CN1431890A - Plug-equipped liquid medicine container - Google Patents

Plug-equipped liquid medicine container Download PDF

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Publication number
CN1431890A
CN1431890A CN01810442A CN01810442A CN1431890A CN 1431890 A CN1431890 A CN 1431890A CN 01810442 A CN01810442 A CN 01810442A CN 01810442 A CN01810442 A CN 01810442A CN 1431890 A CN1431890 A CN 1431890A
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CN
China
Prior art keywords
mixed water
liquid container
water injection
medical liquid
axis direction
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN01810442A
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Chinese (zh)
Inventor
棟近公司
小平英人
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Showa Denko Plastic Products Co Ltd
Mitsubishi Pharma Corp
Original Assignee
Showa Denko Plastic Products Co Ltd
Mitsubishi Pharma Corp
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Publication date
Application filed by Showa Denko Plastic Products Co Ltd, Mitsubishi Pharma Corp filed Critical Showa Denko Plastic Products Co Ltd
Publication of CN1431890A publication Critical patent/CN1431890A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093Containers having several compartments for products to be mixed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
    • A61J1/2024Separating means having peelable seals

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

A plug-equipped liquid medicine container, comprising a liquid medicine container having a liquid medicine storing section with an internal space for storing liquid medicine and an injecting section with a communication passageway communicating with the internal space, and a plug having a microorganism eliminating filter installed in the injection section of the liquid medicine container, wherein the liquid medicine container is of the construction in which it is divided into two chambers partitioned by a peelably heat-sealed partition band, each chamber storing a liquid medicine, the partition band being peeled during use to cause the two chambers to communicate with each other so as to mix the liquid medicines, one chamber storing as a liquid medicine an infusion containing sugar and fatty emulsion, the other chamber storing an infusion containing amino acid and electrolyte.

Description

The medical liquid container of band stopper
Technical field
The present invention relates to inject, specifically in the injection of transfusion etc., mix the medical liquid container of the band stopper that injects other medicinal liquids for mixing aseptic and that carry out simply between the medicinal liquid.
Background technology
When clinical,, often give multiple medicinal liquid to the patient simultaneously for example in the occasion of injections such as intravenously administrable transfusion continuously etc.The administration of above-mentioned multiple medicinal liquid is in the injection in being accommodated in medical liquid container such as transfusion bag, inject to mix other medicinal liquids that should add (this is called mixed water injection) and in medical liquid container, mix, with it to patient's administration.
If in the operation of this mixed water injection, sneak into microorganism (bacterium) from the outside, then in the process of giving to the patient with this Mixtard, microbial reproduction in this Mixtard.Particularly, this injection is for example high calorie transfusion when waiting transfusion that supplements the nutrients to purpose, if sneak into microorganism during as above-mentioned mixed water injection operation, owing to contain nutritional labeling in large quantities, even sneak into seldom amount, the danger of propagate microorganisms is arranged also in the administration process.In this case, might be injected into simultaneously in patient's body in post-drug period a large amount of microorganism and transfusion.Be given the patient of this Mixtard, may have caused serious adverse such as septicemia or endotoxin shock.Therefore, from patient's security consideration, the aseptic in the time of must guaranteeing the mixed water injection operation.
Now, the microorganism of following when preventing the mixed water injection between this medicinal liquid is sneaked into, known have carry out under the gnotobasiss such as mixed water injection operates in the clean bench for example or in the injection portion of medical liquid container the method that sterilizing filter carries out mixed water injection etc., self sterilely carries out be installed during each mixed water injection when mixed water injection is operated.Also known in addition from the medical liquid container that holds Mixtard when patient's administration, at the efferent of medical liquid container sterilizing filter is installed, by behind this filter to the method for patient's administration.
But carry out mixed water injection when operation in clean bench, be necessary to remove in advance the antibacterial of operator and operation region of interest (hands etc.) etc., it is cumbersome that operation is prepared, and all must carry out above-mentioned preparation when carrying out the mixed water injection operation continually at every turn.In clean bench, wait the mixed water injection operation carry out like this, thus since operation miscellaneous be unaccommodated.Compare when also outside clean bench, carrying out with operation itself in addition, be inconvenient to be difficult to successfully carry out.
When the injection portion installation sterilizing filter of medical liquid container carried out the mixed water injection operation, in the fitting operation of this filter, because there is contaminated probability in the injection portion of medical liquid container, one carried out aseptic mixed water injection operation surely hardly.
The method of sterilizing filter is installed at the efferent of medical liquid container in addition, be not to carry out administration by sterilizing filter under any situation, also there is report to point out that the installation rate of sterilizing filter when high calorie of transfusion administration only is 60%~80% (the progress vol.125 of medical science, p1140 (1983), JJPENvol.15, p325 (1993), daily magazine Pharmaceutical vol.38, p159 (1996)).But, for example, wanting can not to utilize this method to the transfusion of the big particle in the aperture of containing lipomul geometric ratio sterilizing filter footpath composition the time.Generally in the product that is used as sterilizing filter, the width of mesh that microorganism is passed through is 0.45 μ m or following, and using the aperture mostly usually is the material of 0.22 μ m.For example lipomul owing to the aperture big (averaged particles directly be about 0.2 μ m~0.4 μ m) of its oil droplet particle that contains footpath than this sterilizing filter, can not pass through sterilizing filter.
This during administration is that mixed water injection between the medicinal liquid of representative is used continually in that medical treatment is on-the-spot with the mixed water injection of other medicinal liquid in transfusion.Therefore, aseptic mixed water injection method of operating can simpler and easy and be more positively carried out in the expectation exploitation.
The object of the present invention is to provide a kind of medical liquid container that can sterilely carry out the band stopper of the mixed water injection operation between medicinal liquid.
Disclosure of an invention
Present inventors further investigate for addressing the above problem, and found that, the medical liquid container of the band stopper by having ad hoc structure can be aseptic and the multiple medicinal liquid of mixed water injection simply, reaches desired purpose, so far finished the present invention.
That is, the present invention is as follows.[1] a kind of medical liquid container with stopper, the medicinal liquid accommodation section of the inner space of the promising receiving medical liquids of this vessel and have the access that is communicated with this inner space injection portion medical liquid container and have the stopper of the sterilizing filter that is installed in this medical liquid container injection portion
This medical liquid container has and is isolated into two single chambers by heat fused every band portion by peelable state, hold medicinal liquid separately in each single chamber, this is peeled off every band portion make two single chambers be communicated with the structure of mixing two medicinal liquids, hold the transfusion that contains sugar and lipomul as medicinal liquid, in a single chamber, in another single chamber, hold and contain aminoacid and electrolytical transfusion.[2] medical liquid container of band stopper of above-mentioned [1] record is characterized in that, above-mentioned stopper possesses perisporium with tubular roughly and the plug member that embeds the rubber stopper of the roughly column in this perisporium,
In axis direction one end side of this plug member, the degerming mixed water injection device with entry needle parts is installed, the point of these entry needle parts is formed in plug member one side.[3] medical liquid container of the band stopper of above-mentioned [2] record, it is characterized in that above-mentioned degerming mixed water injection utensil has injection part, this injection part has, the stream of connection from the inlet of axis direction one end to the delivery outlet of axis direction the other end, this stream way, has sterilizing filter simultaneously
The entry needle parts, the delivery outlet that it is installed in injection part makes the axis of its axis and this injection part roughly consistent,
With part or all of this injection part and these entry needle parts is housed in the housing of the roughly tubular of its inner space.[4] medical liquid container of the band stopper of above-mentioned [3] record, it is the degerming mixed water injection device that moves back and forth freely along its axis direction roughly that injection part and entry needle parts are installed.[5] medical liquid container of band stopper of above-mentioned [4] record, but be equipped with further possess from the sidewall of injection part to the outstanding projecting part in the inner space of housing and near the axis direction both ends of this housing to its inner space outstanding respectively and tying in the degerming mixed water injection device of each tying parts of this projecting part.[6] medical liquid container of band stopper of above-mentioned [4] record is equipped with further to have injection part is fixed on fixed part in the housing, forms roughly the degerming mixed water injection device along the retractile pars contractilis of its axis direction from the fixed part of this housing to above-mentioned axis direction the other end side.
Simple declaration Fig. 1 of accompanying drawing is a sketch map of representing the present invention's preferred one routine degerming mixed water injection device 1 simplifiedly.Fig. 2 is the vertical view of the degerming mixed water injection device 1 of presentation graphs 1.Fig. 3 is the simplified cross-sectional view of a preferred example of expression injection part 2 of the present invention and entry needle parts 3.Fig. 4 is an aseptic mixed water injection application drawing of representing to use degerming mixed water injection device 1 of the present invention interimly.Fig. 5 is the figure that represents the degerming mixed water injection device 41 of preferred other examples of the present invention simplifiedly.Fig. 6 is illustrated among Fig. 5, the preferred illustration intention of concavity part that forms in the filter fixed part and the male member that forms in housing.Fig. 7 is illustrated among Fig. 5, preferred another routine sketch map of concavity part that forms in the filter fixed part and the male member that forms in housing.Fig. 8 is a sketch map of representing preferred another the routine degerming mixed water injection device 51 of the present invention simplifiedly.Fig. 9 is a sketch map of representing to use the stopper 61 of the degerming mixed water injection device 1 of the present invention shown in Fig. 1~Fig. 3 simplifiedly.Figure 10 is a sketch map of representing the medical liquid container 71 of band stopper of the present invention simplifiedly.
Detailed description of the invention
Fig. 1 is a sketch map of representing the present invention's preferred one routine degerming mixed water injection device 1 simplifiedly, and Fig. 2 is the vertical view of the degerming mixed water injection device 1 of presentation graphs 1, and Fig. 3 is the simplified cross-sectional view of a preferred example of expression injection part 2 of the present invention and entry needle parts 3.Fig. 1 is the axis direction A that is parallel to the degerming mixed water injection device 1 of Fig. 2 in addition, and the cutaway view along the simplification of hatching I-I by housing 4 by entry needle parts 3 and sterilizing filter 8 and only.Fig. 3 is the simplified cross-sectional view along the hatching III-III of each central axis of injection part 2 that comprises Fig. 2 and entry needle parts 3.Degerming mixed water injection device 1 as shown in fig. 1 has injection part 2 substantially and is installed in the entry needle parts 3 of this injection part 2 and holds the housing 4 of the part of this injection part 2 and these entry needle parts 3.
Injection part 2 is so long as have the structure of the stream 7 that connects inlet 5 described later, delivery outlet 6, sterilizing filter 8 and get final product, its shape has no particular limits, but preferably further possesses filter fixed part 13 as projecting part, possess as shown in figures 1 and 3 across the discoid filter fixed part 13 of hollow, possess syringe connecting portion 2a in its axis direction A one side with inlet 5, the opposite side at its axis direction A possesses the entry needle parts installation portion 2b with delivery outlet 6 simultaneously.In the inside of filter fixed part 13, insert discoid sterilizing filter 8 and make it in the way of stream 7.Have the material of the injection part 2 of this structure as formation, can enumerate polypropylene, acrylic resin, polyester, Merlon etc.Along the length L 1 of the axis direction of injection part 2,, can be enumerated as 10mm~50mm in addition though there is not specific restriction.
Inlet 5 is the parts that may also be referred to as the injection medicinal liquid of import etc., and preferably its aperture is selected in 0.1mm~10mm.Syringe coupling part 2a with this inlet 5 is the structure that can be connected with the distal portion (luer) that has held the syringe of wanting the mixed water injection medicinal liquid described later, for example is implemented as to have matrix screw socket locking (female lure-lok) structure.Delivery outlet 6 is the parts of discharging from injection part 2 by stream 7 backs from the medicinal liquid that inlet 5 is injected into injection part 2 in addition, and preferably its aperture is selected in 0.1mm~10mm.Entry needle installation portion 2b with this delivery outlet 6 is the structure that entry needle parts 3 can be installed, and for example is implemented as to have convex socket (malelure-slip) structure.
Further, injection part 2 has the stream 7 of connection inlet 5 to delivery outlet 6.This stream 7 is the streams that will be passed through by the medicinal liquid of mixed water injection (other preparations) when mixed water injection described later operation, in its way intermediary at sterilizing filter 8.Sterilizing filter 8, the product of most minute apertures that can use in this field the general formation of using, preferably using mesh rugosity (aperture) is 0.1 μ m~0.5 μ m, 0.2 μ m~0.45 μ m more preferably is preferably the filter of 0.22 μ m especially.Such sterilizing filter 8 is fixed on the inside of the filter fixed part 13 as hollow disc shape projecting part described later.As the material of this sterilizing filter 8, can enumerate cellulose esters, hydrophilic polyethersulfone, hydrophilicity kynoar, hydrophilic polyfluortetraethylemicroporous.
Injection part 2 in addition, preferably as shown in Figure 3, have from two pieces of discoid filters holding sterilizing filter 8 respectively under the arm of inlet 5 sides and delivery outlet 6 sides and support filter screen 17a, 17b.Filter supports filter screen 17a, and 17b is that the general mesh rugosity of using is the filter screen of 1 μ m~100 μ m in this field, by clamping sterilizing filter 8, play the effect of the shape that keeps sterilizing filter 8.This filter supports filter screen 17a, and 17b is also same with sterilizing filter 8, and the state of this filter 8 with clamping is fixed in the filter fixed part 13.
Entry needle parts 3 normally are substantially taper, are preferably the parts of conical shaped, as shown in Figure 3, have 9 through holes 11 to point 10 from its bottom.Such entry needle parts 3 can use the product that generally uses as entry needle at medical field, and the aperture of through hole 11 has no particular limits, but preferably uses the product of 18G~23G.Length L 2 along entry needle parts 3 axis directions does not have specific restriction in addition, selects in 5mm~20mm but can enumerate preferably, more preferably about 10mm.
Material as forming such entry needle parts 3 can use resin materials such as polypropylene, acrylic acid, Merlon, has no particular limits.
Such entry needle parts 3 are installed in the entry needle parts installation portion 2b of axis direction A the other end (delivery outlet 6 sides) of injection part 2, so that the axis of its axis and injection part 2 is roughly consistent from bottom 9.The bottom 9 of entry needle parts 3 is the structures that can be installed among the entry needle installation portion 2b of injection part 2, can be embodied as for example to have matrix socket (femalelure-slip) structure.
Housing 4 is the parts that the part of above-mentioned injection part 2 and entry needle parts 3 are contained in the roughly tubular in its inner space 12, preferably with roughly parts realization cylindraceous, more preferably with the just cylindric realization of circle shown in the vertical view of Fig. 2.Injection part 2 and entry needle parts 3 preferably as shown in Figure 1, the axis of each axis and housing 4 roughly as one man is received in the housing 4.In addition, in this manual, each axis direction of injection part 2, entry needle parts 3 and housing 4 all is same direction A.
The internal diameter of housing 4 does not have specific restriction, but from the angle that degerming mixed water injection device 1 of the present invention is installed to plug member described later, be necessary to form more than the external diameter of this plug member, can carry out suitable selection according to the external diameter of the plug member of installing.The internal diameter of such housing 4 is preferably selected in 10mm~40mm, more preferably selects in 15mm~25mm.Along the length L 3 of the axis direction of housing 4, do not have specific restriction in addition, but preferably in 20mm~60mm, select, more preferably in 30mm~50mm, select.
As the material that forms this housing 4, can enumerate, resin materials such as polyethylene, polypropylene, polrvinyl chloride, vinylacetate, ethylene-vinyl acetate copolymer, polyester, polyamide, polyurethane do not have specific restriction.When the heating by heating or ultrasonic sensing or high-frequency induction is connected degerming mixed water injection device 1 and plug member fusion as described later, preferably from above-mentioned resin material, with answering fused plug member material suitably to select.
Degerming mixed water injection device 1 of the present invention preferably is embodied as injection part 2 and entry needle parts 3 and roughly moves back and forth freely along its axis direction A.In the degerming mixed water injection device 1 of example as shown in Figure 1, but for example by possessing as the above-mentioned filter fixed part 13 of projecting part and tying in the tying parts 14 of this filter fixed part 13,15, above-mentioned injection part 2 and entry needle parts 3 can be realized moving back and forth freely.
Filter fixed part 13 is to give prominence to the inner space 12 of housing 4 from the sidewall of injection part 2 to form.This filter fixed part 13, be got final product by the shape of tying so long as can be fixed in injection part 2 and can pass through each tying parts 14,15, not have specific restriction, but preferably as mentioned above, with the fixedly hollow disc shape realization of sterilizing filter 8 of portion within it.This filter fixed part 13 more preferably has the diameter identical with the internal diameter of housing 4, the end 13a that is implemented as filter fixed part 13 as described later can be on the wall of housing 4 when above-mentioned reciprocating motion fricting movement.The direction outstanding from injection part 2 sidewalls of filter fixed part 13 also has no particular limits, and be preferably as shown in figures 1 and 3, vertically outstanding with respect to the axis direction A formation of injection part 2.Filter fixed part 13 and injection part 2 become one.
Between the delivery outlet 6 of this filter fixed part 13 and injection part 2 along the air line distance L4 of these delivery outlet 6 lateral axis directions, can carry out suitable selection according to the plug member that aftermentioned is installed, but preferably this fixed part 13 is fixed on the sidewall of this injection part 2 and makes L4 reach 10mm~40mm, more preferably reaches 15mm~25mm.
Each tying parts 14,15th, but from outstanding respectively also tying forms in these filter fixed part 13 ground to its inner space 12 near the axis direction A both ends of housing 4.Each tying parts 14,15 like this be so long as can be separately fixed at the both ends of the axis direction A of housing 4, but and tying just passable in the shape of above-mentioned filter fixed part 13, have no particular limits.Each tying parts 14,15 is also had no particular limits from housing 4 outstanding directions, but preferably as shown in Figure 1, vertically outstanding with respect to the axis direction A formation of housing 4.Each tying parts 14,15 can form with housing 4 as shown in Figure 1, perhaps also can be designed to form respectively with housing 4.When being designed to form respectively, can enumerate as the material that forms each tying parts 14,15 with housing 4, polyethylene, polypropylene etc., can suitably from bonding, chimeric, fusion, joint etc., select according to the material that forms housing 4 and each tying parts 14,15, interfix.
Each tying parts 14, distance L 6 between another distolateral tying parts 15 of axis direction A the other end 4a of distance L 5 between 15 and housing 4 and axis direction A also has no particular limits, but can carry out suitable selection according to the plug member of installing, so that entry needle parts 3 do not have to run through the uncomfortable situation of the rubber stopper of plug member when entry needle parts 3 run through the rubber stopper of plug member or aftermentioned mixed water injection when degerming mixed water injection device 1 of the present invention is installed on plug member as described later.Above-mentioned distance L 5 is preferably than the long 5mm~20mm of axis direction length along rubber stopper.Above-mentioned in addition distance L 6 is preferably along about the axis direction length ± 3mm of the distal portion (luer) of mounting of syringe.
By possessing such filter fixed part 13 and each tying parts 14,15,, can be implemented as roughly and can move back and forth 14,15 of tying parts along axis direction A by the constituting body that injection part 2, entry needle parts 3 and filter fixed part 13 are formed.If on the contrary, this constituting body can not be realized from filter fixed part 13 by the reciprocating motion of the position of tying parts 15 tyings to the axis direction opposite side, can not realize from filter fixed part 13 by the reciprocating motion of the position of tying parts 14 tyings to axis direction one side simultaneously.
Fig. 4 is that expression stage ground uses degerming mixed water injection device 1 of the present invention to carry out the sketch map of aseptic mixed water injection operation.Degerming mixed water injection device 1 of the present invention with said structure by in the plug member 22 that is installed in the medical liquid container 21 that generally is widely used clinically and compared in the past, can be realized simpler and easy and positively carries out aseptic mixed water injection operation.Below, on one side with reference to Fig. 4 (a)~Fig. 4 (c), the order of the aseptic mixed water injection operation of using degerming mixed water injection device 1 of the present invention is described simply on one side.Fig. 4 (a)~Fig. 4 (c) is the simplified cross-sectional view of each central axis in plane of imagination that comprises injection part 2 and entry needle parts 3 in addition.
At first shown in Fig. 4 (a), will be installed in the plug member 22 of medical liquid container 21 as Fig. 1~degerming mixed water injection device 1 of the present invention shown in Figure 3.Degerming mixed water injection device 1 is from the opposite side of axis direction A, be installed to the plug member 22 from tip portion 10 sides of entry needle parts 3 in other words.
Medical liquid container 21 possesses the medicinal liquid accommodation section 23 of the inner space 24 with receiving medical liquids substantially and has the injection portion 25 of the access 26 that is communicated with this inner space 24.In medicinal liquid accommodation section 23, receiving medical liquids in advance.Plug member 22 is parts that basic liquid thickly is connected to injection portion 25 formation of medical liquid container 21, for example has the perisporium 27 of roughly tubular as shown in Figure 4 and the rubber stopper 28 of the roughly column that basic liquid thickly embeds in this perisporium 27.The space outerpace 29 that such medical liquid container 21 is formed the inner space 24 of medicinal liquid accommodation section 23 and this medical liquid container 21 is thickly kept by basic liquid.
In addition in Fig. 4 (a), though what show is the state that penetrates that the tip portion 10 of entry needle parts 3 does not run through the rubber stopper 28 of plug member 22, sterilizing filter 1 of the present invention not necessarily is mounted under the state that penetrates rubber stopper 28.
Then, as Fig. 4 (b) installed in the plug member that is shown in 22 in the inlet 5 of injection part 2 of degerming mixed water injection device 1, insert the distal portion (luer) of syringe 30.Syringe 30 is the syringes that generally are widely used as syringe etc., substantially have in the one end outstanding flange 32, and syringe cylinder 31 and the piston 34 that inserts to its inner space from an end side of this syringe cylinder 31 and the distal portion (luer) 35 that forms in the other end of this syringe cylinder 31 side of roughly tubular of the bottom 33 of mortar shape arranged at the other end of its opposite side to diametric(al) foreign side.Syringe cylinder 31 within it portion's space content received will with the medicinal liquid (other preparations) 36 of medicinal liquid mixed water injection in the medical liquid container 21.Piston 34 has the external diameter roughly the same with the internal diameter of syringe cylinder 31, if piston 34 is made it fricting movement to the other end of syringe cylinder 31 side extruding, can realize that the distal portion (luer) 35 in the hole that is communicated with from the inner space that has with said syringe tube 31 is discharged medicinal liquids 36.
Then shown in Fig. 4 (c), push injection part 2 along axis direction A to this axis direction A opposite side with syringe 30.Thus, the constituting body that injection part 2, entry needle parts 3 and filter fixed part 13 are formed moves to the other direction of this axis direction A along axis direction A.At this moment, the tip portion 10 of entry needle parts 3 runs through rubber stopper 28 at least.By running through of such entry needle parts 3, the through hole 11 of the inner space 24 of the medicinal liquid accommodation section 23 of medical liquid container 21 and the access 26 of injection portion 25 and entry needle parts 3 and the stream 7 of injection part 2 are connected.Therefore by piston 34 being pressed to the other end side of syringe cylinder 31 under this state, the medicinal liquid 36 in the syringe cylinder 31 is injected into the inlet 45 of injection part 2 from distal portion (luer) 35.The medicinal liquid 36 that is injected into from inlet 5 by the sterilizing filter in the stream 78, through through hole 11, access 26, is sterilely gone into the inner space 24 of medicinal liquid accommodation section 23 by mixed water injection like this.
Here, the filter fixed part 13 preferred formation as shown in Figure 1 diameter identical with the internal diameter of housing 4.In this state, the end 13a that deviates from a side with the injection part 2 of filter fixed part 13 mutually contacts with the wall of housing 4, makes it that above-mentioned constituting body is moved back and forth.Thus, unless this constituting body presses down from its axis direction one side direction, otherwise can not move to axis direction the opposing party, as Fig. 4 (a) last stage of carrying out mixed water injection that is shown in, can suppress undesirably that entry needle parts 3 run through rubber stopper, can connect rubber stopper 28 first by exerting pressure as mentioned above with syringe 30.
The mixed water injection operation of this use degerming mixed water injection of the present invention device 1 was compared with the former situation of carrying out in clean bench, did not need in advance degerming to be carried out at operator's the position (hands etc.) relevant with operation, can simpler and easy and successfully carry out the mixed water injection operation.This advantage is particularly especially remarkable when carrying out the mixed water injection operation continually.After being installed to degerming mixed water injection device 1 of the present invention in the plug member 22 in addition, the words that former state is preserved after in advance the medical liquid container 21 that comprises degerming mixed water injection device 1 being sterilized, the situation of carrying out the mixed water injection operation with the former injection portion installation sterilizing filter at medical liquid container is different, do not have contaminatedly in the injection portion of filter fitting operation herb liquid container, can sterilely carry out mixed water injection.In addition, degerming mixed water injection device 1 particularly of the present invention is owing to the structure of the plug member 22 of the injection portion side that is mounted in medical liquid container, the method that sterilizing filter was installed with the former efferent at medical liquid container is different, even for example be accommodated in medicinal liquids in the medical liquid container 21 and be lipomul etc., when containing the transfusion of the particle footpath composition bigger, there is no need also to consider whether this transfusion can pass through sterilizing filter than the aperture of sterilizing filter.Therefore promptly be for the transfusion that contains this lipomul, also can sterilely carry out mixed water injection and with it to patient's administration.
In addition, degerming mixed water injection device 1 of the present invention shown in Fig. 1 and Fig. 4 (a), preferably on the axis direction one end 4b of housing 4, further has the bonded sealing gasket 38 that covers this end 4b opening fully.Thus, shown in Fig. 4 (a), can realize under the state of this sterilizing filter 1 of installation that in plug member 22 inner space 12 and its space outerpace of housing 4 is not communicated with.Thus, if sterilizing under the state shown in Fig. 4 (a), take off to will carry out mixed water injection as Fig. 4 (b), (c) the time till the sealing pad 38, it is aseptic that this inner space 12 also can keep.Therefore the state former state of degerming mixed water injection device 1 can be installed in the plug member 22 of Fig. 4 (a) preserve medical liquid container 21.If can preserve like this, the unnecessary sterilizing filter of installing singly as before when wanting mixed water injection can be simpler and easy and sterilely use in mixed water injection.
Degerming mixed water injection device 1 of the present invention in addition as Fig. 1 and described later shown in Figure 5, preferably in the axis direction one end 4b of housing 4, also has the outstanding flange 39 that forms to diametric(al) foreign side.By further having such flange 39, fixedly the becoming of sealing gasket 38 than being easier to.
Fig. 5 is the figure that represents the degerming mixed water injection device 41 of preferred other examples of the present invention simplifiedly.Degerming mixed water injection device 41 shown in Figure 5 except that the filter fixed part have concavity portion along axis direction A, simultaneously have from housing to inner space 12 side-prominent along the convex shaped part of axis direction A, identical with the degerming mixed water injection device 1 of pattern shown in Fig. 1~Fig. 3, same parts are had the reference marks the same with Fig. 1~Fig. 3, and it illustrates omission.
Convex shaped part be from housing to the outstanding parts that extend along this axis direction A that form in its inner space, form make with the vertical section shape of this axis direction A roughly the same.The concavity portion that forms on the filter fixed part has and the mutual chimeric shape of above-mentioned convex shaped part, and is identical with convex shaped part, is formed with the vertical section shape of this axis direction A roughly the samely.The shape of these convex shaped parts and concavity part, as long as can chimericly mutually then have no particular limits, for example can with the filter fixed part 44 of the convex shaped part 43 of the such section wedge-like of the housing 42 of Fig. 6 (a) and Fig. 6 (b) such with this convex shaped part 43 can chimeric shape concavity portion 45 realize, also can with the filter fixed part 48 of the such tabular convex shaped part 47 of the housing 46 of Fig. 7 (a) and Fig. 7 (b) such with this convex shaped part 47 can chimeric shape concavity portion 49 realize.
Can form mutually by the concavity portion of above-mentioned filter fixed part and the convex shaped part of housing, when above-mentioned mixed water injection operation, this concavity portion works as the reciprocating gathering sill that injects part 2 and entry needle parts 3 chimericly.Therefore, when axis direction A other direction is exerted pressure, can prevent that injection part 2 and entry needle parts 3 from undesirable angular displacement taking place with syringe around axis.
Fig. 8 is the figure that represents the degerming mixed water injection device 51 of preferred other examples of the present invention simplifiedly.Though preferred above-mentioned injection part 52 of degerming mixed water injection device of the present invention and entry needle parts 53 can roughly move back and forth freely along its axis direction A, its structure is not limited to above-mentioned state.Degerming mixed water injection device 51 shown in Figure 8 possesses injection part 52, entry needle parts 53, housing 54 basically.In this pattern, filter fixed part 55 is fixed in the housing 54 and is implemented as fixed part.Injection part 52 wherein is identical with entry needle parts 3 with injection part 2 shown in Figure 1 with entry needle parts 53, omits its explanation.
In example shown in Figure 8, housing 54 has pars contractilis 56 from above-mentioned filter fixed part 55 to the other end of above-mentioned axis direction A side.Pars contractilis 56 so long as probably along the retractile structure of its axis direction A can, this is had no particular limits, but preferably realizes with as shown in Figure 8 serpentine canal structure.Even realize, also can obtain the effect same with the degerming mixed water injection device 1 of aforesaid way with such structure.
Injection part in the sterilizing filter of above-mentioned various patterns, housing, filter fixed part and tying parts are formed by resin material respectively, suitably form by existing known manufacturing process.Make up under each pattern by each parts that will form like this, can be suitable for making degerming mixed water injection device of the present invention.Housing among the present invention also may be implemented as and holds the whole of injection part and entry needle parts in addition.
Fig. 9 is the stopper 61 of the use degerming mixed water injection of the present invention device 1 of presentation graphs 1~shown in Figure 3 simplifiedly.Stopper 61 is made of sterilizing filter 1 of the present invention and the plug member 62 that this sterilizing filter 1 has been installed substantially.In addition, Fig. 9 contains each central axis of injection part 2 and entry needle parts 3 in planar simplified cross-sectional view of imagination.
Plug member 62 is the products that generally are widely used at medical field, has the perisporium 63 of tubular roughly substantially and embeds the rubber stopper 64 of the roughly column in this perisporium 63.Perisporium 63 so long as within it the side roughly tubular that can embed rubber stopper 64 get final product, can be cylindric, can be the square tube shape also, this is had no particular limits, but the housing 4 of preferred degerming mixed water injection device 1 can embed the suitable shape and the size in the outside of this perisporium 63.
Though have no particular limits as the material that forms perisporium 63, can enumerate resin materials such as polyethylene, polypropylene, polychlorostyrene ethylene, ethylene-vinyl acetate copolymer, polyester, polyamide, polyurethane.As described later, when housing 4 by making degerming mixed water injection device 1 and the fusion of the injection portion of medical liquid container realize band stopper medical liquid container of the present invention, can carry out suitable selection according to the material of this mixed water injection device and medical liquid container.As the material that forms rubber stopper 64, have no particular limits in addition, can enumerate butyl rubber, chlorinated scoline, butadiene rubber and their synthetic rubber such as mixed rubber.
Stopper 61 of the present invention is installed with bacterium mixed water injection device 1, so that in its axis direction one end 62a of this plug member 62, the tip portion 10 of entry needle parts 3 is in plug member 62 sides.Though this installation can only simply make housing 4 and perisporium 63 chimeric, preferably housing 4 and perisporium 63 are fused mutually by above-mentioned heating or ultrasonic sensing or high-frequency induction heating.
In addition, the perisporium 63 of plug member 62 of the present invention preferably has the flange 65 that forms to the diametric(al) outside in its axis direction the other end as shown in Figure 9.Flange 65 can form with perisporium 63, also can be designed as with perisporium 63 and form respectively, but preferably uses the material with above-mentioned housing 4 fusible to form.By form this flange 65 with such material, the injection portion of medical liquid container and this flange 65 are fused mutually, the sealing medical liquid container.
Figure 10 is a sketch map of representing the medical liquid container 71 of band stopper of the present invention simplifiedly.The medical liquid container 71 of band stopper substantially is made of above-mentioned stopper 61 and medical liquid container 72 that this stopper 61 is installed.And Figure 10 is the simplified cross-sectional view of each central axis in plane of imagination that contains injection part 2 and entry needle parts 3.
The medical liquid container 72 that uses in the present invention as long as can be used on the medical application just passablely, has no particular limits, and still as shape, is restricted to two chambers container (two chamber) as shown in figure 10.Medical liquid container 72 possesses substantially and has for the medicinal liquid accommodation section 73 of the inner space 74 of receiving medical liquids and have the injection portion 75 of the access 76 that is communicated with this inner space 74.Medical liquid container 72 in addition, with form injection portion 75 opposite sides, across medicinal liquid accommodation section 73, also have the efferent 77 that is accommodated in the medicinal liquid in the medicinal liquid accommodation section 73 in order to discharge.
Medical liquid container portion 73 is isolated into two single chambers, first Room 73a and the second Room 73b of injection portion 75 sides and described later efferent side by heat fused every band portion 78 by strippable.In the first Room 73a and the second Room 73b, held each medicinal liquid of aftermentioned respectively.
Injection portion 75 has flange 65 and the thickly engaged bonding part 79 of basic liquid with the plug member 62 of stopper 61 in its end.Bonding part 79 is to form the plate portion have with the hole of access 76 same diameter, for example can pass through resin materials realizations such as polyethylene, polypropylene, polrvinyl chloride, ethylene-vinyl acetate copolymer, polyester, polyamide, polyurethane.By the heating that causes by heating or ultrasonic sensing or high-frequency induction, when making flange 65 fusions of this bonding part 79 and plug member 62, suitably select its material according to the material of this flange 65.
On the bonding part 79 of the injection portion 75 of such medical liquid container 72, engage stoppers 61 by flange 65.This joint can be implemented as between the space outerpace 80 of the inner space 74 of medicinal liquid accommodation section 73 and this medical liquid container 72 and keeps basic liquid close.Like this, the stopper 61 of the invention described above plays the effect of the injection portion 75 of the medical liquid container 72 that seals receiving medical liquids.
As the material that forms medicinal liquid accommodation section 73, so long as usually as just can that infusion vessel uses, have no particular limits, can enumerate, resin materials such as polyethylene, polypropylene, polychlorostyrene ethylene, ethylene-vinyl acetate copolymer, polyester, polyamide, polyurethane etc.Such medicinal liquid accommodation section 73 can be to use above-mentioned material formation to have the case shape that keeps the shape performance, also can be to use the satchel of the thin film formation of above-mentioned material.
Stopper in the medical liquid container 71 of band stopper of the present invention like this as long as have the structure of sterilizing filter, has been not limited to install the product of the stopper 61 of the invention described above.That is, used the stopper preferred example only all the time of the degerming mixed water injection device 1 of the invention described above, so long as possess the plug member of medical liquid container integratedly and the structure of sterilizing filter is included in the scope of the present invention.By the medical liquid container of this band stopper, former state is preserved when mixed water injection not and when not giving with medicinal liquid, can realize when the expectation mixed water injection than medical liquid container original simpler and easy and that positively carry out aseptic mixed water injection operation.
Medicinal liquid as in the medicinal liquid accommodation section 73 of the medical liquid container 71 that is accommodated in band stopper of the present invention can use the transfusion that contains lipomul, sugar, aminoacid and electrolyte.
Lipomul is also referred to as oil-in-water emulsion (o/w type Emulsion), is made up of fat, emulsifying agent and an amount of water substantially.As fat, can enumerate vegetable oil (for example, soybean oil, Oleum sesami, Oleum Gossypii semen, Fructus Canarii albi wet goods), fish oil, median chain triglyceride oil (being MCT) etc.As emulsifying agent, can enumerate phospholipid, nonionic class surfactant etc.Phospholipid can utilize natural product (lecithin, soybean phospholipid, contain their purification product) or composite (phosphatidylcholine etc.).As composition, can enumerate fat is 0.1w/v%~30w/v%, is preferably 1w/v%~20w/v%, emulsifying agent is 0.01w/v%~10w/v%, be preferably 0.1w/v%~5w/v% or be 1 weight portion~50 weight portions and an amount of water with respect to fatty 100 weight portions.
Transfusion of the present invention is to cooperate the sugar that supplements the nutrients with effective dose to form.As sugar, reducing sugar such as preference such as glucose, fructose, xylitol.Can enumerate sugar as the use level of sugar and be 5w/v%~60w/v%, be preferably 10w/v%~60w/v%, more preferably 20w/v%~50w/v%.As the object lesson of this transfusion, can be set forth in transfusion that sugar that the spy opens disclosed cooperation high concentration in the flat 5-301825 communique forms or open the transfusion disclosed cooperation averaged particles footpath in the flat 5-9112 communique formed, open the disclosed transfusion of using buffer such as L-histidine, Tris in the flat 5-65220 communique the spy at 0.17 μ m or following lipomul the spy.
Transfusion of the present invention in addition is to cooperate aminoacid and electrolyte to form.As the object lesson of this transfusion, can be set forth in the spy and open the preparation before the disclosed mixing in the flat 5-31151 communique or open disclosed mixed preparation in the flat 5-32540 communique, open in the flat 6-312923 communique disclosed peripheral intravenous administration with transfusion etc. the spy the spy.
Below to the two chambers of use shown in Figure 10 medical liquid container 72, the method that preparation contains above-mentioned lipomul, sugar, aminoacid and electrolytical transfusion describes.
In Figure 10, held first transfusion 81 that contains lipomul and sugar at the first Room 73a of injection portion 75 sides, in the second Room 73b of efferent 77 sides, held and contained aminoacid and electrolytical second transfusion 82.These various transfusions, for example as special open flat 5-31151 communique or special open flat 5-32540 communique, spy open flat 5-9111 communique, spy open flat 5-9112 communique, spy open flat 5-65220 communique, spy open in the flat 5-301825 communique disclosed hold in following concrete mode after, heat sterilization, then will peel off, make the first Room 73a and the second Room 73b to be communicated with every band portion 78 in use, by mixing two liquid, the preparation transfusion.
Contain first transfusion 81 of lipomul and sugar, specifically, contain oils and fats 0.1w/v%~30w/v%, emulsifying agent 0.01w/v%~10w/v% and sugared 5w/v%~60w/v%.The preferred averaged particles of lipomul directly is 0.17 μ m or following, and sugar is preferably reducing sugar.This first transfusion 81 preferably cooperates the transfusion of L-histidine or three (methylol) aminomethane as Reducing agent in addition.Contain aminoacid and electrolytical second transfusion 82 in addition, specifically, containing total amino acid content is 1w/v%~15w/v%, as electrolyte, contain sodium 50mEq/L~180mEq/L, potassium 40mEq/L~135mEq/L, calcium 10mEq/L~50mEq/L, magnesium 5mEq/L~30mEq/L, chlorine 0mEq/L~225mEq/L, phosphorus 3mEq/L~40mEq/L and zinc 0 μ mol/L~100 μ mol/L.Wherein phosphorus is the phosphate ester with polyhydric alcohol or sugar, or the form of its salt is engaged.These transfusions 81,82 are used organic acid, specifically used the Fructus Citri Limoniae acid for adjusting pH is 5.0~8.0, as the anti-coloring agent, contains thioglycerin or dithiothreitol, DTT.
Peel off every band portion 78 and mix two transfusions 81, the 82 mixing transfusions of forming contain following composition: oils and fats 5g/L~50g/L, emulsifying agent 0.5g/L~10g/L, sugar 50g/L~250g/L, L-isoleucine 0.5g/L~5g/L, L-leucine 0.5g/L~7g/L, L-valine 0.5g/L~5g/L, L-lysine 0.5g/L~7g/L, L-methionine 0.1g/L~4g/L, L-phenylalanine 0.3g/L~5g/L, L-threonine 0.3g/L~5g/L, L-tryptophan 0.1g/L~1g/L, L-arginine 0.3g/L~7g/L, L-histidine 0.2g/L~3g/L, glycine 0.2g/L~3g/L, L-alanine 0.3g/L~5g/L, L-proline 0.2g/L~5g/L, L-aspartic acid 0.03g/L~2g/L, L-serine 0.2g/L~3g/L, L-tyrosine 0.03g/L~0.5g/L, L-glutamic acid 0.03g/L~2g/L, L-cysteine 0.03g/L~1g/L, sodium 15mEq/L~60mEq/L, potassium 10mEq/L~50mEq/L, calcium 3mEq/L~15mEq/L, magnesium 2mEq/L~10mEq/L, chlorine 0mEq/L~80mEq/L, phosphorus 1mEq/L~15mEq/L, zinc 0 μ mol/L~30 μ mol/L.
Be accommodated in the transfusion in the medicinal liquid accommodation section 73 in addition in the present invention, also can further contain the vitamin except that lipomul, sugar, aminoacid, electrolyte.As the transfusion that further contains such vitamin, can enumerate that for example the spy opens flat 6-209979 communique or the spy opens disclosed material etc. in the flat 8-709 communique.
In the transfusion of this mode, as the medical liquid container 71 that uses band stopper of the present invention will be in this transfusion the medicinal liquid (other preparations) of mixed water injection, can enumerate for example vitamin, sleeping pill, tranquilizer, analgesics, pressor agent, cardiac tonic, liver activator, antibiotic, anticarcinogen etc.
The medical liquid container 71 of band stopper of the present invention can be according to the known method manufacturing.At first inject medicinal liquid to medical liquid container 72 by injection portion 75, be accommodated into medicinal liquid accommodation section 73 after, use stopper 61 sealing injection portions 75 as above.At this moment, the inner space 74 of medicinal liquid accommodation section 73 for example preferably uses noble gas such as nitrogen to replace.
The heat sterilization method of having held the medical liquid container 72 of medicinal liquid has no particular limits, and can carry out with known method such as autoclaving, hot water spray sterilization, Hot water immersion sterilization, hot water drip washing sterilizations.When heat sterilization, for example, open in the flat 6-261929 communique as the spy disclosed since in the heat sterilization treatment trough air pressurized, under sterilising temp, than the high 0.4kg/cm of saturated vapour pressure 2~0.9kg/cm 2, preferred high 0.5kg/cm 2~0.8kg/cm 2Down pressurization sterilization of pressure.Though the setting that the pressurization sterilising temp can suit according to the sterilizing methods of use is generally 100 ℃~130 ℃, is generally 110 ℃~125 ℃.In addition, sterilization time carries out suitable adjustment according to sterilising temp etc.
In addition, held the medical liquid container of the medicinal liquid that is heated sterilization, rotten for preventing when preserving, preferably use deoxidizer, for example エ one ジ レ ス (SANLING gas chemistry system) and use the outer bag of forming by the non-permeability plastic material of oxygen to seal the overpacking body that holds.Based on the packing of outer bag, can be the packing of noble gas such as filling nitrogen, also can be vacuum-packed.
Degerming mixed water injection device of the present invention in addition, though preferably be embodied as injection part and the entry needle parts roughly move back and forth along axis direction, but also can be to differ reciprocatingly surely, for example also can be mixed water injection device that injection part, entry needle parts and housing become one, realize running through rubber stopper when plug member is installed.
Embodiment
Below, enumerate embodiment for illustrating in greater detail the present invention, but the present invention is not limited in these
Embodiment.Embodiment 1: the making of degerming mixed water injection device
According to above-mentioned manufacture method, made the degerming mixed water injection device of the present invention of mode as shown in Figure 5.And the concavity portion of mutually chimeric filter fixed part and the convex shaped part of housing are respectively the shape of Fig. 6.Each component condition is as follows.
Injection part (マ イ レ Network ス GV (シ リ Port ア society system))
Internal diameter: 4 μ m
External diameter: 6.6 μ m
The aperture of sterilizing filter: 0.22 μ m
The length of axis direction (L1): 21mm
Material: polypropylene
The entry needle parts
Metering size: 20G
The length of axis direction (L2): 10mm
Material: polypropylene
Housing
The external diameter of cylindrical portions may: 21mm
The internal diameter of cylindrical portions may: 18mm
The length of axis direction (L3): 45mm
Material: polyethylene
The filter fixed part
External diameter: 15mm
Thickness: 4.5mm
Distance (L4) to delivery outlet: 20mm
Material: polypropylene
The tying parts
Distance between the tying parts (L5): 35mm
Distance (L6) to shell end: 10mm
Embodiment 2
The degerming mixed water injection device of the present invention that embodiment 1 makes is installed in plug member, and the housing of this mixed water injection device and the perisporium of plug member make it heat fused by high-frequency induction heating under 100Hz and make stopper of the present invention.As plug member, use the product of formation with the perisporium of the rubber stopper of the resin covering chlorination butene rubber system of polyethylene system.
Embodiment 3 (1) contains the configuration of the transfusion of lipomul and sugar
In water, add soybean oil 66g, lecithin 9.5g and glucose 500g, after the thick emulsifying of homogeneous phase mixing machine, add entry and make total amount reach 1000ml, obtain thick emulsion.The thick emulsion that obtains is passed through マ Application ト Application go one リ Application homogenizer (go one リ Application society system, 15M-8TA type), obtain averaged particles and directly reach 0.17 μ m or following emulsifying Emulsion.In the Emulsion 500ml that obtains, add entry, reach 1000ml.The composition of the transfusion that obtains is as shown in table 1.
Table 1
Composition Component (g)
Soybean oil 33
Lecithin 4.75
Glucose 250
Water for injection Make total amount reach the amount of 1000ml
(2) contain the configuration of aminoacid and electrolytical transfusion
In being heated to about 80 ℃ water for injection, under nitrogen current, add dissolving aminoacid and electrolyte, with Fructus Citri Limoniae acid for adjusting pH to 6.2 by the concentration that will reach in table 2 and the table 3.
Table 2
Composition Concentration (/ liter)
The L-isoleucine ?8.000g
The L-leucine ?14.000g
The L-valine ?8.000g
L-lysine hydrochloride ?10.000g
The L-methionine ?4.000g
The L-phenylalanine ?8.000g
The L-threonine ?6.000g
The L-tryptophan ?1.200g
The L-arginine ?10.500g
The L-histidine ?5.000g
Glycine ?5.300g
The L-alanine ?8.500g
The L-proline ?6.000g
The L-aspartic acid ?1.500g
The L-serine ?3.000g
L-tyrosine ?0.500g
L-glutamic acid ?1.500g
N-acetyl-L-cysteine ?1.100g
Table 3
Composition Concentration (/ liter)
Sodium chloride 1.949g
Potassium chloride 4.302g
Magnesium sulfate 7H 2O 2.054g
Calcium gluconate H 2O 6.352g
Phosphoglycerol
2 potassium (50% liquid) 8.016g
Sodium acetate 3H 2O 11.340g
Zinc sulfate 7H 2O 9.585g
(3) preparation of sterilization and transfusion
Medical liquid container uses the medical liquid container (polyethylene system) of shape as shown in figure 10.In first Room, inject when filling nitrogen from injection portion and to contain the lipomul that above-mentioned (1) obtain and the transfusion 660ml of sugar by the isolated medicinal liquid holding portion of isolation strip portion that may peel off.After the injection, the stopper of the present invention that injection portion and embodiment 3 made merges this injection portion of sealing by the high-frequency induction heating hot melt under 100Hz.In second Room of medicinal liquid accommodation section, contain aminoacid and electrolytical transfusion 340ml and the nitrogen that above-mentioned (2) obtain in addition from the efferent injection.After the injection, with above-mentioned identical condition under efferent and common plug member heat fused are sealed this efferent.
The medical liquid container that holds the band stopper of the present invention that each transfusion constitutes is like this granted autoclaving (110 ℃, 30 minutes), then be cooled to room temperature.
Peel off every band portion, the transfusion that is accommodated in first Room and second Room is fully mixed, obtain containing the transfusion of lipomul.The composition of this transfusion is as shown in table 4.Obtain the medical liquid container of band stopper of the present invention like this.
Table 4
Form
Fat Soybean oil 22.00g
Lecithin 3.17g
Sugar Glucose 166.67g
Aminoacid The L-isoleucine 2.67g
The L-leucine 4.67g
The L-valine 2.67g
L-lysine hydrochloride 3.33g
The L-methionine 1.33g
The L-phenylalanine 2.67g
The L-threonine 2.00g
The L-tryptophan 0.40g
The L-arginine 3.50g
The L-histidine 1.67g
Glycine 1.77g
The L-alanine 2.83g
The L-proline 2.00g
The L-aspartic acid 0.50g
The L-serine 1.00g
L-tyrosine 0.17g
L-glutamic acid 0.50g
N-acetyl-L-cysteine 0.37g
Electrolyte Sodium 38.89mEq
Potassium 30.00mEq
Calcium 9.44mEq
Magnesium 5.56mEq
Chlorine 48.60mEq
Phosphorus 5.37mEq
Zinc 11.11μmol
Other Citric acid 1.401g
Embodiment 4
Contain in the medical liquid container at the band stopper of the transfusion of the lipomul of embodiment 3 preparation the mixed water injection vitamin agent having packed into.In syringe cylinder, inject vitamin agent, insert the distal portion (luer) of this syringe tip at the inlet place of injection part.By to the extruding syringe, injection part and entry needle parts roughly prolong its axis direction and move to the opposing party of this axis, the tip portion of entry needle parts runs through the rubber stopper of plug member.Push down piston, sterilely vitamin agent is injected medical liquid container.
Embodiment 5
Make the degerming mixed water injection device of the present invention that housing as shown in Figure 8 has the pars contractilis mode.Pars contractilis is realized by the serpentine canal structure.
Embodiment 6
The degerming mixed water injection device of in using embodiment 5, making and embodiment 2 make stopper of the present invention in the same manner.
Embodiment 7
The degerming mixed water injection device of in using embodiment 5, making and embodiment 3 make the medical liquid container of band stopper of the present invention in the same manner.
Embodiment 8
In the medical liquid container of the band stopper that embodiment 7 makes, with the embodiment 4 identical vitamin agent of mixed water injection sterilely.
Utilizability on the industry
As above, in the present invention, by use have sterilizing filter specifically with the medical liquid container of stopper, can guarantee as carrying out the mixed water injection operation of other preparations under the aseptic state. Namely, the operation of other preparations of mixed water injection or to patient's administration the time, make the liquid of preparation by the processing of sterilizing filter after not needing method, the operation of other preparation mixed water injections in clean bench in the past and sterilizing filter being installed at every turn, operation becomes easy when clinical on the one hand, and can fully guarantee the security to the patient. In addition the present invention, the transfusion that particularly contains fat emulsion from use are during as other preparation mixed water injections, and be particularly useful.
The application is willing to 2000-165230 based on the spy in Japanese publication, and its content all comprises in this manual.

Claims (6)

1. medical liquid container with stopper, the medicinal liquid accommodation section of the inner space of the promising receiving medical liquids of this vessel and have the access that is communicated with this inner space injection portion medical liquid container and have the stopper of the sterilizing filter that is installed in this medical liquid container injection portion
This medical liquid container has and is isolated into two single chambers by heat fused every band portion by peelable state, hold medicinal liquid separately in each single chamber, to be somebody's turn to do during use to peel off and make two single chambers be communicated with the structure of mixing two medicinal liquids, and hold the transfusion that contains sugar and lipomul as medicinal liquid, in a single chamber, in another single chamber, hold and contain aminoacid and electrolytical transfusion every band portion.
2. the medical liquid container of the band stopper of claim 1 record is characterized in that, above-mentioned stopper possesses perisporium with tubular roughly and the plug member that embeds the rubber stopper of the roughly column in this perisporium,
In axis direction one end side of this plug member, the degerming mixed water injection device with entry needle parts is installed, the point of these entry needle parts is formed in plug member one side.
3. the medical liquid container of the band stopper of claim 2 record, it is characterized in that, above-mentioned degerming mixed water injection utensil has injection part, this injection part has, the stream of connection from the inlet of axis direction one end to the delivery outlet of axis direction the other end, this stream way, has sterilizing filter simultaneously
The entry needle parts, the delivery outlet that it is installed in injection part makes the axis of its axis and this injection part roughly consistent,
With part or all of this injection part and these entry needle parts is housed in the housing of the roughly tubular of its inner space.
4. the medical liquid container of the band stopper of claim 3 record, it is the degerming mixed water injection device that moves back and forth freely along its axis direction roughly that injection part and entry needle parts are installed.
5. the medical liquid container of the band stopper of claim 4 record, but be equipped with further possess from the sidewall of injection part to the outstanding projecting part in the inner space of housing and near the axis direction both ends of this housing to its inner space outstanding respectively and tying in the degerming mixed water injection device of each tying parts of this projecting part.
6. the medical liquid container of the band stopper of claim 4 record is equipped with further to have injection part is fixed on fixed part in the housing, forms roughly the degerming mixed water injection device along the retractile pars contractilis of its axis direction from the fixed part of this housing to above-mentioned axis direction the other end side.
CN01810442A 2000-06-01 2001-05-31 Plug-equipped liquid medicine container Pending CN1431890A (en)

Applications Claiming Priority (2)

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JP2000165230A JP2001340429A (en) 2000-06-01 2000-06-01 Mixing injector for separating microorganism and stopper body using the same, and drug solution container with the stopper body
JP165230/2000 2000-06-01

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CN102098999A (en) * 2008-06-03 2011-06-15 大成化工株式会社 Discharge container with filter
CN102098999B (en) * 2008-06-03 2014-02-19 大成化工株式会社 Discharge container with filter
CN109890705A (en) * 2016-11-04 2019-06-14 Jalca公司 It is a kind of for pressure pack container to be processed method and apparatus and relevant pressure packing machine

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JP2001340429A (en) 2001-12-11

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