CN104984348A - Film coating premixing agent and preparing method thereof - Google Patents
Film coating premixing agent and preparing method thereof Download PDFInfo
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Abstract
The invention relates to a film coating premixing agent. The appearance of the premixing agent is in a particle type, the particle size ranges from 20 meshes to 80 meshes, the repose angle of finished products is smaller than 30 degrees, and the dust fluffy visual inspection value is larger than 3. The premixing agent can be used for producing film coatings after being added into solvents to be stirred for 30 s to 180 s. The premixing agent is prepared with prilling methods such as the fluidization prilling method, the spray drying prilling method, the centrifugal prilling method and the side-spraying prilling method, the appearance and the dispersion characteristic of the film coating premixing agent are changed in a physical mode, and the solvents used for preparing are water. According to the premixing agent, the water serves as a solvent agent system in the preparing process, the premixing agent is green and environmentally friendly, and energy is saved; by means of the premixing agent, the labor productivity can be greatly improved, and the production cost can be reduced; the monochromatic-system premixing agent can be prepared, customers can conveniently obtain favorable colors through mixing in use and do not need to purchase multiple agents in various colors, and therefore the purchase cost, the storage cost and the test cost are reduced.
Description
Technical field
The technical field of drug coating of the present invention, specifically a kind of film coating pre-mix dose and preparation method thereof.
Background technology
Traditional film coating pre-mix dose be more than 60 orders even part be the powder of more than 1000 orders, mobility extreme difference, in use, comprises and weighs and with slurryly all can produce very large dust:
1), pollute production environment, enormous pressure is caused to the cleaning system of pharmaceutical production;
2), one of maximum risk of pharmaceutical production is very easily produced: pollute and cross-contamination;
3), operator must take safeguard procedures, prevent from, in the dust suction body that flies upward in a large number, threatening greatly the healthy generation of operator;
In use, the time of needs with slurry more than at least 45 minutes, the man-hour of coating production at least 1/3 is occupied.
Traditional film coating pre-mix dose is produced as personalized customization, and each pre-mixing agent is produced and terminated to clear out a gathering place, clear out a gathering place at every turn all can account for more than 1/3 the order deadline, the production cycle is long.
The production of traditional film coating pre-mix dose all by: mixing, pulverize, screening, total mode such as mixed produce, complex procedures, length consuming time; And can not all complete in Sealing Arrangement, during production, dust pollution is serious.
Summary of the invention
The object of the invention is to overcome the deficiency existed in above-mentioned existing film coating pre-mix dose and production process thereof, a kind of new film coating pre-mix dose and preparation method thereof is provided.Film coating pre-mix dose of the present invention is wanted to accomplish that preparation is easy, quick, the pre-mixing agent dissolution homogeneity after preparation, stable; Shorten and prepare consuming time, raising more than 30% production efficiency; Can dust pollution be reduced, avoid cross-contamination, reduce the configuration requirement to production environment, the coating pre-mixing agent of patent of the present invention requires that preparation method is efficient, science, simplifies production process, shortens the production cycle, save the production cost of pre-mixing agent, improve the quality of pre-mixing agent.
In order to reach foregoing invention object, the technical scheme of this pre-mixing agent of preparation that patent of the present invention provides is as follows:
A kind of film coating pre-mix dose, is characterized in that:
This pre-mixing agent is granular pattern outward appearance, and particle diameter is 20 order ~ 80 orders, finished product ﹤ angle of repose 30 degree, and dust from flying visual value is greater than 3; This pre-mixing agent adds stirring in solvent and namely can be used for film coating production in 30 ~ 180 seconds; Corpuscular pre-mixing agent is prepared by the method for fluidized granulation, changes outward appearance and the dispersing characteristic of film coating pre-mix dose for physically, and the solvent that preparation uses is water.
A preparation method for above-mentioned film coating pre-mix dose, is characterized in that, this preparation method includes following steps:
The first step, be pulverized and mixed by all the components pulverizer in prescription, the powder after pulverizing is all by 100 object sieve apertures, and color even after mixing;
Second step, to be fed in 0.5-5 times of water by the 20%-80% of first step gained powder gross weight and to be uniformly dispersed, the ratio of powder and water by weight, then uses homogenizing in high pressure homogenizer or ball mill to become particle diameter at the suspension of 20-1000nm;
3rd step, the powder of remaining for second step 20%-80% weight is placed in fluid bed, temperature of charge 40 DEG C is set, the suspension obtained by second step sprays in fluid bed with the speed of 10-100kg/h and granulates, and granulates to granular size at 20-80 order, pellet moisture≤8%.
A kind of film coating pre-mix dose, it is characterized in that, this pre-mixing agent is granular pattern outward appearance, and particle diameter is 20 order ~ 80 orders, finished product ﹤ angle of repose 30 degree, and dust from flying visual value is greater than 3; This pre-mixing agent adds stirring in solvent and namely can be used for film coating production in 30 ~ 180 seconds; Corpuscular pre-mixing agent is prepared by the method for spray-drying process, changes outward appearance and the dispersing characteristic of film coating pre-mix dose for physically, and the solvent that preparation uses is water.
A preparation method for above-mentioned film coating pre-mix dose, is characterized in that, this preparation method includes following steps:
The first step, be pulverized and mixed by all the components pulverizer in prescription, the powder after pulverizing is all by 100 object sieve apertures, and color even after mixing;
Second step, whole for first step gained powder is all fed in 0.5-5 times of water is uniformly dispersed, the ratio of powder and water by weight, then use homogenizing in high pressure homogenizer or ball mill to become particle diameter at the suspension of 20-1000nm, the pressure of high pressure homogenizer is not less than 0.7MPa;
3rd step, to be sprayed into the speed of 10-100kg/h by the suspension of second step gained, granulate, coutroi velocity is to ensure that the granular size after having granulated is at 20-80 order, pellet moisture≤8%.
A kind of film coating pre-mix dose, is characterized in that:
This pre-mixing agent is granular pattern outward appearance, and particle diameter is 20 order ~ 80 orders, finished product ﹤ angle of repose 30 degree, and dust from flying visual value is greater than 3; This pre-mixing agent adds stirring in solvent and namely can be used for film coating production in 30 ~ 180 seconds; Corpuscular pre-mixing agent is prepared by the method for centrifugal granulating or side spray pelletize, changes outward appearance and the dispersing characteristic of film coating pre-mix dose for physically, and the solvent that preparation uses is water.
A preparation method for above-mentioned film coating pre-mix dose, is characterized in that, this preparation method includes following steps:
The first step, be pulverized and mixed by all the components pulverizer in prescription, the powder after pulverizing is all by 100 object sieve apertures, and color even after mixing;
Second step, to be fed in 0.5-5 times of water by the 20%-80% of first step gained powder gross weight and to be uniformly dispersed, the ratio of powder and water by weight, then uses homogenizing in high pressure homogenizer or ball mill to become particle diameter at the suspension of 20-1000nm.
3rd step, the powder of 20%-80% remaining in second step is placed in centrifugal granulator or side spray comminutor; temperature of charge 40 DEG C is set; the suspension of second step is used to spray into fluid bed with the speed of 10-100kg/h; granulate; coutroi velocity ensures that granular size is at 20-80 order, pellet moisture≤8%.
Based on technique scheme, film coating pre-mix dose of patent of the present invention and preparation method thereof compared with prior art has following technological merit:
1. the finished product of Instant film coating pre-mix dose of the present invention is graininess, size is 20 order ~ 80 orders, its microstructure is Fructus Rubi shape, this structure substantially increases specific surface area and mobility, when preparing coating solution, non-water soluble material is wrapped in around water-soluble material, solvent and pre-mixing agent are separated into little dispersion, to meet water-soluble swollen, gelation, the water-soluble material dissolved again is separate, prevent conglomeration after swell gel, cause water to enter inner speed to slow down, thus instant system can be disperseed fast in water, thus original coating solution preparation time was reduced within 3 minutes by 45 minutes to 60 minutes, coated preparation is made to reduce by more than 1/3 man-hour.The 150 type high-efficiency coating machines the most often used for client carry out one day coating production: use traditional premixing machine, needs with slurry 1 hour, and coating production needs 2.5 hours, always 3.5 hours consuming time, within one day 8 hours, can only produce 2 pots; And using pre-mixing agent of the present invention, drilling fluid preparing time is about 3 minutes, and coating production needs 2.5 hours, within one day 8 hours, can produce 3 pots, and labor productivity improves 33%.And labor productivity improves 33%, relevant device, depreciation of the plant, the energy consumption of Factory Building synergic system also reduces greatly, for a medium scale tablet manufacturing workshop, purification area at least 1000 square meter, cleaning system electricity consumption uses product list cleaning system electric cost of the present invention can save 500-700 unit every day in 1500-2000 unit every day.
2, film coating pre-mix dose of the present invention, coloring agent is evenly wrapped in outside film former, coloring agent can not be separated and also can not assemble, improve the uniformity of coating finished color; Due to monochromatic system product can be made, match colors voluntarily as watercolor according to hobby when enterprise uses, reduce client's buying, storage and testing cost.
3, film coating pre-mix dose of the present invention is particulate powder; good fluidity; conveniently take; dust is produced hardly in weighing, process for preparation; strengthen the labor protection of operator, decrease the risk of cross-contamination, reduce the burden of highly effective air purification air system; extend the service time of high efficiency particle air filter, thus reduce production cost.
4, the raw material needed for pre-mixing agent production is all generally the powder of more than 60 orders, and during production, dust is serious.The preparation method of the more traditional pre-mixing agent of preparation method of the present invention is compared: major part completes in hermetic container, greatly reduces pollution and cross-contamination; Decrease production process, improve labor productivity.Coating powder to use same production line to produce yellow, blue, green three colors: often having produced a color when traditional pre-mixing agent is produced all needs thoroughly to clear out a gathering place, with the cross-contamination preventing the coating powder of different colours from producing; And for pre-mixing agent of the present invention, green system directly can use the yellow of production and blue allotment, produce a color pre-mixing agent without the need to more, only need give client by yellow and blue pre-mixing agent, specify each color adding proportion.
Detailed description of the invention
We come to do film coating pre-mix dose that the present invention relates to and preparation method thereof further to elaborate in conjunction with specific embodiments below.
The present invention is a kind of novel film coating pre-mix dose, and this pre-mixing agent is granular pattern outward appearance, and particle diameter is 20 order ~ 80 orders, finished product ﹤ angle of repose 30 degree, and dust from flying visual value is greater than 3; This pre-mixing agent adds stirring in solvent and namely can be used for film-coated production after 30 ~ 180 seconds; This pre-mixing agent, by comprising the method for granulating preparations such as fluidized granulation, spray-drying process, centrifugal granulating and side spray pelletize, changes outward appearance and the dispersing characteristic of film coating pre-mix dose for physically, and the solvent that preparation uses is water.
Be granular pattern outward appearance in one of the parameter of the novel coating pre-mixing agent of patent application of the present invention: make many kinds of substance in prescription be bonded to by film former the microsphere that microstructure is Fructus Rubi shape with physics mode, specific surface area when finished product contacts with solvent can be increased, water insoluble material in easily swelling film former prescription is spread out, when reducing swelling generation, gel group amasss, and accelerates the dissolving process that film former is met water-soluble swollen, gelation, dissolved.
Be 20 order ~ 80 order scope particle diameters in one of the parameter of the novel coating pre-mixing agent of patent application of the present invention: the sieve number that can pass through is larger, illustrates that granule is less.The finished product mobility that particle diameter is larger can be better, and product also not easily dust pollution occurs in toppling process.When order number is less than 20 order, because product particle is excessive, once there is pollution in production process to be mixed into solid impurity, risk impurity effectively cannot removed will be had.When order number is greater than 80 order, granule is too tiny, easily produces dust during transferred product.
3 are greater than for dust from flying visual value: judge dust situation according to ocular estimate described in GB/T663-2009, the classification of ocular estimate dust is as following table in one of the parameter of the novel coating pre-mixing agent of patent application of the present invention:
| Dust visual value | 1 | 2 | 3 | 4 | 5 |
| Evaluate | There is a large amount of dust | Dust is serious | There is dust | Almost dustless | Dustless |
And traditional coating pre-mixing agent dust visual value is generally 1.
Be finished product < angle of repose 30 ° in one of the parameter of the novel coating pre-mixing agent of patent application of the present invention: according in GB1986-1989 described angle of repose < 30 °, powder body can free-flow, is greater than 40 ° of poor fluidities.Conventional powder type film coating pre-mix dose angle of repose: > 45 °.
Be that pre-mixing agent adds in solvent and stirs in 30 ~ 180 seconds and can disperse completely in the performance indications that the novel coating pre-mixing agent of patent application of the present invention is significant, and traditional film coating pre-mix dose need not stop stirring and could disperse completely for about 45 minutes.
Particulate premix of the present invention achieves the change of outward appearance by physics mode.Traditional film coating pre-mix dose is solid dispersion, and microstructure is the particulate material of single component.And product microstructure of the present invention is the Fructus Rubi shape granule combined by material each in prescription with film former, the composition such as coloring agent and antiplastering aid is embedded in Fructus Rubi structure, so not easily there is the situations such as color transfer gathering in this product in storage process, ensure that product appearance concordance, and the stability of product quality.
Particulate premix of the present invention achieves the change of dispersing characteristic by physics mode.Water-soluble material in traditional film coating pre-mix dose prescription is dispersed in pulverous finished product with solid dispersion form, incomparable more firmly interaction force between each powder.Because the water-soluble material in prescription mostly is macromolecular material, its course of dissolution is generally divided into three steps: meet water-soluble swollen, polymer substance gelation, gel dissolves again.In gelation process, gel is rolled into a ball the powder wrapped of drying in centre, prevent contacting of powder and solvent, solvent and powder contact only could be allowed after outer field gel dissolves to start new dissolving step, constantly stir in this process and by the shearing force of liquid and stirring paddle, quickening dissolving process can be broken up by gel group.And the finished product of the coating pre-mixing agent of patent application of the present invention is 20 order ~ 80 object graininess, add the specific surface area of finished product.And the Fructus Rubi shape structure of microcosmic, for non-water soluble material parcel, embed water-soluble material, macromolecular material in finished product is separated by non-water soluble material, after adding solvent, each granule defines a little dispersion, the macromolecular material of easy gelation is formed independently, the inner gel group small without the volume of wrappage.After each gel group completes dissolving, originally wrapped up, be embedded in outer field non-water soluble material, be dispersed in solvent, formed stable suspension.Finished product of the present invention can disperse fast in water as from the foregoing.Thus original coating solution preparation time was reduced within 180 seconds to 60 minutes by 45 minutes.
Film coating pre-mix dose is according to consumer product characteristic and the prescription type product of personalized customization, so the prescription of film coating pre-mix dose has infinite multiple according to the needs of consumer product and the change of color, and preparation method provided by the present invention, can be used for the production of different prescription products, the change of prescription can have an impact to the addition of solvent during preparation and the preparation speed of product, and its excursion is listed in the present invention one by one.
As a rule, film former, coloring agent, antitackiness agent, plasticizer, auxiliary agent and filler is included in film coating pre-mix dose prescription, wherein, the filmogen in film coating pre-mix dose is generally cellulose derivative, acrylic resin and derivant, polyvinyl alcohol, vinylacetate and derivant thereof etc.; Coloring agent is generally: the color lake of titanium dioxide, ferrum oxide, pigment, shades of colour, as: red color lake, yellow lake, blue color lake, green color lake etc.; Antitackiness agent is generally Pulvis Talci, magnesium stearate, stearic acid, Kaolin etc.; Plasticizer is generally Polyethylene Glycol, propylene glycol, triacetyl glycerine, triethyl citrate, neck phthalic acid ester etc.; Auxiliary agent is generally tween, span, sodium lauryl sulphate, defoamer, Oleum Ricini, tristerin etc.; Filler is generally lactose, maltodextrin etc.
Film coating pre-mix dose of our the generation of the present invention patent application concrete with four specific embodiments below and preparation method thereof, with the content that the claims supporting patent of the present invention are claimed.
Embodiment 1
In the present embodiment, film coating pre-mix dose finished product grain size is 98% in 20 order ~ 80 objects, finished product ﹤ angle of repose 26.5 degree, and dust from flying visual value is greater than 3, and 20 grams of pre-mixing agents disperse 120 seconds namely by 100 mesh sieves in 100g water.
Preparation method is as follows:
The first step, by all the components in prescription: adopt hammer pulverizer to carry out being pulverized and mixed as powder, and powder can accomplish color even, and all by 100 mesh sieves;
Second step, to be fed into 50% of first step gained powder be uniformly dispersed in 2 times of water (by weight) after use high pressure homogenizer, homogenizing twice in pressure 0.7MPa, detect particle size range and be in 20-200nm.
3rd step, the first step remained the suspension that 50% powder and second step obtain and granulate, method and the parameter of granulation are as follows:
Fluidized granulation: the powder of residue 50% is placed in fluid bed, arranges temperature of charge 50 DEG C, and inlet temperature is 100 DEG C, the suspension of second step is used to spray into fluid bed with the speed of 60kg/h, granulate, to granular size 95% at 20-80 order, pellet moisture≤8%.
The preparation method of the inventive method just can obtain corpuscular finished product by work 3-4 hour, and yield rate can reach 99%.But existing method needs work 10-12 hour just can obtain powder-type finished product, and yield rate is at 95-97%.
Embodiment 2
In the present embodiment, film coating pre-mix dose finished product grain size is 97% in 20 order ~ 80 objects, finished product ﹤ angle of repose 23.0 degree, and dust from flying visual value is greater than 3, and 20 grams of pre-mixing agents disperse 30 seconds namely by 100 mesh sieves in 100g water.
Preparation method is as follows:
The first step, by all the components in prescription: adopt hammer pulverizer to be pulverized and mixed, reach color even and all by 100 object powder;
Second step, first step gained powder whole are fed into be uniformly dispersed in 5 times of water (by weight) after use high pressure homogenizer, homogenizing twice in pressure 0.8MPa, detect particle diameter at about 20-300nm.
3rd step, spray-drying process: control air intake demeanour 70 DEG C, sprayed into the speed of 100kg/h by second step gained serosity, granulate, coutroi velocity ensures that granular size is at 20-80 order, pellet moisture≤8%.
This preparation method, work just can obtain finished product in 7-8 hour, and yield rate can reach 99.5%, but existing method needs work 10-12 hour just can obtain finished product, and yield rate is at 95-97%.
Embodiment 3
In the present embodiment, film coating pre-mix dose finished product grain size is 97% in 20 order ~ 80 objects, finished product ﹤ angle of repose 27.0 degree, and dust from flying visual value is greater than 3, and 20 grams of pre-mixing agents disperse 180 seconds namely by 100 mesh sieves in 100g water.
Preparation method is as follows:
The first step, by all the components in prescription: adopt hammer pulverizer to be pulverized and mixed, reach color even and all by 100 object powder;
Second step, to be fed into 40% of first step gained powder be uniformly dispersed in 3 times of water (by weight) after use high pressure homogenizer, homogenizing twice in pressure 0.8MPa, detect particle diameter at about 20-1000nm.
3rd step, centrifugal granulating: the powder of 60% is placed in centrifugal granulator; temperature of charge 30 DEG C is set; inlet temperature is 60 DEG C; the suspension of second step is used to spray in centrifugal granulator with the speed of 10kg/h; granulate; coutroi velocity ensures that granular size is at 20-80 order, pellet moisture≤8%.
This preparation method, work just can obtain finished product in 5-6 hour, and yield rate can reach 98%, but existing method needs work 10-12 hour just can obtain finished product, and yield rate is at 95-97%.
Embodiment 4
In the present embodiment, film coating pre-mix dose finished product grain size is 96% in 20 order ~ 80 objects, finished product ﹤ angle of repose 29.0 degree, and dust from flying visual value is greater than 3, and 20 grams of pre-mixing agents disperse 160 seconds namely by 100 mesh sieves in 100g water.
Preparation method is as follows:
The first step, by all the components in prescription: adopt hammer pulverizer to be pulverized and mixed, reach color even and all by 100 object powder;
Second step, to be fed into 20% of first step gained powder be uniformly dispersed in 0.5 times of water (by weight) after use homogenizing twice in ball mill, detect particle diameter at about 20-1000nm.
3rd step, side spray pelletize: the powder of 80% is placed in side spray comminutor; temperature of charge 42 DEG C is set; inlet temperature is 70 DEG C; the suspension of second step is used to spray in centrifugal granulator with the speed of 10kg/h; granulate; coutroi velocity ensures that granular size is at 20-80 order, pellet moisture≤8%.
This preparation method, work just can obtain finished product in 7-8 hour, and yield rate can reach 98%, but existing method needs work 10-12 hour just can obtain finished product, and yield rate is at 95-97%.
Above four all data of embodiment all obtain through overtesting, and the selection gist of these data only selects the part gradient test of partial parameters to be described at this:
The test data of powder particle diameter is selected in the first step
| 60 orders | 80 orders | 100 orders | 120 orders | 140 orders | |
| Crush efficiency, kg/h | 100 | 80 | 80 | 60 | 40 |
| Homogenization cycles, secondary | 4 | 3 | 2 | 1 | 1 |
| Color change before and after homogenizing | Significant difference | Variant | Zero difference | Zero difference | Zero difference |
Comprehensive output and color change, and select powder particle diameter to be optimum selections at 100 orders.
The test data of homogenizing particle diameter is selected in second step
| 1-50um | 500-1000nm | 20-1000nm | 1-100nm | |
| Jitter time, s | 1200-1800 | 600-1200 | 30-180 | 30-180 |
As can be seen from the above table, homogenizing is optimum selection to 20-1000nm.
The temperature setting of the 3rd step considers: temperature can cause fusing point and the stability of some compositions in color fading and film coating pre-mix dose; Spray speed mainly controls particle diameter and the moisture of final finished, and the too fast particle diameter of spray speed is too large, particle size distribution range is too wide and moisture is too high, and the too slow particle diameter of spray speed is too little, produces consuming time oversize.
Technique scheme only embodies the optimal technical scheme of invention technical scheme.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 (6)
1. a film coating pre-mix dose, is characterized in that:
This pre-mixing agent is granular pattern outward appearance, and particle diameter is 20 order ~ 80 orders, finished product ﹤ angle of repose 30 degree, and dust from flying visual value is greater than 3; This pre-mixing agent adds stirring in solvent and within 30 ~ 180 seconds, namely can be used for film coating production;
Corpuscular pre-mixing agent is prepared by the method for fluidized granulation, changes outward appearance and the dispersing characteristic of film coating pre-mix dose for physically, and the solvent that preparation uses is water.
2. a preparation method for film coating pre-mix dose described in claim 1, is characterized in that, this preparation method includes following steps:
The first step, be pulverized and mixed by all the components pulverizer in prescription, the powder after pulverizing is all by 100 mesh sieves, and color even after mixing;
Second step, to be fed in 0.5-5 times of water by the 20%-80% of first step gained powder gross weight and to be uniformly dispersed, the ratio of powder and water by weight, then uses homogenizing in high pressure homogenizer or ball mill to become particle diameter at the suspension of 20-1000nm;
3rd step, the powder of remaining for second step 20%-80% weight is placed in fluid bed, temperature of charge 30-50 DEG C is set, inlet temperature is 60-100 DEG C, the suspension obtained by second step sprays in fluid bed with the speed of 10-100kg/h and granulates, granulate to granular size at 20-80 order, pellet moisture≤8%.
3. a film coating pre-mix dose, is characterized in that, this pre-mixing agent is granular pattern outward appearance, and particle diameter is 20 order ~ 80 orders, finished product ﹤ angle of repose 30 degree, and dust from flying visual value is greater than 3; This pre-mixing agent adds stirring in solvent and within 30 ~ 180 seconds, namely can be used for film coating production;
Corpuscular pre-mixing agent is prepared by the method for spray-drying process, changes outward appearance and the dispersing characteristic of film coating pre-mix dose for physically, and the solvent that preparation uses is water.
4. a preparation method for film coating pre-mix dose described in claim 3, is characterized in that, this preparation method includes following steps:
The first step, be pulverized and mixed by all the components pulverizer in prescription, the powder after pulverizing is all by 100 mesh sieves, and color even after mixing;
Second step, whole for first step gained powder is all fed in 0.5-5 times of water is uniformly dispersed, the ratio of powder and water by weight, then use homogenizing in high pressure homogenizer or ball mill to become particle diameter at the suspension of 20-1000nm, the pressure of high pressure homogenizer is not less than 0.7MPa;
3rd step, sprayed into the speed of 10-100kg/h by the suspension of second step gained, inlet temperature is granulated at 60-100 DEG C, and coutroi velocity is to ensure that the granular size after having granulated is at 20-80 order, pellet moisture≤8%.
5. a film coating pre-mix dose, is characterized in that:
This pre-mixing agent is granular pattern outward appearance, and particle diameter is 20 order ~ 80 orders, finished product ﹤ angle of repose 30 degree, and dust from flying visual value is greater than 3; This pre-mixing agent adds stirring in solvent and within 30 ~ 180 seconds, namely can be used for film coating production;
Corpuscular pre-mixing agent is prepared by the method for centrifugal granulating or side spray pelletize, changes outward appearance and the dispersing characteristic of film coating pre-mix dose for physically, and the solvent that preparation uses is water.
6. a preparation method for film coating pre-mix dose described in claim 5, is characterized in that, this preparation method includes following steps:
The first step, be pulverized and mixed by all the components pulverizer in prescription, the powder after pulverizing is all by 100 mesh sieves, and color even after mixing;
Second step, to be fed in 0.5-5 times of water by the 20%-80% of first step gained powder gross weight and to be uniformly dispersed, the ratio of powder and water by weight, then uses homogenizing in high pressure homogenizer or ball mill to become particle diameter at the suspension of 20-1000nm;
3rd step, the powder of 20%-80% remaining in second step is placed in centrifugal granulator or side spray comminutor; temperature of charge 30-50 DEG C is set; inlet temperature is 60-100 DEG C; the suspension of second step is used to spray into fluid bed with the speed of 10-100kg/h; granulate; coutroi velocity ensures that granular size is at 20-80 order, pellet moisture≤8%.
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| CN103520084A (en) * | 2013-10-29 | 2014-01-22 | 北京英茂药业有限公司 | Preparation method for thin film coated premix |
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Application publication date: 20151021 |