CN114470442A - Pen-shaped drug delivery device for aerosol inhalation - Google Patents

Pen-shaped drug delivery device for aerosol inhalation Download PDF

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Publication number
CN114470442A
CN114470442A CN202210204101.5A CN202210204101A CN114470442A CN 114470442 A CN114470442 A CN 114470442A CN 202210204101 A CN202210204101 A CN 202210204101A CN 114470442 A CN114470442 A CN 114470442A
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CN
China
Prior art keywords
pen
rack
aerosol inhalation
delivery device
drug
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CN202210204101.5A
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Chinese (zh)
Inventor
朱涛
司伟雪
赵晓龙
王月然
王丽萍
蒋悦颖
徐方
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CanSino Biologics Inc
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CanSino Biologics Inc
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Priority to CN202210204101.5A priority Critical patent/CN114470442A/en
Publication of CN114470442A publication Critical patent/CN114470442A/en
Priority to PCT/CN2023/079235 priority patent/WO2023165549A1/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/001Particle size control
    • A61M11/003Particle size control by passing the aerosol trough sieves or filters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1025Respiratory system

Abstract

The invention discloses a pen-shaped drug delivery device for aerosol inhalation, which comprises a quantitative drug delivery control device, a drug storage bottle fixing device and an atomization device. The pen-type atomizer can be used for generating medicine mist, and the medicine mist is inhaled by a subject, so that the effects of treatment or immunity and the like are realized. The vaccine is directly filled into the cassette bottle, and the matched liquid separating pen is used, so that the liquid extracting step of filling the vaccine into the injector is replaced, the workload of vaccinees is reduced, and the injury risk caused by medicine extraction by puncturing the rubber plug by the injector is avoided. The liquid separating needle punctures the cassette bottle once, so that puncturing scraps caused by using the injector to draw medicines for many times are reduced. The pen-shaped atomizer can reduce waste of liquid medicine through accurate liquid distribution and is convenient to transport.

Description

Pen-shaped drug delivery device for aerosol inhalation
Technical Field
The invention relates to an atomization drug delivery device, in particular to a pen-shaped drug delivery device for atomization inhalation.
Background
In the case of air pollution becoming more and more severe today, respiratory illness patients are greatly increasing, coupled with a sudden warming of the climate during seasonal changes. The aerosol inhalation administration can greatly alleviate the problem of respiratory diseases. The existing atomization drug delivery device in the prior art mainly adopts the mode of delivering drug by atomizing and inhaling, the subject needs to be guided before the drug delivery, and children and even many adults often greatly influence the inhalation and absorption of the drug mist due to improper control of the frequency of the inhalation drug delivery and self-breathing, which is very unfavorable for immunization or disease treatment. In addition, misting while sucking may present a risk of cross-infection. The invention relates to a pen-shaped atomizer, which can atomize liquid medicine into a cup in advance and then inhale the liquid medicine into a body, thereby preventing cross infection, reducing the cost and having high inhalation inoculation efficiency. At present, one treatment mode of respiratory diseases is aerosol inhalation administration, liquid medicine is dispersed into tiny fogdrops by using an atomizer, the fogdrops are inhaled through the nose or the mouth of a patient, and atomized medicines directly act on a target organ, so that the local concentration of the medicines can be improved, and the treatment effect is achieved. The aerosol inhalation has good therapeutic effect on capillary bronchitis, asthmatic bronchitis, bronchial asthma, acute and chronic bronchitis, acute laryngitis, acute pneumonia, etc.
The aerosol inhalation type vaccine is a vaccine immunized by aerosol inhalation, and the aerosol inhalation immunization refers to the way that a nebulizer atomizes the vaccine into tiny particles, and the tiny particles enter respiratory tracts and lungs in a respiratory inhalation mode to excite mucosal immunization.
The equipment and devices for realizing the aerosol inhalation therapy and immunization are very important for the implementation and quality of the therapy and immunization and are greatly concerned by developers. The existing atomization drug delivery device in the prior art mainly adopts a mode of delivering drug by atomizing and inhaling, a subject needs to be guided before the drug delivery, children and even many adults often greatly influence the inhalation and absorption of drug mist due to improper control of the frequency of the inhalation drug delivery and self-breathing, and the mode is very unfavorable for immunization. In addition, for immunization, the portion of the device that is inhaled by the subject should be sterilized or disposed of after use in order to prevent cross-infection. In view of the necessity of mass inoculation, it is an urgent problem to provide an aerosol administration device which can prevent cross-infection and reduce the cost, and has high inhalation inoculation efficiency.
Disclosure of Invention
In order to overcome the defects of the prior art, the invention provides the pen-shaped atomizer which can be used for generating medicine mist and enabling a testee to inhale the medicine mist, thereby realizing the effects of treatment, immunity and the like.
The vaccinator does not need to inject and inoculate, and only needs to inhale the vaccine into the respiratory tract and the lung through the pen-shaped atomizer, so that the triple protection of mucosal immunity, cellular immunity and humoral immunity is obtained. Compared with cellular immunity and humoral immunity formed by the injection type new corona vaccine, the vaccine for aerosol inhalation can induce a human body to generate mucosal immunity, prevent infection and block transmission at the first gateway of virus invasion.
By using the pen-shaped administration device, the vaccine for aerosol inhalation can be inoculated by only one inhalation, so that the pen-shaped administration device is safer, more convenient and more suitable for large-scale population popularization and use. Meanwhile, only one fifth of the dose of vaccine for intramuscular injection is needed for one dose of vaccine for aerosol inhalation, and the level of cellular immune response generated is equivalent to that of the vaccine for intramuscular injection, namely the productivity is indirectly improved by five times.
The invention aims to solve the problems of cross infection, high cost and low efficiency of the existing atomizing device during atomizing and sucking. Provides a pen-shaped atomization drug delivery device, when the drug is needed, the drug liquid can be atomized into a cup in advance and then inhaled into the body, thereby achieving the purpose of treatment or immunization.
In order to achieve the purpose, the invention adopts the following technical scheme:
the pen-type atomizing medicine feeder capable of atomizing and inhaling includes quantitative medicine feeding controller, medicine storing bottle fixer and atomizer.
The quantitative dosing control device comprises a pressing button, a sleeve type push rod, a rack, a shell, a reset spring, a first spring limiting component, a rack positioner, a stepping displacement groove, a second spring limiting component, a rack stepping pushing component and a stepping limiting rod, wherein a stepping pushing head is arranged at the lower end of the rack.
Specifically, the first spring limiting part and the second spring limiting part are arranged on the inner walls of the two sides of the shell and used for fixing the return spring.
Specifically, the rack positioner is located at the tail end of the rack and used for fixing the rack when the sleeve type push rod is reset.
Specifically, the stepping limiting rod is positioned in the stepping displacement groove and can move in the stepping displacement groove.
The medicine storage bottle fixing device can fix a medicine storage bottle pre-filled with liquid medicine, and the medicine storage bottle can be a clamp type bottle or a penicillin bottle.
Specifically, the front end of the medicine storage bottle fixing device is provided with a liquid outlet needle; the liquid outlet needle communicates the medicine storage bottle with the atomization device; the medicine storage bottle fixing device is connected with the atomizing device through a double-nut structure.
The atomization device comprises a liquid storage tank, a vibrating screen sheet, a mist outlet and an electric signal control plug, wherein the vibrating screen sheet is located at the opening end of the liquid storage tank and communicated with the mist outlet.
Specifically, the pressing button is pressed, the sleeve type push rod moves downwards, the rack stepping pushing component pushes the rack to move downwards, the stepping pushing head at the tail end of the rack pushes a medicine storage bottle rubber plug in the medicine storage bottle fixing device, and liquid is added into a liquid storage tank of the atomizer through the needle head for liquid medicine in the medicine storage bottle; the pressing button is released, and the return spring reversely pushes the sleeve type push rod to return.
Specifically, in the vibrating mesh screen type atomizer of the atomizing device, the vibrating mesh screen sheet is made of a metal material or a thin film polymer material, and preferably, the metal material is stainless steel or alloy; preferably, the film polymer material is polypropylene, polystyrene, polyimide; more preferably, the vibrating screen sheet is made of palladium alloy material.
The vibrating screen mesh piece is formed by attaching a piezoelectric ceramic element of a vibrating screen mesh piece made of a metal material or a thin film polymer material, the piezoelectric ceramic element receives a high-frequency electric signal sent by a circuit of an electric signal control plug through two external leads, the electric signal can be converted into high-frequency vibration, the high-frequency vibration is transmitted to liquid medicine, the liquid medicine surface is enabled to bulge, cavitation is generated around the bulge, the cavitation can generate shock waves, the shock waves are continuously and repeatedly vibrated at the vibration frequency of the vibrator, surface tension waves with limited amplitude are generated on the liquid surface, wave heads of the waves are dispersed to atomize the liquid medicine, and atomized particles enter an atomizing cup through small holes (phi 1 mu m-5 mu m) in the center of the metal material or thin film polymer material piece by means of gravity to achieve the atomizing purpose.
The beneficial technical effects are as follows:
1. the pen-type atomization drug delivery device can be used for generating drug mist, and the drug mist is inhaled by a subject to achieve the effects of treatment or immunity and the like.
2. The vaccine is directly filled into the cassette bottle, and the matched liquid separating pen is used, so that the liquid extracting step of filling the vaccine into the injector is replaced, the workload of vaccinees is reduced, and the injury risk caused by medicine extraction by puncturing the rubber plug by the injector is avoided.
3. The liquid separating needle punctures the cassette bottle once, so that puncturing scraps caused by using the injector to draw medicines for many times are reduced.
4. The pen-shaped atomization drug delivery device can reduce the waste of liquid medicine through accurate liquid distribution and is convenient to transport.
Drawings
FIG. 1 is a schematic diagram of a device useful for administering an aerosol inhalation according to the present invention;
FIG. 2 is a schematic diagram of an exploded view of a device useful for administration by aerosol inhalation according to the present invention;
FIG. 3 is a schematic cross-sectional view of a dosing control device of a device that may be used for administering an aerosol according to the present invention;
FIG. 4 is a schematic cross-sectional view of a drug storage assembly of a device for administering an aerosol by inhalation according to the present invention;
FIG. 5 is a schematic cross-sectional view of a bolus assembly of a device useful for aerosol administration according to the present invention;
FIG. 6 is a schematic cross-sectional view of a double nut and a liquid outlet needle of the administration device for aerosol inhalation according to the present invention;
FIG. 7 is a schematic cross-sectional view of an aerosol inhalation delivery device provided in accordance with the present invention;
FIG. 8 is a schematic view of a vibrating mesh nebulizer of an aerosolizing inhalation delivery device according to the present invention;
FIG. 9 is a schematic structural view of an atomizing cup of the present invention;
the drawings are numbered as follows:
the device comprises a press button 1, a sleeve type push rod 2, a rack 3, a shell 4, a reset spring 5, a first spring limiting part 6, a rack positioner 7, a stepping displacement groove 8, a second spring limiting part 9, a rack stepping pushing part 10, a stepping limiting rod 11, a stepping pushing head 12, a medicine storage bottle rubber plug 13, a medicine storage bottle 14, a liquid outlet needle 15, a liquid storage tank 16, an atomizing device 17, a mist outlet 18, an electric signal control plug 19, a medicine storage bottle fixing device 20, a double-nut structure 21, a piezoelectric ceramic element 22, a vibrating screen sheet 23, a clamping groove 24, a bulge 25, a cup body 26, a cup cover 27, a mist inlet 28 and a suction nozzle 29.
Detailed Description
Unless defined otherwise, all scientific and technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.
The disclosures of the various publications, patents, and published patent specifications cited herein are hereby incorporated by reference in their entirety.
The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments of the present invention, and it should be understood that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1 as shown in figure 1, an aerosol inhalation delivery device comprising a dosing control device, a vial retaining device and an aerosolization device.
The quantitative dosing control device comprises a pressing button 1, a sleeve type push rod 2, a rack 3, a shell 4, a reset spring 5, a first spring limiting component 6, a rack positioner 7, a stepping displacement groove 8, a second spring limiting component 9, a rack stepping pushing component 10 and a stepping limiting rod 11, wherein a stepping pushing head 12 is arranged at the lower end of the rack 3.
The first spring limiting part 6 and the second spring limiting part 9 are arranged on the inner walls of the two sides of the shell 4 and used for fixing the return spring 5.
The rack positioner 7 is positioned at the tail end of the rack 3 and used for fixing the rack 3 when the sleeve type push rod 2 is reset.
The stepping limiting rod 11 is located in the stepping displacement groove 8 and can move in the stepping displacement groove 8.
The medicine storage bottle fixing device 20 can fix the medicine storage bottle 14 which is pre-filled with medicine liquid, and the medicine storage bottle can be a clamp type bottle or a penicillin bottle.
The front end of the medicine storage bottle fixing device 20 is provided with a liquid outlet needle 15; the outlet needle communicates the storage vial 14 with the aerosolization device, preferably the storage vial holder 20 is connected with the aerosolization device by a double nut arrangement 21.
The atomization device 17 comprises a liquid storage tank 16, a vibrating screen sheet 23, a mist outlet 18 and an electric signal control plug 19, wherein the vibrating screen sheet 23 is located at the opening end of the liquid storage tank 16 and is communicated with the mist outlet 18.
The atomizing cup consists of a cup body 26 and a cup cover 27, and the fog outlet 18 is in butt joint with a fog inlet 28 of the atomizing cup. A suction nozzle 29 is arranged at the edge near the top of the cup cover 27, and through the suction nozzle 29, a patient can inhale the liquid medicine fog into the respiratory tract and the lung through the mouth, so that the treatment effect is achieved.
The pressing button 1 is pressed, the sleeve type push rod 2 moves downwards, the rack stepping pushing component 10 pushes the rack 3 to move downwards, the stepping pushing head 12 at the tail end of the rack pushes the medicine storage bottle rubber plug 13 in the medicine storage bottle fixing device 20, and liquid is added into the liquid storage tank 16 of the atomizer through the needle head from the medicine liquid in the medicine storage bottle; the pressing button 1 is released, and the return spring 5 reversely pushes the sleeve type push rod 2 to return.
The atomization device 17 is a vibrating mesh screen type atomizer which is formed by laminating a piezoelectric ceramic element 22 and a vibrating mesh screen sheet 23, and the electric signal control plug 19 is connected with the piezoelectric ceramic element causing the diaphragm to vibrate.
The vibrating screen is made of metal or thin film polymer, preferably stainless steel,
Alloying; preferably, the thin film polymer material is (PP) polypropylene, (PS) polystyrene, or (PI) polyimide.
The bottom of the injection component is provided with a clamping groove 24, and the medicine storage bottle fixing device 20 is connected with the clamping groove 24 of the injection component through a protrusion 25 at the top end.
Example 2 written test atomizer dosing accuracy test
Select the atomizing inhalation of embodiment 1 device of dosing, do not connect the atomizer, get 3 calorie of card bottles (specification 3ml), assemble to the atomizing pen after filling purified water respectively in with the card bottle, press and divide liquid, collect the liquid of every minute of division, ten thousandth balance is accurately weighed, and the result is as follows:
Figure BDA0003528468130000061
the results show that: the relative error of liquid separation of the atomization pen is within +/-2%, the liquid separation accuracy is high, and the target use requirement can be met; the repeatability is less than 2 percent, the liquid separation precision is high, and the target use requirement can be met.
Example 3 Screen Material screening adapted for an atomizing Pen
Experimental groups: and (3) respectively selecting a vibrating mesh screen made of palladium alloy, stainless steel and polyimide materials, and assembling the vibrating mesh screen into the atomizer.
Model drug: recombinant novel coronavirus vaccine (adenovirus 5 vector) liquid preparation
Figure BDA0003528468130000073
Figure BDA0003528468130000072
And (3) assembling the vaccine-filled cartridge bottle to an atomizing pen, and linking the atomizing pen and an atomizer. Each group was separately nebulized three times and the resulting mist was recorded for the time required to nebulize 0.1ml of vaccine using a inhaled formulation strength detector (Sympatech GmbH, equipment calibrated gas flow rate 15L/min).
Figure BDA0003528468130000071
The results show that:
from the result of particle size distribution, the vibration mesh screens which can be prepared from palladium alloy, stainless steel and polyimide materials are selected, and the median particle size and the particle size distribution range of the palladium alloy mesh screen atomizing pen and the polyimide mesh screen atomizing pen are smaller than those of the stainless steel mesh screen.
The atomization time of the polyimide mesh screen atomization pen is longer than that of a palladium alloy mesh screen and a stainless steel mesh screen atomization pen. The reason for this may be that polymer-based materials are less rigid and more sensitive to the viscosity of the liquid medicine than metal-based materials.
The mist with the particle size of 1-5 μm can realize wide distribution of the lower respiratory tract, and the excessively long atomization time when the mist is matched with an atomizing cup can cause the deposition of the medicine.
The diameter of the metal material or the thin film polymer material can be 5-20 mm according to actual needs, the central diameter is 2-8 mm of convex surface, and the convex surface faces the atomizing cup.
In conclusion, the vibration mesh screen material which is more suitable for the recombinant novel coronavirus vaccine (adenovirus type 5 vector) is palladium alloy.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and the like that are within the spirit and principle of the present invention are included in the present invention.
The foregoing embodiments and methods described in this disclosure may vary based on the abilities, experience, and preferences of those skilled in the art.
The mere order in which the steps of a method are listed in the present invention does not constitute any limitation on the order of the steps of the method.

Claims (10)

1. A pen-type drug delivery device for aerosol inhalation is characterized by comprising a quantitative drug delivery control device, a drug storage bottle fixing device and an atomization device.
2. The pen type drug delivery device for aerosol inhalation according to claim 1, wherein the dosing control device comprises a pressing button (1), a sleeve-type push rod (2), a rack (3), a housing (4), a return spring (5), a first spring limiting component (6), a rack positioner (7), a stepping displacement groove (8), a second spring limiting component (9), a rack stepping pushing component (10), and a stepping limiting rod (11), wherein a stepping pushing head (12) is arranged at the lower end of the rack (3).
3. The pen delivery device for aerosol inhalation according to claim 2, characterized in that the first spring stop (6) and the second spring stop (9) are arranged on the inner walls of the housing (4) on both sides for fixing the return spring (5).
4. A pen delivery device for aerosol inhalation according to any of claims 2 to 3, wherein a rack retainer (7) is located at the end of the rack (3) for securing the rack (3) when the telescopic plunger (2) is reset.
5. Pen type delivery device for aerosol inhalation according to any of claims 2 to 4, characterized in that the step limiter lever (11) is located in the step displacement slot (8) and is movable in the step displacement slot (8).
6. Pen-type drug delivery device for aerosol inhalation according to one of claims 2 to 5, characterized in that the drug reservoir holder (20) holds a drug reservoir (14) of a pre-filled drug solution, which is selected from a cassette or a vial of penicillin.
7. The pen type drug delivery device for aerosol inhalation according to any one of claims 2 to 6, wherein the front end of the drug storage bottle holder (20) is provided with a liquid discharge needle (15); the liquid outlet needle is used for communicating the medicine storage bottle (14) with the atomizing device (17), and preferably, the medicine storage bottle fixing device (20) is connected with the atomizing device through a double-nut structure (21).
8. A pen delivery device for aerosol inhalation according to any of claims 2 to 7, wherein the aerosolization device (17) comprises a reservoir (16), a vibrating mesh screen (23), an aerosol outlet (18), an electrical signal control plug (19), the vibrating mesh screen (23) being located at an open end of the reservoir (16) and communicating with the aerosol outlet (18).
9. The pen-type drug delivery device for aerosol inhalation according to any one of claims 2 to 8, wherein the push button (1) is pressed, the sleeve-type push rod (2) moves downwards, the rack stepping pushing member (10) pushes the rack (3) to move downwards, the stepping pushing head (12) at the tail end of the rack pushes the drug storage bottle rubber plug (13) in the drug storage bottle fixing device (20), and the drug solution in the drug storage bottle is added into the atomizer reservoir (16) through the needle; the pressing button (1) is released, and the return spring (5) reversely pushes the sleeve type push rod (2) to return.
10. A pen delivery device for aerosol inhalation according to any of claims 2 to 9, wherein the aerosolization device is a vibrating mesh screen nebulizer, formed by attaching a piezo-ceramic element (22) and a vibrating mesh screen sheet (23).
CN202210204101.5A 2022-03-02 2022-03-02 Pen-shaped drug delivery device for aerosol inhalation Pending CN114470442A (en)

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CN202210204101.5A CN114470442A (en) 2022-03-02 2022-03-02 Pen-shaped drug delivery device for aerosol inhalation
PCT/CN2023/079235 WO2023165549A1 (en) 2022-03-02 2023-03-02 Pen-shaped drug delivery device for inhalation of nebulized drugs

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023165549A1 (en) * 2022-03-02 2023-09-07 康希诺生物股份公司 Pen-shaped drug delivery device for inhalation of nebulized drugs
WO2024012194A1 (en) * 2022-07-12 2024-01-18 康希诺生物股份公司 Atomization-inhalation-type atomization drug administration device

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023165549A1 (en) * 2022-03-02 2023-09-07 康希诺生物股份公司 Pen-shaped drug delivery device for inhalation of nebulized drugs
WO2024012194A1 (en) * 2022-07-12 2024-01-18 康希诺生物股份公司 Atomization-inhalation-type atomization drug administration device

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