CN114949232A - Sugar fine particles and preparation method, equipment and application thereof - Google Patents
Sugar fine particles and preparation method, equipment and application thereof Download PDFInfo
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- CN114949232A CN114949232A CN202210532006.8A CN202210532006A CN114949232A CN 114949232 A CN114949232 A CN 114949232A CN 202210532006 A CN202210532006 A CN 202210532006A CN 114949232 A CN114949232 A CN 114949232A
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- fluidized bed
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- 235000000346 sugar Nutrition 0.000 title claims abstract description 106
- 239000010419 fine particle Substances 0.000 title claims abstract description 38
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- 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 claims abstract description 86
- 229930006000 Sucrose Natural products 0.000 claims abstract description 86
- 239000005720 sucrose Substances 0.000 claims abstract description 81
- 239000002245 particle Substances 0.000 claims abstract description 72
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 37
- 239000000843 powder Substances 0.000 claims abstract description 29
- 239000007921 spray Substances 0.000 claims abstract description 29
- 239000000463 material Substances 0.000 claims abstract description 19
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 13
- 239000008103 glucose Substances 0.000 claims abstract description 13
- 239000006188 syrup Substances 0.000 claims abstract description 13
- 235000020357 syrup Nutrition 0.000 claims abstract description 13
- 239000011148 porous material Substances 0.000 claims abstract description 8
- 239000002994 raw material Substances 0.000 claims abstract description 5
- 238000005507 spraying Methods 0.000 claims description 17
- 238000002156 mixing Methods 0.000 claims description 13
- 238000004519 manufacturing process Methods 0.000 claims description 12
- 238000007664 blowing Methods 0.000 claims description 10
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 10
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 8
- 238000009835 boiling Methods 0.000 claims description 8
- 239000000945 filler Substances 0.000 claims description 5
- 229940124531 pharmaceutical excipient Drugs 0.000 claims description 5
- 239000007787 solid Substances 0.000 claims description 5
- 239000000796 flavoring agent Substances 0.000 claims description 3
- 235000013355 food flavoring agent Nutrition 0.000 claims description 3
- 150000001720 carbohydrates Chemical class 0.000 claims 1
- 239000002671 adjuvant Substances 0.000 abstract description 2
- 239000004503 fine granule Substances 0.000 abstract 1
- 229960004793 sucrose Drugs 0.000 description 83
- 239000003826 tablet Substances 0.000 description 24
- 239000007938 effervescent tablet Substances 0.000 description 12
- 239000000047 product Substances 0.000 description 11
- 238000005469 granulation Methods 0.000 description 9
- 230000003179 granulation Effects 0.000 description 9
- 239000003814 drug Substances 0.000 description 8
- 239000008187 granular material Substances 0.000 description 8
- 239000000203 mixture Substances 0.000 description 7
- 238000007907 direct compression Methods 0.000 description 6
- 238000009472 formulation Methods 0.000 description 5
- 229920002472 Starch Polymers 0.000 description 4
- 239000013078 crystal Substances 0.000 description 4
- 239000012798 spherical particle Substances 0.000 description 4
- 239000008107 starch Substances 0.000 description 4
- 235000019698 starch Nutrition 0.000 description 4
- 238000000034 method Methods 0.000 description 3
- 229920002261 Corn starch Polymers 0.000 description 2
- 238000000889 atomisation Methods 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 239000011230 binding agent Substances 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 239000008120 corn starch Substances 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 230000002349 favourable effect Effects 0.000 description 2
- 235000003599 food sweetener Nutrition 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 238000003825 pressing Methods 0.000 description 2
- 238000010298 pulverizing process Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000003765 sweetening agent Substances 0.000 description 2
- 229920001353 Dextrin Polymers 0.000 description 1
- 239000004375 Dextrin Substances 0.000 description 1
- 229920002774 Maltodextrin Polymers 0.000 description 1
- 239000005913 Maltodextrin Substances 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- -1 buccal patches Substances 0.000 description 1
- 239000006189 buccal tablet Substances 0.000 description 1
- 239000007910 chewable tablet Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000013270 controlled release Methods 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 239000003405 delayed action preparation Substances 0.000 description 1
- 235000019425 dextrin Nutrition 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 239000007919 dispersible tablet Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000008298 dragée Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000002662 enteric coated tablet Substances 0.000 description 1
- 239000000413 hydrolysate Substances 0.000 description 1
- 229960004903 invert sugar Drugs 0.000 description 1
- 229940035034 maltodextrin Drugs 0.000 description 1
- 239000006191 orally-disintegrating tablet Substances 0.000 description 1
- 230000001590 oxidative effect Effects 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 239000007944 soluble tablet Substances 0.000 description 1
- 229940032147 starch Drugs 0.000 description 1
- 239000006190 sub-lingual tablet Substances 0.000 description 1
- 239000007940 sugar coated tablet Substances 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 239000007939 sustained release tablet Substances 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
- B01J2/16—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by suspending the powder material in a gas, e.g. in fluidised beds or as a falling curtain
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B3/00—Drying solid materials or objects by processes involving the application of heat
- F26B3/02—Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air
- F26B3/06—Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air the gas or vapour flowing through the materials or objects to be dried
- F26B3/08—Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air the gas or vapour flowing through the materials or objects to be dried so as to loosen them, e.g. to form a fluidised bed
- F26B3/084—Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air the gas or vapour flowing through the materials or objects to be dried so as to loosen them, e.g. to form a fluidised bed with heat exchange taking place in the fluidised bed, e.g. combined direct and indirect heat exchange
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Chemical & Material Sciences (AREA)
- Microbiology (AREA)
- Biochemistry (AREA)
- General Engineering & Computer Science (AREA)
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- Medicinal Preparation (AREA)
Abstract
The invention provides a fine sugar particle, which is provided with pores inside and approximately spherical outside, and is prepared by taking pure sucrose and not more than 0.5 percent of glucose syrup powder as raw materials; the grain diameter of the sugar fine particles is 30-100 meshes, the apparent density is 0.4-0.6g/ml, and the angle of repose is 30-35 degrees. The sugar fine granule has good fluidity, solubility and compressibility, and can be used as medicinal adjuvant for direct tabletting; the preparation method can prepare the sugar fine particles for direct tabletting by controlling the ratio of the volume of the fluidized bed to the weight of the material, the pressure of the water spray pump and the amount of hot air.
Description
The application is a divisional application with application number 201910268426.8, named as sugar fine particles and a preparation method, equipment and application thereof, and the application date of the master case (201910268426.8) is 2019, 4 months and 4 days.
Technical Field
The invention belongs to the field of pharmaceutical excipients, and particularly relates to a sugar fine particle, and a preparation method, equipment and application thereof.
Background
Sucrose is an important auxiliary material in pharmaceutical preparations, can be used as a sweetening agent and a filling agent of solid preparation tablets, plays roles of flavoring, shaping and the like, is widely applied to the pharmaceutical preparations, and has the following application forms in China:
1. crystallization of sucrose: i.e., sucrose crystals, as a sweetener, flavoring agent, filler, binder, coating material for sugar-coated tablets in the formulation. The powder is used in tablets, generally can not be directly compressed, but needs to be crushed into powdery sucrose for use;
2. sucrose powder: the sucrose powder collected by USPNF20 is a mixture of sucrose (C12H22O11) and corn starch, and contains not less than 95% of sucrose. In the formulation, sucrose powder may be used when it is desired to rapidly dissolve the sugar therein for flavoring or sweetening. The product can also be used as diluent in solid preparation prescription, and can be used as binder and filler for wet granulation. However, sucrose powder has high viscosity and poor fluidity and cannot be used for direct tabletting of tablets. The particle size range is 14-150 mu m;
3. compressible sucrose: the compressible sucrose carried by USPNF20 contains 95.0% -98% of sucrose (C12H22O11), and also can contain starch, maltodextrin, invert sugar and proper glidant, and can be used for directly tabletting with the particle size range of 75-425 μm;
4. spherical sucrose particles: the sucrose spherical particles carried by USPNF20 have uniform granularity, contain 62.5-91.5% of sucrose and mainly comprise starch as other components; the PhEur-loaded sucrose spherical particles contain no more than 92% of sucrose, and the balance of corn starch, starch hydrolysate and pigment, are used as inert cores in capsules and tablets, particularly multi-particle sustained-release preparations, and are coated with medicaments firstly and then with polymer materials, wherein the particle size of the sucrose spherical particles is 200-2000 mu m. The product label has a nominal particle size range;
on one hand, common sucrose is crystal particles with large granularity, and the sucrose needs to be crushed into sucrose powder for use. The specific usage is as follows: pulverizing sucrose into sugar powder, mixing with other raw materials and adjuvants, making into soft mass, making into wet granule, drying, grading, and tabletting. Common cane sugar and pulverized sugar powder can not be directly tabletted in one step in tablet production, namely all raw and auxiliary materials are uniformly mixed once and then tabletted, and the reason is that: the sucrose has large particles, and although the flowability is good, the original particles exist in the tablet by direct compression, so that the appearance, dissolution, disintegration and other properties of the tablet are influenced; however, after sucrose is pulverized into powdered sugar, although the solubility is improved, the powdered sugar has poor fluidity and poor mixing, and the powdered sugar cannot be discharged smoothly in the production of tablets, so that uniform tablets cannot be pressed.
On the other hand, sucrose products currently available for direct compression, such as compressible sucrose, sucrose spheroids, contain at least 2% or more of non-sucrose components, such as starch, dextrin, etc., and cannot be used in the formulation of effervescent tablets, since these components cannot be dissolved in water, and the quality requirement of effervescent tablet formulations is that they dissolve in water as a clear liquid.
Therefore, the development of the sucrose granules which can be directly used for tabletting has great application prospect.
Disclosure of Invention
In view of the drawbacks of the prior art, it is an object of the present invention to provide fine sugar particles which have good flowability, good solubility and good compressibility and can be used for direct compression.
It is another object of the present invention to provide a method for producing fine sugar particles.
It is still another object of the present invention to provide the use of the fine sugar particles as a pharmaceutical excipient.
It is still another object of the present invention to provide an apparatus for preparing the above fine sugar particles.
In order to achieve the purpose, the invention provides the following technical scheme:
in a first aspect, the present invention provides a fine sugar particle made from pure sucrose and not more than 0.5% glucose syrup powder as raw materials; the grain diameter of the sugar fine particles is 30-100 meshes, the apparent density is 0.4-0.6g/ml, and the angle of repose is 30-38 degrees.
In some preferred embodiments, the present invention provides fine sugar particles having a particle diameter of 40 to 80 mesh, an apparent density of 0.4 to 0.6g/ml, and an angle of repose of 32 ° to 35 °.
In some further preferred embodiments, the present invention provides fine sugar particles having a particle diameter of 60 to 80 mesh, an apparent density of 0.43 to 0.53g/ml, and an angle of repose of about 32 °.
Preferably, the fine sugar particles have pores inside and approximately spherical outside.
The inventor researches and discovers that the particle size, the apparent density and the angle of repose of the fine sugar particles have great influence on the performance of the fine sugar particles as the pharmaceutic adjuvant, and when the apparent density of the sucrose is more than 0.6g/ml, the fine sugar particles are not beneficial to being uniformly mixed with other substances; when the sucrose has an angle of repose larger than 38 degrees, the fluidity is poor, the uniform mixing is poor, and the smooth feeding cannot be realized, but the fine sugar particles provided by the invention have the apparent density of 0.4-0.6g/ml, the angle of repose of 32-35 degrees, good fluidity and good compressibility, and can be used for direct tabletting.
In a second aspect, the present invention provides a method for producing the above-described fine sugar particles, comprising the steps of: the sugar powder is prepared by crushing sucrose, the obtained sugar powder is blown up by hot air flow in a fluidized bed, and water is sprayed simultaneously, wherein the ratio of the volume of the fluidized bed to the weight of the materials is not less than 10.75L/KG, the pressure of a water spray pump is 3-8 KG, and the hot air amount is 3000-8000 cubic meters/hour.
Preferably, the present invention provides a method for preparing the above fine sugar particles, comprising the steps of: mixing 99.5% of sucrose and 0.5% of glucose syrup powder, crushing to obtain powdered sugar, blowing the powdered sugar by hot air flow in a fluidized bed, and spraying water simultaneously to obtain the sugar powder, wherein the ratio of the volume of the fluidized bed to the weight of the materials is not less than 10.75L/KG, the pressure of a water spray pump is 3-8 KG, and the hot air amount is 3000-8000 cubic meters per hour.
According to the preparation method, the water spraying is performed by a two-way compressed air spraying gun, so that the controllable degree of the grain size of the prepared sugar fine grains is higher; preferably, the water spraying is performed by a two-way compressed air spraying gun, and the fog drops sprayed by the two-way compressed air spraying gun are 0.5-20 microns.
The method blows the obtained powdered sugar by hot air flow, sprays water to lead the powdered sugar to be gathered into new particles again, the new particles collide in the hot air flow and are dried, the prepared fine powdered sugar particles have pores inside, smooth surface and good fluidity, and can be used for direct tabletting in the production of tablets, thereby greatly saving the production cost of the tablets.
In a third aspect, the invention also provides the application of the fine sugar particles as a pharmaceutical excipient, in particular the application as a solid preparation excipient (filler) and/or a flavoring agent. The raw material of the prepared sugar fine particles is at least 99.5 percent of sucrose, and the sugar fine particles contain little other reducing sugar components, so that on one hand, the sugar fine particles are compatible with the medicine and have good use stability, and the stability of the prepared medicine preparation is facilitated; on the other hand, the tablet prepared by taking the auxiliary material as the auxiliary material can be completely dissolved in water to form a clear solution, and is particularly suitable for effervescent tablets.
According to the application of the invention, the solid preparation comprises but is not limited to tablets, granules, capsules and powder.
For use according to the present invention, the tablets include, but are not limited to, plain tablets, buccal tablets, sublingual tablets, buccal patches, chewable tablets, dispersible tablets, soluble tablets, effervescent tablets, vaginal effervescent tablets, sustained release tablets, controlled release tablets, enteric-coated tablets and orally disintegrating tablets; preferably, the tablets are plain tablets and effervescent tablets.
In a fourth aspect, the invention also provides a boiling granulation dryer for preparing the fine sugar particles, which comprises an air inlet pipe, a fluidized bed and an air outlet pipe which are sequentially connected, wherein an air filter, a plate heat exchanger, an adjusting air valve, a hot air chamber and a screen are sequentially arranged in the air inlet pipe, a plurality of spray guns are arranged in the fluidized bed from bottom to top, the effective boiling volume of the fluidized bed is not less than 10.75L/KG, and the spray guns are two-way compressed air spray guns.
Further, the number of the spray guns is 5.
The fine sugar particles provided by the invention have good fluidity, can be used for one-step tabletting in tablet production, and greatly saves the production cost; the sucrose content is extremely high, the tablet product can be completely dissolved in water to form a clear solution after being produced into the tablet product, the effervescent tablet is particularly suitable for producing effervescent tablets, and meanwhile, as other reducing sugar components are rarely contained, the effervescent tablet is more stable in compatibility and use with medicines, and is more favorable for the medicine stability of the preparation product.
The invention provides a specific boiling granulation dryer, on one hand, the effective boiling volume during granulation is ensured by controlling the effective boiling volume of the fluidized bed to be not less than 10.75L/KG; on the other hand, a plurality of spray guns are arranged in the fluidized bed from top to bottom at different heights, and the hollow degree, the particle size, the apparent density and the like of the granulation can be adjusted by selecting the spray guns with different heights; in the third aspect, the spray gun of the dryer adopts two paths of compressed air, the atomization effect of the spray gun is obviously better than that of the spray gun with a single air path in the prior art, more uniform and finer atomized droplets of water can be obtained, the atomized droplets are the aggregation center of granulation, and pores are formed in the granules after the granulation and the drying are carried out, so that the water is evaporated. Therefore, the more uniform the atomization, the greater the range in which the particle size of the atomized droplets can be adjusted, and the greater the degree of control over the granulation of the product. The spray gun can spray 0.5-20 micron uniform fog drops by adjusting the pressure of compressed air. By adopting the fluidized granulation dryer, fine sugar particles with good fluidity, good solubility and good compressibility can be produced.
In particular, the present invention has the following outstanding advantages over the prior art:
(1) the sucrose content in the sucrose particles is up to 99.5%: the sugar fine particles consist of 99.5 percent of sucrose (C12H22O11) and 0.5 percent of Spray-dried glucose syrup powder (DE value is less than or equal to 30);
currently, sucrose products that can be used for direct compression, such as compressible sucrose, sucrose spherical granules, all contain at least more than 2% of non-sucrose components; on one hand, the above sucrose product for direct compression cannot be used in the prescription of effervescent tablets, since these components cannot be dissolved in water, and the quality requirement of effervescent tablet formulation is that it is dissolved in water as a clear liquid; on the other hand, it is difficult to use as an oxidative pharmaceutical adjuvant due to the presence of higher levels of non-sucrose components, especially reducing sugars.
The sucrose particles of the invention can be completely dissolved in water to form clear solution after being produced into tablet products due to extremely high sucrose content, and are particularly suitable for producing effervescent tablets; meanwhile, the content of the sucrose component is extremely high, and the content of other components is extremely low, so that the compatibility of the sucrose particles and the medicament is more stable, and the stability of the medicament of a preparation product is more favorable.
(2) The sucrose particles have a particle size of 30-100 meshes, an apparent density of 0.4-0.6g/ml, and an angle of repose of below 38 deg.
The inventors found that the particle diameter, apparent density and angle of repose of fine sugar particles greatly affect the performance of the fine sugar particles as a pharmaceutical excipient; when the apparent density is more than 0.6g/ml, the mixture is not beneficial to being mixed with other substances; sucrose with an angle of repose greater than 38 degrees has poor fluidity and poor mixing, and cannot be discharged smoothly.
The sucrose particles have the apparent density of 0.4-0.6g/ml, the angle of repose of 30-38 degrees, good fluidity, good disintegration and good compressibility, and can be used for direct tabletting.
The mesh number of the sucrose can be adjusted, and the general crystal sucrose has about 20 meshes, so that the mesh number of the sucrose is relatively consistent with that of other materials; the sucrose granules have pores inside, so that the sucrose granules have compressibility and become straight-pressing sucrose (direct-pressing sucrose); the sucrose particles are internally provided with pores, so that the apparent density of the sucrose particles is reduced, and the sucrose particles can be better mixed with other materials.
(3) The preparation process of the sucrose comprises the following steps: pulverizing commercially available sucrose to obtain sugar powder; blowing the obtained powdered sugar with hot air flow in fluidized bed, spraying water, and granulating in hot air flow to obtain white or quasi-white granules; the water spraying is carried out by a two-way compressed air spray gun, so that the controllable degree of the grain diameter of the prepared sugar fine grains is higher.
The method blows the obtained powdered sugar by hot air flow, sprays water to lead the powdered sugar to be gathered into new particles again, the new particles collide in the hot air flow with the ratio of the fluidized bed volume to the material weight not less than 10.75L/KG, and the prepared fine powdered sugar particles have pores inside, smooth surfaces and good fluidity, can be used for direct tabletting in the production of tablets, and greatly saves the production cost of the tablets.
Drawings
Fig. 1 is a schematic structural diagram of a boiling granulation dryer.
Detailed Description
The fine sugar particles of the present invention are further explained below.
Example 1 preparation of sugar Fine particles
Mixing sucrose and glucose syrup powder with the ratio of 99.9:0.1, crushing to prepare powdered sugar with the particle size of 100 meshes, blowing the powdered sugar by hot air flow in a fluidized bed, and spraying water, wherein the ratio of the volume of the fluidized bed to the weight of the materials is 10.75L/KG, the pressure of a water spray pump is 3 kilograms, and the hot air amount is 8000 cubic meters per hour. The prepared sugar fine particles have the particle size of 60 meshes, the apparent density of 0.53g/ml and the angle of repose of 32 degrees.
Example 2 preparation of sugar Fine particles
Mixing sucrose and glucose syrup powder with the ratio of 99.5:0.5, crushing to prepare powdered sugar with the particle size of 100 meshes, blowing the powdered sugar by hot air flow in a fluidized bed, and spraying water, wherein the ratio of the volume of the fluidized bed to the weight of the materials is 10.75L/KG, the pressure of a water spray pump is 5 kilograms, and the hot air amount is 8000 cubic meters per hour. The prepared sugar fine particles have the particle size of 70 meshes, the apparent density of 0.48g/ml and the angle of repose of 32 degrees.
EXAMPLE 3 preparation of sugar Fine particles
Mixing sucrose and glucose syrup powder with the ratio of 99.7:0.3, crushing to prepare powdered sugar with the particle size of 100 meshes, blowing the powdered sugar by hot air flow in a fluidized bed, and spraying water, wherein the ratio of the volume of the fluidized bed to the weight of the materials is 10.75L/KG, the pressure of a water spray pump is 8 KG, and the hot air amount is 5000 cubic meters per hour. The prepared sugar fine particles have the particle size of 100 meshes, the apparent density of 0.43g/ml and the angle of repose of 32 degrees.
EXAMPLE 4 preparation of sugar Fine particles
Mixing sucrose and glucose syrup powder with the ratio of 99.7:0.3, crushing to prepare powdered sugar with the particle size of 120 meshes, blowing the powdered sugar by hot air flow in a fluidized bed, and spraying water, wherein the ratio of the volume of the fluidized bed to the weight of the materials is 10.75L/KG, the pressure of a water spray pump is 7 KG, and the hot air amount is 7000 cubic meters per hour. The prepared sugar fine particles have the particle size of 80 meshes, the apparent density of 0.43g/ml and the angle of repose of 32 degrees.
EXAMPLE 5 preparation of sugar Fine particles
Mixing sucrose and glucose syrup powder with the ratio of 99.7:0.3, crushing to prepare powdered sugar with the particle size of 120 meshes, blowing the powdered sugar by hot air flow in a fluidized bed, and spraying water, wherein the ratio of the volume of the fluidized bed to the weight of the materials is 10.75L/KG, the pressure of a water spray pump is 7 KG, and the hot air amount is 7000 cubic meters per hour. The prepared sugar fine particles have the particle size of 100 meshes, the apparent density of 0.43g/ml and the angle of repose of 38 degrees.
EXAMPLE 6 preparation of sugar Fine particles
Mixing sucrose and glucose syrup powder with the ratio of 99.7:0.3, crushing to prepare powdered sugar with the particle size of 120 meshes, blowing the powdered sugar by hot air flow in a fluidized bed, and spraying water, wherein the ratio of the volume of the fluidized bed to the weight of the materials is 10.75L/KG, the pressure of a water spray pump is 3 kilograms, and the hot air amount is 3000 cubic meters per hour. The prepared sugar fine particles have the particle size of 30 meshes, the apparent density of 0.40g/ml and the angle of repose of 30 degrees.
Example 7 preparation of sugar Fine particles
Mixing sucrose and glucose syrup powder with the ratio of 99.7:0.3, crushing to prepare powdered sugar with the particle size of 120 meshes, blowing the powdered sugar by hot air flow in a fluidized bed, and spraying water, wherein the ratio of the volume of the fluidized bed to the weight of the materials is 10.75L/KG, the pressure of a water spray pump is 8 KG, and the hot air amount is 8000 cubic meters per hour. The prepared sugar fine particles have the particle size of 100 meshes, the apparent density of 0.60g/ml and the angle of repose of 35 degrees.
Experimental example 1 flowability and solubility
The quality standard of the sugar fine particles basically refers to the quality standard of sucrose in the current edition of Chinese pharmacopoeia, European pharmacopoeia and American pharmacopoeia. "sucrose" and "compressible sucrose" are recorded in the "Chinese pharmacopoeia" 2015 edition; the United states pharmacopoeia, European pharmacopoeia and Japanese medicine are loaded with 'cane sugar', 'compressible cane sugar', 'cane sugar powder' and 'cane sugar spherical particles'.
According to the manual of comparison of pharmaceutical adjuvant standards of various countries, which is compiled by the committee of national pharmacopoeia, the recent editions recorded in the pharmacopoeia of sucrose at home and abroad at present are the Chinese pharmacopoeia (2015 edition), the United states pharmacopoeia (38 th edition), the European pharmacopoeia (8.5 edition), and the Japanese medicinal prescription (16 th edition).
The flowability, density and solubility of the fine sugar particles, the commercial sucrose crystals and the commercial sucrose powder prepared in example 4 were measured, and the results are shown in Table 1.
TABLE 1
As can be seen from Table 1, the sugar fine particles prepared in the examples of the present invention have appropriate angle of repose, low bulk and tap densities, good flowability, good disintegratability, and good compressibility, and can be used for direct compression.
Claims (9)
1. A fine sugar particle characterized by: the sugar fine particles are prepared by taking pure sucrose and not more than 0.5 percent of glucose syrup powder as raw materials; the grain diameter of the sugar fine particles is 30-100 meshes, the apparent density is 0.4-0.6g/ml, and the angle of repose is 30-38 degrees.
2. The sugar fine particles according to claim 1, characterized in that: the sugar fine particles have a particle size of 40-80 meshes, an apparent density of 0.4-0.6g/ml and an angle of repose of 32-35 degrees.
3. The sugar fine particles according to claim 1, characterized in that: the sugar fine particles have a particle size of 60 to 80 mesh, an apparent density of 0.43 to 0.53g/ml, and an angle of repose of about 32 °.
4. The sugar fine particles according to claim 1, characterized in that: the inside of the sugar fine particle is provided with pores, and the outside is approximately spherical.
5. The method for producing the sugar fine particles as set forth in claim 1, comprising the steps of: mixing and crushing sucrose and glucose syrup powder according to the formula amount to obtain powdered sugar, blowing the powdered sugar by hot air flow in a fluidized bed, and spraying water simultaneously to obtain the sugar powder, wherein the ratio of the volume of the fluidized bed to the weight of the materials is not less than 10.75L/KG, the pressure of a water spray pump is 3-8 KG, and the hot air amount is 3000-8000 cubic meters per hour.
6. The method for producing sugar fine particles according to claim 5, characterized in that: the water spraying is carried out by a two-way compressed air spray gun, so that the controllable degree of the grain diameter of the prepared sugar fine grains is higher.
7. Use of the fine saccharide particles according to any one of claims 1 to 4 as a pharmaceutical excipient.
8. The use of claim 7, wherein: the fine sugar particles are used as solid preparation excipient (filler) and/or flavoring agent.
9. The boiling granulating drier for preparing sugar fine particles as claimed in any one of claims 1 to 4, comprising an air inlet pipe (1), a fluidized bed (2) and an air outlet pipe (3) which are connected in sequence, wherein an air filter (11), a plate heat exchanger (12), an adjusting air valve (13), a hot air chamber (14) and a screen (15) are arranged in the air inlet pipe (1) in sequence, and a plurality of spray guns (21) are arranged in the fluidized bed (2) from bottom to top, characterized in that: the effective boiling volume of the fluidized bed (2) is 10.75L/KG, and the spray gun (21) is a two-way compressed air spray gun.
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| CN108721631A (en) * | 2018-06-13 | 2018-11-02 | 沈惠 | A kind of sucrose fine grained and preparation method thereof, equipment and application |
| CN110578020A (en) * | 2019-09-24 | 2019-12-17 | 广西南宁万宇科技有限公司 | Method for preparing compressible sucrose from sucrose syrup |
| CN114100508A (en) * | 2021-11-11 | 2022-03-01 | 北京亚东生物制药(安国)有限公司 | Spray granulation equipment |
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