material is mixed with total mixing.
Embodiment 4: calcium carbonate gluconic acid calcium effervescence tablet
The granulation part:
Total part of mixing:
Anhydrous citric acid 60.00kg
Sweeting agent 8.00kg
Spice 4.00kg
Production stage:
One, anhydrous citric acid, sodium bicarbonate, winnofil, calcium gluconate are added in the granulation still, stirring paddle speed is 60rpm, mixes 10 minutes.
Two, pour in the whitewashing jar processing granulation agent behind 30 POVIDONE K 30 BP/USP 30, the 95% ethanol mixed dissolution, liquid is sprayed into evenly in the material of stirring in the still hydrojet flow velocity 1.0L/ minute; After treating that liquid has sprayed, stirring paddle speed is 60rpm, stirs 5 minutes; Open the cutting of cross cutter simultaneously, stir, the cutting knife speed setting is 900 rev/mins, makes formation than homogeneous granules after the cutting; The operation room temperature is 20 ℃, and relative humidity is less than 30%;
Three, start vacuum, startup drying system, vacuum degree control 100mbar is provided with 80 ℃ of heat source temperatures, 75 ℃ of product temperatures; Measure moisture after dry 6 hours,, close drying system, start cooling system less than 0.10% o'clock; Be cooled to 28 ℃, close vacuum, cooling system, discharging.
Four, granule be will make and tabletting, packing carried out after partial material is mixed with total mixing.
Embodiment 5: the ferrous lactate effervescent tablet
The granulation part:
Total part of mixing:
Vitamin C 12.00kg
Sweeting agent 6.00kg
Spice 5.00kg
Production stage:
One, anhydrous citric acid, sodium bicarbonate, ferrous lactate are added in the granulation still, stirring paddle speed is 60rpm, mixes 10 minutes.
Two, pour in the whitewashing jar processing granulation agent behind 30 POVIDONE K 30 BP/USP 30, the 95% ethanol mixed dissolution, liquid is sprayed into evenly in the material of stirring in the still hydrojet flow velocity 1.1L/ minute; After treating that liquid has sprayed, stirring paddle speed is 60rpm, stirs 3 minutes; Open the cutting of cross cutter simultaneously, stir, the cutting knife speed setting is 1000 rev/mins, makes formation than homogeneous granules after the cutting; The operation room temperature is 18 ℃, and relative humidity is less than 30%;
Three, start vacuum, startup drying system, vacuum degree control 90mbar is provided with 80 ℃ of heat source temperatures, 75 ℃ of product temperatures; Measure moisture after dry 8 hours,, close drying system, start cooling system less than 0.10% o'clock; Be cooled to 30 ℃, close vacuum, cooling system, discharging.
Four, granule be will make and tabletting, packing carried out after partial material is mixed with total mixing.
Embodiment 6: the zinc gluconate effervescent tablet
The granulation part:
Total part of mixing:
Sweeting agent 14.00kg
Spice 4.00kg
Production stage:
One, anhydrous citric acid, sodium bicarbonate, anhydrous citric acid sodium, zinc gluconate are added in the granulation still, stirring paddle speed is 60rpm, mixes 10 minutes.
Two, pour in the whitewashing jar processing granulation agent behind 30 POVIDONE K 30 BP/USP 30, the 95% ethanol mixed dissolution, liquid is sprayed into evenly in the material of stirring in the still hydrojet flow velocity 1.2L/ minute; After treating that liquid has sprayed, stirring paddle speed is 60rpm, stirs 3 minutes; Open the cutting of cross cutter simultaneously, stir, the cutting knife speed setting is 800 rev/mins, makes formation than homogeneous granules after the cutting; The operation room temperature is 20 ℃, and relative humidity is less than 30%;
Three, start vacuum, startup drying system, vacuum degree control 70mbar is provided with 80 ℃ of heat source temperatures, 75 ℃ of product temperatures; Measure moisture after dry 6 hours,, close drying system, start cooling system less than 0.10% o'clock; Be cooled to 26 ℃, close vacuum, cooling system, discharging.
Four, granule be will make and tabletting, packing carried out after partial material is mixed with total mixing.
Claims (1)
1. an effervescent acid-base neutralization method of granulating is characterized in that comprising the following steps:
One, major ingredient is added in the granulation still, stirred 8-10 minute, mixing speed is 60-80 rev/min, and said major ingredient is crude drug, acidizer and alkaline agent;
Two, take by weighing in the granulation agent 30 POVIDONE K 30 BP/USP 30 and put in the Agitation Tank, add 95% ethanol, or add purified water as required, begin to be stirred to whole dissolvings, 30 POVIDONE K 30 BP/USP 30 alcoholic solution, wherein: each raw materials quality part is in this granulation agent:
305～24 parts of 30 POVIDONE K 30 BP/USPs,
12～456 parts of 95% ethanol,
0～40 part of purified water;
Three, connect Agitation Tank, start the hydrojet air pump, granulation agent liquid is sprayed into evenly in the material of stirring in the still, hydrojet flow velocity 1.0L-1.2L/ minute, the mass parts of major ingredient and granulation agent is:
96.0～98.0 parts of major ingredients,
2.0～4.0 parts of granulation agents,
After treating that hydrojet finishes, continue to stir granulation 3-5 minute, stirring paddle speed is 60 rev/mins～80 rev/mins; Open the cutting of cross cutter, stir, the cutting knife speed setting is 800-1000 rev/min, makes formation than homogeneous granules after the cutting, and the operation room temperature is 18-26 ℃, and relative humidity is less than 30%;
Four, stop cutting, stirring, 80 ℃ of heat source temperatures are set, 75 ℃ of product temperatures start the automatic drying system, vacuum 60～100mbar; After dry 6～8 hours, behind mensuration pellet moisture≤0.10%, stop heating, start cooling system, be cooled to 20～30 ℃, close vacuum, cooling system, the discharging granulate.
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| CN104546683A (en) * | 2014-12-25 | 2015-04-29 | 海南卫康制药(潜山)有限公司 | Carbocisteine composition freeze-drying tablet and preparation method thereof |
| CN105012254A (en) * | 2015-06-10 | 2015-11-04 | 临汾奇林药业有限公司 | Production process for carbocisteine buccal tablet |
| CN113384549A (en) * | 2021-07-21 | 2021-09-14 | 海南涛生医药科技研究院有限公司 | Acetaminophen vitamin C effervescent tablet and preparation method thereof |
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| CN102641247B (en) | 2013-09-25 |
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