CN103520084A - Preparation method for thin film coated premix - Google Patents
Preparation method for thin film coated premix Download PDFInfo
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- CN103520084A CN103520084A CN201310519179.7A CN201310519179A CN103520084A CN 103520084 A CN103520084 A CN 103520084A CN 201310519179 A CN201310519179 A CN 201310519179A CN 103520084 A CN103520084 A CN 103520084A
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Abstract
The invention discloses a preparation method for a thin film coated premix. The preparation method comprises the following steps: (1) mixing raw materials for the premix with an ethanol solution; (2) subjecting the raw materials treated in the step (1) to granulation by using an oscillating granulator; and (3) drying a granule obtained in the step (2) by using a vacuum freeze-drying method so as to obtain the thin film coated premix. The invention has the following advantages: six procedures consisting of mixing, drying, premixing, crushing, sieving and total blending and 10 to 12 hours are needed by a conventional method for preparation of a thin film coated premix with a size of 80 to 120 meshes and good dissolving properties, time for total blending has to be prolonged to realize fine adjustment of a color if the color is nonuniform, but however, only three procedures consisting of mixing, granulation and drying and 3 to 4 hours are needed by the preparation method provided by the invention for preparation of the thin film coated premix with better dissolving properties, and the color of the thin film coated premix needs no adjustment after direct drying.
Description
Technical field
The invention belongs to the technical field of drug coating, specifically a kind of preparation method of film coating pre-mix dose.
Background technology
The processing technique of traditional film coating pre-mix dose generally comprises: mix, dry, premix, pulverize, sieve, the total step such as mixed, manufacturing procedure is various, life cycle of the product is long, quality controllability is poor, when product granularity generally will reach 80-120 order, solubility property is better, but while reaching 80-120 order, the time of pulverizing will increase, from this respect, to production, extended the time again, the whole operation at least 10-12 hour that gets off, the workman that operation needs more is just many, adds the production cycle long again, is the main cause that production cost is high.
Summary of the invention
Production stage in the time of will obtaining better solubility property for solving pre existing mixture is various, the above-mentioned defects such as the production cycle is long, the invention discloses a kind of preparation method of new film coating pre-mix dose, realized when the pre-mixing agent obtaining has better solubility property, farthest simplified the object of preparation method, production cycle is shortened, thereby further saved production cost, created profit maximization.
For achieving the above object, the technical solution adopted in the present invention is, the preparation method of a kind of new film coating pre-mix dose that the present invention designs, comprise the steps, (1) pre-mixing agent raw material is mixed with alcoholic solution, stir 20～40min, until material all dissolves, is uniformly dispersed, pre-mixing agent raw material comprises filmogen, auxiliary agent, coloring agent; It is in order to coordinate subsequent granulation, vacuum freeze-drying step that this step adds ethanol, pelletize needs solvent by raw material moistening, the inventive method be by material under the condition of low-temperature high-vacuum, make the moisture in material directly distil and reach dry object by ice, so add clean that ethanol makes to evaporate, the production time can be shortened to greatest extent; Raw material disclosed by the invention mixes through practical operation and learns with alcoholic solution, and under this time, the uniform state of mixing of materials is best;
(2) the raw material pelletize that adopts oscillating granulator that (1) step is processed; Obtain granular pre-mixing agent, for place mat is carried out in lower step work, next step directly application seasoning can obtain the pre-mixing agent that solubility property is good, just do not needed to have pulverized again the prolongation production time, the while is also for can be by the color mixture of pre-mixing agent in this step;
(3) granule obtaining through (2) step adopts vacuum freeze-drying method dry, can obtain film coating pre-mix dose.Dry through vacuum freeze-drying method, finally can obtain the pre-mixing agent that surface has loose structure, even this pre-mixing agent 24-30 order, it is also good that but solubility property produces 120 object pre-mixing agent solubility properties than existing method, dissolve, the time that is uniformly dispersed is faster, and the pre-mixing agent of existing 120 these granularities of order, it has been the comparison limit, continue again to pulverize, the one, when producing, be difficult for increasing again the so long time, the bad control of so thin powder besides, be easy to dust from flying, cause waste, and this technique is not passed through high temperature, do not have the diffusions such as dust to run off, can guarantee that colouring evenly, need not repair color.
In step (1), the mass concentration of alcoholic solution is 50～70%, and when the alcoholic solution of every 100kg raw material and this mass concentration mixes, the quality of alcoholic solution is 30～50kg, this is best by the mass concentration of the alcoholic solution of material dissolution and the amount that adds, guaranteed that material can be dissolved in alcoholic solution timely on the one hand, select on the other hand this concentration can save the consumption of ethanol, also for lower step is dry, saved the time simultaneously.
Drum rotation speed in step (2) in oscillating granulator is 50～65r/min, and screen cloth is 24 mesh sieves, and the granularity that obtains granule is 24～30 orders.The rotating speed of selecting, for pre-mixing agent is better painted, the uniform granule that obtains painting, is also can be by the pelletize of (1) step raw material time, is difficult for producing raw material and splashes away, can be very evenly, there is no a pelletize of wasting, the optimal granularity of this granularity for obtaining, this step obtains the granularity of 24～30 order numbers, is conducive to next step dry work, the too little meeting of granularity causes material gap little being unfavorable for to be dried, and extends drying time; It is dry that granularity too greatly also can cause material particles internal moisture to be difficult for, and extends drying time and affect dissolubility to reduce.
In step (3), dry temperature is-10 ℃～-50 ℃, and pressure is 1.3～13 handkerchiefs, and when pre-mixing agent contains water amount≤8%, dry work can stop.Adopt described low temperature, vacuum condition to be dried, material is made under the condition of low-temperature high-vacuum the moisture in material directly distilled and reach dry object by ice, in dry process, material is not subject to
surface tensioneffect,
materialindeformable, and just can obtain standard compliant film coating pre-mix dose after convection drying.
To sum up, the invention has the beneficial effects as follows, largely shortened the production cycle compared with the conventional method, take that to produce 100Kg raw material be example, traditional handicraft need to be established 6 procedures, mixes, be dried, premix, pulverizes, sieves, always mixes, consuming 10-12 can produce to have better solubility property 80-120 object film coating pre-mix dose man-hour, as even in irregular colour also need to extend always do time, color is finely tuned, yield rate is between 93%～95%.And explained hereafter of the present invention, only need 3 procedures, mix, granulate, be dried, consume 3-4 and can reach the better film coating pre-mix dose of 120 order pre-mixing agent solubility property of producing than existing method man-hour, and color does not need to adjust after convection drying, yield rate can reach more than 98%; The present invention adopts vacuum freeze-drying dry technology, first avoided the phenomenon of general existing high temperature to material loss, the colouring that has reached again material after all material mix homogeneously of the first step after vacuum freeze-drying is dry is even, be because by material under the condition of low-temperature high-vacuum, make the moisture in material directly distil and reach dry by ice, in dry process, be not subject to
surface tensioneffect,
materialindeformable, the material of above lechery is non-volatile, thus obtained standard compliant pre-mixing agent, just without repairing again color.
The specific embodiment
Below in conjunction with specific embodiment, content of the present invention is further illustrated, as there is no specified otherwise, the condition of preparation process is and carries out under room temperature normal pressure.
Embodiment mono-: the preparation method of a kind of film coating pre-mix dose that the present invention develops, comprise the steps, (1) pre-mixing agent raw material is mixed with alcoholic solution, stir 20～40min, until material all dissolves and is uniformly dispersed, pre-mixing agent raw material comprises filmogen, auxiliary agent, coloring agent; The filmogen that film coating pre-mix dose comprises generally has cellulose derivative, polyvinyl acetate etc., auxiliary agent is generally Pulvis Talci, triacetyl glycerine, polyvinyl alcohol etc., coloring agent is exactly versicolor color lake, such as red color lake, yellow lake, white color lake, purple color lake, blue color lake etc.
(2) (2) adopt the raw material pelletize that oscillating granulator is processed (1) step;
(3) granule obtaining through (2) step adopts vacuum freeze-drying method dry, can obtain film coating pre-mix dose.
The mass concentration of alcoholic solution is 50% in step (1), and the alcoholic solution of every 100kg raw material and this mass concentration is when mix, and the quality of alcoholic solution is 30kg.
Drum rotation speed in step (2) in oscillating granulator is 50～65r/min, and screen cloth is 24 mesh sieves, and the granularity that obtains granule is 24～30 orders.
In step (3), dry temperature is-10 ℃, and pressure is 1.3 handkerchiefs, dry can stopping when pre-mixing agent Han Shui Liang≤8%.
Under the identical condition of pre-mixing agent raw material, the pre-mixing agent making out through the inventive method and existing method is done dissolubility test, the pre-mixing agent granularity that the present invention obtains is 30 orders, surface has loose structure, when dissolving dispersion, 20min is that solubilized disperses completely, can pass through 100 orders or 120 mesh sieves, during general production, packed in spray gun to use, spray gun is not resulted in blockage completely, the pre-mixing agent obtaining through traditional handicraft, while being milled to 60-80 order, pre-mixing agent is that 43min just dissolves completely and disperses completely, when 80-120 order, within 25 minutes, reaching whole dissolvings disperses, this shows, the 80-120 object pre-mixing agent solubility property that pre-mixing agent solubility property of the present invention and existing method are made is better, invention obtains pre-mixing agent only needs 3 procedures, work can obtain finished product in 3-4 hour, yield rate can reach more than 98%, but existing method obtains 6 procedures, mix, dry, premix, pulverize, sieve, total mixed, work and just can obtain finished product in 10-12 hour, yield rate is 93-95%.
While selecting the mass concentration of ethanol and the amount of interpolation in step (1), according to test, obtain, how the work that the present embodiment only selects part gradient test explanation to select is carried out, under gradient result of the test shown in following table:
As can be seen from the table, when diluted concentration is 50%, 70%, 85%, the dry time is all fewer, but when concentration is 85%, it is many that the ethanol needing is wanted, so comprehensive selection concentration is at 50%-70%, under this mass concentration, it is that 30-50kg is best selection that every 100kg needs the amount of alcoholic solution.
Embodiment bis-: utilize the inventive method to prepare film coating pre-mix dose, preparation method comprises the steps, (1) pre-mixing agent raw material is mixed with alcoholic solution, stir 20～40min, until material all dissolves and is uniformly dispersed, pre-mixing agent raw material comprises filmogen, auxiliary agent, coloring agent;
(2) the raw material pelletize that adopts oscillating granulator that (1) step is processed;
(3) granule obtaining through (2) step adopts vacuum freeze-drying method dry, can obtain film coating pre-mix dose.
The mass concentration of alcoholic solution is 70% in step (1), and the alcoholic solution of every 100kg raw material and this mass concentration is when mix, and the quality of alcoholic solution is 50kg.
Drum rotation speed in step (2) in oscillating granulator is 50～65r/min, and screen cloth is 24 mesh sieves, and the granularity that obtains granule is 24～30 orders.
In step (3), dry temperature is-50 ℃, and pressure is 13 handkerchiefs, dry can stopping when pre-mixing agent Han Shui Liang≤8%.
Under the identical condition of pre-mixing agent raw material, the pre-mixing agent making out through the inventive method and existing method is done dissolubility test, the pre-mixing agent granularity that the present invention obtains is 29 orders, surface has loose structure, when dissolving, 23min is that solubilized disperses completely, can pass through 100 orders or 120 mesh sieves, during general production, packed in spray gun to use, spray gun is not resulted in blockage completely, the pre-mixing agent obtaining through existing method, while being milled to 60-80 order, pre-mixing agent is that 45min just completely dissolves and disperses, when 80-120 order, within 28 minutes, reaching whole dissolvings disperses, this shows, the 80-120 object pre-mixing agent solubility property that pre-mixing agent solubility property of the present invention is made than existing method is better, invention obtains pre-mixing agent only needs 3 procedures, work can obtain finished product in 3-4 hour, yield rate can reach 99%, but existing method obtains 6 procedures, mix, dry, premix, pulverize, sieve, total mixed, work and just can obtain finished product in 10-12 hour, yield rate is 93-95%.
The comparison of the pre-mixing agent that the pre-mixing agent that the inventive method makes and existing method are prepared on aberration, under the same terms, the aberration that duplication of production draws for 10 times the results are shown in following table:
The aberration of pre-mixing agent is evaluated like this, when being more than or equal to 3, value of chromatism need repair color, again always mixed, until value of chromatism is less than at 3 o'clock, it is qualified that side is considered as, and as can be seen from the above table, the produced pre-mixing agent of the present invention does not all need to repair color again, existing method quality is unstable, also needs color to adjust.
Embodiment tri-: the preparation method of a kind of film coating pre-mix dose that the present invention develops, comprise the steps, (1) pre-mixing agent raw material is mixed with alcoholic solution, stir 20～40min, until material all dissolves and is uniformly dispersed, pre-mixing agent raw material comprises filmogen, auxiliary agent, coloring agent;
(2) the raw material pelletize that adopts oscillating granulator that (1) step is processed;
(3) granule obtaining through (2) step adopts vacuum freeze-drying method dry, can obtain film coating pre-mix dose.
The mass concentration of alcoholic solution is 60% in step (1), and the alcoholic solution of every 100kg raw material and this mass concentration is when mix, and the quality of alcoholic solution is 45kg.
Drum rotation speed in step (2) in oscillating granulator is 50～65r/min, and screen cloth is 24 mesh sieves, and the granularity that obtains granule is 24～30 orders.
In step (3), dry temperature is-35 ℃, and pressure is 6 handkerchiefs, dry can stopping when pre-mixing agent Han Shui Liang≤8%.
Under the identical condition of pre-mixing agent raw material, the pre-mixing agent making out through the inventive method and existing method is done dissolubility test, the pre-mixing agent granularity that the present invention obtains is 28 orders, surface has loose structure, when dissolving dispersion, 22min is that solubilized disperses completely, can pass through 100 orders or 120 mesh sieves, during general production, packed in spray gun to use, spray gun is not resulted in blockage completely, the pre-mixing agent obtaining through traditional handicraft, while being milled to 60-80 order, pre-mixing agent is that 46min just completely dissolves and disperses, when 120 order, within 26 minutes, reaching whole dissolvings disperses, this shows, the 120 object pre-mixing agent solubility properties that pre-mixing agent solubility property of the present invention and existing method are made are slightly good, invention obtains pre-mixing agent only needs 3 procedures, work can obtain finished product in 3-4 hour, yield rate can reach more than 98%, but existing method obtains 6 procedures, mix, dry, premix, pulverize, sieve, total mixed, work and just can obtain finished product in 10-12 hour, yield rate is 93-95%.
Technique scheme has only embodied the optimal technical scheme of technical solution of the present invention, and those skilled in the art have all embodied principle of the present invention to some changes that wherein some part may be made, within belonging to protection scope of the present invention.
Claims (4)
1. the preparation method of a film coating pre-mix dose, it is characterized in that, the method comprises the steps, (1) pre-mixing agent raw material is mixed with alcoholic solution, stir 20～40min, until material all dissolves, is uniformly dispersed, pre-mixing agent raw material comprises filmogen, auxiliary agent, coloring agent;
(2) the raw material pelletize that adopts oscillating granulator that (1) step is processed;
(3) granule obtaining through (2) step adopts vacuum freeze-drying method dry, can obtain film coating pre-mix dose.
2. the preparation method of film coating pre-mix dose according to claim 1, it is characterized in that, the mass concentration of alcoholic solution is 50～70% in step (1), and the alcoholic solution of every 100kg raw material and this mass concentration is when mix, and the quality of alcoholic solution is 30～50kg.
3. the preparation method of film coating pre-mix dose according to claim 1, is characterized in that, the drum rotation speed in step (2) in oscillating granulator is 50～65r/min, and screen cloth is 24 mesh sieves, and the granularity that obtains granule is 24～30 orders.
4. the preparation method of film coating pre-mix dose according to claim 1, is characterized in that, in step (3), dry temperature is-10 ℃～-50 ℃, and pressure is 1.3～13 handkerchiefs, dry can stopping when pre-mixing agent Han Shui Liang≤8%.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104984348A (en) * | 2015-07-20 | 2015-10-21 | 上海浦力膜制剂辅料有限公司 | Film coating premixing agent and preparing method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101199854A (en) * | 2007-06-29 | 2008-06-18 | 天津爱勒易医药材料有限公司 | Stomach dissolved film coating pre-mix dose and preparing method thereof |
| CN101380475A (en) * | 2008-10-22 | 2009-03-11 | 北京英茂药业有限公司 | Preparation method of film coating pre-mixing agent and uses thereof |
| CN101467978A (en) * | 2007-12-29 | 2009-07-01 | 谭光明 | Complete-water stomach dissolved type moisture-proofing film coating premix |
| CN102988994A (en) * | 2013-01-06 | 2013-03-27 | 北京英茂药业有限公司 | Slow-release film-coated premixed agent and preparation method thereof |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101199854A (en) * | 2007-06-29 | 2008-06-18 | 天津爱勒易医药材料有限公司 | Stomach dissolved film coating pre-mix dose and preparing method thereof |
| CN101467978A (en) * | 2007-12-29 | 2009-07-01 | 谭光明 | Complete-water stomach dissolved type moisture-proofing film coating premix |
| CN101380475A (en) * | 2008-10-22 | 2009-03-11 | 北京英茂药业有限公司 | Preparation method of film coating pre-mixing agent and uses thereof |
| CN102988994A (en) * | 2013-01-06 | 2013-03-27 | 北京英茂药业有限公司 | Slow-release film-coated premixed agent and preparation method thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104984348A (en) * | 2015-07-20 | 2015-10-21 | 上海浦力膜制剂辅料有限公司 | Film coating premixing agent and preparing method thereof |
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