CN1329016C - Granulation method of raw medicine component preparation - Google Patents
Granulation method of raw medicine component preparation Download PDFInfo
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- CN1329016C CN1329016C CNB031570291A CN03157029A CN1329016C CN 1329016 C CN1329016 C CN 1329016C CN B031570291 A CNB031570291 A CN B031570291A CN 03157029 A CN03157029 A CN 03157029A CN 1329016 C CN1329016 C CN 1329016C
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- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- 239000003814 drug Substances 0.000 title claims description 109
- 238000000034 method Methods 0.000 title claims description 23
- 238000005469 granulation Methods 0.000 title abstract 2
- 230000003179 granulation Effects 0.000 title abstract 2
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- 238000002156 mixing Methods 0.000 claims abstract description 8
- 229940079593 drug Drugs 0.000 claims description 106
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- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 2
- 240000006661 Serenoa repens Species 0.000 description 2
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- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
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- 241000218236 Cannabis Species 0.000 description 1
- 241000190633 Cordyceps Species 0.000 description 1
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- 241000628997 Flos Species 0.000 description 1
- 235000011201 Ginkgo Nutrition 0.000 description 1
- 244000194101 Ginkgo biloba Species 0.000 description 1
- 235000008100 Ginkgo biloba Nutrition 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 244000131316 Panax pseudoginseng Species 0.000 description 1
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- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 238000005411 Van der Waals force Methods 0.000 description 1
- 230000002546 agglutinic effect Effects 0.000 description 1
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- 239000008187 granular material Substances 0.000 description 1
- 230000012010 growth Effects 0.000 description 1
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- 235000019605 sweet taste sensations Nutrition 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Provided is a galenical component preparation, having a high content of galenical components (effective components), heavy and having a sharp particle distribution. While one galenical component powder selected from a galenical dry powder, a galenical extract powder and a mixed powder of the galenical dry powder and the galencial extract is let flow in a fluidized layer container, a binder liquid obtained by mixing an aqueous solution containing a galenical extract as the same kind of the selected galenical component powder with 0.01 to 20wt.% alcohol is sprayed to perform granulation.
Description
Technical field
The present invention is about a kind of prilling process that is used for the crude drug component preparation of preparation goods such as dietary supplement, health food, traditional Chinese medical science crude drug.
Background technology
The dietary supplement and the preparation goods such as health food, traditional Chinese medical science crude drug that contain the crude drug composition, normally will be to the dry end of crude drug, extracts from crude drugs is last or the mixing end at dry end of crude drug and extracts from crude drugs end (crude drug composition end) carried out pelletize and handled resultant pelletize thing as powder, granula subtilis, granule, or again these pelletize things are adjusted into dosage forms such as tablet and capsule and sell.But, in the manufacturing of crude drug component preparation, owing to, make pelletize thing well with uniform grading so be difficult to yield rate as the crude drug drying end of raw material and tack, the cohesiveness height at extracts from crude drugs end.Given this, up to the present propose to have various prilling process.
For example, as known prilling process, well-known have: one side is swum excipient and flowed simultaneously carries out the extracts from crude drugs liquid that has added high temperature dehydration starch the method (patent documentation 1) of mist projection granulating, one side makes the mixture of Chinese medicine abstract powder and the water absorption additive rotational flow one side of swimming in hot blast the aqueous solution of water or bonding agent be carried out off and on the method (patent documentation 2) of mist projection granulating, with silicon dioxide, synthetic silicic acid, aluminum, lactose, the high powder of water absorption rates such as starch is as the pelletize nuclear particle, and one side is ventilated them and stirred the method (patent documentation 3) that one side is carried out bonding agent liquid mist projection granulating, and the method (patent documentation 4) of carrying out pelletize with crude drug composition and additive.
Patent documentation 1: the public clear 55-12889 communique of the spy of Japanese patent laid-open publication gazette
Patent documentation 2: the spy of Japanese Patent Laid Open Publication opens flat 2-300135 communique
Patent documentation 3: the spy of Japanese Patent Laid Open Publication opens flat 5-49901 communique
Patent documentation 4: the spy of Japanese Patent Laid Open Publication opens flat 6-192113 communique
When pelletize is handled, when and during with various additives such as excipient, crude drug composition (effective ingredient) shared content ratio in the pelletize thing of finishing tails off.So one day dose is issued to 20~30 in the situation that for example adopts the tablet form sometimes, taking so, a large amount of tablets can make user's burden increase.
And though water can be carried out pelletize as bonding agent, there is problem many to adhering to of container handling inwall, goods yield rate step-down in the dissolubility height of extracts from crude drugs foot couple water in this case.
On the other hand, oil content is contained at the dry end of crude drug more, is difficult to utilize aqueous solution to carry out pelletize as bonding agent.This is poor because contain the affinity of dry end of the crude drug of oil content and water-binding agent liquid, and bonding agent is difficult to attached on the dry end of crude drug.At this problem, also once consider to adopt the bonding agent liquid of organic solvent, but protect and the labor safety aspect from earth environment in recent years, still do one's utmost to be reduced to good to the use of organic solvent.
Summary of the invention
The prilling process that the purpose of this invention is to provide the clear crude drug component preparation of a kind of amount height, heavy and the particle size distribution that can utilize water-binding agent liquid to obtain crude drug composition (effective ingredient).
In order to solve above-mentioned problem, the invention provides a kind of prilling process, one side make from the dry end of crude drug, extracts from crude drugs is last and the mixing end at dry end of crude drug and extracts from crude drugs end any crude drug composition end of selecting in the fluidized bed container, flow, it is that the aqueous solution of the extracts from crude drugs of 20~35 weight % carries out mist projection granulating as bonding agent liquid that one side will contain with aforementioned crude drug composition end of the same race and solid component concentration, and wherein the alcohol of 0.01~20 weight % is gone in allotment in aforementioned bonding agent liquid.
Crude drug raw materials such as said here " crude drug dry end " is meant the root of for example plant of representatives such as Radix Curcumae, Fructus Momordicae charantiae, Pericarpium Citri tangerinae, Radix Ginseng, Flos Cannabis, dried plum (prune), Aloe, Semen Ginkgo, Serenoa repens (serenoa repens), Cordyceps, Herb Gynostemmae Pentaphylli, Radix Glycyrrhizae, Radix Puerariae, leaf, stem, reality, flower, does, Agaricus blazei Murrill (agaricus), birch pore fungi, algae, mushroom, animal, fish Jie class carry out sectionalization and the dry powder that forms.And, in this " the dry end of crude drug ", comprise and carry out powder dry and that sectionalization forms from above-mentioned crude drug raw material, extracting extracts from crude drugs remnant afterwards out.So-called " extracts from crude drugs end " is meant that the extracts from crude drugs (aqueous) that will extract out carries out the dry powder that forms from above-mentioned crude drug raw material.For example, when extracts from crude drugs being utilized spray drying form powder, can be according to the character of Extract, dry adjuvant such as interpolation dextrin carry out dried.At this moment,, except the extracts from crude drugs end, also contain the dry end of dry adjuvant, but in this manual, comprise that this powder all is called " extracts from crude drugs end " by the resulting powder of dried.
In employed in the present invention " crude drug composition end " (material powder), normally used various additives when making per os have not been allocated, for example excipient (lactose, sucrose etc.), bonding agent (hydroxypropyl cellulose, polyvinylpyrrolidone etc.), decay agent additives such as (carboxymethyl cellulose, starch based etc.) with solid preparation.As crude drug composition end, can use the powder that the dry end of one or more crude drugs is allocated, or the powder that one or more extracts from crude drugs ends are allocated.Perhaps, also can use the mixing end at the dry end of one or more crude drugs and one or more extracts from crude drugs ends.Occasion at employing mixing end, dry end of crude drug and extracts from crude drugs end can be used identical type, also can use different types of.
Employed among the present invention " bonding agent liquid " is good with the water-binding agent of the alcohol of allocating 0.01~20 weight % (in the gross weight of bonding agent liquid pure shared part by weight) in the aqueous solution that contains above-mentioned crude drug composition end and extracts from crude drugs of the same race.Do not contain normally used polymeric additive, for example additives such as hydroxypropyl cellulose, methylcellulose, carboxymethyl cellulose, polyvinylpyrrolidone when making per os with solid preparation.In the occasion of the dry end of multiple crude drug or multiple extracts from crude drugs end being allocated as the end use of crude drug composition, or the mixing end at dry end of use crude drug and extracts from crude drugs end is as the occasion at crude drug composition end, the extracts from crude drugs of allocating in bonding agent liquid can be identical with at least a powder that crude drug composition end is comprised (when with powder more than 2 kinds when identical, extracts from crude drugs is allocated multiple according to the kind of powder).
As the alcohol of allocating in bonding agent liquid, can use ethanol, methanol etc., but be good especially with ethanol.
Allocate the solid component concentration (the shared part by weight of extracts from crude drugs solid in the gross weight of bonding agent liquid) of the extracts from crude drugs in bonding agent liquid, according to kind, the rerum natura of extracts from crude drugs, it is good adopting high as far as possible concentration in sprayable scope.That is, the extracts from crude drugs that viscosity is high is sprayable under the low concentration about 1 weight %, even but the low extracts from crude drugs of viscosity is also sprayable under the high concentration about 70 weight %.Therefore, the solid component concentration of extracts from crude drugs is good with 1~70 weight %.In general, the solid component concentration of 20~35 weight % is comparatively suitable.
Employed fluidized bed equipment normally simultaneously utilizes the liquidation gas that imports from the bottom of fluidized bed container to make powder body particle swim mobile among the present invention; and in the fluidized bed container, form the fluidized bed of powder body particle, one side by spray gun with jetting fluid (bonding agent liquid, membrane liquid etc.) mist projection granulating or the processing that is covered.As spray pattern, the mode (tangential spray pattern) that the mode (top spray pattern) of downwards spray liquid being sprayed from the top of fluidized bed, the mode (bottom spray mode) of upward spray liquid being sprayed from the bottom of fluidized bed container is arranged, to tangential direction slightly spray liquid is sprayed from the sidepiece (near bottom side) of fluidized bed.In this fluidized bed equipment, be attended by powder body particle rotation, jet flow and stirring more than one, be known as compound fluidized bed equipment.In compound flow device, have in the bottom of fluidized bed container rotating circular disk is set, and at the rotational flow bed device that makes the rotation of powder body particle on the rotating circular disk, again stirring vane and pay the rotational flow bed device add mixing effect, set ventilation duct in the inside of fluidized bed container is set on rotating circular disk, and the so-called single step fluidized bed equipment that the powder body particle that the ascending air of taking advantage of in the ventilation duct rises is upwards sprayed spray liquid etc.In the present invention, comprise all well-known fluidized bed equipment in above-mentioned being illustrated in, no matter how its kind and spray pattern can both use.
The present invention is when use as material powder at the crude drug composition end that will not contain above-mentioned various additives, to contain and use as bonding agent liquid with above-mentioned crude drug composition end extracts from crude drugs of the same race and the aqueous solution that do not contain above-mentioned various additive and carry out pelletize, and can especially improve crude drug composition (effective ingredient) shared amount in final pelletize thing so compare with known techniques.By this, can reduce the per 1 time dose of preparation goods, alleviate user's burden.
Because use allotment to have the bonding agent liquid with crude drug composition end extracts from crude drugs of the same race to carry out pelletize, so the affinity height at bonding agent liquid and crude drug composition end, pelletize is good.And, by a spot of alcohol of allotment in bonding agent liquid, the interfacial tension of bonding agent liquid is descended, to the power of impregnation enhancing at crude drug composition end, so pelletize further improves.Because the pelletize raising can obtain the final clearly pelletize thing (crude drug component preparation) of particle size distribution with high yield rate.And, because the power of impregnation of the bonding agent liquid at crude drug composition end is strengthened, can access the final pelletize thing of heavy.
Oil content is contained at the dry end of crude drug more, in most cases is difficult to utilize water-binding agent to carry out pelletize.But, as mentioned above,, the interfacial tension of bonding agent liquid is descended, with the affinity raising at the dry end of crude drug, so pelletize has obtained improving significantly by a spot of alcohol of allotment in bonding agent liquid.On the other hand, most extracts from crude drugs is insoluble to alcohol, measures when too high when the allotment of alcohol, and the decreased solubility of the extracts from crude drugs in bonding agent liquid can not show enough adhesions.And when the allotment amount of alcohol increased, the ignition point step-down of bonding agent liquid met the category of the determined dangers of decree such as Fire Prevention Act sometimes.At this moment, the dangerous probability during the pelletize operation increases, and needs the explosion-proof type equipment of high price aspect equipment.In order to give full play to by the resulting above-mentioned effect of allotment alcohol, make the ignition point of bonding agent liquid be higher than temperature with the determined danger phase region of decree branch simultaneously, the allotment amount of alcohol is 0.01~20 weight %, is preferably 0.01~10 weight %, and the best is 0.5~10 weight %.In addition, as the method for the interfacial tension that reduces bonding agent liquid, once considered the allotment interfacial agent, but be restricted, and can not say preferable from healthy and safe aspect as pharmaceuticals additive, the approved goods of food additives.In bonding agent liquid, also can again (suspend, disperse) be allocated at the dry end of the crude drug of institute's fixed solid constituent concentration.
Utilize the crude drug component preparation of prilling process manufacturing of the present invention, because that the amount of crude drug composition (effective ingredient) in each particle compared with known preparation is high extraordinarily, so per 1 time dose can solve on a small quantity, makes user's burden reduce.
The specific embodiment
One side is lowered to crude drug composition end in the fluidized bed container of common fluidized bed equipment or rotational flow bed device, and make its rotation of in the fluidized bed container, swimming, one side will be in the aqueous solution that contains with above-mentioned crude drug composition extracts from crude drugs of the same race allotment go into 0.01~20 weight % ethanol the spraying of bonding agent liquid and carry out pelletize.Here, give gas air quantity one regularly when what make liquidation gas (hot blast), by the increase of the particle weight of the carrying out that follows pelletize (particle growths), the flowability that produces the high step-down of fluidized bed, particle is hanged down the purgation phenomenon.Given this, give the stage increase of gas air quantity by what make the carrying out that follow pelletize, the decline of the floor height that can prevent to flow and the particle flow that is caused thus low kept the good flow regime of particle.
Good flow regime by keep particle when pelletize is operated can suppress the generation of oversize grain, makes the particle size distribution of final pelletize thing clear.And, fallen to returning fluidized bed owing to dialling by the particle of dynamic flow in this container, so the yield rate of final pelletize thing is improved attached to the particle on the fluidized bed wall of a container face.
In this fluidized bed equipment, generally can set filtration system, and catch the fine-powder that in the fluidized bed container, flies upward and fly to exhaustor by the filter of filtration system on the top of fluidized bed container.The fine-powder that filter is caught is stroked and is returned fluidized bed by the cleanup action of filter system, and as its mode, single mode of vibration and two mode of vibration are known.The former a kind ofly the time stops the gas of giving of liquidation gas in cleaning, and the mode of utilizing the vibration action of filter that the fine-powder of catching is stroked.When the tack, cohesiveness at the crude drug composition end in the prescription is low, even adopt single mode of vibration also can carry out the pelletize operation, but because mobile stopping, making that particles in the pelletize excessively adhere to, coagulation, generate oversize grain easily.In addition, the tack at the crude drug composition end in prescription, when cohesiveness is high is difficult to restart to flow after stopping flowing, and can't carry out the pelletize operation sometimes.In order to avoid this ill-considered situation, adopting two mode of vibrations is good as manner of cleaning up.In general, two mode of vibrations are a kind of the filter chamber to be divided into 2 parts, and make the filter of each filter chamber carry out vibration action alternately and mode that the fine-powder of catching is stroked.Because when the filter in a filter chamber carried out cleanup action, the filter of another filter chamber can carry out aerofluxus, carry out successive pelletize so can not stop to flow.Therefore, by adopting two mode of vibrations, can avoid above-mentioned ill-considered situation.
Crude drug composition end side and bonding agent liquid prescription is changed and pelletize variedly, and ask the particle size distribution and the apparent specific gravity (embodiment 1~7, comparative example 1) of resultant pelletize thing.Its result is concentrated expression in table 1.
Table 1
| Particle diameter μ m | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | Embodiment 6 | Embodiment 7 |
| 710μm on | 1.2 | 0.32 | 2.5 | 0.15 | 0.54 | 0.45 | 3.12 |
| 500-710μm | 5.71 | 1.75 | 17.31 | 2.67 | 1.95 | 2.11 | 18.52 |
| 300-500μm | 32.18 | 38.92 | 49.12 | 41.84 | 39.72 | 39.15 | 47.36 |
| 180-300μm | 42.19 | 39.39 | 21.92 | 37.39 | 38.65 | 39.11 | 26.71 |
| 106-180μm | 15.51 | 12.92 | 6.98 | 12.02 | 14.12 | 13.75 | 2.71 |
| 75-106μm | 1.44 | 4.15 | 1.32 | 3.86 | 4.31 | 4.51 | 0.92 |
| 75μm pass | 1.77 | 2.55 | 0.85 | 2.08 | 0.71 | 0.92 | 0.66 |
| Mean diameter μ m | 247.5 | 219.1 | 312.3 | 222.7 | 234.5 | 232.2 | 331.8 |
| Apparent specific gravity g/ml | 0.29 | 0.29 | 0.42 | 0.31 | 0.29 | 0.30 | 0.41 |
| Particle diameter μ m | Comparative example 1 |
| 710μm on | 0 |
| 500-710μm | 0 |
| 300-500μm | 0.1 |
| 180-300μm | 0.67 |
| 106-180μm | 12.35 |
| 75-106μm | 32.54 |
| 75μm pass | 54.34 |
| Mean diameter μ m | 66 |
| Apparent specific gravity g/ml | 0.31 |
Embodiment 1
Crude drug composition end side: the dry last 600g of birch pore fungi, birch pore fungi extract end 200g
Bonding agent liquid prescription: dissolving birch pore fungi extract end 200g (solid component concentration in the solution=25%) in the mixed liquor 600g of ethanol 60g, water 540g
One side is lowered to fluidized bed equipment with the pharmaceutical composition end of above-mentioned prescription, and it is flowed in the fluidized bed container, and one side is carried out mist projection granulating with the bonding agent liquid of above-mentioned prescription downwards from the top of fluidized bed.In addition, when the fine-powder at pelletize initial stage utilizes spray gun to fly upward up, reduced by the combined dose of chance that liquid is moistening, the postponing of pelletize, it is clear that particle size distribution becomes.Therefore, to be controlled to be to the gas air quantity at the pelletize initial stage and to be suitable for flowing of fine-powder, along with particle is followed the carrying out of pelletize and grown up change heavily, add owing to bonding agent liquid cause moistening make adhere to, coagulation, cohesiveness increase, can progressively increase, keep the good flow regime of particle to the gas air quantity.
Because a little oil portion is contained at the dry end of birch pore fungi, so when using the water-binding agent liquid of not allocating alcohol (comparative example 1 of table 1), the affinity of dry end of birch pore fungi and bonding agent liquid is poor, when the spraying of bonding agent liquid by moistening and slightly adhere to, produce in the dry engineering of agglutinative particles in the back and separate, can't pelletize.
To this, embodiment 1 allocates in bonding agent liquid and goes into a spot of ethanol, so the affinity at the dry end of bonding agent liquid and birch pore fungi strengthens (because the interfacial tension of bonding agent liquid descends), can improve pelletize.In addition, the alcohol of being allocated in the bonding agent liquid evaporates in pelletize engineering or dry engineering thereafter.
And, by following making of pelletize to increase step by step to the gas air quantity, can make at the pelletize initial stage utilizes electrostatic force and van der waals force (interparticle force) to be attached to the fine-powder of fluidized bed wall of a container face, in this container, dialled and fallen to returning fluidized bed by the particle of dynamic flow, so yield rate also becomes 98~99%, obtains high productivity.
As shown in table 1, utilize the particle size distribution of the resulting pelletize thing of the prilling process clear display of embodiment 1, and be heavy.When utilizing this pelletize thing to play ingot, can not spray the good tablet that obtains of ingot obstacle.
Embodiment 2
Crude drug composition end side: the dry last 800g of spring Radix Curcumae
Bonding agent liquid prescription: the dry last 200g (solid component concentration in the solution=25%) of dissolving spring Radix Curcumae in the mixed liquor 600g of ethanol 60g, water 540g
One side is lowered to fluidized bed equipment with the pharmaceutical composition end of above-mentioned prescription, and it is flowed in the fluidized bed container, and one side is carried out mist projection granulating with the bonding agent liquid of above-mentioned prescription downwards from the top of fluidized bed.In addition, give gas air quantity (75 ° of charged air temperatures) similarly to Example 1, follow the carrying out of pelletize progressively to be increased.
Even in embodiment 2, also can obtain the high productivity of yield rate 98~99%.And, as shown in table 1, utilize the particle size distribution of the resulting pelletize thing of the prilling process clear display of embodiment 2, and be heavy.When utilizing this pelletize thing to play ingot, can not spray the good tablet that obtains of ingot obstacle.
Embodiment 3
Crude drug composition end side: the dry last 400g of spring Radix Curcumae, spring Radix Curcumae extract end 200g, Agaricus blazei Murrill extract end 200g
Bonding agent liquid prescription: dissolving spring Radix Curcumae extract end 200g (solid component concentration in the solution=25%) in the mixed liquor 600g of ethanol 60g, water 540g
One side is lowered to the rotational flow bed device with the pharmaceutical composition end of above-mentioned prescription, and it is flowed in the fluidized bed container, and one side is carried out mist projection granulating with the bonding agent liquid of above-mentioned prescription downwards from the top of fluidized bed.In addition, give gas air quantity (75 ° of charged air temperatures) similarly to Example 1, follow the carrying out of pelletize progressively to be increased.
Even in embodiment 3, also can obtain the high productivity of yield rate 98~99%.And, as shown in table 1, utilize the particle size distribution of the resulting pelletize thing of the prilling process clear display of embodiment 3, and be heavy.When utilizing this pelletize thing to play ingot, can not spray the good tablet that obtains of ingot obstacle.
Embodiment 4
Crude drug composition end side: the dry last 40kg of spring Radix Curcumae, spring Radix Curcumae extract end 10kg
Bonding agent liquid prescription: dissolving spring Radix Curcumae extract end 5kg (solid component concentration in the solution=25%) in the mixed liquor 15kg of ethanol 1.5kg, water 13.5kg
One side is lowered to fluidized bed equipment (POWREX corporate system [WSG-60] type) with the pharmaceutical composition end of above-mentioned prescription, and it is flowed in the fluidized bed container, and one side is carried out mist projection granulating with the bonding agent liquid of above-mentioned prescription downwards from the top of fluidized bed.In addition, give gas air quantity (75 ° of charged air temperatures) similarly to Example 1, follow the carrying out of pelletize progressively to be increased.
Even in embodiment 4, also can obtain the high productivity of yield rate 98~99%.And, as shown in table 1, utilize the particle size distribution of the resulting pelletize thing of the prilling process clear display of embodiment 4, and be heavy.When utilizing this pelletize thing to play ingot, can not spray the good tablet that obtains of ingot obstacle.
Embodiment 5
Crude drug composition end side: Agaricus blazei Murrill extract end 300g, the dry last 500g of Agaricus blazei filament (young pilose antler)
Bonding agent liquid prescription: dissolving Agaricus blazei Murrill extract end 200g (solid component concentration in the solution=25%) in the mixed liquor 600g of ethanol 5g, water 595g
One side is lowered to fluidized bed equipment with the pharmaceutical composition end of above-mentioned prescription, and it is flowed in the fluidized bed container, and one side is carried out mist projection granulating with the bonding agent liquid of above-mentioned prescription downwards from the top of fluidized bed.In addition, give gas air quantity (75 ° of charged air temperatures) similarly to Example 1, follow the carrying out of pelletize progressively to be increased.
Even in embodiment 5, also can obtain the high productivity of yield rate 98~99%.And, as shown in table 1, utilize the particle size distribution of the resulting pelletize thing of the prilling process clear display of embodiment 5, and be heavy.When utilizing this pelletize thing to play ingot, can not spray the good tablet that obtains of ingot obstacle.
Embodiment 6
Crude drug composition end side: Agaricus blazei Murrill extract end 15kg, the dry last 45kg of Agaricus blazei filament (young pilose antler)
Bonding agent liquid prescription: dissolving Agaricus blazei Murrill extract end 5kg (solid component concentration in the solution=25%) in the mixed liquor 15kg of ethanol 0.5kg, water 14.5kg
One side is lowered to fluidized bed equipment with the pharmaceutical composition end of above-mentioned prescription, and it is flowed in the fluidized bed container, and one side is carried out mist projection granulating with the bonding agent liquid of above-mentioned prescription downwards from the top of fluidized bed.In addition, give gas air quantity (75 ° of charged air temperatures) similarly to Example 1, follow the carrying out of pelletize progressively to be increased.
Even in embodiment 6, also can obtain the high productivity of yield rate 98~99%.And, as shown in table 1, utilize the particle size distribution of the resulting pelletize thing of the prilling process clear display of embodiment 6, and be heavy.When utilizing this pelletize thing to play ingot, can not spray the good tablet that obtains of ingot obstacle.
Embodiment 7
For example, used Radix Curcumae has distinctive bitterness in embodiment 4.Therefore, in order to relax (sheltering) this bitterness, nigecose aqueous solution (solid component concentration 30 weight %) is added in spraying in embodiment 4 resulting pelletize things, the bitterness of the Radix Curcumae when taking with the sweet taste mitigation of nigecose.Utilize soaking into, being covered of nigecose solution, can obtain the more pelletize thing of medium solid.
As utilize the present invention, can use amount height, heavy and particle size distribution that water-binding agent liquid obtains crude drug composition (effective ingredient) crude drug component preparation clearly.
Claims (3)
1. the prilling process of a crude drug component preparation, it is characterized in that: one side make from the dry end of crude drug, extracts from crude drugs is last and the mixing end at dry end of crude drug and extracts from crude drugs end any crude drug composition end of selecting in the fluidized bed container, flow, it is that the aqueous solution of the extracts from crude drugs of 20~35 weight % carries out mist projection granulating as bonding agent liquid that one side will contain with aforementioned crude drug composition end of the same race and solid component concentration, and wherein the alcohol of 0.01~20 weight % is gone in allotment in aforementioned bonding agent liquid.
2. the prilling process of crude drug component preparation as claimed in claim 1 is characterized in that: described alcohol is ethanol.
3. a crude drug component preparation is characterized in that: utilize claim 1 or 2 described prilling process manufacturings.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2002270218 | 2002-09-17 | ||
| JP2002270218 | 2002-09-17 | ||
| JP2003142105 | 2003-05-20 | ||
| JP2003142105A JP2004160165A (en) | 2002-09-17 | 2003-05-20 | Granulation method of crude drug ingredient formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1494885A CN1494885A (en) | 2004-05-12 |
| CN1329016C true CN1329016C (en) | 2007-08-01 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB031570291A Expired - Fee Related CN1329016C (en) | 2002-09-17 | 2003-09-11 | Granulation method of raw medicine component preparation |
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| JP (1) | JP2004160165A (en) |
| CN (1) | CN1329016C (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2006131548A (en) * | 2004-11-05 | 2006-05-25 | Pauretsuku:Kk | Method for producing particles |
| CH698627B1 (en) * | 2007-08-16 | 2009-09-15 | Alpinia Laudanum Inst Of Phytopharmaceutical | Production and use of extracts or extractives from Piper cubeba L. as active ingredients in a drug used to treat cancers. |
| JP5958100B2 (en) * | 2011-06-14 | 2016-07-27 | 大正製薬株式会社 | Herbal medicine-containing solid preparation |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1087026A (en) * | 1992-09-25 | 1994-05-25 | 武田药品工业株式会社 | The method of granulating of crude drug and solid preparation |
| CN1109779A (en) * | 1995-01-25 | 1995-10-11 | 余练康 | Once-granulating process of ginseng and bupleurum root particles for curing hepatitis |
| DE19645712A1 (en) * | 1996-11-06 | 1998-05-07 | Laevosan Gmbh & Co Kg | Manufacture of dry lactulose dosage forms |
| JPH10128098A (en) * | 1996-09-06 | 1998-05-19 | Takeda Chem Ind Ltd | Granulation control device and granulation control method |
| CN1045161C (en) * | 1990-10-22 | 1999-09-22 | 镜纺株式会社 | Granulating materials of extractives of traditional Chinese medinine and process for preparing for solid preparation containing extractives of traditional Chinese medicine |
| WO2001083704A1 (en) * | 2000-05-02 | 2001-11-08 | Biofermin Pharmaceutical Co., Ltd. | Spray-dried microbial cells |
-
2003
- 2003-05-20 JP JP2003142105A patent/JP2004160165A/en active Pending
- 2003-09-11 CN CNB031570291A patent/CN1329016C/en not_active Expired - Fee Related
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1045161C (en) * | 1990-10-22 | 1999-09-22 | 镜纺株式会社 | Granulating materials of extractives of traditional Chinese medinine and process for preparing for solid preparation containing extractives of traditional Chinese medicine |
| CN1087026A (en) * | 1992-09-25 | 1994-05-25 | 武田药品工业株式会社 | The method of granulating of crude drug and solid preparation |
| CN1109779A (en) * | 1995-01-25 | 1995-10-11 | 余练康 | Once-granulating process of ginseng and bupleurum root particles for curing hepatitis |
| JPH10128098A (en) * | 1996-09-06 | 1998-05-19 | Takeda Chem Ind Ltd | Granulation control device and granulation control method |
| DE19645712A1 (en) * | 1996-11-06 | 1998-05-07 | Laevosan Gmbh & Co Kg | Manufacture of dry lactulose dosage forms |
| WO2001083704A1 (en) * | 2000-05-02 | 2001-11-08 | Biofermin Pharmaceutical Co., Ltd. | Spray-dried microbial cells |
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| Publication number | Publication date |
|---|---|
| JP2004160165A (en) | 2004-06-10 |
| CN1494885A (en) | 2004-05-12 |
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