CN101357310A - Device for preparing particulates using supercritical fluid assistant spray and use thereof - Google Patents
Device for preparing particulates using supercritical fluid assistant spray and use thereof Download PDFInfo
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Abstract
The invention provides a device for producing microparticles by supercritical fluid auxiliary spray. The device consists of a carbon dioxide cylinder, a cooling water tank, a valve, a plunger pump, a heater, a gas-liquid mixing chamber, a pressure monitoring system, a heating jacket, a valve, a nozzle base, a drying box, a valve, a constant flow pump, a solvent storage tank, a heating jacket, a cyclone separator, a collection tank, an air pump, an air heater, a supercritical carbon dioxide storage tank, an air filter and a nozzle. The device provided by the invention can be applied to the preparation of pharmaceutical microparticles or nanoparticles, and drug-loaded microparticles or nanoparticles containing carriers. The device is characterized by reasonable design and low cost and adopts the integrated insulation design of the gas-liquid mixing chamber and the nozzle, which can reduce the nozzle temperature drop caused by the injection of the mixture of carbon dioxide and solvent, can ensure the spray to go smoothly; can decrease the change of particle sizes caused by temperature fluctuation, can continuously, efficiently and conveniently prepare and collect microparticles, and can be applicable to industrialized continuous production.
Description
Technical field
The invention belongs to the manufacturing equipment of pharmaceutical preparation, relate generally to and make a kind of equipment that adopts supercritical fluid assistant spray to make particulate, and the method that adopts this device fabrication drug microparticles.
Background technology
The micronize technology is a kind of important technical process of field of pharmaceutical preparations always.Medicine after micronize can greatly increase the specific area of medicine, improves the dissolution rate of medicine in body fluid, thereby significantly improves bioavailability of medicament, reduces individual difference, reduces toxic and side effect; Medicine is wrapped in the drug-carried fine particle of making in the carrier material, has the control medicine according to the character of use material and discharge advantage; And some particle diameters also promote multiple functions such as drug absorption and target administration less than 1 micron subparticle.Simultaneously, drug microparticles with suitable size also is the fundamental of some dosage forms, the suction preparation of respiratory tract administration for example, when being used to produce systemic treatment, it does the time spent, medicine must be able to reach the deep of respiratory tract, be the position of alveolar, be subjected to the influence of respiratory tract physiological structure, have only particle diameter can reach and stay in the alveolar position effectively at 1～6 micron particle.What prepare that the method for minuteness particle generally uses at present has comminuting method, high pressure breast even method, mini-emulsion process and a solvent diffusion method etc., and there are shortcomings such as the inhomogeneous and preparation process Chinese traditional medicine stability decreases of the size distribution of manufacturing cycle length, complex technical process, particle in these methods in preparation particulate fashion.
Preparing subparticle and crystallization with supercritical fluid is the noticeable new technology of active development in the world in recent ten years.Compare with traditional pulverizing and crystallization technique, use supercritical fluid can avoid the loaded down with trivial details step that with an organic solvent reaches the environmental pollution that causes therefrom and remove residual organic solvent in the product in a large number, and can be used for protein, the polypeptide drug of thermo-responsive, structural instability and easy inactivation sex change, therefore get more and more people's extensive concerning in recent years.Micronize technology based on supercritical fluid technique can be divided into it 4 classes haply: (1) supercritical solution rapid expanding method; (2) gas saturated solution precipitating technology; (3) the anti-solvent deposition of supercritical fluid (crystallization) method; (4) supercritical fluid assisted atomization method.Wherein supercritical solution rapid expanding method requires the medicine or the carrier material of use can be dissolved in the supercritical fluid, gas saturated solution precipitating technology is for to be dissolved in supercritical fluid in the pharmaceutical liquid of fusion, and these two kinds of methods all are subjected to physicochemical property of medicine own and stable restriction when using; And the anti-solvent deposition of supercritical fluid (crystallization) the method cycle is long, preparation amount is little, can't satisfy the industrial continuous production requirement.Supercritical fluid assisted atomization method is with the supercritical fluid dissolving or is emulsifiable in the drug solution that after the mixed liquor ejection, form fine liquid drops under the supercritical fluid expansion, drop obtains particulate in drying; The mode that can adopt saturator or miniature three-way of mixing of its supercritical fluid and drug solution.This preparation method is main at present to be used and experimental study, under continuous preparation condition, the collection of particle and the eliminating of solvent still lack effective means, and it uses the preparation that also mainly is drug microparticles, the drug-carried fine particle that contains carrier is not had deep research.
Summary of the invention
An object of the present invention is to provide supercritical fluid assistant spray and make particulate equipment, form by carbon dioxide steel cylinder 1, bosh 2, valve 3, plunger displacement pump 4, heater 5, gas-liquid mixed chamber 6, pressure monitor 7, heating jacket 8, valve 9, nozzle base 10, drying box 11, valve 12, constant flow pump 13, solvent fluid reservoir 14, heating jacket 15, cyclone separator 16, collecting tank 17, air exhauster 18, air heater 19, supercritical carbon dioxide storage tank 20, air cleaner 21 and nozzle 22.
Carbon dioxide steel cylinder 1, valve 3, supercritical carbon dioxide storage tank 20, plunger displacement pump 4, between the gas-liquid mixed chamber 6 by pipeline with thread connection, supercritical carbon dioxide storage tank 20 places in the bosh 2, the section of tubing of the centre between plunger displacement pump 4 and the gas-liquid mixing chamber 6 places (heater can adopt the form of water-bath heating) in the heater 5, by heater the supercritical carbon dioxide in the pipeline is heated, gas-liquid mixed chamber 6, adopt welding to connect between valve 9 and the nozzle base 10, heating jacket 8 is wrapped in gas-liquid mixed chamber 6, valve 9 and nozzle base 10 peripheries are with electrically heated form temperature control; Mode with thread connection is connected the top that places drying box 11 with gas-liquid mixed chamber 6, valve 9 and nozzle base 10; Solvent fluid reservoir 14, between constant flow pump 13 and the gas-liquid mixing chamber 6 by pipeline with thread connection, heating jacket 15 is wrapped in solvent fluid reservoir 14 peripheries, with electrically heated form temperature control, air cleaner 21 adopts high efficiency particulate air filter (HEPA), between air heater 19 and the drying box 11 by pipeline with thread connection, utilize the air heat of air heater 19 electrical heating to introducing, and be delivered in the drying box 11, also high purity nitrogen directly can be connected with air heater 19, replace pure air with high pure nitrogen, the bottom of drying box 11, cyclone separator 16 and air exhauster 17 by pipeline with thread connection, collecting tank 17 connects with cyclone separator 16 by screw thread, and the valve in the equipment adopts plug valve.The diameter of nozzle (22) is between 0.08～1.0mm, and an end flexibly connects by screw thread and nozzle base (10), and the other end is provided with the aperture that sprays gas-liquid mixture.
Another object of the present invention provides this equipment at preparation drug microparticles or nanoparticle, and contains the drug-carried fine particle of carrier or the application in the nanoparticle.
Described application realizes in the following manner: at first open air exhauster, introduce air or nitrogen, with the hot-air that adds the thermosetting cleaning (nitrogen), enter drying box after filtration.Liquid CO 2 boosts by plunger displacement pump after cooling, sends into the gas-liquid mixed chamber that is preheated to 40～90 ℃ after heating; The solution of medicine (or medicine and carrier) after the heater via heating, delivers into the gas-liquid mixed chamber by constant flow pump in storage tank.Solvent and supercritical carbon dioxide mix in the gas-liquid mixed chamber, observe pressure the gas-liquid mixed chamber from pressure monitor and reach the critical pressure of carbon dioxide when above, open valve, gas-liquid mixture sprays into drying box by nozzle, in drying box under the effect of thermal current, solvent and carbon dioxide volatilization, medicine (or medicine and carrier) are separated out with particulate form, particle with air motion to cyclone separator, produce gas solid separation, particle falls into collecting tank.The solvent and the carbon dioxide of vaporization are discharged by air exhauster.Medicine (or medicine and carrier) flow velocity of solution and the velocity ratio of supercritical fluid are 1: 0.5～1: 5.
By the concentration of solvent Chinese traditional medicine or carrier material, the speed that pumps into of supercritical carbon dioxide, the pressure of gas-liquid mixed chamber and the big I of nozzle bore the size that forms particle is regulated.
Adopt the incorporate INSULATION DESIGN of gas-liquid mixed chamber and nozzle, the nozzle cooling that causes in the time of can reducing the mixed liquor ejection of carbon dioxide and solvent, what can guarantee to spray carries out smoothly, and the particle size variation that causes because of temperature fluctuation of minimizing.
Innovation part of the present invention is the device that supercritical fluid assistant spray is granulated is connected with the dry gathering-device of particular design, can prepare continuously, efficiently, easily and the collection particulate, is suitable for industrialized continuous production.
Description of drawings
Fig. 1 is the profile that supercritical fluid assistant spray is made particulate equipment.
Fig. 2 is the influence of preparation liquid concentration to diameter of aspirin particle.
Fig. 3 is the influence of carbon dioxide flow velocity to the stearic acid particles particle diameter.
Fig. 4 is the influence of nozzle bore to the drug-carried fine particle particle diameter.
The specific embodiment
The present invention is further described with specific embodiment in conjunction with the accompanying drawings.
Embodiment 1: supercritical fluid assistant spray is made particulate equipment
Referring to Fig. 1, supercritical fluid assistant spray is made particulate equipment and is made up of carbon dioxide storage tank 1, bosh 2, valve 3, plunger displacement pump 4, heater 5, gas-liquid mixed chamber 6, pressure monitor 7, heating jacket 8, valve 9, nozzle base 10, drying box 11, valve 12, constant flow pump 13, solvent fluid reservoir 14, heating jacket 15, cyclone separator 16, collecting tank 17, air exhauster 18, air heater 19, supercritical carbon dioxide storage tank 20, air cleaner 21 and nozzle 22.
Carbon dioxide steel cylinder 1, valve 3, supercritical carbon dioxide storage tank 20, plunger displacement pump 4, between the gas-liquid mixed chamber 6 by pipeline with thread connection, supercritical carbon dioxide storage tank 20 is placed in the bosh 2, section of tubing between plunger displacement pump 4 and the gas-liquid mixing chamber 6 places (heater can adopt the form of water-bath heating) in the heater 5, by heater the supercritical carbon dioxide in the pipeline is heated, gas-liquid mixed chamber 6, adopt welding to connect between valve 9 and the nozzle base 10, heating jacket 8 is wrapped in gas-liquid mixed chamber 6, valve 9 and nozzle base 10 peripheries are with electrically heated form temperature control; By the screw thread of nozzle periphery,, gas-liquid mixed chamber 6, valve 9 and nozzle 10 are connected the top that places drying box 11 in the mode of thread connection; Solvent fluid reservoir 14, between constant flow pump 13 and the gas-liquid mixing chamber 6 by pipeline with thread connection, heating jacket 15 is wrapped in solvent fluid reservoir 14 peripheries, with electrically heated form temperature control, air cleaner 21 adopts high efficiency particulate air filter (HEPA), between air heater 19 and the drying box 11 by pipeline with thread connection, utilize the air heat of air heater 19 electrical heating to introducing, and be delivered in the drying box, also high purity nitrogen directly can be connected with air heater, replace pure air with high pure nitrogen, the bottom of drying box 11, cyclone separator 16 and air exhauster 17 by pipeline with thread connection, collecting tank 17 connects with cyclone separator 16 by screw thread, and the valve in the equipment adopts plug valve.The diameter of nozzle 22 is between 0.08～1.0mm, and an end flexibly connects by screw thread and nozzle base 10, and the other end is provided with aperture, to spray gas-liquid mixture.
Equipment in use, at first open air exhauster, introduce pure air or directly feed nitrogen from air cleaner 21, hot-air through adding the thermosetting cleaning (nitrogen), enter drying box 11, the liquid CO 2 that derives from carbon dioxide storage tank 1 enters supercritical carbon dioxide storage tank 20, after bosh 2 coolings, boost by plunger displacement pump 4, through sending into the gas-liquid mixed chamber 6 that is preheated to 40～90 ℃ after heater 5 heating; The solution of medicine (or medicine and carrier) after heating jacket 15 heating, delivers into gas-liquid mixed chamber 6 by constant flow pump 13 in solvent fluid reservoir 14; Solvent and supercritical carbon dioxide mix in gas-liquid mixed chamber 6, observe pressure the gas-liquid mixed chamber 6 from pressure monitor and reach the critical pressure 7.28Mpa of carbon dioxide when above, open valve 9, gas-liquid mixture sprays into drying box 11 by nozzle 22, in drying box 11 under the effect of thermal current, solvent and carbon dioxide volatilization, medicine (or medicine and carrier) are separated out with particulate form, particle with air motion to cyclone separator 16, produce gas solid separation, particle falls into collecting tank 17, and the solvent of vaporization and carbon dioxide are discharged by air exhauster 18.
Embodiment 2: adopt supercritical fluid assistant spray to make particulate equipment and prepare drug microparticles
Take by weighing Nimodipine 0.1,0.2,0.5,2,5,10,20g respectively in addition, the particle for preparing is collected in the same operation.
Get the particle that obtains of collection, be scattered in 0.1% the poloxamer solution, by the particle diameter of MarveinZetasize 3000 particle diameters with surface potential analyzer or Coulter-counter mensuration particulate by ultrasonic.The result is referring to Fig. 2.
Embodiment 3: adopt supercritical fluid assistant spray to make particulate equipment and prepare drug-carried fine particle
Get the particle that obtains of collection, be scattered in 0.1% the poloxamer solution, by the particle diameter of MarveinZetasize 3000 particle diameters with surface potential analyzer or Coulter-counter mensuration particulate by ultrasonic.The result is referring to Fig. 3.
Embodiment 4: adopt supercritical fluid assistant spray to make particulate equipment and prepare drug-carried fine particle
In addition take by weighing glycerin monostearate 0.5g, Nimodipine 0.05g respectively, the same operation adopts respectively that the aperture is 0.08,0.5, the nozzle spray of 1mm, collects the particle for preparing.
Get the particle that obtains of collection, be scattered in 0.1% the poloxamer solution, by the particle diameter of MarveinZetasize 3000 particle diameters with surface potential analyzer or Coulter-counter mensuration particulate by ultrasonic.The result is referring to Fig. 4.
Claims (7)
1. a supercritical fluid assistant spray is made the equipment of particulate, it is characterized in that: by carbon dioxide steel cylinder (1), bosh (2), valve (3), plunger displacement pump (4), heater (5), gas-liquid mixed chamber (6), pressure monitor (7), heating jacket (8), valve (9), nozzle base (10), drying box (11), valve (12), constant flow pump (13), solvent fluid reservoir (14), heating jacket (15), cyclone separator (16), collecting tank (17), air exhauster (18), air heater (19), supercritical carbon dioxide storage tank (20), air cleaner (21) and nozzle (22) constitute, carbon dioxide steel cylinder (1) wherein, valve (3), supercritical carbon dioxide storage tank (20), plunger displacement pump (4), between the gas-liquid mixed chamber (6) by pipeline to be threaded, supercritical carbon dioxide storage tank (20) places in the bosh (2), section of tubing between plunger displacement pump (4) and the gas-liquid mixing chamber (6) places in the heater (5), gas-liquid mixed chamber (6), adopt between valve (9) and the nozzle base (10) and be welded to connect, heating jacket (8) is wrapped in gas-liquid mixed chamber (6), valve (9) and nozzle base (10) periphery, in the mode that is threaded with gas-liquid mixed chamber (6), valve 9 is connected the top that places drying box (11) with nozzle base (10), solvent fluid reservoir (14), between constant flow pump (13) and the gas-liquid mixing chamber (6) by pipeline to be threaded, heating jacket 15 is wrapped in solvent fluid reservoir (14) periphery, air cleaner (21), between air heater (19) and the drying box (11) by pipeline to be threaded, the bottom of drying box (11), cyclone separator (16) and air exhauster (17) by pipeline to be threaded, collecting tank (17) is connected with cyclone separator (16) by screw thread, nozzle (22) one ends flexibly connect by screw thread and nozzle base (10), and the other end is provided with the aperture that sprays gas-liquid mixture.
2. a kind of supercritical fluid assistant spray according to claim 1 is made the equipment of particulate, and it is characterized in that: the diameter of nozzle (22) is 0.08～1.0mm.
3. a kind of supercritical fluid assistant spray according to claim 1 is made the equipment of particulate, and it is characterized in that: heater (5) is selected water-bath heater or electric heater for use.
4. a kind of supercritical fluid assistant spray according to claim 1 is made the equipment of particulate, it is characterized in that: valve (9) adopts plug valve.
5. the application of equipment in preparation drug microparticles, nanoparticle that provides according to claim 1.
6. the equipment that provides according to claim 1 contains the drug-carried fine particle of carrier or the application in the nanoparticle in preparation.
7. according to claim 5 or 6 described application, it is characterized in that realizing in the following manner: 1 equipment that provides is provided application rights, at first open air exhauster, introduce air or nitrogen, with the hot-air that adds the thermosetting cleaning, enter drying box after filtration, liquid CO 2 is after cooling, boost by plunger displacement pump, after heating, send into the gas-liquid mixed chamber that is preheated to 40～90 ℃; The solution of medicine or medicine and carrier is in storage tank after the heater via heating, deliver into the gas-liquid mixed chamber by constant flow pump, solvent and supercritical carbon dioxide mix in the gas-liquid mixed chamber, observe pressure the gas-liquid mixed chamber from pressure monitor and reach the critical pressure of carbon dioxide when above, open valve, gas-liquid mixture sprays into drying box by nozzle, in drying box under the effect of thermal current, solvent and carbon dioxide volatilization, medicine or medicine and carrier are separated out with particulate form, particle with air motion to cyclone separator, produce gas solid separation, particle falls into collecting tank, the solvent and the carbon dioxide of vaporization are discharged by air exhauster, and the flow velocity of the solution of medicine or medicine and carrier and the velocity ratio of supercritical fluid can be 1: 0.5～and 1: 5.
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| CN2008101206909A CN101357310B (en) | 2008-09-02 | 2008-09-02 | Device for preparing particulates using supercritical fluid assistant spray and use thereof |
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| CN2008101206909A CN101357310B (en) | 2008-09-02 | 2008-09-02 | Device for preparing particulates using supercritical fluid assistant spray and use thereof |
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| WO2011143953A1 (en) * | 2010-05-20 | 2011-11-24 | Wu Chuanbin | Method and apparatus for manufacturing microspheres |
| CN103127889A (en) * | 2011-11-29 | 2013-06-05 | 北京大学 | Decompression induction micro-jet mixing method for preparing functional nano particles and application thereof |
| CN105727579A (en) * | 2016-01-28 | 2016-07-06 | 苏州鼎烯聚材纳米科技有限公司 | Low-cost high-efficiency supercritical spray drying method and equipment for slurry |
| CN106563399A (en) * | 2016-11-18 | 2017-04-19 | 中北大学 | Method for preparing nano microcapsule of shell-core structure from supercritical fluid |
| CN108144324A (en) * | 2017-12-26 | 2018-06-12 | 上海纳米技术及应用国家工程研究中心有限公司 | Multi-functional overcritical particle preparation system |
| CN109333144A (en) * | 2018-10-29 | 2019-02-15 | 广州汇专工具有限公司 | A kind of transmission technique of supercritical carbon dioxide |
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| CN110511406A (en) * | 2018-05-21 | 2019-11-29 | 广东裕纵新材料科技股份有限公司 | A kind of production method of nanometer of PA |
| CN110511407A (en) * | 2018-05-21 | 2019-11-29 | 广东裕纵新材料科技股份有限公司 | A kind of production method of nanometer of PE |
| CN110508373A (en) * | 2018-05-21 | 2019-11-29 | 广东裕纵新材料科技股份有限公司 | A kind of production method of nanometer of PPS |
| CN111012671A (en) * | 2019-11-25 | 2020-04-17 | 上海强德食品科技有限公司 | Physical preparation method of microcapsule |
| CN111530103A (en) * | 2020-05-08 | 2020-08-14 | 厦门大学 | Supercritical spray drying method |
| CN112427646A (en) * | 2020-12-02 | 2021-03-02 | 山东理工大学 | Method for preparing magnetic abrasive material by supercritical carbon dioxide assisted plasma spray |
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2008
- 2008-09-02 CN CN2008101206909A patent/CN101357310B/en not_active Expired - Fee Related
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| WO2011143953A1 (en) * | 2010-05-20 | 2011-11-24 | Wu Chuanbin | Method and apparatus for manufacturing microspheres |
| CN103127889A (en) * | 2011-11-29 | 2013-06-05 | 北京大学 | Decompression induction micro-jet mixing method for preparing functional nano particles and application thereof |
| CN103127889B (en) * | 2011-11-29 | 2016-01-13 | 北京大学 | Decompression induction micro-jet mixing method for preparing functional nano particles and application thereof |
| CN105727579B (en) * | 2016-01-28 | 2018-01-09 | 苏州鼎烯聚材纳米科技有限公司 | Low-cost high-efficiency supercritical spray drying method and equipment for slurry |
| CN105727579A (en) * | 2016-01-28 | 2016-07-06 | 苏州鼎烯聚材纳米科技有限公司 | Low-cost high-efficiency supercritical spray drying method and equipment for slurry |
| CN106563399A (en) * | 2016-11-18 | 2017-04-19 | 中北大学 | Method for preparing nano microcapsule of shell-core structure from supercritical fluid |
| CN106563399B (en) * | 2016-11-18 | 2019-07-09 | 中北大学 | A kind of method that supercritical fluid prepares " shell-core " structure nano microcapsules |
| CN108144324A (en) * | 2017-12-26 | 2018-06-12 | 上海纳米技术及应用国家工程研究中心有限公司 | Multi-functional overcritical particle preparation system |
| CN110511406A (en) * | 2018-05-21 | 2019-11-29 | 广东裕纵新材料科技股份有限公司 | A kind of production method of nanometer of PA |
| CN110511407A (en) * | 2018-05-21 | 2019-11-29 | 广东裕纵新材料科技股份有限公司 | A kind of production method of nanometer of PE |
| CN110508373A (en) * | 2018-05-21 | 2019-11-29 | 广东裕纵新材料科技股份有限公司 | A kind of production method of nanometer of PPS |
| CN109333144A (en) * | 2018-10-29 | 2019-02-15 | 广州汇专工具有限公司 | A kind of transmission technique of supercritical carbon dioxide |
| CN109589414A (en) * | 2018-12-27 | 2019-04-09 | 佳木斯大学 | A method of use supercritical carbon dioxide extraction apparatus to carry out drug loading by carrier of GO or CNTs |
| CN109589414B (en) * | 2018-12-27 | 2022-02-15 | 佳木斯大学 | Method for carrying out drug loading by using GO or CNTs as carrier through supercritical carbon dioxide extraction device |
| CN109943313A (en) * | 2019-04-23 | 2019-06-28 | 中国石油大学(华东) | A kind of Microemulsions in Supercritical Carbon Dioxide compounds dispersion Preparation equipment and method with fly ash grain |
| CN109943313B (en) * | 2019-04-23 | 2021-03-12 | 中国石油大学(华东) | Equipment and method for preparing supercritical carbon dioxide microemulsion and fly ash particle compound dispersion |
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| CN110396396A (en) * | 2019-08-06 | 2019-11-01 | 西南石油大学 | A kind of includes the drying agent nanoscale ultramicro powder production method that ionic type metal carbide is applied to compact reservoir |
| CN111012671A (en) * | 2019-11-25 | 2020-04-17 | 上海强德食品科技有限公司 | Physical preparation method of microcapsule |
| CN111530103A (en) * | 2020-05-08 | 2020-08-14 | 厦门大学 | Supercritical spray drying method |
| CN111530103B (en) * | 2020-05-08 | 2021-08-31 | 福建蓝烟新材料有限公司 | Supercritical spray drying method |
| CN112427646A (en) * | 2020-12-02 | 2021-03-02 | 山东理工大学 | Method for preparing magnetic abrasive material by supercritical carbon dioxide assisted plasma spray |
| CN112774611A (en) * | 2021-01-18 | 2021-05-11 | 广西大学 | Hypergravity micro-interface mass transfer enhanced reaction-crystallization drying coupling all-in-one machine |
| CN112774611B (en) * | 2021-01-18 | 2024-01-30 | 广西大学 | Super-gravity micro-interface mass transfer strengthening reaction-crystallization drying coupling integrated machine |
| CN114832740A (en) * | 2022-04-28 | 2022-08-02 | 长安大学 | Carbon nanotube aerosol preparation device and preparation method |
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