Outer barrier bag fills inert gas infusion bag
Technical field
Present invention relates particularly to a kind of medical great transfusion preparation.
Background technology
Great transfusion preparation is the transfusion that we often say, and finished product is also referred to as infusion bag, it be it is direct by built-in liquid infusion in
Human vein.
The packaging of infusion bag is plastic soft bag, and infusion bag occurs very trickle breakage in some cases, referred to as micro-
Leakage.Micro- leakage hidden periodicity is long, and small opening very little, can not visually see, but small opening is sufficient for bacterium and enters inside liquid, produces safety
Problem.As liquid all has surface tension, the liquid in infusion bag can not pass through or clearly by trickle micro-
Hole, so people's naked eyes are invisible, in detection, it is difficult to exclude this infusion bag for having produced micropore.Generate germ contamination
Infusion bag there is great potential safety hazard, or even patient death can be caused.The at present soft bag infusion product dispatched from the factory by the whole nation
In, there is the up to 0.5 ‰ trickle seepage of generation, and cannot detect, be that medical procedure buries potential safety hazard.
Micro- leakage Producing reason is analyzed, it is seen that, the unreasonable and packaging material sheet in the technical process of processing
The defect of body is the main two big reasons for constituting micro- leakage.
As medicine trade is belonging to special industry, for manufacture and the selection of packaging material have strict and require, especially
Which is for infusion preparation industry, because the infusion products in packaging are direct infusions in human vein blood.So many close
Sealing property and the preferable packaging material of strength character cannot apply to infusion preparation packaging.In the bag for selecting infusion preparation
During package material, the packaging material for considering are needed at least to possess following performance condition:(1) packaging material possess fusion with liquid
Property, liquid can be kept stable in properties, chemical reaction does not occur with liquid.(2) possess intensity, adapt to the carrying in later stage, use one
Serial procedures.(3) possesses the good transparency.(4) liquid technology of the package is suitable for, can thermosol sealing well.
In a word, medical infusion packaging material primary concern is that the safety packaging to infusion preparation.
Patent:A kind of five-layer co-squeezing composite membrane based on pharmaceutical pack, numbers 201210318456.3;And patent:It is a kind of
Five-layer coextrusion transfusion medicine packing film and its manufacture method, numbers 201010107744.5.Above-mentioned two pieces patent is medical infusion
Preparation is provided and meets the packaging material for requiring, but remains certain lacking with infusion preparation made by above-mentioned packaging material
Fall into.1st, packaging intensity still shows inadequate, and infusion preparation, can during the product quality inspection in filling and later stage, accumulating, use
Occur there is the situation for damaging packaging.2nd, a number of infusion bag always is inevitably generated damage, above-mentioned two skills
Art is not made corresponding prevention and is processed to later stage package failure that may be present, it is most likely that generation is damaged and is produced
Micro- bottom pour ladle dress described above flows into hospital.3rd, it is uncontrollable to micro- leakage with infusion bag made by above-mentioned packaging material.
The content of the invention
In order to solve the above problems, the invention provides outer barrier bag filling inert gas infusion bag, it is intended to carry for medical treatment
For safer infusion bag product.
The outer barrier bag filling inert gas infusion bag of the present invention, is made up of the liquid in packaging and packaging, and will packaging
Bag surrounding carries out hot melt edge sealing, and described is packaged as multilayer material packaging, is followed successively by from the inside to the outside:Thermal synthesis layer 2-1, membrane layer 2-
2nd, the glutinous layer 2-7 of strength layer 2-3, adhesive linkage 2-4, refractory layer 2-5, gas blanket 2-6, heat, enhancement layer 2-8, barrier layer 2-9;It is described
Gas blanket in filling inert gas;Humidity indicator 3 is provided with gas blanket.
Thermal synthesis layer as above is PP resins, membrane layer is POE resin, strength layer is POE resin, adhesive linkage is POE
Resin, refractory layer are thermoplastic resin, the glutinous layer of the interior filling nitrogen air and heats of gas blanket 2-6 is PP resins, enhancement layer is nylon resin,
Barrier layer PET resin.
Humidity indicator 3 as above is to install some spherical drier 3-2 in a tubule, tubule, the one of tubule
End seal is closed, another end opening, and arranges limited block in openend, prevents bead from dropping out tubule;Tubule is by inwall and inwall periphery
Some reinforcing ring 3-1 composition, reinforcing ring is ring-type, and the distribution spacing on inwall is 0.1-0.5mm.
Humidity indicator 3 as above is humidity indicating card.
Fluted 6 are distributed on the inside of the glutinous layer 2-7 of heat, for carrying out equilibrium to the negative pressure value in gas blanket 2-6 everywhere.
Groove 6 as above is longitudinal linear pattern groove, and grooved section is V-shaped, slot opening 0.5-1mm, deep 0.1-
1mm, the distribution spacing on outer sealing are 7-10mm.Hot melt edge sealing 5 as above arranges bending 4, and in rear doubling
The beneficial effects of the present invention is:
1st, transfusion package bag of the invention is made up of the packaging material of multilayer material, the main liquid layer for including internal layer, middle
Gas blanket, outside outer sealing.Its Chinese medicine liquid layer is directly contacted with transfusion, and the structure setting characteristic of liquid layer meets and transfusion
Amalgamation, the high barrier to liquid play very crucial effect to long term guarantee quality transfusion.Middle gas blanket is indifferent gas
Body, prevents residual oxygen in gas blanket, when liquid layer bag occurs micro- leakage, can prevent oxygen from entering in liquid to enter liquid
Row destruction.The oxygen in the air that outer sealing is penetrated into can be removed simultaneously.
2nd, the present invention outer sealing inner surface setting longitudinal fluting, form the road network that flows away of inert gas, allow indifferent gas
Body is impartial in the everywhere of gas blanket, does not produce bubble.
If liquid layer has micro- leakage to produce, the liquid for spilling can be automatically flowed into and is stacked in groove, and form light
Refraction effect, makes naked eyes easily find.
3rd, infusion bag of the invention possesses general infusion bag completely and requires.The liquid layer of innermost layer possesses heat sealer, side
Just the heat-sealing and high-temperature sterilization in technique productions, and possess intensity with the transparency.Outer sealing also enhances whole packaging simultaneously
Intensity.
4th, humidity indicator can help judge whether the liquid in packing inside bag leaks into external packing.
5th, hot melt edge sealing of the invention is after several times doubling, effectively can offset because being unfavorable for of producing of gas blanket, groove is defeated
The defect of liquid bag sealing.
Description of the drawings
Fig. 1 is schematic structural view of the invention.
Fig. 2 is multilayer packaging material structural representation of the present invention.
Fig. 3 is the outer sealing groove structure schematic diagram of the present invention.
Fig. 4 is the outer sealing groove distribution schematic diagram of the present invention.
Fig. 5 is humidity indicator setting structure schematic diagram of the present invention.
Fig. 6 is humidity indicator structural representation of the present invention.
Fig. 7 is present invention hot melt edge sealing structural representation.
Accompanying drawing number is to illustrating:
1st, liquid;2nd, pack;2-1, thermal synthesis layer;2-2, membrane layer;2-3, strength layer;2-4, adhesive linkage;2-5, refractory layer;
2-6, gas blanket;The glutinous layer of 2-7, heat;2-8, enhancement layer;2-9, barrier layer;3rd, humidity indicator;3-1, reinforcing ring;It is 3-2, spherical
Drier;4th, bending;5th, heat edge sealing;6th, groove.
Specific embodiment
For making the object, technical solutions and advantages of the present invention clearer, below in conjunction with the specific embodiment of the invention and
Corresponding accompanying drawing is clearly and completely described to technical solution of the present invention.
Referring to the drawings 1, Fig. 2, the packaging of the present invention is broadly divided into three parts:Liquid layer, gas is followed successively by from inside to outside
Layer, outer sealing;, for possessing liquid barrier property and there is confluent material to constitute with liquid, gas blanket is by medicine for described liquid layer
Liquid layer is separated with outer sealing, and applies negative pressure to liquid layer, and described outer sealing is made up of the material for possessing barrier properties for gases.
Innermost layer is the liquid layer with liquid directly contact, and liquid layer is total up to five layers of material, in processing using five layers
Coextrusion process carries out blown film processing, i.e.,:Thermal synthesis layer 2-1, membrane layer 2-2, strength layer 2-3, adhesive linkage 2-4, refractory layer 2-5 are adopted
The technique productions processed with co-extrusion film are fabricated by.The concrete material of liquid layer is referred to following resinae processing, thermal synthesis layer
For PP resins, membrane layer be POE resin, strength layer be POE resin, adhesive linkage be POE resin, refractory layer be thermoplastic resin.
The resin of various group polymer or compound under above-mentioned polymer big class can be used, as long as background skill of the present invention can be met
The general requirement of the liquid packaging described in art can (i.e.:Amalgamation of intensity, the transparency and liquid etc.).Except above-mentioned liquid
Outside the structure design of layer, the liquid layer of the present invention may also be employed the five-layer co-squeezing composite membrane that prior art is produced.The present invention is carried
For liquid Rotating fields scheme in, thermal synthesis layer 2-1 be innermost layer, using PP production of resins, possess good heat sealer, be easy to heat
Sealing is closed, and energy Jing high-temperature sterilizations do not produce breakage.Membrane layer 2-2 is POE resin, has preferable intensity, and the transparency is good.By force
Degree layer 2-3 is POE resin, is likewise supplied with preferable intensity and the transparency.Adhesive linkage 2-4 selects the preferable POE resin of cementability,
Good bonding effect is played to strength layer and refractory layer.Refractory layer 2-5 is thermoplastic resin, possesses good heat sealer, just
In heat seal, and energy Jing high-temperature sterilizations do not produce breakage.
Intermediate layer is gas blanket, and the forming method of gas blanket is that liquid layer is fitted with outer sealing, is then carried out surrounding
Thermosol edge sealing, then using the inert gas for filling certain value between liquid layer and outer sealing.It is after filling inert gas, resistance to
Thermosphere 2-5 is fitted with hot glutinous layer 2-7, it should be noted that laminating herein is only not that refractory layer is sticked layer continuously with heat
Gap is fitted, but also keeps certain inert gas space between refractory layer and the glutinous layer of heat.
Outer sealing is composite membrane, and outer sealing is to be followed successively by from the inside to the outside:The glutinous layer 2-7 of heat, enhancement layer 2-8, barrier layer 2-9.
Wherein, the glutinous layer of heat is PP resins;Enhancement layer is nylon resin;Barrier layer PET resin.Various groups under above-mentioned polymer big class
The resin of polymer or compound can be used, in the concrete group from fluoropolymer resin, the performance requirement master that need to be met
Including:Good gas permeability, the high barrier to air, oxygen resistance, high tenacity, good hot melt can be suitable for high temperature
Sterilization.Specifically, the glutinous layer of heat is PP resins, possess the PP resins of good hot melt.Enhancement layer is nylon resin, is possessed
Toughness and barrier.Barrier layer PET resin, it is possible to achieve in top layer printing figure message, and possess to air oxygen barrier
Can, the PET resinoids of this kind of speciality can be realized.
Fluted 6 are distributed on the inside of outer sealing, for carrying out equilibrium to the gas in gas blanket 2-6 everywhere.Groove can be
Blown film completes, it is also possible to after the completion of coating materials is made, and is suppressed using embossing machine.Groove 6 is longitudinal linear pattern groove, groove
Section is V-shaped, naturally it is also possible to for semicircle, or other any shapes, and slot opening 0.5-1mm, deep 0.1-1mm, groove exist
The distribution spacing of outer sealing is 7cm, inert gas is more uniformly spread in gas blanket, makes the everywhere of the outer surface of liquid layer
There is inert gas, the filling of inert gas can effectively exclude the oxygen that may be present of gas blanket.Inert gas can be prevented simultaneously
Only there is the situation for penetrating into air in outer sealing.Gas blanket occurs without oxygen, the liquid in packaging is guaranteed the quality and plays very effective
Effect.
The selection species of the inert gas of the present invention is not limited, by the concrete composition of institute's powder charge liquid in specific medicinal fluid bag
Fixed, as long as the inert gas for selecting will not occur chemical reaction with liquid, the safety for not interfering with liquid just may be used.The present embodiment
From nitrogen.
The transfusion filling technique of the present invention, sterilization, vanning technique technology as known to those skilled in the art of the present technique are carried out.
Because being provided with gas blanket 2-6 in the packaging material of the present invention, and the inner side distribution on outer sealing being fluted
6, so if using general hot melt edge sealing process, then can seal imperfect at groove and gas blanket, groove is heat-sealable
Small opening is actually formed on side 5.In order to offset this phenomenon, hot melt edge banding machine is set to into concavo-convex die orifice, is compressed during edge sealing
Edge sealing, makes to form bending 4 at hot melt edge sealing, heats the groove destruction at edge sealing, reaches due sealing effectiveness.
Humidity indicator 3 is to install some spherical drier 3-2 in a tubule, tubule, and one end closing of tubule is another
End opening, and limited block is set in openend, prevent bead from dropping out tubule;Tubule is by inwall and some reinforcing rings of inwall periphery
3-1 is constituted, and reinforcing ring is ring-type, and the distribution spacing on inwall is 0.1-0.5mm.Certainly, humidity indicator 3 can also be adopted
The more succinct humidity indicating card sold on the market.Humidity indicating card can be put into when liquid layer is fitted and takes out negative pressure with outer sealing.
With reference to Fig. 6, with regard to the humidity indicator of the present invention:The tubule one end open of humidity indicator, one end closing are built-in
Drier be meet moisture discoloration silica gel particle.If involved in the environment of moisture, moisture is entered from openend, gradually
To blind end permeate, therefore observe moisture penetration degree, you can judge ambient humidity, by moisture penetration in place of, at this
Spherical drier will change colour, and be changed into asymptotic from navy blue and be changed into white.
The liquid of the present invention carries out filling, sterilization, warehouse-in, lamp inspection by already known processes.Wherein, lamp inspection technique is outstanding to the present invention
Which is important, and due to using the liquid packing technique of the offer for the present invention, lamp inspection technique is different from routine techniques, this
Bright lamp inspection technique is as follows:Filling, sterilization, warehouse-in are being carried out by above-mentioned technology;Then determine what warehouse-in was kept in by design technology
Time, the temporary storage time can be set as 240-480 hours.After the time reaches, temporary liquid is thrown into into production detection again
On line, first each humidity indicating card color is observed, color is normal, it is possible to determine that liquid layer does not have breakage, directly
Assert that product is qualified;If it find that humidity indicating card color change (be changed into asymptotic from navy blue and be changed into white), you can just point is recognized
Determine washing lotion wrapper and can have disrepair phenomenon.Then by the doubtful damaged liquid against the coal bin that illumination is 2000 lumens
Carry out lamp inspection.If infusion bag has micro- leakage, can be stacked in groove, naked eyes are visible.This drop ply of examining has the liquid bag of water spots
Pack as defective work, such process, just the defective work hidden is detected, product qualified rate of dispatching from the factory is improve, give medical treatment single
Position provides more secure liquid packaging bag, ensures patient's drug safety.
Above-mentioned embodiment is used for illustrating the present invention, rather than limits the invention, in the spirit of the present invention
In scope of the claims, any modifications and changes made to the present invention both fall within protection scope of the present invention.