CN104721052A - Nanometer drug preparation device - Google Patents
Nanometer drug preparation device Download PDFInfo
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- CN104721052A CN104721052A CN201510069755.1A CN201510069755A CN104721052A CN 104721052 A CN104721052 A CN 104721052A CN 201510069755 A CN201510069755 A CN 201510069755A CN 104721052 A CN104721052 A CN 104721052A
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Abstract
The invention discloses a nanometer drug preparation device. The device is composed of a constant sample injector, a direct current high voltage electricity generator, a reactor, a constant temperature electromagnetic stirrer and a central controller; a mixed solution of ingredients for preparing nanometer drugs is spayed into the reactor through the top end of a capillary tube of the constant sample injector; the direct current high voltage electricity generator generates a direct current high voltage electric field between a positive electrode and a negative electrode, and the high voltage electric field generated by the direct current high voltage electricity generator is loaded on the positive electrode and the negative electrode which are located at the upper end and the lower end of the reactor; under the action of the high voltage electric field, the mixed solution is atomized into fine liquid drops, and the liquid drops move downward to enter into solvent in the reactor; under the action of the constant temperature electromagnetic stirrer, the atomized liquid drops form nanometer drug micelles in the solvent, and the nanometer drug micelles are solidified into nanometer drug particles. The nanometer drugs obtained through preparation are even in particle size, the drug loading efficiency, the encapsulation efficiency and the yield coefficient are high, and by adjusting the voltage of the direct current high voltage electric field, the constant sample feeding flow velocity and the concentration of the fed solution, the nanometer drugs with different particle sizes can be prepared.
Description
Technical field
The present invention is specifically related to a kind of Nano medication preparation facilities.
Background technology
The preparation method of current Nano medication has a lot, and the chemical preparation techniques such as existing liquid phase reactor, vapour deposition, also have the physics technologies of preparing such as mechanical activation comminution.The Nano medication preparation method of normal employing has the technology such as dialysis and solvent evaporation method, the sedimentation method, emulsion method, microemulsion method, liposome method, supercritical fluid technology.
Spray drying technology utilizes compressed air that the emulsion or solution spray that are dissolved with medicine and wall material are become little droplet, is dried to powder rapidly at a higher temperature, then isolated the dry technology of medicine by segregation apparatus.The pattern of medicine and granularity and can add various excipient to regulate by air intake flow, intake air temperature, concentration of raw material, the amount of pumping into.Spray drying technology also can be applicable to the micro encapsulation preparing porous drug-loading nanoparticles and insoluble medicine.The shortcoming of spray drying method: 1. prepare the granularity of granule usually at micron order; 2. thermally sensitive medicine is not suitable for; 3. spray drying method is used for embedding oil-soluble medicine, and for water soluble drug, prepared granule has obvious burst release effect.Thus these shortcomings limit spray drying technology and apply in Nano medication field.
High pressure homogenization method is under high pressure (1.5 × 10
5more than Kpa) hole of drug solution by diameter about 25 μm to be extruded, the dynamic pressure moment of fluid in hole greatly increases, but its static pressure reduces rapidly after extruding hole.According to Bernoulli equation, the sharply increase of dynamic pressure can cause the sharply reduction of static pressure, makes the boiling point of water be reduced to below room temperature.Consequently water occurs acutely seethe with excitement and produce cavitation and microexplosion at ambient temperature, and the instantaneous high pressure that explosion produces makes the micropowder of particulate breakup Cheng Geng little.By repeatedly (10 ~ 15 times) high pressure homogenize operation continuously, grain size can be obtained in 100 to 1000nm scope, the nanometer suspension agent medicine of solids content 10% ~ 20%.
Supercritical fluid technology is by medicine dissolution in supercritical liq, when liquid passes through the nozzle atomization under pressure of micro-aperture, along with the rapid gasification of supercritical liq, separates out a kind of technology of solid nano grain immediately.Supercritical fluid technology has significant advantage: be 1. easy to industrialization, and product characteristics are adjustable; 2. high diffusivity rate, low viscosity; 3. low interfacial tension, strong solvability.The weak point of this method is: 1. can only be applied to relative molecular mass 10, and the preparation of the polylactic acid nano particle of less than 000, is not suitable for the polylactic acid of more macromolecule; 2. medicine can be at least solvable in a kind of solvent, and this solvent easily must mix with a kind of non-solvent.But compound out newly developed is difficult to possess above condition at present, and supercritical fluid technology thus cannot be adopted to prepare simultaneously.
Dialysis and solvent evaporation method are dissolved medicine or carrier oil (or water), then gained medicine or carrier solution are joined dispersion in water (or oil), evaporation or dialysis removing organic solvent, medicine or carrier assemble nucleation because dissolubility sharply reduces in water (or oil).The sedimentation method generate particulate matter precipitation in the solution by chemical reaction, controls to precipitate growing up of particle diameter, thus prepare Nano medication by the control of various reaction condition.
Emulsion method is the method preparing Nano medication in emulsion.The peptizaiton of general surfactant, adds that the shear action of external force forms droplet, and react on drop surface or inside nucleation, obtains granule.Also have and utilize amphoteric macromolecule polymer self assembly nucleation in emulsion.Concrete grammar has emulsion polymerization, emulsion self assembly nucleation process, emulsion-crosslinking method and film emulsion process etc.
Although microemulsion and emulsion are all the dispersions that oil phase and aqueous phase are formed, there is essence difference between the two.Microemulsion be thermodynamically stable can spontaneous formation or the transparent or semitransparent dispersion that can be formed through slight External Force Acting.And emulsion is unstable, standing a period of time will layering.Microemulsion can form the little Chi of nanometer scale, carries out if various reaction is limited in this little Chi, can imagine that product is also nanometer.And, microemulsion method reaction condition is very gentle, by changing the formula of microemulsion, change external condition and can make microemulsion covert (oil-in-water, Water-In-Oil, two-arch tunnel) easily, the shape changing little Chi is (spherical, bar-shaped, stratiform etc.), thus obtain the product of different nanostructured.And the most attractive spot of microemulsion be it can solubilising is a large amount of simultaneously water and a large amount of oil, thus water-soluble substances and oil soluble material can be made to mix fully, greatly improve reaction efficiency.Positive microemulsion method (O/W) and reverse microemulsion process (W/O) can be divided into according to the type of microemulsion.
Nano-lipid preparation mainly contains film evaporation method, reverse phase evaporation, membrane-sonic method etc.Medicine is dissolved in organic solvent by film evaporation method .. together with cholesterol, phospholipid, and evaporating solvent makes the filmogen such as medicine and phospholipid form even class membrane of lipoprotein in flask walls, adds flushing liquor and washes film and obtain liposome turbid liquor.Reverse phase evaporation is mixed lecithin, cholesterol and organic solvent, the aqueous solution having dissolved medicine is added in the organic solution formed, form more stable w/o type emulsion, then reduction vaporization removing organic solvent, after reaching colloidal state, add phosphate buffered solution, aquation, continue reduction vaporization in short-term, obtain light yellow liposome turbid liquor.Membrane-sonic method first prepares phospholipid bilayer rete, more ultrasonic aquation disperses to obtain liposome.
But the Nano medication that at present prepared by these methods has, and repeatability is poor, particle diameter is uneven, carrying drug ratio and envelop rate is lower, yield is lower, technique is unstable, be difficult to the shortcoming of expanding production amount.
Summary of the invention
The object of the invention is to provide a kind of Nano medication preparation facilities, in order to prepare uniform particle sizes, stable various nanometer or microsphere particle medicine on a large scale.
A kind of Nano medication preparation facilities, is made up of constant injector, high direct voltage electric generator, reactor, thermostatic electromagnetic agitator, central controller; The mixed solution of Nano medication raw materials sprays in reactor by the capillary tip of constant injector; Described high direct voltage electric generator produces DC high voltage electric field between positive and negative electrode, its produce high tension voltage be carried in be positioned at the upper and lower two ends of reactor positive and negative electrode on; Spray into the mixed solution in reactor under the effect of high voltage electric field, be atomized into tiny drop, and move downward in the solvent entered in reactor; Under the effect of thermostatic electromagnetic agitator, atomized drop forms Nano medication micelle at solvent, is solidified into Nano medication granule further, and is uniformly dispersed.
By such scheme, size, the time of described high direct voltage electric generator voltage carry out control and regulation by high direct voltage electric generator sub-controller in central controller, and video data.
By such scheme, flow velocity, the sample injection time of mixed solution are undertaken operating by constant injector sub-controller in central controller and manage, and video data.
By such scheme, in reactor, pressure, temperature, solvent volume carry out control and regulation by reactor sub-controller in central controller, and video data.
By such scheme, the temperature of solvent, rise heat with cooling rate, mixing speed by thermostatic electromagnetic agitator sub-controller control and regulation in central controller, and video data.
The application of above-mentioned Nano medication preparation facilities in macromolecule carrier, Inorganic Non-metallic Materials, nanometer or microsphere drug, the preparation of capsule-type medicine.
The carrier such as medicine, macromolecule, various auxiliary agents etc. are dissolved and form certain density mixed solution in a solvent, mixed solution, with certain flow velocity, by the capillary tip of certain pore size, sprays in reactor.Under the effect of high tension voltage, the mixed solution sprayed in reactor carries out being atomized into tiny drop, and move downward and enter in different solvents, under the effect of uniform temperature, certain mixing speed, atomized drop forms Nano medication micelle in a solvent, be solidified into Nano medication granule further, and be uniformly dispersed.
Compared with Nano medication preparation method traditional at present, Nano medication preparation facilities of the present invention can make the mixed solution of carrier, the various auxiliary agents etc. such as certain density medicine, macromolecule under the effect of high tension voltage, abundant mixing is also atomized into required various tiny drop, enter again in different solvents, thus form Nano medication micelle, be solidified into the uniform Nano medication granule of size further.
Beneficial effect of the present invention is:
(1) uniform particle sizes of the Nano medication prepared, carrying drug ratio and envelop rate is higher, yield is high.
(2) the grain size size of the Nano medication prepared is controlled, by regulating voltage swing, the flow velocity of constant sample introduction, the concentration of sample introduction solution of DC high voltage electric field, can prepare the Nano medication of different-grain diameter size.
(3) grain size of the Nano medication prepared reproducible, stable, easy and simple to handle.
Accompanying drawing explanation
Fig. 1: Nano medication preparation facilities schematic diagram;
Fig. 2: the TEM photo 35nm of embodiment 1 nano-particle;
Fig. 3: the TEM photo 100nm of embodiment 1 nano-particle;
Fig. 4: the TEM photo 80nm of embodiment 1 nano-particle;
1-constant injector; 2-high direct voltage electric generator; 3-reactor; 4-thermostatic electromagnetic agitator; 5,6-positive and negative electrode; 7-central controller; 8-charging aperture; 9-discharging opening; Wherein 7-1-constant injector sub-controller; 7-2-high direct voltage electric generator sub-controller; 7-3-reactor sub-controller; 7-4-thermostatic electromagnetic agitator sub-controller.
Detailed description of the invention
Following examples explain technical scheme of the present invention further, but not as limiting the scope of the invention.
Nano medication preparation facilities of the present invention, with reference to shown in accompanying drawing 1, is made up of constant injector 1, high direct voltage electric generator 2, reactor 3, thermostatic electromagnetic agitator 4, central controller 7; The mixed solution of Nano medication raw materials sprays in reactor 3 by the capillary tip of constant injector 1; Described high direct voltage electric generator produces DC high voltage electric field between positive and negative electrode, its produce high tension voltage be carried in be positioned at reactor about 3 two ends positive and negative electrode (5,6) on; Spray into the mixed solution in reactor 3 under the effect of high voltage electric field, be atomized into tiny drop, and move downward in the solvent entered in reactor; Under the effect of thermostatic electromagnetic agitator 4, atomized drop forms Nano medication micelle at solvent, is solidified into Nano medication granule further, and is uniformly dispersed.Simultaneous reactions device about 7 is also provided with charging aperture 8 and discharging opening 9.
Wherein, size, the time of high direct voltage electric generator voltage carry out control and regulation by high direct voltage electric generator sub-controller 7-2 in central controller, and video data; Voltage range is 0-40000V.
Flow velocity, the sample injection time of mixed solution are undertaken operating by constant injector sub-controller 7-1 in central controller and manage, and video data; Flow rates is 0.001-5000mL/min.
By such scheme, in reactor, pressure, temperature, solvent volume carry out control and regulation by reactor sub-controller 7-3 in central controller, and video data; The charging aperture measuring control valve of reactor regulates and controls; The discharging opening of reactor is regulated and controled by measuring control valve.。
The temperature of solvent, rise heat with cooling rate, mixing speed by thermostatic electromagnetic agitator sub-controller 7-4 control and regulation in central controller, and video data; The range of speeds is 0-10000rpm.
Central controller is provided with four independently state modulator color LCD screen, touch sensitive display, manual knob, gear adjusting device or other display screens, be respectively the controller display screen of regulation and control corresponding intrument, for regulating, controlling the various operational factors of corresponding intrument.
The complex that above-mentioned Nano medication preparation facilities can be used for macromolecule carrier, Inorganic Non-metallic Materials and various kinds of drug prepares nanometer or various nanometer or the microsphere particle material such as microsphere drug, capsule-type medicine.The diameter range of its nano-particle is 0.1-100nm, and the diameter range of nano-particle is 0.1-100nm, and the diameter range of microsphere particle is 0.1 μm of-1mm.
Embodiment 1
The preparation of polycarbonate nano medicine:
10mg Copolycarbonate and 1mg 5-fluorouracil are dissolved in the dimethyl sulfoxine (DMSO) of 2mL, are placed in mother liquid multi-cavity bottle, adopt high voltage electric field electrospray legal system for polymer nanocomposite medicine.Obtained Nano medication deposits in dehydrated alcohol, after draining solvent, dissolves dispersion micelle with distilled water.Biopolymer nanoparticles size adopts ZetasizerNano ZS particle instrument to measure.
High voltage electric field electrospray legal system, in the process of nano-micelle, adopts the method for orthogonal experiment, further study the impact on micelle size such as sample concentration, capillary tube on-load voltage, flow.Result display in table 1, strengthens the on-load voltage of capillary tube or reduces sample concentration, being conducive to the preparation compared with small particle diameter micelle; And increasing the input flow rate of sample, the drug particles particle diameter prepared also can become large.Prepare the method for Nano medication by contrast dialysis and high voltage electric field electrospray method two kinds, can find out, the standby Nano medication particle diameter of high voltage electric field electrospray legal system will much smaller than the Nano medication particle diameter adopting dialysis prepare.
Table 1
Embodiment 2:
The Copolycarbonate of 100mg hydroxyl and 10mg amycin are dissolved in the dimethyl sulfoxine (DMSO) of 20mL, are placed in mother liquid multi-cavity bottle, adopt high voltage electric field electrospray legal system for polymer nanocomposite medicine.Obtained Nano medication deposits in dehydrated alcohol, after draining solvent, dissolves dispersion micelle with distilled water.
High molecular nanometer micellar conformation adopts Tecnai G220 type transmission electron microscope and atomic force microscope to measure.Nano-micelle size adopts Zetasizer Nano ZS particle instrument to measure.
Variable the having of running parameter of liquid electric atomization: class of liquids, capillary tube on-load voltage, fluid flow, electrode distance.The viscosity of liquid, surface tension, electrical conductivity, dielectric constant are relevant with class of liquids.Electric field intensity, electric capacity are relevant with electrode distance.Liquid carried charge is relevant with fluid flow.Above-mentioned parameter affects fluid drips diameter.Adopt high voltage electric field electrospray legal system for copolymer nano medicine, mainly have studied the impact of polymer rate of charge, capillary tube on-load voltage, fluid flow and solution concentration.Above factor on the impact of polymer nano micelle in table 2.
Table 2
As can be seen from Table 2, reduce the on-load voltage of sample concentration or increasing capillary tube, be conducive to preparing the micelle compared with small particle diameter; And adding the input flow rate of large sample, then the drug particles particle diameter prepared becomes large.
With reference to shown in accompanying drawing 1,2,3, from the observed result of transmission electron microscope, high voltage electric field electrospray obtains the more homogeneous spherical Nano medication of size, does not adhere to each other.
Claims (6)
1. a Nano medication preparation facilities, is characterized in that being made up of constant injector, high direct voltage electric generator, reactor, thermostatic electromagnetic agitator, central controller; The mixed solution of Nano medication raw materials sprays in reactor by the capillary tip of constant injector; Described high direct voltage electric generator produces DC high voltage electric field between positive and negative electrode, its produce high tension voltage be carried in be positioned at the upper and lower two ends of reactor positive and negative electrode on; Spray into the mixed solution in reactor under the effect of high voltage electric field, be atomized into tiny drop, and move downward in the solvent entered in reactor; Under the effect of thermostatic electromagnetic agitator, atomized drop forms Nano medication micelle at solvent, is solidified into Nano medication granule further, and is uniformly dispersed.
2. Nano medication preparation facilities as claimed in claim 1, is characterized in that the size of described high direct voltage electric generator voltage, the time carries out control and regulation by high direct voltage electric generator sub-controller in central controller, and video data.
3. Nano medication preparation facilities as claimed in claim 1, is characterized in that the flow velocity of described mixed solution, sample injection time are undertaken operating by constant injector sub-controller in central controller and manage, and video data.
4. Nano medication preparation facilities as claimed in claim 1, is characterized in that pressure in described reactor, temperature, solvent volume carry out control and regulation by reactor sub-controller in central controller, and video data.
5. Nano medication preparation facilities as claimed in claim 1, is characterized in that the temperature of described solvent, rises heat with cooling rate, mixing speed by thermostatic electromagnetic agitator sub-controller control and regulation in central controller, and video data.
6. the application of Nano medication preparation facilities described in claim 1 in macromolecule carrier, Inorganic Non-metallic Materials, nanometer or microsphere drug, the preparation of capsule-type medicine.
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| CN1830536A (en) * | 2000-05-16 | 2006-09-13 | 明尼苏达大学评议会 | High mass throughput particle generation using multiple nozzle spraying |
| DE10024154A1 (en) * | 2000-05-19 | 2001-11-22 | Inotech Encapsulation Ag Dotti | Encapsulation of cells/substances uses an injection pump to form small spherical particles in an immobilizing mixture with external vibration on the pump and an electrical field at the hardening vessel |
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Application publication date: 20150624 |