CN103099789A - Preparation method of vitamin C granules - Google Patents

Preparation method of vitamin C granules Download PDF

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Publication number
CN103099789A
CN103099789A CN2013100555922A CN201310055592A CN103099789A CN 103099789 A CN103099789 A CN 103099789A CN 2013100555922 A CN2013100555922 A CN 2013100555922A CN 201310055592 A CN201310055592 A CN 201310055592A CN 103099789 A CN103099789 A CN 103099789A
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China
Prior art keywords
vitamin
granules
preparation
powder
quality
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Pending
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CN2013100555922A
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Chinese (zh)
Inventor
周晓冰
崔永涛
张红艳
许朴勤
陈志彬
孟静思
王淑华
张鑫鑫
滕紫维
周峰
马辉
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HEBEI WELCOME PHARMACEUTICAL CO Ltd
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HEBEI WELCOME PHARMACEUTICAL CO Ltd
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Priority to CN2013100555922A priority Critical patent/CN103099789A/en
Publication of CN103099789A publication Critical patent/CN103099789A/en
Pending legal-status Critical Current

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Abstract

The invention provides a preparation method of vitamin C granules. The method comprises: smashing a vitamin C crystal, then adding an adhesive to prepare them into a soft material, then preparing the soft material into wet granules by a rounding machine, and carrying out drying and sieving treatment, thus finally obtaining the vitamin C granules that can undergo direct tabletting. The preparation method provided in the invention has the advantages of simple steps and low cost, and the prepared vitamin C granules have good fluidity and compression molding performance.

Description

A kind of preparation method of vitamin C granules
Technical field
The invention belongs to the technology of pharmaceutical engineering field, specifically, relate to a kind of preparation method of the vitamin C granules for direct compression.
Background technology
Vitamin C granules is one of vitamin C deep processed product, can be used for direct compression, produces vitamin C tablet.The traditional preparation method of vitamin C granules comprises dry granulation and high shear stirring granulation.Wherein, dry granulation " ease dirt " is serious, easily causes environmental pollution; And high shear stirring granulation water consumption is many, easily ascorbic stability is produced harmful effect.For addressing the above problem, document " bed spray prepares vitamin C granules prescription screening and process optimization " (Zhou Shuyan, University Of Tianjin, master's thesis) a kind of method that bed spray prepares vitamin C granules is disclosed, the method is as follows: the vitamin C raw material is placed in fluidised bed granulator, pass into compressed air, make the vitamin C raw material be in fluidized state; Then pass into steam, after 5-8 minute, open spray pump, whitewash, whitewash lower the temperature after complete, discharging, obtain vitamin C granules; The slurry that adopts of wherein whitewashing comprises hydroxypropyl emthylcellulose, pregelatinized Starch, hydroxypropyl cellulose and water.
Although said method has overcome dust pollution in the vitamin C granules preparation process, has improved the stability of raw material, the part yet it still comes with some shortcomings: the method gained vitamin C granules tap density lower (being about 0.62g/mL) causes the tablet hardness (being about 6kg) on the low side by the preparation of this kind vitamin C granules; In addition, the method need to be purchased special-purpose production equipment---fluidised bed granulator, causes its production cost higher, is unfavorable for applying.
Summary of the invention
The preparation method that the purpose of this invention is to provide a kind of step vitamin C granules simple, with low cost, the prepared vitamin C granules of the method has good mobility and compact property.
For realizing the object of the invention, the invention provides the preparation method of following vitamin C granules: comprise the following steps:
A, the vitamin C crystal is pulverized, crossed 80,90 or 100 mesh sieves, collect siftage, obtain the vitamin C powder; When sieving, preferably select 100 mesh sieves;
B, take two parts of binding agents respectively, add first part of binding agent in the vitamin C powder, its quality is the 1.5-3.0% of vitamin C powder quality, and mix homogeneously is placed in wet granulator, add the mixing slurry by second part of binding agent, solvent composition, this mass concentration of mixing second part of binding agent in slurry is 4-10%, and described solvent is the mixed liquor of any one or two kinds in water, ethanol, and the quality of described mixing slurry is the 10-20% of vitamin C powder quality, stir 3-5min, obtain soft material;
C, soft material is placed in spheronizator is prepared into wet granular, dry, cross 20 mesh sieves, collect siftage, obtain described vitamin C granules; Described spheronizator, its rotating speed are 1500-2800 r/min, and preparation time is 30-600s.
Above-mentioned binding agent can be selected in starch, cellulose, cellulose derivative, polyvinylpyrrolidone any one, preferred cellulose or cellulose derivative.
The described spheronizator of above-mentioned c step, the preferred 1900-2300 r/min of its rotating speed, the preferred 60-180s of preparation time.The vitamin C granules for preparing under these process conditions, its good fluidity, tap density are high.
The preparation method of vitamin C granules provided by the invention has effectively utilized present common equipment and raw material, has obtained outstanding effect.The method preparation process water consumption is few, is conducive to keep ascorbic stable.Prepared vitamin C granules, epigranular, mobility, good dispersion, angle of repose≤40 °, and have higher tap density (greater than 0.900g/mL) and good compact property; By the tablet of this kind vitamin C granules compacting, hardness is greater than 70N, and friability is less than 0.5%.
The specific embodiment
The below further illustrates content of the present invention with specific embodiment, but and means never in any form and limit the invention.In the following example, method therefor is conventional method if no special instructions.
Embodiment 1
Preparation can be used for the vitamin C granules of direct compression:
A, the vitamin C crystal is pulverized, crossed 80 mesh sieves, collect siftage, obtain the vitamin C powder;
B, take two parts of starch respectively, add first part of starch in the vitamin C powder, its quality is 1.5% of vitamin C powder quality, mix homogeneously is placed in wet granulator, adds the mixing slurry that is comprised of second part of starch, water, in this mixing slurry, the mass concentration of second part of starch is 4%, the quality of described mixing slurry is 10% of vitamin C powder quality, stirs 3min, obtains soft material;
C, soft material is placed in spheronizator is prepared into wet granular, dry, cross 20 mesh sieves, collect siftage, obtain described vitamin C granules; Described spheronizator, its rotating speed are 1500-1900 r/min, and preparation time is 30-60s.
Measure angle of repose, the tap density of said vitamin C granule, result is respectively 39 ° of angle of reposes, tap density 0.9g/mL.Result shows, the vitamin C granules of the present embodiment preparation, and epigranular, good fluidity, and have higher tap density.
Embodiment 2
Preparation can be used for the vitamin C granules of direct compression:
A, the vitamin C crystal is pulverized, crossed 90 mesh sieves, collect siftage, obtain the vitamin C powder;
B, take two parts of polyvinylpyrrolidones respectively, add first part of polyvinylpyrrolidone in the vitamin C powder, its quality is 3.0% of vitamin C powder quality, mix homogeneously is placed in wet granulator, adds the mixing slurry that is comprised of second part of polyvinylpyrrolidone, ethanol, this mass concentration of mixing second part of polyvinylpyrrolidone in slurry is 10%, the quality of described mixing slurry is 20% of vitamin C powder quality, stirs 5min, obtains soft material;
C, soft material is placed in spheronizator is prepared into wet granular, dry, cross 20 mesh sieves, collect siftage, obtain described vitamin C granules; Described spheronizator, its rotating speed are 2300-2800 r/min, and preparation time is 180-600s.
Measure angle of repose, the tap density of said vitamin C granule, result is respectively 38 ° of angle of reposes, tap density 0.95g/mL.Result shows, the vitamin C granules of the present embodiment preparation, and epigranular, good fluidity, and have higher tap density.
Embodiment 3
Preparation can be used for the vitamin C granules of direct compression:
A, the vitamin C crystal is pulverized, crossed 100 mesh sieves, collect siftage, obtain the vitamin C powder;
B, take two parts of celluloses respectively, add first part of cellulose in the vitamin C powder, its quality is 2.0% of vitamin C powder quality, and mix homogeneously is placed in wet granulator, add the mixing slurry by second part of cellulose, solvent composition, this mixes, and in slurry, second part of cellulosic mass concentration is 8%, and described solvent is the mixed liquor of water, ethanol volume ratio 1:1, and the quality of described mixing slurry is 15% of vitamin C powder quality, stir 4min, obtain soft material;
C, soft material is placed in spheronizator is prepared into wet granular, dry, cross 20 mesh sieves, collect siftage, obtain described vitamin C granules; Described spheronizator, its rotating speed are 1900-2300 r/min, and preparation time is 60-180s.
Measure angle of repose, the tap density of said vitamin C granule, result is respectively 38 ° of angle of reposes, tap density 1.02g/mL.Result shows, the vitamin C granules of the present embodiment preparation, and epigranular, good fluidity, and have higher tap density.
Embodiment 4
The preparation vitamin C tablet:
Get the vitamin C granules 500g of embodiment 3 preparations, add magnesium stearate 5g, direct compression after mix homogeneously obtains 1010 of vitamin C tablets.The hardness of measuring this vitamin C tablet is 90N, and friability is 0.48%, and weight differential is 3.0%.This result shows, the vitamin C granules of method preparation of the present invention, and epigranular, good fluidity, and have good compact property, can be used for direct compression process and prepare vitamin C granules.

Claims (3)

1. the preparation method of a vitamin C granules is characterized in that comprising the following steps:
A, the vitamin C crystal is pulverized, crossed 80,90 or 100 mesh sieves, collect siftage, obtain the vitamin C powder;
B, take two parts of binding agents respectively, add first part of binding agent in the vitamin C powder, its quality is the 1.5-3.0% of vitamin C powder quality, and mix homogeneously is placed in wet granulator, add the mixing slurry by second part of binding agent, solvent composition, this mass concentration of mixing second part of binding agent in slurry is 4-10%, and described solvent is the mixed liquor of any one or two kinds in water, ethanol, and the quality of described mixing slurry is the 10-20% of vitamin C powder quality, stir 3-5min, obtain soft material;
C, soft material is placed in spheronizator is prepared into wet granular, dry, cross 20 mesh sieves, collect siftage, obtain described vitamin C granules; Described spheronizator, its rotating speed are 1500-2800 r/min, and preparation time is 30-600s.
2. the preparation method of described vitamin C granules according to claim 1 and 2 is characterized in that: described binding agent be in starch, cellulose, cellulose derivative, polyvinylpyrrolidone any one.
3. the preparation method of described vitamin C granules according to claim 1 and 2, it is characterized in that: the described spheronizator of c step, its rotating speed are 1900-2300 r/min, preparation time is 60-180s.
CN2013100555922A 2013-02-21 2013-02-21 Preparation method of vitamin C granules Pending CN103099789A (en)

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105497221A (en) * 2014-10-11 2016-04-20 山东淄博新达制药有限公司 Preparation method of infantile antitussive granules
CN106983734A (en) * 2017-06-01 2017-07-28 海南妙音春制药有限公司 A kind of ibuprofen sustained release capsules and preparation method thereof
CN107184565A (en) * 2017-06-01 2017-09-22 海南妙音春制药有限公司 A kind of preparation method of ibuprofen sustained release capsules
CN108186582A (en) * 2018-03-23 2018-06-22 海南金贝康制药有限公司 A kind of preparation method of iron Victoria C particle
CN112741303A (en) * 2019-10-29 2021-05-04 湖南补天药业股份有限公司 Poria cocos vitamin C granules and preparation method thereof
CN112826800A (en) * 2021-03-30 2021-05-25 浙江新维士生物科技有限公司 Vitamin C particle composition and preparation method thereof
CN112930166A (en) * 2018-11-05 2021-06-08 重庆小丸生物科技股份有限公司 Water-soluble active substance particle and preparation method and application thereof

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JP2009161495A (en) * 2008-01-09 2009-07-23 Everest Pharm Industrial Co Ltd Kind of quickly disintegrable oral tablet containing slow-dissolving microparticle ascorbic acid
CN102908319A (en) * 2012-11-09 2013-02-06 东北制药(沈阳)科技发展有限公司 Vitamin C sustained-release pellets and method for preparing same

Patent Citations (2)

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Publication number Priority date Publication date Assignee Title
JP2009161495A (en) * 2008-01-09 2009-07-23 Everest Pharm Industrial Co Ltd Kind of quickly disintegrable oral tablet containing slow-dissolving microparticle ascorbic acid
CN102908319A (en) * 2012-11-09 2013-02-06 东北制药(沈阳)科技发展有限公司 Vitamin C sustained-release pellets and method for preparing same

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Title
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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105497221A (en) * 2014-10-11 2016-04-20 山东淄博新达制药有限公司 Preparation method of infantile antitussive granules
CN106983734A (en) * 2017-06-01 2017-07-28 海南妙音春制药有限公司 A kind of ibuprofen sustained release capsules and preparation method thereof
CN107184565A (en) * 2017-06-01 2017-09-22 海南妙音春制药有限公司 A kind of preparation method of ibuprofen sustained release capsules
CN107184565B (en) * 2017-06-01 2018-04-03 海南妙音春制药有限公司 A kind of preparation method of ibuprofen sustained release capsules
CN106983734B (en) * 2017-06-01 2018-09-14 海南妙音春制药有限公司 A kind of ibuprofen sustained release capsules and preparation method thereof
CN108186582A (en) * 2018-03-23 2018-06-22 海南金贝康制药有限公司 A kind of preparation method of iron Victoria C particle
CN112930166A (en) * 2018-11-05 2021-06-08 重庆小丸生物科技股份有限公司 Water-soluble active substance particle and preparation method and application thereof
CN112741303A (en) * 2019-10-29 2021-05-04 湖南补天药业股份有限公司 Poria cocos vitamin C granules and preparation method thereof
CN112826800A (en) * 2021-03-30 2021-05-25 浙江新维士生物科技有限公司 Vitamin C particle composition and preparation method thereof

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Application publication date: 20130515