Humidity guarantee device for laser particle analyzer applied to inhalation preparation detection

Abstract

The invention discloses a humidity guaranteeing device for a laser particle analyzer applied to inhalation preparation detection, and belongs to the technical field of medical instruments, the humidity guaranteeing device comprises a wet gas generating device and a gas pipeline, the wet gas generating device comprises a gas inlet and a gas outlet, and the gas outlet is in sealed connection with the gas pipeline; a sample bin and a fog drop testing device are mounted on the gas pipeline, and the sample bin is positioned between the fog drop testing device and the gas outlet; the sample bin is provided with a medicine containing cavity, the medicine containing cavity is communicated with the gas pipeline, the fog drop testing device is provided with a fog drop containing cavity, the fog drop containing cavity is communicated with the sample bin, and the fog drop testing device is provided with a first light-transmitting part and a second light-transmitting part. The device can be adapted to a laser particle analyzer, fog drops can meet requirements when the laser particle analyzer is used for detection, and an accurate detection result is obtained.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, in particular to a humidity protection device for a laser particle size analyzer used for inhalation preparation detection. Background Art

[0002] Inhalation preparations refer to preparations that deliver drugs in aerosol form to the respiratory tract and / or lungs through a specific device to exert local or systemic effects. They are the first choice for the treatment of asthma and chronic obstructive pulmonary disease. When using inhalation preparations, droplets of different sizes will be deposited in different parts of the respiratory system. Therefore, it is necessary to test the particle size distribution of the droplets after atomization to evaluate whether its lung drug delivery efficiency is qualified.

[0003] Laser particle size analyzer is a common device for testing the droplet size of inhalation preparations. When using a laser particle size analyzer to test the atomization effect of a product with solution properties, it is necessary to simulate the actual conditions of the atomizer in the human body, and the relative humidity of the environment must be as close to the saturation state as possible (greater than 93%). In an open indoor environment, these conditions are not met, and accurate test results under target conditions cannot be obtained.

[0004] Although there are related devices for humidifying air, these devices cannot be adapted to laser particle size analyzers, and there is no guarantee that the humidity can meet the requirements when the laser particle size analyzer detects the droplet size distribution of inhalation preparations. Summary of the invention

[0005] The purpose of the present invention is to provide a humidity protection device for a laser particle size analyzer used for inhalation preparation detection, which can be adapted to the laser particle size analyzer to ensure that the humidity when the laser particle size analyzer detects the droplet particle size distribution of the inhalation preparation can meet the requirements and obtain detection results simulating the real environment in the human body.

[0006] The technical solutions to achieve the above objectives include the following:

[0007] Humidity protection device for laser particle size analyzer used for inhalation preparation testing, including:

[0008] A wet gas generating device and a gas pipeline, wherein the wet gas generating device comprises an air inlet and an air outlet, and the air outlet is sealed and connected to the gas pipeline;

[0009] A sample chamber and a droplet testing device are installed on the gas pipeline, and the sample chamber is located between the droplet testing device and the gas outlet;

[0010] The sample chamber has a medicine containing cavity, the medicine containing cavity is communicated with the gas pipeline, and the humidified gas generated by the humid gas generating device flows through the medicine placed in the medicine containing cavity to generate droplets;

[0011] The droplet testing device has a droplet containing chamber, which is connected to the sample chamber. The droplet testing device has a first light-transmitting portion and a second light-transmitting portion, which form a channel for light from a laser particle size analyzer to illuminate droplets flowing into the droplet containing chamber and diffract to the outside of the droplet testing device.

[0012] In one embodiment, the wet gas generating device includes: a heating element and a humidification generator, the humidification generator is provided with the air inlet and the air outlet, the air inlet is sealedly connected with an air inlet pipe, the air inlet pipe extends into the humidification generator, and the wet gas generating element is installed at one end of the air inlet pipe located in the humidification generator.

[0013] In one embodiment, the wet gas generating element is an air stone, the diameter of the air inlet hole of the air stone is not less than 6 mm, and the ratio between the volume of the air stone and the volume of the humidification generator is greater than 15:1000.

[0014] In one embodiment, the humidification generator is further provided with a detection port, and a barometer and / or a thermometer is sealed and installed on the detection port.

[0015] In one embodiment, optical glass is installed on two opposite side walls of the droplet testing device to form the first light-transmitting portion and the second light-transmitting portion. The visible light reflectivity of the optical glass is less than 0.5%, and the visible light transmittance is not less than 99%. The optical glass is circular and has a diameter of not less than 40 mm.

[0016] In one embodiment, the droplet testing device is a quadrangular prism, a first end of the quadrangular prism is provided with an inlet connected to the sample chamber, and a second end of the quadrangular prism is provided with an exhaust port.

[0017] In one embodiment, the exhaust port is connected to a vacuum pump, and the pumping speed of the vacuum pump is not less than 80m / s. 3 / h, the ultimate pressure is not less than 0.8mbar, and the gas flow rate in the droplet containing chamber is not less than 20L / min.

[0018] In one embodiment, the gas pipeline includes a plastic pipe and a support member disposed in the plastic pipe, wherein the support member is made of stainless steel and extends in a spiral shape in the plastic pipe.

[0019] In one embodiment, the sample chamber includes a chamber cover and a chamber body, wherein the chamber cover is disposed on the chamber body, the interior of the chamber body is hollow to form the drug containing chamber, the first end of the chamber body is connected to the gas pipeline, and the second end of the chamber body is connected to the droplet testing device.

[0020] In one embodiment, a lifting device is further included, wherein the lifting device is located below the mist droplet testing device, and the mist droplet testing device is fixed on the lifting device.

[0021] The technical solution provided by the present invention has the following advantages and effects:

[0022] The wet gas is generated by the wet gas generating device and transported to the gas pipeline. The sample chamber and the droplet testing device are installed on the gas pipeline. The medicine is placed in the sample chamber. The humidified gas in the gas pipeline that meets the requirements is directly introduced into the sample chamber to generate droplets. The droplets in the droplet testing device are then illuminated by the light of the laser particle size analyzer to detect the droplet size. The seal from the gas outlet to the external environment during the test is achieved, which can ensure that the droplets meet the requirements during the laser particle size analyzer test and obtain the test results simulating the real environment in the human body. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The accompanying drawings herein show specific examples of the technical solutions described in the present invention, and together with the specific implementation methods, constitute a part of the specification, and are used to explain the technical solutions, principles and effects of the present invention.

[0024] Unless otherwise specified or defined, the same reference numerals in different drawings represent the same or similar technical features, and the same or similar technical features may also be represented by different reference numerals.

[0025] Figure 1 is a schematic diagram of a humidity assurance device in one embodiment of the present invention;

[0026] Figure 2 for Figure 1 Schematic diagram of the sample chamber in the embodiment.

[0027] Description of reference numerals:

[0028] 10. Wet gas generating device, 11. Heating element, 12. Humidifier generator, 121. Air inlet, 122. Air outlet, 123. Detection port, 13. Air inlet pipe, 14. Air bubble stone, 15. Air inlet valve, 16. Air outlet valve, 17. Thermometer, 18. Barometer,

[0029] 20. Gas pipeline, 21. Plastic pipe, 22. Support parts,

[0030] 30. Sample chamber, 31. Chamber cover, 32. Chamber body, 33. Drug containing chamber,

[0031] 40. a mist drop testing device, 41. a mist drop receiving chamber, 42. a first light-transmitting portion, 43. a second light-transmitting portion, 44. an inlet, 45. an exhaust port,

[0032] 50. Lifting device,

[0033] 60. Vacuum pump. DETAILED DESCRIPTION

[0034] In order to facilitate the understanding of the present invention, specific embodiments of the present invention will be described in more detail below with reference to the accompanying drawings.

[0035] Unless otherwise specified or defined, the "first, second..." used in this article is merely used to distinguish names and does not represent a specific quantity or order.

[0036] Unless specifically stated or defined otherwise, the term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0037] It should be noted that when a component is considered to be "fixed to" another component, it can be directly fixed to the other component or there can be a central component; when an component is considered to be "connected to" another component, it can be directly connected to the other component or there can be a central component at the same time; when an component is considered to be "installed on" another component, it can be directly installed on the other component or there can be a central component at the same time. When an component is considered to be "set on" another component, it can be directly set on the other component or there can be a central component at the same time.

[0038] Most of the existing air humidification devices are not compatible with laser particle size analyzers. Moreover, after the air is humidified, the humidified gas is directly passed into the measuring chamber of the laser particle size analyzer through a pipe. At this time, the humidified gas will expand and be mixed with external environmental gases or impurities that do not meet the humidity requirements. Therefore, even if the humidity in the pipeline meets the requirements, the indicators will decrease when connected to the laser particle size analyzer, resulting in the humidified gas not meeting the requirements. The droplets formed by the wrapped medicine will also become unstable, and the particle size will easily change, so accurate test results cannot be obtained.

[0039] In order to enable the laser particle size analyzer to obtain more accurate detection results when detecting the droplet particle size distribution of the inhalation preparation, the present invention installs a sample bin and a droplet test device on the gas pipeline, places the medicine in the sample bin, and the humidified gas in the pipeline that meets the requirements directly enters the sample bin. In order to prevent the phenomenon that the detection result is inaccurate due to volume change and other gas or impurity doping during the laser particle size analyzer detection, the droplets generated in the sample bin are passed into the droplet test device, and the droplet test device is placed in the measurement room of the laser particle size analyzer. The light emitted by the laser particle size analyzer enters the droplet test device through the light-transmitting part of the droplet test device, and after diffraction reaction with the droplets, it is transmitted to the outside of the droplet test device through another light-transmitting part. The computer system of the laser particle size analyzer analyzes the detected diffraction light signal, and uses the light diffraction theory (such as Mie diffraction theory) to associate the diffraction light intensity with the particle size distribution, and finally calculates the particle size distribution curve. The sample bin and the droplet test device ensure that the droplets are stable during detection and obtain accurate detection results.

[0040] like Figure 1 As shown, the embodiment of the present invention provides a humidity assurance device, which mainly includes a wet gas generating device 10 and a gas pipeline 20. The wet gas generating device 10 is used to generate wet gas that meets the humidity requirements. The sample chamber 30 and the droplet testing device 40 are installed on the gas pipeline 20. The gas pipeline 20 is used to transport the wet gas to the sample chamber 30 to form qualified droplets, and then the droplets flow into the droplet testing device 40. After the droplet testing device 40 is placed in the measuring room of the laser particle size analyzer, the particle size of the droplets can be detected.

[0041] The wet gas generating device 10 includes a heating element 11 and a humidification generator 12. The humidification generator 12 is filled with purified water. The heating element 11 is used to heat the purified water to quickly generate wet gas that meets the humidity requirements. In this embodiment, the heating element 11 is an electric furnace. The humidification generator 12 is similar in shape to a flask, with the bottom placed on the heating element 11 and an air inlet 121 and an air outlet 122 provided on the top.

[0042] The air inlet 121 of the humidification generator 12 is sealedly connected with an air inlet pipe 13 for introducing air. The air inlet pipe 13 extends into the humidification generator 12 and is located below the liquid surface of the purified water. An air bubble stone 14 is installed at one end of the air inlet pipe 13 located in the humidification generator 12. Wet gas is generated by flowing air into the purified water through the air bubble stone 14. The porous structure of the air bubble stone 14 is used to increase the evaporation area of ​​the purified water, thereby improving the air humidity and the efficiency of generating wet gas. Obviously, it is not limited to the use of air bubble stones, and other devices or materials that can easily generate wet gas can also be used as wet gas generating components, such as: ceramic humidifiers or wet curtains.

[0043] The gas outlet 122 of the humidification generator 12 is sealedly connected to the gas pipeline 20 , and the generated humid gas flows to the gas pipeline 20 through the gas outlet 122 .

[0044] For convenient control, an air inlet valve 15 is installed on the air inlet pipe 13 in this embodiment, and an air outlet valve 16 is installed on the gas pipeline 20 adjacent to the air outlet 122. In order to perform relevant tests, a detection port 123 is also provided on the humidification generator 12 of this embodiment, and a barometer 18 and / or a thermometer 17 are sealed and installed on the detection port 123. The barometer 18 is used to detect the air pressure in the humidification generator 12 to ensure safety, and the thermometer 17 is used to detect the temperature in the humidification generator 12 to control the heating efficiency of the heating element 11.

[0045] It should be noted that the specific implementation method of the sealing installation of the air inlet 121, the air outlet 122, and the detection port 123 is not limited, and conventional technology can be used to design according to the structure and material of the humidification generator 12. For example, the humidification generator 12 in this embodiment is a transparent glass flask, and frosted glass stoppers are used at the air inlet 121 and the air outlet 122 for connection and sealing. The overall structure of the device is simple, the frosted glass interface is not easy to leak, and it is easy to disassemble, which is convenient for daily maintenance and cleaning, and the device structure is stable and not easy to tip over. Obviously, the shape of the humidification generator 12 is not limited to the shape of a flask.

[0046] The sample chamber 30 is located between the mist droplet testing device 40 and the gas outlet 122, and is used to introduce wet gas and form mist droplets. Figure 2 As shown, the sample chamber 30 includes a chamber cover 31 and a chamber body 32, the chamber cover 31 is hinged to the chamber body 32, and the chamber cover 31 can be covered on the chamber body 32. The chamber body 32 is hollow inside to form a drug receiving chamber 33. The first end of the chamber body 32 is connected to the gas pipeline 20, and the drug receiving chamber 33 is connected to the gas pipeline 20. There is wet gas that meets the humidity requirements generated by the wet gas generating device 10 in the gas pipeline 20. The drug is placed in the drug receiving chamber 33. After the wet gas flows into the drug receiving chamber 33, it flows through and wraps the drug placed in the drug receiving chamber 33, interacts with the drug, and generates droplets; the second end of the chamber body 32 is connected to the droplet testing device 40, and the generated droplets flow into the droplet testing device 40.

[0047] The droplet testing device 40 has a droplet receiving chamber 41, which is connected to the sample chamber 30, and the droplets generated by the sample chamber 30 flow into the droplet receiving chamber 41. The droplet testing device 40 has a first light-transmitting portion 42 and a second light-transmitting portion 43, such as optical glass installed on two opposite side walls of the droplet testing device 40 to form the first light-transmitting portion 42 and the second light-transmitting portion 43. The light of the laser particle size analyzer enters the droplet testing device 40 from the first light-transmitting portion 42, irradiates the droplets in the droplet receiving chamber 41, and after diffraction, is emitted from the second light-transmitting portion 43 to the outside of the droplet testing device 40. In other words, the first light-transmitting portion 42 and the second light-transmitting portion 43 form a channel for the light of the laser particle size analyzer to irradiate the droplets and diffract to the outside of the droplet testing device.

[0048] By generating mist droplets in the sample chamber 30, mist droplets can be generated in a wet gas environment that meets the requirements, ensuring that the mist droplets are qualified. However, the prior art directly passes wet gas into the measuring chamber of the laser particle size analyzer, which, under the influence of the external environment, will cause the humidity of the wet gas to change or impurities to cause the mist droplets to be unqualified. By isolating the external environment through the mist droplet testing device 40, it can be ensured that the mist droplets are qualified during the test. Therefore, by using the mist droplet testing device 40 and the sample chamber 30, a seal relative to the external environment from the air outlet to the test is achieved, which can ensure that the mist droplets are qualified during the test.

[0049] Specifically, in this embodiment, the droplet testing device 40 is a quadrangular prism, the first end of the quadrangular prism is provided with an inlet 44 connected to the sample chamber, the second end is provided with an exhaust port 45, and optical glass is provided on two opposite circumferential side walls of the quadrangular prism. In order to ensure the transmission effect of the laser emitted by the laser particle size analyzer, preferably, the visible light reflectance of the optical glass is less than 0.5%, and the visible light transmittance is not less than 99%; preferably, the diameter of the optical glass is not less than 40 mm.

[0050] In order to make the droplet testing device 40 adaptable to laser particle size analyzers of different specifications, a lifting device 50 is further provided below the droplet testing device 40. The droplet testing device 40 is fixed on the lifting device 50, and the height of the droplet testing device 40 can be adjusted to ensure the irradiation effect of the laser particle size analyzer.

[0051] In this embodiment, in order to ensure the detection effect, the gas flow rate in the droplet receiving chamber 41 needs to be no less than 20L / min. To ensure this, in this embodiment, a vacuum pump 60 is connected to the exhaust port 45, and the pumping speed of the vacuum pump 60 is no less than 80m / min. 3 / h, and the ultimate pressure is not less than 0.8mbar, so as to ensure that the detection requirements can be met by exhausting the vacuum pump 60. By adopting the vacuum pump 60, ordinary air can be introduced into the air inlet 121 to meet the gas flow rate without using compressed air. In addition, the main body of the humidification generator 12 is sealed. Due to the exhaust effect of the vacuum pump 60, a negative pressure effect is formed in the humidification generator 12, which can not only speed up the generation efficiency of the wet gas, but also reduce the boiling point of purified water, so that high-humidity gas can be obtained under conditions close to room temperature.

[0052] Since a negative pressure effect is also generated in the gas pipeline 20 at the same time, in order to prevent the collapse of the gas pipeline 20, the gas pipeline 20 of this embodiment includes a plastic tube 21 and a support member 22 arranged in the plastic tube 21. The support member 22 is a steel wire made of stainless steel and extends in a spiral shape in the plastic tube 21. The rigidity of the plastic tube 21 is strengthened by the steel wire to prevent collapse.

[0053] Since the vacuum pump 60 is used for extraction, in order to ensure the timely generation of wet gas, preferably, the diameter of the air inlet hole of the bubble stone 14 is not less than 6 mm, and the ratio between the volume of the bubble stone 14 and the volume of the humidification generator 12 is greater than 15:1000, so that the efficiency of wet gas generation can be ensured, thereby satisfying the extraction of the vacuum pump 60. Obviously, if the vacuum pump 60 is not used for extraction, the use of the bubble stone 14 of the above specifications can also quickly generate wet gas. In this embodiment, the volume of the bubble stone placed in the flask is not less than 15 cubic centimeters, preferably greater than 18 cubic centimeters.

[0054] When in use, add enough purified water to the humidifier generator, install the bubble stone, thermometer, barometer and gas pipeline with wire bracket on the humidifier generator, and then place the humidifier generator on the heating element for heating. Put the drug sample in the sample chamber, close the cover of the sample chamber to seal the sample chamber, adjust the height of the droplet holding chamber to match the height of the laser particle size analyzer light source through the lifting device, connect the vacuum pump to the exhaust port to negative pressure exhaust, and adjust to the target flow rate. The ambient air enters the humidifier generator from the air inlet through the bubble stone, and the wet gas is obtained after humidification by the humidifier generator. The wet gas enters the gas pipeline from the air outlet, passes through the sample chamber and enters the droplet test device, and is detected by the laser particle size analyzer.

[0055] In summary, the humidity protection device of this embodiment can be used in conjunction with an existing laser particle size analyzer. By adopting a droplet test device and a sample chamber, a seal from the air outlet to the external environment during detection is achieved, which can ensure that the droplets are qualified during detection. In addition, a negative pressure steam generation chamber is implemented, which can obtain high-humidity gas at close to room temperature; the air outlet pipe uses a plastic pipe with a wire bracket to avoid pipe shrinkage caused by negative pressure; the flow rate is adjusted by a vacuum pump without external pressure; the droplet test device can adjust the height to adapt to laser particle size analyzers from different manufacturers; the structure is simple and easy to clean daily.

[0056] When quoting drawing descriptions, new features that appear are described; in order to avoid repeated quotations of drawings resulting in less concise descriptions, features that have been described clearly will not be quoted in the drawings one by one.

[0057] The purpose of the above embodiments is to exemplarily reproduce and deduce the technical solution of the present invention, and to fully describe the technical solution, purpose and effect of the present invention. Its purpose is to make the public understand the disclosed content of the present invention more thoroughly and comprehensively, and it does not limit the scope of protection of the present invention.

[0058] The above embodiments are not exhaustive enumerations of the present invention, and there may be multiple other implementations not listed. Any replacement and improvement made without violating the concept of the present invention shall fall within the protection scope of the present invention.

Claims

1. A humidity protection device for a laser particle size analyzer used for inhalation preparation detection, characterized in that: include: A wet gas generating device and a gas pipeline, wherein the wet gas generating device comprises an air inlet and an air outlet, and the air outlet is sealed and connected to the gas pipeline; A sample chamber and a droplet testing device are installed on the gas pipeline, and the sample chamber is located between the droplet testing device and the gas outlet; The sample chamber has a medicine containing cavity, the medicine containing cavity is communicated with the gas pipeline, and the humidified gas generated by the humid gas generating device flows through the medicine placed in the medicine containing cavity to generate droplets; The droplet testing device has a droplet containing chamber, which is connected to the sample chamber. The droplet testing device has a first light-transmitting portion and a second light-transmitting portion, which form a channel for light from a laser particle size analyzer to illuminate droplets flowing into the droplet containing chamber and diffract to the outside of the droplet testing device.

2. The humidity protection device according to claim 1, characterized in that: The wet gas generating device comprises: a heating element and a humidification generator, the humidification generator is provided with the air inlet and the air outlet, the air inlet is sealedly connected with an air inlet pipe, the air inlet pipe extends into the humidification generator, and the wet gas generating element is installed at one end of the air inlet pipe located in the humidification generator.

3. The humidity protection device according to claim 2, characterized in that: The wet gas generating component is an air stone, the diameter of the air inlet hole of the air stone is not less than 6 mm, and the ratio between the volume of the air stone and the volume of the humidification generator is greater than 15:1000.

4. The humidity protection device according to claim 2, characterized in that: The humidification generator is also provided with a detection port, on which a barometer and / or a thermometer is sealed and installed.

5. The humidity protection device according to claim 1, characterized in that: Optical glass is installed on two opposite side walls of the droplet testing device to form the first light-transmitting part and the second light-transmitting part. The visible light reflectivity of the optical glass is less than 0.5%, and the visible light transmittance is not less than 99%. The optical glass is circular and has a diameter of not less than 40 mm.

6. The humidity protection device according to claim 5, characterized in that: The mist drop testing device is a quadrangular prism, a first end of the quadrangular prism is provided with an inlet connected to the sample chamber, and a second end of the quadrangular prism is provided with an exhaust port.

7. The humidity protection device according to claim 6, characterized in that: The exhaust port is connected to a vacuum pump, and the vacuum pump has a pumping speed of not less than 80m 3 / h, the ultimate pressure is not less than 0.8mbar, and the gas flow rate in the droplet containing chamber is not less than 20L / min.

8. The humidity protection device according to claim 1, characterized in that: The gas pipeline comprises a plastic pipe and a support member arranged in the plastic pipe. The support member is made of stainless steel and extends in a spiral shape in the plastic pipe.

9. The humidity protection device according to any one of claims 1 to 8, characterized in that: The sample bin comprises a bin cover and a bin body, wherein the bin cover is arranged on the bin body, the interior of the bin body is hollow to form the drug containing chamber, the first end of the bin body is connected to the gas pipeline, and the second end of the bin body is connected to the droplet testing device.

10. The humidity assurance device according to any one of claims 1 to 8, characterized in that: It also includes a lifting device, which is located below the mist droplet testing device and is fixed on the lifting device.

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