CN208389001U - A kind of dual-chamber bag for packing alanyl glutamine and amino acid (18) injection - Google Patents
A kind of dual-chamber bag for packing alanyl glutamine and amino acid (18) injection Download PDFInfo
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- CN208389001U CN208389001U CN201720400641.5U CN201720400641U CN208389001U CN 208389001 U CN208389001 U CN 208389001U CN 201720400641 U CN201720400641 U CN 201720400641U CN 208389001 U CN208389001 U CN 208389001U
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Abstract
One kind containing the infusion bag of alanyl glutamine and amino acid (18) injection, the infusion bag includes the infusion bag ontology hermetic barrier material external with this is covered on, two chambers are divided by the way that weak welding rod is arranged in infusion bag, are respectively provided with the moriamin-s of alanyl-glutamine injection and 18 kinds of amino acid composition.It is provided with oxygen absorbent between above-mentioned hermetic barrier material and ontology, to reduce the oxygen content in packaging, extends the pot-life of drug.
Description
Technical field
The utility model relates to a kind of multicell liquid liquid infusion products more particularly to a kind of packaging alanyl glutamines and ammonia
The dual-chamber bag of base acid (18) injection.
Background technique
Parenteral Nutrition Treatment is to provide an important means of nutritional support to inpatient, especially to tumour and
Enterogastric diseases etc. cannot be orally ingested for the patient of sufficient nutrition.Alanyl-glutamine injection is applicable to supplement
The patient of glutamine parenteral nutrition, the patient including being in catabolism and hypermetabolism situation.
Single bag of traditional alanyl-glutamine injection, before infusion, it is necessary to after being mixed with other carrier solutions together
Infusion, such as infusion with clinically common compatible amino acid solution or containing amino acid mix.Match in above-mentioned mixing
During liquid, the problems such as being easy to happen prescription compatibility of medicines taboo or mistake, the mistake of preparation or dosage, and also mixed liquid is store
Deposit the time shorten, stability it is poor, be not easy for a long time save.
In clinical practice, usually alanyl-glutamine injection, Amino Acid Compound Injection are filled by mixing duct
Enter and mixed in a specially designed aseptic plastic bag, human body is then inputted by the infusion port of polybag simultaneously again.This infusion
The greatest drawback of mode is to need the mixing tube for using a band there are three syringe needle, two of them syringe needle is each passed through to mixed
For the rubber plug of the two kinds of products closed into the liquid, third syringe needle is inserted into mixed bag, and medical fluid flows via a conduit in mixed bag, mixed
It closes uniform.Clearly as entire mixed process is manual operations, multiple puncture behavior destroys the sealing of product, slightly makes mistakes,
It is easy to cause the pollution of microorganism to product, and then after bringing infusion reaction, blood infection, septicemia etc. serious to patient
Fruit.For this purpose, large hospital usually aseptically carries out hybrid manipulation in the sterile preparation room specially set up.However, even if
Using aseptic technique, the probability of contaminating microorganisms is also more than one thousandth.In addition, the construction of sterile preparation room, dimension
Shield expense is quite high, will be a no small burden for the hospital of some middle and small hospitals and economically underdeveloped area,
It promotes with hindering mixing infusion model to a certain extent.Another disadvantage of this hybrid mode is repeatedly to puncture glue
Plug, be inevitably generated a large amount of rubber plug particle, into blood after be easy blocking capillary, cause microcirculation embolism.
Multicell liquid liquid infusion bag belongs to one kind of instant-matching type multi-chamber bag, is filled with liquid medicine in each chamber, chamber it
Between separated by openable weak welding rod, when in use, by bag body apply pressure can from weak welding rod open so that mixing
Drug is sufficiently mixed after medical fluid and is infused to human body from medical liquid discharge port.In general, weak welding rod in the prior art exist open by mistake open and
Contradiction easy to open is not allowed when use, therefore, it is necessary to the weld strengths of the weak welding rod to dual-chamber bag to carry out fine regulation, to protect
Demonstrate,prove weak welding rod unlatching and drug mixing it is controllable, while avoid storage and transportational process in opening by mistake for weak welding rod open.
Infusion products from factory to clinical use have certain period, dual-chamber bag during storage and placement, by
Certain air penetrability is still had in bag body, the oxygen in air can penetrate progressively through bag body and enter in bag to react with drug,
To influence the quality of medicament.Especially for the medicament of oxygen sensitive, there is very big quality risk.
It can be used in packing the material of infusion products soft bag including PVC, polyethylene, polypropylene etc., but above-mentioned material itself
Have the defects that it is certain, if PVC material contains carcinogenicity plasticizer phthalic acid di-isooctyl (DEHP), due to DEHP energy
For enough leakages in medical fluid, long-time service will affect hematopoiesis function；PVC material itself has gas permeability and permeability, and such as sterilize temperature
Degree control is bad, and infusion bag will appear situations such as whiting of free time water is opaque；And polythene material high temperature resistance is poor, disappears to high temperature
Poison is made troubles, and brittleness is higher at low temperature for polypropylene material.Therefore there is an urgent need to have the packaging material of good characteristic to protect
Demonstrate,prove the safety of infusion products.
Utility model content
It is unique that the purpose of the utility model is to provide a kind of structure novels, easy to use, and can be effectively reduced oxygen
The packaging alanyl glutamine of infiltration capacity, material safety and stable product quality, the dual-chamber bag of amino acid (18) injection produce
Product；The specific technical proposal is: a kind of dual-chamber bag for packing alanyl glutamine and amino acid (18) injection, including infusion
Bag ontology, the infusion bag ontology are divided into two chambers by weak welding rod；Infusion bag ontology two sides are covered with sealing
Barrier film；Described two chambers are independently packaged with alanyl-glutamine injection, amino acid (18) injection.
Further, the ratio between the utility model amino acid (18) injection and the liquid amount of alanyl-glutamine injection
The volume of at least 5:1, described two chambers are arranged in a manner of being suitable for accommodate respective liquid amount.Those skilled in the art can be with
Each chamber size can hold respective liquid amount after above-mentioned set-up mode, such as infusion bag forming is expressly understood, and after dress liquid
It will not cause infusion bag excessive bulging or sunken.
Further, the ratio between the utility model amino acid (18) injection and the liquid amount of alanyl-glutamine injection
It is 250ml for 5:1, such as liquid amount of amino acid (18) injection, the liquid amount of alanyl-glutamine injection is 50ml.
Further, in the alanyl-glutamine injection of the utility model and amino acid (18) injection, can contain
Qs pH adjuster, such as sodium hydroxide or dilute hydrochloric acid；Preferably, alanyl-glutamine injection pH range is 5.4-6.0,
Amino acid (18) injection is 5.0-7.0.
The infusion bag ontology of the utility model is mainly made of modified polypropene.Optionally, the modified polypropene membrane material
It is divided into three layers from the inside to the outside, wherein internal layer is made of polypropylene material, and middle layer is by polypropylene, polyethylene, styrene-ethylene-fourth
Alkene copolymer mixing composition, outer layer are made of polypropylene, the mixing of styrene-ethylene-butadiene copolymer.
In another embodiment, the modified polypropene membrane material is divided into three layers from the inside to the outside, and wherein internal layer is by poly- third
Alkene copolymer, hydrogenated styrene block copolymers, ethylene hydroxy acid ester copolymer composition, middle layer is by polypropylene copolymer, hydrogenation of benzene
Ethylene block copolymer composition, outer layer is by polypropylene copolymer, hydrogenated styrene block copolymers composition.
In the utility model, oxygen absorbent can be set between the infusion bag ontology and the barrier film.
Further, the oxygen absorbent is bulk, and quantity is 1 piece or muti-piece.
Further, the oxygen absorbent can be plane coating, stripe coating or netted coating.
Further, the oxygen absorbent can be one or more independent oxygen absorbent packagings.
Further, the oxygen uptake ability of the oxygen absorbent is not less than 100ml, is preferably not less than 200ml.
Further, the oxygen transit dose of the barrier film is not more than 1.0cm3/(m2Its 0.1MPa).
Wherein, oxygen transit dose cm3/(m2Its 0.1MPa) refer under 0.1MPa (atmospheric pressure) pressure differential, often put down
The volume for the gas that the barrier film of square rice is penetrated daily.
On the other hand, for need to avoid weak welding rod open by mistake open and need guarantee use when be easy open between there are lances
Shield, the utility model concentrate circular arc to solve the above problems using in the same side setting stress；Stress concentrate circular arc be corner to
The weak welding rod of the arc-shaped that inside is arched upward concentrates circular arc to make that stress point is concentrated on cambered one in artificial open by stress
End, guarantee suitably to increase still be easy when using after the weld strength of weak welding rod the weak welding rod opened, and increased welding it is strong
Degree can with maximum probability avoid weak opening by mistake for welding rod from opening.
Further, the same end of the weak welding rod have unidirectional circular arc radian, described one end be weak welding rod with it is defeated
One end of liquid bag ontology connection, described one end is preferably one end of liquid feeding mouth.
Further, the arc radius is 5mm between 23mm, preferably 8mm-20mm, such as 8mm, 10mm, 12mm,
15mm, 16mm, 18mm, 20mm.
Further, the weld strength of the weak welding rod is 5N/15mm-12N/15mm, preferably 7N/15mm-10N/
15mm, such as 7N/15mm, 8N/15mm, 8.5N/15mm, 9N/15mm, 9.5N/15mm, 10N/15mm.
In order to improve medication accuracy and bag stability, the liquid after reducing infusion is remained, provided by the utility model
The height of infusion bag ontology described in dual-chamber bag is not less than width.
It is further preferred that the width of the infusion bag ontology and the ratio of height are 0.7-1.0 or 0.8-1.0, such as
0.7,0.8,0.9,1.0。
Any one or more in the liquid feeding mouth of the two sides of the bottom of the utility model infusion bag ontology are arranged far from this chamber
The middle position of room, and can be used as medical liquid discharge port, preferably as far as possible with it is ipsilateral in the short transverse of infusion bag ontology
Real welding rod is close.
Any one or more in the liquid feeding mouth of the utility model bottom are arranged far from this chamber in a manner of integrally formed
The middle position of room.Liquid filling is arranged in the welding of mouth pipe on the body simultaneously when the integrally formed mode is included in ontology preparation
The position of mouth, makes a mouthful Guan Yuben body by integral forming.
A kind of illustrative scheme provided by the utility model is packaging alanyl glutamine and amino acid (18) injection
The dual-chamber bag of liquid, including infusion bag ontology, the infusion bag ontology are divided into two chambers by weak welding rod；The infusion bag sheet
Body two sides cover Packed barrier film；Described two chambers are independently packaged with alanyl-glutamine injection, ammonia
Base acid (18) injection；Oxygen absorbent is provided between infusion bag ontology and the barrier film；Weak welding rod is close to one end of liquid feeding mouth
It is provided with stress and concentrates circular arc, the width of infusion bag ontology and the ratio of height are 0.7-0.9.
Another illustrative scheme provided by the utility model is packaging alanyl glutamine and amino acid (18) note
The dual-chamber bag of liquid, including infusion bag ontology are penetrated, the infusion bag ontology is divided into two chambers by weak welding rod；The infusion bag
Ontology two sides cover Packed barrier film；Described two chambers be independently packaged with alanyl-glutamine injection,
Amino acid (18) injection；Oxygen absorbent is provided between infusion bag ontology and the barrier film；Weak welding rod close to liquid feeding mouth one
End is provided with stress and concentrates circular arc, and the ratio of the width of infusion bag ontology and height is 0.7-1.0, and the bottom two of infusion bag ontology
Any one or more in the liquid feeding mouth of side are arranged far from the middle position of this chamber in a manner of integrally formed.
The dual-chamber bag of further above-mentioned example also has one or more in following characteristics:
(1) infusion bag ontology membrane material is divided into three layers from the inside to the outside, and wherein internal layer is made of polypropylene material, and middle layer is by poly- third
Alkene, polyethylene, styrene-ethylene-butadiene copolymer mixing composition, outer layer is by polypropylene, styrene-ethylene-butadiene copolymer
Mixing composition or internal layer are made of polypropylene copolymer, hydrogenated styrene block copolymers, ethylene hydroxy acid ester copolymer, middle layer
It is made of polypropylene copolymer, hydrogenated styrene block copolymers, outer layer is by polypropylene copolymer, hydrogenated styrene block copolymerization
Object composition；
(2) it is 5mm to 23mm that stress, which concentrates the diameter of circular arc,；
(3) weld strength of weak welding rod is 5N/15mm-12N/15mm；
(4) oxygen absorbent is bulk, and quantity is 1 piece or muti-piece；Or the oxygen absorbent is plane coating, stripe coating or netted
Coating；Or the oxygen absorbent is one or more independent oxygen absorbent packagings；
(5) the oxygen uptake ability of oxygen absorbent is not less than 200ml；Or the oxygen transit dose of the barrier film is not more than 1.0cm3/
(m2Its 0.1MPa).
Further, it is 8mm-20mm that stress, which concentrates the diameter of circular arc, in the dual-chamber bag of above-mentioned example；The weldering of weak welding rod
Connecing intensity is 7N/15mm-10N/15mm；The width of infusion bag ontology and the ratio of height are 0.7,0.8,0.9 or 1.0.
Further, (18) injection of amino acid described in the dual-chamber bag of above-mentioned example and alanyl glutamine are injected
The ratio between liquid amount of liquid is at least 5:1, and the volume of described two chambers is arranged in a manner of being suitable for accommodate respective liquid amount.As institute
The liquid amount for stating alanyl-glutamine injection is 50 ± 5ml, the liquid amount of amino acid (18) injection is 250 ±
10ml。
In the dual-chamber bag of the utility model, every 50ml injection contains alanyl in the alanyl-glutamine injection
Glutamine 8-12g；Every 250ml injection contains valine 0.72-1.08g, threonine in amino acid (18) injection
0.5-0.75g, tryptophan 0.18-0.27g, R-gene 1-1.5g, alanine 0.4-0.6g, serine 0.2-0.3g, paddy
Propylhomoserin 0.15-0.23g, cystine 0.02-0.03g, isoleucine 0.7-1.06g, leucine 0.98-1.47g, phenylalanine
1.05-1.6g, methionine 0.45-0.68g, lysine hydrochloride 0.86-1.29g, histidine monohydrochloride 0.5-0.75g, proline
0.2-0.3g, tyrosine 0.05-0.08g, L-aminobutanedioic acid 0.5-0.75g, glycine 1.52-2.28g, sorbierite 10-15g are sub-
Sodium bisulfate 0.1-0.15g.
The utility model dual-chamber bag is by using the weak welding rod with the equidirectional radian in side, so that when using more easily
Weak welding rod is opened, and is opened alternately through the control of weak welding rod weld strength to avoid opening by mistake, ease of use is improved, overcomes
Weak welding rod in the prior art exist open by mistake open and using when do not allow contradiction easy to open.By being set in infusion bag outer body
Antioxygen barrier film is set, the barrier property of infusion bag and oxygen is improved.Oxygen absorbent is placed between antioxygen barrier film and infusion bag, into
One step improves the antioxidant capacity of infusion bag, extends the pot-life of medicament, it is ensured that product safety and stability within the shelf-life.By setting
The width of infusion bag ontology and the ratio of height are set, the position of medical liquid discharge port is set, the liquid residual after reducing infusion improves
The stability of bag body especially in infusion process improves medication accuracy and safety.The utility model selects modified polypropene
Material prepares three layers of infusion bag ontology as membrane material, overcomes the risk factors and self-defect that the traditional materials such as PVC come,
The heat resistance, clarity and mechanical strength of infusion bag are further improved, the safety and stability of infusion products is improved；Together
When, due to having different fusing points between trilaminate material, gradually rise from inside to outside, so that heat seal from the inside to the outside when welding, makes
It is more tight secured, and welding effect this product preferably that meets is to the particular/special requirement of weak weldering and fierce different weld strengths.
Detailed description of the invention
Fig. 1 is the dual-chamber bag structural schematic diagram of the utility model embodiment 1-3；
Fig. 2 is the dual-chamber bag structural schematic diagram of the utility model embodiment 4；
Fig. 3 is the structural schematic diagram of the infusion bag ontology of the utility model dual-chamber bag embodiment 5 and 6.
In figure: 1, infusion bag ontology；2, weak welding rod；3, barrier film；4, oxygen absorbent；5, stress concentrates circular arc；6, liquid feeding mouth.
Specific embodiment
The utility model is made a more thorough explanation below with embodiment.The utility model can be presented as it is a variety of not
Same form, should not be construed as limited to the exemplary embodiments described herein.
Embodiment 1
Dual-chamber bag in the present embodiment, as shown in Figure 1, including infusion bag ontology 1, infusion bag ontology 1 is according to alanyl paddy
The liquid amount of aminoacyl amine injection and amino acid (18) injection is divided into 2 chambers by weak welding rod 2, wherein larger chamber is built-in
Amino acid (18) injection, compared with the built-in alanyl-glutamine injection of small chamber, 1 two sides of infusion bag ontology are covered with sealing
Barrier film 3.
In order to further decrease the amount that oxygen penetrates into medicament, oxygen absorbent is provided between infusion bag ontology 1 and barrier film 3
4.The form packed with independent oxygen absorbent is arranged in oxygen absorbent, is placed on the region between infusion bag ontology and barrier film.
Oxygen absorbent 4 can be bulk, and quantity can be 1 piece, be also possible to muti-piece.
Two compartments of dual-chamber bag are distinguished into 18 kinds of filling 50ml alanyl-glutamine injection, 250ml amino acid notes
Liquid is penetrated, by adjusting the dosage of oxygen absorbent and the thickness of barrier film or material；By repetition test, find saturating in barrier bag oxygen
Guo Shuai≤1.0cm3/(m20.1MPa for 24 hours), oxygen absorbent oxygen uptake ability Man Zu≤200ml when, guarantee two chambers note
It is lower to penetrate the not exceeded lower product cost of the impurity of liquid before the deadline.
It wherein, include: 8g alanyl glutamine, appropriate dilute salt in filling 50ml alanyl-glutamine injection
Acid/sodium hydroxide and water.
Specifically, including following components and water in filling 250ml amino acid (18) injection:
| Component | Weight (g) |
| Leucine | 0.98g |
| Valine | 0.72g |
| Threonine | 0.5g |
| Tryptophan | 0.18g |
| R-gene | 1.00g |
| Alanine | 0.40g |
| Serine | 0.20g |
| Glutamic acid | 0.15g |
| Cystine | 0.02g |
| Isoleucine | 0.7g |
| Phenylalanine | 1.05g |
| Methionine | 0.45g |
| Lysine hydrochloride | 0.86g |
| Histidine monohydrochloride | 0.5g |
| Proline | 0.2g |
| Tyrosine | 0.05g |
| L-aminobutanedioic acid | 0.5g |
| Glycine | 1.52g |
| Sorbierite | 10g |
| Sodium hydrogensulfite | 0.1g |
| Sodium hydroxide | In right amount |
Embodiment 2
In the present embodiment, the filling 50ml alanyl-glutamine injection into infusion bag of the present invention, wherein wrapping
It includes: 10g alanyl glutamine, appropriate dilute hydrochloric acid/sodium hydroxide and water；Filling 250ml amino acid (18) injection, wherein
Including following components and water:
Embodiment 3
In the present embodiment, the filling 50ml alanyl-glutamine injection into infusion bag of the present invention, wherein wrapping
It includes: 10g alanyl glutamine, appropriate dilute hydrochloric acid/sodium hydroxide and water；Filling 250ml amino acid (18) injection, wherein
Including following components and water:
Embodiment 4
The dual-chamber bag of the present embodiment is as shown in Fig. 2, dual-chamber bag ontology is divided into 2 chambers by weak welding rod, not with embodiment 1
With in order to keep oxygen uptake ability in barrier film uniform, oxygen absorbent 4 being fixed in barrier film 3 with coating form, coating can be with
It is plane coating, stripe coating or netted coating.
Embodiment 5
The infusion bag of the present embodiment is as shown in figure 3, include infusion bag ontology 1, infusion bag ontology 1 is mainly by modified polypropene
Material is made, and ontology 1 is separated according to the liquid amount of alanyl-glutamine injection and amino acid (18) injection by weak welding rod 2
For 2 chambers, wherein the built-in amino acid of larger chamber (18) injection, volume 250ml, compared with the built-in alanyl paddy ammonia of small chamber
Amide injection, volume 50ml, the composition of two injections is as described in Example 1, and the weld strength of weak welding rod 2 is 10N/
15mm, in the same side, setting stress concentrates circular arc 5, and the diameter of stress circular arc 5 is 12mm, and stress concentrates circular arc 5 to be located at weak welding rod
Close to the side of liquid feeding mouth 6；Certainly, in other embodiments, also can be set in side of the weak welding rod far from liquid feeding mouth 6.
Using the present embodiment dual-chamber bag when, from the barrier film 3 of sealing take out infusion bag ontology 1, from liquid feeding mouth
Opposite side starts to squeeze infusion bag ontology 1 in any way to liquid feeding mouth direction, for example, with by infusion bag rolled fashion to
Liquid feeding mouth direction squeezes, and the stress that stress point concentrates on weak welding rod concentrates 5 region of circular arc, can help opening manually for weak welding rod
It opens.And the dual-chamber bag of the present embodiment is in storage and transport, and is not susceptible to open by mistake and open.
A series of infusion bag ontologies including the infusion bag ontology of the present embodiment are placed on storage transport test dress
It is tested in setting, the structure of these infusion bag ontologies is similar to Example 5, unlike, the stress of these infusion bag ontologies
The diameter of circular arc 5 is is respectively 0mm (unstressed circular arc), 2mm, 3mm, 5mm, 8mm, 12mm, 20mm, 25mm, through repetition test
It was found that the infusion bag ontology that stress arc diameter is 25mm is significantly larger than this examination in the rate of opening that opens by mistake stored in trafficking experiments device
The infusion bag ontology of other stress arc diameters opens by mistake the rate of opening in testing.Further, after storing trafficking experiments, by institute
Some infusion bag ontologies take out, manually opened, find through repetition test, and stress arc diameter is the infusion bag of 0mm, 2mm, 3mm
Ontology, manually opened difficulty is big, is far longer than the manually opened difficulty of the infusion bag ontology of other stress arc diameters in this test
Degree, especially the infusion bag ontology of stress arc diameter 0mm, manually opened difficulty are maximum.
Embodiment 6
As shown in figure 3, the infusion bag ontology 1 of the present embodiment, the width of infusion bag ontology 1 and the ratio of height are 0.8, often
A chamber is provided with a liquid feeding mouth 6, and liquid feeding mouth 6 can also be used as medical fluid delivery outlet, in the present embodiment, in order to further
The liquid residue for reducing infusion port selects a liquid feeding mouth in two side cavities as medical fluid delivery outlet, exports as medical fluid
The middle position far from this chamber, in the present embodiment, two side cavities is arranged in the position of the liquid feeding mouth of mouth in a manner of being integrally formed
Liquid feeding mouth be arranged in this wise, the option as medical fluid delivery outlet is selective, such as selection right side compared with small chamber liquid feeding mouth make
For medical fluid delivery outlet or select the larger chamber liquid feeding mouth in left side as medical fluid delivery outlet.In fact, it should be understood that also can be set
The liquid feeding mouth of leftmost side chamber or rightmost side chamber is in a manner of being for example integrally formed as close to the leftmost side or the rightmost side
Real welding rod in short transverse, the liquid feeding mouth being arranged so are preferentially selected as medical fluid delivery outlet when in use, other chambers
There is no restriction for the setting position of liquid feeding mouth.
The two chambers of dual-chamber bag are distinguished into filling 50ml alanyl-glutamine injection, 18 kinds of amino acid notes of 250ml
Liquid is penetrated, the ratio of the width and height that adjust different infusion bag ontologies obtains different pouch-shapeds；By repetition test, find in width
When the ratio of degree and height is 1.2, the Liquid Residue scale of construction will be more than 1%, extreme influence infusion accuracy.
Different in width and the infusion bag ontology of height ratio (the ratio of width to height) are further subjected to filling test (the third ammonia of 50ml
Acyl glutamine injection, 18 kinds of amino acid injections of 250ml), in addition to width and height ratio are different, infusion bag its
His structure feature is identical as the present embodiment, and width and height ratio are respectively 0.5,0.7,0.8,0.9,1.0,1.3,1.5, warp
Repetition test discovery is crossed, width and height ratio are significantly greater than for the liquid residue of 0.5 and 1.3,1.5 infusion bag ontology
The infusion bag ontology that width and height ratio are 0.7,0.8,0.9,1.0, and at the end of infusion closes on, width and height
The infusion bag ontology that ratio is 0.5 and 1.3,1.5 is easier to run-off the straight than the infusion bag of other the ratio of width to height in this test.
Embodiment 7
Infusion bag (3 infusion bag of embodiment) packaging material performance after 121 DEG C of moist heat sterilizations is investigated, specific method packet
It includes:
Thermal adaptability: taking 10 bags of each batch of sample inner bag, under the conditions of -25 DEG C ± 2 DEG C, places 24 hours, then 50
Under the conditions of DEG C ± 2 DEG C, continue to place 24 hours, then under the conditions of 23 DEG C ± 2 DEG C, places 24 hours, it is flat that sample is first placed in two
Between row plate, the internal pressure of 30kPa is born, is maintained 10 minutes, investigates whether weak weldering position opens；By appropriate ways by weak weldering
After item fully opens, sample is placed between two parallel plates, bears the internal pressure of 67kPa, is maintained 10 minutes, checks bag body surrounding
(real weldering position) has no liquid leakage.
Light transmittance: taking 5 bags of each batch of sample, discard chamber contents, chooses the smooth position of ontology, is cut into 5 0.9cm
The slice of × 4cm, is cleaned up with deionized water, is put into absorption cell along incident light vertical direction respectively, topped up with water, and with water
As blank, according to UV-VIS spectrophotometry (four general rules 0401 of " Chinese Pharmacopoeia " version in 2015), surveyed at 450nm
Determine light transmittance.
Inner bag heat sealing strength: taking 1 bag of each batch of sample, according to compound in heat sealing strength measuring method (YBB00122003-2015)
The method measurement of bag.
Overall tightness: taking 10 bags of each batch of sample, is respectively put into sample in the closed container of dress water, keeps bag body in water
It is middle to be flooded completely, to the negative pressure of container application -67kPa, 5min is kept, has seen whether that bubble is overflowed from bag body into water.
Test result is as follows:
By test result it is found that three layers of infusion bag being made into of modified polypropylene material are selected in the utility model, at 121 DEG C
Still have good light transmittance in each test phase after moist heat sterilization, 88% or more, meet relevant criterion, shows this
Utility model membrane material heat resistance is good；The membrane material weak weldering position in temperature adaptability test is able to bear the pressure of 30kPa
Power and be not turned on, real weldering is able to bear the pressure of 67kDa and no liquid leaks out, and weldering part heat sealing strength is not in fact for inner bag bag body surrounding
Lower than 20N/15mm, weak weldering position is not less than 5N/15mm, and is not higher than 12N/15mm, and infusion bag overall tightness is good, can
See the heat seal welding carried out using the utility model trilamellar membrane material, can be good at adapting to the weak weldering of this double-chamber transfusion bag and welds in fact
It is specific to need, product mechanical strength with higher.
After two-chamber injection is mixed, the compatibility and safety of infusion bag material and injection are further investigated, as a result
It is as shown in the table:
The results show that the infusion bag of the utility model modified polypropene material preparation, not plasticizer-containing, with alanyl paddy ammonia
Amidoamino acid (18) injection compatibility is good, and conventional character is good, osmotic pressure molar density, visible foreign matters, insoluble micro-
Grain, Bacteria Detection, endotoxin detection, depressor, undue toxicity detection and conventional shape etc. meet pharmacopoeial requirements, and display is originally
Alanyl glutamine amino acid (18) the injection liquid two-chamber transfusion Product Safety of utility model is good.
In conclusion the dual-chamber bag of the application has the following characteristics that
(1) the setting extension of oxygen absorbent and barrier bag includes the pharmaceutical liquid pot-life；
(2) welding rod is not easy to open by mistake during transporting or save, and it is convenient to open when use；
(3) discharge of the Width x Height than being conducive to include pharmaceutical liquid of the setting position of outlet, pouch-shaped；
(4) selection of modified polypropene membrane material further improves drug safety, clarity and mechanical performance.
It should be understood that the infusion bag ontology described in the utility model for being divided into several chambers by weak welding rod may include
Such as: three Room, four Room, five Room etc..It is (including for example raw to can be also used for containing liquid according to use demand for other described chambers
Manage brine injections etc.).
Above-mentioned example is only intended to illustrate the utility model, and in addition to this, also there are many different embodiments, and these
Embodiment be all those skilled in the art after comprehension the utility model thought it is also envisioned that therefore, no longer arrange one by one herein
It lifts.
Claims (3)
1. a kind of dual-chamber bag for packing alanyl glutamine and amino acid (18) injection, including infusion bag ontology, described defeated
Liquid bag ontology is divided into two chambers by weak welding rod, and each cavity bottom is provided with liquid feeding mouth, liquid feeding mouth setting with infusion bag
Ipsilateral real welding rod in the short transverse of ontology is close；Infusion bag ontology two sides cover Packed barrier film；It is described
Two chambers are independently packaged with alanyl-glutamine injection, amino acid (18) injection；Infusion bag ontology with it is described
Oxygen absorbent is provided between barrier film；Weak welding rod is provided with stress close to one end of liquid feeding mouth and concentrates circular arc, and stress concentrates circular arc
Corner arch upward inwardly, the same end of weak welding rod has unidirectional circular arc radian, and one end is weak welding rod and infusion bag sheet
One end of body connection, described one end are preferably one end of liquid feeding mouth, and the width of infusion bag ontology and the ratio of height are 0.7-0.9；
The ratio between amino acid (18) injection and the liquid amount of alanyl-glutamine injection are at least 5:1, described two chambers
Volume be arranged in a manner of being suitable for accommodate respective liquid amount, the liquid amount of the alanyl-glutamine injection is 50 ±
5ml, the liquid amount of amino acid (18) injection are 250 ± 10ml, and the dual-chamber bag has in following characteristics one or more
:
(1) it is 5mm to 23mm that stress, which concentrates the diameter of circular arc,；
(2) weld strength of weak welding rod is 5N/15mm-12N/15mm；
(3) oxygen absorbent is bulk, and quantity is 1 piece or muti-piece；Or the oxygen absorbent is plane coating, stripe coating or netted painting
Layer；Or the oxygen absorbent is one or more independent oxygen absorbent packagings；
(4) the oxygen uptake ability of oxygen absorbent is not less than 200ml；Or the oxygen transit dose of the barrier film is not more than 1.0cm3/(m2·
Its 0.1MPa).
2. dual-chamber bag as described in claim 1, it is 8mm-20mm that the stress, which concentrates the diameter of circular arc,；The weldering of the weak welding rod
Connecing intensity is 7N/15mm-10N/15mm；The width of the infusion bag ontology and the ratio of height are 0.7,0.8 or 0.9.
3. a kind of dual-chamber bag for packing alanyl glutamine and amino acid (18) injection, including infusion bag ontology, described defeated
Liquid bag ontology is divided into two chambers by weak welding rod, and each cavity bottom is provided with liquid feeding mouth, liquid feeding mouth setting with infusion bag
Ipsilateral real welding rod in the short transverse of ontology is close；Infusion bag ontology two sides cover Packed barrier film；It is described
Two chambers are independently packaged with alanyl-glutamine injection, amino acid (18) injection；Infusion bag ontology with it is described
Oxygen absorbent is provided between barrier film；Weak welding rod is provided with stress close to one end of liquid feeding mouth and concentrates circular arc, and stress concentrates circular arc
Corner arch upward inwardly, the same end of weak welding rod has unidirectional circular arc radian, and one end is weak welding rod and infusion bag sheet
One end of body connection, described one end are preferably one end of liquid feeding mouth, and the width of infusion bag ontology and the ratio of height are 0.7-1.0,
The ratio between amino acid (18) injection and the liquid amount of alanyl-glutamine injection are at least 5:1, and infusion bag ontology
Two sides of the bottom liquid feeding mouth in any one or more the middle position of this chamber is arranged far from a manner of integrally formed.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201620739119 | 2016-07-14 | ||
| CN2016207391195 | 2016-07-14 |
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|---|---|
| CN208389001U true CN208389001U (en) | 2019-01-18 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201720400641.5U Active CN208389001U (en) | 2016-07-14 | 2017-04-17 | A kind of dual-chamber bag for packing alanyl glutamine and amino acid (18) injection |
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| CN (1) | CN208389001U (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021043120A1 (en) * | 2019-09-05 | 2021-03-11 | 复旦大学附属中山医院 | Compound amino acid dipeptide injection and preparation method therefor and application thereof |
| CN113171340A (en) * | 2021-05-07 | 2021-07-27 | 四川科伦药业股份有限公司 | Alanyl glutamine injection and production process thereof |
| WO2022022358A1 (en) * | 2020-07-27 | 2022-02-03 | 四川科伦药业股份有限公司 | Liquid-leakage-proof polypropylene infusion bag having composite weak welding rods |
-
2017
- 2017-04-17 CN CN201720400641.5U patent/CN208389001U/en active Active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021043120A1 (en) * | 2019-09-05 | 2021-03-11 | 复旦大学附属中山医院 | Compound amino acid dipeptide injection and preparation method therefor and application thereof |
| WO2022022358A1 (en) * | 2020-07-27 | 2022-02-03 | 四川科伦药业股份有限公司 | Liquid-leakage-proof polypropylene infusion bag having composite weak welding rods |
| CN113171340A (en) * | 2021-05-07 | 2021-07-27 | 四川科伦药业股份有限公司 | Alanyl glutamine injection and production process thereof |
| WO2022233209A1 (en) * | 2021-05-07 | 2022-11-10 | 四川科伦药业股份有限公司 | Alanyl-glutamine injection and production process therefor |
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