CN102578564A - Preparation method for rapid-disintegrating directly-pressed particle mannitol preparation - Google Patents
Preparation method for rapid-disintegrating directly-pressed particle mannitol preparation Download PDFInfo
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- CN102578564A CN102578564A CN2011103406244A CN201110340624A CN102578564A CN 102578564 A CN102578564 A CN 102578564A CN 2011103406244 A CN2011103406244 A CN 2011103406244A CN 201110340624 A CN201110340624 A CN 201110340624A CN 102578564 A CN102578564 A CN 102578564A
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Abstract
The invention relates to a preparation method for a rapid-disintegrating directly-pressed granular mannitol preparation. The preparation method comprises the following steps of: 1) weighing the following raw materials in percent by weight according to a particle mannitol formula: 0.2-5.0 percent of adhesive and 8-2 percent of purified water, pouring the adhesive into the purified water and preparing adhesive slurry for future use; 2) putting crushed or uncrushed mannitol and 0.2-5.0 percent of disintegrating agent in a high-speed agitating and granulating machine, starting up the high-speed agitating and granulating machine, adding the slurry and preparing high-quality soft materials; 3) transferring the product wet granules into a fluidized drying machine for drying, screening the dried materials and completely tidying the granules; and 4) mixing the screened and tidied materials with lubricating agent, pressing the mixture into tablets and conducting hardness and disintegration tests. By adopting the preparation method, widely applicable directly-pressed granules with different content and fineness can be produced, have a rapid disintegrating characteristic and satisfy the American standard that the disintegrating time of sublingual tablets is less than or equal to 30 seconds. Moreover, the preparation method has the advantages of easiness in operation, low production cost, simple technology and high product quality.
Description
Technical field:
The present invention relates to the health food technology field, be specifically related to the preparation method that a kind of speed collapses vertical compression type mannite particle preparation.
Background technology:
Sweet mellow wine is a kind of hexitol, 166 ℃ of fusing points, relative density 1.52; These article of 1g dissolve in about 5.5ml water (25 ℃), are dissolved in hot water morely, heat absorption during because of dissolving; Pleasantly sweet; There are comfort sense and extremely low hygroscopicity in the oral cavity, thus more be widely used in hangover medicine, mouthful in the manufacturing of chewable tablets such as freshener, have been widely used in pharmacy and field of food.But domestic sweet mellow wine commonly used on the market is acicular crystal, and is mobile poor, often need use more lubricant and glidant to help the demoulding during compressing tablet, thereby influence the content and the taste of tablet, and the difficult directly compression of crystal structure, and dissolution velocity is also slow.
Existing mannite particle mainly is to be main technical method with the import, is sweet mellow wine or the sweet mellow wine that adds adhesive are heated to more than the fusing point, makes it be melt into liquid, and the cooling caking is pulverized or extruder grain obtains mannite particle then; This method heating-up temperature is high, is prone to make the material high-temperature discoloration, influences quality and use, and the melting time is difficult to hold; Specification requirement is high, and it is big to control difficulty, and qualification rate is low; Yield rate is low, and manufacturing cost is high, and price is also high.Also having the Nanning patent No. in addition is the method for CN200610019626.2: be in the sweet mellow wine that drops into blender, to add the water of 25%-35% or melt the water that binding agent is arranged to mix, and in the agglomerating back input rotary vacuum drier, the oven dry of high temperature high vacuum; Sub-sieve is pulverized in cooling then, and this method material shifts difficulty, merges oven dry again with the vast scale water yield; Consumed the energy more, made the siccative humidifying agglomerating, the oven dry hardening is pulverized again; Difficulty strengthens, and yield is not high, and yield rate is not high yet; Yield rate is also with regard to 50-60% according to one's introduction, and such end product quality that goes out is also unstable.
Summary of the invention:
The purpose of this invention is to provide the preparation method that a kind of speed collapses vertical compression type mannite particle preparation, can produce different content, fineness, the vertical compression particle of broad applicability is arranged; Have the speed that speed collapses characteristic and collapse vertical compression type mannite particle preparation; And easy operating control, low cost of manufacture, technology is simple; Good product quality, production efficiency is high.
The objective of the invention is to realize like this; A kind of speed collapses the preparation method of vertical compression type mannite particle preparation, may further comprise the steps: (1), take by weighing according to the mannite particle prescription: adhesive 0.2-5.0%, purified water 8-20%; Adhesive is poured in the purified water, and it is subsequent use to process the adhesive slurries; Described adhesive comprises one or more in starch, maltodextrin, carboxylic propyl methocel, the polyvinylpyrrolidone; (2), sweet mellow wine and 0.2-5.0% disintegrant that in High Speed Stirring Machine, drop into to pulverize or do not pulverize, open granulator, add slurries, process softwood; Disintegrant comprises Ac-Di-Sol, sodium carboxymethyl starch, one or more of PVPP; (3), the wet granular of processing transferred in the fluidized drying machine dry, the material sub-sieve that baking is good, the whole grain of chieftain, or overall whole grain; (4), the material of sieve after whole add mix lubricant, compressing tablet, carries out the test of hardness and disintegration.
The present invention can produce different content, fineness, and the vertical compression particle of broad applicability is arranged, and have the speed that speed collapses characteristic and collapse vertical compression type mannite particle preparation, and easy operating control, low cost of manufacture, technology is simple, good product quality, yield rate is high, and production efficiency is high.
The specific embodiment:
Below in conjunction with specific embodiment the present invention is further specified:
Embodiment 1:
Sweet mellow wine with pulverizing is done experiment:
Produce 99% mannite particle
Prescription:
Sweet mellow wine (crossing 80 order grinding screens) 1980g
PVPP 10g (in add)
Polyvinylpyrrolidone (K30) 10g (adding)
1,10g polyvinylpyrrolidone (K30) is dissolved in the 260g purified water, processes the adhesive slurries.
2, the high-speed stirred that sweet mellow wine and the 10g PVPP of 1980g being crossed 80 order Crushing net sheets drops into 4L is granulated in the pot, opens granulator, adds the polyvinylpyrrolidone slurries that prepare and granulates, and adopts the low mode that stirs high chopping during granulation.
3, discharging behind the granulation 240s changes fluid-bed drier over to and carries out drying, and temperature of charge is shut down discharging after drying 42 ℃, and with 20 purpose sieve sub-sieves, the gained top sieve carries out whole grain with the whole grain sieve of 20 purposes cage on Fastgranulatemachine, mix obtaining finished granule then mutually.
4, with the test of 100 mesh, 100 sieve 26%, bulk density now: 0.75g/ml.The gained material added 0.6% dolomol and mix total back moisture content that mixes: 0.42%, rush in capable compressing tablet test with ￠ 12mm circle, average sheet weighs: 0.71g, can press hardness: 125N, disintegration time: 50s, after hardness is reduced to 95N, disintegration time 28s.
Adopt different prescriptions and same operating process to carry out the test of other several kinds of content, the result is following:
Embodiment 2:
Sweet mellow wine with not pulverizing is done experiment:
99% mannite particle
Prescription:
Sweet mellow wine 1980g
PVPP 10g (in add)
Polyvinylpyrrolidone (K30) 10g (adding)
1,10g polyvinylpyrrolidone (K30) is dissolved in the 240g purified water, processes the adhesive slurries.
2, the high-speed stirred that the sweet mellow wine of 1980g and 10g PVPP is dropped into 4L is granulated in the pot, opens granulator, adds the polyvinylpyrrolidone slurries that prepare and granulates, and adopts the low mode that stirs high chopping during granulation.
3, discharging behind the granulation 240s changes fluid-bed drier over to and carries out drying, and temperature of charge is shut down discharging after drying 42 ℃, and with 20 purpose sieve sub-sieves, the gained top sieve carries out whole grain with the whole grain sieve of 20 purposes cage on Fastgranulatemachine, mix obtaining finished granule then mutually.
4, with the test of 100 mesh, 100 sieve 22%, bulk density now: 0.73g/ml.The dolomol of gained material adding 0.6% is mixed once more total back moisture that mixes: 0.40%, rush in capable compressing tablet with ￠ 12mm circle and test.Behind the compressing tablet, crack performance is arranged at the top during push jack depanning continuously, and scrutinizing the slice, thin piece side has cut, and drift has the sizing phenomenon, and material is emitted in the not event of powder of sweet mellow wine raw material when analyzing to granulation, increases dolomol to 1.1% and presses, does not have this phenomenon.The average sheet of pressing again is heavy: 0.72g, hardness: 108N, disintegration time: 26s.
Adopt different prescriptions and same operating process to carry out the test of other several kinds of content, the result is following:
Embodiment 3:
The crystal sweet mellow wine compressing tablet of directly not pulverizing with the front:
Prescription:
The few gloss of the sheet of being pressed, there is cut the side, sliver, this has also proved and singly need increase lubricant really with the sweet mellow wine crystal, thus again lubricant is added to 1.1%, but hardness presses not get on, and ￠ 12mm circle dashes, and on average sheet weighs: 0.724g, hardness: 24N.
In sum, can find out:
1, homemade sweet mellow wine directly is used for compressing tablet, the poor quality, and hardness is low.
2, the present invention has directly improved this situation, can hardness and content be accomplished good height, and can guarantee to reach the disintegration time limited of U.S.'s sublingual tablet, has widened the utilization field of sweet mellow wine.
3, use the sweet mellow wine of pulverizing can hardness be done more, the sweet mellow wine fusing point is higher, does not have and has melted sticking phenomenon, so convenient the pulverizing can also get thinner by powder.The sweet mellow wine of pulverizing can not cooked better yet, but need increase the ratio of lubricant during compressing tablet, can consider the raw material processing mode selectively according to product requirement.
The invention is not restricted to these disclosed embodiment; The present invention is with the described scope of soverlay technique scheme; And the various distortion of claim scope change with equivalence; Under the prerequisite that does not depart from technical solution of the present invention, any modification or improvement that those skilled in the art that the present invention did are realized easily all belong to the present invention's scope required for protection.
Claims (1)
1. preparation method that speed collapses vertical compression type mannite particle preparation is characterized in that: may further comprise the steps:
(1), take by weighing according to the mannite particle prescription: adhesive 0.2-5.0%, purified water 8-20% is poured adhesive in the purified water into, and it is subsequent use to process the adhesive slurries; Described adhesive comprises one or more in starch, maltodextrin, carboxylic propyl methocel, the polyvinylpyrrolidone;
(2), sweet mellow wine and 0.2-5.0% disintegrant that in High Speed Stirring Machine, drop into to pulverize or do not pulverize, open granulator, add slurries, process softwood; Disintegrant comprises Ac-Di-Sol, sodium carboxymethyl starch, one or more of PVPP;
(3), the wet granular of processing transferred in the fluidized drying machine dry, the material sub-sieve that baking is good, the whole grain of chieftain, or overall whole grain;
(4), the material of sieve after whole add mix lubricant, compressing tablet, carries out the test of hardness and disintegration.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2011103406244A CN102578564A (en) | 2011-11-01 | 2011-11-01 | Preparation method for rapid-disintegrating directly-pressed particle mannitol preparation |
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| CN2011103406244A CN102578564A (en) | 2011-11-01 | 2011-11-01 | Preparation method for rapid-disintegrating directly-pressed particle mannitol preparation |
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| CN102578564A true CN102578564A (en) | 2012-07-18 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103202817A (en) * | 2013-04-28 | 2013-07-17 | 山东天力药业有限公司 | Preparation method for mannitol grains capable of being directly pressed |
| CN107823144A (en) * | 2017-11-15 | 2018-03-23 | 山东天力药业有限公司 | A kind of preparation method of high-purity mannitol vertical compression particle |
| CN108056474A (en) * | 2018-01-22 | 2018-05-22 | 山东天力药业有限公司 | A kind of multidimensional effervescent tablet and preparation method thereof |
| CN117860688A (en) * | 2024-03-12 | 2024-04-12 | 山东天力药业有限公司 | Direct-compression mannitol particles and preparation method thereof |
| CN117860688B (en) * | 2024-03-12 | 2024-05-31 | 山东天力药业有限公司 | Direct-compression mannitol particles and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1310999A (en) * | 2000-02-29 | 2001-09-05 | 布里斯托尔-迈尔斯斯奎布公司 | Low dose Etikavi Prepn. and the use thereof |
| CN101637461A (en) * | 2008-07-28 | 2010-02-03 | 东莞太力生物工程有限公司 | Moguisteine dispersible tablet and preparation method thereof |
| WO2010020970A1 (en) * | 2008-08-22 | 2010-02-25 | Wockhardt Research Centre | Single unit oral dose pharmaceutical composition comprising levodopa, carbidopa and entacapone or salts thereof |
-
2011
- 2011-11-01 CN CN2011103406244A patent/CN102578564A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1310999A (en) * | 2000-02-29 | 2001-09-05 | 布里斯托尔-迈尔斯斯奎布公司 | Low dose Etikavi Prepn. and the use thereof |
| CN101637461A (en) * | 2008-07-28 | 2010-02-03 | 东莞太力生物工程有限公司 | Moguisteine dispersible tablet and preparation method thereof |
| WO2010020970A1 (en) * | 2008-08-22 | 2010-02-25 | Wockhardt Research Centre | Single unit oral dose pharmaceutical composition comprising levodopa, carbidopa and entacapone or salts thereof |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103202817A (en) * | 2013-04-28 | 2013-07-17 | 山东天力药业有限公司 | Preparation method for mannitol grains capable of being directly pressed |
| CN107823144A (en) * | 2017-11-15 | 2018-03-23 | 山东天力药业有限公司 | A kind of preparation method of high-purity mannitol vertical compression particle |
| CN108056474A (en) * | 2018-01-22 | 2018-05-22 | 山东天力药业有限公司 | A kind of multidimensional effervescent tablet and preparation method thereof |
| CN117860688A (en) * | 2024-03-12 | 2024-04-12 | 山东天力药业有限公司 | Direct-compression mannitol particles and preparation method thereof |
| CN117860688B (en) * | 2024-03-12 | 2024-05-31 | 山东天力药业有限公司 | Direct-compression mannitol particles and preparation method thereof |
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Application publication date: 20120718 |