CN1130356A - Device for preparation of solution, suspension or emulsion of medical substance - Google Patents

Abstract

The invention relates to a device for the preparation of a medicinal solution from two compounds, one of which is in the form of powder, a lyophilisate or a liquid and the other one is a dilute or a liquid solvent. These compounds are respectively stored in a distal closed container and a proximal container, each having an opening sealed by an obturator-pistons-valve are connected by a transfer rod arranged to provide for rigid, sealed and sterile coupling link between the two obturators-pistons-valve when the device is in a storage position, and to define a liquid tight and sterile communication channel between the two cantainers when the device is a utilisation position. The obturators-pistons-valve have a central area provided with a slot which is highly compressed and sealingly closed when the device is in a storage position, and opened when an extremity of the transfer rod is inserted, the device being then in the utilisation position.

Description

The device of preparation drug solution, suspension or emulsion

The present invention relates to device, the liquid state of at least a composition in these two kinds of compositions with medication preparation solution, suspension or emulsion with at least two kinds of compositions.

Prepare a kind of medicine in order to using and can preventing that in preparation process foreign object from invading is difficulty rather with being stored in the airtight assembly and remaining in this assembly blended one or more compositions.People develop many medicine bottles of adorning two kinds of compositions for this reason, and in general these medicine bottles comprise that a usefulness one removable closure member is divided into the container of two cells.These two cells are all airtight when the storage medicine.Medicine can mix its composition before being about to use, and wherein at least a composition is liquid.For this reason, promoting this separates the removable closure member of two cells and inserts it into one and enlarge the position or make liquid or solvent streams to another cell of liquid, solid or magma or the like is housed with branch road.

The manufacturing of this pair of chamber container also is not easy, and always can not satisfy the needs of pharmaceuticals industry and be used in special occasions.The theme of U.S. Patent No. 4014330 is needle tubings of adorning two kinds of compositions in a kind of, this patents state adorn the needle tubing of two kinds of compositions in a kind of, these two kinds of compositions are divided in two cells by two chock plugs or piston closes.This device is made of two parts, and these two parts must be assembled together before use.This doleiform becomes the assembling of chamber, back to decide on the application scenario of this device.Because preparation and mixed process can't be carried out, can't prevent that therefore product is not subjected to next door medical worker's pollution, thereby this mixture loses aseptic in sealed environment.

And effective ingredient is contained in a both ends open and has in the anterior container of spiral.Difficult especially this a kind of concerning preparing " lyophily agent ", powder or the liquid.

In fact, must have these effective products of preparation in the heat insulation flat round vase one, and preparing empty bottle (flushing with existing equipment, siliconising, silicon diaphragm is installed, " desuperheating (depyroge-nization " and sterilization), the sealing of the powder charge (liquid, medicated powder, " lyophily agent ") of bottle, bottle and be transported to assembling workshop section so that must consider the specific (special) requirements of these medication preparation in this composition packed in the cell of dress diluent the time.

United States Patent (USP) 404330 described devices can't satisfy these requirements, because effective ingredient should prepare in the container of rear portion, and, can't be prepared under these conditions owing to its structure,

It is separately to prepare this two kinds of compositions that two kinds of compositions are divided in the special problem that the device in two cells in the same container is difficult to solve.In other words, a kind of preparation of composition and sterilization may not help the preparation of another kind of composition.Solvent can't use the mode identical with lyophily agent or some medicated powder to be handled.The anti-required heat of solvent of sterilizing in the autoclave that do not stay in of lyophily agent.The lyophily agent is separated with solvent by elasticity chock plug movably in same container.Solvent contacts with this removable chock plug all the time, thereby partial steam pressure is maximum all the time.Steam is very big along the danger that this removable chock plug infiltrates, thereby can reduce the storage life of lyophily agent, so the selection of material must be limited to the sealing that its elastic energy obtains maximum.

This last restrictive condition causes sealing and interchangeability problem, and this is extremely expensive, is perplexing pharmacy corporation for a long time, because they must be maked decision to its product of preparation in two chamber devices.

Except these problems, also has the problem of the danger increase of container aseptic in wet environment.In addition, under the monomer preparation condition, the product of doing is a disinfectant not, because the product of doing in dry environment is not easy breed bacteria.But breed bacteria easily just when coexisting in the container preparation with a liquid.Add antiseptic good plan by no means, forbid sometimes, especially for disposable products.

Be divided in nonexpondable medicine and be added with antiseptic, but this is not to suppress growing of antibacterial when storage, but the preparation back keeps aseptic condition whole being in operating period of several days.

Another masty problem of existing apparatus is, controls for medicine without the external action of spiral after mixed liquor is made, for example as described in the European patent No.029806781.

The present invention is intended to alleviate the problems referred to above with a kind of device, and in this kind device, a kind of composition can not pollute another kind of composition; The basis that is used for preparing mixture can separately prepare and control preparation process in not being subjected to the strict gnotobasis of external action.

This purpose realizes with the described apparatus of the present invention of claim 1.

In a preferred embodiment, this device comprises a sleeve pipe, anterior container and be that part rear portion container is arranged in this sleeve pipe at least.

This sleeve pipe can be connected with a cup-shaped spare and a gradation doser.

According to another embodiment, this sleeve pipe can be integrally molded with anterior container.

Look the difference of the application scenario of this device, this sleeve pipe is equipped with the joint that is made of eye dropper that fuses with anterior container or nasal atomizer.

In a preferred embodiment, this sleeve pipe comprises first tube-like piece and second tube-like piece that is nested together mutually, adorns anterior container in first tube-like piece, dress rear portion container in second tube-like piece.On best first tube-like piece gripper is arranged, have two tongue shape bars that can cooperate on second tube-like piece at least with these grippers.

The shutoff piston cup of apparatus of the present invention all has a central slot, realizes sealing, the aseptic parts that are connected and have with piston cup on the transfusion axle.

When this device is in user mode, the respective surfaces of abutment face abuts against plunger cup is arranged on the transfusion axle.

When this device was in the powder charge state, piston cup can be guaranteed the tight of corresponding container against container inner wall, sterile sealing, thus can be separately to container powder charge and disposal.

In all versions, this transfusion axle all can be guaranteed rigidity, sealing and aseptic being connected of piston cup and front and rear container.

In apparatus of the present invention, anterior container can insert different joints and administration part, to be used for various treatment occasions.

Can better understand the present invention in conjunction with description of a preferred embodiment and accompanying drawing.In the accompanying drawing:

Fig. 1 is the structure chart of apparatus of the present invention one preferred embodiment to Fig. 4, represents powder charge, standby and user mode successively;

The structure chart of the specific embodiments when Fig. 5 is used as eye dropper for this device;

Fig. 6 is the structure chart of another embodiment of apparatus of the present invention to Fig. 9, represent successively powder charge, standby, bring into use and each state of finishing using;

Figure 10 illustrates a kind of improvement that Fig. 1 is made to device shown in Figure 4 to Figure 13;

Another kind of structure when Figure 14 to 18 illustrates this device as needle tubing, it is connected with a multiple dosing spare;

Figure 19 to 22 illustrates the apparatus of the present invention that can be used for ophthalmology;

Figure 23 and 24 is the enlarged drawing of the shutoff piston cup of resting state;

Figure 25 and Figure 26 are standby and the enlarged drawing of the piston cup of user mode;

The enlarged drawing of this device fitting when Figure 27 to 30 is use;

Figure 31 is illustrated in the different phase of different application occasion with different basic element of character preparations and each parts of assembling apparatus of the present invention to 62 letters.

Fig. 1 represents to prepare with two kinds of bases a kind of preferred structure of the device of medicinal liquid such as Injectable solution to Fig. 4.Fig. 1 is illustrated in this device in powder charge stage especially.First container 11 of dress lyophily agent 12 in it comprises, second container 13 and of interior in this example dress solvent 14 has the transfusion axle (bar) 15 of hollow tubing conductor 16.Rear portion container 11 has a closing bottom 17 and an opening 18, and a piston cup 19 wherein is housed, and this glass 19 defines the cell 20 of dress lyophily agent 12 in the container of rear portion.Be noted that this lyophily agent 12 can be replaced by different active drug, for example a kind of solution, medicated powder or the medicine of certain viscosity is arranged.Anterior container 13 both ends opens.In described example, opening 21 usefulness one hard-wired bottle cap 22 covers.This bottle cap can be used for the bottle of many interior powder charge things, and the plastic compound that available sealing is very strong is made or made with the very high lead of mechanical strength, thereby can stop that outside antibacterial enters in the bottle.The opening 23 usefulness one shutoff piston cup 24 of container 13 is sealed.Piston cup 19 and 24 all has a central recess 25,26, has in the groove and transfusion axle 15 joints that link 27 and 28.Piston cup 24 defines the cell 29 of adorning solvent 14 in one with the inwall and the lid 22 of container 13.According to the medicine that the cell 20 of rear portion container 11 is adorned, solvent 14 can replace diluent.No matter which kind of active drug composition the back is in the chamber, ingredient in the cup always also can be mixed into a kind of solution, suspension or emulsion with medicine for liquid, and can be used in the therapy system by injection system, this side says with pin, trocar, dropper, aerosol apparatus or the like administrator and is administered into human external or inside.

Piston cup 24 has a little connecting portion 30 that inserts for the front end of transfusion axle 15 therein in the extension of the groove 26 of the heart.In the extension of this connecting portion 30, this piston cup has an otch of going out in advance 31, thus make this piston cup can be used to the sealing by tank body and other stage promptly in use this otch open.The elastic wall that surrounds otch 31 edges of piston cup 24 is very thick, and the edge that this otch can be guaranteed in this position, otch place is tightly compressed because of in piston ring the is compressed in anterior container, thereby can seal effectively by dress liquid, guarantee the sealing and the aseptic of the material in this cell and the anterior container simultaneously.

Equally, piston cup 19 has an other end insertion center dimple 32 wherein for transfusion axle 15.A kerf 33 is arranged in the extension of this piston cup, thus make these parts salable by dress liquid and other working stage of this device also promptly in use otch open.Equally, the material around otch 33 lips is enough thick, thereby can guarantee that lip is compressed when this piston cup is contained in the container of rear portion, thereby guarantees the sealing and the aseptic of the cell 20 of rear portion container 11.Shown in this structure, the internal diameter of rear portion container is substantially equal to the external diameter of anterior container, thus they in use at least can be partly intussusception mutually.For the ease of making, two containers are generally elongated cylindrical.Because the diameter difference of two containers, the diameter of piston cup 19 is greater than the diameter of piston cup 24, when resting state shown in Figure 2, it is motionless to hold anterior container, on the bottom 17 of rear portion container, apply axial compressive force, thereby the otch 31 and 33 of piston cup 24 and 19 is inserted at the two ends of transfusion axle respectively, thus cell 20 and 19 is communicated and make solvent 14 flow into along conduit 16 in the cell 20 of dress lyophily agent 12.The diameter of conduit 16 and the size of length are made and can be controlled the liquid stream of the solvent in the conduit 16 14.Should see that the end of transfusion axle is not to be tip, its effect is not to pierce through thin film, but with the vertical flat-headed of transfusion axis all thin extensions can be arranged also.

This shape is convenient to insert in the otch of sealing, aseptic effect, opens the medicine outlet of piston cup thereby the end of transfusion axle separates the lip of these otch, and these are different with many existing apparatus, and in existing apparatus, the transfusion axle is for piercing through the tip of a thin film.If the thickness of thin film obviously greater than the length of tip, just can't be guaranteed the sealing between thin film and the tip, and this does not meet compact conformation, is convenient to pierce through the requirement of this thin film.In addition, also should see on the transfusion axle 15 first disk 34 and second disk 35 being arranged, they distinguish the surface of abuts against plunger cup 24 and 19 in use.The effect of these disks is that accurate qualification transfusion shaft end inserts the degree of depth in corresponding rear portion and the anterior container.

When user continues to depress the bottom 17 the time, all solvents in the anterior container 13 flow into cells 20, contact with lyophily agent 12 and form 12 and 14 mixed liquor, thereby form described medicinal liquid.Poor by the surface pressing between the two-piston cup, piston cup 24 enters the front end of anterior container 13 and piston cup 19 enters and can guarantee the position that outgases, thus the degassing of this bottle herb liquid.If this medicinal liquid is used for injecting, then this joint is a pin.If will transfer to this medicinal liquid in one transfusion bag, then this joint is a trocar.Can be by this joint of different corresponding selection of medicinal liquid use occasion.No matter which kind of joint, medicinal liquid is through conduit 16 outputs.

Press down the bottom is set on the anterior container 13 rear portion container 11 for this reason.Piston cup 19 constantly sinks to rear portion container 11 up to its abuts against bottom 17.For preventing to reuse this device, particularly when this device is used as needle tubing, connect transfusion axle 15 joint 27 and 29 and the parts of piston cup 19 and 27 do enough thinly, thereby piston cup can come off when attempt is extracted anterior container out from the container of rear portion, thereby can't pour into liquid again in this device.

Fig. 5 illustrates the apparatus of the present invention that are used for ophtalmic treatments.Be nested together front and rear two containers 11 and 13 this moment in advance.The whole emptyings of air in the rear portion container 11 of interior dress lyophily agent 12.Inject the interior piston cup 19 of this container near the material that is contained in this container.But the advantage of this structure is evacuation of air or bubble, thereby prevents that mixed liquor from oxidation taking place also promptly installing at this after the preparation when standby.

As previously mentioned, the both ends open of anterior container 13, one end are by piston cup 24 sealings, and the other end is by chock plug 50 sealings.One bottle cap 51 covers this chock plug, and a filtration members 52 with oligodynamic silver strip and so on is inserted between this bottle cap and this chock plug.This silver strip can replace with different materials, for example silver oxide or the chemical compound that is made of the material with same function.One guard shield 53 covers this assembly.One joint 54 at injection screwed pipe 55 places is contained in the place, end of bottle cap 51.In this example, transfusion axle 15 the most handy synthetic materials are integrally molded.Should see.Thereby the structure of chock plug 50 is also identical with piston cup 24 roughly the same its effects, and at least with regard to its central opening, this opening makes it become a cup shell that comprises an otch of going out in advance, and this otch is opened at transfusion shaft end place when this device uses.

Simultaneously in this structure, bottle cap 51 has a skirt section, this skirt section long enough, thus cover the part of this rear portion container 11 in the open end of rear portion container 11.This rear portion container itself is arranged in one by the molded guard shield that forms 56 of synthetic plastic.Guard shield 56 inserts in the skirt section of bottle cap 51 in advance.In other use occasion, can save guard shield 56, the pre-end of the opening of rear portion container can directly be inserted in the skirt section of bottle cap 51.

Fig. 6 to Fig. 9 illustrate this device as one the injection described medicinal liquid needle tubing the time another kind of structure.Fig. 6 express liquid is stored.Fig. 7 is in using, and Fig. 8 and Fig. 9 represent to use in a multiple dosing machinery.As before, this device comprises and adorns the transfusion axle 15 that for example anterior container 13 and of solvent 14 makes these two containers communicate by conduit 16 in the rear portion container 11, of adorning for example lyophily agent 12 in one.This rear portion container has a bottom 17 and is positioned at an opening 18 at 17 opposite end places, bottom.Thereby this opening is sealed the cell 20 that forms dress lyophily agent 12 in by piston cup 19.Anterior container 13 has a upper opening 21 that is covered by a bottle cap 22.Because these container two ends are opening all, so its other end 23 is sealed by piston cup 24.Piston cup 19 has a central recess 25, and piston cup 24 has a central recess 26, and these two piston cup are inserted for the both ends joint 27 and 28 at place, transfusion axle 15 two ends respectively.Piston cup 24 has an otch of going out in advance 31 as medicine outlet that can insert for an end of transfusion axle 15, and same piston cup 19 has an otch of going out in advance 33 as medicine outlet that can insert for the other end of transfusion axle 15.

Some parts is described identical to Fig. 4 with Fig. 1.Anterior container 13 is arranged in first tubular member 40 that a front end has a guard shield 41 to cover, and rear portion container 11 is arranged in second tubular member 42 that its part is inserted in first tubular member 40.At drug storage state shown in Figure 6, two tubular member 40 and 42 define one and are preferably columniform chamber, and device 10 shown in Figure 1 promptly is arranged in this chamber.For using this device, can be distributed with a series of grippers 43 on the whole peripheral surface of second tubular member 42 or above this side face one free position, single gripper be arranged.These grippers are used for cooperating with at least one flexible tongue bars 44 in first tubular member, 40 sides, regulate tubular member 40 and 42 s' axial location and form the anti-supporter that returns so that produce certain brake force, and after second tubular member 42 is inserted in first tubular member 40, prevent that second tubular member 42 from screwing out once again or extracting out.

Fig. 7 illustrates the mixture of resting state and two kinds of components of preparation.Sunk in the tubular member 40 in this state tubular member 42, so that mobile rear portion container on the container direction forwardly.The result partly inserts in the otch of the medicine outlet constitute the two-piston cup respectively at the infuse two ends of axle, and piston cup 24 moves in the front end container vertically and solvent is adorned the cell 20 of lyophily agent 12 in injecting.At last in this operational phase, two kinds of materials of medicine or basis intermingling are in order to using.

Fig. 8 illustrates last preparatory phase, so that to this device degassing, the pin 45 of the described medicine of an injection is housed in this example.Second tubular member 42 is all inserted in first tubular member 40, and the rear portion container that wherein is full of the lyophily agent solution all outgases, and can make piston cup solution against rear portion container in the bottom 12 of an appropriate button 45 promotion rear portion containers this moment.This moment this piston cup can solution through transfusion axle 15 conduit 16 extrude along entry needle 45 directions.

Finish using the stage shown in Figure 9, the front end of this device pushed the rear portion container to by button 46, thereby piston cup 19 all is pressed in the container of rear portion nearly all described injectable drug discharged.In addition, should see that second tubular member 42 and gripper 43 block two tubular member with the effect of working in coordination of flexible tongue bars 44 and prevent that second tubular member from returning to original position.These parts guarantee that this device can't use once again.

Figure 10 illustrates a kind of device after Fig. 1 made improvements to device shown in Figure 4 and that can be described as main storage chamber to Figure 13, the device that spice is housed shown in Figure 10 is the combination of main storage chamber shown in Figure 1 and its rear portion container 1, anterior container 13 and transfusion axle 15, and they all are positioned within a cylinder or the sleeve pipe 60 at least in part.Molded the forming of the most handy synthetic material of this sleeve pipe.

As shown in figure 12, its front end has thin portion 61, is easy to pierce through it with pin.Should see in the transfusion axle conduit 16 being arranged in addition, it preferably is made of the hollow metal syringe of overmolded.

Figure 11 illustrates this device 10 when standby, and solvent 14 enters in the chamber 20 of rear portion container 11 and the agent of dissolving lyophily through transfusion axle 15.

Figure 12 illustrates the deaeration stage of this needle tubing, and this need only add that one is preloaded onto on the flange 63 and by the pins 62 of anti-cover 64 protections.Can see, rear portion container 11 towards the device before extreme direction move, thereby after preparing mixed liquor the air in the chamber 20 of emptying rear portion container.

Figure 13 illustrates this device after the use.Can see that guard shield 64 covers again, stab the medical worker because of carelessness to prevent syringe needle.The front and rear pocket is nested together mutually and is arranged in sleeve pipe 60 fully, thereby prevents to use once again this needle tubing, because just can't not extract the rear portion container backward out if do not damage sleeve pipe.Promptly enable to extract out the rear portion container, but as to Fig. 1 described in the explanation of Fig. 4, piston cup can be thrown off with the transfusion axle and can't be used once again.Figure 14 illustrates a kind of structure different with said structure to Figure 18, wherein uses a longer sleeve pipe 60 ' to replace sleeve pipe 60.One cup shell 70 and is called " PEN " and so on market gradation doser 71 on sale and links to each other with this sleeve pipe 60 '.

As previously mentioned, the critical piece of this device 10 has rear portion container 11, anterior container 13 and transfusion axle 15.Figure 14 illustrates this device that is in the powder charge state, and Figure 15 illustrates this device that gradation doser 71 is housed and is in resting state, and Figure 17 illustrates this device that gradation doser and entry needle 72 are housed and is in resting state.This device after Figure 18 represents to use.

Figure 19 and 20 illustrates this device that is applicable to ophthalmology.As can be seen, in this structure, anterior container 13 usefulness synthetic materials and sleeve pipe 60 are integrally molded, this front portion container are housed and at least at some rear portion container 11 of powder charge state fashionable dress in this sleeve pipe.The front end of this sleeve pipe 60 is executed part for the medicament for the eyes water droplet that is made of a joint 54, and this joint 54 is identical with Fig. 5 on function at least.This joint also can be used as nasal atomizer.One helmet 53 guarantees that this device obtains tight, aseptic sealing when powder charge state shown in Figure 19.Figure 20 illustrates resting state, and Figure 21 illustrates user mode, and Figure 22 illustrates the back state that uses.As can be seen, rear portion container 11 all enters in the sleeve pipe 60, thereby prevents to use once again this device.

Figure 23 is the enlarged drawing of the end of piston cup 24 when the powder charge state and transfusion axle that is connected with piston cup 24 and centre pipe thereof.Under this state, the end 15a of transfusion axle is owing to tightly be inserted in the elastic compression of surperficial 15b place generation among the first position 24a of piston cup 24 and guarantee to obtain tightly aseptic sealing.At this moment, the end 16a that opens of the quilt of conduit 16 and a butt end of conduit axis approximate vertical props up the import of the otch 31 of the medicine outlet that constitutes piston cup 24.

As previously shown, this medicine outlet is owing to being compressed than thick material around its two lip closed.Different with many existing apparatus, the opening of this medicine outlet can not be opened because of the pressure that is subjected to the liquid in the conduit 16, and only under the mechanical pressure of the end 16a that stretches into this conduit, just open, because this fact, therefore can keep the sealing between the wall of lip of the wall of conduit 16 and otch 31, and the central recess 26 of piston cup 24 neither contacts with any parts of two containers, does not also contact with described medicine.

The similar Figure 23 of Figure 24, but the piston cup 19 when the powder charge state is shown.As previously mentioned, the other end 15c of transfusion axle 15 is inserted in the central recess 32 of piston cup 19, and the end 16c of conduit props up the import as the otch 33 of medicine outlet.Guarantee to obtain to seal and aseptic by the pressure that the material of piston cup 19 at the 15c place, end of transfusion axle causes at surperficial 15d place.Because the end 16c of conduit 16 is tight against otch, thereby guarantee sealing between two lips of this end 16c and otch 33.

Can see herein, be harpoon shape by the piston cup 59 and 24 of Figure 24 and 23 expressions, the end 15A and the 15C of transfusion axle 15 respectively, the axle of guaranteeing to infuse under the powder charge state of the abutment face on it is connected with the firm of piston cup.Because this harpoon shape, end 15A and 15C had both formed abutment face, formed connector again, thereby made the split-hair location of the inner acquisition of this device of piston cup.

Figure 25 illustrates the shown in Figure 23 piston cup 24 of this device when resting state.The end 15a of transfusion axle pushes in the central recess 26 backward and the end 16a of conduit 16 pushes the otch of going out in advance 31 backward.This figure clearlys show that the sealing at above-mentioned position and aseptic are still kept this moment.

Figure 26 illustrates the shown in Figure 23 piston cup 19 of this device when resting state.Equally, the end 15C of transfusion axle 15 pushes in the central recess 32 backward, and the end 16C of conduit 16 has pushed the otch 33 that is washed in advance.Equally, under this state, still keep respectively sealing position and aseptic barrier layer.

Figure 27 is illustrated in concrete use to Figure 30, and this installs the adnexa that was attached thereto at 10 o'clock.Figure 17 is device 10 end enlarged drawings shown in Figure 12, and the pin 62 that is contained on the flange 63 is covered by guard shield 64.

Figure 28 illustrates another kind of structure, and wherein, pin 62a is subjected to the rigid protection case's 80 that a usefulness synthetic material makes protection.In addition, this pin 62a entangles with a sleeve 81.The effect of this sleeve 81 is that the described medicinal liquid in anti-locking apparatus 10 when this device of pin 62 steering handles is connected on another container of transfusion bag and so on sprays.In fact, because there is a light pressure in the inside of device 10, therefore can spray, and this can hurt the medical worker on next door.The protective effect that this spraying phenomenon can provide with flexible sleeve 81 and prevented that this sleeve from closing up when pin inserts in the suitable joint that is connected with transfusion bag, then withdraw from break away from open when being connected and clog device 10 mouthful.

Figure 29 illustrates the device 10 that a sleeve pipe 60a is housed, and effect and the sleeve pipe shown in Figure 10 60 of this sleeve pipe 60a are roughly the same.One joint 60b is housed on this telescopic end, and its shape is made and can be connected punch block, joint or the like adnexa.

Figure 30 is Figure 29 roughly the same, but joint 60b is replaced by a male cone shape joint 60C.

It respectively illustrates each assembling stage of this device 10 and each parts when different phase down, that is to say the situation when injecting lyophily agent, the medicinal liquid that certain viscosity is arranged or medicated powder in the container of rear portion.Figure 31 illustrates this rear portion container and is arranged in a box 90.Can see,, therefore can closely arrange and save institute and take up space because the rear portion container is cylindrical.Figure 32 represents with remaining lyophilic solution injection rear portion container 11.

Figure 33 represents the pre-aligned stage of piston cup 19.

Figure 34 represents the lyophily stage, and this moment, steam and gas can be overflowed from the gap 91 of piston cup 19 bottoms.Can see, because bottle is flat, thereby can evenly form ice crystal and almost whole dry lyophily goods, thereby be easy to make gas evolution.

Figure 35 represents the tight seal stage of rear portion container.At this moment the available button 92 at this top, chamber that directly places inserts piston cup 19.

Figure 36 represents the positioning stage of piston cup 19, in addition, because of being vacuum in the container of rear portion, therefore sucker cup 19 automatically, and then piston cup 19 is adjusted to the final position with mechanical means.

Figure 37 represents the container of having adorned medicine is put back in the box 90.

Can see that everything operation all uses the standardization program of using in the pharmaceuticals industry to realize.

When being equipped with in the container 11 that to imitate medicine be liquid but not lyophily agent, said process can be reduced to the last assembling stage that includes only powder charge stage shown in Figure 32, piston cup intended orientation stage shown in Figure 33 and piston cup, this stage can be used appropriate button, and this button can make the internal tank degassing.

Figure 38 to 44 expression medication powder injects rear portion container 11.Figure 38 represents that container 11 is placed in the box 90.Figure 39 represents the medicated powder of some dosage is injected container 11, and the medicated powder of these dosage is contained in each bowl of the pipe fitting 93 that is installed in employed transporter 94 in the pharmaceuticals industry.Figure 40 represents the pre-aligned stage of piston cup 19, outgases with a joint 95 in this stage.This joint can insert for a syringe 96 that passes the otch 33 of piston cup.After joint withdraws from, each rear portion containers sequentially is introduced transmission parts 97 tops, so that carry out disposal shown in Figure 41.Figure 42 represents rear portion container and piston cup thereof are placed to its transporter 97 rise from Figure 41 in advance.This vibration stage of medicated powder is used for guaranteeing that medicated powder is fixed on container bottom.

As shown in figure 43, the rear portion container 11 when Figure 44 represents easily piston cup to be positioned is realized by the gas above the described syringe 96 sucking-off medicated powder of Figure 40 in the accurate location of piston cup 19 in rear portion container 11.Can act on pressure on the chamber wall in assembling with piston cup during piston cup, strike off the medicated powder on the chamber wall.But still need remove the inside and outside lip-deep remaining medicated powder of rear portion container.

Figure 45 to 54 illustrates the assembling of the device 10 that is exclusively used in ophthalmology.Figure 45 illustrates the anterior container 13 that is placed in the box 100.This container arrives Figure 19 and shown in Figure 22 identical with Fig. 5.Figure 46 is illustrated in the liquid 14 that injects aforesaid solvent or diluent and so in the container 13.Figure 47 represents piston cup 24 is packed in the container 13.Then container 13 is put back in the box 100 and (seen Figure 48).Equally, because these containers are cylindrical that coarse and remarkable outstanding spiral is housed, so can be closely arranged in very much in this box.

Be contained in the processing that the container 13 in the box can spend certain hour fill and carry out disinfection and so on, see Figure 49.Figure 50 represents wherein to be placed with rear portion container 11 1 boxes 90.Figure 51 represents the transfusion axle 15 anterior container 13 of packing into.

Figure 52 represents rear portion container 11 is installed to last assembling stage on the transfusion axle 15 that before has been arranged in anterior container 13.

Figure 53 represents to regulate according to vision the stage of the device 10 that installs in advance.This device 10 that Figure 54 represents all to assemble and adjusts according to above steps.

Can see that all these operations all can be used the off-the-shelf equipment in the pharmaceuticals industry to carry out and need not the different parts that special equipment assembles this device.For ease of assembling and reducing cost, the change of linkage editor particularly is constrained to minimum from becoming unordered change in order.

The step of anterior container 13 and assembling transfusion axle 15 is prepared in Figure 55 to 62 expression.Empty container 13 is placed on shown in Figure 55 in the box 100.Figure 56 represents piston cup 24 is put into container 13.Figure 57 represents to inject solvent or diluent 14.Figure 58 represents to cover cap 22.Figure 59 represents container 13 is put back in the box 100, so that the external treatment that carries out disinfection and so on.Figure 60 represent in the box 100 in the container 13 that sterilization and so on is handled is packed sleeve pipe 60 shown in Figure 10 and so on into.These sleeve pipes 60 originally placed box 110 in order to assembling.Figure 61 represents transfusion axle 15 is installed on the anterior container 13 that has before installed in the sleeve 60.Figure 62 represents rear portion container 11 is installed on the other end of the transfusion axle 15 that has before assembled shown in Figure 61.

This ready-made standard set-up that assembles in the available pharmaceuticals industry carries out.

In addition, the sleeve pipe of the anterior container of most of parts, particularly rear portion and anterior container and interior cover all is placed in the box, thereby reduces the quantity that is transformed into disordered state from order state.

Claims (12)

1. the solution for preparing active drug with two kinds of compositions, the device of suspension or emulsion, a kind of composition is Powdered, a kind of lyophily agent, a kind of liquid or pastel, second kind of composition is diluent or solvent, they are contained in respectively in two elongated vessel, one of them container is the rear portion container (11) of bottom (17) sealing, another container is anterior container (13), one end of two containers all has one can make axially movable piston cup sealed opening by one in corresponding container, these two piston cup (19,24) link together with a transfusion axle (15), this transfusion axle is at this device can be guaranteed when first state is powder charge or drug storage state in these two piston cup (19,24) form rigidity between, sealing is connected with aseptic, and when being in second state and promptly using state, this device between these containers (11,13), forms a sealing and the passage of aseptic connection; Wherein, the constituents of Powdered, lyophily agent, liquid or pastel is housed in the rear portion container (11), and dress diluent or solvent (14) in the anterior container (13); Rear portion container (11) is in than the high position of anterior container (13), and the piston cup (19) of rear portion container (11) is than the position height of the piston cup (24) of anterior container (13); The shape at transfusion axle (15) two ends make be positioned at one with the plane of its longitudinal axis approximate vertical; These piston cup comprise that one is provided with a kerf (31,33) central recess, when this device was in the powder charge state, these otch were pressed, and tightly sealing, and when this device be in second state and an end of infuse spool (15) when inserting in this otch otch open.

2. by the described device of claim 1, it is characterized in that this device comprises a sleeve pipe (60), at least a portion of anterior container (13) and rear portion container (11) is arranged in this sleeve pipe.

3. by the described device of claim 2, it is characterized in that, this sleeve pipe (60) and a cup shell (70) with one in batches doser (71) be connected.

4. by the described device of claim 2, it is characterized in that this sleeve pipe (60) is made one with anterior container (13).

5. by the described device of claim 2, it is characterized in that this sleeve pipe (60) is provided with a joint, this joint is connected a collyrium on the anterior container (13) by one and drips and execute part or a nasal atomizer constitutes.

6. by the described device of claim 2, it is characterized in that this sleeve pipe comprises first tube-like piece (40) and second tube-like piece (42) that is nested together mutually, overlap anterior container (13) and the interior cover of second tube-like piece rear portion container (11) in first tube-like piece.

7. by the described device of claim 6, it is characterized in that gripper (43) being arranged on first tube-like piece, and at least two ligule bars (44) that can cooperate with these grippers are arranged on second tube-like piece.

8. by the described device of claim 1, it is characterized in that each piston cup (19,24) has a central recess (32,26); Device with piston cup (19,24) sealing, aseptic connection is arranged on the transfusion axle (15).

9. by the described device of claim 1, it is characterized in that, connect face on the transfusion axle (15), but when this device uses the respective surfaces of abuts against plunger cup.

10. by the described device of claim 1, it is characterized in that piston cup (19,24) is passed through to guarantee that against the surface, inside of corresponding container (11,13) these containers obtain tight and aseptic sealing, thereby can be carried out powder charge and disposal to these two containers respectively.

11., it is characterized in that transfusion axle (15) can be guaranteed respectively two-piston cup (19,24) the acquisition rigidity, the sealing and aseptic being connected that link with rear portion container (11) and anterior container (13) by the described device of claim 1.

12., it is characterized in that anterior container (13) can be used according to different treatments and insert different joints and administration part by the described device of claim 1.

Images