Suction nozzle with multi-stage depolymerization grid plate and medicine powder inhaler

Abstract

The utility model provides a suction nozzle with multistage depolymerization grid trays and a medicine powder inhaler, the suction nozzle comprises a suction pipe, the inner wall of the suction pipe is provided with a spiral channel and three layers of depolymerization grid trays, and the spiral channel is located between the adjacent layers of depolymerization grid trays; each layer of depolymerization grid plate is provided with a medicine through hole, the shape of the medicine through hole is selected from a square shape, a round shape or an oval shape, the hole diameter is gradually reduced from bottom to top, and the medicine through hole is in an inverted funnel shape. According to the utility model, agglomerated particles are dissociated by adding the depolymerization grid plates, and then the multiple layers of grid plates are connected through the spiral channel, so that the dissociation effect is further improved by step-by-step acceleration; tests show that the drug delivery dosage can be increased, particle depolymerization is improved, and the number of layers of depolymerization grid plates of FPF is increased; the optimal aperture range of the medicine through holes in each layer of depolymerization grid plate capable of improving the atomization effect is obtained through research, and a new solution is provided for improvement of the structure of the dry powder inhaler.

Description

Technical Field

[0001] The utility model belongs to the technical field of medicine taking appliances, in particular to a suction nozzle and a medicine powder inhaler with a multi-stage depolymerization grid plate. Background Art

[0002] The application of pulmonary inhalation drug delivery is becoming more and more widespread. The deposition distribution of particles inhaled by the human body in the respiratory tract is mainly related to their aerodynamic diameter. Dry Powder Inhaler (DPI) is one of the most commonly used pulmonary inhalation drug delivery devices on the market today. The dry powder inhaler is filled with solid micronized drugs or a mixture of micronized drugs and carriers. Under the auxiliary action of the patient's respiratory airflow or the power source in the device, the micronized drug particles are sheared, collided and dragged away from the carrier to be atomized, and enter the targeted part of the lungs with the airflow. The atomization and dispersion ability of the DPI device for drug particles is an important indicator for evaluating the performance of the device. The atomization and dispersion of dry powder particles mainly includes the crushing of large particles and the deagglomeration of particle agglomerates. In order to make the drug particles deposit in the lungs more effectively, first, sufficient turbulence needs to be generated in the inhaler to release the drug powder from the capsule and minimize the amount of drug residue in the capsule and in the inhaler; then, the airflow in the device must generate a certain shear force to disperse the drug particles and the carrier; finally, the speed at which the drug particles enter the oral cavity must be effectively controlled. Too fast or too slow will result in the deposition of drug particles outside the lungs.

[0003] like It has 14 parts including spiral nozzle, dosage indicator, medicine storage tank, dosing unit, operating unit, etc. ("Development and Design of Dry Powder Inhaler", Zhou Enlong et al., China Pharmaceutical Industry Journal). The performance of capsule dry powder inhalers on the market is related to the patient's inhalation airflow speed. For critically ill patients, children and elderly patients, the inhalation airflow is low and it is impossible to generate enough flow in the capsule and cavity. In order to better disperse the drug particles and carriers and achieve a more suitable speed to be inhaled into the lungs, the nozzle and screen are studied and optimized accordingly: for the screen, it is mainly by changing the porosity of the grid, and for the nozzle, it is mainly by changing the length of the nozzle.

[0004] In summary, there is still room for improvement in the drug dispersion effect of existing inhalers. Utility Model Content

[0005] In order to overcome the shortcomings of the prior art, the utility model provides a nozzle and a powder inhaler with a multi-stage deagglomeration grid plate to improve the deagglomeration effect. The technical solution of the utility model is as follows:

[0006] As the first aspect of the utility model, it is to provide a suction nozzle with a multi-stage deagglomeration grid, including a suction tube, a spiral channel arranged on the inner wall of the suction tube, and a deagglomeration grid. In the study of the suction nozzle structure, the inventor unexpectedly discovered that increasing the number of layers of the deagglomeration grid in the suction nozzle can improve the drug dispersion effect. Through experimental comparison, it is preferred that the number of layers of the deagglomeration grid is three, and the spiral channel is located between adjacent layers of the deagglomeration grid.

[0007] Preferably, each layer of the depolymerization grid is provided with drug through holes, and the shape of the drug through holes is selected from square, circular or elliptical.

[0008] Preferably, the number of drug through holes of the first depolymerization grid is in the range of 30-60, the number of drug through holes of the second depolymerization grid is in the range of 20-50, and the number of drug through holes of the third depolymerization grid is in the range of 10-40.

[0009] Furthermore, the diameter of the drug through holes on each layer of the depolymerization grid gradually decreases from bottom to top, forming an inverted funnel shape.

[0010] Preferably, the narrowest aperture of the drug through hole on each layer of the deaggregation grid is in the range of 0.3 to 0.9 mm. Studies have shown that when the narrowest aperture is greater than 0.9 mm, the particles are difficult to deaggregate, resulting in a decrease in FPF, and when the narrowest aperture is less than 0.3 mm, the delivered dose is too small and there is a lot of residue.

[0011] Furthermore, from top to bottom, the narrowest aperture of the upper depolymerization grid is smaller than the narrowest aperture of the lower depolymerization grid.

[0012] Preferably, the first layer of deagglomeration grid is located at the top of the suction nozzle and is flush with the suction nozzle; the second layer of deagglomeration grid is located in the middle of the suction pipe; and the third layer of deagglomeration grid is located at the bottom of the suction nozzle pipe.

[0013] As a typical embodiment, the narrowest point of the aperture of the first layer of depolymerization grid is 0.3mm, the largest point is 1.0mm, and the thickness is 2.0mm; the narrowest point of the aperture of the second layer of depolymerization grid is 0.6mm, the largest point is 1.5mm, and the thickness is 2.0mm; the narrowest point of the aperture of the third layer of depolymerization grid is 0.9mm, the largest point is 2.0mm, and the thickness is 2.0mm.

[0014] Preferably, the spiral channel may be a double helix structure, and spiral ribs may be provided on the inner wall of the spiral channel to further enhance the turbulence effect.

[0015] As a second aspect of the utility model, there is provided a medicinal inhaler, comprising the mouthpiece with the multi-stage deagglomeration grid.

[0016] Compared with the prior art, the beneficial effects of the utility model are:

[0017] 1. The utility model dissociates the agglomerated particles by adding a deagglomeration grid plate, and then connects the multi-layer grid plates through a spiral channel to further increase the dissociation effect by step-by-step acceleration; through experiments, the number of deagglomeration grid plates that can not only increase the drug delivery dose, but also improve particle deagglomeration and increase FPF is proposed; the optimal aperture range of the drug through holes on each layer of the deagglomeration grid plate that can improve the atomization effect is also obtained, which provides a new solution for the modification of the dry powder inhaler structure;

[0018] 2. The utility model achieves a significant increase in the dissociation effect through experimental comparison and structural modification by utilizing a structure in which multi-stage depolymerization grid plates are connected by spiral channels. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The drawings in the specification, which constitute a part of the present invention, are used to provide a further understanding of the present invention. The illustrative embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation on the present invention.

[0020] Figure 1 A schematic diagram of a nozzle structure with a multi-stage depolymerization grid provided in Example 1 of the utility model;

[0021] Figure 2 A cross-sectional view of a three-layer depolymerized grid.

[0022] Among them, 1- nozzle, 2- cover plate;

[0023] 11-suction pipe, 12-spiral channel, 13-depolymerization grid;

[0024] 131-Drug access hole. DETAILED DESCRIPTION

[0025] It should be noted that the following detailed descriptions are exemplary and are intended to provide further description of the present invention. Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those commonly understood by those skilled in the art to which the present invention belongs.

[0026] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the utility model. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0027] Example 1, a nozzle with a multi-stage depolymerization grid

[0028] like Figure 1 and Figure 2As shown, the suction nozzle 1 comprises a suction pipe 11 , the inner wall of which is provided with a spiral channel 12 ; and a deagglomeration grid 13 , which is provided on the inner wall 11 of the suction pipe.

[0029] The bottom end of the suction pipe 11 is connected to the cover plate 2 .

[0030] As a typical embodiment, the depolymerization grid 13 is three-layered, and each layer of the depolymerization grid 13 is provided with drug through holes 131, and the apertures of the drug through holes 131 on each layer of the depolymerization grid 13 are different, forming a multi-level structure. The apertures of the drug through holes 131 on each layer of the depolymerization grid 13 gradually decrease from bottom to top, and the cross section is in the shape of an inverted funnel. The drug moves from the wider entrance to the narrower exit in each layer of the depolymerization grid, and the flow rate increases. The number of drug through holes on the upper layer of the depolymerization grid can be 30 to 60, the number of drug through holes on the middle layer of the depolymerization grid can be 20 to 50, and the number of drug through holes on the bottom layer of the depolymerization grid can be 10 to 40.

[0031] The shape of the drug through hole 131 can be square, circular or oval.

[0032] As a typical embodiment, the first layer of deagglomeration grid is located at the top of the suction nozzle, flush with the suction nozzle, the drug through hole is circular, the narrowest hole diameter is 0.3mm, the largest hole diameter is 1.0mm, and the thickness of the deagglomeration grid is 2.0mm; the second layer is located in the middle of the suction pipe 11, the narrowest hole diameter is 0.6mm, the largest hole diameter is 1.5mm, and the thickness of the deagglomeration grid is 2.0mm; the third layer is located at the bottom of the suction nozzle pipe, the narrowest hole diameter is 0.9mm, the largest hole diameter is 2.0mm, and the thickness of the deagglomeration grid is 2.0mm.

[0033] The spiral channel 12 is located between the multiple layers of depolymerization grids 13 .

[0034] Taking indacaterol in indacaterol glycopyrronium bromide inhalation powder (each powder contains 110 μg indacaterol maleate and 50 μg glycopyrronium) as an example, the performance of inhalers with different mouthpiece structures was measured with device residue, drug delivery dose and fine particle fraction (FPF) as indicators, referring to the pharmacopoeia method.

[0035] The numbers of drug through holes of the fixed lower depolymerization grid, the middle depolymerization grid and the upper depolymerization grid were 40, 50 and 60 respectively, and the following experiment was carried out.

[0036] Test Example 1

[0037] The aperture of the depolymerization grid is 0.6 mm at the narrowest aperture and 1.5 mm at the widest aperture. The depolymerization grid is matched with different numbers of layers. The test results are shown in Table 1.

[0038] Table 1 Performance test of nozzles for depolymerization grid plates with different numbers of layers

[0039]

[0040] Conclusion: The depolymerization grid is 3 layers with spiral channels, FPF is greater than 45%, and the atomization effect is significant; the depolymerization grid is 3 layers alone, FPF is about 30%, and the atomization effect is poor; the depolymerization grid is 1 layer with spiral channels, FPF is about 20%, and the atomization effect is poor. The depolymerization grid is 3 layers with spiral channels.

[0041] Test Example 2

[0042] The effects of three layers of depolymerization grids with different apertures from top to bottom on the preparation are shown in Table 2.

[0043] Table 2 Effect of three-layer depolymerization grids with different apertures on the preparation

[0044]

[0045] Conclusion: The larger the aperture, the lower the residual in the device, which in turn increases the delivered dose. When the narrowest aperture is greater than 0.9 mm, the particles are difficult to disaggregate, resulting in a decrease in FPF. When the narrowest aperture is less than 0.3 mm, the delivered dose is too small and there is a lot of residual. Therefore, the narrowest aperture is preferably in the range of 0.3 mm to 0.9 mm.

[0046] Test Example 3

[0047] The effects of the three-layer depolymerization grids with different aperture combinations from top to bottom on the preparation are shown in Table 3.

[0048] Table 3 Effect of different aperture combinations of depolymerization grids on the preparation

[0049]

[0050] Conclusion: The larger the aperture of the lower layer of the depolymerization grid, the more beneficial it is to increase the delivered dose; the smaller the aperture of the uppermost layer of the depolymerization grid, the more beneficial it is to increase FPF. A combination of large, medium and small apertures of the depolymerization grid is preferred.

[0051] It can be seen from the experiment that adding a multi-stage deagglomeration grid (3 layers) in the middle of the suction nozzle and the structure of the deagglomeration grid with a narrow aperture at the top and a wide aperture at the bottom are beneficial to the capture and dissociation of the drug powder. At the same time, the deagglomeration grids are connected by spiral channels.

[0052] When the number of grid layers is less than 3, the dissociation effect is not obvious, and when the number of grid layers is greater than 3, the residual of the device increases; the structure of the grid plate that is narrow at the top and wide at the bottom is more conducive to dissociation.

[0053] If the grid plate aperture is too small, the device residue will increase, and if it is too large, the dissociation effect will not be obvious.

[0054] Embodiment 2,

[0055] As a further modification of Example 1, the spiral channel 12 may be a double helix structure, and spiral ribs may be provided on the inner wall of the spiral channel to further enhance the turbulence effect.

[0056] Embodiment 3, a kind of medicine powder inhaler

[0057] Including the suction nozzle provided in Example 1, other structures can refer to the structure provided in the patent publication "An inhalation device for soft ball particle drug delivery" (publication number: CN115429986A). The suction nozzle is located in the drug placement device, and the structure of the cover plate, rotating groove, card plate, and card block is the same as the prior art.

[0058] The above description is only the preferred embodiment of the utility model, and is not intended to limit the utility model. For those skilled in the art, the utility model can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the utility model shall be included in the protection scope of the utility model.

Claims

1. A suction nozzle with a multi-stage deagglomeration grid, comprising a suction pipe, a spiral channel is arranged on the inner wall of the suction pipe, and a deagglomeration grid, characterized in that: The number of layers of the depolymerization grid is three, and the spiral channel is located between adjacent layers of the depolymerization grid; and drug through holes are respectively arranged on each layer of the depolymerization grid.

2. The suction nozzle with a multi-stage deagglomeration grid according to claim 1, characterized in that: The shape of the drug through hole is selected from square, circle or oval.

3. The nozzle with a multi-stage deagglomeration grid according to claim 1, characterized in that: The number of drug through holes of the first layer of depolymerization grid is in the range of 30 to 60, the number of drug through holes of the second layer of depolymerization grid is in the range of 20 to 50, and the number of drug through holes of the third layer of depolymerization grid is in the range of 10 to 40.

4. The nozzle with a multi-stage deagglomeration grid according to claim 1, characterized in that: The diameter of the drug through holes on each layer of the depolymerization grid plate gradually decreases from bottom to top, forming an inverted funnel shape.

5. The suction nozzle with a multi-stage deagglomeration grid according to claim 4, characterized in that: The narrowest diameter of the drug through holes on each layer of the depolymerization grid is in the range of 0.3-0.9 mm, and the widest diameter is in the range of 1.0-2.0 mm.

6. The suction nozzle with a multi-stage deagglomeration grid according to claim 1, characterized in that: The narrowest point of the aperture of the upper depolymerization grid is smaller than the narrowest point of the aperture of the lower depolymerization grid.

7. The suction nozzle with a multi-stage deagglomeration grid according to claim 1, characterized in that: The first layer of depolymerization grid is located at the top of the suction nozzle and is flush with the suction nozzle; the second layer of depolymerization grid is located in the middle of the suction pipe; and the third layer of depolymerization grid is located at the bottom of the suction nozzle pipe.

8. The suction nozzle with a multi-stage deagglomeration grid according to claim 7, characterized in that: The narrowest point of the aperture of the first layer of depolymerization grid is 0.3mm, the largest point is 1.0mm, and the thickness is 2.0mm; the narrowest point of the aperture of the second layer of depolymerization grid is 0.6mm, the largest point is 1.5mm, and the thickness is 2.0mm; the narrowest point of the aperture of the third layer of depolymerization grid is 0.9mm, the largest point is 2.0mm, and the thickness is 2.0mm.

9. The nozzle with a multi-stage deagglomeration grid according to claim 1, characterized in that: The spiral channel is a double helix structure.

10. A powder inhaler, characterized in that: A suction nozzle with a multi-stage deagglomeration grid as claimed in any one of claims 1 to 9.

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