CN1586475A - Vitamin C oral disintegration tablet and its preparing method - Google Patents
Vitamin C oral disintegration tablet and its preparing method Download PDFInfo
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- CN1586475A CN1586475A CN 200410062742 CN200410062742A CN1586475A CN 1586475 A CN1586475 A CN 1586475A CN 200410062742 CN200410062742 CN 200410062742 CN 200410062742 A CN200410062742 A CN 200410062742A CN 1586475 A CN1586475 A CN 1586475A
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Abstract
The present invention relates to one kind of orally disintegrated vitamin C tablet capable of disintegrating to release in oral cavity fast, and its preparation. The orally disintegrated vitamin C tablet is prepared with vitamin C as main material, and through adding stuffing, disintegrating agent, corrective, flow assistant and other supplementary material, pressing into tablet and other steps. The present invention has the features of low production cost, fast disintegration, good taste, clear chemical components, fast absorption, high bioavailability, etc.
Description
[technical field]
The present invention relates to a kind of Vitamin C preparation that can be used for treating vitamin C deficiency and diseases such as anemia anaphylactic disease, myocarditis, chronic hepatitis, Keshan disease and acute and chronic poisoning, relate in particular to a kind of vitamin C oral disintegration tablet preparation with rapid release effect.
[background technology]
Vitamin C and dehydrogenation vitamin C form reversible oxidation-reduction system in vivo, and this system plays an important role in biological oxidation and reduction He in the Cellular respiration.Vitamin C participates in the synthetic of matter between synthetic, the collagen protein of amino acid metabolism, neurotransmitter and histiocyte.Can reduce the permeability of blood capillary, solidifying of accelerate blood stimulates coagulation function, promote that ferrum absorbs at enteral, impel rate and blood-lipid decreased, increase resistance infecting, participate in function of detoxification, and the effect that antfhistamine effect is arranged and stop carcinogen (nitrosamine) to generate.Normal person's daily requirement amount (in mg) is as follows: moderate physical labor, 50; Heavy physical labour, 70～100; The breast woman, 100; The anemia of pregnant woman, 70; The child is below 7 years old, and 30～35; More than 7 years old, 50.The vitamin C that obtain every day in fresh vegetables fruit generally can satisfy goes up item needs, but runs into special circumstances (as the trouble infectious disease time), can cause deficiency disease and vitamin C deficiency.
Vitamin C is used for clinical: 1. scorbutic prevention and treatment.2. during the acute and chronic infectious disease, consumption increases, and should suitably replenish, with the enhancing body resistance.After being ill convalescent period, the bad person of wound healing also should suitably replenish this product.3. cardiogenic shock when taking place in the Keshan disease patient, and available this product is heavy dose of treats.Liver injury when 4. being used for chronic poisonings such as liver cirrhosis, acute hepatitis and arsenic, hydrargyrum, lead, benzene.5. other: be used for various anemias, anaphylaxis dermatosis, aphtha, promotion wound healing etc.Reporting in recent years all has certain effect to flu, some cancer, hyperlipemia etc., but clinical efficacy is still unsure.
Vitamin C has various dosage forms such as ordinary tablet, chewable tablet, effervescent tablet, dispersible tablet, buccal tablet and injection at present, but finds no vitamin C oral disintegration tablet listing or relevant report.Vitamin C is made oral cavity disintegration tablet, help taking of patient, increase patient's compliance.
[summary of the invention]
The objective of the invention is to improve existing vitamin C aspect peroral dosage form deficiency, provide a kind of to extensive patients and medical personnel and carry taking convenience, absorb rapid-action vitamin C oral disintegration tablet preparation.Needn't drink water when the present invention relates to take, in the oral cavity, only need get final product rapid disintegrate or dissolving in tens seconds, can finish vitamin C oral disintegration tablet of taking medicine and preparation method thereof with saliva hypopharynx.
One, prescription
The vitamin C oral disintegration tablet that reaches of the present invention comprises the material medicine vitamin C, needs following former, the auxiliary material of 9 classes altogether, and wherein: when not making Cotton seeds, then do not use coating material, effervescent also can for selecting adjuvant for use as one sees fit.
Vitamin C (5-50) %, binding agent (0-5) %, filler (10-80) %, disintegrating agent (2-35) %, correctives (1-40) %, coating material (0-40) %, effervescent (0-30) %, fluidizer (0.01-5) %, lubricant (0.3-3) %.
Wherein:
Binding agent includes but are not limited to starch, pregelatinized Starch, dextrin, maltodextrin, sucrose, arabic gum, methylcellulose, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone (PVP), alginic acid and alginate, xanthan gum and hydroxypropyl emthylcellulose (HPMC), can use use also capable of being combined separately.
Filler includes but are not limited to mannitol (granular or powdery), xylitol, sorbitol, maltose, microcrystalline Cellulose, polymerization sugar (EMDEX
), glucose, lactose, sucrose, dextrin and starch etc., can use separately, also can applied in any combination, consumption is generally (10-80) %.
Disintegrating agent includes but are not limited to crospolyvinylpyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), low substituted hydroxy-propyl methylcellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa) and soybean polysaccharide (EMCOSOY
) etc., can use use also capable of being combined separately.
Correctives includes but are not limited to mannitol, xylitol, stevioside, lactose, fructose, sucrose, protein sugar, maltose alcohol, glycyrrhizin, Sodium Cyclamate, gelatin, aspartame, flavoring banana essence, flavoring pineapple essence, vanillin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, citric acid etc., can use use also capable of being combined separately.
Coating material includes but are not limited to gelatin, arabic gum, alginate, chitosan, carboxymethyl cellulose salt, cellulose acetate phthalate ester, ethyl cellulose, methylcellulose, hypromellose, crylic acid resin (homemade acrylic resin I, II, III, IV, Eudragit
Series), polyvinyl alcohol, polyvinylpyrrolidone, Polyethylene Glycol etc., can use use also capable of being combined separately.
Fluidizer includes but are not limited to micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, hydrated sodium aluminosilicate etc., can use use also capable of being combined separately.
Lubricant includes but are not limited to magnesium stearate, calcium stearate, zinc stearate, glyceryl monostearate, Polyethylene Glycol, hydrogenated vegetable oil, sodium stearyl fumarate, polyoxyethylene monostearate, single Laurel sucrose acid ester, sodium laurylsulfate, lauryl alcohol sulphuric acid younger sister, Stepanol MG and Pulvis Talci etc., can use use also capable of being combined separately.
Effervescent includes but are not limited to the mixture of malic acid, citric acid or citric acid and sodium bicarbonate or sodium carbonate.
Two, preparation method
The vitamin C oral disintegration tablet that reaches of the present invention, its preparation method is a direct compression process, the manufacturer with preparation conventional tablet all can adopt.
The vitamin C mildly bitter flavor is and sweet, and the present invention can adopt two kinds of distinct methods to carry out flavoring or taste masking: 1. adopt the direct flavoring of correctives; 2. in advance vitamin C is carried out powder coating with taste masking.
Concrete preparation method is as follows:
The ascorbic preprocess method of the first step:
1. directly the flavoring method---this law is granulated to the vitamin C raw material or is not dealt with, and directly enters for second step;
2. powder coating taste masking---get selected coating material, with the dissolving of the solvent that adapts with it and to be diluted to debita spissitudo standby, getting vitamin C again places ebullated bed to make boiling, spray into above-mentioned solution with suitable speed then and carry out powder coating, get vitamin C powder coated granule, dry back sieving for standby;
Second step took by weighing correctives and vitamin C or the feed particles after first step taste masking processing according to quantity, and mix homogeneously is standby;
The 3rd step took by weighing filler, disintegrating agent, effervescent, fluidizer and mix homogeneously according to quantity, made evenly again with through second mixing of materials that goes on foot gained, and adding lubricant mixing is standby;
The 4th step gained material detects through intermediate, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
[beneficial effect]
Tablet is a kind of conventional dosage forms, because of its steady quality, dosage accurately, take, easy to carry, mechanization degree is high, low one of the at present the most frequently used dosage form that becomes of production cost, but because of the tablet extrusion forming, disintegrate is slow, bioavailability is lower, and part patient swallows comparatively difficult, thereby promoting the use of to a certain extent of tablet is restricted.The oral administration solid quick releasing formulation becomes a focus, particularly oral cavity disintegration tablet of new drug development in recent years for this reason, because of its taking convenience, rapid-action, bioavailability is high, the good emphasis that becomes tablet exploitation of mouthfeel.
Oral cavity disintegration tablet is meant not to be needed water or only needs low amounts of water, need not to chew, and tablet places lingual surface, meets after saliva separates rapidly or collapse, and borrows and swallows power, and medicine can be gone into the tablet of stomach onset.The characteristics of oral cavity disintegration tablet are that absorption is fast, bioavailability is high, and intestinal is residual few, and side effect is low, avoids liver first-pass effect etc.
According to the requirement of " formulation characteristic of oral cavity disintegration tablet and quality control meeting summary ", oral cavity disintegration tablet has essential leap than the disintegration rate of drop pill and ordinary tablet, and the disintegrate of oral cavity disintegration tablet generally in 30 seconds, is no more than 1 minute at most.And the dissolve scattered time limit of drop pill Chinese Pharmacopoeia regulation is in 30 minutes, and be all molten loosing about 5 minutes the disintegration of conventional tablet Chinese Pharmacopoeia regulation.
[specific embodiment]
For the preparation method of vitamin C oral disintegration tablet of the present invention better is described, in conjunction with directly flavoring method and powder coating taste masking method are as follows for an embodiment respectively:
Embodiment one direct flavoring method
One. prescription
1. raw material---vitamin C 250.0g;
2. binding agent---polyvinylpyrrolidone K-30 2.0g;
3. filler---mannitol 200.0g;
Microcrystalline Cellulose 59.0g;
4. correctives---aspartame 6.0g;
Flavoring orange essence 12.0g;
5. disintegrating agent---crospolyvinylpyrrolidone 25.0g;
L-HPC 35.0g；
6. fluidizer---micropowder silica gel 5.0g;
7. lubricant---magnesium stearate 6.0g.
Gross weight 600.0g makes 1000 altogether, the heavy 600mg/ sheet of designation card.
Two. preparation method
1) get the vitamin C raw material pulverizing, granulate, cross 26 mesh sieves with polyvinylpyrrolidone K-30, standby;
2) with micropowder silica gel, flavoring orange essence and aspartame, cross 40 mesh sieves respectively, mix homogeneously adds the vitamin C granules of having granulated again, and mix homogeneously is standby;
3) get mannitol, microcrystalline Cellulose, L-HPC and crospolyvinylpyrrolidone and cross 40 mesh sieves respectively, mix homogeneously will add and mix homogeneously through the raw material of flavoring again, adds magnesium stearate and mix homogeneously at last;
4) intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Embodiment two effervescent flavoring methods
One. prescription
1. raw material---vitamin C 250.0g;
2. binding agent---polyvinylpyrrolidone K-30 4.0g;
3. filler---mannitol 163.0g;
4. effervescent---sodium bicarbonate 100.0g;
5. correctives---aspartame 6.0g;
Flavoring orange essence 6.0g;
6. disintegrating agent---crospolyvinylpyrrolidone 25.0g;
L-HPC 35.0g；
7. fluidizer---micropowder silica gel 5.0g;
8. lubricant---magnesium stearate 6.0g.
Gross weight 600.0g makes 1000 altogether, the heavy 600mg/ sheet of designation card.
Two. preparation method
1) get vitamin C and sodium bicarbonate raw material pulverize separately, granulate with polyvinylpyrrolidone K-30 respectively again, cross 26 mesh sieves, standby;
2) with micropowder silica gel, flavoring orange essence and aspartame, cross 40 mesh sieves respectively, mix homogeneously adds the vitamin C and the sodium bicarbonate particle of having granulated again, and mix homogeneously is standby;
3) get mannitol, L-HPC and crospolyvinylpyrrolidone and cross 40 mesh sieves respectively, mix homogeneously will add and mix homogeneously through the raw material of flavoring again, adds magnesium stearate and mix homogeneously at last;
4) intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Embodiment three powder coating taste masking methods
One. prescription
1. raw material---vitamin C 250.0g;
2. coating material---Eudragit
E100 25.0g;
3. filler---mannitol 237.0g;
4. correctives---aspartame 6.0g;
Fragrant citrus essence 6.0g;
5. disintegrating agent---crospolyvinylpyrrolidone 35.0g;
L-HPC 25.0g；
6. fluidizer---micropowder silica gel 10.0g;
7. lubricant---magnesium stearate 6.0g.
Gross weight 600.0g makes 1000 altogether, the heavy 600mg/ sheet of designation card.
Two. preparation method
1) gets Eudragit
E100 is with the medical ethanol more than 95% dissolving and to be diluted to finite concentration standby;
2) get vitamin C and place ebullated bed to seethe with excitement, spray into above-mentioned solution by certain speed and carry out powder coating, make vitamin C powder coated granule, dry back is standby;
3) with mannitol, micropowder silica gel, PVPP, L-HPC, aspartame, magnesium stearate and fragrant citrus essence mix homogeneously, again and sieve after the coated granule mixing standby;
4) intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Disintegration of the foregoing description and slice, thin piece hardness numerical value are as follows:
Embodiment disintegration (second) slice, thin piece hardness (newton)
1 15-35 17-29
2 16-32 16-27
3 15-33 16-28
Claims (9)
1. vitamin C oral disintegration tablet and preparation technology thereof.By supplementary materials such as vitamin C, filler, disintegrating agent, correctives, fluidizer, lubricants, according to circumstances can also add binding agent, effervescent or coating material, with suitable proportioning, form through specific method for preparing, it is characterized in that its prescription is composed as follows: vitamin C (5-50) %, binding agent (0-5) %, filler (10-80) %, disintegrating agent (2-35) %, correctives (1-40) %, coating material (0-40) %, effervescent (0-30) %, fluidizer (0.01-5) %, lubricant (0.3-3) %.
2. various adjuvants of addressing according to claim 1 of being addressed is characterized in that selection kind separately is as follows:
Binding agent---include but are not limited to starch, pregelatinized Starch, dextrin, maltodextrin, sucrose, arabic gum, methylcellulose, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone (PVP), alginic acid and alginate, xanthan gum and hydroxypropyl emthylcellulose (HPMC), can use use also capable of being combined separately.
Filler---include but are not limited to mannitol (granular or powdery), xylitol, sorbitol, maltose, microcrystalline Cellulose, polymerization sugar (EMDEX
), glucose, lactose, sucrose, dextrin and starch etc., can use separately, also can applied in any combination, consumption is generally (10-80) %.
Disintegrating agent---include but are not limited to crospolyvinylpyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), low substituted hydroxy-propyl methylcellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa) and soybean polysaccharide (EMCOSOY
) etc., can use use also capable of being combined separately.
Correctives---include but are not limited to mannitol, xylitol, stevioside, lactose, fructose, sucrose, protein sugar, maltose alcohol, glycyrrhizin, Sodium Cyclamate, gelatin, aspartame, flavoring banana essence, flavoring pineapple essence, vanillin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, citric acid etc., can use use also capable of being combined separately.
Coating material---include but are not limited to gelatin, arabic gum, alginate, chitosan, carboxymethyl cellulose salt, cellulose acetate phthalate ester, ethyl cellulose, methylcellulose, hypromellose, crylic acid resin (homemade acrylic resin I, II, III, IV, Eudragit
Series), polyvinyl alcohol, polyvinylpyrrolidone, Polyethylene Glycol etc., can use use also capable of being combined separately.
Fluidizer---include but are not limited to micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, hydrated sodium aluminosilicate etc., can use use also capable of being combined separately.
Lubricant---include but are not limited to magnesium stearate, calcium stearate, zinc stearate, glyceryl monostearate, Polyethylene Glycol, hydrogenated vegetable oil, sodium stearyl fumarate, polyoxyethylene monostearate, single Laurel sucrose acid ester, sodium laurylsulfate, lauryl alcohol sulphuric acid younger sister, Stepanol MG and Pulvis Talci etc., can use use also capable of being combined separately.
3. preparation method that is used for the vitamin C oral disintegration tablet that claim 1 addresses is characterized in that being made up of following steps:
The ascorbic pretreatment of the first step:
(1) directly flavoring---this law is granulated to the vitamin C raw material or is not dealt with, and directly enters for second step;
(2) powder coating taste masking---get selected coating material, with the dissolving of the solvent that adapts with it and to be diluted to debita spissitudo standby, getting vitamin C again places ebullated bed to make boiling, spray into above-mentioned solution with suitable speed then and carry out powder coating, get vitamin C powder coated granule, dry back sieving for standby;
Second step took by weighing correctives and vitamin C or the feed particles after first step taste masking processing according to quantity, and mix homogeneously is standby;
The 3rd step took by weighing filler, disintegrating agent, effervescent, fluidizer and mix homogeneously according to quantity, made evenly again with through second mixing of materials that goes on foot gained, and adding lubricant mixing is standby;
The 4th step gained material detects through intermediate, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
4. the preparation method of addressing according to claim 3 is characterized in that: the method for the first step (2) need be used coating material that vitamin C is carried out taste masking in advance and handle.
5. the preparation method of addressing according to claim 4, it is characterized in that: the coating material that is used for the taste masking processing is gelatin, arabic gum, alginate, chitosan, carboxymethyl cellulose salt, cellulose acetate phthalate ester, ethyl cellulose, methylcellulose, hypromellose, crylic acid resin (homemade acrylic resin I, II, III, IV, Eudragit
Series), any one or two or more mixture such as polyvinyl alcohol, polyvinylpyrrolidone, Polyethylene Glycol.
6. any preparation method of addressing according to claim 3 is characterized in that: according to circumstances also can add the adjuvant effervescent.
7. the effervescent of addressing according to claim 6, it is characterized in that: this adjuvant is the mixture of malic acid, citric acid or citric acid and sodium bicarbonate or sodium carbonate.
8. preparation method that is used for the vitamin C oral disintegration tablet that claim 1 addresses, the hardness that it is characterized in that the tablet that obtains are between 10 to 45 newton, and disintegration time is at 1-60 in second.
9. a preparation method that is used for the vitamin C oral disintegration tablet that claim 1 addresses is characterized in that it adopts direct compression process preparation technology.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100627423A CN1327838C (en) | 2004-07-08 | 2004-07-08 | Vitamin C oral disintegration tablet and its preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100627423A CN1327838C (en) | 2004-07-08 | 2004-07-08 | Vitamin C oral disintegration tablet and its preparing method |
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| CN1586475A true CN1586475A (en) | 2005-03-02 |
| CN1327838C CN1327838C (en) | 2007-07-25 |
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| CN1327838C (en) | 2007-07-25 |
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