CN101120928B - Vitamin K1 orally disintegrating tablets preparation and preparation method thereof - Google Patents
Vitamin K1 orally disintegrating tablets preparation and preparation method thereof Download PDFInfo
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- CN101120928B CN101120928B CN2007101371367A CN200710137136A CN101120928B CN 101120928 B CN101120928 B CN 101120928B CN 2007101371367 A CN2007101371367 A CN 2007101371367A CN 200710137136 A CN200710137136 A CN 200710137136A CN 101120928 B CN101120928 B CN 101120928B
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Abstract
The present invention relates to an oral disintegration tablets preparation and the preparation method, which is capable of quick releasing vitamin K1 in the mouth. The preparation comprises the vitamin of effective quantity and the medicinal excipient. The optimal medicinal excipient comprises an adsorbent, a filling agent, a disintegrating agent and a binder. The more optimal medicinal excipient comprises a corrective agent, a lubricant and a flow agent. Because the preparation in the present invention is capable of rapid disintegration, the therapy method is added in order to bring convenience for the patients who need swallowing drugs.
Description
Technical field
The present invention relates to a kind of orally disintegrating tablet preparation that comprises vitamin K1 and preparation method thereof.
Background technology
The vitamin K1 chemical name is: 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecene base)-1,4-naphthalenedione.Vitamin K1 is a vitamin medicaments, is the synthetic necessary material of thrombin of liver.The K1 that is deficient in vitamin may cause these thrombin dyssynthesises or unusual, and clinical manifestation is for having bleeding tendency and cruor time extending.Vitamin K1 and blood coagulation are closely related, when vitamin K1 lacks, can cause the dyssynthesis of liver to multiple thrombin, cause body cruor time extending and bleeding tendency, and in time vitimin supplement K1 can make coagulation function recover.Vitamin K1 also has direct hepatoprotective and antiinflammation, for jaundice and the ALT rising person due to the hepatitis, bilirubin level is descended, and reaches and fall the enzyme effect.Vitamin K1 shortage property is hemorrhage to be the modal hemorrhage of infancy stage.Lacking the intracranial hemorrhage that causes by vitamin K1 is the 7th cause of death of China baby.Portion studies show that, the K1 that generally is deficient in vitamin during China baby due has 44.2% baby to have subclinical performance.Preventing the administration principle of intracranial hemorrhage for baby in 3 months is to begin oral vitamin K1 the same day in neonate birth back, every day 2mg, logotype 3 days; Or birth back oral vitamin K12mg on the same day, each oral 5mg during 1 week and 1 month, totally 3 times; Or birth back oral vitamin K11-2mg on the same day, weekly 1 time later on, each 1-2mg is until the baby in the time of 3 months.
Commercially available oral vitamin K1 preparation is common oral Pharmaceutical dosage forms at present, as tablet, capsule etc., for many patients that dysphagia is arranged, child particularly, especially ewborn infant, because of its function of deglutition a little less than, be inconvenient to take these solid dosage formss, be easy to generate the dangerous consequences of bringing by dysphagia.At present common commercially available vitamin K1 oral tablet is a coated tablet, and specification is 10mg, for the baby clothes of new birth with existing problems such as dosage is excessive, dysphagia.Re-use after being divided into 2.5mg/ part for reducing many it is broken into two with one's hands of dosage clinically, but cause problems such as dosage is inaccurate easily.
Summary of the invention
The object of the present invention is to provide a kind of vitamin K 1 orally disintegrating tablets preparation that discharges at intraorally rapidly disintegrating.
The present invention combines with the vitamin K1 of effective dose by selecting suitable pharmaceutical excipient, made a kind of can be in the oral cavity tablet of disintegrate rapidly.Compare with conventional tablet, preparation of the present invention need not to use water delivery service, also need not to chew, and medicine is placed on the tongue, after the rapid disintegrate of chance saliva, borrows swallowing act to go into the stomach onset, also can place the Sublingual, and medicine passes through the mucosa absorption onset after the disintegrate rapidly.Technical scheme of the present invention can fine solution baby's dysphagia and problem, the convenience and the safety that have improved clinical administration such as dosage is inaccurate.In addition, do not need when taking medicine to drink water and can be fast make the restriction that said preparation is not drunk water aspect practical in the characteristics of intraoral disintegration, can not bring problems such as dysphagia yet, bring great convenience for the patient's who the adult of dysphagia is arranged or temporarily can't find drinkable water use.
The invention provides a kind of vitamin K 1 cavity disintegrating tablet preparation that discharges at intraorally rapidly disintegrating, the vitamin K1 and the pharmaceutically acceptable excipient that wherein comprise effective dose, preferred described pharmaceutically acceptable excipient comprises adsorbent, filler, disintegrating agent, binding agent, and more preferably described pharmaceutically acceptable excipient also comprises correctives, lubricant or fluidizer.In particular, by weight, contain following component in the vitamin K 1 orally disintegrating tablets preparation of the present invention:
Vitamin K1 1-10 part
Adsorbent 1-15 part
Filler 10-30 part
Disintegrating agent 1-10 part
Correctives 0-0.3 part
Binding agent 0-2 part
Lubricant or fluidizer 0-2 part
Preferably wherein:
Correctives 0.01-0.3 part
Binding agent 0.1-2 part
Lubricant or fluidizer 0.2-2 part;
More preferably each component content is as follows in the preparation:
Vitamin K1 1-5 part
Adsorbent 2-10 part
Filler 15-25 part
Disintegrating agent 2-8 part
Correctives 0.02-0.2 part
Binding agent 0.5-1.5 part
Lubricant or fluidizer 0.5-1.5 part.
In according to the preferred embodiments of the invention:
Described adsorbent is selected from: micropowder silica gel, light magnesium oxide, crospolyvinylpyrrolidone, aluminium hydroxide desiccant gel and composition thereof, or the combination of above two or more materials; Preferred crospolyvinylpyrrolidone and micropowder silica gel; More preferably micropowder silica gel and crospolyvinylpyrrolidone INF-10;
Described filler is selected from: microcrystalline Cellulose, dextrin, low-substituted hydroxypropyl methylcellulose, lactose, precoking starch, sucrose, glucose, mannitol, sorbitol, starch, or the combination of above two or more materials; Preferably microcrystalline cellulose, mannitol and low-substituted hydroxypropyl cellulose;
Described disintegrating agent is selected from: low-substituted hydroxypropyl methylcellulose, crospolyvinylpyrrolidone, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, methylcellulose, or the combination of above two or more materials; Preferred crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose and carboxymethyl starch sodium; More preferably cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone XL and crospolyvinylpyrrolidone XL-10;
Described correctives is selected from: mannitol, stevioside, aspartame, Oleum menthae, wintergreen oil, Oleum Caryophylli, Oleum Anisi Stellati, Fructus Citri Limoniae oil, citrus seed oil, menthol, sorbitol, citric acid, or the combination of above two or more materials;
Described binding agent is selected from: arabic gum, gelatin, liquid glucose, maltose, polyvinylpyrrolidone, sodium carboxymethyl cellulose, carboxymethylcellulose calcium, starch, pregelatinized Starch, sucrose, tragacanth, acrylic resin, methylcellulose, ethyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, alginic acid, alginate, Pseudobulbus Bletillae (Rhizoma Bletillae) glue, colloid silicic acid magnalium, guar gum, or the combination of above two or more materials; The preferably polyethylene ketopyrrolidine; More preferably polyvinylpyrrolidone K17, polyvinylpyrrolidone K25, polyvinylpyrrolidone K 30, polyvinylpyrrolidone K90 and K90D;
Described lubricant or fluidizer are selected from: boric acid, lauryl sulfate magnesium, sodium benzoate, sodium acetate, leucine, Macrogol 4000, polyethylene glycol 6000, sodium lauryl sulfate, enuatrol, magnesium stearate, Stepanol MG, Pulvis Talci, sodium benzoate, micropowder silica gel, or the combination of above two or more materials; The preferred micropowder silica gel of lubricant or fluidizer;
The present invention also provides the method for preparing the above-mentioned vitamin K 1 orally disintegrating tablets preparation that discharges at intraorally rapidly disintegrating.In one embodiment of the present invention, can adopt compressing dry granulation, described method comprises: various adjuvants are crossed 30-150 mesh sieve (preferred 100 mesh sieves) respectively, the parts by weights another name is got the raw material of recipe quantity, vitamin K1 is uniformly dispersed with adsorbents adsorb,, carries out centre product check again with other adjuvant mix homogeneously, tabletting promptly gets oral cavity disintegration tablet.Perhaps, also can adopt tabletting behind the wet granulation, described method comprises: various adjuvants are crossed 30-150 mesh sieve (preferred 100 mesh sieves) respectively, the parts by weights another name is got the raw material of recipe quantity, vitamin K1 is uniformly dispersed with adsorbents adsorb, again with other adjuvant mix homogeneously, add binding agent and make soft material, sieve, granulate, oven dry, granulate, add lubricant or fluidizer, tabletting promptly gets orally disintegrating tablet preparation.
Vitamin K 1 orally disintegrating tablets preparation of the present invention has produced good effect, can be in mouth disintegrate and sheltered the disagreeable taste of medicine fast, solved the deficiency of existing coated tablet preferably.This pharmaceutical dosage form is the compressed tablets (friability meets Chinese Pharmacopoeia version related request in 2005) with conventional hardness, when taking, only needs medicine is contained in the mouth, need be not moisture with regard to fully disintegrate in the oral cavity, and its disintegration time is just finished in second about 1-30.Preparation of the present invention is applicable to: (1) has the patient of dysphagia, as child and elderly patients, particularly baby; (2) digestive tract disease patient, described patient can't swallow or swallowing act can cause serious vomiting reaction; When (3) bed patient or be busy with one's work personage or traveller etc. can't obtain water.Preparation of the present invention can use conventional tablet pharmaceutical equipment production, uses conventional tablet forming technique preparation, has avoided overlapping investment, and its processing technology is simple, prescription is unique, can give full play to drug effect, has the excellent popularization prospect.
Contain vitamin K1 1-50mg according to each sheet of orally disintegrating tablet preparation of the present invention, preferred 1-25mg, preferred especially 1mg, 2mg, 5mg, 10mg.。Be used for the treatment of hemorrhage or when the symptom of bleeding tendency is arranged, the recommended dose of wherein being grown up be the 10mg/ sheet/time, 3 times on the 1st, maximum dose level must not surpass 50mg in one day, the child recommends the using dosage should be less than 5mg/ day, the consumption of baby below 1 years old is a 2mg/ sheet/time/day.
Preventing the administration principle of intracranial hemorrhage for baby in 3 months is to begin oral vitamin K1 the same day in neonate birth back, every day 2mg, logotype 3 days; Or birth back oral vitamin K1 2mg on the same day, each oral 5mg during 1 week and 1 month, totally 3 times; Or birth back oral vitamin K11-2mg on the same day, weekly 1 time later on, each 1-2mg is until the baby in the time of 3 months.
Because the easy moisture absorption of vitamin K 1 orally disintegrating tablets, therefore ambient humidity should be controlled at below 50% in tablet press process of the present invention, and preferred humidity is below 45%.
The specific embodiment
Embodiment 1
Adopt direct powder compression, prepare oral cavity disintegration tablet of the present invention.Each prescription in the table 1 is the content of each component in 1000 oral cavity disintegration tablets.
The prescription of table 1: embodiment 1
| Component | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 | Prescription 5 | Prescription 6 | Prescription 7 | Prescription 8 |
| Vitamin K1 | 1g | 1g | 2g | 2g | 5g | 5g | 10g | 10g |
| Crospolyvinylpyrrolidone INF-10 | 2g | 3g | 3g | 1g | 6g | 8g | 4g | 3g |
| Component | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 | Prescription 5 | Prescription 6 | Prescription 7 | Prescription 8 |
| Micropowder silica gel (absorption is used) | 1g | 2g | 1g | 3g | 3g | 2.5g | 3g | 3g |
| Microcrystalline Cellulose | 13g | 16g | 15g | 10g | 30g | 34g | 10g | 15g |
| Low-substituted hydroxypropyl cellulose | 5g | 4g | 5g | 5g | 10g | 12g | 5g | 4g |
| Mannitol | 30g | 25g | 30g | 28g | 65g | 72g | 30g | 25g |
| Carboxymethyl starch sodium | 3g | -- | 2g | 3g | 5g | 4.5g | 3g | -- |
| Crospolyvinylpyrrolidone XL-10 | 2g | 3g | 2g | -- | 5g | 4.5g | 6g | 9g |
| Cross-linking sodium carboxymethyl cellulose | 2g | 3g | 2g | 3g | 5g | 4.5g | 2g | -- |
| Micropowder silica gel (fluidizer) | -- | 2g | 2g | -- | 5g | 4.5g | 2g | -- |
Various adjuvants are crossed 80 mesh sieves respectively, and the parts by weights another name is got, and vitamin K1 is uniformly dispersed with crospolyvinylpyrrolidone INF-10 and micropowder silica gel absorption, again with other adjuvant mix homogeneously, carries out centre product check, and tabletting promptly gets orally disintegrating tablet preparation.
In order to investigate the disintegrate effect of orally disintegrating tablet preparation of the present invention, we control the granularity after the disintegrate simultaneously to measuring disintegration.As the disintegrate medium, 37 ℃ of temperature adopt static method with 2ml water, the complete disintegrate of planted agent in 1 minute, and the granule after the disintegrate should pass through 30 purpose screen clothes (mesh size is less than 710 μ m).The result is as follows:
Table 2:
| The prescription of embodiment 1 | The result of embodiment 1 each prescription |
| Prescription 1 | Complete disintegrate in 10 seconds is all by 30 mesh sieves |
| Prescription 2 | Complete disintegrate in 8 seconds is all by 30 mesh sieves |
| Prescription 3 | Complete disintegrate in 9 seconds is all by 30 mesh sieves |
| Prescription 4 | Complete disintegrate in 7 seconds is all by 30 mesh sieves |
| Prescription 5 | Complete disintegrate in 9 seconds is all by 30 mesh sieves |
| Prescription 6 | Complete disintegrate in 12 seconds is all by 30 mesh sieves |
| Prescription 7 | Complete disintegrate in 10 seconds is all by 30 mesh sieves |
| Prescription 8 | Complete disintegrate in 8 seconds is all by 30 mesh sieves |
Embodiment 2
Adopt the back pressed disc method of granulating to prepare oral cavity disintegration tablet of the present invention.Each prescription in the table 3 is the content of each component in 1000 oral cavity disintegration tablets.
The prescription of table 3: embodiment 2
| Component | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 | Prescription 5 | Prescription 6 | Prescription 7 | Prescription 8 |
| Vitamin K1 | 1g | 1g | 2g | 2g | 5g | 5g | 10g | 10g |
| The crosslinked polyethylene pyrrole is alkane ketone INF-10 slightly | 1g | 3g | 2g | 2g | 4g | 8g | 3g | 4g |
| Micropowder silica gel (absorption is used) | 2g | 2g | 2g | 3g | 3g | 3g | 4g | 3g |
| Microcrystalline Cellulose | 11g | 10g | 10g | 12g | 15g | 34g | 10g | 15g |
| Low-substituted hydroxypropyl cellulose | 4g | 8g | 2g | 3g | 5g | 11.5g | 5g | 4g |
| Mannitol | 32g | 25g | 30g | 20g | 26g | 72g | 30g | 30g |
| Carboxymethyl starch sodium | 2g | 4g | -- | 3g | 3g | 5g | 3g | 2g |
| Crospolyvinylpyrrolidone XL-10 | 2g | -- | 3g | -- | 3g | -- | -- | -- |
| Crospolyvinylpyrrolidone XL | -- | -- | -- | -- | -- | 5g | 6g | 4g |
| Cross-linking sodium carboxymethyl cellulose | 2g | 4g | 3g | 3g | 3g | 5g | -- | 4g |
| 3% polyvinylpyrrolidone K30 | 18g | -- | -- | 20g | -- | -- | -- | 65g |
| 3% polyvinylpyrrolidone K25 | -- | 19g | -- | -- | -- | -- | -- | -- |
| 3% polyvinylpyrrolidone K90 | -- | -- | 11g | -- | -- | 12g | 15g | -- |
| 3% polyvinylpyrrolidone K90D | -- | -- | -- | -- | 15g | -- | -- | -- |
| Micropowder silica gel (fluidizer) | 1g | 2g | 2g | 2.5g | 3g | 5g | 3g | 4g |
Various adjuvants are crossed 80 mesh sieves respectively, and the parts by weights another name is got, and vitamin K1 is uniformly dispersed with crospolyvinylpyrrolidone INF-10 and micropowder silica gel absorption, again with other adjuvant mix homogeneously, with 3% polyvinylpyrrolidone (75% alcoholic solution) system soft material, cross 30 mesh sieves, granulate, oven dry, cross 30 mesh sieve granulate, add micropowder silica gel (fluidizer), carry out centre product check, tabletting promptly gets orally disintegrating tablet preparation.
In order to investigate the disintegrate effect of orally disintegrating tablet preparation of the present invention, we control the granularity after the disintegrate simultaneously to measuring disintegration.As the disintegrate medium, 37 ℃ of temperature adopt static method with 2ml water, the complete disintegrate of planted agent in 1 minute, and the granule after the disintegrate should pass through 30 purpose screen clothes (mesh size is less than 710 μ m).The result is as follows:
Table 4:
| The prescription of embodiment 2 | The result of embodiment 2 each prescription |
| Prescription 1 | Complete disintegrate in 5 seconds is all by 30 mesh sieves |
| Prescription 2 | Complete disintegrate in 8 seconds is all by 30 mesh sieves |
| Prescription 3 | Complete disintegrate in 11 seconds is all by 30 mesh sieves |
| Prescription 4 | Complete disintegrate in 6 seconds is all by 30 mesh sieves |
| Prescription 5 | Complete disintegrate in 8 seconds is all by 30 mesh sieves |
| Prescription 6 | Complete disintegrate in 9 seconds is all by 30 mesh sieves |
| Prescription 7 | Complete disintegrate in 8 seconds is all by 30 mesh sieves |
| Prescription 8 | Complete disintegrate in 8 seconds is all by 30 mesh sieves |
Embodiment 3
In the preparation method of present embodiment, use adsorbent vitamin K1 with adding again after the granulation earlier of other adjuvants, tabletting prepares oral cavity disintegration tablet of the present invention then.Each prescription in the table 5 is the content of each component in 1000 oral cavity disintegration tablets.
The prescription of table 5: embodiment 3
| Component | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 | Prescription 5 | Prescription 6 | Prescription 7 | Prescription 8 |
| Vitamin K1 | 1g | 1g | 2g | 2g | 5g | 5g | 10g | 10g |
| Crospolyvinylpyrrolidone INF-10 | 2g | 2g | 3g | 2g | 5g | 4g | 3g | 4g |
| Micropowder silica gel (absorption is used) | 1g | 2g | 2g | 3g | 3g | 4g | 4g | 2g |
| Microcrystalline Cellulose | 10g | 10g | 10g | 12g | 34g | 32g | 10g | 15g |
| Component | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 | Prescription 5 | Prescription 6 | Prescription 7 | Prescription 8 |
| Low-substituted hydroxypropyl cellulose | 5g | 6g | 4g | 3g | 12g | 11g | 8g | 5g |
| Mannitol | 30g | 28g | 32g | 25g | 72g | 60g | 28g | 30g |
| Carboxymethyl starch sodium | -- | -- | 3g | 2g | 4g | 5g | 3g | 2g |
| Crospolyvinylpyrrolidone XL-10 | 3g | 6g | 3g | 2g | -- | -- | -- | -- |
| Crospolyvinylpyrrolidone XL | -- | -- | -- | -- | 4g | 5g | 6g | 4g |
| Cross-linking sodium carboxymethyl cellulose | 3g | -- | -- | 2g | 4g | 5g | -- | 2g |
| 3% polyvinylpyrrolidone K 30 (75% alcoholic solution) | 15g | 15g | -- | 30g | -- | -- | -- | 60g |
| 3% polyvinylpyrrolidone K25 (75% alcoholic solution) | -- | 19g | -- | -- | -- | -- | -- | -- |
| 3% polyvinylpyrrolidone K90 (75% alcoholic solution) | -- | -- | 13g | -- | -- | 11g | 14g | -- |
| 3% polyvinylpyrrolidone K90D (75% alcoholic solution) | -- | -- | -- | -- | 17g | -- | -- | -- |
| Micropowder silica gel (fluidizer) | 1g | 1g | 2g | 2.5g | 4g | 5g | 2g | 4g |
Various adjuvants are crossed 80 mesh sieves respectively, the parts by weights another name is got, with 3% polyvinylpyrrolidone (75% alcoholic solution) system soft material, cross 30 mesh sieves and granulate, oven dry, cross 20-40 mesh sieve (preferred 30 mesh sieves) granulate, add with crospolyvinylpyrrolidone INF-10 and micropowder silica gel (absorption is used) finely dispersed vitamin K1 of absorption and micropowder silica gel (fluidizer), mix homogeneously carries out centre product check, tabletting promptly gets orally disintegrating tablet preparation.
In order to investigate the disintegrate effect of orally disintegrating tablet preparation of the present invention, we control the granularity after the disintegrate simultaneously to measuring disintegration.As the disintegrate medium, 37 ℃ of temperature adopt static method with 2ml water, the complete disintegrate of planted agent in 1 minute, and the granule after the disintegrate should pass through 30 purpose screen clothes (mesh size is less than 710 μ m).The result is as follows:
| The prescription of embodiment 3 | The result of embodiment 3 each prescription |
| Prescription 1 | Complete disintegrate in 10 seconds is all by 30 mesh sieves |
| Prescription 2 | Complete disintegrate in 7 seconds is all by 30 mesh sieves |
| Prescription 3 | Complete disintegrate in 9 seconds is all by 30 mesh sieves |
| Prescription 4 | Complete disintegrate in 8 seconds is all by 30 mesh sieves |
| Prescription 5 | Complete disintegrate in 8 seconds is all by 30 mesh sieves |
| Prescription 6 | Complete disintegrate in 11 seconds is all by 30 mesh sieves |
| Prescription 7 | Complete disintegrate in 9 seconds is all by 30 mesh sieves |
| Prescription 8 | Complete disintegrate in 7 seconds is all by 30 mesh sieves |
Result of the test shows that oral cavity disintegration tablet of the present invention is all disintegrates fully in 15 seconds, and the granularity after the disintegrate all can be by the screen cloth of aperture less than 710 μ m.When guaranteeing clinical use, it can quick disintegrate be the tiny granule of particle diameter that said preparation does not need moisture in mouth, and rapid delivery of pharmaceuticals is for the use of dysphagia patients brings great convenience.
Claims (18)
1. vitamin K 1 orally disintegrating tablets preparation that discharges at intraorally rapidly disintegrating wherein comprises the vitamin K1 and the pharmaceutically acceptable auxiliaries of effective dose, it is characterized in that, by weight, contains following component in the preparation:
Vitamin K1 1-10 part
Adsorbent 1-15 part
Filler 10-30 part
Disintegrating agent 1-10 part
Correctives 0-0.3 part
Binding agent 0-2 part
Lubricant or fluidizer 0-2 part;
Wherein, each tablet preparation contains vitamin K1 1-50mg;
Described adsorbent is the combination of crospolyvinylpyrrolidone INF-10 and micropowder silica gel;
Described disintegrating agent is selected from: the combination of crospolyvinylpyrrolidone XL, crospolyvinylpyrrolidone XL-10, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose or above multiple material;
Described filler is selected from: microcrystalline Cellulose, low-substituted hydroxypropyl methylcellulose, dextrin, lactose, precoking starch, sucrose, glucose, mannitol, sorbitol, starch, or the combination of above multiple material.
2. according to the described vitamin K 1 orally disintegrating tablets preparation of claim 1, it is characterized in that, by weight, contain following component in the preparation:
Correctives 0.01-0.3 part
Binding agent 0.1-2 part
Lubricant or fluidizer 0.2-2 part.
3. according to the described vitamin K 1 orally disintegrating tablets preparation of claim 2, it is characterized in that, by weight, contain following component in the preparation:
Vitamin K1 1-5 part
Adsorbent 2-10 part
Filler 15-25 part
Disintegrating agent 2-8 part
Correctives 0.02-0.2 part
Binding agent 0.5-1.5 part
Lubricant or fluidizer 0.5-1.5 part.
4. according to the described vitamin K 1 orally disintegrating tablets preparation of claim 1, it is characterized in that each tablet preparation contains vitamin K1 1-25mg.
5. according to the described vitamin K 1 orally disintegrating tablets preparation of claim 4, it is characterized in that each tablet preparation contains vitamin K1 1mg, 2mg, 5mg or 10mg.
6. according to the vitamin K 1 orally disintegrating tablets preparation of claim 1, wherein said filler is selected from: microcrystalline Cellulose, mannitol and low-substituted hydroxypropyl methylcellulose.
7. according to the vitamin K 1 orally disintegrating tablets preparation of claim 1, wherein said correctives is selected from: stevioside, aspartame, Oleum menthae, wintergreen oil, Oleum Caryophylli, Oleum Anisi Stellati, Fructus Citri Limoniae oil, citrus seed oil, menthol, citric acid, or the combination of above multiple material.
8. according to the vitamin K 1 orally disintegrating tablets preparation of claim 1, wherein said binding agent is selected from: arabic gum, gelatin, liquid glucose, maltose, polyvinylpyrrolidone, sodium carboxymethyl cellulose, carboxymethylcellulose calcium, pregelatinized Starch, tragacanth, acrylic resin, methylcellulose, ethyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, alginic acid, alginate, Pseudobulbus Bletillae (Rhizoma Bletillae) glue, colloid silicic acid magnalium, guar gum, or the combination of above multiple material.
9. according to the vitamin K 1 orally disintegrating tablets preparation of claim 8, wherein said binding agent is selected from: polyvinylpyrrolidone.
10. according to the vitamin K 1 orally disintegrating tablets preparation of claim 9, wherein said binding agent is selected from: polyvinylpyrrolidone K17, polyvinylpyrrolidone K25, polyvinylpyrrolidone K30, polyvinylpyrrolidone K90 and K90D.
11. vitamin K 1 orally disintegrating tablets preparation according to claim 1, wherein said lubricant or fluidizer are selected from: boric acid, lauryl sulfate magnesium, sodium benzoate, sodium acetate, leucine, Macrogol 4000, polyethylene glycol 6000, sodium lauryl sulfate, enuatrol, magnesium stearate, Stepanol MG, Pulvis Talci, or the combination of above multiple material.
12. a method for preparing each described vitamin K 1 orally disintegrating tablets preparation that discharges at intraorally rapidly disintegrating of claim 1-11,
Described method adopts compressing dry granulation, comprising: various adjuvants are sieved respectively, and the parts by weights another name is got the raw material of recipe quantity, vitamin K1 is uniformly dispersed with adsorbents adsorb,, carries out centre product check again with other adjuvant mix homogeneously, tabletting promptly gets oral cavity disintegration tablet; Perhaps,
Tabletting behind the described method employing wet granulation comprises: various adjuvants are sieved respectively, and the parts by weights another name is got the raw material of recipe quantity, vitamin K1 is uniformly dispersed with adsorbents adsorb, with other adjuvant mix homogeneously, add binding agent and make soft material again, sieve, granulate, oven dry, granulate adds lubricant or fluidizer, tabletting promptly gets orally disintegrating tablet preparation.
13., wherein when adopting compressing dry granulation, described adjuvant is crossed the 30-150 mesh sieve according to the method for claim 12.
14., wherein described adjuvant is crossed 100 mesh sieves according to the method for claim 13.
15., wherein after adopting wet granulation, described adjuvant is crossed the 30-150 mesh sieve during tabletting according to the method for claim 12.
16., wherein described adjuvant is crossed 100 mesh sieves according to the method for claim 15.
17. according to the method for claim 12, wherein ambient humidity is controlled at below 50% in the preparation.
18. according to the method for claim 12, wherein ambient humidity is controlled at below 45% in the preparation.
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| CN102284012B (en) * | 2011-08-09 | 2013-05-15 | 临沂大学 | Gel plaster containing curcumin and bletilla hyacinthina gum and preparation method thereof |
| CN102631336B (en) * | 2012-02-07 | 2013-09-18 | 海南卫康制药(潜山)有限公司 | Freeze-drying orally disintegrating tablet with vitamin K1 composition for infants and preparation method for freeze-drying orally disintegrating tablet |
| CN103191023B (en) * | 2013-03-22 | 2014-06-25 | 海南卫康制药(潜山)有限公司 | Low-temperature pressing method of rapidly disintegrating tablet |
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| CN1819819A (en) * | 2003-05-07 | 2006-08-16 | 阿克纳公司 | Highly plastic granules for making fast melting tablets |
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2007
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1819819A (en) * | 2003-05-07 | 2006-08-16 | 阿克纳公司 | Highly plastic granules for making fast melting tablets |
Non-Patent Citations (2)
| Title |
|---|
| 张兆旺等.中药药剂学 1.中国中医药出版社,2003,403-404. |
| 张兆旺等.中药药剂学 1.中国中医药出版社,2003,403-404. * |
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| CN101120928A (en) | 2008-02-13 |
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