CN103520084B - A kind of preparation method of film coating pre-mix dose - Google Patents
A kind of preparation method of film coating pre-mix dose Download PDFInfo
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- CN103520084B CN103520084B CN201310519179.7A CN201310519179A CN103520084B CN 103520084 B CN103520084 B CN 103520084B CN 201310519179 A CN201310519179 A CN 201310519179A CN 103520084 B CN103520084 B CN 103520084B
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Abstract
The invention discloses a kind of preparation method of film coating pre-mix dose, pre-mixing agent raw material mixes with alcoholic solution by (1); (2) adopt oscillating granulator by the raw material pelletize of (1) step process; (3) granule obtained through (2) step adopts vacuum freeze-drying method dry, can obtain film coating pre-mix dose.Advantage of the present invention is, existing method needs to establish 6 procedures, namely mixing, drying, premix, pulverize, sieve, always mix, consume 10-12 and can produce the 80-120 object film coating pre-mix dose with better solubility property man-hour, always do time as uneven color also needs to extend, color is finely tuned, and explained hereafter of the present invention, only need 3 procedures, namely mix, granulate, dry, consume 3-4 and can reach solubility property better film coating pre-mix dose man-hour, and after convection drying, color does not need to adjust.
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: mixing, drying, 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 when reaching 80-120 order, the time of pulverizing will increase, the time is extended to production again from this respect, whole operation is got off will at least 10-12 hour, the workman of the many needs of operation is just many, and it is long again to add the production cycle, is the main cause that production cost is high.
Summary of the invention
For the production stage solved when pre existing mixture will obtain better solubility property 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, achieve while the pre-mixing agent obtained has better solubility property, farthest simplify the object of preparation method, production cycle is shortened, thus further saves production cost, create 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 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, moisture in material is directly distilled by ice and reaches dry object, so add that ethanol makes to evaporate clean, the production time can be shortened to greatest extent; Raw material disclosed by the invention mixes with alcoholic solution to be learnt through practical operation, and at that time, the uniform state of mixing of materials is best;
(2) adopt oscillating granulator by the raw material pelletize of (1) step process; Obtain granular pre-mixing agent, for place mat is carried out in lower step work, next step directly application seasoning can obtain the good pre-mixing agent of solubility property, just do not need to have carried out again the pulverizings prolongation production time, while be also in order to can by the color mixture of pre-mixing agent in this step;
(3) granule obtained 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, but it is also good that 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, compare the limit, continue pulverizing again to go down, one is not easily increase the so long time again when producing, the bad control of powder so thin besides, be easy to dust from flying, cause waste, and this technique is not through high temperature, the diffusions such as dust are not had to run off, can ensure that colouring evenly, color need not be repaiied.
In step (1), the mass concentration of alcoholic solution is 50 ~ 70%, and during the alcoholic solution mixing of every 100kg raw material and this mass concentration, 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, ensure that material can be dissolved in alcoholic solution timely on the one hand, select this concentration can save the consumption of ethanol on the other hand, also save the time for lower step drying simultaneously.
Drum rotation speed in step (2) in oscillating granulator is 50 ~ 65r/min, and screen cloth is 24 mesh sieves, and the granularity obtaining granule is 24 ~ 30 orders.The rotating speed selected, in order to pre-mixing agent is better painted, obtain uniform granule of painting, be also can by the pelletize of (1) step raw material time, not easily produce raw material splash away, can very evenly, there is no the pelletize of waste, this granularity is the optimal granularity that will obtain, and this step obtains the granularity of 24 ~ 30 order numbers, is conducive to the work of next step drying, the too little meeting of granularity causes that material gap is little is unfavorable for drying, extends drying time; Granularity also can cause material particles internal moisture not easily dry too greatly, extends drying time and affect dissolubility to reduce.
Temperature dry in step (3) is-10 DEG C ~-50 DEG C, and pressure is 1.3 ~ 13 handkerchiefs, and pre-mixing agent can stop containing work dry during water amount≤8%.Adopt described low temperature, vacuum condition to carry out drying, under the condition of low-temperature high-vacuum, made by material the moisture in material directly be distilled by ice reach dry object, in the process of drying, 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 shorten the production cycle compared with the conventional method, to produce 100Kg raw material, traditional handicraft needs to establish 6 procedures, namely mixing, drying, premix, pulverize, sieve, always mix, consume 10-12 can to produce man-hour there is better solubility property 80-120 object film coating pre-mix dose, always do time as uneven color also needs to extend, finely tune color, yield rate is between 93% ~ 95%.And explained hereafter of the present invention, only need 3 procedures, namely mix, granulate, dry, consume 3-4 and can to reach the 120 order pre-mixing agent solubility property better film coating pre-mix dose produced 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 general existing high temperature is avoided to the phenomenon of material loss, the colouring reaching material after the first step all materials mix homogeneously again after vacuum freeze-drying drying is even, because by material under the condition of low-temperature high-vacuum, moisture in material is directly distilled by ice and reaches dry, be not subject in the process of drying
surface tensioneffect,
materialindeformable, the material of above lechery is non-volatile, so obtain standard compliant pre-mixing agent, just repaiies color without the need to carrying out again.
Detailed description of the invention
Be further illustrated content of the present invention below in conjunction with specific embodiment, as not having specified otherwise, then the condition of preparation process is carried out under being room temperature normal pressure.
Embodiment one: 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, be uniformly dispersed until material all dissolves, 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 the color lake of shades of colour, such as red color lake, yellow lake, white color lake, purple color lake, blue color lake etc.
(2) (2) adopt oscillating granulator by the raw material pelletize of (1) step process;
(3) granule obtained through (2) step adopts vacuum freeze-drying method dry, can obtain film coating pre-mix dose.
In step (1), the mass concentration of alcoholic solution is 50%, and during the alcoholic solution mixing of every 100kg raw material and this mass concentration, 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 obtaining granule is 24 ~ 30 orders.
Temperature dry in step (3) is-10 DEG C, and pressure is 1.3 handkerchiefs, and when pre-mixing agent Han Shui Liang≤8%, drying can stop.
Under the condition that pre-mixing agent raw material is identical, the pre-mixing agent obtained out through the inventive method and existing method does dissolubility test, the pre-mixing agent granularity that the present invention obtains is 30 orders, surface has loose structure, when dissolving dispersion, 20min and solubilized are disperseed completely, by 100 orders or 120 mesh sieves, loaded in spray gun to use, spray gun is not resulted in blockage completely, through the pre-mixing agent that traditional handicraft obtains, when being milled to 60-80 order, pre-mixing agent is that 43min just dissolves dispersion completely completely, when 80-120 order, within 25 minutes, reach and all dissolve dispersion, 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, namely mix, dry, premix, pulverize, sieve, total mixed, work and just can obtain finished product in 10-12 hour, yield rate is 93-95%.
Select in step (1) to obtain according to test during the amount of the mass concentration of ethanol and interpolation, how the work that the present embodiment only selects the explanation of part gradient test to select is carried out, under gradient test result 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%, the ethanol needed wants many, so comprehensive selection concentration is at 50%-70%, under this mass concentration, it is best selection that every 100kg needs the amount of alcoholic solution to be 30-50kg.
Embodiment two: 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, be uniformly dispersed until material all dissolves, pre-mixing agent raw material comprises filmogen, auxiliary agent, coloring agent;
(2) adopt oscillating granulator by the raw material pelletize of (1) step process;
(3) granule obtained through (2) step adopts vacuum freeze-drying method dry, can obtain film coating pre-mix dose.
In step (1), the mass concentration of alcoholic solution is 70%, and during the alcoholic solution mixing of every 100kg raw material and this mass concentration, 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 obtaining granule is 24 ~ 30 orders.
Temperature dry in step (3) is-50 DEG C, and pressure is 13 handkerchiefs, and when pre-mixing agent Han Shui Liang≤8%, drying can stop.
Under the condition that pre-mixing agent raw material is identical, the pre-mixing agent obtained out through the inventive method and existing method does dissolubility test, the pre-mixing agent granularity that the present invention obtains is 29 orders, surface has loose structure, when dissolving, 23min and solubilized are disperseed completely, by 100 orders or 120 mesh sieves, loaded in spray gun to use, spray gun is not resulted in blockage completely, through the pre-mixing agent that existing method obtains, when being milled to 60-80 order, pre-mixing agent is that 45min just dissolves dispersion completely, when 80-120 order, within 28 minutes, reach and all dissolve dispersion, 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, namely mix, dry, premix, pulverize, sieve, total mixed, work and just can obtain finished product in 10-12 hour, yield rate is 93-95%.
Pre-mixing agent the comparing on aberration that the pre-mixing agent that the inventive method obtains and existing method are prepared, 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, need carry out repairing color when value of chromatism is more than or equal to 3, namely again always mix, until when value of chromatism is less than 3, 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 carry out repairing color again, existing method then quality is unstable, also needs to adjust color.
Embodiment three: 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, be uniformly dispersed until material all dissolves, pre-mixing agent raw material comprises filmogen, auxiliary agent, coloring agent;
(2) adopt oscillating granulator by the raw material pelletize of (1) step process;
(3) granule obtained through (2) step adopts vacuum freeze-drying method dry, can obtain film coating pre-mix dose.
In step (1), the mass concentration of alcoholic solution is 60%, and during the alcoholic solution mixing of every 100kg raw material and this mass concentration, 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 obtaining granule is 24 ~ 30 orders.
Temperature dry in step (3) is-35 DEG C, and pressure is 6 handkerchiefs, and when pre-mixing agent Han Shui Liang≤8%, drying can stop.
Under the condition that pre-mixing agent raw material is identical, the pre-mixing agent obtained out through the inventive method and existing method does dissolubility test, the pre-mixing agent granularity that the present invention obtains is 28 orders, surface has loose structure, when dissolving dispersion, 22min and solubilized are disperseed completely, by 100 orders or 120 mesh sieves, loaded in spray gun to use, spray gun is not resulted in blockage completely, through the pre-mixing agent that traditional handicraft obtains, when being milled to 60-80 order, pre-mixing agent is that 46min just dissolves dispersion completely, when 120 order, within 26 minutes, reach and all dissolve dispersion, 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, namely 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 only embodies the optimal technical scheme of technical solution of the present invention, and those skilled in the art all embody principle of the present invention to some variations that wherein some part may be made, and belong within protection scope of the present invention.
Claims (1)
1. the preparation method of a film coating pre-mix dose, it is characterized in that, the method comprises the steps:, and pre-mixing agent raw material mixes with alcoholic solution by (1), stir 20 ~ 40min, until material all dissolves, is uniformly dispersed, pre-mixing agent raw material comprises filmogen, auxiliary agent, coloring agent; Wherein, the mass concentration of alcoholic solution is 50 ~ 70%, and during the alcoholic solution mixing of every 100kg raw material and this mass concentration, the quality of alcoholic solution is 30 ~ 50kg;
(2) adopt oscillating granulator by the raw material pelletize of (1) step process; Drum rotation speed in oscillating granulator is 50 ~ 65r/min, and screen cloth is 24 mesh sieves, and the granularity obtaining granule is 24 ~ 30 orders;
(3) granule obtained through (2) step adopts vacuum freeze-drying method dry, can obtain film coating pre-mix dose; Wherein, dry temperature is-10 DEG C ~-50 DEG C, and pressure is 1.3 ~ 13 handkerchiefs, and when pre-mixing agent water content≤8%, drying can stop.
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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 |
| 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 |
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