CN100417392C - An effervescence tablet of cold-treating preparation and preparation method thereof - Google Patents
An effervescence tablet of cold-treating preparation and preparation method thereof Download PDFInfo
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- CN100417392C CN100417392C CNB2006100832323A CN200610083232A CN100417392C CN 100417392 C CN100417392 C CN 100417392C CN B2006100832323 A CNB2006100832323 A CN B2006100832323A CN 200610083232 A CN200610083232 A CN 200610083232A CN 100417392 C CN100417392 C CN 100417392C
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- Prior art keywords
- tablet
- essence
- acid
- cold
- sodium
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- 238000002360 preparation method Methods 0.000 title claims abstract description 42
- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 claims abstract description 28
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims abstract description 19
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- 239000002253 acid Substances 0.000 claims abstract description 15
- LPHGQDQBBGAPDZ-UHFFFAOYSA-N Isocaffeine Natural products CN1C(=O)N(C)C(=O)C2=C1N(C)C=N2 LPHGQDQBBGAPDZ-UHFFFAOYSA-N 0.000 claims abstract description 14
- WOLHOYHSEKDWQH-UHFFFAOYSA-N amantadine hydrochloride Chemical compound [Cl-].C1C(C2)CC3CC2CC1([NH3+])C3 WOLHOYHSEKDWQH-UHFFFAOYSA-N 0.000 claims abstract description 14
- 229960001280 amantadine hydrochloride Drugs 0.000 claims abstract description 14
- 229960001948 caffeine Drugs 0.000 claims abstract description 14
- VJEONQKOZGKCAK-UHFFFAOYSA-N caffeine Natural products CN1C(=O)N(C)C(=O)C2=C1C=CN2C VJEONQKOZGKCAK-UHFFFAOYSA-N 0.000 claims abstract description 14
- 239000003513 alkali Substances 0.000 claims abstract description 12
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- 238000000034 method Methods 0.000 claims abstract description 4
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- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 24
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- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical group OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 13
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- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 4
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- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The present invention relates to a common cold medicine effervescent tablet and a preparation method thereof. The common cold medicine effervescent tablet has the advantages of portability, good mouth feel and fast release, and comprises active ingredients and effervescence acid-base pairs, wherein the active ingredients are paracetamol, amantadine hydrochloride, caffeine, artificial bezoar and chlorpheniramine. The formability and the effervescence property of the effervescent tablet can be improved through the selection of acid and alkali pairs and suitable medicinal auxiliary materials are complemented. The release speed of the medicine is enhanced, the taste is corrected, and the common cold medicine effervescent tablet is particularly suitable for a child patient to use; simultaneously, an adult's resistance can also be greatly enhanced. The present invention reduces the harsh requirement for environment in the process of preparation, and the effervescent tablet can also be easily made even under high humidity conditions. The tablet weight of each optimized tablet is from 100 mg to 5000 mg.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to the oral administration effervescing tablet form, specifically a kind of easy to carry and use, dissolving rapidly, the paracetamol compound effervescent tablet of good taste arranged.
Background technology
Flu is a kind of modal disease, seriously affects people's live and work.The medicine that is used for the treatment of flu has many, and the medicine that wherein contains components such as acetaminophen, amantadine hydrochloride, chlorphenamine is common cold-treating preparation.
The dosage form of traditional cold medicine has capsule, sheet, granule and oral liquid etc., but these dosage forms exist drug release rate slow, carry shortcomings such as inconvenience, taste be not good, particularly make child patient be difficult to accept.
Effervescent tablet preparation formulation is one as the cold medicine solid dosage forms to be selected preferably.After making effervescent tablet preparation formulation, advantage such as rapid, easy to carry because of its release, that taste is pleasant is subjected to liking of extensive patients; Produce a large amount of bubbles during dissolving, tempting color and good mouthfeel makes it to be very suitable for child patient.
But because the working condition of effervescent tablet requires relatively harshness, mainly show less, limited the application of such dosage form greatly control strictness especially, the examples of suitable lubricants kind of ambient humidity.
Summary of the invention
Effervescent tablet makes conventional wet granulation and granule tabletting subsequently all be difficult to carry out because easy moisture absorption has unstability.
The objective of the invention is to overcome the existing defective of cold medicine effervescent tablet preparation in preparation process, for the patient provides a kind of easy to carry, good mouthfeel, discharges cold medicine effervescent tablet rapidly; This sheet is particularly suitable for child patient, also can improve adult's toleration greatly simultaneously.
The present invention finds, and is right by acid, the alkali selecting to suit, and is aided with suitable pharmaceutic adjuvant, can improve mouldability, the effervescency of effervescent tablet, and reduces in the preparation process the harsh requirement to environment.
Especially, the present invention is by selecting suitable acid, alkali right, and be aided with suitable pharmaceutic adjuvant, can improve mouldability, the effervescency of the effervescence tablet of cold-treating preparation agent of components such as containing acetaminophen, amantadine hydrochloride, chlorphenamine, and reduce in the preparation process harsh requirement environment.By above-mentioned cold-treating preparation is made effervescent tablet, keeping original function to cure mainly under the constant prerequisite, improved medicine rate of release, corrected taste, be convenient for carrying, this medicine extensive patients of being more convenient for is accepted.
The present invention also aims to reduce above-mentioned effervescence tablet of cold-treating preparation preparation process to the undue harsh requirement of humidity,, also can more successfully make effervescent tablet even under higher damp condition.
This effervescence tablet of cold-treating preparation provided by the present invention comprises active component and effervescent acid-base pair;
The active component here is acetaminophen, amantadine hydrochloride, caffeine, artificial Calculus Bovis and chlorphenamine;
The acid source of the effervescent acid-base pair here can be any one or a few in citric acid, tartaric acid, fumaric acid, boric acid, potassium citrate dihydrogen, potassium hydrogen tartrate, fumaric acid sodium, adipic acid, the malic acid etc.; Alkali source can be carbonate or bicarbonate, for example is in sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium carbonate, the sodium glycine carbonate etc. any one;
Further preferred acid source is made up of above-mentioned two or more acid, and the proportion of mixed acid can be decided according to tablet mouldability, the requirement in effervescent time limit.
In addition, this effervescence tablet of cold-treating preparation also can contain filler, edible essence, pigment, sweeting agent, binding agent or lubricant etc.
Described filler is selected from any one or a few in the pharmaceutic adjuvant of solubilities such as lactose, mannitol, sucrose, glucose, soluble starch, sodium chloride, sorbitol;
Described edible essence is selected from Fructus Citri Limoniae essence, orange flavor essence, flavoring orange essence, flavoring pineapple essence, Herba Menthae essence, almond essence, Fructus Myricae rubrae essence, flavoring banana essence, strawberry essence, chocolate essence, vanilla, fresh milk essence;
Described pigment is selected from carmine, light green, lemon yellow, D C Yellow No. 10;
Described sweeting agent is selected from aspartame, saccharin sodium, aspartame, cyclamate, stevioside;
Described lubricant is selected from Polyethylene Glycol, magnesium stearate, Pulvis Talci, leucine, alanine, glycine, Stepanol MG, the micropowder silica gel of molecular weight more than 4000;
Described binding agent is selected from polyvinylpyrrolidone, hydroxypropyl emthylcellulose, methylcellulose, sodium carboxymethyl cellulose, ethyl cellulose, the starch slurry solution that concentration is 1%～30% (w/v); For example, the ethanol solution of polyvinylpyrrolidone, preferred concentration are the ethanol solution of 8% polyvinylpyrrolidone.
Described wetting agent is selected from ethanol or Different concentrations of alcohol solution.
Each components contents is in every tablet of tablet of this effervescence tablet of cold-treating preparation: acetaminophen 50～500mg, amantadine hydrochloride 10～200mg, caffeine 1～50mg, artificial Calculus Bovis 1～50mg, chlorphenamine 0.1～10mg;
Filler is 10～4000mg, and sweeting agent is 2～500mg, and edible essence is 0.02～250mg, and pigment is 0.002～50mg, and lubricant is 0.2～400mg, and binding agent is an amount of, and the gross weight of acid source and alkali source consumption is 20～4500mg;
The sheet of preferred every tablet of tablet heavily is 100mg～5000mg.
The preparation method of this effervescence tablet of cold-treating preparation provided by the present invention comprises the steps:
With each component of effervescence tablet of cold-treating preparation, according to prescription and technological requirement, mix, wet granulation, drying, granulate, at the appropriate condition lower sheeting, get final product.
Preferred wet granulation, less than 40% condition lower sheeting, the gained tablet weight is 100mg～5000mg at room temperature and relative humidity.
For example, after chlorphenamine, lemon yellow and small amount of sodium chloride just mixed, sieve, mix with 100 mesh sieves; Then remaining sodium chloride, aspartame, artificial Calculus Bovis, caffeine, amantadine hydrochloride and acetaminophen are added, continue to sieve, mix; Add acid source, alkali source and sucrose at last, behind the mix homogeneously, the polyvinylpyrrolidone alcoholic solution with 8% is the binding agent wet granulation.45 ℃ of forced air dryings add PEG6000 behind the granulate, then with mixture at room temperature and relative humidity less than 40% condition lower sheeting.
Effervescence tablet of cold-treating preparation slaking test provided by the present invention:
Get the distilled water of about 150ml room temperature or 25 ℃, get 1 of effervescent tablet and put into wherein, make its disintegrate voluntarily, just be dissolved into fast near transparent solution with interior tablet in 2 minutes, the taste of solution and color and luster all are easy to be accepted by the patient; The pH value of dissolving back solution is about 4.27.
That cold medicine effervescent tablet preparation provided by the invention has is easy to carry, good mouthfeel, discharge advantage rapidly, is particularly suitable for child patient and takes, and also can improve adult's toleration greatly simultaneously.
The present invention is by selecting suitable acid, alkali right, and is aided with suitable pharmaceutic adjuvant, improved mouldability, the effervescency of effervescent tablet, and reduces in the preparation process the harsh requirement to environment; Can be easily at room temperature and relative humidity less than 40% condition lower sheeting, that is,, also can more successfully make effervescent tablet even under higher damp condition.
Following embodiment can further specify the present invention, but and unrestricted range of application of the present invention.
The specific embodiment
Embodiment 1,
A kind of effervescence tablet of cold-treating preparation that is suitable for child patient, its table 1 composed as follows of writing out a prescription:
Table 1
| Prescription is formed | Consumption |
| Acetaminophen | 100mg |
| Amantadine hydrochloride | 40mg |
| Caffeine | 6mg |
| The artificial Calculus Bovis | 4mg |
| Chlorphenamine | 0.8mg |
| Citric acid | 170mg |
| Tartaric acid | 250mg |
| Sodium bicarbonate | 340mg |
| Sucrose | 600mg |
| Sodium chloride | 200mg |
| Flavoring lemon oil essence | 4.5ul |
| Flavoring orange oil essence | 4.5ul |
| Lemon yellow | 0.44mg |
| Aspartame | 22mg |
| Polyethylene glycol 6000 | 26mg |
Every weight of the tablet that makes is about 1.76g.
Embodiment 2,
As a kind of effervescence tablet of cold-treating preparation that is suitable for child patient of embodiment 1, the amount ranges of its each component is shown in the table 1 ± 5% between.
Embodiment 3,
A kind of effervescence tablet of cold-treating preparation preparation method that is suitable for child patient as embodiment 1,2 comprises the steps:
After chlorphenamine, lemon yellow and small amount of sodium chloride just mixed, sieve with 100 mesh sieves and to mix 3 times;
Remaining sodium chloride, aspartame, artificial Calculus Bovis, caffeine, amantadine hydrochloride and acetaminophen are added, continue to sieve and mix 3 times;
Add acid source, alkali source and sucrose at last, mix homogeneously, the polyvinylpyrrolidone ethanol solution of getting concentration and be 8% (w/v) is the binding agent wet granulation in right amount; 45 ℃ of forced air dryings add PEG6000 behind the granulate, then with mixture at room temperature and relative humidity less than 40% condition lower sheeting, the weight of gained tablet is about 1.76g.
Get the distilled water of about 150ml room temperature or 25 ℃, get 1 and put into and wherein make its disintegrate voluntarily, just be dissolved into fast near transparent solution with interior tablet in 2 minutes, and taste and color and luster all be easy to accept, the pH value of dissolving back solution is 4.27.
Embodiment 4
A kind of effervescence tablet of cold-treating preparation that is suitable for adult patient, its table 2 composed as follows of writing out a prescription:
Table 2
| Prescription is formed | Consumption |
| Acetaminophen | 250mg |
| Amantadine hydrochloride | 100mg |
| Caffeine | 15mg |
| The artificial Calculus Bovis | 10mg |
| Chlorphenamine | 2mg |
| Citric acid | 300mg |
| Tartaric acid | 204mg |
| Sodium bicarbonate | 408mg |
| Sucrose | 500mg |
| Sodium chloride | 250mg |
| Strawberry essence | 10ul |
| Carmine | 0.33mg |
| Aspartame | 30mg |
| Polyethylene glycol 6000 | 31.8mg |
The about 2.1g of every weight of the tablet that makes.
Embodiment 5,
As a kind of effervescence tablet of cold-treating preparation that is suitable for adult patient of embodiment 4, the amount ranges of its each component is shown in the table 2 ± 5% between.
Embodiment 6,
As a kind of effervescence tablet of cold-treating preparation preparation method that is suitable for adult patient of embodiment 4,5, this method is similar to embodiment 3, the great about 2.1g of gained sheet.Gained tablet surface smoother, tablet weight variation are little.
Get about 200ml, about 25 ℃ distilled water, this sheet is put into wherein, all be dissolved into fast near transparent solution with interior in 3 minutes, taste and color and luster are all more acceptant.
Embodiment 7
A kind of preparation method of effervescence tablet of cold-treating preparation of the table 3 composed as follows of writing out a prescription takes that the technology similar to embodiment 3 is granulated, tabletting, and tabletting process environment humidity is 45%, the great about 1.8g of gained sheet.
Compacting under above-mentioned ambient humidity is smooth in flakes, and the gained tablet surface is more more smooth than embodiment 6, and taste is also more acceptant.
Table 3:
| Prescription is formed | Consumption |
| Acetaminophen | 200mg |
| Amantadine hydrochloride | 80mg |
| Caffeine | 12mg |
| The artificial Calculus Bovis | 8mg |
| Chlorphenamine | 1.6mg |
| Citric acid | 157mg |
| Tartaric acid | 192mg |
| Sodium bicarbonate | 333mg |
| Lactose | 300mg |
| Sucrose | 300mg |
| Sodium chloride | 210mg |
| Strawberry essence | 7ul |
| Carmine | 0.2mg |
| Aspartame | 12mg |
| Leucine | 30mg |
Claims (5)
1. an effervescence tablet of cold-treating preparation comprises active component, effervescent acid-base pair, filler, edible essence, pigment, sweeting agent, binding agent and lubricant; Described effervescent acid-base pair is made up of acid source and alkali source;
It is characterized in that described active component is acetaminophen, amantadine hydrochloride, caffeine, artificial Calculus Bovis and chlorphenamine;
Described acid source is any one or a few in citric acid, tartaric acid, fumaric acid, boric acid, potassium citrate dihydrogen, potassium hydrogen tartrate, fumaric acid sodium, adipic acid, the malic acid;
Described alkali source is any one in sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium carbonate, the sodium glycine carbonate;
Described filler is selected from any one or a few in lactose, mannitol, sucrose, glucose, soluble starch, sodium chloride, the sorbitol;
Described edible essence is selected from Fructus Citri Limoniae essence, orange flavor essence, flavoring orange essence, flavoring pineapple essence, Herba Menthae essence, almond essence, Fructus Myricae rubrae essence, flavoring banana essence, strawberry essence, chocolate essence, vanilla, fresh milk essence;
Described pigment is selected from carmine, light green, lemon yellow, D C Yellow No. 10;
Described sweeting agent is selected from aspartame, saccharin sodium, aspartame, cyclamate, stevioside;
Described lubricant is selected from Polyethylene Glycol, magnesium stearate, Pulvis Talci, leucine, alanine, glycine, Stepanol MG, the micropowder silica gel of molecular weight more than 4000;
Described binding agent is selected from polyvinylpyrrolidone, hydroxypropyl emthylcellulose, methylcellulose, sodium carboxymethyl cellulose, ethyl cellulose, the starch slurry solution that concentration is 1%～30% (w/v);
Described wetting agent is selected from ethanol or Different concentrations of alcohol solution;
Described each components contents is: acetaminophen 50～500mg, amantadine hydrochloride 10～200mg, caffeine 1～50mg, artificial Calculus Bovis 1～50mg, chlorphenamine 0.1～10mg; Filler is 10～4000mg, and sweeting agent is 2～500mg, and edible essence is 0.02～250mg, and pigment is 0.002～50mg, and lubricant is 0.2～400mg, and binding agent is an amount of, and the gross weight of acid source and alkali source consumption is 20～4500mg.
2. a kind of effervescence tablet of cold-treating preparation according to claim 1 is characterized in that each components contents is in every tablet of tablet: acetaminophen 100mg, amantadine hydrochloride 40mg, caffeine 6mg, artificial Calculus Bovis 4mg, chlorphenamine 0.8mg, citric acid 170mg, tartaric acid 250mg, sodium bicarbonate 340mg, sucrose 600mg, sodium chloride 200mg, flavoring lemon oil essence 4.5ul, flavoring orange oil essence 4.5ul, lemon yellow 0.44mg, aspartame 22mg, polyethylene glycol 6000 are 26mg.
3. a kind of effervescence tablet of cold-treating preparation according to claim 1 is characterized in that each components contents is in every tablet of tablet: acetaminophen 250mg, amantadine hydrochloride 100mg, caffeine 15mg, artificial Calculus Bovis 10mg, chlorphenamine 2mg, citric acid 300mg, tartaric acid 204mg, sodium bicarbonate 408mg, sucrose 500mg, sodium chloride 250mg, strawberry essence 10ul, carmine 0.33mg, aspartame 30mg, polyethylene glycol 6000 are 31.8mg.
4. a kind of effervescence tablet of cold-treating preparation according to claim 1 is characterized in that each components contents is in every tablet of tablet: acetaminophen 200mg, amantadine hydrochloride 80mg, caffeine 12mg, artificial Calculus Bovis 8mg, chlorphenamine 1.6mg, citric acid 157mg, tartaric acid 192mg, sodium bicarbonate 333mg, lactose 300mg, sucrose 300mg, sodium chloride 210mg, strawberry essence 7ul, carmine 0.2mg, aspartame 12mg, leucine 30mg.
5. according to the preparation method of claim 1 or 4 described a kind of effervescence tablet of cold-treating preparation, it is characterized in that adopting the wet granule compression tablet legal system heavily to be the tablet of 100mg～5000mg in flakes; Described wet granule compression tablet method is after chlorphenamine, lemon yellow and small amount of sodium chloride are just mixed, to sieve with 100 mesh sieves, mixes; Then remaining sodium chloride, aspartame, artificial Calculus Bovis, caffeine, amantadine hydrochloride and acetaminophen are added, continue to sieve, mix; Add acid source, alkali source and sucrose at last, behind the mix homogeneously, the polyvinylpyrrolidone alcoholic solution with 8% is the binding agent wet granulation; 45 ℃ of forced air dryings add PEG6000 behind the granulate, then with mixture at room temperature and relative humidity less than 40% condition lower sheeting.
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| CN102114112B (en) * | 2011-02-28 | 2013-06-05 | 辽宁盛生医药集团有限公司 | Effervescent tablet for improving immunity and preparation method thereof |
| CN105412041A (en) * | 2012-08-02 | 2016-03-23 | 佳格食品股份有限公司 | Effervescent tablet with energizing enhancing effect |
| CN105640981B (en) * | 2016-01-21 | 2018-09-11 | 国药集团汕头金石制药有限公司 | Oyster shell calcium effervescence tablet composition and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1124618A (en) * | 1994-05-31 | 1996-06-19 | 江西南昌济生制药厂 | Quick-acting cold oral liquid for child and preparing process thereof |
| CN1689565A (en) * | 2004-04-27 | 2005-11-02 | 浙江康裕制药有限公司 | Cold resistance compound rimantadine preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1124618A (en) * | 1994-05-31 | 1996-06-19 | 江西南昌济生制药厂 | Quick-acting cold oral liquid for child and preparing process thereof |
| CN1689565A (en) * | 2004-04-27 | 2005-11-02 | 浙江康裕制药有限公司 | Cold resistance compound rimantadine preparation |
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