CN101099747A - Compound alginic acid chewing tablet and preparation method thereof - Google Patents
Compound alginic acid chewing tablet and preparation method thereof Download PDFInfo
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- CN101099747A CN101099747A CNA2007101198289A CN200710119828A CN101099747A CN 101099747 A CN101099747 A CN 101099747A CN A2007101198289 A CNA2007101198289 A CN A2007101198289A CN 200710119828 A CN200710119828 A CN 200710119828A CN 101099747 A CN101099747 A CN 101099747A
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- chewable tablet
- alginic acid
- fructus
- magaldrate
- sodium
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Abstract
The present invention is aimed at providing a compound alginic acid masticatory tablet and its preparation method. Said masticatory table is good in taste, high in bioavailability, quick in disintegration speed and can quickly neutralize supernumerary gastric acid, and can be formed into gastric mucosa protection layer.
Description
Technical field
The present invention relates to medicine of a kind of taking convenience and preparation method thereof, what be particularly related to is to be used for and gastric acid, the preparation method and the application thereof of chewable tablet of the symptom of the heartburn and gastroxia that is caused by dyspepsia, esophageal reflux alleviated rapidly in the secretion of gastric acid inhibitory.
Background technology
Along with the quickening of urban life rhythm, the digestive system disease incidence rate comes out at the top always, peptic ulcer particularly, and sickness rate accounts for 10% of population.This must follow the demand in such disease medication market constantly to increase.The antacid and the medication amount of money of treatment peptic ulcer disease class medicine in 7 years are sure to occupy preceding 2,3 of medicine for digestive system always.
The basic reason of peptic ulcer is hyperchlorhydria, and makes the patient feel stomach discomfort, acid regurgitation water, heartburn (stomach burn feeling).
In the medicine of treatment peptic ulcer, mainly contain three classes at present.The first kind is an antacid magnesium hydroxide, as aluminium hydroxide, magnesium trisilicate, sodium bicarbonate, sucralfate, hydrotalcite etc., be difficult for behind this type of drug oral being absorbed, in directly and the gastric acid, still can on ulcer surface, form one deck protectiveness thin film by gastrointestinal, to reduce gastric acid and pepsin corrosion and Digestion, so claim them to be treatment Peptic Ulcers optimal drug to ulcer surface; Second class is a proton pump inhibitor, as omeprazole, and lansoprazole, pantoprazole, rabeprazole etc.; The 3rd class is a H1 receptor blocking agent cimetidine, ranitidine, famotidine, nizatidine.Wherein second and third class medicine or price are higher, or exist more untoward reaction.Therefore, antacid is the most widely used clinically medicine at present, and not only low price, and onset is rapid, and it has occupied 45% of about peptic ulcer total sales volume.
Three active component of the present invention, alginic acid, magaldrate, sodium bicarbonate.Magaldrate has another name called the magnalium hydrate, and English name magaldrate is a kind of novel antiacid medicine.Its metabolic process in vivo is: the reaction of magaldrate and gastric acid, generate magnesium hydroxide and aluminium hydroxide, and this moment, the response speed of aluminium hydroxide slowed down, and kept a stable reaction rate, thereby in continuing and gastric acid.Generate aluminum chloride after the aluminium hydroxide generation neutralization reaction, enter and have a small amount of aluminum chloride again behind the intestinal and reuptaked, and insoluble aluminium chlorhydrate salt and hydrophosphate are thanked by row.The reaction of magnesium hydroxide and gastric acid generates magnesium chloride, and magnesium chloride is drained be converted into magnesium carbonate in intestinal after, although magnesium ion can be rapidly through renal excretion in the normal human, can be absorbed by the body but have 10%～30% magnesium ion.Alginic acid does not have change after entering gastrointestinal tract, and thanks with the prototype of alginic acid or the form row of alginate.Sodium bicarbonate and gastric acid reaction back generates sodium chloride, and with unreacted sodium bicarbonate through urine excretion.
Analyze from pharmacology pharmacodynamic: alginic acid is a stomach esophageal acid reflux inhibitors, can form gassiness froth bed at stomach surface, stops by its physical action that gastroesophageal acid is counter flows, thereby mucous membrane of esophagus is down shielded.The sustainable neutralization buffer gastric acid of aluminum magnesium hydroxide reduces stomach and duodenal spasm, and suppresses cholate and pepsic secretion.Sodium bicarbonate is quick-acting antacids, and the hydrochloric acid reaction in itself and the gastrointestinal tract produces sodium chloride and carbon dioxide.The three has good synergism, and is evident in efficacy.
Because the amount of the active component in this prescription is relatively large, therefore it is designed to chewable tablet, chewable tablet compares to other conventional tablets, and its distinguishing feature is:
1. good dispersing state, disintegration time is short, and the medicine stripping is rapid;
2. can make medicine can be absorbed or take place pharmacological reaction under one's belt, rapid-action, the bioavailability height;
3. the tablet mouthfeel is good, and taking convenience can be chewed, buccal etc., especially is fit to dysphagia person.
Inquiry is not by retrieval domesticly seen the composing prescription preparation of forming with three kinds of active component of the present invention, does not see the report of the chewable tablet of this prescription yet.
Summary of the invention
The purpose of this invention is to provide that a kind of mouthfeel is good, taking convenience, disintegrate is fast, bioavailability is high; can neutralize rapidly unnecessary gastric acid and form the gastric mucosal protection layer, quick-acting and long-acting combine be used for the treatment of compound alginic acid chewable tablet of peptic ulcer and preparation method thereof.
Compound alginic acid chewable tablet of the present invention also contains adjuvant except principal agent alginic acid, magaldrate, sodium bicarbonate.Adjuvant can comprise filler, binding agent, correctives, lubricant etc., can also add an amount of pigment in case of necessity.In each oral formulations unit, the ratio of active component is an alginic acid: magaldrate: sodium bicarbonate=1: 2: 1, concrete consumption is preferably 200mg, 400mg, 200mg.If only with the doubling or reduce by half of the above active component amount of carrying out, and itself ratio inconvenience then should be considered as preparation units activity composition and the present invention and be equal to.
Owing to chewable tablet requirement good mouthfeel, to the oral mucosa nonirritant.Therefore extremely important to the selection of supplementary product kind and performance thereof.
The present invention is through selecting, found the pharmaceutic adjuvant of chewable tablet of the present invention, filler includes but are not limited to any one or the mixture in starch, microcrystalline Cellulose, sucrose, glucose, lactose, dextrin, mannitol, sorbitol, xylitol, beta cyclodextrin, calcium carbonate, calcium hydrogen phosphate, the calcium phosphate etc.; Binding agent includes but are not limited to a kind of or its mixture in water, water/alcoholic solution, starch slurry, polyvinylpyrrolidone, methylcellulose, hydroxypropyl methylcellulose, carboxymethyl starch sodium, sodium carboxymethyl cellulose, the hydroxyethyl-cellulose etc.; Correctives one of includes but are not limited in Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, stevioside, the acesulfame-K or wherein several mixture; Lubricant includes but are not limited to one or more in Polyethylene Glycol of micropowder silica gel, magnesium stearate, Pulvis Talci, micronizing etc.; Can also add an amount of coloring agent therein in case of necessity, coloring agent includes but not limited to as sunset yellow, carmine, curcumin, light green etc.
Compound alginic acid chewable tablet of the present invention, its preparation method can adopt tabletting behind direct powder compression and the wet granulation.Adopt direct powder compression, higher requirement is arranged for flowability, the compressibility of material, therefore must be careful for the selection of the water content of material, fluidizer, and also before mixing, all supplementary materials all should carry out corresponding drying.
Compound alginic acid chewable tablet of the present invention; when adopting the wet granulation process tabletting; in its preparation process; consider the convenience of stability of formulation and operation; should adopt following technology to carry out: the separately suitable and partially filled dose of granulation of alginic acid; magaldrate, sodium bicarbonate then should mix with other filleies granulates, and with after adding other adjuvant after two kinds of granules mixing, mix homogeneously carries out tabletting again
The specific embodiment
Come compound alginic acid chewable tablet of the present invention done further specifying by following example, but be not limited in following example.
Embodiment 1
Prescription:
| Alginic acid | 200g |
| Magaldrate | 400g |
| Sodium acid carbonate sweet mellow wine sorbierite 70% ethanolic solution purified water flavoring orange essence is made altogether | 1000 of an amount of 20g of 200g 380g 800g |
Preparation method:
1. above all solids supplementary material is crossed 65 mesh sieves, standby;
2. after getting recipe quantity alginic acid and half sorbitol mix homogeneously, add 70% alcoholic solution and make the granulation of soft material .16 mesh sieve in right amount, 60 ℃ of dryings, 16 mesh sieve granulate, standby;
3. get recipe quantity magaldrate, sodium bicarbonate and surplus sorbitol and mannitol mix homogeneously, granulate in right amount with purified water, 16 mesh sieves are granulated, 60 ℃ of dryings, and 16 mesh sieve granulate, standby;
4. above two kinds can be mixed, add flavoring orange essence, always be mixed even after, heavily about 2.0g of adjustment sheet and pressure 7-12kgN, tabletting.
Embodiment 2
Prescription:
| Alginic acid magaldrate sodium acid carbonate sorbierite pregelatinized starch aspartame lemon extract superfine silica gel powder is made altogether | 1000 of 200g 400g 200g 550g 100 20g 10g 20g |
Preparation method:
1. get alginic acid, magaldrate, sodium bicarbonate, sorbitol, 80 ℃ of dry 0.5-1 of pregelatinized Starch hour;
2. get micropowder silica gel, Fructus Citri Limoniae essence, aspartame and 50g pregelatinized Starch mix homogeneously, adopt equivalent incremental method other supplementary material mix homogeneously in advance again.
3. behind the mix homogeneously, adjustment sheet weighs 1.5g and pressure, direct powder compression.
Embodiment 3
Prescription:
| Alginic acid magaldrate sodium bicarbonate sucrose microcrystalline Cellulose | 200g 400g 200g 300g 600g |
| Acesulfame potassium Fructus Citri Limoniae essence Pulvis Talci 2.5%pvp50% alcoholic solution curcumin is made altogether | An amount of 1000 of 20g 20g 20g |
Preparation method:
1. above all solids supplementary material is crossed 65 mesh sieves, standby;
2. get curcumin and be dissolved in the 2.5%pvp50% alcoholic solution, stir;
3. after getting recipe quantity alginic acid and sucrose mix homogeneously, add the above-mentioned binder solution that contains pigment and make the granulation of soft material .16 mesh sieve in right amount, 60 ℃ of dryings, 16 mesh sieve granulate, standby;
4. get recipe quantity magaldrate, sodium bicarbonate and surplus sorbitol and mannitol mix homogeneously, granulate in right amount with the above-mentioned binding agent that contains pigment, 16 mesh sieves are granulated, 60 ℃ of dryings, and 16 mesh sieve granulate, standby;
5. above two kinds can be mixed, add acesulfame potassium, Fructus Citri Limoniae essence, Pulvis Talci, always be mixed even after, heavily about 1.75g of adjustment sheet and pressure 7-12kgN, tabletting.
Claims (7)
1. a chewable tablet is characterized in that: with the active component of alginic acid, magaldrate, sodium bicarbonate mutual group cost tablet, also include other pharmaceutic adjuvant, comprise filler, binding agent, correctives, lubricant etc.
2. chewable tablet as claimed in claim 1 is characterized in that: the ratio of active component is an alginic acid in the unit formulation: magaldrate: sodium bicarbonate=1: 2: 1, general consumption is 200mg, 400mg, 200mg.
3. chewable tablet as claimed in claim 1 is characterized in that: described filler includes but are not limited to any one or the mixture in starch, microcrystalline Cellulose, sucrose, glucose, lactose, dextrin, mannitol, sorbitol, xylitol, beta cyclodextrin, calcium carbonate, calcium hydrogen phosphate, the calcium phosphate etc.
4. chewable tablet as claimed in claim 1 is characterized in that: described binding agent includes but are not limited to a kind of or its mixture in water, water/alcoholic solution, starch slurry, polyvinylpyrrolidone, methylcellulose, hydroxypropyl methylcellulose, carboxymethyl starch sodium, sodium carboxymethyl cellulose, the hydroxyethyl-cellulose etc.
5. chewable tablet as claimed in claim 1 is characterized in that: described correctives one of includes but are not limited in Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, stevioside, the acesulfame-K or wherein several mixture.Can also add an amount of coloring agent therein in case of necessity, as sunset yellow, carmine, curcumin, light green etc.
6. chewable tablet as claimed in claim 1 is characterized in that: described lubricant includes but are not limited to one or more in Polyethylene Glycol of micropowder silica gel, magnesium stearate, Pulvis Talci, micronizing etc.
7. the preparation method of chewable tablet as claimed in claim 2 is characterized in that: can adopt tabletting behind direct powder compression and the wet granulation.Should be before the employing direct powder compression with each supplementary material drying; When adopting the wet granulation process tabletting; preferred following technology: the separately suitable and partially filled dose of granulation of alginic acid; magaldrate, sodium bicarbonate then should mix with other filleies granulates, and with after adding other adjuvant after two kinds of granules mixing, mix homogeneously carries out tabletting again.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101198289A CN101099747A (en) | 2007-08-01 | 2007-08-01 | Compound alginic acid chewing tablet and preparation method thereof |
| CNA2008100943043A CN101259141A (en) | 2007-08-01 | 2008-04-25 | Compound alginic acid chewable tablet and preparation thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101198289A CN101099747A (en) | 2007-08-01 | 2007-08-01 | Compound alginic acid chewing tablet and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN101099747A true CN101099747A (en) | 2008-01-09 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2007101198289A Pending CN101099747A (en) | 2007-08-01 | 2007-08-01 | Compound alginic acid chewing tablet and preparation method thereof |
| CNA2008100943043A Pending CN101259141A (en) | 2007-08-01 | 2008-04-25 | Compound alginic acid chewable tablet and preparation thereof |
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| Application Number | Title | Priority Date | Filing Date |
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| CNA2008100943043A Pending CN101259141A (en) | 2007-08-01 | 2008-04-25 | Compound alginic acid chewable tablet and preparation thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104337783A (en) * | 2013-08-02 | 2015-02-11 | 山东新时代药业有限公司 | Capecitabine tablet and preparation method of capecitabine tablet |
| CN111388436A (en) * | 2020-04-20 | 2020-07-10 | 北京健讯医药科技有限公司 | Sodium alginate chewable tablet and preparation method thereof |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102488708B (en) * | 2011-12-30 | 2013-01-16 | 浙江丽水众益药业有限公司 | Magaldrate chewable tablets and preparation method thereof |
-
2007
- 2007-08-01 CN CNA2007101198289A patent/CN101099747A/en active Pending
-
2008
- 2008-04-25 CN CNA2008100943043A patent/CN101259141A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104337783A (en) * | 2013-08-02 | 2015-02-11 | 山东新时代药业有限公司 | Capecitabine tablet and preparation method of capecitabine tablet |
| CN104337783B (en) * | 2013-08-02 | 2018-06-22 | 山东新时代药业有限公司 | A kind of capecitabine tablet and preparation method thereof |
| CN111388436A (en) * | 2020-04-20 | 2020-07-10 | 北京健讯医药科技有限公司 | Sodium alginate chewable tablet and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101259141A (en) | 2008-09-10 |
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