CN1183057A - Device and process for mixing a pharmaceutical composition with another agent and method for oral administration of the pharmaceutical preparation - Google Patents

Abstract

Device for mixing a pharmaceutical composition stored in a chamber (38) in said device with an agent to be added shortly before administration to form a preparation to be administered. The device should be capable of being shaken without leaking. It comprises a hollow body (2) having an outlet (4), sealed by a removably closure (12) and a plunger (6), which includes a flexible sealing member (20) having a circumferential edge in sealing contact with the inner wall (8) of the hollow body. The plunger (6), the hollow body (2) and the removable closure (12) define said chamber (38). A hollow rod (30) is connected to the plunger (6) for displacing the same in the hollow body (2) and includes at least one opening, which communicates with the interior of the rod (30) with the upper side of the flexible member (20). The flexible member (20) is supported on the plunger (6), so that it can only flex downwards. At a predetermined pressure differential over the upper side and the lower side of the flexible member (20) the flexible member will flex downwards to open a communication at the inner wall (8) of the hollow body into the chamber (38), so that said agent flows into the chamber (38).

Description

The apparatus and method of hybrid medicine composition and another reagent and the method for oral this pharmaceutical preparation

Technical field

The present invention relates to according to the said a kind of device of the preorder of claim 1, it can be with that preferably do and granular pharmaceutical composition, with another kind of reagent, preferably fluid mixes and is made into a kind of preparation, gel preparation preferably.

Background of invention

The subject matter that becomes basis of the present invention relate to how to dispose, store and take must with the pharmaceutical composition of another kind of reagent mix, and this reagent may play page influence to the stability of said composition, and how both is made and be suitable for the particularly preparation taken of livestock of being (living being).

Animal doctor circle knows, the drug combination preparation of feeding the drink pasty state to horse is that the device with syringe-like carries out.Be discharged on the root of the tongue syringe insertion Ma Zui and preparation when the time comes.The thickness character of transferring and be put into the Ma Zui rear portion horse is felt bad and the medicament that spues.

In some cases, such preparation, for example pharmaceutical composition and denseness form the mixture of agent, have only the storage stability of very short time.Therefore, two kinds of components in this preparation must be isolated mutually before taking and be preserved, up to just they being mixed into the preparation of requirement mutually from taking very short time.

Existing a lot of ways can solve the problem that the sort of component stored and be mixed into the preparation that can not store up for a long time.

Prevailing existing solution is the syringe of US-A-3 340 873 disclosed the sort of types, and it has columniform syringe body, in the plunger of a slip is arranged.Two kinds of mutual isolation of components to be mixed are placed in two subregions that separate with film.From taking preparation during very short time, film is torn or pokes, so that two subregions communicate.Rock then mixture is housed syringe to form uniform preparation, uncap open wireless tunnel is after this discharged content by the pushing plunger by needle tubing.

This prior art proves satisfied and reliably as a rule, and can be for example with the plastic injected die method easily, produce at an easy rate.

But this syringe is unsuitable for taking gel, mainly is because have needle tubing.In addition, a bit be to have two mixing arrangements usually can not be used for the pharmaceutical composition of some kind in addition to water vapor sensitive with the subregion of rubber or plastic sheeting isolation.An example of this based composition contains the composition of proton pump inhibitor (proton pump inhibitor) exactly, and as Omeprazole (Omeprazole), it exists under the situation of steam if long term storage will be degraded.The molecular migration phenomenon of passing through rubber or plastic sheeting that can exist usually in long term storage just is enough to cause the degraded of this class sensing composition.

Therefore, two traditional subregion mixing arrangements are inapplicable to this based composition.

Danish Patent specification 112893 (submission on July 25th, 1996) discloses a kind of syringe that is used for injectable pharmaceutical compositions, and this composition can not be stored in for a long time in the solution and illeffects does not take place.This syringe is equivalent to standard syringe basically, and the main distinction is that the hole of adorning needle tubing sealing with film.Composition is contained in the syringe with dry state.Be contained on the needle tubing hole with the double end entry needle, in the time will using syringe, just poke film for one of pin.Solvent is just by in the needle tubing inhalation syringe.Rock syringe then, the solution for preparing is injected away by needle tubing again.

The shortcoming of such syringe is, fills the operation more complicated, and it need load onto two injection needle tubing so that poke film.In addition, after film breaks, mixing chamber will be opened air, therefore when rocking carefully mixture spill by needle tubing.Moreover, since syringe particularly the passage of needle tubing is narrow, flow resistance is big, so it be not suitable for viscosity, pasty state or gelatinous preparation.What is more, and this apparatus is unsuitable for using as drug oral because needle tubing is arranged.In addition, the production cost of this syringe is also than higher.

Purpose of the present invention

Purpose of the present invention is the shortcoming that will get rid of prior art, provides a kind of pharmaceutical composition of long term storage therein, and can face take before the preparation convenient promptly toward wherein adding the mixing arrangement that needs reagent.This device also should be able to firmly rock and can not spill after adding reagent.In addition, the production cost of device of the present invention also should be lower.

Purpose of the present invention reaches, and provides according to the said device of the preorder of claim 1, and it comprises said those features of characteristic in the claim 1.

Other independent claims define the method for using this device mixing pharmaceutical formulation, and the method for taking mix preparation by this device.

In the time will being used for taking preparation, at first to remove packing or end socket that the tube chamber of giving interior powder charge thing when storage prevents steam.Add then will be contained in the liquor that intraluminal composition mixes, this liquor is kept apart tube chamber by resilient seal.Plunger is moved to the rightabout of discharging then, causes the expansion of sealing tube chamber, thereby cause vacuum in tube chamber.The boundary of tube chamber is to be delimited by the sidewall of plunger, pipe and seal cover.At the beginning, the pressure differential on seal two sides is also too low, not enough so that its deflection, but continue outer moving when connector, and intraluminal vacuum strengthens gradually, just makes the seal distortion, cracks it open and the contacting of tube wall, thereby just has been communicated with tube chamber.So liquor just is inhaled into tube chamber.After the liquor of requested number flowed into tube chamber, at this moment also just rebound its poised state of elastic sealing element was just rocked this device and can be taken up to preparation.Face take before, the seal cover on the tube chamber is removed, and just can insert this device in the mouth of horse for example.But at this moment push the just content discharge of handle assembly of plunger.

Preferred embodiment is described

Now, will describe with reference to accompanying drawing the preferred embodiments of the invention with example, accompanying drawing has:

Fig. 1 is the axial sectional drawing of the present invention's first preferred embodiment;

Fig. 2 amplifies the part that stroke circle among Fig. 1 is shown;

Fig. 3 is along the cross-sectional view of III-III line among Fig. 1;

Fig. 4 is the axial sectional drawing of another embodiment, and it has change slightly than Fig. 1-3;

Fig. 5 amplifies the part that stroke circle among Fig. 4 is shown;

Fig. 6 is along the sectional drawing of VI-VI line among Fig. 4;

Fig. 7 amplifies the part that change is arranged slightly that embodiment among Fig. 4 is shown;

Fig. 8 is the axial sectional drawing of yet another embodiment of the invention;

Fig. 9 is along the sectional drawing of IX-IX line among Fig. 8;

Figure 10 amplifies the part of drawing circle among Fig. 8 is shown;

Figure 11 discloses the little change of the embodiment of Fig. 8-10.

As shown in Figure 1, the device of the syringe-like of the present invention's first preferred embodiment includes theducted body 2 of a tubulose elongated cylindrical, and all open at its two ends.Lower end among Fig. 1 is an outlet side 4.Plunger 6 inserts by theupper end 10 of opening.A flange orhandgrip part 13 are arranged around the upper end, it basically with vertically the stretching perpendicularly of ducted body 2.Outlet side 4 is airtight by 12 on a removable lid, and fluted 14 on the lid, the diameter of groove is equivalent to the diameter of thesidewall 8 of ducted body 2.Groove 14 is made certain depth, so that have bubble-tight sealing between the inner chamber of cylinder lower end 4 and ducted body 2.Lid 12 has thelug 16 of circumferentially extending, so that take offlid 12 easily when discharging preparation.

Can be clear that from Fig. 2plunger 6 comprises 18 and 20 two parts: the rest facility 18 of panels of plane shape and thin and resilient disc-shaped seal 20; The rest facility stretches in diametric(al), and with the axis normal ofducted body 2, seal size of (when not adding external force) when loosening is done to such an extent that can contact with inwall 8 sealings of ductedbody 2, thereby the space onseal 20 both sides is kept apart mutually.Connector 22 is equipped with at the center ofdish 20, and a compressible cydariform end 24 is arranged at connector top, and the centre bore 26 of its diameter less than cydariform end 24 then arranged on the support plate 18.The handle 28 ofconnector 22 is suitable with the thickness of support plate 18, so thatconnector 22 can be pressed in thecentre bore 26, thereby makesdish 20 be close to support plate 18.

Plunger 6 is made an integral body with plunger 30.The overall diameter of plunger is slightly smaller than the interior diameter of ductedbody 2, so thatplunger 30 can slide in ducted body.Plunger 30 is tubular, and itsannular end 32 and support plate 18 are made of one, and the end face ofend 32 flushes with the end face (lower surface among Fig. 1) of support plate 18.Thehandgrip 23 of circumferentially extending is housed on theopening end 40 ofplunger 30.

Resilient disc 20 usefulness elastomeric materials are made, and it can tilt when being subjected to enough big external force, and it can return to original state when removing external force.Whenlid 12 or other end socket covered outlet side 4, just the inwall bylid 12 or other end socket,resilient disc 20 and ductedbody 20 surrounded anairtight tube chamber 38, becauseplunger 6 can move axially, so the volume of tube chamber is variable.Afterresilient disc 20 was pressedcentre bore 26, it just pushed against the annular end of support plate 18 and plunger 30.Therefore the annular limit portion 34 ofresilient disc 20 is just withstood and can not be bent upwards by support plate 18 and annular end 32.But limit portion 34 is can be reclinate.When being bent downwardly, limit portion 34 will crack it open and contact with the sealing of theinwall 8 of ductedbody 2, thereby is leaving a passage betweenresilient disc 20 upper and lower surfaces on the inwall 8.Like this, the effect ofresilient disc 20 resembles a check (non-return) valve.

Must be pointed out that available any method is assembled toresilient disc 20 on the plunger 30.For example available keyhole joint.At this moment, just can do the hole that can clamp key in the end ofplunger 30, then, the connector ofseal disc 20 just is admitted in the hole of broad of keyhole, is pushed into subsequently in the slit of keyhole.Another kind of assembly method is, can do a handle at the center ofresilient disc 20, and handle imports in the hole ofplunger 30 lower ends then, and the end of handle is heated to softening temperature then, flattens on the hole, forms the joint of similar riveted joint.

As mentioned above, can find out also thatplunger 30 is tubular and the bottom is open from Fig. 1-3, the bottom normally seals with resilient disc 20.Theinner chamber 36 of plunger anddish 20 are formed a filled chamber, in order to deposit the liquor that will mix mutually with the composition deposited in the tube chamber.

This function of installing first embodiment below will illustrate with embodiment.This device suitable compositions is described in WO/SE94/25070.In following example, pharmaceutical composition is the globule by active material, the cellulose derivative of for example enteric-coated Omeprazole (Omeprazole) ball and gelling agent such as synthesising biological polymeric gel, guar gum, locust bean gum, gum tragacanth, improvement etc. mixes, later also in the mixture of this dried component, add liquor, Ru Shui, so that form the gelinite of viscosity.Use the defined device of the present invention will be not limited to the use relevant with Omeprazole.

The mixture of enteric-coated Omeprazole ball and gelling agent is placed in thetube chamber 38 with appropriate dosage.Can add buffer or pH conditioning agent such as lemon carboxylic selectively, in case enteric-coated globule dissolves prematurely add water later in composition after.The available two kinds of ways of this operation are carried out, a kind of is thatplunger 6 is placed on the appropriate location in the ductedbody 2, andlid 12 is taken off, and puts medicine inward by lower end 4 then, a kind of is thatlid 12 covers on lower end 4 andplunger 6 is taken out, and puts medicine inward by thehole 10 on top then.The quantity of mixture or volume can be chosen wantonly in certain limit, becauseplunger 6 can move vertically, so the volume oftube chamber 36 is variable.4cover lids 12 or other end socket in the end respectively after pharmaceutical composition is put well perhaps insertducted bodies 2 to plunger 6.

Should be pointed out that under favo(u)red state, should the bear the responsibility task of the metering device that will join the liquor that goes in thetube chamber 38 of hollow plunger 30.It should be transparent and preferably be decorated with graduation mark, makes the liquor that will add accurately measure with this device.Unnecessary liquor can be poured out inplunger 30 before plunger 30 moves and open the path that enters tube chamber 38.Like this,, therefore need not any optional equipment, depend merely on syringe itself, just can measure very accurately the liquor that will add owing to the special design ofplunger 20 has had measurement means.

Hygroscopicity and the viewpoint that requires for up to the several years from gelling agent; concerning pharmaceutical composition; must protect when being stored in the tube chamber and not be subjected to water vapor permeable, otherwise steam will gather in gelling agent, in long term storage or early or can cause the degraded of Omeprazole late.Therefore, after putting into medicine, this device should be enclosed in the packaging container of waterproof vapour, preferably has the water blocking layer of aluminum, but other material that can satisfy same purpose also it is contemplated that certainly.Enclose drier in packaging container, preferably with being contained in the pouch, it is suitable being used for further waterproof.If need not above-mentionedly pack, add air-locked end socket or the capping of making of similar material at the top of theopening end 40 ofplunger 30, also just can meet the demands.At this moment can in end socket or capping, add drier, to absorb the moisture that any infiltration is come in.Like this, but this device just stored for years up to use.

When using, take out or take off the end socket attubular plunger 30 tops with installing in the packing of vapor pervious never.To be added to an amount of water that the mixtures in thetube chamber 38 go toward the interior injection of the tubular cavity ofplunger 30 then, be added to the height (indicating) of requirement with scale orheight graticule.Plunger 6 up moves then, therefore causes vacuum in tube chamber 38.In displacement after enough distances, vacuum wherein is just by force to making the downward-sloping degree ofresilient disc 20, the circumferential edges 34 ofresilient disc 20 just cracks it open and contacts with the sealing ofinwall 8, so just opened the passage that enterstube chamber 38, therefore existed thecavity 36 interior water ofplunger 30 will be inhaled intotube chamber 38 from cavity 36.After water was carried in the past,resilient disc 20 will be returned to its poised state, after this can rock this device, contains till the viscogel that the Omeprazole ball is arranged up to formation.When rocking,resilient disc 20 can prevent themixture cavity 36 that bleeds.Mixture can only store very short time in device before taking.Lid 12 is taken off facing when taking, handle assembly is put into the place that will take preparation.Just pushplunger 30 then and discharge preparation.

The axial length ofplunger 30 is a most convenient can all preparations all be discharged from device after all compressing into.Resilient disc 20 preferably has even curface so that all discharge composition, thereby avoid any residue, pill or gel stay in the hole or seam in, as the slit is arranged on the fruit tray, just this thing may take place.

The end socket that available energy tears off or staves replacesvinyl cover 12 toseal tube chamber 38.

The slight variations of the embodiment of Fig. 4 exploded view 1-3.The bottom of itstubular plunger 30a is not to open, but two relative longitudinally cuttinggrooves 42 are arranged, it extend to from the bottom ofplunger 30a plunger 30a height pact half, thereby the inner chamber 36a ofplunger 30a is communicated with the top edge of resilient disc 20a.Include a hole 26a in bottom centre, the effect in this hole is similar to thehole 26 in the embodiment of Fig. 1.The bottom ofplunger 30 is circular, and it is supporting the middle part ofresilient disc 20a.

Another change of embodiment is among Fig. 4, and seal 20 ' a and plunger 30 ' a are made of one, and seal 20 ' a is that an annular resilient collar constitutes, and sees Fig. 7.The advantage of this embodiment is to only require once-through operation when making plunger 30 ' a and seal 20 ' a.

Another change of previous embodiments (Fig. 8-10) is, the top ofplunger 30b is tubulose, and itsunderpart 46 has one section to be criss-cross, and this can be clear that from Fig. 9.Therefore, mutually perpendicular plate 48,50 constitutes by two extending longitudinallies in the bottom, they extend to from the bottom ofplunger plunger 30b height pact half.Extendcross section 46 downwards fromtubular segments 44, it comprises the first with constant section, provide enough rigidity and the guide effect that props up inwall 8 with it, 56 of next parts are tapered towards the bottom downwards, this part itself also comprisesannular lip 60, in order to supportelastic dish 20b, and prevent its upward.The bottom also comprises ahole 62, and the cydariform end 24b ofresilient disc 20b just presses (see figure 10) in this hole.

A modification of Fig. 8-10 embodiment is shown in Figure 11.Also in Fig. 7, elastic sealing element 34 ' b andplunger 30b are made of one, it have theannular lip 60 of circumferentially extending ', flange then contacts with inwall 8 sealings ofducted body 2 with the thin elastic edge 34 ' b lengthening of a circle, elastic edge.

In the embodiment of Fig. 8-11, the water that add still like before the opening end byplunger 30b 40 inject, but different with previous embodiments be that water is not to exist in the lower tubular part of plunger, but rises to certain height along the cross section.In this scheme, cross Duan Shangying draws multi-color cord to indicate the volume level.In this embodiment, plunger must be opaque, and can make suitable color.

Should be appreciated that the mechanism of action of all these embodiments all is similar.A kind of liquor, preferably water is injected into theupper end 40 ofplunger 30, flows down the upper surface that arrives elastic sealing element along pore then.Seal stops water to enter tube chamber 38.Plunger is moved backward then, thereby causes vacuum in tube chamber 38.The synergy meeting of the weight of water and vacuum makes the downward deflection of seal, and like this, water just is inhaled into tube chamber 38.When water entered tube chamber from the disappearance of elastic sealing element top, the sealing part can return its original poised state, andtube chamber 38 is sealed.

Above-mentioned solution provides different advantages.If seal is a constitutional detail separately, just in the selection of material, provide great freedom.The material of seal may be selected to be has optimal seal and elastic performance, and the material of plunger may be selected to be and can provide enough rigidity and to the support force of seal.If plunger and seal are made of one, the selection of material must take into account the desired rigidity of plunger and needed elasticity of seal and flexibility so.But this a kind of solution in back has advantage aspect production cost.

Should further point out, in these two kinds of embodiments, all parts all can be made of polymeric material, and for example available polyethylene, polypropylene, polyester, synthetic rubber, Merlon, rubber or silicone etc. are also made with traditional inexpensive method such as injection molding.Moreover, the structure of all parts all very simple and be easy to the assembling.Consequently, this device can be produced with low cost.

In above-mentioned all embodiments of the present invention,lid 12 is provided with a radially-protrudinglug 16, and it extends on a part of circumference oflid 12, forms the part of a handgrip, so that take off lid.Will be appreciated that the handgrip part can be made any suitable shape.For example, can be avette, also can be by constituting along all peripheral flange that stretches of lid.

This device is particularly suitable for using to animal, particularly horse combination of oral medication, particularly contains the prescription of proton pump inhibitor such as the water of Omeprazole and becomes gel or similar compositions.But, it will be apparent to those skilled in the art that, this device is not limited to use in this field because it can be used to mix multiple pharmaceutical composition and other liquor, and can give different types of live body, comprise the people do oral, rectum with or any other suitable application method use.

Be also pointed out that pharmaceutical composition one speech, say on the meaning of this utilization that do not mean medicine merely, it also comprises useful preparation, for example essential nutrients just can be encompassed within this word.

Claims (32)

Translated fromChinese

1.一种能将优选是干的和颗粒状的药物的组合物，与另一种试剂、优选是液剂进行混合而配成一种制剂、优选是凝胶或类似制剂，并能随后将该制剂给活体、例如畜类或人类服用的装置，该装置包括中空体(2)、柱塞(6、6a、6′a、6b、6′b)和推动器(30、30a、30b)，中空体上有排出口(4)，排出口被一个可取下的密封盖(12)密封着；柱塞插在中空体(2)中，可以移动，并与中空体的内壁(8)密封接触；推动器与柱塞(6、6a、6′a、6b、6′b)相连结，以便使柱塞在中空体(2)内移动；柱塞、中空体和可取下的密封盖限定着放组合物用的管腔的界限；本装置的特征在于，柱塞(6、6a、6′a、6b、6′b)包括有密封件(20、20a、20′a、20b、20′b)，密封件上有弹性的边缘部分(34、34a、34′a、34b、34′b)与中空体(2)的内壁(8)密封接触，该边缘部分的一面对着管腔(38)，从而把管腔与弹性边缘部分的另一面分隔开来，该边缘部分被支撑成只能向一个方向挠曲足够的程度来松开它与中空体(2)的内壁(8)的密封接触，以便在柱塞向离开管腔(38)的方向移动后在管腔(38)和边缘部分另一面之间建立起通道。1. A composition that is preferably dry and granular drug can be mixed with another agent, preferably a liquid, to form a formulation, preferably a gel or similar formulation, and can be subsequently A device for administering the preparation to a living body, such as an animal or a human being, the device comprising a hollow body (2), a plunger (6, 6a, 6'a, 6b, 6'b) and a pusher (30, 30a, 30b), There is a discharge port (4) on the hollow body, and the discharge port is sealed by a removable sealing cover (12); the plunger is inserted in the hollow body (2), can move, and is in sealing contact with the inner wall (8) of the hollow body ; The pusher is connected to the plunger (6, 6a, 6'a, 6b, 6'b) so that the plunger moves in the hollow body (2); the plunger, the hollow body and the removable sealing cover define The limit of the lumen used to put the composition; the device is characterized in that the plunger (6, 6a, 6'a, 6b, 6'b) includes a seal (20, 20a, 20'a, 20b, 20' b), the seal has an elastic edge portion (34, 34a, 34'a, 34b, 34'b) in sealing contact with the inner wall (8) of the hollow body (2), one side of the edge portion facing the lumen (38), thereby separating the lumen from the other side of the elastic edge portion, which is supported to flex in one direction only enough to loosen it from the inner wall (8) of the hollow body (2) ) sealing contact to establish a passage between the lumen (38) and the other side of the edge portion after the plunger moves away from the lumen (38).2.权利要求1的装置，其特征在于，推动器是一根管形插棒(30、30a、30b)，在它底部至少开有一个通孔。2. Device according to claim 1, characterized in that the pusher is a tubular plunger (30, 30a, 30b) having at least one through hole in its bottom.3.权利要求2的装置，其特征在于，插棒(30、30a、30b)具有一块沿直径伸展的支托板(18)，支托板(18)的侧边和管形插棒(30)的内壁划定了通孔的限界。3. The device of claim 2, characterized in that the plunger (30, 30a, 30b) has a support plate (18) that extends diametrically, the sides of the support plate (18) and the tubular plunger (30 ) The inner wall delimits the limit of the through hole.4.权利要求3的装置，其特征在于，支托板(18)上有一个中心孔(26)，该孔适宜于把弹性密封件(20)可拆式地连结到插棒(30)上，该密封件是圆形的并至少伸展到管形插棒的外壁处。4. The device of claim 3, characterized in that there is a central hole (26) on the support plate (18), which is suitable for detachably connecting the elastic seal (20) to the plunger (30) , the seal is circular and extends at least to the outer wall of the tubular plunger.5.权利要求2的装置，其特征在于，管形插棒(30a)具有封闭的底部和从底部向上的两个轴向剖切槽(42)。5. Device according to claim 2, characterized in that the tubular plunger (30a) has a closed bottom and two axially cut grooves (42) upwards from the bottom.6.权利要求5的装置，其特征在于，弹性密封件是一个可拆式地连结在插棒底部的圆盘(20a)。6. The device of claim 5, characterized in that the elastic sealing member is a disc (20a) detachably attached to the bottom of the plunger.7.权利要求6的装置，其特征在于，弹性密封件与管形插棒(30′a)做成一体，并包括一个环形弹性圈(34′a)，它从插棒底部径向伸展到中空体(2)的内壁(8)上。7. The device of claim 6, wherein the elastic seal is integrated with the tubular plunger (30'a) and includes an annular elastic ring (34'a) extending radially from the bottom of the plunger to On the inner wall (8) of the hollow body (2).8.权利要求2-7中任一项的装置，其特征在于，管形插棒(30、30a、30′a)上包括有测量要加的液剂容积用的设施。8. Device according to any one of claims 2-7, characterized in that the tubular plunger (30, 30a, 30'a) comprises means for measuring the volume of liquid agent to be added.9.权利要求8的装置，其特征在于，管形插棒(30、30a、30′a)上有要加的液剂的液面刻度。9. The device according to claim 8, characterized in that the tubular plunger (30, 30a, 30'a) has a level scale for the liquid agent to be added.10.权利要求8或9的装置，其特征在于，管形插棒(30、30a、30′a)是透明的。10. Device according to claim 8 or 9, characterized in that the tubular plunger (30, 30a, 30'a) is transparent.11.权利要求2的装置，其特征在于，插棒(30b)包括管形的第一部分(44)，它连结着十字形断面的第二部分(46)。11. The device of claim 2, characterized in that the plunger (30b) comprises a tubular first portion (44) joined to a second portion (46) of cross-section.12.权利要求11的装置，其特征在于，所说的第二部分(46)向插棒(30b)的底部成锥形。12. The device of claim 11, wherein said second portion (46) tapers toward the bottom of the plunger (30b).13.权利要求11或12的装置，其特征在于，插棒的平板底部有一个中心孔(62)，该孔适宜于把弹性密封件(20b)可拆式连结到插棒(30b)上，该密封件是圆形的，并伸展到中空体(2)的内壁上。13. The device according to claim 11 or 12, characterized in that the bottom plate of the plunger has a central hole (62) suitable for detachably connecting the elastic seal (20b) to the plunger (30b), The seal is circular and extends onto the inner wall of the hollow body (2).14.权利要求11或12的装置，其特征在于，该密封件与插棒(30b)做成一体，并包括一个环形弹性圈(34′b)，它从插棒底部径向伸展到中空体(2)的内壁(8)上。14. The device of claim 11 or 12, characterized in that the seal is integral with the plunger (30b) and comprises an annular elastic ring (34'b) extending radially from the bottom of the plunger to the hollow body (2) on the inner wall (8).15.权利要求11-14中任一项的装置，其特征在于，该十字形的第二部分(46)上包括有测量要加的液剂容积用的设施。15. Device according to any one of claims 11-14, characterized in that the cross-shaped second part (46) comprises means for measuring the volume of liquid agent to be added.16.权利要求15的装置，其特征在于，该第二部分(46)上有要加的液剂的液面刻度。16. The device according to claim 15, characterized in that the second part (46) has a liquid level scale for the liquid agent to be added.17.权利要求16的装置，其特征在于，该液面刻度是彩色线。17. The device of claim 16, wherein the liquid level scale is a colored line.18.权利要求11-17中任一项的设备，其特征在于，该第二部分(46)是着了色的。18. Device according to any one of claims 11-17, characterized in that the second part (46) is coloured.19.权利要求2-18中任一项的装置，其特征在于，管形插棒(30、30a、30b)包括一个远离柱塞(6)的开口端(40)，该端被用防水汽的封头封闭着。19. The device according to any one of claims 2-18, characterized in that the tubular plunger (30, 30a, 30b) comprises an open end (40) away from the plunger (6), which end is used to protect against moisture The head is closed.20.权利要求1-19中任一项的装置，其特征在于，该封盖是可取下的盖子(12)。20. Device according to any one of claims 1-19, characterized in that the cover is a removable cover (12).21.权利要求1-19中任一项的装置，其特征在于，该封盖(12)是可弄破或撕去的封盖。21. Device according to any one of claims 1-19, characterized in that the cover (12) is a breakable or tear-off cover.22.前述任一项权利要求的装置，其特征在于，管腔(38)内预先放入了药物组合物，该装置被包封在防水汽的密封容器内，该容器至少包括一层阻水层。22. The device according to any one of the preceding claims, characterized in that the pharmaceutical composition is pre-placed in the lumen (38), and the device is enclosed in a watertight sealed container comprising at least one layer of water-blocking layer.23.权利要求22的装置，其特征在于，该至少一层的阻水层用的是铝层。23. The device of claim 22, wherein the at least one water blocking layer is made of aluminum.24.权利要求22或23的装置，其特征在于，密封容器内放有催干剂。24. The device according to claim 22 or 23, characterized in that a drying agent is placed in the sealed container.25.前述任一项权利要求的装置，其特征在于，所说的药物组合物是由含有质子泵抑制剂的、包有肠溶衣的丸剂例如奥美拉唑丸与干的胶凝剂混合而构成的。25. The device according to any one of the preceding claims, characterized in that said pharmaceutical composition is composed of enteric coated pellets containing a proton pump inhibitor, such as omeprazole pellets, mixed with a dry gelling agent And constituted.26.一种制备药物制剂的方法，它在给活体服用前很短时间，把优选是干的和颗粒状的药物组合物，与一种试剂、优选是液剂进行混合，它包括下列具体步骤：26. A method for the preparation of a pharmaceutical preparation, which mixes, preferably a dry and granular pharmaceutical composition, with an agent, preferably a liquid, shortly before administration to a living body, comprising the following specific steps :a)将该组合物装入本装置的管腔38内，本装置包括中空体(2)和柱塞(6)，柱塞可在中空体内移动并与中空体(2)的内壁密封接合，以此界定管腔(38)的可动端壁，柱塞(6)上包括有密封件(20)，密封件上有弹性的边缘部分(34)与中空体(2)的内壁(8)密封接触，把管腔(38)与边缘部分的另一面分隔开来，边缘部分(34)能够挠曲而使管腔(38)和边缘部分(34)的另一面之间连通起来；a) loading the composition into the lumen 38 of the device, the device comprising a hollow body (2) and a plunger (6), the plunger is movable within the hollow body and sealingly engages with the inner wall of the hollow body (2), In order to define the movable end wall of the lumen (38), the plunger (6) includes a seal (20), the seal has an elastic edge portion (34) and the inner wall (8) of the hollow body (2). Sealing contact separates the lumen (38) from the other side of the edge portion, and the edge portion (34) can flex to communicate between the lumen (38) and the other side of the edge portion (34);b)用封盖(12)将管腔封闭起来；b) seal the lumen with a cap (12);c)给装药的管腔(38)加上不透水汽的封头；c) add a water vapor-tight seal to the lumen (38) of the charge;d)将该装置储存起来直到使用时为止；d) storing the device until use;e)除去管腔(38)上的不透水汽的封头；e) remove the water vapor impermeable head on the lumen (38);f)移动柱塞(6)使管腔(38)内发生扩大，从而引起柱塞的边缘部分(34)开启，在管腔(38)和边缘部分另一面之间建立起通道，因此液剂就被输入管腔(38)。f) Moving the plunger (6) expands the lumen (38), thereby causing the edge portion (34) of the plunger to open, and a passage is established between the lumen (38) and the other side of the edge portion, so that the liquid is delivered into the lumen (38).g)需要的话就摇晃该装置，直到制剂形成为止；g) shaking the device if necessary until the formulation is formed;h)当要服用该制剂时，取下封盖(12)，给管腔(38)提供一个排出孔，移动柱塞(6)将制剂向该孔排出。h) When the formulation is to be administered, the cap (12) is removed, providing the lumen (38) with a discharge hole towards which the plunger (6) is moved to expel the formulation.27.权利要求26的方法，其特征在于，(c)步骤中所说的往管腔(38)中加的封头是借助于把该装置封入防水汽的容器中来实现的，该容器至少包括一层阻水层。27. the method for claim 26 is characterized in that, said in (c) step adds the sealing head in the lumen (38) to realize by means of this device sealing in the container of waterproofing, and this container is at least Includes a water-blocking layer.28.权利要求27的方法，其特征在于，所说的至少一层的阻水层是铝层。28. The method of claim 27, wherein said at least one water blocking layer is an aluminum layer.29.权利要求26-28的方法，其特征在于，所说的药物组合物是由包有肠溶衣的质子泵抑制剂例如奥美拉唑丸与干的胶凝剂混合而构成的，而所说的优选液剂是水。29. The method of claims 26-28, characterized in that said pharmaceutical composition is formed by mixing enteric-coated proton pump inhibitors such as omeprazole pellets with a dry gelling agent, and Said preferred liquid is water.30.一种给活体口服药用制剂的方法，它是用权利要求1-25中任一项的装置，把优选是干的和颗粒状的组合物与优选的液剂加以混合而实现的。30. A method of administering a pharmaceutical formulation orally to a living subject by mixing a preferably dry and granular composition with a preferably liquid formulation, using a device according to any one of claims 1-25.31.权利要求30的方法，其特征在于，活体是畜类，例如马。31. The method according to claim 30, characterized in that the living body is a livestock such as a horse.32.权利要求31的方法，其特征在于，本装置是被插入马嘴中紧挨第一个前磨牙的地方，制剂是被放在舌根上。32. The method of claim 31 wherein the device is inserted into the horse's mouth next to the first premolar and the formulation is placed on the base of the tongue.

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