CN105167995B - A kind of sodium bicarbonate injection double-layer sterile butt-ended bag packaging system and preparation method - Google Patents
A kind of sodium bicarbonate injection double-layer sterile butt-ended bag packaging system and preparation method Download PDFInfo
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- CN105167995B CN105167995B CN201510502214.3A CN201510502214A CN105167995B CN 105167995 B CN105167995 B CN 105167995B CN 201510502214 A CN201510502214 A CN 201510502214A CN 105167995 B CN105167995 B CN 105167995B
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Abstract
The invention discloses a kind of sodium bicarbonate injection double-layer sterile butt-ended bag packaging systems and preparation method thereof.The packaging system includes: polypropylene vertical type inner bag, and inside is equipped with the medicament chamber for accommodating sodium bicarbonate injection medical fluid and carbon dioxide gas；Barrier protection bag, inside are equipped with the seal chamber for accommodating the polypropylene vertical type inner bag, and the polypropylene vertical type inner bag is sealingly received in the seal chamber, and wherein seal chamber is vacuum-sealed cavity.The sodium bicarbonate injection butt-ended bag packaging system is by forming vacuum-sealed cavity in barrier protection bag; it is intracavitary that polypropylene vertical type inner bag is contained in vacuum sealing; it can be while preventing gas permeation problems; because avoiding the filling gas in seal chamber; and overcome the defect of the deformation of bag body caused by the gas expansion in high-temperature sterilization or broken bag; improve the quality and safety of sodium bicarbonate injection butt-ended bag packaging system; the thermal break-through power of sterilization process is also improved simultaneously, improves sterilization effect.
Description
Technical field
The present invention relates to medical packaging field, in particular to a kind of sodium bicarbonate injection butt-ended bag packaging system and its system
Preparation Method.
Background technique
Transfusion package is realized substantially from bottle processed to filling and sealing same clean in production after vial, plastic bottle
Net workshop is completed, and has accomplished to be put into semi-open progress from standard-sized sheet in clinical use.In order to avoid secondary pollution, totally-enclosed is realized
Infusion, infusion of the researching and designing with the plastic bag packaging that can be shunk automatically.Most widely used at present is non-PVC co-extrusion film bag
With polypropylene butt-ended bag.
With the development of infusion clinical application, infusion kind is no longer simple physiological saline and glucose.Bicarbonate
Sodium class injection is also more and more researched and developed and is widely used in clinic.There is storage condition in this sodium bicarbonate injection
Wherein sodium bicarbonate is readily decomposed into carbon dioxide and sodium carbonate for higher requirement, causes liquid PH value to increase denaturation, influences to make
With needing to be filled with carbon dioxide gas in bag thus, to inhibit its hydrolysis to avoid product rotten.
Currently, the feature preferable using vial barrier property, this kind of infusion products mostly use glass bottle packaging.But glass
Bottle packaging has the disadvantage that (1) matter is crisp frangible, this is insufficient very big in the presence of bringing in clinical use to glass bottle packaging
Inconvenience；(2) air must be imported when being transfused, this insufficient presence is likely to result in this glass bottle packaging in infusion process
Secondary pollution and drug change of properties；(3) soda-lime glass surface corrosion-vulnerable and generate and fall off, in glass bottle packaging
The alkalinity of the volatilization of carbon dioxide, medical fluid gradually increases, this allows for soda-lime glass surface corrosion-vulnerable and generates and fall off, in turn
Infusion and the safety of patient may seriously be jeopardized.How problem above is solved, it has also become the emphasis of transfusion package technical field
Research topic.
Some research staff think, directly vial can be substituted with co-extrusion film infusion bag or butt-ended bag, to solve to be transfused
Bring pollution and medicament denaturing problem.However, existing infusion bag majority is to be welded by common PP TYPE and polypropylene
Particle is formed through infusing stretch blow, and bag body barrier property can meet the requirement of most basic infusion products.And bag domestic demand is filled with
The product of gas, for this infusion bag during subsequent high temperature sterilizes and stores, gas can penetrate bag body, and infiltration problem occurs,
Influence drug quality.
Also some researchers think, can increase on the basis of existing co-extrusion film infusion bag or butt-ended bag are as inner bag
Add outer protective bag to form the infusion bag of double-layer structure, and be filled with carbon dioxide gas between interior outer bag.However, this structure exists
There are the following problems for subsequent sterilisation process: if (1) first carrying out high-temperature sterilization to internal bag, then again plus with barrier property
The outer bag of energy.In this case, be on the one hand easy to cause in high-temperature sterilization it is saturating outside gas in inner bag, on the other hand after sterilization
Outer bag is sealed up again, it is non-sterile outside inner bag at this time.Moreover, because carbon dioxide gas is filled between interior outer bag, so that this defeated
The sealing of liquid Over-bag is difficult, it is easy to cause bag body broken bag, it is difficult to guarantee Product Safety.(2) if adding with barrier property
Integral high-temperature sterilizing is carried out to transfusion package after the outer bag of energy, thermal break-through may be prevented because of the presence of carbon dioxide gas, made
It is inhomogenous at sterilizing；But also may gas expansion when heated, easily cause bag body broken bag or deformation.
Summary of the invention
The main purpose of the present invention is to provide a kind of sodium bicarbonate injection butt-ended bag packaging system and preparation method thereof,
To improve going out for sodium bicarbonate injection butt-ended bag packaging system while avoiding gas that extravasation occurs and influences drug quality
Bacterium effect and safety.
For this purpose, providing a kind of sodium bicarbonate injection butt-ended bag packaging system in the present invention, which includes:
Polypropylene vertical type inner bag, inside are equipped with the medicament chamber for accommodating sodium bicarbonate injection medical fluid and carbon dioxide gas；Barrier is protected
Bag is protected, inside is equipped with the seal chamber for accommodating the polypropylene vertical type inner bag, and the polypropylene vertical type inner bag is sealingly received within
In the seal chamber, wherein the seal chamber is vacuum-sealed cavity.
Preferably, above-mentioned barrier protection bag, is prepared by barrier material, and the barrier material successively includes outward by seal chamber
It is poly- to benzene coated with aluminum oxide on inner layer of polypropylene, polycaprolactam or modified polypropene middle layer and inner surface
Dimethyl glycol ester outer layer；Preferably, it is fixed between each layer by adhesive layer in the barrier material；Preferably, the resistance
Barrier material is transparent material.
Preferably, above-mentioned polypropylene vertical type inner bag includes: inner bag ontology and lid, and inner bag ontology is equipped with flange, institute
Medicament chamber is stated to be arranged in the inner bag ontology；Lid is connected to seal the medicament chamber with the flange of the inner bag ontology, excellent
Selection of land, the inner bag ontology blow drawing process integrated molding using note.
Preferably, above-mentioned lid is combined cap, and the combined cap includes: including outer cover, inner cover and setting in the inner cover
Gasket between outer cover, the gasket are the integrated design, including partly overlapping two circular portions, described two circles
It is in butterfly that part, which combines, is provided with unlatching boss at the top of the outer cover, is provided with and the pad on the inside of the unlatching boss
The card slot that piece fastens.
Preferably, positioning groove and the pinprick positioned at the positioning groove bottom are provided on above-mentioned gasket, it is described interior
It covers and is provided with positioning convex platform, the positioning convex platform is combined closely with the positioning groove on the gasket, it is preferable that described in two
Two circular portions for opening boss and the gasket are arranged in a one-to-one correspondence, it is preferable that are respectively provided with and are pulled on each unlatching boss
That rolls over the unlatching boss pulls folding valve.
Meanwhile a kind of preparation method of sodium bicarbonate injection butt-ended bag packaging system is additionally provided in the present invention, it should
Preparation method the following steps are included: formed is filled with sodium bicarbonate injection medical fluid and carbon dioxide gas in internal medicament chamber
Polypropylene vertical type inner bag；The polypropylene vertical type inner bag is fitted into barrier protection bag, sealing vacuumizes to form the double-deck knot
Structure butt-ended bag；The double-layer structure butt-ended bag is subjected to sterilization treatment, obtains sodium bicarbonate injection butt-ended bag packaging system
System.
Preferably, the poly- of sodium bicarbonate injection medical fluid and carbon dioxide gas is filled with inside above-mentioned formation in medicament chamber
The step of propylene vertical type inner bag includes: preparation sodium bicarbonate injection medical fluid, and into the sodium bicarbonate injection medical fluid
It inputs carbon dioxide gas and forms sodium bicarbonate injection medicine liquid mixture；It is respectively formed inner bag ontology and lid；By the carbon
In the sour hydrogen sodium injection medical fluid inner bag ontology, it is filled with carbon dioxide gas into bag, replaces the sky in dosing space
Gas seals the flange of the inner bag ontology with lid, forms the polypropylene vertical type inner bag.
Preferably, the step of preparation sodium bicarbonate injection medical fluid includes: concentrated compounding: appropriate note is injected in dissolving tank
It penetrates and uses water, the sodium bicarbonate of calculation amount is added, by the dilute medicinal carbon that 0.01g is added with volume of 100ml, stir, filtering obtains
To concentrated wiring liquid；It is dilute to match: to mend and add to the full amount of water for injection in concentrated wiring liquid, preparation obtains sodium bicarbonate injection medical fluid.
Preferably, it is filled with carbon dioxide gas into the sodium bicarbonate injection medical fluid and forms sodium bicarbonate injection medicine
The step of liquid mixture includes: that will be filled by the 0.22 filtered carbon dioxide of micrometer polytetrafluoroethylene material filter device
Sodium bicarbonate injection medicine liquid mixture is formed in sodium bicarbonate injection medical fluid.
Preferably, above-mentioned polypropylene vertical type inner bag is fitted into barrier protection bag.
Using in the above-mentioned sodium bicarbonate injection butt-ended bag packaging system of the present invention, by using including polypropylene vertical type
The sodium bicarbonate injection butt-ended bag packaging system of inner bag and barrier protection bag replaces vial, can be to avoid because using vial
It is insufficient caused by packaging.By forming vacuum-sealed cavity in barrier protection bag, polypropylene vertical type inner bag is contained in very
In empty seal chamber, because avoiding the filling gas in seal chamber, it can be overcome in height while improving gas permeation problems
The defect of bag body deformation or broken bag caused by gas expansion when temperature sterilizing improves sodium bicarbonate injection butt-ended bag packaging
The safety of system, while because avoiding the filling gas in seal chamber, the thermal break-through power in sterilization process is also improved, is improved
Sterilization effect.
Meanwhile using high-barrier protective bag to gas in sodium bicarbonate injection butt-ended bag packaging system in the present invention
High barrier can ensure that the gas in the sealed package system is in equilibrium state, to guarantee the quality of product.
In addition, sodium bicarbonate injection butt-ended bag packaging system is two layers of bag like construction in the present invention, it is simply, convenient,
Easy to produce, processing and storage, are suitable for industrialized production.
Detailed description of the invention
The accompanying drawings constituting a part of this application is used to provide further understanding of the present invention, and of the invention shows
Examples and descriptions thereof are used to explain the present invention for meaning property, does not constitute improper limitations of the present invention.In the accompanying drawings:
Fig. 1 shows the structural representation of sodium bicarbonate injection butt-ended bag packaging system according to an embodiment of the present invention
Figure；
Fig. 2 shows the structural schematic diagrams of middle combined cap according to an embodiment of the present invention；
Fig. 3 shows the schematic perspective view of the gasket of combined cap according to an embodiment of the present invention；
Fig. 4 shows the schematic perspective view of the inner cover of combined cap according to an embodiment of the present invention；
Fig. 5 shows the top view of the inner cover of combined cap according to an embodiment of the present invention；
Each label indicates in figure:
10 polypropylene vertical type inner bag, 11 inner bag ontology
13 lid, 131 outer cover
132 inner cover, 133 gasket
134 open 135 positioning groove of boss
136 positioning convex platforms 137 pull folding valve
138 pierce through 15 medicament chamber of pinprick
17 sodium bicarbonate injection medical fluid, 18 carbon dioxide gas
19 hanging ring, 20 barrier protection bag
21 seal chambers
Specific embodiment
It should be noted that in the absence of conflict, the features in the embodiments and the embodiments of the present application can phase
Mutually combination.The present invention will be described in detail below with reference to the accompanying drawings and embodiments.Unless otherwise expressly defined, the skill of this field
Art personnel, which are considered as the technical terms of chemistry used in the full text description of this paper, has common meaning used in the art.
As shown in Figure 1, in an embodiment of the present invention, providing a kind of sodium bicarbonate injection butt-ended bag packaging system
System, which includes: polypropylene vertical type inner bag 10 and barrier protection bag 20.Wherein inside polypropylene vertical type inner bag 10
Equipped with the medicament chamber 15 for accommodating sodium bicarbonate injection medical fluid 17 and carbon dioxide gas 18；It is equipped with and holds inside barrier protection bag 20
Receive the seal chamber 21 of the polypropylene vertical type inner bag 10, the polypropylene vertical type inner bag 10 is sealingly received within the seal chamber
In 21, wherein the seal chamber 21 is vacuum-sealed cavity.
In above-mentioned sodium bicarbonate injection butt-ended bag packaging system, by using including polypropylene vertical type inner bag and barrier
The sodium bicarbonate injection butt-ended bag packaging system of protective bag replaces vial, can be to avoid because using produced by glass bottle packaging
Deficiency.By forming vacuum-sealed cavity in barrier protection bag, it is intracavitary that polypropylene vertical type inner bag is contained in vacuum sealing,
It, because avoiding the filling gas in seal chamber, can be overcome in high-temperature sterilization while improving gas permeation problems
The defect of bag body caused by gas expansion deformation and broken bag, improves the life of sodium bicarbonate injection butt-ended bag packaging system product
Efficiency and safety are produced, while because avoiding the filling gas in seal chamber, also improving the thermal break-through power in sterilization process, mentioning
High sterilization effect.Meanwhile high-barrier protective bag pair is used in sodium bicarbonate injection butt-ended bag packaging system in the present invention
The high barrier of gas can ensure that the gas in the sealed package system is in equilibrium state, to guarantee the quality of product.In addition,
Sodium bicarbonate injection butt-ended bag packaging system is two layers of bag like construction in the present invention, simply, convenient, easy to produce, processing
And storage, it is suitable for industrialized production.
In above-mentioned sodium bicarbonate injection butt-ended bag packaging system, barrier protection bag 20 is prepared by barrier material, at this
For barrier material, there is no particular/special requirements in invention, as long as having barriers function.Preferably above-mentioned resistance in the present invention
Barrier material successively includes inner layer of polypropylene, polycaprolactam or modified polypropene middle layer and interior table by seal chamber 21 outward
Parylene's glycol ester outer layer of aluminum oxide is coated on face.Preferably, the inner layer of polypropylene with a thickness of
70-100 μm, according to inner bag amount of capacity, preferably in single chamber inner bag volume≤500ml packaging system, the thickness of inner layer of polypropylene
Degree is 70-80 μm；In the packaging system of single chamber inner bag volume > 500ml or more or dual chamber, inner layer of polypropylene with a thickness of 80-100
μm；Preferably, polycaprolactam or polypropylene middle layer with a thickness of 10-26 μm, its buffer protection function of middle layer；It is preferred that
Ground, inner surface be coated with parylene's glycol ester outer layer of aluminum oxide with a thickness of 10-14 μm, wherein poly- pair
Xyxylene glycol ester film mainly plays high temperature resistant, and aluminum oxide mainly takes blocking effect；Preferably, the barrier film
Overall thickness be 100-150 μm.Preferably, the bag width of barrier protection bag 20 is 10-40cm, a length of 10-50cm of bag, seals hem width
Degree is 6-10mm.
Preferably, its steam penetrating capacity of this barrier material of the present invention is lower than 1.0g/ (m2It (surveys for 24 hours)
The quasi- ASTM F-1249 of test-object, condition are 37.8 DEG C, 80%RH), nitrogen, carbon dioxide gas, oxygen transit dose are lower than
1.0cm3/(m20.1MPa for 24 hours) (testing standard ASTM D-3985,23 DEG C of condition, 0%RH), it in this way can be preferably real
Existing barriers function, it is ensured that the gas in the sealed package system is in equilibrium state, to guarantee the quality of product.Preferably, by
This barrier material barrier protection bag 20 sterilizing front and back heat seal strength be 30-45N/15mm (220 DEG C of puller system, 2.0kgf/
cm2.2sec)。
The above-mentioned steam penetrating capacity referred to is measured according to vapor permeation amount measuring method (YBB00092003), and item is measured
Part is 37.8 DEG C ± 0.6 DEG C of temperature, relative humidity 90% ± 2%.The above-mentioned nitrogen referred to, carbon dioxide gas, oxygen penetrate
Amount is measured according to gas transit dose measuring method (YBB00082003), and measuring condition is 23 DEG C ± 2 DEG C of temperature.
For the formation of barrier material, there is no particular/special requirements in the present invention, as long as having above-mentioned three-decker.
Preferably, it is fixed between each layer by adhesive layer in above-mentioned barrier material.It is preferred that the material of the adhesive layer is aliphatic bonding
Agent, preferably polyester polyol -Zhi Fang race oligomeric isocyanates.Using this binder material with transparent, degree of adhesion is high
Advantage.It is highly preferred that the barrier material is transparent material.
In above-mentioned sodium bicarbonate injection butt-ended bag packaging system, polypropylene vertical type inner bag 10 includes inner bag ontology 11
With lid 13.Inner bag ontology 11 is equipped with flange, and the medicament chamber 15 is arranged in the inner bag ontology 11；Lid 13 with it is described
The flange of inner bag ontology 11 is connected to seal the medicament chamber 15.Wherein inner bag ontology 11 blows drawing process integrated molding using note.
It is this that leakproofness and impact resistance that the integrally formed mode of drawing process is conducive to improve prepared inner bag ontology 11 are blown using note
Property, reduce the possibility of gas leak.
In the present invention for 13 structure of lid in polypropylene vertical type inner bag 10 there is no particular/special requirement, it can be and appoint
The lid of meaning conventional structure, as long as can be realized the sealing of polypropylene vertical type inner bag 10.It is preferred in one kind of the invention
In embodiment, as shown in Fig. 2 to 5, according to an embodiment of the invention, combined cap includes that outer cover 131, inner cover 132 and setting exist
Gasket 133 between inner cover 132 and outer cover 131, gasket 133 are the integrated design, including partly overlapping two circular portions,
Two circular portions and decentraction, maximum periphery overlap to form engaging portion, so that two circular portions combine and are in
Butterfly, the top of outer cover 131, which is provided with, opens boss 134, and the inside for opening boss 134, which is provided with, to fasten with gasket 133
Card slot.Preferably, two circular portion structures are identical.
Preferably, card slot and unlatching boss 134 are integrated two sides, i.e., the top of outer cover 131 is to open boss in terms of outside
134, in terms of inside, the structure that boss 134 is opened at the top of outer cover 131 is rendered as card slot, the shape phase of the card slot and gasket 133
It adapts to, gasket 133 can be fastened in card slot when being assembled to inner cover 132, outer cover 131 and gasket 133, thus to pad
Relative position between piece 133 and outer cover 131 is positioned, and gasket 133 can be effectively prevent to misplace when carrying out needle thorn,
Guarantee the corresponding relationship opened between boss 134 on the pinprick 138 and outer cover 131 on gasket 133, improves combined cap and carry out
Reliability and accuracy when needle pierces improve working efficiency.
Preferably, two circular portions of two unlatching boss 134 and gasket 133 are arranged in a one-to-one correspondence, so that opening convex
Having between platform 134 and gasket 133 has preferable corresponding relationship between good corresponding relationship namely card slot and gasket 133,
It can preferably be positioned.
Since gasket is the integrated design, and being combined by two partly overlapping circular portions is in butterfly, therefore can be saved
The bound fraction among two circular portions is removed, so that two circular portions are directly joined together, the structure of gasket can be made
It is more compact, convenient for being arranged to gasket, it can not only save material, reduce cost, when using two pinpricks not
It will cause secondary pollution, and the resulting gasket can provide bigger retraction force, so that the colloid of gasket is held syringe needle tightly, prevent
Leakage does not occur for only gasket sliding and invagination, and design is reasonable, securely and reliably.
It is provided with positioning groove 135 and the pinprick 138 positioned at 135 bottom of positioning groove on gasket 3, is set on inner cover 132
It is equipped with positioning convex platform 136, positioning convex platform 136 is combined closely with the positioning groove 135 on gasket 133.Positioning groove 135 and positioning
Boss 136 matches, so that the available guarantee of the relative positional relationship between gasket 133 and inner cover 132, so as to guarantee
Positional relationship when carrying out needle thorn between gasket 133 and inner cover 132 is correct, so that gasket is by syringe needle after being pierced through, Neng Gouyou
Preferable retraction force, and pinprick can be bounced back, it is held tightly with puncture needle, effectively prevent that the phenomenon of leakage occurs.
It is each open be respectively provided on boss 134 pull unlock open boss 134 pull folding valve 137.Lid heating is welded on infusion
Sack flange, one of them that folding falls on outer cover 131 when making up a prescription pull folding valve 137, expose corresponding pinprick 138, pass through thorn
It threads a needle acanthopore 138 and inner cover 132, sodium bicarbonate injection medical fluid is added in bag, folding falls another covered outside when infusion
Folding valve 137 is pulled, corresponding pinprick 8 is exposed, is exported medical fluid by piercing through pinprick 138 and inner cover 132.
In the present embodiment, it opens boss 134 and positioning groove 135 is butterfly-shaped, so as to have and 133 phase of gasket
Same contour structures, can be more accurately and rapidly fitting with, and realize more quick and precisely between gasket 133 with gasket 133
Ground positioning.
Inner cover 132, gasket 133 and outer cover 131 are press-fitted together as one, and can make the three have preferable fit structure,
So that finally formed combined cap has more reliable and more stable structure.
According to an embodiment of the invention, in butt-ended bag infusion production aseptic packing system, using the group with above structure
Closing lid, polypropylene inner bag is vertical contraction bag, and polypropylene inner bag bottom is equipped with hanging ring 19, without importing outside air, energy
It is enough effectively to realize totally-enclosed transfusion mode, the self-constriction and dual-valve cover dosing, infusion complementation of soft bag are had both, is effectively avoided secondary
Pollution, ensure that the safety of infusion to greatest extent.
Meanwhile a kind of preparation side of above-mentioned sodium bicarbonate injection butt-ended bag packaging system is additionally provided in the present invention
Method, the preparation method are filled with sodium bicarbonate injection medical fluid and titanium dioxide the following steps are included: being formed in internal medicament chamber 15
The polypropylene vertical type inner bag 10 of carbon gas；The polypropylene vertical type inner bag 10 is fitted into barrier protection bag 20, sealing is taken out
It is vacuum formed double-layer structure butt-ended bag；The double-layer structure butt-ended bag is subjected to sterilization treatment, obtains the sodium bicarbonate injection
Liquid butt-ended bag packaging system.
The above method provided by the present invention, by the way that the polypropylene vertical type inner bag 10 is being packed into barrier protection bag 20
After be sealed and vacuumize and then in barrier protection bag form vacuum-sealed cavity, thus improving the same of gas permeation problems
When, because avoiding the filling gas in seal chamber, overcome the deformation of bag body caused by the gas expansion in high-temperature sterilization or
The defect of broken bag improves the productivity and safety of sodium bicarbonate injection butt-ended bag packaging system.Moreover, this method is in shape
At sterilization treatment is carried out after the double-deck structure vertical bag, the secondary pollution of polypropylene vertical type inner bag 10 is avoided, production is improved
Product safety in utilization.Meanwhile because avoiding the filling gas in seal chamber, the thermal break-through power in sterilization process is also improved, is mentioned
High sterilization effect.In addition, simplifying preparation process, avoids and expanded because gas heats, caused bag body broken bag or deformation.
Preferably, in the above-mentioned methods, it is formed in internal medicament chamber 15 and is filled with sodium bicarbonate injection medical fluid and dioxy
The step of changing polypropylene vertical type inner bag 10 of carbon gas includes: to prepare sodium bicarbonate injection medical fluid, and to the bicarbonate
Carbon dioxide gas is inputted in sodium injection medical fluid forms sodium bicarbonate injection medicine liquid mixture；It is respectively formed inner bag ontology 11
With lid 13；By in the sodium bicarbonate injection medical fluid inner bag ontology 11, carbon dioxide gas is filled in bag
Body thoroughly replaces the air in dosing space；The flange that the inner bag ontology 11 is sealed with lid 13, it is straight to form the polypropylene
Vertical inner bag 10.
The preparation method of inner bag ontology 11 is the following steps are included: take pp material successively to be infused in the above-mentioned methods
Modeling, biaxial tension and blow molding form bag body.Specifically, above-mentioned steps can be completed in hollow molding Bag Making Machine, by poly- third
Alkene raw material is added in Bag Making Machine, is molded by Bag Making Machine, complete injection molding bag base after, to bag base carry out heating and it is two-way
Pre-blowing is stretched, after stretching blows to predetermined length in advance, in place by blow moiding method one-pass molding, guarantees that bag body is uniform, has good
Good self-constriction and independence.Connecting flange can be formed in the present invention by welding in above-mentioned molding bag body
State inner bag ontology 11.
During forming bag body, to guarantee raw material melting, heating temperature is molded by 5th area and upgrades to 7th area.7 area's temperature
Respectively nozzle area；180-230℃；Proparea: 190-230 DEG C；Middle area: 190-230 DEG C；1st area afterwards；190-245℃；2nd area afterwards
190-245℃；Hot flow path body district: 190-230 DEG C；Hot runner nozzle district: 190-230 DEG C；Increase pre- stretch blow moulding heating temperature
100-140 DEG C, pressure 0.3-0.6MPa, time 1-5s；Blow molding sizing is upgraded to 2 times, a blow pressure power 0.5-0.7MPa by 1 time,
Delay time 0.3-0.5s；Two blow pressure power 0.7-0.9MPa, delay time 0.25-0.8s.After bag body makes plus hanging ring melts.This
Kind is low with blow molding rapid one-step bag forming process energy consumption by injection molding, stretching, and bag body is uniform, pollution-free, and the upright no-welding-seam of bag body,
Impact resistance is suitable for clinical dosing and market transport.
Barrier protection bag 20 is to be formed by two panels barrier material film through three edge sealing bag makings in the above-mentioned methods.Described in preparation
The step of barrier protection bag 20 includes: the compound of each functional sheet film, curing, and requires heat-sealing bag making according to pouch-shaped size.With
Under the manufacturing process of barrier protection bag 20 will be further described:
(1), each functional sheet film is compound: making polypropylene screen, polycaprolactam film (or modified polypropene film) respectively, gathers
Terephthaldehyde's ethyl glycol ester film, and aluminum oxide slurry is coated on the inboard surface of parylene's glycol ester film
Material；Three are coated in polypropylene screen, polycaprolactam film (or modified polypropene film) and parylene's glycol ester film
Three-layer tablet film is closely bonded together by applied adhesive on the surface of Al 2 O, by pressing composite material film；
(2), it cures: by prepared composite material film, 24-36h is cured at a temperature of 23-26 DEG C, to obtain product ruler
Very little stable barrier material film, the test of the product Key Quality include barrier properties for gases etc..
(3), bag making: according to pouch-type size requirements, being cut into specific dimensions for aforementioned barrier material film, is made three through heat-sealing
The outer bag of face sealing is for subsequent use.Wherein polypropylene is as weld seam layer, and polyester layer is as heatproof barrier layer.In this process
In, it needs to detect the heat-sealing peel strength of barrier protection bag 20, seals air-tightness, pouch-shaped size.
Above-mentioned process is process known in the art, and details are not described herein for specific process step.
When lid 13 is the bivalve combined cap of structure in Fig. 2-Fig. 5 in the above-mentioned methods, the preparation method of combined cap includes
Following steps: injection molding forms inner cover 132 and outer cover 131 respectively, and forming includes partly overlapping two circular portions, two circles
Shape part combines butterfly-shaped gasket 133: gasket 133 being arranged between inner cover 132 and outer cover 131, by inner cover 132, gasket
133 and outer cover 131 be press-fitted together as one to form combined cap.Above-mentioned inner cover 132 and outer cover 131 is made of polypropylene material,
Gasket 133 is made of a material with good elastic shrinkage.In the present embodiment, gasket 133 is rubber mat.
Through the above steps, by forming two circular portions with partial overlap, and two circular portions combine
Butterfly-shaped gasket 133, can not only save material, reduce cost, make two pinpricks using when not will cause secondary dirt
Dye, and the resulting gasket can provide bigger retraction force, and the colloid of gasket is made to hold syringe needle tightly, prevent gasket sliding and
Leakage does not occur for invagination, and design is reasonable, securely and reliably.
The step of sealing the flange of the inner bag ontology 11 with lid 13 in the above-mentioned methods includes: to protect in hundred-level laminar flow
Under, the sack flange of ontology and combined cap heat (heter temperature: 750-850 simultaneously to internal bag after filling and sealing medical fluid is filling
DEG C), the duration 1 to 5s keeps bag body and combined cap melting sealed.Hundred-level laminar flow is pharmaceutical environment air cleaning rank.
The step of sodium bicarbonate injection is prepared in the above method includes: (1) concentrated compounding: appropriate brand-new is injected in dissolving tank
The sodium bicarbonate of calculation amount is added in water for injection, by dilute medicinal carbon that 0.01% (g/ml) is added with volume, stirring, mistake
Filter, flushing water are filled into dilute preparing tank together.(2) dilute to match: benefit adds to the full amount of water for injection, cycle balance.
In the above method, it is filled with carbon dioxide gas into the sodium bicarbonate injection medical fluid and forms sodium bicarbonate injection
The step of liquid medicine liquid mixture includes: that will pass through the 0.22 filtered carbon dioxide of micrometer polytetrafluoroethylene material filter device
(the above high-purity carbon dioxide of purity 99.99vt%) is filled with and (is filled with by stainless steel pipes) shape into sodium bicarbonate injection medical fluid
At sodium bicarbonate injection medicine liquid mixture.After being filled with carbon dioxide, pH value (7.8~8.3), content are detected, are filtered after qualified,
Check that medicinal liquid clarity obtains sodium bicarbonate injection medical fluid.It is filling: in the presence of carbon dioxide gas, by the sodium bicarbonate
In the injection medical fluid inner bag ontology 11, it is filled with the air of carbon dioxide gas displacement liquid level to sack, uses lid
The flange of the 13 sealing inner bag ontologies 11, forms the polypropylene vertical type inner bag 10.
In the preparation method of above-mentioned butt-ended bag infusion double-layer sterile packaging system, by the polypropylene vertical type inner bag 10
It being fitted into barrier protection bag 20, sealing vacuumized in the step of forming double-layer structure butt-ended bag, and sealing is to use vacuum packing machine,
It is carried out using heating in vacuum welding procedure.Specifically, the barrier protection bag 20 of polypropylene vertical type inner bag 10 will be housed, put into
On the indoor silica gel strip of the vacuum of vacuum packing machine, the lid of vacuum chamber is covered, vacuum pump starts to generate vacuum, when vacuum reaches
After required vacuum degree 95% (being equivalent to -0.095Mpa), start the opening for sealing barrier protection bag 20.In order to pack heat-sealing portion
Position tolerance high-temperature sterilization, using the double envelope line heat-sealable ways of the bis- envelope types of 3-5mm.Meanwhile for barrier protection bag 20 when clinical use
Convenient for opening, tearable mouth is equipped at left and right sides of the lower part of double envelope lines of outer bag.
In the preparation method of above-mentioned sodium bicarbonate injection butt-ended bag packaging system, by the double-layer structure butt-ended bag into
In the step of row sterilization treatment, according to the filling sodium bicarbonate injection medical fluid of sodium bicarbonate injection butt-ended bag packaging system
Property condition selected to use.By taking sodium bicarbonate injection medical fluid as an example, sterilising conditions are 119-121 DEG C of constant temperature sterilizing 12-
15 minutes, preferably 121 DEG C of constant temperature sterilized 12 minutes.
Using the above-mentioned sodium bicarbonate injection butt-ended bag packaging system of the present invention, by using including in polypropylene vertical type
The double-deck sodium bicarbonate injection butt-ended bag packaging system of bag and barrier protection bag replaces vial, can be to avoid because using glass
It is insufficient caused by bottle packaging.By forming vacuum-sealed cavity in barrier protection bag, polypropylene vertical type inner bag is contained in
Vacuum sealing is intracavitary, because avoiding the filling gas in seal chamber, can overcome while improving gas permeation problems
The defect of the deformation of bag body caused by gas expansion when high-temperature sterilization or broken bag, improves sodium bicarbonate injection butt-ended bag packet
The safety of dress system, it is advantageously ensured that the gas in the sealed package system is in equilibrium state, to guarantee the quality of product.
Moreover, the preparation method of the above-mentioned sodium bicarbonate injection butt-ended bag packaging system of the application present invention, by by institute
It states polypropylene vertical type inner bag 10 and is fitted into after barrier protection bag 20 to be sealed and vacuumize and then formed in barrier protection bag true
Empty seal chamber, to, because avoiding the filling gas in seal chamber, be overcome in high temperature while improving gas permeation problems
The defect of the deformation of bag body caused by gas expansion when sterilizing or broken bag improves sodium bicarbonate injection butt-ended bag packaging system
The safety of system.Moreover, this method carries out sterilization treatment after forming double-layer structure butt-ended bag, polypropylene vertical type is avoided
The secondary pollution of inner bag 10 improves product safety in utilization.Meanwhile because avoiding the filling gas in seal chamber, also improve
Thermal break-through power in sterilization process, improves sterilization effect.In addition, simplifying preparation process, avoid because gas heating is swollen
It is swollen, caused bag body broken bag or deformation.
It is upright below with reference to the above-mentioned sodium bicarbonate injection butt-ended bag packaging system of the present invention and sodium bicarbonate injection
The practical application of the preparation method of bag packaging system is illustrated its effect.
One, the barriering effect of barrier protection bag proves
(1) material illustrates: outward successively including inner layer of polypropylene (100 μm), adhesive layer, polycaprolactam by seal chamber
Parylene's glycol ester outer layer of aluminum oxide is coated on middle layer (14 μm), adhesive layer and inner surface
(12μm)
(2) test item and test method:
Steam penetrating capacity: measuring referring to steam penetrating capacity measuring method (YBB00092003), and condition is 37.8 DEG C of temperature
± 0.6 DEG C, relative humidity 90% ± 2%.
Nitrogen, carbon dioxide gas, oxygen transit dose: it is measured referring to gas transit dose measuring method (YBB00082003), item
23 DEG C ± 2 DEG C of part temperature.
Heat seal strength: being tested using puller system, and condition is 220 DEG C, 2.0kgf/cm2.2sec。
(3) test result: three groups of samples of different batches are taken to be tested respectively, test result is as shown in table 1.
Table 1
By data in table 1 it is found that the steam penetrating capacity of this barrier material of the present invention can be lower than 1.0g/
(m2For 24 hours), nitrogen, carbon dioxide gas, oxygen transit dose can be lower than 1.0cm3/(m20.1MPa for 24 hours), and sterilize
Preceding heat seal strength is 35-45N/15mm, and the heat seal strength after sterilizing is 30-40N/15mm, can using this barrier material
Preferably realize barriers function, it is ensured that the gas in the sealed package system is in equilibrium state, to guarantee the quality of product.
Two, sodium bicarbonate injection medical fluid pH value detection proves
Using the above-mentioned sodium bicarbonate injection butt-ended bag packaging system of the present invention and sodium bicarbonate injection butt-ended bag packaging
The preparation method of system, before high-temperature sterilization step, the pH value of sodium bicarbonate injection butt-ended bag packaging system herb liquid is
7.8-8.3, after high-temperature sterilization step, sodium bicarbonate injection butt-ended bag packaging system herb liquid pH value is 7.8-8.3, is passed through
After storage in 24 months, the pH value of sodium bicarbonate injection butt-ended bag packaging system herb liquid is 7.8-8.3.
As shown in the above, using the above-mentioned sodium bicarbonate injection butt-ended bag packaging system of the present invention, by using packet
The sodium bicarbonate injection butt-ended bag packaging system for including polypropylene vertical type inner bag and barrier protection bag replaces vial, can keep away
Exempt from because using deficiency caused by glass bottle packaging.It is by forming vacuum-sealed cavity in barrier protection bag, polypropylene is upright
It is intracavitary that formula inner bag is contained in vacuum sealing, can fill in seal chamber while improving gas permeation problems because avoiding
Gas overcomes the defect of the deformation of bag body caused by the gas expansion in high-temperature sterilization or broken bag, improves sodium bicarbonate
The safety of injection butt-ended bag packaging system, while because avoiding the filling gas in seal chamber, also improve sterilization process
In thermal break-through power, improve sterilization effect.
The foregoing is only a preferred embodiment of the present invention, is not intended to restrict the invention, for the skill of this field
For art personnel, the invention may be variously modified and varied.All within the spirits and principles of the present invention, made any to repair
Change, equivalent replacement, improvement etc., should all be included in the protection scope of the present invention.
Claims (7)
1. a kind of sodium bicarbonate injection butt-ended bag packaging system, which is characterized in that the packaging system includes:
Polypropylene vertical type inner bag (10), inside, which is equipped with, accommodates sodium bicarbonate injection medical fluid (17) and carbon dioxide gas (18)
Medicament chamber (15)；
Barrier protection bag (20), seal chamber (21) of the inside equipped with the receiving polypropylene vertical type inner bag (10), described poly- third
Alkene vertical type inner bag (10) is sealingly received in the seal chamber (21), wherein the seal chamber (21) is vacuum-sealed cavity；
The barrier protection bag (20), is prepared by barrier material, and the barrier material successively includes poly- by seal chamber (21) outward
It is poly- to benzene two coated with aluminum oxide on propylene internal layer, polycaprolactam or modified polypropene middle layer and inner surface
Propylene Glycol ester outer layer；The inner layer of polypropylene with a thickness of 70-100 μm, polycaprolactam or modified polypropene middle layer
With a thickness of 10-26 μm, inner surface be coated with parylene's glycol ester outer layer of aluminum oxide with a thickness of 10-14
μm；
The polypropylene vertical type inner bag (10) includes: inner bag ontology (11) and lid (13), and inner bag ontology (11) is equipped with method
Orchid, the medicament chamber (15) are arranged in the inner bag ontology (11)；The flange phase of lid (13) and the inner bag ontology (11)
Even to seal the medicament chamber (15), the inner bag ontology (11) blows drawing process integrated molding using note.
2. sodium bicarbonate injection butt-ended bag packaging system according to claim 1, which is characterized in that the barrier material
In fixed by adhesive layer between each layer.
3. sodium bicarbonate injection butt-ended bag packaging system according to claim 2, which is characterized in that the lid (13)
For combined cap, the combined cap includes: including outer cover (131), inner cover (132) and to be arranged in the inner cover (132) and outer cover
(131) gasket (133) between, the gasket (133) are the integrated design, including partly overlapping two circular portions, institute
Stating two circular portions and combining is in butterfly, is provided at the top of the outer cover (131) and opens boss (134), the unlatching boss
(134) card slot to fasten with the gasket (133) is provided on the inside of.
4. sodium bicarbonate injection butt-ended bag packaging system according to claim 3, which is characterized in that the gasket
(133) it is provided with positioning groove (135) on and is located at the pinprick (138) of the positioning groove (135) bottom, the inner cover
(132) it is provided on positioning convex platform (136), the positioning groove (135) on the positioning convex platform (136) and the gasket (133)
It combines closely,
Two unlatchings boss (134) and two circular portions of the gasket (133) are arranged in a one-to-one correspondence,
It is each it is described open boss (134) on be respectively provided with pull folding it is described open boss (134) pull folding valve (137).
5. the method for preparing a kind of sodium bicarbonate injection butt-ended bag packaging system according to claim 1, feature exist
In, the preparation method the following steps are included:
Form the polypropylene vertical type that sodium bicarbonate injection medical fluid and carbon dioxide gas are filled in internal medicament chamber (15)
Inner bag (10)；
The polypropylene vertical type inner bag (10) is fitted into barrier protection bag (20), sealing vacuumizes that form double-layer structure upright
Bag；
The double-layer structure butt-ended bag is subjected to sterilization treatment, obtains the sodium bicarbonate injection butt-ended bag packaging system；
Sodium bicarbonate injection medical fluid is filled in medicament chamber (15) inside the formation and the polypropylene of carbon dioxide gas is straight
The step of vertical inner bag (10) includes:
Sodium bicarbonate injection medical fluid is prepared, and is filled with carbon dioxide gas into the sodium bicarbonate injection medical fluid and forms carbon
Sour hydrogen sodium injection medicine liquid mixture；
It is respectively formed inner bag ontology (11) and lid (13)；
By in the sodium bicarbonate injection medical fluid inner bag ontology (11), carbon dioxide gas is filled with into bag,
The air for replacing dosing space seals the flange of the inner bag ontology (11) with lid (13), forms the polypropylene vertical type
Inner bag (10).
6. preparation method according to claim 5, which is characterized in that the step of the preparation sodium bicarbonate injection medical fluid
Include:
Concentrated compounding: injecting appropriate water for injection in dissolving tank, and the sodium bicarbonate of calculation amount is added, and is added by 100ml is dilute with volume
The medicinal carbon of 0.01g stirs, and filtering obtains concentrated wiring liquid；
It is dilute to match: to mend and add to the full amount of water for injection in concentrated wiring liquid, preparation obtains sodium bicarbonate injection medical fluid.
7. preparation method according to claim 6, which is characterized in that be filled with two into the sodium bicarbonate injection medical fluid
The step of carbon oxide gas formation sodium bicarbonate injection medicine liquid mixture includes: that will pass through 0.22 micrometer polytetrafluoroethylene material
The filtered carbon dioxide of filter device, which is filled into sodium bicarbonate injection medical fluid, forms the mixing of sodium bicarbonate injection medical fluid
Object.
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| CN107199734A (en) * | 2017-06-06 | 2017-09-26 | 石家庄鹏海制药股份有限公司 | The production technology of big soft infusion bag |
| CN110065713A (en) * | 2019-05-14 | 2019-07-30 | 嘉兴稳耀新材料有限公司 | A kind of transparent barrier property multi cavity container |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN202236306U (en) * | 2011-08-30 | 2012-05-30 | 北京锐业制药有限公司 | Multilayer co-extrusion transfusion double-chamber bag |
| CN103431996A (en) * | 2013-08-30 | 2013-12-11 | 山东华鲁制药有限公司 | Transfusion plastic container for containing medicine liquid |
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| US20030209453A1 (en) * | 2001-06-22 | 2003-11-13 | Herman Craig Steven | Method and package for storing a pressurized container containing a drug |
| CN201082253Y (en) * | 2007-09-10 | 2008-07-09 | 湖南千山制药机械股份有限公司 | Sodium bicarbonate injection plastic bag packaging |
| CN101401769A (en) * | 2008-11-12 | 2009-04-08 | 湖南千山制药机械股份有限公司 | Package container for sodium bicarbonate injection and method of preparing the same |
| CN104287965B (en) * | 2014-10-22 | 2018-02-16 | 石家庄四药有限公司 | Combination cover, upright infusion bag of bivalve and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN202236306U (en) * | 2011-08-30 | 2012-05-30 | 北京锐业制药有限公司 | Multilayer co-extrusion transfusion double-chamber bag |
| CN103431996A (en) * | 2013-08-30 | 2013-12-11 | 山东华鲁制药有限公司 | Transfusion plastic container for containing medicine liquid |
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