WO2023011015A1 - 一种单剂量可抛弃型粉雾剂装置 - Google Patents
一种单剂量可抛弃型粉雾剂装置 Download PDFInfo
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- WO2023011015A1 WO2023011015A1 PCT/CN2022/099104 CN2022099104W WO2023011015A1 WO 2023011015 A1 WO2023011015 A1 WO 2023011015A1 CN 2022099104 W CN2022099104 W CN 2022099104W WO 2023011015 A1 WO2023011015 A1 WO 2023011015A1
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- Prior art keywords
- drug
- powder
- sliding cover
- cover
- bottom cover
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- 239000000843 powder Substances 0.000 title claims abstract description 84
- 239000000443 aerosol Substances 0.000 title claims abstract description 36
- 239000003814 drug Substances 0.000 claims abstract description 111
- 229940079593 drug Drugs 0.000 claims abstract description 62
- 238000013461 design Methods 0.000 claims abstract description 20
- 230000001174 ascending effect Effects 0.000 claims abstract description 15
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 17
- 229910052782 aluminium Inorganic materials 0.000 claims description 17
- 239000011888 foil Substances 0.000 claims description 17
- 238000000034 method Methods 0.000 claims description 13
- 238000007789 sealing Methods 0.000 claims description 4
- 229940098458 powder spray Drugs 0.000 claims description 3
- 238000004519 manufacturing process Methods 0.000 abstract description 4
- 238000012377 drug delivery Methods 0.000 abstract description 3
- 230000000149 penetrating effect Effects 0.000 abstract 2
- 239000000243 solution Substances 0.000 description 17
- 238000010586 diagram Methods 0.000 description 7
- 238000004364 calculation method Methods 0.000 description 6
- 238000002360 preparation method Methods 0.000 description 4
- 238000011160 research Methods 0.000 description 4
- 230000008859 change Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000009776 industrial production Methods 0.000 description 3
- 241000065675 Cyclops Species 0.000 description 2
- 238000013475 authorization Methods 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 239000006185 dispersion Substances 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 238000005429 filling process Methods 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 238000012827 research and development Methods 0.000 description 2
- 238000004088 simulation Methods 0.000 description 2
- 229960005486 vaccine Drugs 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 208000006673 asthma Diseases 0.000 description 1
- 238000000889 atomisation Methods 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 239000013583 drug formulation Substances 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000002360 explosive Substances 0.000 description 1
- 238000010579 first pass effect Methods 0.000 description 1
- 238000012395 formulation development Methods 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 229940041682 inhalant solution Drugs 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 239000003380 propellant Substances 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
Definitions
- the invention belongs to the field of medical devices, in particular to an inhalation drug delivery device for injecting medicine into or onto a human body.
- Pulmonary administration (or inhalation administration) has the advantages of rapid onset of action, low toxicity and side effects, and no liver first-pass effect. This administration method has become the preferred treatment method for the treatment of asthma and chronic obstructive pulmonary disease.
- powder aerosol has the following advantages:
- powder aerosol has gradually become the research focus of some international pharmaceutical companies and research institutions that study inhalation preparations.
- the single-dose disposable powder aerosol device is characterized by the fact that after the patient uses up a single inhalation of the drug, , the device is directly discarded and no longer used.
- the internal structure of this type of device is relatively simple (compared with capsule, reservoir and vesicle-type devices), and the manufacturing cost is relatively low.
- Vaccines are traditionally administered by injection, and thus there is a risk of needle infection (for less developed areas).
- the way of inhalation administration can not only avoid the above-mentioned risks, but also make the drug take effect faster.
- the device accelerates the passing airflow through the narrow air inlet, which intensifies the turbulence of the airflow inside the flow channel and accelerates the collision between the particles and the wall of the device; the drug dispersion process of the device will generate relatively high Higher flow resistance may make it difficult for patients to inhale drugs, affect the inhalation experience of patients, reduce the compliance of patients with medication, and affect the final treatment effect of clinical diseases.
- the medicine powder of the device is filled in the mobile medicine warehouse of the device, and there are through holes on the upper and lower sides of the mobile medicine warehouse. In the industrial production process, special filling equipment is required for filling, and the production cost of the product is lower than that of general-purpose filling. The equipment is higher.
- Cyclops compared to Another disposable powder aerosol device, Cyclops, has lower flow resistance when inhaling drugs, but the Cyclops device has three parts.
- the powder When filling, the powder must be filled into the aluminum foil blister first, and then the aluminum foil blister should be installed on the corresponding position, and then install the three parts, it is still inconvenient in the filling process of industrial production, and it is not suitable for the early research and development of inhalation products that need to adjust the powder aerosol device.
- the technical problem to be solved by the present invention is to provide a single-dose disposable powder aerosol device.
- the modular structure design mode adopts the design structure in the form of a sliding cover, which is convenient for the filling operation of the built-in drug powder; while maintaining the main structure of the flow channel, the device itself can be used between the disposable type and the reusable type. Switch between them to meet different prescription requirements; the structure of the device itself is simple, the number of parts is simplified to the minimum (only 3 parts), and the processing cost is relatively low.
- the technical solution of the present invention is to provide a single-dose disposable powder aerosol device, which is characterized in that:
- the powder spray device consists of three parts: the bottom cover, the suction nozzle and the sliding cover;
- suction nozzle and the sliding cover are respectively assembled on one side of the bottom cover;
- suction nozzle is assembled on the front half of the bottom cover;
- sliding cover is assembled on the second half of the bottom cover;
- an air inlet, a medicine pit, a medicine feeding channel and a vortex chamber are arranged sequentially through;
- At least one side air inlet is provided on the side of the vortex cavity
- an ascending air passage and a drug outlet are arranged sequentially through;
- a curved protrusion which is used to guide the airflow from the air inlet into the medicine pit, so as to facilitate and assist in taking away the medicine powder in the medicine pit;
- suction nozzle and sliding cover are assembled into one body, the air inlet, drug pit, drug inlet channel, vortex chamber, ascending air channel and drug outlet form a complete flow channel cavity body;
- the powder aerosol device realizes the filling operation of the medicine powder in the medicine pit by sliding the sliding cover, loading the powder, and closing the sliding cover in three steps.
- a slideway is provided on the bottom cover, and the slide cover can be opened and closed by sliding along the slideway.
- the powder aerosol device adopts a slide cover with a slidable opening and closing design structure to facilitate the filling operation or replenishment of the medicinal powder in the medicine pit.
- two side air inlets are provided on the side of the vortex cavity
- the two side air inlets are arranged on both sides of the vortex chamber in axial symmetry or mirror symmetry, taking the longitudinal axis of the drug inlet channel as the axis of symmetry;
- the two side air inlets are arranged on both sides of the vortex chamber with the center of the vortex chamber being rotationally symmetrical with the air inlet.
- the inlet end of the ascending air passage is arranged above the vortex chamber, and the outlet end of the ascending air passage is connected to the drug outlet.
- protruding pin structures and corresponding pin hole structures are respectively provided, and on the contact surface between the sliding cover and the suction nozzle, protruding pin structures and corresponding The pin hole structure;
- the powder aerosol device described in this technical solution without changing the flow channel structure inside the device, changes the filling method of the powder, and then realizes that the whole device can be used between a single-dose reusable type and a single-dose disposable type. Switch between them arbitrarily.
- the filling method of the medicine powder includes filling the medicine powder into aluminum foil plates containing small doses in advance, tearing off a small dose when in use, putting it into the medicine pit of the device, and then pulling out the aluminum foil strip, that is, It can realize the single-filling function of the powder, and then realize the single-dose reusable function of the whole device.
- the filling method of the medicine powder includes directly filling the medicine powder into the medicine well of the device, and then sealing the medicine well with aluminum foil to complete the one-time filling function of the medicine powder, and then realize the single-dose disposable function of the whole device.
- Fig. 1a is a schematic structural view of the bottom cover of the present invention.
- Figure 1b is a schematic top view of the bottom cover
- Figure 2a is a schematic structural view of the suction nozzle of the present invention.
- Fig. 2b is a schematic longitudinal sectional structure diagram of the suction nozzle
- Figure 3a is a schematic structural view of the slide cover of the present invention.
- Fig. 3b is a longitudinal sectional structural schematic diagram of the sliding cover
- Fig. 4 is a schematic diagram of the explosive structure of the inhalation device of the present invention.
- Fig. 5 is a schematic diagram of the overall shape and structure of the inhalation device of the present invention.
- Fig. 6 is the internal airflow velocity nephogram of inhalation device of the present invention.
- Figure 7 is a vector diagram of the airflow inside the inhalation device of the present invention.
- 1 is the bottom cover
- 2 is the suction nozzle
- 3 is the sliding cover
- 4 is the drug pit
- 5 is the vortex cavity
- 6 is the drug feeding channel
- 7 is the air inlet
- 8a is the first side air inlet
- 8b Be the second side air inlet
- 9 is an ascending airway
- 10 is a drug outlet
- 11 is a slideway
- 12 is a curved protrusion.
- the powder spray device in the technical solution of the present invention consists of three parts: a bottom cover 1 , a suction nozzle 2 and a sliding cover 3 .
- an air inlet 7, a drug pit 4, a drug inlet channel 6 and a vortex chamber 5 are arranged sequentially through;
- a first side air inlet 8a and a second air inlet 8b are arranged; the two side air inlets are arranged symmetrically on both sides of the vortex chamber 5 .
- the two side air inlets are arranged on both sides of the vortex chamber axially or mirror-symmetrically, taking the longitudinal axis of the drug inlet channel as the axis of symmetry.
- the two side air inlets are arranged on both sides of the vortex chamber with the center of the vortex chamber being rotationally symmetrical with the air inlet.
- the medicine pit is located in the bottom cover part.
- the suction nozzle part and the bottom cover part can be matched and installed first (or these two parts have been installed when the device leaves the factory), and then the medicine powder can be carried out separately. of filling.
- the powder can be filled into the medicine pit directly through the filling equipment or manually, and then the sliding cover can be closed (for the early stage of research and development, the sliding cover can be opened again, and then the powder can be filled again for use.
- the device requires one-time use at this time, and can be designed to be locked after closing).
- an ascending air channel 9 and a drug outlet 10 are arranged sequentially through.
- the inlet end of the ascending airway is arranged above the vortex cavity, and the outlet end of the ascending airway is connected with the drug outlet.
- a curved protrusion 12 is provided under the sliding cover 3 .
- the curved protruding structure guides the airflow entering the air inlet into the medicine pit, so as to facilitate and assist in taking away the medicine powder.
- the powder aerosol device in this technical solution is composed of three parts: a bottom cover 1, a suction nozzle 2 and a sliding cover 3;
- suction nozzle and the sliding cover are respectively assembled on one side of the bottom cover;
- suction nozzle is assembled on the front half of the bottom cover; the sliding cover is assembled on the second half of the bottom cover.
- the powder aerosol device in the technical solution realizes the filling operation of the traditional Chinese medicine powder in the medicine pit through three operation steps of "sliding the sliding cover" ⁇ "loading the powder" ⁇ "closing the sliding cover".
- a slideway 11 is provided on the bottom cover, and the slide cover can slide along the slideway to realize the function of opening and closing.
- the powder aerosol device adopts a slide cover with a slidable opening and closing design structure to facilitate the filling operation or replenishment of the medicinal powder in the medicine pit.
- the slide cover can slide in a certain limited space position.
- the slide cover slides to the closed state as shown in Figure 5
- two The protruding structure will snap into the two pin holes at the bottom of the bottom cover, and the protruding structure at the bottom of the nozzle part will snap into the concave hole of the slide cover, so that the three parts form a closed state.
- the bottom cover and the suction nozzle are over-tightly fitted through the three protruding pins at the bottom of the suction nozzle.
- other special designs can be made on the shape of the flow channel in the bottom cover (keep the other two components unchanged) according to the actual situation, so as to adapt to different prescription designs and requirements.
- the fit between the two parts of the bottom cover and the suction nozzle can be over-tight fit, or ultrasonic welding or other methods can be used to weld the two parts to death.
- the powder aerosol device described in this technical solution can realize the use of the whole device between the single-dose reusable type and the single-dose disposable type by changing the filling method of the powder without changing the flow channel structure inside the device. Switch between them arbitrarily.
- the powder aerosol device described in this technical solution can change the device from a single-dose disposable type to a single-dose reusable type according to different situations of actual drug administration prescriptions under the condition that the internal structure remains unchanged.
- the drug powder can be filled into aluminum foil vesicles of small dosage units, and the patient can tear off a small part and fill it into the device when using, and pull off the aluminum foil strip on the vesicles during use. Inhale a single dose of medicine, slide off the slide cover after use, pour out the empty vesicles, and refill them for the next use.
- the device is of a reusable type, the cooperation between the suction nozzle and the bottom cover parts in the design of the device needs to be changed to be detachable, which can facilitate cleaning.
- the fit between the suction nozzle and the bottom cover can be changed to welding (that is, it cannot be disassembled after installation), so as to ensure its single-dose disposable use and reproducibility. Disposable functions.
- the filling method of the medicine powder includes filling the medicine powder into aluminum foil plates containing small doses in advance, tearing off a small dose when in use, putting it into the medicine pit of the device, and then pulling out the aluminum foil strip, that is, It can realize the single-filling function of the powder, and then realize the single-dose reusable function of the whole device.
- the filling method of the drug powder includes directly filling the drug powder into the drug pit of the device, and then sealing the drug pit with aluminum foil to complete the one-time filling function of the drug powder, and then realize the single-dose disposable function of the entire device.
- the pharmaceutical powder filling process is simple when the device is used for industrial production (the use of general-purpose filling equipment can also be used for pharmaceutical powder filling) Filling), which is convenient for operators to use simple equipment to fill (or manually fill) inhalation product prescriptions in the early laboratory research stage of drug formulation development.
- the geometric structure of the flow channel cavity in this technical solution can be seen in Figure 1a and Figure 1b. Its overall structure is a vortex structure, which is different from the general traditional vortex structure.
- the geometric structure is designed as a structure with a gradually narrowing cross section, in order to allow the airflow to obtain a certain acceleration when entering the dispersion chamber, and to ensure the turbulence intensity of the airflow in the vortex structure.
- the authorization announcement date is August 28, 2020, and the authorization announcement number It is the relevant content in the Chinese invention patent of CN 107737393B "a preparation atomization channel for powder inhalation device", and will not be described here.
- the result of the simulation calculation is that, under the pressure difference condition of 4Kpa, the air flow rate inside the device is 63.40L/min, which shows that the flow channel design adopted in this technical solution belongs to the low-medium flow resistance as a whole (calculated by CFD Convergence accuracy 10-4), in the design of the flow channel structure (especially the design of the air inlet), it is relatively reasonable.
- the simulation of computational fluid dynamics of this technical solution adopts unstructured grid and uses the Reynolds two-equation turbulence model K-e model to perform calculations.
- the criteria for judging the convergence of calculations are: when the three directions of velocity x, y, z and turbulent kinetic energy K and turbulent flow.
- the residual accuracy of the dissipation rate e reaches about 1 ⁇ 10-4 or below, and the outlet flow value remains unchanged with the number of iteration steps, it is judged that the CFD calculation is converged, and the Standard Wall Function model (Standard Wall Function) is used.
- the place with the highest air velocity is concentrated in the middle of the vortex channel (in the cloud image, the darker the color, the higher the air velocity, and the whiter the lower velocity), the highest air velocity is concentrated in the vortex.
- the middle position of the swirl channel has the highest air turbulence intensity. According to the results of the airflow vector diagram, the airflow successfully swirls in the vortex chamber.
- the present invention has the following advantages:
- the filling part of the built-in drug powder in this device adopts the design form of the sliding cover structure, which is convenient for powder filling operation or replenishment;
- the whole device adopts a modular and customized structural design, so that the shape of the cavity inside the suction nozzle and the bottom cover can be individually designed according to the characteristics of the drug prescription;
- the filling or replenishing mode of the built-in drug powder is easy to change, regardless of the cavity shape inside the suction nozzle and the bottom cover, while maintaining the main internal structure (ie flow channel structure) unchanged
- the device itself can be switched between disposable and reusable under certain conditions.
- the technical solution of the present invention adopts the design form of the sliding cover structure to facilitate the powder filling operation or replenishment of the drug powder built in the device; at the same time, through the modular structure design mode, while maintaining the main structure of the flow channel , the filling or replenishing mode of the built-in drug powder is easy to change, and the device itself can be switched between a single-use type and a reusable type to meet different drug prescription needs; in addition, the overall structure of the device itself is simple, and the number of parts is simplified To a minimum, processing costs are relatively low.
- the technical scheme of the invention can be widely used in the field of design and manufacture of inhalation drug delivery devices.
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Abstract
一种单剂量可抛弃型粉雾剂装置，由底盖（1）、吸嘴（2）和滑盖（3）组成；吸嘴（2）和滑盖（3）装配在底盖的一侧；吸嘴（2）装配在底盖（1）的前半部分，滑盖（3）装配在底盖（1）的后半部分；在底盖（1）上设置有依次贯通的进气口（7）、药坑（4）、进药通道（6）和涡旋腔（5）；在涡旋腔（5）的侧面设置有至少一个侧进气口；在吸嘴（2）本体中设置有依次贯通的上升气道（9）和出药口（10）；在底盖（1）、吸嘴（2）和滑盖（3）装配为一体后，进气口（7）、药坑（4）、进药通道（6）、涡旋腔（5）、上升气道（9）和出药口（10），构成一个完整的流道腔体；通过滑开滑盖（3），装入药粉，关上滑盖（3）三个步骤，来实现药坑中药粉的灌装操作。采用滑盖（3）结构，便于内置药物粉末的灌装操作或补充，可在一次性使用型和重复使用型之间进行切换。该装置可广泛用于吸入式给药装置的设计制造领域。
Description
本发明属于医疗器械领域，尤其涉及一种用于将药物输入人体内或输到人体上的吸入式给药装置。
基于肺部给药(或者吸入给药)具有起效快、低毒副作用以及无肝脏首过效应等优点，该给药方式成为了治疗哮喘疾病和慢性阻塞性肺病的首选治疗方式。
而在众多吸入制剂的剂型中，粉雾剂和其他剂型的吸入制剂相比(如气雾剂、雾化吸入溶液以及雾化吸入混悬液)，具有以下优点：
1)不含抛射剂，对环境友好；
2)体积小，便于患者携带使用；
3)药物浪费相对较少等优势和特点。
因此，粉雾剂逐渐成为国际上一些研究吸入制剂的制药公司及研究机构的研究重点。
和一般传统的粉雾剂装置相比(如胶囊粉雾剂、囊泡型粉雾剂以及储库型粉雾剂)，单剂量抛弃型粉雾剂装置的特点是患者用完单吸药物之后，装置直接被丢弃不再使用，一般而言这类装置的内部结构较为的简单(较胶囊、储库以及囊泡型装置)，制造成本较为低廉。
目前，这类装置已经开始应用于疫苗以及其他大分子药物的递送。传统的疫苗给药方式为注射，因而存在针头感染的风险(对于欠发达地区)。而采用吸入给药的方式，不仅可避免上述风险，也可以使得药物起效变快。
国内目前关于可抛弃型粉雾剂装置的设计以及研究相对较少，而国外目前已经出现了许多这方面的产品(装置产品)。2010年，以Hovione公司研制的
作为载药装置，产品
在日本上市。也因此，
成为了第一个商业获批的抛弃型粉雾剂装置产品。
相比于
另外一款抛弃型粉雾剂装置Cyclops在吸入药物时流阻更低，但是Cyclops装置有三个零部件，灌装时先要将粉末灌装至铝箔泡罩内，然后将铝箔泡罩安装至对应的位置，然后将三个零件进行安装，在工业化生产的灌装环节依然不方便，不适用于需要调整粉雾剂装置的吸入产品的早期研发。
发明内容
本发明所要解决的技术问题是提供一种单剂量可抛弃型粉雾剂装置。其通过模块化结构设计模式，采用滑盖形式的设计结构，便于内置药物粉末的灌装操作；在维持流道主结构不变的情况下，装置本身可在一次性使用型和重复使用型之间进行切换，以满足不同的处方需求；装置本身结构简单，零件数量简化至最小(仅3个部件)，加工成本相对较低。
本发明的技术方案是：提供一种单剂量可抛弃型粉雾剂装置，其特征是：
粉雾剂装置由底盖、吸嘴和滑盖三部分组成；
所述的吸嘴和滑盖分别装配在所述底盖的一侧；
其中，所述的吸嘴装配在所述的底盖的前半部分；所述的滑盖装配在所述的底盖的后半部分；
在所述的底盖上，沿着底盖的纵向轴线，设置有依次贯通的进气口、药坑、进药通道和涡旋腔；
在涡旋腔的侧面，设置有至少一个侧进气口；
在所述吸嘴的本体中，沿着吸嘴的纵向轴线，设置有依次贯通的上升气道和出药口；
在所述滑盖的下方，设置有一个弯曲突出，用于将进气口进入的气流导入药坑内，以方便协助带走药坑中的药粉；
在所述的底盖、吸嘴和滑盖装配为一体后，所述的进气口、药坑、进药通道、涡旋腔、上升气道和出药口，构成一个完整的流道腔体；
所述的粉雾剂装置，通过滑开滑盖，装入药粉，关上滑盖三个步骤，来实现 药坑中药粉的灌装操作。
具体的，在所述的底盖上设置有滑道，所述的滑盖可沿滑道滑动开、合。
进一步的，所述的粉雾剂装置采用滑盖的可滑动开、合设计结构，来便于药坑中药粉的灌装操作或补充。
进一步的，在涡旋腔的侧面，设置有两个侧进气口；
所述的两个侧进气口，以进药通道的纵向轴心线为对称轴线，轴向对称或镜像对称地设置在涡旋腔的两侧；
或者，所述的两个侧进气口，以涡旋腔的中心为轴心，与进气口旋转对称地设置在涡旋腔的两侧。
进一步的，所述上升气道的进口端，设置在涡旋腔的上方，所述上升气道的出口端，与出药口相接。
具体的，在所述底盖与滑盖的接触面上，分别设置有突出插销结构和对应的插销孔结构，在滑盖与吸嘴的接触面上，同样也分别设置有突出插销结构和对应的插销孔结构；
当滑盖沿滑道向前滑动到位后，相应的突出插销结构卡入对应的插销孔内，使得滑盖与底盖之间，以及滑盖与吸嘴之间，固接为一体，底盖、吸嘴和滑盖三部分构成一个完整的封闭式结构。
本技术方案所述的粉雾剂装置，在不改变装置内部的流道结构的前提下，通过改变药粉的充填方式，进而实现整个装置的使用在单剂量重复使用型和单剂量可抛弃型之间任意切换。
进一步的，所述药粉的充填方式包括事先将药粉灌装入含一个个小剂量的铝箔板上，在用的时候掰下一小剂量，装入装置的药坑内，然后拔开铝箔条，即可实现药粉的单次填充功能，进而实现整个装置的单剂量重复使用型功能。
进一步的，所述药粉的充填方式包括直接将药粉灌装入装置的药坑内，然后使用铝箔将药坑封上，完成药粉的一次性填充功能，进而实现整个装置的单剂量可抛弃型功能。
附图概述
图1a是本发明底盖的结构示意图；
图1b是底盖的俯视结构示意图；
图2a是本发明吸嘴的结构示意图；
图2b是吸嘴的纵向剖视结构示意图；
图3a是本发明滑盖的结构示意图；
图3b是滑盖的纵向剖视结构示意图；
图4是本发明吸入装置的爆炸结构示意图；
图5是本发明吸入装置的整体外形结构示意图；
图6是本发明吸入装置的内部气流速度云图；
图7是本发明吸入装置内部气流的矢量图。
图中1为底盖，2为吸嘴，3为滑盖，4为药坑，5为涡旋腔，6为进药通道，7为进气口，8a为第一侧进气口，8b为第二侧进气口，9为上升气道，10为出药口，11为滑道，12为弯曲突出。
下面结合附图对本发明做进一步说明。
本发明技术方案中的粉雾剂装置，由底盖1、吸嘴2和滑盖3三部分组成。
如图1a和图1b中所示，在底盖1上，沿着底盖的纵向轴线，设置有依次贯通的进气口7、药坑4、进药通道6和涡旋腔5；
在涡旋腔的侧面，设置有第一侧进气口8a和第二进气口8b；两个侧进气口对称设置在涡旋腔5的两侧。
如图1b中所示，两个侧进气口，以进药通道的纵向轴心线为对称轴线，轴向对称或镜像对称地设置在涡旋腔的两侧。
或者，两个侧进气口，以涡旋腔的中心为轴心，与进气口旋转对称地设置在涡旋腔的两侧。
由图1a或1b所述可知，所述的进气口、药坑、进药通道和涡旋腔，依次设置在底盖的纵向轴线上。
药坑位于底盖部件中，在实际应用中，可先将吸嘴部件和底盖部件进行配合安装完毕后(也可以是装置在出厂时这两个零部件已经安装好)，再单独进行药粉的灌装。
对于湿度环境要求不是太高的处方，可直接通过灌装设备或者手动，将药粉灌装入药坑内，然后关上滑盖(对于研发早期而言，滑盖可以再打开，然后再次灌装药粉使用，当商业化后，此时装置要求一次使用，可以设计为关上后锁死的状态)。
对于环境湿度要求较高的处方，可以考虑先将定制形状的铝箔泡罩卡入药坑内，灌装入药粉之后，封上铝箔，然后依次安装上吸嘴和滑盖。只是患者或操作实验时，需要多一个步骤就是将铝箔条拉开后，装置才能正常递送和分散药物。
如图2a和图2b中所示，在所述吸嘴2的本体中，沿着吸嘴的纵向轴线，设置有依次贯通的上升气道9和出药口10。
其中上升气道的进口端，设置在涡旋腔的上方，所述上升气道的出口端，与出药口相接。
图3a和图3b中，在所述滑盖3的下方，设置有一个弯曲突出12。
当底盖、吸嘴和滑盖装配为一体，构成一个完成的流道腔体时，该弯曲突出结构将进气口进入的气流导入药坑内，以方便协助带走药粉。
如图4和图5中所示，本技术方案中的粉雾剂装置，由底盖1、吸嘴2和滑盖3三部分组成；
所述的吸嘴和滑盖分别装配在所述底盖的一侧；
其中，所述的吸嘴装配在所述的底盖的前半部分；所述的滑盖装配在所述的底盖的后半部分。
结合图1a、图1b和图4中所示可知，在本技术方案中，在底盖、吸嘴和滑盖装配为一体后，进气口、弯曲突出、药坑、进药通道、涡旋腔、上升气道和出药口，构成了一个完整的流道腔体。
本技术方案中的粉雾剂装置，通过“滑开滑盖”→“装入药粉”→“关上滑盖”三个操作步骤，来实现药坑中药粉的灌装操作。
参见图1a、图1b和图4中所示，在底盖上设置有滑道11，滑盖可沿滑道滑动实现开、合动作功能。
在本技术方案中，所述的粉雾剂装置采用滑盖的可滑动开、合设计结构，来便于药坑中药粉的灌装操作或补充。
同时，由于在底盖上设计有滑道结构，使得滑盖可以在一定限制的空间位置内进行滑动，当滑盖滑动至关闭状态时(如图5中所示位置)，滑盖底部两个突出的结构会卡入底盖的底部两个插销孔内，同时吸嘴部件底部的突起结构会卡入滑盖的凹孔内，使得三个零部件形成封闭的状态。
进一步的，本技术方案中底盖和吸嘴两个部件通过吸嘴底部三个突出的插销，实现过紧配合。在实际应用中，可根据实际的情况，对底盖中流道的形状进行其他的特殊设计(维持其他两个部件不变)，以适应不同的处方设计及需求。
底盖和吸嘴两个部件之间的配合，可采用过紧配合的方式，也可采用超声焊接或者其他方式，将两个零部件焊死。
本技术方案所述的粉雾剂装置，在不改变装置内部的流道结构的前提下，通过改变药粉的充填方式，可以实现整个装置的使用在单剂量重复使用型和单剂量可抛弃型之间任意切换。
本技术方案所述的粉雾剂装置，根据实际给药处方的不同情况，在内部结构不变的情况下，可以将装置从单剂量可抛弃型转变为单剂量可重复使用的类型。
例如，如果需要重复使用，可将药粉装填入一个个小剂量单元的铝箔囊泡中，患者使用时可掰下一小部分装填入装置中，使用时拉掉囊泡上的铝箔条后吸入单剂量的药物，使用完毕后滑开滑盖，将空囊泡倒出，待下次使用重新装填。
需要指出，若装置为可反复使用的类型，装置设计中吸嘴和底盖的零部件之间的配合需改为可拆卸，这样可便于清洗。
若药物只需单次使用，则滑开滑盖，将药粉直接灌入装置中，将药坑用铝箔封上(可采用热封、胶水等方式)，装置的使用步骤不变。
需要指出的是，如果装置为一次性使用后抛弃型的类型，则吸嘴和底盖之间的配合可改为焊死(即安装之后不可拆卸)，进而保证其单剂量一次性使用和可抛弃型的功能。
具体的，所述药粉的充填方式包括事先将药粉灌装入含一个个小剂量的铝箔板上，在用的时候掰下一小剂量，装入装置的药坑内，然后拔开铝箔条，即可实现药粉的单次填充功能，进而实现整个装置的单剂量重复使用型功能。
具体的，所述药粉的充填方式包括直接将药粉灌装入装置的药坑内，然后使用铝箔将药坑封上，完成药粉的一次性填充功能，进而实现整个装置的单剂量可抛弃型功能。
采用本技术方案后，在保证零件数量较少的同时(不超过3个)，使得应用该装置进行工业化生产时的药物粉末灌装工艺过程简便(使用通用型灌装设备也能进行药物粉末的灌装)，方便操作人员在药物制剂研发早期的实验室研究阶段，使用简易的设备即可进行吸入产品处方的灌装(或者手动灌装)。
本技术方案中流道腔体的几何结构，可参见图1a和图1b中所示，其整体结构为涡旋状结构，与一般传统的涡旋状结构不同的是，本技术方案中进气口的几何结构设计为截面逐渐缩小的结构，为的是让气流在进入分散腔内的时候，能够获得一定的加速，保证在涡旋状结构内，气流的湍流强度。
关于采用如上流道腔体的几何结构后，其气流流经的路径、形成气体涡旋的原理等，可参见本申请人此前申请的、授权公告日为2020年8月28日、授权公告号为CN 107737393B的中国发明专利“一种用于粉雾剂吸入装置的制剂雾化流道”中的相关内容，在此不再叙述。
本技术方案中流道结构及形状的优化，通过计算流体力学仿真软件计算获得，主要从如下几个方面：
1)通过给定边界条件4kpa的压力查，计算得到在装置内部，气流运动的速度，从而计算得到理论流速，近而获得装置本身的理论计算流阻；
通过仿真计算的结果为，在4Kpa的压差条件下，装置内部的气流流速为63.40L/min，说明在本技术方案中采用的流道设计，整体属于中低的流阻大小(CFD的计算收敛精度10-4)，在流道结构的设计上(尤其是进气口的设计)，是相对较为合理的。
2)通过CFD计算云图，判断装置内部气流的运动情况，考察流道的设计是否合理；
本技术方案计算流体力学的仿真，采用非结构化网格，使用雷诺两方程湍流模型K-e模型进行运算，判断计算收敛的标准是：当三个方向速度x,y,z以及湍流动能K以及湍流耗散率e的残差精度达到1×10-4左右或者以下时，且出口流量值随着迭代步数不变时，判断CFD计算收敛，使用标准壁面函数模型(Standard Wall Function)。
本技术方案流道CFD计算结果的速度云图和矢量图如图6和图7中所示。
从云图结果看，气流速度最高的地方集中在涡旋流道的中间位置(在云图中，颜色越黑说明气流的速度越高，越白说明速度越低)，气流速度最高的地方集中在涡旋流道的中间位置，该位置气流湍流强度也是最高的。而根据气流矢量图的结果显示，气流成功地在涡旋腔内进行打旋。
综上，与现有技术比较，本发明的优点是：
1.本装置内置药物粉末的灌装部分，用了滑盖结构的设计形式，便于粉末灌装操作或补充；
2.装置的整体采用模块化定制的结构设计，使得吸嘴和底盖内部的腔道形状均可以根据药物处方的特点单独进行设计；
3.由于采用了滑盖结构，使得内置药物粉末的灌装或补充的模式易于改变，与吸嘴和底盖内部的腔道形状无关，在维持内部的主要结构(即流道结构)不变 的前提下，装置本身可在抛弃型和重复使用型之间进行切换。
以上的各实施例仅仅是用来解释和说明本发明的，而并非用作对本发明技术方案的限定；本领域的普通技术人员应当认识到，只要在本发明的实质精神范围内，对以上实施例的变化、变形，都将落在本发明权利要求所要求的保护范围内。
工业应用性
本发明的技术方案，采用了滑盖结构的设计形式，以方便于装置内置药物粉末的粉末灌装操作或补充；同时，通过模块化结构设计模式，在维持流道主结构不变的情况下，内置药物粉末的灌装或补充的模式易于改变，装置本身可在一次性使用型和重复使用型之间进行切换，以满足不同的药物处方需求；此外，装置本身整体结构简单，零件数量简化至最小，加工成本相对较低。
本发明的技术方案，可广泛用于吸入式给药装置的设计和制造领域。
Claims (9)
- 一种单剂量可抛弃型粉雾剂装置，其特征是：粉雾剂装置由底盖、吸嘴和滑盖三部分组成；所述的吸嘴和滑盖分别装配在所述底盖的一侧；其中，所述的吸嘴装配在所述的底盖的前半部分；所述的滑盖装配在所述的底盖的后半部分；在所述的底盖上，沿着底盖的纵向轴线，设置有依次贯通的进气口、药坑、进药通道和涡旋腔；在涡旋腔的侧面，设置有至少一个侧进气口；在所述吸嘴的本体中，沿着吸嘴的纵向轴线，设置有依次贯通的上升气道和出药口；在所述滑盖的下方，设置有一个弯曲突出，用于将进气口进入的气流导入药坑内，以方便协助带走药坑中的药粉；在所述的底盖、吸嘴和滑盖装配为一体后，所述的进气口、药坑、进药通道、涡旋腔、上升气道和出药口，构成一个完整的流道腔体；所述的粉雾剂装置，通过滑开滑盖，装入药粉，关上滑盖三个步骤，来实现药坑中药粉的灌装操作。
- 按照权利要求1所述的单剂量可抛弃型粉雾剂装置，其特征是在所述的底盖上设置有滑道，所述的滑盖可沿滑道滑动开、合。
- 按照权利要求1所述的单剂量可抛弃型粉雾剂装置，其特征是所述的粉雾剂装置采用滑盖的可滑动开、合设计结构，来便于药坑中药粉的灌装操作或补充。
- 按照权利要求1所述的单剂量可抛弃型粉雾剂装置，其特征是在涡旋腔的侧面，设置有两个侧进气口；所述的两个侧进气口，以进药通道的纵向轴心线为对称轴线，轴向对称或镜像对称地设置在涡旋腔的两侧；或者，所述的两个侧进气口，以涡旋腔的中心为轴心，与进气口旋转对称地设置在涡旋腔的两侧。
- 按照权利要求1所述的单剂量可抛弃型粉雾剂装置，其特征是所述上升气道的进口端，设置在涡旋腔的上方，所述上升气道的出口端，与出药口相接。
- 按照权利要求1所述的单剂量可抛弃型粉雾剂装置，其特征是在所述底盖 与滑盖的接触面上，分别设置有突出插销结构和对应的插销孔结构，在滑盖与吸嘴的接触面上，同样也分别设置有突出插销结构和对应的插销孔结构；当滑盖沿滑道向前滑动到位后，相应的突出插销结构卡入对应的插销孔内，使得滑盖与底盖之间，以及滑盖与吸嘴之间，固接为一体，底盖、吸嘴和滑盖三部分构成一个完整的封闭式结构。
- 按照权利要求1所述的单剂量可抛弃型粉雾剂装置，其特征是所述的粉雾剂装置，在不改变装置内部的流道结构的前提下，通过改变药粉的充填方式，进而实现整个装置的使用在单剂量重复使用型和单剂量可抛弃型之间任意切换。
- 按照权利要求7所述的单剂量可抛弃型粉雾剂装置，其特征是所述药粉的充填方式包括事先将药粉灌装入含一个个小剂量的铝箔板上，在用的时候掰下一小剂量，装入装置的药坑内，然后拔开铝箔条，即可实现药粉的单次填充功能，进而实现整个装置的单剂量重复使用型功能。
- 按照权利要求7所述的单剂量可抛弃型粉雾剂装置，其特征是所述药粉的充填方式包括直接将药粉灌装入装置的药坑内，然后使用铝箔将药坑封上，完成药粉的一次性填充功能，进而实现整个装置的单剂量可抛弃型功能。
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| CN101856531A (zh) * | 2010-06-22 | 2010-10-13 | 于清 | 用于药物输送的高效干粉吸入器及其药物输送方法 |
| US20170106154A1 (en) * | 2014-05-15 | 2017-04-20 | Astrazeneca Ab | Dry powder inhaler |
| CN107737393A (zh) * | 2017-10-12 | 2018-02-27 | 上海新黄河制药有限公司 | 一种用于粉雾剂吸入装置的制剂雾化流道 |
| CN110812635A (zh) * | 2019-11-18 | 2020-02-21 | 德必来福有限公司 | 一种吸入粉雾剂给药装置 |
-
2021
- 2021-08-03 CN CN202110886052.3A patent/CN115702961A/zh active Pending
-
2022
- 2022-06-16 WO PCT/CN2022/099104 patent/WO2023011015A1/zh unknown
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1666788A (zh) * | 2005-04-04 | 2005-09-14 | 陈庆堂 | 干粉气溶胶化吸入器 |
| WO2010037961A1 (fr) * | 2008-09-30 | 2010-04-08 | Valois Sas | Dispositif d'inhalation de poudre |
| CN101856531A (zh) * | 2010-06-22 | 2010-10-13 | 于清 | 用于药物输送的高效干粉吸入器及其药物输送方法 |
| US20170106154A1 (en) * | 2014-05-15 | 2017-04-20 | Astrazeneca Ab | Dry powder inhaler |
| CN107737393A (zh) * | 2017-10-12 | 2018-02-27 | 上海新黄河制药有限公司 | 一种用于粉雾剂吸入装置的制剂雾化流道 |
| CN110812635A (zh) * | 2019-11-18 | 2020-02-21 | 德必来福有限公司 | 一种吸入粉雾剂给药装置 |
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| CN115702961A (zh) | 2023-02-17 |
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