CN115445526A - Powder and film surface treatment fluidization equipment and working method thereof - Google Patents
Powder and film surface treatment fluidization equipment and working method thereof Download PDFInfo
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Abstract
A powder and membrane surface treatment fluidization device and a working method thereof are disclosed, the device comprises a temperature and humidity control box and a box door, the temperature and humidity control box comprises a constant temperature and humidity chamber and an electric appliance chamber, an air outlet is arranged at the top of the temperature and humidity control box, a control system is arranged at one side of the temperature and humidity control box, which is far away from the box door, the control system comprises a control unit, a compressor, a liquid box, a radiator, an air pump, a humidification unit and an exhaust hole, and the control unit is respectively and electrically connected with the humidification unit, the compressor and the radiator; an air inlet hole of an air pump, an air outlet hole and a fluidization tank assembly are arranged in the constant-temperature and constant-humidity cavity, and a compressor, a liquid tank, a radiator, a humidification unit and an air pump are arranged in the electric appliance cavity; the humidifying unit is respectively connected with the liquid tank and the exhaust hole, the air pump is respectively connected with the air inlet hole of the air pump and the bottom of the fluidization tank assembly through pipelines, and the top of the fluidization tank assembly is connected with the air outlet. Can be used for aging treatment, static electricity removal, moisture removal, residual solvent removal and powder particle surface modification treatment of powder and coated particles.
Description
Technical Field
The invention belongs to the technical field of medical equipment, and particularly relates to powder and film surface treatment fluidization equipment and a working method thereof.
Background
In the pharmaceutical field, almost all preparations involve processing of powder particles, such as mixing, precipitation, micronization, coating, etc. The drug and adjuvant particles may generate static electricity in these processes, contain residual solvent or moisture, have an amorphous surface, have high surface potential energy, and are unstable in plating.
To eliminate these disadvantages, a number of process technologies have been developed. However, the treatment of respiratory tract preparation powder and the treatment of aging of coated particles are lack of effective technical means.
Therefore, the above problems need to be solved.
Disclosure of Invention
The purpose of the invention is as follows: in order to overcome the defects of the prior art, the invention aims to provide a fluidizing device for powder and film surface treatment, which is used for aging treatment, static electricity removal, moisture removal, residual solvent removal and powder particle surface modification treatment of powder and coated particles.
The technical scheme is as follows: the invention provides powder and film surface treatment fluidization equipment which comprises a temperature and humidity control box and a box door, wherein the temperature and humidity control box comprises a constant-temperature constant-humidity cavity and an electrical appliance cavity, an air outlet is formed in the top of the temperature and humidity control box, a control system is arranged on one side, away from the box door, of the temperature and humidity control box, the control system comprises a control unit, a compressor, a liquid box, a radiator, an air pump, a humidification unit and an exhaust hole, and the control unit is electrically connected with the humidification unit, the compressor and the radiator respectively;
an air inlet hole of an air pump, an air outlet hole and a fluidization tank assembly are arranged in the constant-temperature and constant-humidity cavity, and a compressor, a liquid tank, a radiator, a humidifying unit and an air pump are arranged in the electric appliance cavity; the humidifying unit is respectively connected with the liquid tank and the exhaust hole, the air pump is respectively connected with the air inlet hole of the air pump and the bottom of the fluidization tank assembly through a pipeline, and the top of the fluidization tank assembly is connected with the air outlet. The powder and film surface treatment fluidization equipment is reasonable in structure, wherein a humidity sensor and a temperature sensor are arranged in a constant-temperature and constant-humidity cavity and are electrically connected with a control unit, and a humidification unit breaks water in a liquid tank into tiny particles and enables the air to be humidified to a set humidity through air entering the humidification unit in a dispersing mode through a fan; the compressor and/or the radiator are operated to maintain the humidified air at a set temperature, thereby obtaining constant temperature and humidity of the air. The constant-temperature and constant-humidity air is conveyed into the fluidized tank assembly through the air pump, and the powder in the fluidized tank assembly is subjected to fluidization treatment, so that the fluidized tank assembly can be used for aging treatment, static electricity removal, moisture removal, residual solvent removal and powder particle surface modification treatment of the powder and coated particles, and can treat 0.1-1500 microns of powder and coated particles.
As an improvement mode of the invention, after the gas outlet of the fluidization equipment is connected with the waste gas recovery device, the liquid tank can also contain organic solvents such as methanol, acetone, ethanol, hexane and the like according to samples to be processed, the humidifying device can send organic solvent steam into the constant-temperature constant-humidity cavity by using the humidifying principle for the organic solvents to obtain supersaturated solvent steam, and the solvent steam also carries out fluidization treatment on powder in the fluidization tank component through the fluidization tank component, so that the fluidization equipment can process more kinds of samples and has good adaptability. At the same time, the compressor and/or the heat sink may also heat the organic solvent vapor to a set temperature.
Further, in the powder and film surface treatment fluidization device, the fluidization tank assembly comprises an upper end cover, a fluidization tank body, a lower end cover and a rotary transmission mechanism, the upper end cover and the lower end cover are respectively arranged at the upper end part and the lower end part of the fluidization tank body, and the lower end cover is also connected with the rotary transmission mechanism; the upper end cover is connected with the air outlet. The fluidization tank assembly is reasonable in structure, the fluidization tank body can be replaced, and the volume can be selected from different specifications of 0.5L-40L. Preferably, the fluidization tank body is installed in an inclined mode, and the tank body is designed to be installed in an inclined mode, so that the powder particles in the fluidization tank body can be continuously turned over through the reciprocating rotation driven by the rotary transmission mechanism, and gas can uniformly flow through the tank body conveniently. Preferably, the fluidization tank body is made of a completely transparent PC material, so that whether the medicine powder particles in the fluidization tank body are uniformly turned can be clearly monitored, the trend of air flow can be conveniently observed, and the medicine powder particles are uniformly fluidized.
Further, in the powder and film surface treatment fluidization device, the rotary transmission mechanism comprises a rotating shaft, a transmission box body, a helical gear, a right-angle pipeline joint, a straight gear, a motor fixing seat and a servo motor, the rotating shaft is arranged on the transmission box body, and the helical gear is arranged on the rotating shaft; a servo motor is arranged on the motor fixing seat, a straight gear is arranged on the servo motor, and the helical gear is meshed with the straight gear; the right-angle pipeline joint is arranged on the transmission box body and is connected with the air pump through a pipeline. The rotary transmission mechanism has reasonable structure and good driving stability.
Furthermore, according to the powder and film surface treatment fluidization device, the sealing rings are arranged between the fluidization tank body and the upper end cover and between the fluidization tank body and the lower end cover respectively, so that the sealing performance is good, and the device performance is stable.
Furthermore, according to the powder and film surface treatment fluidization device, the locking ring is arranged between the rotating shaft and the lower end cover, so that the rotating shaft and the lower end cover are fixed stably, can be prevented from falling off, and can ensure that the fluidization tank body rotates stably.
Furthermore, in the powder and film surface treatment fluidization device, a filter screen cloth and a shunt net component are arranged in the upper end cover and the lower end cover. The end cover of the fluidization tank body adopts the design of the sub-channel/the sub-flow mesh and the filter screen cloth, so that the airflow can be uniformly distributed in the whole fluidization tank body.
Further, foretell powder and membrane surface treatment fluidizing device, the chamber door includes chamber door and lower chamber door, it is equipped with the chamber door handle to go up the chamber door side, still be equipped with fluidization jar control panel and temperature and humidity control screen on going up the chamber door, fluidization jar control panel and temperature and humidity control screen and the control unit electric connection. In addition, the fluidization box body/the upper box door/the lower box door and the constant-temperature constant-humidity chamber are all provided with heat insulation layers, and heat insulation media are arranged in the heat insulation layers for heat insulation. Wherein the temperature and humidity of the gas in the constant temperature and humidity chamber can be adjusted by the temperature and humidity control panel to maintain the constant temperature and humidity conditions in the constant temperature and humidity chamber, wherein the temperature is controlled to be within a range of 20-90 deg.C, with an error of + -1.5 deg.C, and the humidity is controlled to be within a range of 20-90% RH, with an error of + -2% RH. Meanwhile, the constant-temperature and constant-humidity cavity is designed by adopting built-in light, and the temperature and humidity control screen can control the light of the constant-temperature and constant-humidity cavity. In addition, the rotating angle and the rotating speed of the fluidization tank body can be adjusted through the fluidization tank control screen, and the flow and the speed of gas entering the fluidization tank can be adjusted through adjusting a pressure gauge in the air pump. In addition, the reciprocating rotation angle and speed of the fluidization tank body are adjusted by the fluidization tank control screen, so that each powder particle can be uniformly fluidized as much as possible.
Furthermore, the upper box door of the powder and film surface treatment fluidization device is also provided with a transparent window. The upper box door of the fluidization box is designed to adopt a middle large transparent window, so that the working condition of the fluidization tank body in the constant-temperature and constant-humidity cavity can be conveniently observed and monitored.
Further, foretell powder and membrane surface treatment fluidization device, still be equipped with the case backplate behind the atmospheric control case, still be equipped with a set of louvre on the case backplate, the louvre is located electrical apparatus chamber one end. The box back plate is reasonable in structure, dust prevention and heat dissipation are facilitated, the stable performance of the whole equipment can be guaranteed, and the working efficiency is improved.
The invention also provides a working method of the powder and film surface treatment fluidization equipment, which comprises the following steps:
the control unit controls the humidifying unit, the compressor and/or the radiator to work, humidifies the air to a preset temperature and humidity, obtains constant-temperature and constant-humidity gas, and sends the constant-temperature and constant-humidity gas into the constant-temperature and constant-humidity cavity through the exhaust hole;
the air pump pumps out the constant-temperature and constant-humidity air in the constant-temperature and constant-humidity cavity from the air inlet hole of the air pump, and the constant-temperature and constant-humidity air sequentially passes through the right-angle pipeline joint, the central hole of the bevel gear, the central hole of the rotating shaft and the lower end cover through the pipeline and enters the fluidized tank body; after the lower end cover performs shunting filtration on the gas, the gas uniformly enters the fluidized tank body to uniformly contact with the material, and the overflowed gas is filtered through the upper end cover and then discharged through the gas outlet;
meanwhile, the servo motor rotates, and the rotating shaft drives the fluidization tank body to rotate in a reciprocating mode through transmission of the straight gear and the helical gear.
The working method of the powder and film surface treatment fluidization equipment is reasonable, convenient to apply and capable of treating 0.1-1500 micron powder and coated particles. The gas passing through the fluidization tank assembly can be air with constant temperature and humidity, dry nitrogen, organic steam and the like, different types of samples can be processed, and the adaptability is good.
The technical scheme shows that the invention has the following beneficial effects: the powder and film surface treatment fluidization equipment provided by the invention is reasonable in structure and convenient to apply, can be used for aging treatment, static electricity removal, moisture removal, residual solvent removal and powder particle surface modification treatment of powder and coated particles, and can treat 0.1-1500 micron powder and coated particles.
Drawings
FIG. 1 is a schematic structural view of a powder and film surface treatment fluidizing apparatus according to the present invention;
FIG. 2 is a schematic view of the construction of a fluidization tank assembly according to the present invention;
FIG. 3 is a schematic diagram of the electrical connection of the powder and film surface treatment fluidizing apparatus according to the present invention;
FIG. 4 is a graph showing the results of detecting the particle size distribution before and after the fluidization treatment in example 3 of the present invention;
FIG. 5 is a graph showing the results of the dynamic steam adsorption method for determining the adsorption characteristics after the fluidization treatment in example 3 of the present invention;
FIG. 6 is a graph showing the results of detecting the particle size distribution before and after the fluidization treatment in example 4 of the present invention;
FIG. 7 is a graph showing the results of detecting the particle size distribution before and after the fluidization treatment in example 5 of the present invention;
FIG. 8 is a graph showing the results of detecting the particle size distribution before and after the fluidization treatment in example 6 of the present invention;
FIG. 9 is a graph showing the results of detecting the particle size distribution before and after the fluidization treatment in example 7 of the present invention;
in the figure: 1 temperature and humidity control box, 11 constant temperature and humidity chamber, 12 electric appliance chamber, 13 air outlet, 14 air pump air inlet holes, 15 exhaust holes, 2 box doors, 21 upper box door, 22 lower box door, 211 box door handle, 212 fluidization tank control screen, 213 temperature and humidity control screen, 214 transparent window, 3 compressor, 4 liquid box, 5 radiator, 6 air pump, 7 box back plate, 71 heat dissipation holes, 8 fluidization tank assembly, 81 upper end cover, 82 fluidization tank body, 83 lower end cover, 84 rotation transmission mechanism, 841 rotating shaft, 842 transmission box body, 843 helical gear, 844 right-angle pipeline connector 845, spur gear, 846 motor fixing seat, 847 servo motor, 85 sealing ring and 86 locking ring.
Detailed Description
Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention.
In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "clockwise", "counterclockwise", and the like, indicate orientations and positional relationships based on those shown in the drawings, and are used only for convenience of description and simplicity of description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be considered as limiting the present invention.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, unless otherwise specified, "a plurality" means two or more unless explicitly defined otherwise.
In the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
In the present invention, unless otherwise expressly stated or limited, "above" or "below" a first feature means that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact with each other via another feature therebetween. Also, the first feature "on," "above" and "over" the second feature may include the first feature being directly above and obliquely above the second feature, or simply indicating that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature includes the first feature being directly under and obliquely below the second feature, or simply meaning that the first feature is at a lesser elevation than the second feature. The liquid tank is a general name, and not only can contain water, but also can contain other liquids.
Example 1
The powder and film surface treatment fluidization equipment shown in fig. 1 comprises a temperature and humidity control box 1 and a box door 2, wherein the temperature and humidity control box 1 comprises a constant-temperature constant-humidity cavity 11 and an electrical appliance cavity 12, an air outlet 13 is formed in the top of the temperature and humidity control box 1, and a control system (not shown) is arranged on one side, away from the box door 2, of the temperature and humidity control box 1. The control system comprises a control unit, a compressor 3, a liquid tank 4, a radiator 5, a humidifying unit and an exhaust hole 15, and as shown in fig. 3, the control unit is electrically connected with the humidifying unit, the compressor 3, the radiator 5 and the air pump 6 respectively.
Further, an air pump air inlet 14, an air outlet 15 and a fluidization tank assembly 8 are arranged in the constant-temperature and constant-humidity chamber 11, a humidity sensor and a temperature sensor (not shown) are further arranged in the constant-temperature and constant-humidity chamber 11, and the humidity sensor and the temperature sensor are electrically connected with the control unit. In addition, a compressor 3, a liquid tank 4, a radiator 5, a humidifying unit and an air pump 6 are arranged in the electric appliance cavity 12. The humidifying unit (not shown) is connected with the liquid tank 4 and the exhaust hole 15 respectively, the air pump 6 is connected with the air inlet hole 14 of the air pump and the bottom of the fluidization tank assembly 8 through pipelines respectively, and the top of the fluidization tank assembly 8 is connected with the air outlet 13.
As shown in fig. 2, the fluidization tank assembly 8 includes an upper end cover 81, a fluidization tank 82, a lower end cover 83 and a rotation transmission mechanism 84, the upper end cover 81 and the lower end cover 83 are respectively disposed at the upper end and the lower end of the fluidization tank 82, and the lower end cover 83 is further connected to the rotation transmission mechanism 84; the upper end cover 81 is connected to the air outlet 13. Moreover, the fluidization tank 82 can be replaced, the volume of the fluidization tank is 0.5L-40L, the fluidization tank 82 is installed in an inclined mode, and the fluidization tank 82 is installed in an inclined mode, so that the powder particles in the fluidization tank 82 are continuously turned over through reciprocating rotation driven by the rotary transmission mechanism 84, and gas can uniformly flow through the tank. In addition, the fluidization tank 82 is made of a completely transparent PC material, so that whether the medicine powder particles in the fluidization tank 82 are uniformly turned over or not can be clearly monitored.
Further, the rotation transmission mechanism 84 includes a rotation shaft 841, a transmission case 842, a helical gear 843, a right-angle pipe joint 844, a spur gear 845, a motor fixing seat 846, and a servo motor 847. The transmission case 842 is provided with a rotating shaft 841, and the rotating shaft 841 is provided with a helical gear 843. In addition, a servo motor 847 is arranged on the motor fixing seat 846, a straight gear 845 is arranged on the servo motor 847, and the helical gear 843 is meshed with the straight gear 845. The right-angle pipe connector 844 is arranged on the transmission case 842, and the right-angle pipe connector 844 is arranged on the transmission case 842 and connected with the air pump 6 through a pipe. Moreover, sealing rings 85 are respectively arranged between the fluidization tank 82 and the upper end cover 81 and between the fluidization tank and the lower end cover 83. And a filter screen cloth and a shunt net component are arranged in the upper end cover 81 and the lower end cover 83. In addition, a locking ring 86 is further disposed between the rotating shaft 841 and the lower end cover 83.
In addition, the box door 2 comprises an upper box door 21 and a lower box door 22, a box door handle 211 is arranged on the side surface of the upper box door 21, a fluidization tank control screen 212 and a temperature and humidity control screen 213 are further arranged on the upper box door 21, and a transparent window 214 is further arranged on the upper box door 21. The fluidization tank control screen 212 and the temperature and humidity control screen 213 are electrically connected with the control unit. The humidity sensor and the temperature sensor are electrically connected with the temperature and humidity control screen 213 through the control unit. The temperature and humidity of the gas in the constant temperature and humidity chamber 11 can be adjusted by the temperature and humidity control panel 213, and the constant temperature and humidity condition in the constant temperature and humidity chamber can be maintained, wherein the temperature can be controlled within 20-90 ℃, the error is + -1.5 ℃, the humidity can be controlled within 20-90% RH, and the error is + -2% RH. Meanwhile, the constant temperature and humidity chamber 11 adopts a built-in light design, and the temperature and humidity control screen 213 can control the light of the constant temperature and humidity chamber 11. In addition, the angle of rotation and the speed of rotation of the fluidization tank 82 can be adjusted by the control unit through the fluidization tank control panel 212, and the flow rate and speed of the gas entering the fluidization tank 82 can be adjusted by adjusting the pressure gauge in the gas pump 6. In addition, the angle and speed of the reciprocating rotation of the fluidization tank 82 are adjusted by the fluidization tank control screen 212, so that each powder particle can be uniformly fluidized as much as possible. In addition, the fluidization tank 82, the upper box door 21, the lower box door 22 and the constant temperature and humidity chamber 11 are all provided with heat insulation layers, and heat insulation media are arranged in the heat insulation layers for heat insulation.
Further, according to the powder and film surface treatment fluidization device, a box back plate 7 is further arranged behind the temperature and humidity control box 1, a group of heat dissipation holes 71 are further formed in the box back plate 7, and the heat dissipation holes 71 are formed in one end of the electric appliance cavity 12.
When in work, based on the structure foundation, the method comprises the following steps:
the control unit controls the humidifying unit, the compressor 3 and/or the radiator 5 to work, humidifies the air to a preset temperature and humidity, obtains constant-temperature and constant-humidity gas, and sends the constant-temperature and constant-humidity gas into the constant-temperature and constant-humidity chamber 11 through the exhaust hole 15; the gas in the constant temperature and humidity chamber 11 is always kept at constant temperature and humidity;
the air pump 6 pumps the constant-temperature and constant-humidity air in the constant-temperature and constant-humidity cavity 11 out of the air pump air inlet 14, and the constant-temperature and constant-humidity air sequentially passes through the right-angle pipeline joint 844, the central hole of the helical gear 843, the central hole of the rotating shaft 841 and the lower end cover 83 through pipelines and enters the fluidization tank body 82; after the lower end cover 83 divides the flow of the gas and filters the gas, the gas uniformly enters the fluidization tank 82 to uniformly contact with the material, and the overflowed gas is filtered through the upper end cover 81 and then is discharged through the gas outlet 13;
meanwhile, the servo motor 847 rotates, and the rotating shaft 841 drives the fluidization tank 82 to rotate in a reciprocating manner through transmission of the straight gear 845 and the helical gear 843.
The powder and film surface treatment fluidization equipment can be used for aging treatment, static electricity removal, moisture removal, residual solvent removal and powder particle surface modification treatment of powder and film coating particles, and can treat 0.1-1500 micron powder and film coating particles.
Example 2:
on the basis of the structure of embodiment 1, the fluidizing apparatus of this embodiment is further provided with an exhaust gas recovery device (not shown), and the exhaust gas recovery device is connected to the gas outlet 13. In this embodiment, the liquid tank 4 may contain organic solvents such as methanol, acetone, ethanol, hexane, etc., according to the sample to be processed.
In operation, based on the above structure, in this embodiment, the humidifying device can send the organic solvent vapor into the constant temperature and humidity chamber 11 by using the "humidifying" principle to obtain the supersaturated solvent vapor, and the solvent vapor also fluidizes the powder in the fluidization tank assembly 8 through the fluidization tank assembly 8, similar to the operation process of embodiment 1. At the same time, the compressor 3 and/or the heat radiator 5 may also heat the organic solvent vapor to a set temperature.
Example 3: effect of fluidization equipment treatment on particle size and surface properties of salbutamol sulfate powder
The powder and film surface treatment fluidization device described in example 1 was used for treatment, the micronized salbutamol sulfate bulk drug was placed in the fluidization tank assembly 8, and the fluidization device gas flow rate was adjusted: 1L/min, setting fluidization conditions: temperature 25 deg.C, humidity 60%. And detecting the particle size before and after fluidization treatment, and determining the dynamic vapor adsorption characteristic after fluidization treatment.
By measuring the particle size of salbutamol sulfate powder before and after fluidization, as shown in FIG. 4, X 10 、X 50 、X 90 Respectively represents that the grain diameter of 10 percent, 50 percent and 90 percent of powder is less than or equal to the grain diameter value; VMD is the volume equivalent average particle size of the powder; SPAN represents the width of the particle size distribution of the powder, and the calculation formula is SPAN = (X) 90 -X 10 ）/X 50 . The Dynamic Vapor Sorption (DVS) properties of the fluidized powder were examined, as shown In fig. 5, and the left ordinate Change In Mass (%) -Ref indicates the Change In Mass with time and humidity, and the Mass (dm-dry) decreased from 0 and then increased with increasing humidity; the right ordinate, target% P/Po, represents the actual humidity, and the two regular ascending-descending stair-shaped graphs in the graph are humidity values. The dynamic vapor adsorption result is shown in fig. 5, and whether the two cycles have difference is detected and observed through the two adsorption and desorption cycles, if the difference exists, the existence of amorphous substances is indicated.
In summary, as shown in fig. 4 to 5, the difference between the particle sizes before and after the fluidization treatment is small, the particle size after the fluidization treatment is slightly small, and the particle size distribution becomes narrow (the SPAN value becomes small), because the fluidization treatment reduces the surface energy of the micronized salbutamol sulfate and reduces the cohesive force between the salbutamol sulfate particles. The dynamic vapor adsorption detection results are almost consistent in two cycles, which shows that the micronized salbutamol sulfate after fluidization has very high surface crystallinity and almost no amorphous substance exists.
Example 4: effect of organic steam fluidization on particle size of micronized budesonide powder
Using the fluidising apparatus described in example 2, 10g of micronised budesonide drug substance was dosed into each of the two fluidising tank assemblies 8. In this embodiment, the liquid tank 4 contains methanol and acetone, methanol saturated steam and acetone saturated steam are introduced into the apparatus, respectively, and the gas flow rate of the fluidizing apparatus is adjusted as follows: 9.8L/min, setting the fluidization conditions: the temperature is 25 ℃, the rotation is performed for 5 circles clockwise and 5 circles anticlockwise, the automatic rotation speed is 90 DEG/s, and the time is 6h. Sampling at 0h, 2h, 4h and 6h to detect the particle size.
In this example, the particle size of budesonide powder before and after different organic vapor fluidization treatments was measured, and the results are shown in fig. 6. After the budesonide powder is fluidized by methanol steam and acetone steam, the SPAN value is reduced compared with that before the treatment, and the particle size distribution is narrowed. The budesonide powder X50 treated with methanol vapor tended to grow gradually larger.
Example 5: effect of organic vapor and 95% humidity fluidization on the particle size of budesonide powder
10g of budesonide drug substance was put into each of the two fluidization tank assemblies 8, and the two drug substances were introduced into the fluidization apparatuses described in examples 2 and 1, respectively, and were processed. In this embodiment, the liquid tank 4 contains ethanol and water, ethanol saturated steam and 95% humidity (95% RH) are introduced, and the gas flow rate of the fluidizing device is adjusted: 8.0L/min, set the fluidization conditions: the temperature is 25 ℃, the clockwise rotation is 5 circles, the anticlockwise rotation is 5 circles, the automatic rotation speed is 90 degrees/s, and the time is 48 hours. Sampling at 2h, 4h, 6h, 24h and 48h to detect the particle size.
By detecting the particle size of the powder in different time periods of different steam fluidization treatment, the result is shown in fig. 7, X of budesonide particles after ethanol saturated steam fluidization treatment of budesonide powder 10 、X 50 、X 90 All are increased to a certain extent; x of the powder after 95% RH treatment 10 、X 50 Remains substantially unchanged, X 90 Slightly increased. This shows that with different kinds of saturated steam, particle size variations of the particles can be controlled. The desired particle size can be controlled by selecting different fluidization process streams.
Example 6: effect of fluidization temperature on the particle size of formoterol powder
3 parts of formoterol bulk drug, 10g each, were treated separately under different fluidisation conditions using the fluidisation equipment described in example 2.
Sample one: 10g of the sample is put into a fluidization tank assembly 8, absolute ethyl alcohol saturated steam is introduced through a liquid tank 4 containing absolute ethyl alcohol, and the gas flow rate of a fluidization device is adjusted: 1L/min, setting fluidization conditions: the temperature is 25 ℃, the rotation is performed for 3 circles clockwise and 3 circles counterclockwise, the automatic rotation speed is 90/s, and the time is 24h. Sampling was carried out at 2h, 4h, 6h and 24h respectively and particle size detection was carried out.
Sample two: 10g of the sample is put into a fluidization tank assembly 8, absolute ethyl alcohol saturated steam is introduced through a liquid tank 4 containing absolute ethyl alcohol, and the gas flow rate of a fluidization device is adjusted: 1L/min, setting fluidization conditions: the temperature is 30 ℃, the rotation is performed for 3 circles clockwise, the rotation is performed for 3 circles anticlockwise, the automatic rotation speed is 90 degrees/s, and the time is 24h. Samples were taken at 2h, 4h, 6h and 24h respectively and particle size measurements were performed.
Sample three: 10g of the sample is put into a fluidization tank assembly 8, absolute ethyl alcohol saturated steam is introduced through a liquid tank 4 containing absolute ethyl alcohol, and the gas flow rate of a fluidization device is adjusted: 1L/min, setting fluidization conditions: the temperature is 40 ℃, the rotation is performed for 3 circles clockwise, the rotation is performed for 3 circles anticlockwise, the automatic rotation speed is 90 degrees/s, and the time is 18h. Sampling was carried out at 2h, 4h, 6h, 12h, 16h and 18h respectively and particle size detection was carried out.
The particle size of formoterol powder was measured by different fluidization temperatures and the results are shown in figure 8, where the powder was subjected to three fluidization conditions, resulting in an increase in particle size. The fluidization temperature is set to be 25 ℃ and 30 ℃, the grain size growth is slow, the grain size growth trend is stable at 25 ℃, the grain size is changed obviously under the condition of 40 ℃. The desired particle size can be controlled by selecting different fluidization treatment temperatures.
Example 7: effect of the fluidization Equipment treatment on the particle size of the formoterol powder
10g of sample are introduced into the fluidization tank assembly 8 and treated using the fluidization device described in example 2, saturated vapor of absolute ethanol is introduced via the tank 4 containing absolute ethanol, the fluidization device gas flow rate is adjusted: 1L/min, setting fluidization conditions: the temperature is 40 ℃, the rotation is performed for 3 circles clockwise and 3 circles counterclockwise, the automatic rotation speed is 90/s, and the time is 21h. Sampling is carried out at 2h, 4h, 6h, 8h, 12h, 14h, 16h, 18h, 20h and 21h respectively, and particle size detection is carried out.
By detecting the particle size of the formoterol powder before and after fluidization, as shown in fig. 9, the particle size gradually increases with the increase of the fluidization treatment time, and the particle size is gradually increased in a relatively smooth manner, so that the desired particle size can be effectively controlled.
The above examples show that the fluidization equipment of the present invention can treat the surface of powder particles with amorphous substances and the like without changing the particle size significantly, so as to obtain completely crystallized powder, achieve the aging (aging means reducing the surface activity of the powder and making the powder more stable), and have less treatment time in a fluidization state, more uniformity and better controllability. The fluidizing equipment of the invention can modify the powder by selecting different humidity, different temperature and different solvent steam to change the particle size distribution of the powder, such as X 10 、X 50 、X 90 And SPAN value, etc. The data of the examples also show that the fluidizing device of the present invention can control the particle size of the powder to a level of 0.1 μm by controlling appropriate conditions, which cannot be achieved by conventional methods, and has great application value.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that modifications can be made by those skilled in the art without departing from the principle of the present invention, and these modifications should also be construed as the protection scope of the present invention.
Claims (10)
1. The utility model provides a powder and membrane surface treatment fluidizing apparatus, includes atmospheric control case (1) and chamber door (2), its characterized in that: the temperature and humidity control box (1) comprises a constant-temperature constant-humidity cavity (11) and an electrical appliance cavity (12), an air outlet (13) is formed in the top of the temperature and humidity control box (1), a control system is arranged on one side, away from the box door (2), of the temperature and humidity control box (1), the control system comprises a control unit, a compressor (3), a liquid box (4), a radiator (5), an air pump (6), a humidification unit and an exhaust hole (15), and the control unit is electrically connected with the humidification unit, the compressor (3) and the radiator (5) respectively;
an air inlet hole (14) of an air pump, an air outlet hole (15) and a fluidization tank assembly (8) are arranged in the constant-temperature and constant-humidity cavity (11), and a compressor (3), a liquid tank (4), a radiator (5), a humidifying unit and the air pump (6) are arranged in the electric appliance cavity (12); the humidifying unit is respectively connected with the liquid tank (4) and the exhaust hole (15), the air pump (6) is respectively connected with the air inlet hole (14) of the air pump and the bottom of the fluidization tank assembly (8) through a pipeline, and the top of the fluidization tank assembly (8) is connected with the air outlet (13).
2. The powder and film surface treatment fluidizing apparatus according to claim 1, characterized in that: the fluidization tank assembly (8) comprises an upper end cover (81), a fluidization tank body (82), a lower end cover (83) and a rotary transmission mechanism (84), the upper end cover (81) and the lower end cover (83) are respectively arranged at the upper end and the lower end of the fluidization tank body (82), and the lower end cover (83) is further connected with the rotary transmission mechanism (84); the upper end cover (81) is connected with the air outlet (13).
3. The powder and film surface treatment fluidizing apparatus according to claim 2, characterized in that: the rotary transmission mechanism (84) comprises a rotating shaft (841), a transmission case body (842), a helical gear (843), a right-angle pipeline joint (844), a straight gear (845), a motor fixing seat (846) and a servo motor (847), wherein the rotating shaft (841) is arranged on the transmission case body (842), and the helical gear (843) is arranged on the rotating shaft (841); a servo motor (847) is arranged on the motor fixing seat (846), a straight gear (845) is arranged on the servo motor (847), and the helical gear (843) is meshed with the straight gear (845); the right-angle pipe joint (844) is arranged on the transmission case body (842) and is connected with the air pump (6) through a pipe.
4. The powder and film surface treatment fluidizing apparatus according to claim 2, characterized in that: and sealing rings (85) are respectively arranged between the fluidization tank body (82) and the upper end cover (81) and between the fluidization tank body and the lower end cover (83).
5. The powder and film surface treatment fluidizing apparatus according to claim 3, characterized in that: and a locking ring (86) is also arranged between the rotating shaft (841) and the lower end cover (83).
6. The powder and film surface treatment fluidizing apparatus according to claim 2, characterized in that: and filter screen cloth and a shunt net component are arranged in the upper end cover (81) and the lower end cover (83).
7. The powder and film surface treatment fluidizing apparatus according to claim 1, characterized in that: the box door (2) comprises an upper box door (21) and a lower box door (22), a box door handle (211) is arranged on the side face of the upper box door (21), and a fluidization tank control screen (212) and a temperature and humidity control screen (213) are further arranged on the upper box door (21).
8. The powder and film surface treatment fluidizing apparatus according to claim 7, characterized in that: the upper box door (21) is also provided with a transparent window (214).
9. The powder and film surface treatment fluidizing apparatus according to any one of claims 1-8, wherein: still be equipped with case backplate (7) behind atmospheric control case (1), still be equipped with a set of louvre (71) on case backplate (7), louvre (71) are located electrical apparatus chamber (12) one end.
10. The working method of the powder and film surface treatment fluidization equipment is characterized in that: the method comprises the following steps:
the control unit controls the humidifying unit, the compressor (3) and/or the radiator (5) to work, humidifies the air to a preset temperature and humidity, obtains constant-temperature and constant-humidity gas, and sends the constant-temperature and constant-humidity gas into the constant-temperature and constant-humidity cavity (11) through the exhaust hole (15);
the air pump (6) pumps the constant-temperature and constant-humidity air in the constant-temperature and constant-humidity cavity (11) out of the air inlet hole (14) of the air pump, and the constant-temperature and constant-humidity air sequentially passes through the right-angle pipeline joint (844), the central hole of the helical gear (843), the central hole of the rotating shaft (841) and the lower end cover (83) through pipelines and enters the fluidization tank body (82); after the lower end cover (83) divides the flow of the gas and filters the gas, the gas uniformly enters the fluidization tank body (82) to uniformly contact with the materials, and the overflowed gas is filtered through the upper end cover (81) and then is discharged through the gas outlet (13);
meanwhile, the servo motor (847) rotates, and the rotating shaft (841) drives the fluidization tank body (82) to rotate in a reciprocating mode through transmission of the straight gear (845) and the helical gear (843).
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| CN202310526487.6A CN116637557B (en) | 2022-11-09 | Powder surface fluidization treatment process |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116637557A (en) * | 2022-11-09 | 2023-08-25 | 苏州欧米尼医药有限公司 | Powder surface fluidization treatment process |
| CN116637557B (en) * | 2022-11-09 | 2024-06-04 | 苏州欧米尼医药有限公司 | Powder surface fluidization treatment process |
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| EP0608844A1 (en) * | 1993-01-26 | 1994-08-03 | Freund Industrial Co., Ltd. | Method of granulation and apparatus therefor |
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| CN217410692U (en) * | 2022-05-26 | 2022-09-13 | 青海河湟青牧饲料科技开发有限公司 | Granulation machine for feed production |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| EP0608844A1 (en) * | 1993-01-26 | 1994-08-03 | Freund Industrial Co., Ltd. | Method of granulation and apparatus therefor |
| CN108888513A (en) * | 2017-10-02 | 2018-11-27 | 宁波西敦医药包衣科技有限公司 | Dry powder coating equipment in sugar production line for granular preparation |
| CN210058167U (en) * | 2019-04-29 | 2020-02-14 | 浙江小伦制药机械有限公司 | Jacket heating temperature control type wet granulator |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116637557A (en) * | 2022-11-09 | 2023-08-25 | 苏州欧米尼医药有限公司 | Powder surface fluidization treatment process |
| CN116637557B (en) * | 2022-11-09 | 2024-06-04 | 苏州欧米尼医药有限公司 | Powder surface fluidization treatment process |
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| Publication number | Publication date |
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| CN115445526B (en) | 2023-06-09 |
| CN116637557A (en) | 2023-08-25 |
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