CN101683325A - Cydiodine buccal tablets and preparation method thereof - Google Patents
Cydiodine buccal tablets and preparation method thereof Download PDFInfo
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- CN101683325A CN101683325A CN200810223386A CN200810223386A CN101683325A CN 101683325 A CN101683325 A CN 101683325A CN 200810223386 A CN200810223386 A CN 200810223386A CN 200810223386 A CN200810223386 A CN 200810223386A CN 101683325 A CN101683325 A CN 101683325A
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- cydiodine
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- binding agent
- cyclodextrin
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Abstract
The invention relates to cydiodine buccal tablets and a preparation method thereof. The cydiodine buccal tablets comprise the following components in percentage by mass: 0.1 to 6 percent of cydiodine,0.5 to 5 percent of sildenafil, 0 to 2 percent of lubricant, and 84.4 to 98.5 percent of filler. The filler is one or combination of the following components: mannitol, lactose, xylitol, sorbitol, erythritol, fructose, isomalt, dextrin, microcrystalline cellulose, starch, pregelatinized starch, sodium chloride. The invention also proposes a method for preparing the buccal tablets, which comprisesthe following steps: preparing cydiodine and sildenafil; weighing the components according to proportioning rate, granulating and mixing the components; determining the content of every component inmixed medicaments and calculating the weight difference of products; and tabletting the mixed medicament. In the process of treating oral or other diseases, the cydiodine buccal tablets prepared by the method have the advantages of reducing the amount of sucrose taken in by patients and reducing harm to the patients.
Description
Technical field
The present invention relates to a kind of Cydiodine buccal tablet and preparation method thereof, belong to cydiodine goods field.
Background technology
Iodine is used the history in existing more than 100 year as disinfectant, and it all has or not optionally killing action to antibacterial, fungus, virus etc.Be made into the iodo-cydiodine of molecular state, this I by the inclusion technique of cyclodextrin
2Physics, the chemical property of clathrate relatively stable, do not have I yet
2Zest and stink, can be made into various preparations, extensive use and treatment oral cavity, laryngopharyngeal diseases.
China Poison ﹠ Medicine Inst. of Military Medicial Sciences Academy has applied for the patent (patent No.: ZL90106682.6) of " compound xidi iodine sucked tablet and preparation method thereof " August 16 nineteen ninety, use sucrose as filler in this patent in the prescription, make tablet have comparatively good mouldability, can well regulate mouthfeel again, extensive in clinical practice, determined curative effect.
Yet along with the raising day by day of living standard, the cases relevant with diet such as obesity, diabetes constantly rise, and make people pay attention to the safety of diet, medication more.For this reason, increased the intake of patient's sucrose as the xidi iodine sucked tablet of filler, and be not suitable for patients such as obesity, diabetes and take, brought potential harm to patient's body with sucrose.
Summary of the invention
Technical problem to be solved by this invention provides a kind of Sugarless type Cydiodine buccal tablet, in treatment oral cavity, laryngopharyngeal diseases, reduces the sucrose amount that the user takes in, and reduces the potential hazard that brings to the patient.
The technical scheme that the present invention solves the problems of the technologies described above is as follows: a kind of Cydiodine buccal tablet, its composition comprise cydiodine, west ground brain and lubricant, it is characterized in that: also comprise filler, according to the mass percent meter, the ratio of each component is:
Cydiodine: 0.1～6%
Ground, west brain: 0.5～5%
Lubricant: 0～2%
Filler: 84.4～98.5%
Wherein said filler is one or more the combination in the following ingredients:
Mannitol, lactose, xylitol, sorbitol, erythritol, fructose, hydroxyl isomaltulose, dextrin, microcrystalline Cellulose, starch, pre-paying starch, sodium chloride.
The invention has the beneficial effects as follows: employing mannitol etc. can reduce the sucrose amount that the user takes in as filler in treatment oral cavity, laryngopharyngeal diseases, reduce the potential hazard that brings to the patient.
On the basis of technique scheme, the present invention can also do following improvement.
Further, according to the mass percent meter, the component of described Cydiodine buccal tablet also comprises 0～3% correctives, and described correctives is one or more the combination in the following ingredients:
Sweetleaf centautin, aspartame, glucide, saccharin sodium, compound essence, citric acid, tartaric acid, fumaric acid, maleic acid, sorbic acid, Oleum menthae, Borneolum Syntheticum.
Further, according to the mass percent meter, the component of described Cydiodine buccal tablet also comprises 0～0.5% binding agent, and described binding agent is one or more the combination in the following ingredients:
Starch slurry, maltose, arabic gum, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose (HPMC), ethyl cellulose, polyvinylpyrrolidone.
Further, according to the mass percent meter, described cydiodine the ratio of each component is:
Iodine: 3～20%
Potassium iodide: 1.5～15%
Cyclodextrin: 65～95.5%
Further, according to the mass percent meter, ground, described west brain the ratio of each component is:
Mentholum: 3～30%
Cyclodextrin: 70～97%
Further, described cyclodextrin is one or more in the following ingredients:
Alpha-cyclodextrin, beta-schardinger dextrin-, gamma-cyclodextrin, cyclodextrin derivative.Cyclodextrin derivative wherein can be hydroxypropyl alpha-cyclodextrin, hydroxypropyl, hydroxypropyl gamma-cyclodextrin, methylol beta-schardinger dextrin-, dimethyl-, iodine butyl ether beta-schardinger dextrin-, maltose beta-schardinger dextrin-etc.
Further, described lubricant is one or more the combination in the following ingredients:
Stearic acid, magnesium stearate, calcium stearate, zinc stearate, refining hydrogenated vegetable oil, Macrogol 4000, polyethylene glycol 6000, Pulvis Talci, sodium lauryl sulphate, Stepanol MG, adipic acid, micropowder silica gel.
Adopt the beneficial effect of above-mentioned further scheme to be: each component in the buccal tablet can have multiple choices, has increased the source of raw material greatly, makes the preparation of buccal tablet also reduce cost of drugs more easily simultaneously.
The invention allows for a kind of method for preparing the described Cydiodine buccal tablet of claim 1, this method may further comprise the steps:
1) preparation cydiodine and ground, west brain;
2) take by weighing each component according to the described proportioning of claim 1, component is granulated and mixing;
3) measure each components contents in the mixed medicine and calculate the weight differential of product;
4) with mixed medicine tabletting.
Based on the above method, the present invention can also do following improvement.
Further, described cydiodine and ground, west brain adopt the cyclodextrin inclusion technique preparation, and described cyclodextrin inclusion technique can be saturated water solution method or polishing or freeze-drying.
Further, described component also comprises binding agent, described component is granulated and is mixed specifically may further comprise the steps:
A. with cydiodine and filler uniform mixing;
B. in the mixture of cydiodine and filler, add the solution of an amount of binding agent, make soft material;
C. described soft material is made granule, and with particle drying;
D. binding agent, lubricant and ground, west brain are mixed with described dried uniform particles.
Further, described component can also comprise correctives, in described steps d correctives, Xi Dinao, lubricant and binding agent is mixed with described dried uniform particles.
Further, the solution of described binding agent, its solvent are that mass percent concentration is 10～80% ethanol water.
Further, the solution of described binding agent is that mass percent concentration is 3% hydroxypropyl methylcellulose aqueous solution.
Further, particulate 10 orders～30 orders that are of a size of made of described soft material.
Further, the granule that described soft material is made carries out drying under 40～60 ℃ temperature.
Further, described component also comprises one or both in correctives, the binding agent, described component is granulated and mixes specifically be meant each component made granule, and uniform mixing.Described granular size can be 60 orders.
Adopt the beneficial effect of above-mentioned further scheme to be: for the Cydiodine buccal tablet of different component provides different preparation methoies, be that the preparation of medicine is faster, better effects if.
The specific embodiment
Below in conjunction with accompanying drawing principle of the present invention and feature are described, institute gives an actual example and only is used to explain the present invention, is not to be used to limit scope of the present invention.
Embodiment 1
Each component and the weight of Cydiodine buccal tablet are:
Cydiodine 8g, ground, west brain 18g, lactose 400g, magnesium stearate 4g, mass percent concentration are 3% HPMC (hydroxypropyl methylcellulose) aqueous solution.
Wherein, the component of cydiodine and weight are: iodine 6.97g, potassium iodide 5.06g, β～cyclodextrin 35g.The component and the weight of ground, west brain are: Mentholum 5.5g, beta-schardinger dextrin-55g.
The preparation method of Cydiodine buccal tablet:
1) preparation cydiodine and ground, west brain: described cydiodine and ground, west brain adopt the cyclodextrin inclusion technique preparation, and described cyclodextrin inclusion technique is a saturated water solution method.
2) press group component with cydiodine and lactose with equivalent incremental method mix homogeneously after, adding an amount of mass percent concentration is the 3%HPMC aqueous solution, makes soft material;
3) described soft material is made 14 purpose granules, and dry under 60 ℃ of temperature;
4) take by weighing west ground brain and magnesium stearate by group component, and with described dried granule mix homogeneously;
5) measure each components contents in the mixed medicine and calculate the weight differential of product;
6) use the circular flat oblique impact tabletting of Φ 11mm with mixed sample tabletting.
Embodiment 2
Each component and the weight of Cydiodine buccal tablet are:
Cydiodine 8g, mannitol 400g, ground, west brain 18g, aspartame 2g, magnesium stearate 4g, mass percent concentration are the 3%HPMC aqueous solution.
Wherein, the component of cydiodine and ground, west brain and weight are with embodiment 1.
The preparation method of Cydiodine buccal tablet:
1) the 1st step with embodiment 1 is identical;
2) press group component with cydiodine and mannitol with equivalent incremental method mix homogeneously after, adding an amount of mass percent concentration is the 3%HPMC aqueous solution, makes soft material;
3) the 3rd step with embodiment 1 is identical;
4) take by weighing Xi Dinao, aspartame and magnesium stearate by group component, and with described dried granule mix homogeneously;
5) following steps are identical with the 5th, 6 steps of embodiment 1.
Embodiment 3
Each component and the weight of Cydiodine buccal tablet are:
Cydiodine 8g, xylitol 80g, ground, west brain 18g, hydroxyl isomaltulose 320g, magnesium stearate 4g.
Wherein, the component of cydiodine and ground, west brain and weight are with embodiment 1.
The preparation method of Cydiodine buccal tablet:
1) the 1st step with embodiment 1 is identical;
2) taking by weighing each component according to quantity also screens with 60 mesh sieves;
The 60 purpose components that 3) will filter out equivalent incremental method mix homogeneously;
4) following steps are identical with the 5th, 6 steps of embodiment 1.
Embodiment 4
Each component and the weight of Cydiodine buccal tablet are:
Cydiodine 8g, mannitol 400g, aspartame 2g, ground, west brain 18g, magnesium stearate 4g.
Wherein, the component of cydiodine and ground, west brain and weight are with embodiment 1.
The preparation method of Cydiodine buccal tablet is identical with the preparation method of embodiment 3.
The stability of the Cydiodine buccal tablet of above embodiment under different affecting factors compares:
The Cydiodine buccal tablet of above embodiment is carried out simple and easy aluminium strip packing, under the varying environment condition, placed 10 days then, investigate the situation of change of its content of iodine.Described different environmental condition is respectively: ((illumination is 4500Lx ± 500Lx) to high humidity for 90%RH ± 5%RH), high temperature (60 ℃), high light.Experimental study result such as following table:
Result of the test shows Cydiodine buccal tablet of the present invention after placing 10 days under high temperature, high humidity, the high light condition, and content of iodine is all qualified, and is wherein best according to the Cydiodine buccal tablet effect of embodiment 2 preparations.
The Cydiodine buccal tablet of embodiment 2 preparations is reached accelerated stability test for a long time.
Experimental condition:
1) accelerated test: press commercially available back, it is that 40 ℃ ± 2 ℃, relative humidity are in the water isolation type constant incubator of 75% ± 5%RH that Cydiodine buccal tablet is placed on temperature, in sampling in the 1st, 2,3,6 month, carries out content of iodine and measures;
2) long term test: press commercially available back, it is to preserve under 25 ℃ ± 2 ℃, the condition of relative humidity 60% ± 10%RH that Cydiodine buccal tablet is placed on temperature.In sampling in the 0th, 3,6,9,12 month, carry out content of iodine and measure.Experimental study result such as following table:
Stability accelerated test result:
Above result of the test shows, Cydiodine buccal tablet of the present invention, and its stability is better, and content of iodine reduces slow.
The above only is preferred embodiment of the present invention, and is in order to restriction the present invention, within the spirit and principles in the present invention not all, any modification of being done, is equal to replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (16)
1. Cydiodine buccal tablet, its composition comprise cydiodine, west ground brain and lubricant, it is characterized in that: also comprise filler, according to the mass percent meter, the ratio of each component is:
Cydiodine: 0.1～6%
Ground, west brain: 0.5～5%
Lubricant: 0～2%
Filler: 84.4～98.5%
Wherein said filler is one or more the combination in the following ingredients:
Mannitol, lactose, xylitol, sorbitol, erythritol, fructose, hydroxyl isomaltulose, dextrin, microcrystalline Cellulose, starch, pre-paying starch, sodium chloride.
2. Cydiodine buccal tablet according to claim 1 is characterized in that: according to the mass percent meter, the component of described Cydiodine buccal tablet also comprises 0～3% correctives, and described correctives is one or more the combination in the following ingredients:
Sweetleaf centautin, aspartame, glucide, saccharin sodium, compound essence, citric acid, tartaric acid, fumaric acid, maleic acid, sorbic acid, Oleum menthae, Borneolum Syntheticum.
3. Cydiodine buccal tablet according to claim 1 and 2 is characterized in that: according to the mass percent meter, the component of described Cydiodine buccal tablet also comprises 0～0.5% binding agent, and described binding agent is one or more the combination in the following ingredients:
Starch slurry, maltose, arabic gum, methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, polyvinylpyrrolidone.
4. Cydiodine buccal tablet according to claim 1 is characterized in that: according to the mass percent meter, described cydiodine the ratio of each component is:
Iodine: 3～20%
Potassium iodide: 1.5～15%
Cyclodextrin: 65～95.5%.
5. Cydiodine buccal tablet according to claim 1 is characterized in that: according to the mass percent meter, ground, described west brain the ratio of each component is:
Mentholum: 3～30%
Cyclodextrin: 70～97%.
6. according to claim 4 or 5 described Cydiodine buccal tablets, it is characterized in that: described cyclodextrin is one or more in the following ingredients:
Alpha-cyclodextrin, beta-schardinger dextrin-, gamma-cyclodextrin, cyclodextrin derivative.
7. Cydiodine buccal tablet according to claim 1 is characterized in that: described lubricant is one or more the combination in the following ingredients:
Stearic acid, magnesium stearate, calcium stearate, zinc stearate, refining hydrogenated vegetable oil, Macrogol 4000, polyethylene glycol 6000, Pulvis Talci, sodium lauryl sulphate, Stepanol MG, adipic acid, micropowder silica gel.
8. method for preparing the described Cydiodine buccal tablet of claim 1, it is characterized in that: this method may further comprise the steps:
1) preparation cydiodine and ground, west brain;
2) take by weighing each component according to the described proportioning of claim 1, component is granulated and mixing;
3) measure each components contents in the mixed medicine and calculate the weight differential of product;
4) with mixed medicine tabletting.
9. the method for preparing Cydiodine buccal tablet according to claim 8 is characterized in that: described cydiodine and ground, west brain adopt the cyclodextrin inclusion technique preparation, and described cyclodextrin inclusion technique can be saturated water solution method or polishing or freeze-drying.
10. the method for preparing Cydiodine buccal tablet according to claim 8 is characterized in that: described component also comprises binding agent, described component is granulated and is mixed specifically may further comprise the steps:
A. with cydiodine and filler uniform mixing;
B. in the mixture of cydiodine and filler, add the solution of an amount of binding agent, make soft material;
C. described soft material is made granule, and with particle drying;
D. binding agent, lubricant and ground, west brain are mixed with described dried uniform particles.
11. the method for preparing Cydiodine buccal tablet according to claim 10 is characterized in that: described component can also comprise correctives, in described steps d correctives, Xi Dinao, lubricant and binding agent is mixed with described dried uniform particles.
12. according to claim 10 or the 11 described methods that prepare Cydiodine buccal tablet, it is characterized in that: the solution of described binding agent, its solvent are that mass percent concentration is 10～80% alcoholic acid aqueous solution.
13. according to claim 10 or the 11 described methods that prepare Cydiodine buccal tablet, it is characterized in that: the solution of described binding agent is that mass percent concentration is the aqueous solution of 3% hydroxypropyl methylcellulose.
14., it is characterized in that: particulate 10 orders～30 orders that are of a size of that described soft material is made according to claim 10 or the 11 described methods that prepare Cydiodine buccal tablet.
15. according to claim 10 or the 11 described methods that prepare Cydiodine buccal tablet, it is characterized in that: the granule that described soft material is made carries out drying under 40～60 ℃ temperature.
16. the method for preparing Cydiodine buccal tablet according to claim 8 is characterized in that: described component also comprises one or both in correctives, the binding agent, described component is granulated and mixes specifically be meant each component made granule, and uniform mixing.
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| Application Number | Priority Date | Filing Date | Title |
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| CN200810223386A CN101683325A (en) | 2008-09-28 | 2008-09-28 | Cydiodine buccal tablets and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103251002A (en) * | 2013-05-17 | 2013-08-21 | 邹桂怀 | Water shield buccal tablet and preparation method thereof |
| CN103385894A (en) * | 2013-07-29 | 2013-11-13 | 李春艳 | Buccal tablets prepared from ganoderma broken-down wall spore powder |
| CN104337786A (en) * | 2014-11-08 | 2015-02-11 | 山东新时代药业有限公司 | Cetyl pyridinium chloride buccal tablet |
| CN107517963A (en) * | 2017-08-31 | 2017-12-29 | 山东省农业科学院家禽研究所 | A kind of high stability BETA Cyclodextrin Inclusion Compound of Iodine powder and its preparation, application method |
-
2008
- 2008-09-28 CN CN200810223386A patent/CN101683325A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103251002A (en) * | 2013-05-17 | 2013-08-21 | 邹桂怀 | Water shield buccal tablet and preparation method thereof |
| CN103251002B (en) * | 2013-05-17 | 2014-06-04 | 邹桂怀 | Water shield buccal tablet and preparation method thereof |
| CN103385894A (en) * | 2013-07-29 | 2013-11-13 | 李春艳 | Buccal tablets prepared from ganoderma broken-down wall spore powder |
| CN104337786A (en) * | 2014-11-08 | 2015-02-11 | 山东新时代药业有限公司 | Cetyl pyridinium chloride buccal tablet |
| CN107517963A (en) * | 2017-08-31 | 2017-12-29 | 山东省农业科学院家禽研究所 | A kind of high stability BETA Cyclodextrin Inclusion Compound of Iodine powder and its preparation, application method |
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Open date: 20100331 |