CN1689639A - Tannalbin rapid disintegration preparation and preparing method thereof - Google Patents
Tannalbin rapid disintegration preparation and preparing method thereof Download PDFInfo
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- CN1689639A CN1689639A CN 200410014797 CN200410014797A CN1689639A CN 1689639 A CN1689639 A CN 1689639A CN 200410014797 CN200410014797 CN 200410014797 CN 200410014797 A CN200410014797 A CN 200410014797A CN 1689639 A CN1689639 A CN 1689639A
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Abstract
The present invention relates to quickly disintegrated tannic protein preparation and its preparation process. The quickly disintegrated tannic protein preparation features the supplementary material including disintegrating agent, corrective, coloring agent, adhesive and lubricant; and the disintegrating agent being cellulose and its derivative. The oral preparation may be swallowed, held in mouth and taken after being dissolved in water, so that it is suitable also for children and patient with dysphagia. The oral preparation has the features of granule and powder, including determined curative effect.
Description
Technical field
The present invention relates to a kind of medicament and preparation method, specifically tannalbin fast disintegrating preparations and preparation method thereof people.
Background technology
Tannalbin (Aldumin tannate) does not decompose at gastric, decomposites tannic acid to small intestinal, makes protein coagulation, forms layer protecting film and abirritate, reduces the inflammation penetrant and slows down enterokinesia and play the astringing to arrest diarrhea effect.Tannalbin is used for the medicine of lienteric diarrhea treatment.
At present, the preparation of tannalbin has conventional tablet and granule, and the disintegration time of tannalbin ordinary tablet in water is longer, and granule is all poor than tablet at aspects such as production, packing, transportation and stability.If tablet disintegrate in vivo is slow excessively, then influence tannalbin in enteral decomposition, be unfavorable for that decomposition discharges tannic acid, thereby influence its curative effect.
Summary of the invention
The purpose of this invention is to provide that a kind of disintegrate fast becomes tiny microgranule, has granule concurrently, powder determined curative effect characteristics are tannalbin fast disintegrating preparations.
Another object of the present invention provides a kind of method for preparing the tannalbin fast disintegrating preparations.
Specific implementation of the present invention is as follows:
1, the tannalbin fast disintegrating preparations comprises tannalbin, it is characterized in that: also comprise pharmaceutic adjuvant, described pharmaceutic adjuvant comprises disintegrating agent, correctives, coloring agent, binding agent and lubricant;
Described preparation is to press column weight amount proportion raw material to make:
Tannalbin 55-88 part
Adjuvant 12-45 part;
Described disintegrating agent is cellulose family and derivant thereof;
Described correctives is sucrose, is cyclamate, is glucide, is saccharin sodium, is sodium glutamate, is sodium chloride, is citric acid, is glycerol, is sorbitol, is stevioside, is protein sugar, is Fructus Citri Limoniae, is Oleum menthae and various essence;
Described coloring agent is lemon yellow, is sunset yellow, is carmine, is amaranth;
Described binding agent is povidone solution, is starch slurry;
Described lubricant is magnesium stearate, is Pulvis Talci.
2, according to above-mentioned 1 described tannalbin fast disintegrating preparations, it is characterized in that: the disintegrating agent of described cellulose family and derivant thereof is pregelatinized Starch, is cross-linking sodium carboxymethyl cellulose, is polyvinylpolypyrrolidone, is starch, is carboxymethyl starch sodium, is low-substituted hydroxypropyl cellulose, is microcrystalline Cellulose, is sodium carboxymethyl cellulose.
3, according to above-mentioned 2 described tannalbin fast disintegrating preparations, it is characterized in that: the amount ranges of described pregelatinized Starch: 0～40%; The amount ranges of low-substituted hydroxypropyl cellulose: 0～25%; The amount ranges of microcrystalline Cellulose: 0～42%; The amount ranges of carboxymethylstach sodium: 0～10%.
4, the preparation method of tannalbin fast disintegrating preparations: it is characterized in that: behind tannalbin powder and disintegrating agent, correctives, coloring agent, binding agent and lubricant mixing, direct powder compression.
5, the preparation method of tannalbin fast disintegrating preparations: it is characterized in that: with tannalbin powder and disintegrating agent, correctives, coloring agent mixing, add an amount of wetting agent or binding agent and make soft material, the granulation of sieving after the drying, promptly gets granule.Get dried granule, add suitable lubricant after, tabletting.
6, the preparation method of tannalbin fast disintegrating preparations: it is characterized in that: with tannalbin powder and disintegrating agent, correctives, coloring agent mixing, add an amount of wetting agent or binding agent and make soft material, the granulation of sieving, add suitable lubricant after, the wet granular tabletting.The gained tablet gets rapid disintegration tablet through vacuum drying.
7, according to the preparation method of above-mentioned 5 or 6 described tannalbin fast disintegrating preparations: it is characterized in that: described wetting agent is a water, is alcoholic solution.
The present invention has the advantage of several respects:
1, the tablet of this dosage form can directly be swallowed or buccal in the oral cavity, also can put and take after melting in the water facing the time spent, all disintegrates fast in the oral cavity or in the water, both had the characteristics that tablet is easy to carry, physical stability is high, have the convenience that granule is easy to take again concurrently, the patient of being convenient to old man, child and dysphagia takes.
2, the tannalbin fast disintegrating preparations not only has the low characteristics of production efficiency height, cost of tablet, and since fast disintegrate become tiny microgranule, had the characteristics of granule, powder determined curative effect concurrently.
3, process of the present invention is simple, reliable, can guarantee the curative effect of medicament active ingredient; The pharmaceutic adjuvant cost is low, be easy to get.
The specific embodiment
Below by embodiment, the present invention is further described.
Embodiment 1
Get tannalbin 300g, pregelatinized Starch 30g, low-substituted hydroxypropyl cellulose 10g, sucrose 5g, Pulvis Talci 10g, essence is an amount of and 3% povidone solution is an amount of.
Be prepared into the method for disperseing sheet: get tannalbin 300g, add 30g pregelatinized Starch and 10g low-substituted hydroxypropyl cellulose, mixing, it is an amount of to add 3% povidone solution, makes soft material; Reuse 20 mesh sieve system granules.Wet granular is put 60 ℃ of aeration-dryings after 3 hours, add an amount of Pulvis Talci mixing, tabletting.Every contains tannalbin 0.3g
Disintegration time mensuration result: disintegrate fully in 1 minute.
Embodiment 2
It is an amount of to get tannalbin 300g, microcrystalline Cellulose 100g, carboxymethyl starch sodium 50g, magnesium stearate 2g, citric acid 1g, lemon yellow 0.1g and 3% povidone solution.
Preparation method: get tannalbin 300g, add 100g microcrystalline Cellulose and 50g carboxymethyl starch sodium, mixing adds 5% povidone solution an amount of (wherein containing citric acid 1g and lemon yellow 0.1g), makes soft material, and reuse 20 mesh sieves are made granule.Wet granular is put 60 ℃ of aeration-dryings after 3 hours, add an amount of magnesium stearate mixing, tabletting.Every contains tannalbin 0.3g
Disintegration time mensuration result: disintegrate fully in 1 minute.
Embodiment 3
Get tannalbin 300g, mannitol 40g, lactose 20g, polyvinylpolypyrrolidone 20g, sodium glutamate 0.2g, Pulvis Talci 3g, essence is an amount of and 1% povidone solution is an amount of.
Preparation method: get tannalbin 300g, add 40g mannitol and 20g lactose, mixing, it is an amount of to add 1% polyvidone (PVP) solution (wherein containing sodium glutamate), makes soft material, and reuse 20 mesh sieves are made granule.Wet granular is put 60 ℃ of aeration-dryings after 3 hours, add an amount of polyvinylpolypyrrolidone, essence and Pulvis Talci mixing, tabletting.Every contains tannalbin 0.3g
Intraoral disintegration time limit measurement result: be contained in the oral cavity disintegrate fully in 10～30 seconds.Delicate mouthfeel is fragrant and sweet.
Embodiment 4
Get tannalbin 300g, mannitol 50g, sucrose 15g, cross-linking sodium carboxymethyl cellulose 30g, amaranth 0.01g, magnesium stearate 3g, Oleum menthae is an amount of and 0.5% starch slurry solution.
Preparation method: get tannalbin 300g, add 50g mannitol and 15g sucrose, mixing, it is an amount of to add 0.5% starch slurry solution (wherein containing amaranth), makes soft material, and reuse 20 mesh sieves are made granule.Wet granular is put 60 ℃ of aeration-dryings after 3 hours, add an amount of cross-linked carboxymethyl cellulose sodium, Oleum menthae and magnesium stearate mixing, tabletting.Every contains tannalbin 0.3g
Intraoral disintegration time limit measurement result: be contained in the oral cavity disintegrate fully in 10～30 seconds.Delicate mouthfeel is fragrant and sweet.
Embodiment 5
It is an amount of to get tannalbin 300g, lactose 40g, stevioside 0.1g, polyvinylpolypyrrolidone 30g, sunset yellow 0.01g, Pulvis Talci 4g, 3% povidone solution 3g and Oleum menthae.
Preparation method: get above-mentioned each composition mixing, direct compression.Every contains tannalbin 0.3g
Intraoral disintegration time limit measurement result: be contained in the oral cavity disintegrate fully in 10～30 seconds.Cool taste is fragrant and sweet.
Embodiment 6
Get tannalbin 300g, starch 10g, sucrose 35g, cross-linking sodium carboxymethyl cellulose 40g, lemon yellow 0.01g, magnesium stearate 1g, Oleum menthae is an amount of and 1% povidone solution is an amount of.
Preparation method: get tannalbin 300g, add 10g starch and 35g lactose, mixing, it is an amount of to add 1% polyvidone PVP solution (containing lemon yellow and Oleum menthae), system soft material, 20 mesh sieve system granules.Add an amount of cross-linked carboxymethyl cellulose sodium and magnesium stearate mixing again, tabletting.The gained tablet gets rapid disintegration tablet through vacuum drying.Every contains tannalbin 0.3g
Intraoral disintegration time limit measurement result: be contained in the oral cavity disintegrate fully in 10～30 seconds.Delicate mouthfeel is fragrant and sweet.
Claims (7)
1, the tannalbin fast disintegrating preparations comprises tannalbin, it is characterized in that: also comprise pharmaceutic adjuvant, described pharmaceutic adjuvant comprises disintegrating agent, correctives, coloring agent, binding agent and lubricant;
Described preparation is to press column weight amount proportion raw material to make:
Tannalbin 55-88 part
Adjuvant 12-45 part;
Described disintegrating agent is cellulose family and derivant thereof;
Described correctives is sucrose, is cyclamate, is glucide, is saccharin sodium, is sodium glutamate, is sodium chloride, is citric acid, is glycerol, is sorbitol, is stevioside, is protein sugar, is Fructus Citri Limoniae, is Oleum menthae and various essence;
Described coloring agent is lemon yellow, is sunset yellow, is carmine, is amaranth;
Described binding agent is povidone solution, is starch slurry;
Described lubricant is magnesium stearate, is Pulvis Talci.
2, tannalbin fast disintegrating preparations according to claim 1 is characterized in that: the disintegrating agent of described cellulose family and derivant thereof is pregelatinized Starch, is cross-linking sodium carboxymethyl cellulose, is polyvinylpolypyrrolidone, is starch, is carboxymethyl starch sodium, is low-substituted hydroxypropyl cellulose, is microcrystalline Cellulose, is sodium carboxymethyl cellulose.
3, tannalbin fast disintegrating preparations according to claim 2 is characterized in that: the amount ranges of described pregelatinized Starch: 0～40%; The amount ranges of low-substituted hydroxypropyl cellulose: 0～25%; The amount ranges of microcrystalline Cellulose: 0～42%; The amount ranges of carboxymethylstach sodium: 0～10%.
4, the preparation method of tannalbin fast disintegrating preparations according to claim 1: it is characterized in that: behind tannalbin powder and disintegrating agent, correctives, coloring agent, binding agent and lubricant mixing, direct powder compression.
5, the preparation method of tannalbin fast disintegrating preparations according to claim 1: it is characterized in that: with tannalbin powder and disintegrating agent, correctives, coloring agent mixing, add an amount of wetting agent or binding agent and make soft material, the granulation of sieving after the drying, promptly gets granule.Get dried granule, add suitable lubricant after, tabletting.
6, the preparation method of tannalbin fast disintegrating preparations according to claim 1: it is characterized in that: with tannalbin powder and disintegrating agent, correctives, coloring agent mixing, add an amount of wetting agent or binding agent and make soft material, the granulation of sieving, add suitable lubricant after, the wet granular tabletting.The gained tablet gets rapid disintegration tablet through vacuum drying.
7, according to the preparation method of claim 5 or 6 described tannalbin fast disintegrating preparations: it is characterized in that: described wetting agent is a water, is alcoholic solution.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200410014797 CN1689639A (en) | 2004-04-27 | 2004-04-27 | Tannalbin rapid disintegration preparation and preparing method thereof |
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| CN 200410014797 CN1689639A (en) | 2004-04-27 | 2004-04-27 | Tannalbin rapid disintegration preparation and preparing method thereof |
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| CN1689639A true CN1689639A (en) | 2005-11-02 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103100079A (en) * | 2013-03-01 | 2013-05-15 | 申长乐 | Compound medicine for treating infantile diarrhea and preparation method of compound medicine |
| CN107281110A (en) * | 2017-07-20 | 2017-10-24 | 山东福美乐动物药业有限公司 | A kind of tannalbin soluble powder and preparation method |
| CN108159390A (en) * | 2016-12-07 | 2018-06-15 | 康芝药业股份有限公司 | A kind of powder containing tannalbin |
| CN108815514A (en) * | 2018-07-11 | 2018-11-16 | 浙江工业大学 | A kind of tannic acid hirudin tablet and preparation method thereof |
| CN114586892A (en) * | 2022-02-25 | 2022-06-07 | 潍坊加易加生物科技有限公司 | Preparation method of rapidly-dispersed tannate protein granules |
-
2004
- 2004-04-27 CN CN 200410014797 patent/CN1689639A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103100079A (en) * | 2013-03-01 | 2013-05-15 | 申长乐 | Compound medicine for treating infantile diarrhea and preparation method of compound medicine |
| CN108159390A (en) * | 2016-12-07 | 2018-06-15 | 康芝药业股份有限公司 | A kind of powder containing tannalbin |
| CN107281110A (en) * | 2017-07-20 | 2017-10-24 | 山东福美乐动物药业有限公司 | A kind of tannalbin soluble powder and preparation method |
| CN107281110B (en) * | 2017-07-20 | 2020-05-05 | 山东福美乐动物药业有限公司 | Tannic acid protein powder capable of being administrated by drinking water and preparation method thereof |
| CN108815514A (en) * | 2018-07-11 | 2018-11-16 | 浙江工业大学 | A kind of tannic acid hirudin tablet and preparation method thereof |
| CN114586892A (en) * | 2022-02-25 | 2022-06-07 | 潍坊加易加生物科技有限公司 | Preparation method of rapidly-dispersed tannate protein granules |
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