A flow channel applicable to a dual-reservoir powder aerosol device

Abstract

A flow channel applicable to a dual-reservoir powder inhaler device belongs to the field of drug delivery devices. It includes two medicine storage barrels, two independent medicine pits, two delivery channels, and a vortex dispersion chamber; each medicine storage barrel corresponds to one medicine pit; each medicine pit corresponds to one delivery channel; the two delivery channels and one vortex dispersion chamber form the flow channel of the dual-reservoir powder inhaler device; the said flow channel has two independent drug particle delivery channels, which can simultaneously deliver drugs from two independent medicine pits to the same vortex dispersion chamber; two different formulation prescriptions are separately filled in the two medicine storage barrels, making them correspond to different medicine pits and drug delivery channels, so that the powder inhaler particles of the two different prescriptions can be delivered from their respective independent medicine pits along their respective delivery channels to the common vortex dispersion chamber, and after being dispersed by the vortex dispersion chamber, they are delivered out of the powder inhaler device together, realizing the simultaneous administration of at least two different varieties of formulation prescriptions. It can be applicable to the design and manufacturing field of powder inhaler devices.

Description

Technical Field

[0001] The present invention belongs to the field of devices for introducing a medium into the human body, and particularly relates to an inhalable drug delivery device. Background Art

[0002] As a special preparation of a drug-device combination, the efficacy of a powder aerosol depends not only on the characteristics of the preparation formula itself, but also on the characteristics of the device used to deliver the drug formula.

[0003] Traditional powder aerosol preparation formulas (referring to some small molecule drugs for treating asthma and COPD (Chronic Obstructive Pulmonary Disease)) generally attach micronized active pharmaceutical ingredients to the surface of carrier lactose by a mixing method (high shear or three-dimensional mixing), forming a particle agglomerate of carrier lactose + active pharmaceutical ingredient.

[0004] During the mixing process, the active pharmaceutical ingredient particles achieve attachment to the lactose surface through the action of van der Waals force, mechanical contraction force (the binding force of the pits on the surface of carrier lactose to the drug particles), electrostatic force, and liquid bridge force.

[0005] If the above-mentioned particle agglomerates are directly delivered, the drug cannot be delivered to the human lungs. Therefore, the drug particles need to be depolymerized to separate the drug particles from the surface of the carrier lactose to reach a suitable particle size range before the drug can be delivered to the human lungs.

[0006] As a special functional packaging material, one of the functions of a powder aerosol device is to depolymerize the micronized active pharmaceutical ingredient from the carrier lactose and deliver the depolymerized drug particles to the human lungs through the mouthpiece of the device.

[0007] The component or component combination in the powder aerosol device that realizes the above depolymerization function is usually called a "flow path" (Flowpath / channel).

[0008] In the flow path of the powder aerosol device, there are mainly two ways to depolymerize the particle agglomerates: inertial mechanical collision and gas flow shear.

[0009] When a patient uses a powder aerosol device to inhale the drug, the inhalation airflow will enter the flow path of the powder aerosol device through the air-inlet of the powder aerosol device. Under the action of the drag force of the airflow, the drug particles will fly out from the drug pit (reservoir powder aerosol device) or the capsule (capsule powder aerosol device) or the vesicle (vesicle powder aerosol device). During the flight of the drug particles, when they encounter a position with a large bending angle in the flow path, due to the inertia of the particles themselves and the angle between the flight and the airflow movement direction, the particles will collide with the flow path wall surface.

[0010] From the perspective of energy conversion, the collision energy loss between the particulate aggregate and the wall surface of the flow channel of the powder inhaler device (mainly kinetic energy is lost) will be converted into the work done by the drug particles on the surface of the carrier lactose to overcome the surface energy, that is, the energy required to detach from the carrier lactose.

[0011] When the drug particles fall off, due to their small particle size (compared with the lactose carrier), their fluidity (the ability to move with the airflow) is better relative to the carrier lactose, and they are more easily carried away by the airflow.

[0012] In addition, when the particulate aggregate flies in the flow channel of the powder inhaler device, due to the relatively high airflow velocity in the flow channel and the sharp decrease in the velocity of the particles after experiencing collisions with the wall surface in the flow channel, the velocity of the particulate aggregate will be lower than that of the airflow, so that the airflow shear force will continuously act during this process (the generation of the airflow shear force results from the velocity difference between the particles and the airflow in all directions).

[0013] In order to make the particulate aggregate collide more violently in the flow channel of the powder inhaler device to improve the dispersion effect and drug efficacy (for powder inhalers, the better the drug particles are depolymerized, the easier they are to deposit in the lungs and the better the efficacy), when designing the core dispersion chamber (a component of the flow channel) in the flow channel of the powder inhaler device, many original research products adopt a "cyclone-shaped" design. Its characteristics are that the air inlet is tangential and generally centrally symmetrically distributed, and most of the center of the dispersion chamber is a circular chamber.

[0014] After the airflow passes through the tangential air inlet, due to the guidance and acceleration of the air inlet, the airflow will rotate along the wall surface, thus forming a low-speed and low-pressure area at the center of the circular chamber. Since the curvature of the airflow in this type of flow channel is relatively large and the large particulate aggregate itself has a large inertia, it is very easy to collide with the wall surface, thus generating depolymerized drug particles. After the drug particles are depolymerized, due to their good fluidity and small inertia, they are relatively easy to be carried away by the airflow, while the remaining large particles (particles composed of lactose or a mixture of lactose and some undepolymerized active pharmaceutical ingredients) will continue to swirl in the flow channel chamber due to their large inertia and the centrifugal force they receive.

[0015] For a reservoir-type powder inhaler device, the flow channel, the medicine pit (used to quantify the drug dose for a single inhalation), and the medicine storage barrel corresponding to the medicine pit together constitute the flow channel system of the powder inhaler device (as a functional component for dispersing the prescription particles from the medicine storage barrel and the medicine pit, the flow channel needs to be combined with the medicine storage barrel and the medicine pit to play its role).

[0016] The existing drug delivery steps / mode are as follows: The drug falls from the medicine storage barrel into the medicine pit (separating a single inhalation dose) → The medicine pit carrying a single inhalation dose moves to the entrance of the delivery channel in a certain way (linear or rotational) → The drug particles are entrained by the airflow from the medicine pit into the delivery channel of the flow channel (the first half of the flow channel, and for some types of powder inhaler devices, there is no delivery channel, and the medicine pit is directly aligned with the dispersion chamber) → The drug particles enter the dispersion chamber from the delivery channel (the second half of the flow channel is also the core part, where the particle collisions and shear forces in the dispersion chamber are the strongest and most intense) → Dispersion is completed in the dispersion chamber of the flow channel → The dispersed drug particles are carried out of the flow channel outlet by the airflow.

[0017] As the core component of the powder inhaler device, although the principle of depolymerizing (dispersing) drug particles is the same, in terms of specific design forms, the flow channels of each type of powder inhaler device are different, and its structure is determined by the characteristics of the powder inhaler device itself (structural design, function, and device type).

[0018] Currently on the market, most reservoir-type powder inhaler devices (Reservoir Dry Powder Inhaler) are "single reservoir" devices, and the corresponding flow channel systems are also designed in a single reservoir structure: one medicine storage barrel, a single medicine pit, one delivery channel, and one dispersion chamber.

[0019] This kind of structural design is commonly used in general single reservoir powder inhaler devices, and there are also application examples directly used for triple complex preparations (containing three active pharmaceutical ingredients), such as the products of the company. However, if there are compatibility problems between different active pharmaceutical ingredients, the above "single reservoir" flow channel system design will be subject to certain limitations:

[0020] 1. First of all, if there is only one medicine storage barrel, then after the compatible active pharmaceutical ingredients are prepared into a preparation prescription and stored in one medicine storage barrel for a long time (the reaction rate of solids is relatively slow), it will affect the impurities of the drug.

[0021] 2. If there is only one drug delivery channel, then even if the device itself has two medicine storage barrels, there will still be a situation where two drug prescriptions are delivered successively, which will be a bit inconvenient in clinical administration (especially in the case of an emergency onset). What is hoped for is that two drug prescriptions can be delivered out of the device and reach the patient's lungs simultaneously. Moreover, due to electrostatic and other factors after the drug powder is delivered out of the medicine pit, some drugs will remain on the surface of the medicine pit. If there is only one medicine pit, there is still a possibility that two compatible drugs will react.

[0022] 3. As described above, the function of the flow channel component is to generate air flow turbulence so that the API particles can fall off from the surface of the lactose carrier, thereby generating aerosol particles within an appropriate particle size range that can reach the human lungs. Due to the differences in their own physical and chemical properties, the binding ability of each API to lactose during mixing will also vary. When several APIs are mixed together, it is possible that the dispersion results of one or more component APIs do not meet the standards, such as the fine particle dose (which is a major indicator for evaluating the in vitro performance of inhaled powder aerosols).

[0023] In summary, it is necessary to design a flow channel system that includes two medicine storage barrels and two drug delivery channels, separately pack (isolate) two different formulation prescriptions in different medicine storage barrels, make them correspond to different medicine pits and drug delivery channels, so that two different prescriptions (i.e., the particles of two different powder aerosols) can be delivered from their respective separate medicine pits along their respective delivery channels to a common dispersion and rotation chamber, and after dispersion, be delivered out of the device together, realizing the simultaneous administration of different APIs (two different powder aerosols).

[0024] However, during the design process of the flow channel system with two medicine storage barrels and two drug delivery channels, there are several difficulties that need to be overcome as follows:

[0025] a) As described in the third point of the above limitations, due to the differences in physical and chemical properties, there are differences in the binding force between different APIs and the surface of lactose. Although different prescriptions are currently delivered to the rotating cavity for simultaneous dispersion and delivery through two independent medicine pits and two independent drug particle delivery channels, the difference in the binding between the API and lactose still exists. It is possible that one prescription binds tightly to lactose while the other binds loosely. Therefore, it is necessary to consider accommodating such differences in the design (especially when two independent delivery channels share a dispersion chamber).

[0026] b) Since the flow channel system is a double-reservoir flow channel system, there may be differences in the single inhalation drug delivery specifications of the two stored prescriptions (based on the clinical efficacy of different APIs), that is, there are differences in the amount of drug particles delivered by the two delivery channels (and there will also be differences in the overall prescription dose). This may lead to differences in the fluidity of the drug powders in these two channels. And fluidity will directly affect the drug powder's drug delivery situation from the medicine pit under the action of air flow. One of the requirements for a double-reservoir flow channel system is that after the two prescriptions are delivered through two independent delivery channels, the residual amount (including the total drug dose remaining in the medicine pit, delivery channel, and dispersion chamber) cannot be too much. Therefore, when designing a double-reservoir flow channel system, it is necessary to take into account the differences in the fluidity of the drug particles of the two prescriptions to ensure the most complete delivery to the greatest extent possible.

[0027] For the traditional single-reservoir flow channel system, since there is only one delivery specification throughout, there is no need to consider this design difficulty.

[0028] c) In the runner design, the trajectory arrangements of the two independent medicine pits moving from the medicine discharging port of the medicine storage barrel to the inlet of the delivery channel need to be considered. It is required that these two trajectories do not overlap. Once they overlap, it will inevitably cause "interference" in the mechanical sense, which will lead to the failure of the component to be successfully processed and manufactured.

[0029] d) The three elements of the medicine storage barrel, the medicine delivery channel, and the dispersion chamber should not cause the overall volume of the entire component to be too large in the spatial arrangement, so as not to affect the overall volume of the powder inhaler device (in the design, it is required that the overall volume of the powder inhaler device should not be too large and should be easily held in the user's hand).

[0030] e) After the difficulty point d), it is easy to think of saving space by bending the delivery channel in the runner design. However, from the perspectives of aerodynamics and gas-solid two-phase flow, there should be no large-bending parts (such as "U" shape) in the runner design. Otherwise, it is easy to occur the phenomena of powder jamming and residue. In addition, too many bends will also affect the resistance of the device. Therefore, in the runner design, the spatial arrangement and the above limiting factors need to be taken into account.

[0031] f) For the designed double-reservoir runner system, its "flow resistance" (abbreviation: flow resistance) should be maintained within a reasonable range of medium and low resistance (under the pressure difference condition of 4 pka, the air flow velocity passing through the device should be maintained at about 60 - 70 L / min); through literature research, the resistance of this device is more suitable for patients to use, and it is not strenuous for patients to inhale. In addition, as one of the important parameters of the powder inhaler device, "flow resistance" will affect the dispersion and depolymerization effect of the drug formulation, and each geometric structure in the runner may affect the final overall flow resistance. Therefore, when designing the double-reservoir runner system, it is necessary to always consider the influence of the designed geometric structure on the device resistance.

[0032] In the above description, the so-called delivery channel refers to the channel through which the particles fly with the airflow entrainment from the medicine pit until before the dispersion chamber. For some powder inhaler devices, after the medicine pit separates a single inhalation dose, it directly aims at the dispersion chamber (such as the products of the company), and no delivery channel is added.

[0033] The above-mentioned delivery channel and dispersion chamber together constitute the runner of the powder inhaler device. Summary of the Invention

[0034] The technical problem to be solved by the present invention is to provide a flow channel applicable to a dual-reservoir powder aerosol device. This flow channel (also known as a flow channel system) has two independent drug particle delivery channels, capable of delivering drugs from two independent medicine pits. The two independent medicine pits do not interfere with or affect each other, and the drug particles in each medicine pit do not come into contact with each other. Similarly, when the drug particles fly in their respective delivery channels, they do not come into contact with or interfere with each other, minimizing compatibility problems caused by contact between the active pharmaceutical ingredients to the greatest extent.

[0035] The technical solution of the present invention is: to provide a flow channel applicable to a dual-reservoir powder aerosol device, characterized in that:

[0036] The dual-reservoir powder aerosol device includes two medicine storage barrels, two independent medicine pits corresponding to the medicine storage barrels, two delivery channels, and a vortex dispersion chamber;

[0037] The medicine outlet of each medicine storage barrel corresponds to an independent medicine pit;

[0038] Each independent medicine pit corresponds to a delivery channel;

[0039] The outlets of the two delivery channels communicate with the vortex dispersion chamber respectively;

[0040] The two delivery channels and a vortex dispersion chamber together form the flow channel of the dual-reservoir powder aerosol device;

[0041] The two medicine storage barrels are the first medicine storage barrel and the second medicine storage barrel; the two independent medicine pits are the first medicine pit and the second medicine pit; the two delivery channels are the first delivery channel and the second delivery channel;

[0042] The flow channel has two independent drug particle delivery channels, capable of simultaneously delivering drugs from two independent medicine pits to the same vortex dispersion chamber;

[0043] The flow channel is composed of a lower flow channel member, a middle flow channel member, and an upper flow channel member stacked in sequence and combined into one body;

[0044] The vortex dispersion chamber simultaneously disperses the drug prescriptions from the two channels, enabling the drug particles in the two prescriptions to complete depolymerization in the vortex dispersion chamber simultaneously, thereby ensuring that multiple drugs can be delivered from the powder aerosol device simultaneously;

[0045] Two different preparation prescriptions are sub-packed / isolated in different medicine storage barrels, corresponding to different medicine pits and drug delivery channels, so that the particles of the two different prescription powder aerosols can be delivered from their respective independent medicine pits along their respective delivery channels to the common vortex dispersion chamber, and after being dispersed by the vortex dispersion chamber, they are delivered from the powder aerosol device together, realizing the simultaneous administration of at least two different varieties of preparation prescriptions.

[0046] Specifically, the flow channel has two independent drug particle delivery channels, capable of delivering drugs from two independent medicine pits; the two independent medicine pits do not interfere with or affect each other, and the drug particles in each medicine pit do not come into contact with each other; similarly, when two different drug particles fly in their respective delivery channels, they do not come into contact with or interfere with each other, minimizing compatibility problems caused by contact between the two active pharmaceutical ingredients.

[0047] Furthermore, the flow channel is based on two independent drug delivery channels: the first delivery channel and the second delivery channel, to deliver two different drug formulations, isolating the formulations with compatibility problems to the greatest extent, so that the two drug formulations do not come into contact before entering the vortex dispersion chamber, thus avoiding compatibility problems between different active pharmaceutical ingredients.

[0048] Specifically, two cylindrical medicine storage barrels are provided on the lower member of the flow channel: the first medicine storage barrel and the second medicine storage barrel; each medicine storage barrel is a vertically connected / through tubular structure; a first flow port and a second flow port are also provided on the lower member of the flow channel; a line is connected between the geometric centers of the first flow port and the second flow port, called the first line; a line is connected between the geometric centers of the first medicine storage barrel and the second medicine storage barrel, called the second line; then the angle between the first line and the second line is 90 degrees; the first line is the movement trajectory of the second medicine pit aligned with the first flow port, that is, the movement trajectory for transporting the powder in the second medicine pit; the second line is the movement trajectory of the first medicine pit aligned with the second flow port, that is, the movement trajectory for transporting the powder in the first medicine pit; the two movement trajectories do not cross or overlap.

[0049] Furthermore, after the particles of the two powder aerosol formulations are separately dosed from the first medicine storage barrel and the second medicine storage barrel into the first medicine pit and the second medicine pit, the first medicine pit and the second medicine pit respectively bring the two different drug formulation particles to the first flow port and the second flow port by means of rotation.

[0050] Specifically, on the bodies of the lower member and the upper member of the flow channel, pins are provided; on the body of the middle member of the flow channel, pin holes are correspondingly provided; the corresponding pins and pin holes are correspondingly matched; through the plug-in fit between the pins and the pin holes, the assembly and fixation of the upper member, the middle member and the lower member of the flow channel are realized.

[0051] Specifically, the shape of the vortex dispersion chamber is a regular hexagon, to increase the number of collisions and residence time of drug particle aggregates in the vortex dispersion chamber, thereby improving the efficiency of the flow channel system in dispersing drug particles and taking into account the dispersion requirements of two different formulations;

[0052] The described vortex dispersion chamber is evenly distributed with three tangential air inlets in the circumferential direction, namely the first tangential air inlet, the second tangential air inlet, and the third tangential air inlet; among them, the first tangential air inlet is an independent air inlet, and the existence of the independent air inlet enables the air flow to form a centrally symmetric vortex air flow in the vortex dispersion chamber; the second tangential air inlet and the third tangential air inlet are respectively connected to the first delivery channel and the second delivery channel in correspondence; based on the above structural design of the tangential air inlets, the air flow will rotate in the vortex dispersion chamber to form a "vortex" and a strong turbulent air flow field; when the drug particles enter the vortex dispersion chamber, they will collide violently with the wall surface of the vortex dispersion chamber, and at the same time will also be subjected to a strong air flow shear force; the drug particles and the lactose carrier particles will thus "depolymerize" to complete the dispersion.

[0053] Specifically, the bending angle at the connection between the second delivery channel and the third tangential air inlet is greater than the bending angle at the connection between the first delivery channel and the second tangential air inlet;

[0054] Let the prescription with tightly bound active pharmaceutical ingredient and lactose be delivered through the second delivery channel, and let it experience a collision before entering the vortex dispersion chamber, so that it can compensate for part of the required dispersion energy and help it disperse and depolymerize better.

[0055] Furthermore, before the air flow enters the first delivery channel and the second delivery channel through the air inlets of the first delivery channel and the second delivery channel, it first passes through a flow channel acceleration structure, which gives it a guiding effect, so that the air flow can more effectively carry away the drug powder in the first medicine pit and the second medicine pit and complete the "emptying" function as much as possible.

[0056] Furthermore, the flow channel acceleration structure located at the front ends of the first delivery channel and the second delivery channel has an "inward concave semi-circular" shape on the inner side, and combines with the corresponding independent medicine pits to form an air flow guiding channel;

[0057] The orientations of the air inlets of the first delivery channel and the second delivery channel are "outward eight" orientations, which are the same as or similar to the bending shapes of the two corresponding flow channel acceleration structures, so as to ensure that the air flow entering from the air inlets of the first delivery channel and the second delivery channel is smoothly guided to the first flow port and the second flow port.

[0058] Compared with the prior art, the advantages of the present invention are:

[0059] 1. The double reservoir flow channel system described in the present invention is based on two independent drug delivery channels: the first delivery channel and the second delivery channel, and can realize the delivery of two different drug prescriptions, isolating the prescriptions with compatibility problems to the greatest extent, so that the two drug prescriptions do not come into contact before entering the vortex dispersion chamber, thereby avoiding the compatibility problems between the active pharmaceutical ingredients.

[0060] 2. The dual-reservoir flow channel system described in the present invention can simultaneously disperse drug prescriptions from two channels, enabling the drug particles in the two prescriptions to be depolymerized simultaneously in the vortex dispersion chamber, thereby ensuring that multiple drugs can be delivered to the patient's lungs simultaneously;

[0061] 3. Based on the description in 2) above, the dual-reservoir flow channel system in the technical solution of the present invention can deliver two or more types of drug particles simultaneously. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Figure 1 It is a schematic diagram of the external structure of the flow channel component of the present invention;

[0063] Figure 2 It is a schematic top view structure of the lower flow channel component of the present invention;

[0064] Figure 3 It is a schematic diagram of the included angle between the flow port of the lower flow channel component and the connection line of the medicine storage barrel of the present invention;

[0065] Figure 4 It is a three-dimensional structure schematic diagram of the lower flow channel component of the present invention;

[0066] Figure 5 It is a three-dimensional structure schematic diagram of the middle flow channel component of the present invention;

[0067] Figure 6 It is a schematic diagram of another view structure of the middle flow channel component of the present invention;

[0068] Figure 7 It is a schematic cross-sectional structure diagram when the medicine pit of the present invention is aligned with the medicine storage barrel;

[0069] Figure 8 It is a schematic top view structure diagram when the medicine pit of the present invention is aligned with the medicine storage barrel;

[0070] Figure 9 It is a schematic diagram of the external structure of the upper flow channel component of the present invention;

[0071] Figure 10 It is an exploded view of the upper, middle, and lower flow channel components of the present invention;

[0072] Figure 11 It is a schematic diagram of the morphological structure of the dispersion chamber on the back of the middle flow channel component of the present invention;

[0073] Figure 12 It is a schematic diagram of the inner structure of the first delivery channel of the present invention;

[0074] Figure 13 It is a schematic diagram of the inner structure of the upper flow channel of the present invention;

[0075] Figure 14It is a schematic diagram of the orientation structure of the air inlet of the flow channel system of the present invention;

[0076] Figure 15 It is a schematic diagram of the spatial geometric structure of the flow channel system of the present invention;

[0077] Figure 16a It is a schematic diagram of the CFD - air flow velocity calculation result of the double - reservoir flow channel of the present invention;

[0078] Figure 16b It is a schematic diagram of the CFD - air flow velocity calculation result of the single - reservoir flow channel;

[0079] Figure 17a and Figure 17b It is a schematic diagram of the situation when the two drug particles of the present invention fly out separately from two channels.

[0080] In the figure, 1 is the lower member of the flow channel, 2 is the middle member of the flow channel, 3 is the upper member of the flow channel, 4 is the first medicine pit, and 5 is the second medicine pit;

[0081] 101 is the first medicine storage barrel, 102 is the second medicine storage barrel, 103 is the first flow port, 104 is the second flow port, 105 is the pin, 106 is the pin, 107 is the pin, 108 is the pin, 109 is the pin, 110 is the first step, 111 is the downhill of the flow port, and 112 is the uphill of the flow port;

[0082] 201 is the pin hole, 202 is the pin hole, 203 is the pin hole, 204 is the pin hole, 205 is the pin hole, 206 is the pin hole, 207 is the pin hole, 208 is the pin hole, 209 is the first delivery channel, 210 is the second delivery channel, 211 is the circular hole for particle rising, 212 is the lower surface of the flow channel outlet, 213 is the vortex dispersion cavity, 214 is the second step, 215 is the flow channel acceleration structure, 216 is the air inlet of the second delivery channel, 217 is the air inlet of the first delivery channel, 218 is the third step, 219 is the first tangential air inlet, 220 is the second tangential air inlet, and 221 is the third tangential air inlet;

[0083] 301 is the pin, 302 is the pin, 303 is the pin, 304 is the upper surface of the upper member of the flow channel, 305 is the edge of the upper member of the flow channel, 321 is the bypass air inlet, and 322 is the upper - flow channel. Detailed implementation mode

[0084] The present invention will be further described below with reference to the drawings and embodiments.

[0085] T The present invention relates to a flow channel system adapted to a double - reservoir powder aerosol device. This flow channel system has two independent drug particle delivery channels and can deliver drugs from two independent medicine pits (referred to as medicine pits).

[0086] Two independent medicine pits do not interfere with or affect each other, and the medicine particles in their respective pits do not come into contact with each other.

[0087] Similarly, when the medicine particles fly in their respective delivery channels, they do not come into contact with or interfere with each other, which can minimize the compatibility problems caused by the contact between the active pharmaceutical ingredients.

[0088] The purpose of adopting the above flow channel system design is mainly for the following points:

[0089] 1. To adapt to the existing double reservoir powder inhaler device (the specific structural design of this double reservoir powder inhaler device is described in detail in another patent "A Double Reservoir Powder Inhaler Device" submitted by the inventor on the same day). Based on the design of the single reservoir dispersion cavity (referring to the flow channel design of the existing single reservoir powder inhaler device), the newly designed flow channel can depolymerize the medicine particles from two different delivery channels.

[0090] 2. Before the medicine prescriptions are delivered to the dispersion cavity, the two medicine prescriptions do not come into contact. The delivery channels and medicine pits corresponding to the medicine storage barrels where the two prescriptions are located are independent of each other, maximizing the avoidance of compatibility problems between the active pharmaceutical ingredients (the two medicine prescription particles will only come into contact in the dispersion cavity for a very short time).

[0091] 3. It includes the functions of the single reservoir flow channel and can only deliver and depolymerize a single powder inhaler medicine prescription.

[0092] Based on the above premises, concepts or requirements, the flow channel component group involved in the technical solution of the present invention is as Figure 1 shown. The flow channel component group is composed of a lower flow channel member 1 (also abbreviated as "lower flow channel"), a middle flow channel member 2 (also abbreviated as "middle flow channel"), and an upper flow channel member 3 (also abbreviated as "upper flow channel").

[0093] The top view structure of the lower flow channel member 1 is as Figure 2 shown. Two cylindrical medicine storage barrels are provided on the lower flow channel member 1, namely a first medicine storage barrel 101 and a second medicine storage barrel 102. Each medicine storage barrel is a cylindrical structure that is vertically connected / penetrated.

[0094] There are also two flow channel openings on the lower flow channel member 1, namely a first flow channel opening 103 and a second flow channel opening 104.

[0095] Connect the geometric centers of the first flow channel opening 103 and the second flow channel opening 104 to form a connection line (referred to as the first connection line), and connect the geometric centers of the first medicine storage barrel 101 and the second medicine storage barrel 102 to form a connection line (referred to as the second connection line). Then, the included angle between the first connection line between the first flow channel opening 103 and the second flow channel opening 104 and the second connection line between the first medicine storage barrel 101 and the second medicine storage barrel 102 is 90 degrees, and its included angle connection line is asFigure 3 as shown

[0096] Figure 3 The two arc dotted lines a1 and a2 in [figure reference] are the respective movement trajectories (the movement trajectories for transporting the medicinal powder in the medicine pits) of the second medicine pit 5 and the first medicine pit 4 that are respectively aligned with the first flow port 103 and the second flow port 104. It can be seen that the trajectory design of this flow channel system meets the requirements in the difficulty c) described in the background technology above: the movement trajectories do not cross or overlap.

[0097] such as Figure 4 As shown, on the body of the lower flow channel member 1, there are also pins 105 - 109 provided, and the pins 105 - 109 are used to cooperate with the pin holes 201 - 205 of the middle flow channel member 2.

[0098] The outer shapes of the middle flow channel member 2 are respectively as shown in Figure 5 and Figure 6 as shown

[0099] The middle flow channel member 2 realizes the assembly and fixation between the middle flow channel member 2 and the lower flow channel member 1 through the shaft - hole fit between the pins 105 - 109 and the pin holes 201 - 205.

[0100] Finally, the upper flow channel member 3 is mutually matched with the pin holes 206 - 208 on the middle flow channel member 2 through the pins 301 - 303 (the appearance of the upper flow channel member 3 is as shown in Figure 9 as shown), to complete the assembly between the three flow channel components.

[0101] The exploded view of the assembly of the lower flow channel member 1, the middle flow channel member 2, and the upper flow channel member 3 is as shown in Figure 10 as shown, Figure 10 and the arrow direction in [figure reference] is the installation direction of the three components.

[0102] The paths for the delivery and dispersion of two kinds of medicament prescription granules (abbreviation: prescription) in the flow channel system described in the technical solution of the present invention are as follows:

[0103] After the two medicament prescriptions are separately fed from the first medicine storage barrel 101 and the second medicine storage barrel 102 into the two independent medicine pits - the first medicine pit 4 and the second medicine pit 5 (as shown in Figure 7 and Figure 8 as shown, during the feeding process, the first medicine pit 4 and the second medicine pit 5 are respectively facing the first medicine storage barrel 101 and the second medicine storage barrel 102. Figure 7 and Figure 8 show this process from the two perspectives of the sectional view and the top view respectively), the first medicine pit 4 and the second medicine pit 5 respectively move along the two dotted line trajectories a2 and a1 in Figure 3 (the angle is 90 degrees, based on Figure 3It is determined by the included angle between the connection line of the first medicine storage barrel 101 and the second medicine storage barrel 102 and the connection line of the first flow port 103 and the second flow port 104), and two different prescription granules of medicine are respectively brought to the first flow port 103 and the second flow port 104 (as Figure 3 shown).

[0104] When the patient inhales the medicine, the inhalation airflow will enter the first delivery channel 209 and the second delivery channel 210 through the first delivery channel air inlet 217 and the second delivery channel air inlet 216.

[0105] The geometric shapes of the first delivery channel 209 and the second delivery channel 210 are shown in Figure 6 . It can be seen from the perspective of Figure 6 that the bending angle of the second delivery channel 210 is much larger than that of the first delivery channel 209. The purpose of this design is to take into account the difference in the binding force between the raw material medicine and the lactose surface in the two prescriptions as described in the aforementioned difficulty a). The purpose of this structural design is to allow the prescription with a tight binding of the raw material medicine and lactose to be delivered through the second delivery channel 210. Before entering the vortex dispersion chamber 213 (abbreviated as the dispersion chamber), it first experiences a collision, so that it can compensate for a part of the required dispersion energy and help it disperse and depolymerize better.

[0106] Before the first delivery channel 209 and the second delivery channel 210, there are respectively the same flow channel acceleration structures 215 (this structure is as shown in Figure 6 , Figure 8 , Figure 12 and Figure 13 shown. The four figures show the geometric shape of the flow channel acceleration structure 215 from various angles).

[0107] The function of the flow channel acceleration structure 215 is: before the airflow enters the first delivery channel 209 and the second delivery channel 210 through the first delivery channel air inlet 217 and the second delivery channel air inlet 216, it gives a flow guiding effect to the airflow, so that the airflow can more effectively carry away the medicine powder in the first medicine pit 4 and the second medicine pit 5 and complete "emptying" as much as possible (this structure can solve the aforementioned difficulty b) to the greatest extent).

[0108] When the medicine particles pass through the first delivery channel 209 and the second delivery channel 210 respectively, they enter the vortex dispersion chamber 213.

[0109] As shown in Figure 11 , the vortex dispersion chamber 213 is evenly distributed with three tangential air inlets in the circumferential direction, namely the first tangential air inlet 219, the second tangential air inlet 220 and the third tangential air inlet 221.

[0110] Figure 11 The three arrows marked in the figure respectively represent the air flow directions when the air flow passes through the first tangential air inlet 219, the second tangential air inlet 220, and the third tangential air inlet 221.

[0111] Based on the above structural design of the tangential air inlet, the air flow will form a "vortex" in the vortex dispersion chamber 213, that is, the air flow will rotate in the vortex dispersion chamber 213 to form a strong turbulent air flow field. When the drug particles enter the vortex dispersion chamber 213, they will collide violently with the wall surface of the vortex dispersion chamber 213 and will also be subjected to a strong air flow shear force. The drug particles and the lactose carrier particles will thus undergo "depolymerization" to complete the dispersion.

[0112] After depolymerization, the drug particles pass through the particle rising circular holes 211 (as shown in Figure 5 , Figure 6 , Figure 11 and Figure 13 ), and rise into the upper flow channel 322 composed of the flow channel upper member 3 and the flow channel middle member 2 (the upper flow channel 322 is shown as the dotted circle in Figure 13 ).

[0113] After passing through the upper flow channel 322, the depolymerized drug particles reach the outlet position of the flow channel system, thereby completing functions such as sub-dose - delivery - dispersion - delivery of the entire drug particles in the flow channel system.

[0114] It should be noted that the flow channel system in the present invention has a total of 5 air inlets, namely the first delivery channel air inlet 217, the second delivery channel air inlet 216, the first tangential air inlet 219, and two identical bypass air inlets 321.

[0115] Among them, the first delivery channel air inlet 217 and the second delivery channel air inlet 216 are respectively communicated with the second tangential air inlet 220 and the third tangential air inlet 221 via the first delivery channel 209 and the second delivery channel 210.

[0116] The first tangential air inlet 219 exists as an independent air inlet, and its design purpose is to enable the air flow to form a centrally symmetric vortex air flow in the vortex dispersion chamber 213.

[0117] The two bypass air inlets 321 (see Figure 7 i.e. Figure 13 shown in) only play a role in adjusting the flow resistance of the entire flow channel system (according to the difficulty f described in the previous background technology, the flow resistance of the double - reservoir flow channel system needs to be restricted and controlled).

[0118] It should be noted that the vortex dispersion chamber 213 is the core part of the depolymerization and dispersion of this flow channel system, which plays a crucial role in the depolymerization and dispersion of drug particles.

[0119] As Figure 11 shown, in this technical solution, the shape of the vortex dispersion chamber 213 is a regular hexagon. The purpose of this shape design is to increase the collision times of drug particle aggregates in the vortex dispersion chamber 213, thereby improving the dispersion efficiency of the flow channel system for drug particles and taking into account the dispersion requirements of two different prescriptions (as described in the difficult point a in the previous background technology, the binding tightness between the active pharmaceutical ingredient and lactose in different prescriptions is different).

[0120] It should be noted that in this technical solution, above the first flow port 103 and the second flow port 104, and in front of the first delivery channel 209 and the second channel 210, there is a flow channel acceleration structure 215 respectively.

[0121] The inner shape of the flow channel acceleration structure 215 can be seen Figure 12 as shown in

[0122] Figure 12 Fig. is a side cross-sectional view of the first delivery channel 209 (here, the first delivery channel 209 is taken as an example, and the second delivery channel 210 is the same as it). It can be seen from this that the inner shape of the flow channel acceleration structure 215 is a "concave semi-circular" shape, which forms an air flow diversion channel in combination with the second medicine pit 5. The arrows in the figure indicate the direction of the air flow.

[0123] It should be noted that in this technical solution, considering the arrangement space and position of the first medicine storage barrel 101 and the second medicine storage barrel 102 in space, and at the same time, sufficient design space needs to be left for the pins 105 to 109, the shapes of the first flow port 103 and the second flow port 104 are designed as "semicircular crescent" shapes that converge towards the center of the flow channel lower member 1 (as shown in Figure 2 and Figure 3 ).

[0124] In addition, in this technical solution, the orientations of the two air inlets of the flow channel system, the first delivery channel air inlet 217 and the second delivery channel air inlet 216, are in an "outer eight" orientation (as shown in Figure 14 ). At the same time, the bending shapes of the two flow channel acceleration structures 215 are consistent with the first flow port 103 and the second flow port 104 in the view direction of Figure 11 and Figure 14 . Coupled with the "concave semi-circular" design of the flow channel acceleration structure 215, the two can ensure that the air flow entering from the first delivery channel air inlet 217 and the second delivery channel air inlet 216 is smoothly diverted to the first flow port 103 and the second flow port 104.

[0125] It should be noted that in this technical solution, the upper runner component 3, the middle runner component 2, and the lower runner component 1 are fitted together by inserting pins into holes. In practice, other mechanical fitting methods such as snap fits or welding can also be used for the fitting between the three components.

[0126] In addition, in this technical solution, a first step 110 is provided on the surface of the lower runner component 1, and the contour line of this step matches the contour line of the second step 214 of the middle runner component 2. When installing the lower runner component 1 and the middle runner component 2, the contour line of the second step 214 of the middle runner component 2 will fit with the contour line of the first step 110 of the lower runner component 1.

[0127] The purpose of the step structure design is to increase the airtightness between the runner components.

[0128] At the same time, the first runner opening 103 and the second runner opening 104 on the lower runner component 1 are symmetric with each other in size and shape along the connection line of the first medicine storage barrel 101 and the second medicine storage barrel 102 (as Figure 3 shown).

[0129] It should be noted that in the technical solution of the present invention, the number of vortex dispersion chambers 213 set in the runner system is 1, and the determination of this number is based on the requirement of the difficulty d) in the previous background technology: adding the structure of double medicine storage barrels and double medicine pits in the entire runner system should not make the volume of the entire runner component group too large.

[0130] Embodiment:

[0131] A. Selection of medicine pits and sub - metering methods:

[0132] In this embodiment, the sizes (referring to volumes) of the two medicine pits, the first medicine pit 4 and the second medicine pit 5, are selected to be 5 mg and 10 mg respectively.

[0133] The two medicine pits move from the first medicine storage barrel 101 and the second medicine storage barrel 102 to the first runner opening 103 and the second runner opening 104 by rotation, and the rotation angle is 90 degrees (this angle is the included angle between the first medicine storage barrel 101 and the second medicine storage barrel 102 and the first runner opening 103 and the second runner opening 104 in Figure 3 ), and this movement method is based on the geometric appearance design of the components of the entire lower runner component 1.

[0134] B. Computational Fluid Dynamics Simulation - CFD:

[0135] Under the boundary condition of a given pressure difference of 4 kPa through Computational Fluid Dynamics (CFD) simulation, the approximate air velocity within the flow channel system is calculated (this velocity will be lower than the actually measured velocity because CFD calculations cannot account for air leakage caused by assembly gaps between components), thereby obtaining the approximate calculated flow resistance of the flow channel system. In this embodiment, the turbulence model used in the CFD calculation is the standard K-E model, and the residual convergence accuracy is 10 -4 , and the pressure-velocity coupling method used is "Simple", and the discretization algorithm for K and ε adopts the "second-order upwind method".

[0136] In this embodiment, a closed space geometry is established by separating the space of the flow channel system composed of the upper flow channel member 3, the middle flow channel member 2, and the lower flow channel 1 as the CFD simulation region. The spatial geometry of this flow channel system is as Figure 15 shown.

[0137] Unstructured grids (tetrahedral grids) are used to "discretize" (mesh) the Figure 15 shown flow channel system space. The following results are obtained from this CFD calculation: under the pressure difference condition of 4 kPa, the air velocity is 57.5 L / min.

[0138] The CFD calculation results are post-processed to obtain the velocity and turbulent kinetic energy of the air flow within the double reservoir flow channel system space respectively.

[0139] By comparison, it can be seen that the ability of the flow channel system in the technical solution of the present invention to generate turbulence is consistent with that of the existing single reservoir flow channel system.

[0140] Figure 16a And Figure 16b give the CFD-airflow velocity calculation results of this technical solution, where Figure 16a is the CFD-airflow velocity calculation result of the double reservoir flow channel of this embodiment, Figure 16a is the CFD-airflow velocity calculation result of the single reservoir flow channel.

[0141] C. Particle motion simulation:

[0142] Purpose of the simulation: To investigate whether particles will cross channels when the particles are delivered separately from their respective medicine pits.

[0143] Model simplification: Considering computer resources, the particle simulation in this embodiment only simulates the motion of lactose particles (assuming that the API adheres to the surface of lactose and does not affect the motion of lactose during the movement with lactose), and the particle size adopts spherical particles close to the lactose particle size.

[0144] Figure 17a AndFigure 17b As shown, the cases where the granules of two different drugs (also known as prescriptions) fly out separately from two channels are given.

[0145] According to the cases where the granules fly out separately from two channels, during the process that the granules in the first delivery channel fly to the rotary dispersion cavity and then to the outlet, they will not fly into the second delivery channel, and vice versa. This shows that in the flow channel system described in the technical solution of the present invention, the two prescriptions will only meet in the rotary dispersion cavity and then leave the flow channel together.

[0146] The above results reflect that in the present technical solution, the dual delivery channel and dual medicine pit design adopted can theoretically isolate the prescriptions with compatibility problems, that is, it realizes the function of "the granules of two different drugs can be delivered from their respective medicine pits along their respective delivery channels to the common dispersion rotary cavity, and after dispersion, they are delivered out of the device together to achieve the simultaneous administration of different active pharmaceutical ingredients".

[0147] In summary, the key technical points of the present invention are as follows:

[0148] 1) In the technical solution of the present invention, the described flow channel system has two independent and non-interfering drug granule delivery channels - the first delivery channel 209 and the second delivery channel 210, which respectively correspond to two different independent medicine pits and medicine storage barrels. The whole flow channel system shares a vortex dispersion cavity, and the two prescription granules are delivered out from their corresponding medicine pits respectively and reach the vortex dispersion cavity through their respective independent delivery channels.

[0149] 2) In the technical solution of the present invention, flow channel acceleration structures 215 are respectively provided on the two drug granule delivery channels, that is, the total number is two.

[0150] Viewed from the plane, the shape of this structure is consistent with that of the first flow port 103 and the second flow port 104. Viewed from the side cross-sectional view (as Figure 12 shown), the shape is arc-shaped and concave.

[0151] The purpose of this design is to better direct the air flow to these two flow ports.

[0152] 3) In the technical solution of the present invention, the vortex dispersion cavity 213 has three tangential air inlets, namely the first tangential air inlet 219, the second tangential air inlet 220 and the third tangential air inlet 221, and the three tangential air inlets are evenly distributed in a circle.

[0153] The cross-sectional shape of each air inlet along the air flow direction is rectangular.

[0154] See Figure 11As shown in [figure], among the three air inlets, the second tangential air inlet 220 communicates with the first delivery channel 209, and the third tangential air inlet 221 communicates with the second delivery channel 210. That is, the second tangential air inlet 220 and the third tangential air inlet 221 respectively serve as the "inlet channels" for the two-way particle delivery, and the first tangential air inlet 219 serves as an independent tangential air inlet channel, directly communicating with the outside.

[0155] 4) In the technical solution of the present invention, there are five air inlets in the entire flow channel, namely the second delivery channel air inlet 216, the first delivery channel air inlet 217, the first tangential air inlet 219, and two bypass air inlets 321.

[0156] Among them, the second delivery channel air inlet 216 communicates with the second delivery channel 210 and the third tangential air inlet 221 to form a delivery branch; the first delivery channel air inlet 217 communicates with the first delivery channel 209 and the second tangential air inlet 220 to form another delivery branch.

[0157] The function of the two bypass air inlets 321 is only to adjust the flow resistance of the device.

[0158] 5) In the technical solution of the present invention, the two delivery branches are arranged in a "V" shape in space, and the two branches sandwich the first medicine storage barrel 101 and the second medicine storage barrel 102 in the middle.

[0159] Correspondingly, the connection line between the first flow port 103 and the second flow port 104 is distributed at a 90-degree angle to the connection line between the first medicine storage barrel 101 and the second medicine storage barrel 102.

[0160] 6) In the technical solution of the present invention, based on the "double reservoir" design, the number of medicine storage barrels, flow ports, and delivery branches above and below the flow channel is two.

[0161] 7) In the technical solution of the present invention, the shapes of the first flow port 103 and the second flow port 104 are: "semicircular crescent" shapes that converge towards the center of the lower part of the flow channel (as shown in Figure 2 and Figure 3 ). The design of this shape is based on the arrangement space and position of the first medicine storage barrel 101 and the second medicine storage barrel 102 in space, and at the same time, sufficient design space needs to be left for the pins 105 to 109.

[0162] The technical solution of the present invention provides a flow channel system adapted to a dual-reservoir powder inhaler device. The flow channel system has two independent drug particle delivery channels, which can deliver drugs from two independent medicine pits. The two independent medicine pits do not interfere with or affect each other, and the drug particles in their respective medicine pits do not come into contact with each other. Similarly, when the drug particles fly in their respective delivery channels, they do not come into contact with or interfere with each other, which can minimize the compatibility problems caused by the contact between the active ingredients to the greatest extent.

[0163] The present invention can be widely used in the design and manufacturing fields of powder inhaler devices.

Claims

1. A flow channel applicable to a dual-reservoir powder aerosol device, characterized in that: The dual-reservoir powder aerosol device includes two medicine storage barrels, two independent medicine pits corresponding to the medicine storage barrels, two delivery channels, and a vortex dispersion chamber; The medicine outlet of each medicine storage barrel corresponds to an independent medicine pit; Each independent medicine pit corresponds to a delivery channel; The outlets of the two delivery channels communicate with the vortex dispersion chamber respectively; The two delivery channels and a vortex dispersion chamber together form the flow channel of the dual-reservoir powder aerosol device; The two medicine storage barrels are the first medicine storage barrel and the second medicine storage barrel; the two independent medicine pits are the first medicine pit and the second medicine pit; the two delivery channels are the first delivery channel and the second delivery channel; The flow channel has two independent drug particle delivery channels, and can simultaneously deliver drugs from two independent medicine pits to the same vortex dispersion chamber; The flow channel is composed of a lower flow channel member, a middle flow channel member, and an upper flow channel member stacked in sequence and combined into one body; The vortex dispersion chamber simultaneously disperses the drug prescriptions from the two channels, so that the drug particles in the two prescriptions can be depolymerized simultaneously in the vortex dispersion chamber, thereby ensuring that multiple drugs can be delivered from the powder aerosol device simultaneously; Two different preparation prescriptions are separately packed / isolated in different medicine storage barrels, corresponding to different medicine pits and drug delivery channels, so that the particles of the two different prescription powder aerosols can be delivered from their respective independent medicine pits along their respective delivery channels to the common vortex dispersion chamber, and after being dispersed by the vortex dispersion chamber, they are delivered out of the powder aerosol device together, realizing the simultaneous administration of at least two different varieties of preparation prescriptions.

2. The flow channel applicable to the dual-reservoir powder aerosol device according to claim 1, characterized in that The flow channel has two independent drug particle delivery channels and can deliver drugs from two independent medicine pits; The two independent medicine pits do not interfere with and affect each other, and the drug particles in their respective medicine pits do not come into contact with each other; Similarly, when two different drug particles fly in their respective delivery channels, they do not come into contact with and interfere with each other, so as to minimize the compatibility problems caused by the contact between the two raw materials.

3. The flow channel applicable to the dual-reservoir powder aerosol device according to claim 1, characterized in that The flow channel is based on two independent drug delivery channels: the first delivery channel and the second delivery channel, to realize the delivery of two different drug prescriptions, and to isolate the prescriptions with compatibility problems to the greatest extent, so that the two drug prescriptions do not come into contact before entering the vortex dispersion chamber, thereby avoiding the compatibility problems between different raw materials.

4. The flow channel applicable to the dual-reservoir powder aerosol device according to claim 1, characterized in that two columnar medicine storage barrels are provided on the lower flow channel member: the first medicine storage barrel and the second medicine storage barrel; each medicine storage barrel is a cylindrical structure that is vertically connected / penetrated; A first flow port and a second flow port are also provided on the member of the lower flow channel member; Connect a line between the geometric centers of the first flow port and the second flow port, which is called the first line; Connect a line between the geometric centers of the first medicine storage barrel and the second medicine storage barrel, which is called the second line; then the included angle between the first line and the second line is 90 degrees. The first connection line is the movement trajectory of the second medicine pit aligned with the first flow orifice, that is, the movement trajectory for transporting the medicinal powder in the second medicine pit; The second connection line is the movement trajectory of the first medicine pit aligned with the second flow orifice, that is, the movement trajectory for transporting the medicinal powder in the first medicine pit; The two movement trajectories do not cross or overlap.

5. The flow channel applicable to the double-reservoir powder aerosol device according to claim 4, characterized in that After the granules of the two aerosol preparation prescriptions are separately discharged from the first medicine storage barrel and the second medicine storage barrel into the first medicine pit and the second medicine pit respectively, the first medicine pit and the second medicine pit respectively bring the two different drug prescription granules to the first flow orifice and the second flow orifice by means of rotational movement.

6. The flow channel applicable to the double-reservoir aerosol device according to claim 1, characterized in that on the bodies of the lower flow channel member and the upper flow channel member, there are bolts; On the body of the middle flow channel member, there are bolt holes correspondingly arranged; Each corresponding bolt and bolt hole are correspondingly matched; Through the plug-in fit between the bolt and the bolt hole, the assembly and fixation between the upper flow channel member, the middle flow channel member and the lower flow channel member are realized.

7. The flow channel applicable to the dual-reservoir powder aerosol device according to claim 1, characterized in that The shape of the vortex dispersion chamber is a regular hexagon to increase the number of collisions of the drug particle aggregates in the vortex dispersion chamber, thereby improving the efficiency of the flow channel system for dispersing drug particles and taking into account the dispersion requirements of the two different prescriptions; The vortex dispersion chamber is evenly provided with three tangential air inlets in the circumferential direction, namely the first tangential air inlet, the second tangential air inlet and the third tangential air inlet; Among them, the first tangential air inlet is an independent air inlet, and the existence of the independent air inlet enables the air flow to form a centrally symmetric vortex air flow in the vortex dispersion chamber; The second tangential air inlet and the third tangential air inlet are respectively connected to the first delivery channel and the second delivery channel correspondingly; Based on the above structural design of the tangential air inlets, the air flow will rotate in the vortex dispersion chamber to form a "vortex" and form a strong turbulent air flow field; When the drug particles enter the vortex dispersion chamber, they collide violently with the wall surface of the vortex dispersion chamber and are also subjected to a strong air flow shear force; the drug particles and the lactose carrier particles are thus "depolymerized" to complete the dispersion.

8. The flow channel applicable to the dual-reservoir powder aerosol device according to claim 7, characterized in that The bending angle at the connection between the second delivery channel and the third tangential air inlet is greater than the bending angle at the connection between the first delivery channel and the second tangential air inlet; Let the prescription with the raw material drug and lactose tightly combined be delivered through the second delivery channel, and let it experience a collision before entering the vortex dispersion chamber, so that it can compensate for a part of the required dispersion energy and help it disperse and depolymerize better.

9. The flow channel applicable to the dual-reservoir powder aerosol device according to claim 1, characterized in that Before the air flow enters the first delivery channel and the second delivery channel through the air inlets of the first delivery channel and the second delivery channel, it first passes through a flow channel acceleration structure, which gives it a guiding effect, so that the air flow can more effectively carry away the drug powders in the first medicine pit and the second medicine pit and complete the "emptying" function as much as possible.

10. The flow channel applicable to the dual-reservoir powder aerosol device according to claim 9, characterized in that The flow channel acceleration structure located at the front ends of the first delivery channel and the second delivery channel is "concave semi-circular" in shape on the inner side and forms an air flow guiding channel in combination with the corresponding independent medicine pit; The orientations of the first delivery channel air inlet and the second delivery channel air inlet are in an "outward V" orientation, which is the same as or similar to the bending shape of the two corresponding flow channel acceleration structures, so as to ensure that the air flow entering from the first delivery channel air inlet and the second delivery channel air inlet is smoothly guided to the first flow port and the second flow port.

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