CN208943130U - A kind of powder inhaler - Google Patents

Abstract

The utility model discloses a kind of powder inhaler, described device includes the container for filling powdered drug, the device further includes having the locator for limiting the container aperture position, and the driving structure in the aperture position to open container, described device is formed with the outlet being connected with the container opened, the drug of powdery can be sucked from the container opened by the outlet user, the flow restrictor being provided on the locator between the locator and outlet, the flow restrictor and the locator and outlet, and the gas-flow resistance of the powder inhaler is increased.The powder inhaler for adding flow restrictor can meet the needs of delivering different pharmaceutical, and reach good delivering effect.

Description

A kind of powder inhaler

One, technical field

The utility model relates to a kind of powder inhaler, specifically a kind of suction that user can be allowed to suck dry powder pharmaceutical Enter device.

Two, background technique

Dry powder inhalation therapy refers to the form that drug is made to dry powder particle, and heavy breathing is treated in a manner of sucking air flue and intrapulmonary A kind for the treatment of method of the respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD).And it is actively sucked used by user dry The suction apparatus of powder particles is the key factor for influencing clinical therapeutic efficacy.Powder inhaler huge number, by the storage of drug The mode of depositing is divided into: vesicle type, capsule-type, depot.

GSK company discloses the embodiment of a variety of vesicle type suction apparatus in patent GB2242134B, wherein specification The exploitation listing of the embodiment of suction apparatus shown in attached drawing 13-16, exactly GSK companySeries of products are used for As sucking dress of the delivering including multiple products such as fluticasone, salmeterol, fluticasone/salmeterol compound preparation It sets, provides excellent therapeutic scheme for asthma and patient COPD,Series of products are also due to its good performance It is widely used and is received by patient.

The Foradil Aerolizer formoterol fumarate and its suction apparatus of the treatment asthma and/or COPD that have listed further include, in the exploitation of BI company CityThe suction apparatus that the said firm discloses in EP1496858A1 is capsule-type, for delivering a water thiophene support Bromine ammonium preparation；The exploitation listing of TEVA companyThe suction apparatus is also capsule-type, for delivering anhydrous tiotropium bromide Preparation；Astrazeneca AB's exploitation listing(SE453566B), which is depot, for passing Send budesonide formulation, formoterol formulations, Budesonide/formoterol compound preparation.

Although these products are the identical diseases for the treatment of, but since the drug of suction apparatus delivering is different, pharmaceutical activity Ingredient and clinical testing data have differences, and drug development person has conducted extensive research for the suction apparatus of different pharmaceutical, grind Study carefully the certain performance parameters for showing suction apparatus, such as air flow resistance (AFR), has to the administering effect of suction apparatus important It influences.Document (" Can all patients with COPD use the correct inhalation flow with All inhalers and does training help? " " Respiratory Medicine " 2007,101,2395- 2401, R.A.M.Al-Showair et al.) it has studiedWithThree kinds The difference of the AFR parameter of suction apparatus, research shows that under same airflow speed,AFR it is minimum,Highest,Between two parties, i.e., different suction apparatus has embodied different AFR physical properties, To meet the clinical use characteristic of product itself.Device has listed for many years, due to its excellent performance quilt extensively Patient receives, therefore many businesses and institutions, all attempts to be further developed as general medicinal inhalation devices, i.e., applicable InThe drug that equal suction apparatus are delivered.This just needs improvedDevice is consistent in this parameter of AFR with other suction apparatus.

In addition, " oral cavity sucks the clinical documentation requirements of preparation, packet to the Xiang Zhinan that European drug administration (EMEA) is issued Including proves for treating Adults Asthma and chronic obstructive pulmonary disease (COPD) and two kinds for treating children and non-Adults Asthma Sucking preparation has the requirement for the treatment of equivalence " it points out: simplifying for imitation medicine is applied, it is necessary to prove trial drug and reference The treatment equivalence of drug, in some cases, as fruit product meets required all 9 standards (with reference agent phase Than), then external correlation data can be used only, so as to exempt clinical internal correlative study, clinical drug can be greatly shortened Test period allows drug to list as early as possible, seizes market and obtains economic benefit, is of great significance for enterprise.Required 9 standards in, having a requirement is exactly that the suction apparatus of trial drug, should be with reference agent to the resistance (AFR) of air stream Suction apparatus it is identical, fluctuate in +/- 15% range.

It in terms of comprehensive, if willDevice is further developed as general suction apparatus, is suitable forThe drug that equal suction apparatus are delivered, that just needs to improveDevice, make its AFR withThe AFR of equal suction apparatus becomes Nearly consistent (+/- 15%), to reach identical drug delivery effect.Meanwhile AFR is to prove that trial drug and reference agent have There is in 9 standards for the treatment of equivalence very important one, it is necessary to realize unanimously, be exempted to improve imitation medicine enterprise The probability of clinical In vivo study greatlys save product development time and the economic cost of imitation medicine enterprise.

Three, summary of the invention

The utility model provides a kind of powder inhaler, and utility model, which is designed to provide one kind, can be suitable for passing Send the powder inhaler of a variety of drugs.

To achieve the goals above, the utility model provides a kind of powder inhaler, and described device includes can by two The container for the dress powdered drug that component fixed with each other limits is peeled off, which further includes having to limit the container The locator of one aperture position, and in the aperture position to peel off two components to open the driving structure of the container, Described device is formed with the outlet being connected with the container opened, can be from the appearance opened by the outlet user Device sucks powdered drug, the flow restrictor being provided between the locator and outlet on the locator, the gas Ductility limit product and the locator and outlet, and the gas-flow resistance (AFR) of the powder inhaler is increased.

Further, the flow restrictor is tubular conduit.

Further, the tubular conduit is the tubular conduit of the cone of cylindrical tube channel or truncation.

Further, two components are the elongated thin slice for limiting many drug containers spaced apart along its length, One of thin slice is the substrate with multiple cavitys, another thin slice is cover plate, the cover plate portion of each cavity and covering cavity Divide and constitutes a cell therefor.

Further, described device includes the main wheel for having multiple grooves on it, and the main wheel and the drug hold Device is meshed, and each groove is made to accommodate corresponding cavity, and the driving structure includes for uncapping in aperture position removing The cover plate driving structure and substrate driving structure of piece and substrate.

Further, the main wheel and cover plate driving structure and the main wheel and substrate driving structure are connected to, so as to The rotation and cover plate driving structure, the rotation associated of substrate driving structure of main wheel.

Further, the locator is correspondingly formed medicinal powder outlet portion, medicinal powder outlet portion top in the aperture position Portion is provided with air inlet, air inlet described in shield portions.

Further, the medicinal powder outlet portion is formed with the limit being arranged above and below on the side wall towards the aperture position Discharge orifice, the current limliting hole rows become circular hole and are formed with cross grid in circular hole.

Further, the grid of cross grid described in shield portions.

Further, described device includes rotational handle, which includes the arc with a finger-type trimmer Shape wall and one inwardly stretch out from the arcwall and have the wall of row's arc-shaped gear in its terminal, and the tail portion of the arcwall offers Groove, for accommodating flow restrictor during driving.

Further, the arcwall of the rotational handle can be not provided with groove, but the length of arcwall should be suitable, with true It protects during driving, flow restrictor will not be touched.

Four, Detailed description of the invention

Fig. 1 is the top view of powder inhaler；

Fig. 2 is the partial structural diagram inside powder inhaler；

Fig. 3 is the structural schematic diagram of powder inhaler locator；

Fig. 4 is the structural schematic diagram that locator is dispensed inside powder inhaler；

Fig. 5-7 is the partial structural diagram that powder inhaler adds flow restrictor；

Fig. 8 is the partial structural diagram of powder inhaler partial occlusion air inlet；

Fig. 9 is the partial structural diagram of powder inhaler arcwall tail portion.

Specific embodiment

Detailed description furtherly is made to the utility model in the following with reference to the drawings and specific embodiments, so as to this field skill Art personnel understand.

Fig. 1-4 is shownPowder inhaler.As shown in Figure 1, the powder inhaler includes with cover 2 Shell 1, shell 1 include bottom and top, the two is essentially all circular.When device assembly, 1 bottom of shell and top Portion's snap-assembly is together.The device is arranged below lid 2, and lid 2 is by means of the convex block and shell on 1 top of shell A corresponding convex block (not shown) on 1 bottom is pivotally mounted on shell 1.The lid 2 exposes in a mouthpiece 3 It is pivoted between the closed position that open position and mouthpiece 3 are not exposed.

As shown in Fig. 2, powder inhaler includes that can peel off the dress that component fixed with each other limits by two The container 4 of powdered drug, two components are the elongated thin slice for limiting many drug containers spaced apart along its length, wherein One thin slice is the substrate 6 with multiple cavitys 5, another thin slice is that hermetic seal is on the substrate 6 other than 5 range of cavity Cover plate 7,7 part of cover plate of each cavity 5 and covering cavity 5 constitutes a corresponding drug container, and each drug container is held Receive one powdered drug that can be inhaled into.The method of 7 hermetic seal of cover plate on the substrate 6 can be peeled away from substrate 6. The two thin slices on they the external entire width of front end portion on it in addition to sealing against each other, front end portion preferably phase It does not seal completely mutually.

As in Figure 2-4, which further includes having the positioning for limiting the container 4 of the dress powdered drug aperture position Device 8, and the driving structure of container 4 is opened to peel off two components in the aperture position, the driving structure includes stripping The cover plate driving structure and substrate driving structure of cover plate 7 and substrate 6 are left, the cover plate driving structure is to remove for winding The lid winding wheel 11 for the back cover plate 7 opened, the substrate driving structure are to wind for winding the substrate for the meron 6 peeled away Wheel 10.Described device further includes a main wheel 9.The main wheel 9 and lid winding wheel 11 and the main wheel 9 and substrate winding wheel 10 are Connected, so as to the rotation associated of the rotation of main wheel 9 and lid winding wheel 11 and substrate winding wheel 10.Described device is formed There is the outlet 14 being connected with the container 4 opened, can be sucked from the container 4 opened by 14 users of the outlet The drug of powdery.

Locator 8 defines four internal chambers in shell 1.One to by container 4 be initially contained in it and from that In the chamber 8a that sends out, the locator 8 is formed with the axis 801 passed through for 4 core of container in the middle part of chamber 8a.One For accommodating the chamber 8b of the substrate 6 after peeling away, the gear 101 of substrate winding wheel 10, and engaged with the gear 101 Driven wheel 12 is located at the downside of the chamber 8b, through-hole is formed in the middle part of the chamber 8b, substrate winding wheel 10 is for winding The groove 102 of used substrate 6 passes through the through-hole.One accommodates the chamber 8c for the back cover plate 7 peeled away, will in chamber 8c Used cover plate 7 is wrapped on lid winding wheel 11, and lid winding wheel 11 is formed by two parts, i.e., with teeth 1111 and axis 1112 Gear 111 and wheel 112 of giving with a hollow center axis 1121 and multiple elastic arms 1122, for example, wheel 112 of giving can be with Be it is as shown in Figure 4 from hollow center axis 1121 respectively with eight this arms of radius stretching at an angle.Gear 111 has one Convex block, it is engaged with the corresponding groove on hollow center axis 1121, so that gear 111 and wheel 112 of giving rotate in concert this arm. One placement main wheel 9 chamber 8d, the main wheel 9 have many be parallel to its axis extension grooves 901, these grooves 901 with The pitch interval of the distance between one center line for being equal to two adjacent pockets 5 is opened, which is meshed with container 4, makes each Groove 901 accommodates corresponding cavity 5.Main wheel 9 has external tooth 902, and the gear 111 of the external tooth 902 and lid winding wheel 11 is nibbled It closes, and is engaged by driven wheel 12 with the gear 101 of substrate winding wheel 10.Main wheel 9 be it is hollow, ratchet in it, Hook tooth is formed on the inner wall of main wheel 9, and there are two the pawls being meshed with hook tooth for ratchet tool, so that main wheel 9 It can move in the counterclockwise direction, thereby guarantee that the container 4 of the dress powdered drug can only travel forward by the device.

As shown in figure 4, there are one handles 13 for the device, it includes the arcwall 13b with a finger-type trimmer 13a It is inwardly stretched out from arcwall 13b and with one in wall 13c of its terminal with row's arc-shaped gear 13d.The handle is pivotally pacified Mounted in the center of housing bottom 1a, so as to around the axial-movement of the pitch circle center in tooth 13d, tooth 13d and 9 bottom of main wheel Ratchet on tooth engagement.In operation, lid 2 is moved on to its open position by user, then pushes down the finger-type adjustment of handle 13 Piece 13a moves it with the pivot of handle.This operation makes the ratchet wheel in main wheel 9, and this rotation is made by pawl Main wheel 9 also rotates.The rotation of main wheel 9 generates the rotation of both substrate winding wheel 10 and lid winding wheel 11, is thus enough opening Mouth position peels off the substrate 6 and cover plate 7 for the cavity 5 being previously not switched on, and then user is by exporting 14 for one powdered drug Sucking.

Four chambers of the locator 8 are sealed by case top (not shown).As shown in figure 3, chamber 8a is logical It crosses channel 802 to communicate with chamber 8d, chamber 8b is communicated by channel 803 with chamber 8d, and chamber 8c passes through channel 804 and chamber 8d It communicates, enables and the unstripped substrate 6 opened and cover plate 7 or peel away substrate 6 and cover plate 7 passes in and out between different chamber.Institute It states locator 8 and is arranged at the aperture position of container 4 and be correspondingly formed a medicinal powder outlet portion 805, the medicinal powder outlet portion 805 packet The air inlet 805a at top is included, medicinal powder outlet portion 805 is formed with the metering hole being arranged above and below on the side wall towards aperture position 805b and 805c, the metering hole 805b and 805c is formed as circular hole, and cross grid is formed in circular hole, medicinal powder outlet portion 805 are formed on export-oriented 14 side wall and are in mutually level venthole 805d with metering hole 805c, when user is logical When crossing 3 air-breathing of mouthpiece, air stream is caused to enter medicinal powder outlet portion 805 by air inlet 805a, air stream passes through metering hole 805b enters the cavity 5 that the container 4 of dress powdered drug is opened, and effectively carries medicinal powder secretly and exports from metering hole 805c across medicinal powder Portion 805, and finally sprayed from venthole 805d.

If willDevice is further developed as general suction apparatus, is suitable forThe drug that equal suction apparatus are delivered, that just needs to improveDevice makes Its AFR withGas-flow resistance (AFR) approach of equal suction apparatus it is consistent (+/- 15%), To reach identical drug delivery effect.Table one is the gas-flow resistance (AFR) of three kinds of different devices:

Table one:

Device	DISKUS	Handihaler	Turbuhaler
				Gas-flow resistance value ((cmH2O)0.5min/L)	0.0873	0.1582	0.1109

As it can be seen thatThe gas-flow resistance of powder inhaler is minimum, in order to enableDry powder sucking The gas-flow resistance of device reaches unanimity with other devices, needs to increaseThe gas-flow resistance of powder inhaler is This, the utility model pairEach component on the air flow path of powder inhaler improves, and is improved with reaching The purpose of gas-flow resistance, and then realize identical drug delivery effect.

Embodiment 1

Using describedPowder inhaler deliveringThe drug that suction apparatus is delivered, It shouldPowder inhaler adds flow restrictor, as shown in figure 5, the flow restrictor 15 be installed on it is described fixed On export-oriented 14 side wall of position device 8, the flow restrictor 15 and the outlet in the outlet 14 and medicine outlet portion 805 Hole 805d connection.The drug powder is prepared according to US6585959B2.

Design and prepare the powder inhaler sample of 5 tubular air limited parts with different geometrical size, 1-3 The tubular air limited part of number sample is cylindrical tube, as shown in figure 5,4-5 pipeline is formed the cone of truncation, Cone apex angle is 60 °, and truncation is carried out at high 1/2 of cone, as shown in fig. 6, the pipeline of No. 4 sample is to be attached to A side opening on locator 8 is small, as shown in fig. 7, the pipeline of No. 5 sample is that the side opening that is attached on locator 8 is big. The sample gas Resistance Value of the size of the chimneying limited part 15 and corresponding sample is as shown in Table 2:

Table two:

Specimen coding	1	2	3	4	5	Handihaler	It is unmodified
								Entrance outer diameter (mm)	4.0	4.0	4.0	4.0	2	-	-
Inlet inside diameter (mm)	2.0	2.5	3.0	2.0	1.5	-	-
								Gas-flow resistance value (cmH2O)0.5min/L)	0.1597	0.1562	0.1538	0.1668	0.1692	0.1582	0.0873

As shown in Table 2, the gas of the powder inhaler is made by adding the flow restrictor 15 on locator Flow resistance power (AFR) increase, and can satisfy withGas-flow resistance (AFR) approach of suction apparatus is consistent (+/- 15%) requirement.

Embodiment 2

Using describedPowder inhaler deliveringThe drug that suction apparatus is delivered, no Flow restrictor is added, only covers the partial-air admission mouth 805a of the 8 medicinal powder outlet portion 805 of locator of the powder inhaler, such as Shown in Fig. 8, the drug powder is prepared according to US5674860A:

5 powder inhaler samples are designed and prepare, No. 1-5 has the air inlet 805a for covering different area, such as Shown in Fig. 8, shielded area is respectively 20%, 30%, 40%, 50%, 60%.Gas-flow resistance value such as three institute of table of corresponding sample Show:

Table three:

Specimen coding	1	2	3	4	5	Turbuhaler	It is unmodified
								Air-flow resistance value (cmH2O)0.5min/L)	0.0987	0.1001	0.1013	0.1024	0.1054	0.1109	0.0873

As shown in Table 3, it in the case where not adding flow restrictor, is hidden only by locator medicinal powder outlet portion 805 Stopper divides air inlet 805a, and the gas-flow resistance (AFR) of the powder inhaler may make to increase, and can satisfy withThe gas-flow resistance (AFR) of suction apparatus approaches the consistent (requirement of +/- 15%).

Embodiment 3

Using describedPowder inhaler deliveringThe drug that suction apparatus is delivered is done Metering hole 805b and 805c in the locator medicinal powder outlet portion 805 of powder suction apparatus are formed as circular hole, and are formed in circular hole There is cross grid, the grid protocol of the part cross grid has baffle, and the preparation of the drug powder is with embodiment 2:

5 powder inhaler samples are designed and prepare, it is same as Example 2, flow restrictor is not added, only occlusion part Divide metering hole, No. 1-3 has the metering hole 805b for covering different area, and shielded area is respectively 25%, 50%, 75%, the No. 4-5 has the metering hole 805c for covering different area, and shielded area is respectively 25%, 50%.The gas-flow resistance of corresponding sample Value is as shown in Table 4:

Table four:

Specimen coding	1	2	3	4	5	Turbuhaler	It is unmodified
								Air-flow resistance value (cmH2O)0.5min/L)	0.0987	0.1001	0.1013	0.1024	0.1054	0.1109	0.0873

As shown in Table 4, by locator shield portions into metering hole 805b or 805c make dry powder sucking dress The gas-flow resistance (AFR) set increases, and can satisfy withGas-flow resistance (AFR) approach one of suction apparatus Cause (the requirement of +/- 15%).

Embodiment 4

Using describedPowder inhaler deliveringThe drug that suction apparatus is delivered, The powder inhaler adds flow restrictor, while air inlet or metering hole in shield portions locator medicinal powder outlet portion, The preparation of the drug powder is with embodiment 1:

5 powder inhaler samples are designed and prepare, 1-5 sample increases air-flow and limits component, the air-flow limit Component 15 processed be cylindrical tube, outer diameter 4.0mm, internal diameter 2.5mm, meanwhile, 1-3 sample covering part air inlet 805a, Shielded area is respectively 40%, 50%, 60%, 4-5 sample covering part metering hole 805b, and shielded area is respectively to cover 25%, 50%.The air-flow resistance value of corresponding sample is as shown in Table 5:

Table five:

Specimen coding	1	2	3	4	5	Handihaler	It is unmodified
								Air-flow resistance value (cmH2O)0.5min/L)	0.1634	0.1697	0.1741	0.1593	0.1603	0.1582	0.0873

As shown in Table 5, flow restrictor is added in the powder inhaler, while shield portions locator medicinal powder exports Air inlet or metering hole in portion so that the gas-flow resistance (AFR) of the powder inhaler increases, and can satisfy withThe gas-flow resistance (AFR) of suction apparatus approaches the consistent (requirement of +/- 15%).

As can be seen from the above embodiments, using on the locator of powder inhaler increase flow restrictor, block The mode of partial-air admission mouth or shield portions metering hole, can increase the gas-flow resistance value of powder inhaler, and wherein use Increase the mode of flow restrictor, AFR amplification effect is the most obvious.For user when sucking medicinal powder, mouth, which is received, contains mouthpiece 3, User's forced suction exports 14, medicinal powder outlet portion 805 as a result, and forms negative pressure, and portion of air passes through medicinal powder outlet portion 805 Air inlet 805a enter, pass through metering hole 805b reach cavity 5, mealy medicine is raised at this time, mealy medicine with sucking gas Stream further passs through venthole 805d across metering hole 805c, into outlet 14, finally enters in user oral cavity.Due to There are gap 14a (as shown in Figure 2) between outlet 14 and locator 8, and when the wearer inhales the air, air passes through from gap 14a Stomata 805d is entered in medicinal powder outlet portion 805, causes air-flow resistance value small, by being arranged between 14 and venthole 805d of outlet Flow restrictor can prevent the air in gap from entering in medicinal powder outlet portion 805, to effectively increase gas-flow resistance.Together Sample, the mode of shield portions air inlet and shield portions metering hole also functions to the effect that limitation air flows into, and achievement unit Divide the purpose for increasing gas-flow resistance.

Since the flow restrictor 15 added is in the tracks of the arcwall 13b of rotational handle 13, gas in order to prevent Ductility limit product 15 hinders the movement of rotational handle 13, opens up groove in the tail portion of the arcwall 13, as shown in figure 9, for accommodating Flow restrictor 15.

Although above-described embodiment is made that detailed description to the utility model, it is only the utility model a part Embodiment, rather than whole embodiments, people can also obtain other implementations according to the present embodiment under the premise of without creativeness Example, these embodiments belong to scope of protection of the utility model.

Claims (10)

1. a kind of powder inhaler, described device includes that can peel off the dress that component fixed with each other limits by two The container of powdered drug, the device further include the locator having to the container one aperture position of restriction, and in the opening The driving structure of the container, the container phase that described device is formed with one and has opened are opened to peel off two components in position The outlet of connection can suck powdered drug from the container opened by the outlet user, it is characterised in that: the positioning The flow restrictor being provided between the locator and outlet on device, the flow restrictor is with the locator and out Mouth connection, and the gas-flow resistance (AFR) of the powder inhaler is increased.

2. powder inhaler as described in claim 1, it is characterised in that: the flow restrictor is tubular conduit.

3. powder inhaler as claimed in claim 2, it is characterised in that: the tubular conduit is cylindrical tube channel or cuts The tubular conduit of the cone on top.

4. powder inhaler as described in claim 1, it is characterised in that: two components are to limit many along its length The elongated thin slice of drug container spaced apart, one of thin slice are the substrate with multiple cavitys, another thin slice is cover plate, The cover plate part of each cavity and covering cavity constitutes a cell therefor.

5. powder inhaler as claimed in claim 4, it is characterised in that: described device includes one on it with multiple The main wheel of groove, the main wheel are meshed with the drug container, and each groove is made to accommodate corresponding cavity, and the driving structure includes For peeling away the cover plate driving structure and substrate driving structure of cover plate and substrate in the aperture position.

6. powder inhaler as claimed in claim 5, it is characterised in that: the main wheel and cover plate driving structure and the main wheel It is connected to substrate driving structure, so as to the rotation and cover plate driving structure, the rotation associated of substrate driving structure of main wheel.

7. powder inhaler as described in claim 1, it is characterised in that: the locator is correspondingly formed in the aperture position Medicinal powder outlet portion, the medicinal powder outlet portion top are provided with air inlet, air inlet described in shield portions.

8. powder inhaler as claimed in claim 7, it is characterised in that: the medicinal powder outlet portion is towards the opening position The metering hole being arranged above and below is formed on the side wall set, the current limliting hole rows become circular hole and are formed with crossed grid in circular hole Grid.

9. powder inhaler as claimed in claim 8, it is characterised in that: the grid of cross grid described in shield portions.

10. powder inhaler as described in claim 1, it is characterised in that: described device includes rotational handle, the rotation hand Handle includes that arcwall with finger-type trimmer and one inwardly stretch out from the arcwall and has row's arc in its terminal The wall of shape tooth, the tail portion of the arcwall open up fluted.