CN107554877A - A kind of non-PVC-soft-bag-packaged peritoneal dialysis liquid product and its production method - Google Patents
A kind of non-PVC-soft-bag-packaged peritoneal dialysis liquid product and its production method Download PDFInfo
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- CN107554877A CN107554877A CN201610502431.7A CN201610502431A CN107554877A CN 107554877 A CN107554877 A CN 107554877A CN 201610502431 A CN201610502431 A CN 201610502431A CN 107554877 A CN107554877 A CN 107554877A
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Abstract
The invention discloses a kind of non-PVC-soft-bag-packaged peritoneal dialysis liquid product and its production method, belong to the technical field of peritoneal dialysis.The present invention includes packaging system, and packaging system includes peritoneal dialysis liquid bag, liquid medicine catheter and waste pipe, and peritoneal dialysis liquid bag is provided with sterile outer bag built with dialyzate, the outside of packaging system；Peritoneal dialysis liquid bag is co-extrusion film and the non-PVC plastic infusion bag produced in the form of double width film, infusion bag has been welded to connect chemical feed pipe, infusion bag has also been welded to connect woven hose, liquid medicine catheter and waste pipe can disk into a diameter of 10 15cm circle, be equipped with gripping mechanism on liquid medicine catheter and waste pipe.The present invention contains dialyzate using non-PVC plastic infusion bag, avoids harm of the PVC packaging bags to patient；The infusion bag of the present invention avoids the phenomenon that leakage easily occurs when the soft bag that non-PVC film material makes contains Large Copacity preparation in itself and its with chemical feed pipe and woven hose using being welded to connect.
Description
Technical field
The invention belongs to the technical field of peritoneal dialysis, particularly relates to a kind of non-PVC-soft-bag-packaged peritoneal dialysis solution production
Product and its production method.
Background technology
Currently, peritoneal dialysis occupies more and more consequence in the alternative medicine of chronic renal failure.Successfully
Peritoneal dialysis peritonaeum good dependent on function first.Factors may cause the damage of this natural pellicle, such as abdomen
Film is scorching, peritoneal dialysis solution biocompatibility is relatively bad, abdominal cavity can cause peritonaeum that pathologic, physiologic occurs using various medicines etc.
Change, including permeability changes, ultrafiltration failure, defence capability reduction easily cause infection and generation fibrosis etc., finally result in dialysis
It is insufficient, it has to abandon such a treatment.For many years, one of direction that nephrosis scholar and relevant expert are continually striving to is to study simultaneously
Improve the biocompatibility of peritoneal dialysis solution, extend peritonaeum service life, improve the survival rate of patients undergoing peritoneal dialysis.
At present, the peritoneal dialysis solution of clinical practice uses PVC（Polyvinyl chloride）The plastic soft bag packaging of material, in order to protect
Demonstrate,prove infusion bag flexibility and resilience, it is necessary in polyvinyl chloride resin add 30-40% plasticizer, such as widely used DEHP
[phthalic acid two (2- ethyl hexyls) ester].Meanwhile in order to improve the heat endurance in polyvinyl chloride resin process, it is necessary in base
A certain amount of heat stabilizer is added in body resin.Because plasticizer and heat stabilizer can migrate out into being used as medicine under certain condition
In thing solution, the health of patient is brought potentially hazardous.Plasticizer is main to influence life based on environmental hormone class toxicity
The normal physiological function of thing body internal hormone class material.
Further, since the plastic soft bag hardness of non-PVC material is big, heat seal difficulty is big, and 1000mL is packed using non-PVC material
Large Copacity preparation above, leakage easily occurs in use is transported；Also, the easy scratch patient in corner of sack.At present, it is domestic
Commercially available peritoneal dialysis solution is with PVC packed in flexible pouchy.
The content of the invention
The present invention provides a kind of non-PVC-soft-bag-packaged peritoneal dialysis liquid product and its production method, solves existing skill
There is PVC soft packaging bags potentially hazardous and non-PVC soft packaging bags easily to be sent out when containing Large Copacity preparation to patient body in art
The problem of raw leakage.
A kind of non-PVC-soft-bag-packaged peritoneal dialysis liquid product of the present invention, it mainly adds by the following technical programs
With realization：The peritoneal dialysis liquid product includes packaging system, and the packaging system includes peritoneal dialysis liquid bag, decoction is led
Pipe, waste pipe, Y-connector, waste fluid bag and protective cap, the peritoneal dialysis liquid bag is built with peritoneal dialysis solution, the bag
The outside of dress system is provided with sterile outer bag；The bottom of the peritoneal dialysis liquid bag is connected with the Y by the liquid medicine catheter
Type connector, the other both ends of the Y-connector are connected with the protective cap and the waste pipe in turn, and the waste liquid is led
The end of pipe is connected with the waste fluid bag；The peritoneal dialysis liquid bag is non-PVC plastic infusion bag, the non-PVC plastic transfusion
Bag is the co-extrusion film produced in the form of double width film, and the non-PVC plastic infusion bag is provided with chemical feed pipe and woven hose, described to add
Pencil is provided with dosing valve, and the woven hose is provided with easy folding plug；The non-PVC plastic infusion bag connects with chemical feed pipe welding
Connect, the non-PVC plastic infusion bag and the woven hose also to be welded to connect, the liquid medicine catheter can disk into a diameter of 10-
15cm circle, the liquid medicine catheter are provided with gripping mechanism, the waste pipe also can disk into a diameter of 10-15cm circle
Enclose, gripping mechanism also is provided with the waste pipe.
The present invention is a complete peritoneal dialysis liquid product, and its outermost layer is sterile outer packing, sterile outer packing it is interior
Portion is provided with peritoneal dialysis liquid bag, and peritoneal dialysis liquid bag is connected with Y-connector by liquid medicine catheter, in the effect of Y-connector
Under, the dialysis that can be done directly peritoneal dialysis solution uses；Its is easy to use, without configuration transfusion catheter, waste pipe in addition
And connector, in the presence of protective cap, the dialyzate that ensure that into human body cleans, is clean and sterile, and can be by useless
Waste liquid is received between liquid bag.Meanwhile the present invention contains dialyzate using non-PVC plastic infusion bag, avoids and increases in PVC packaging bags
Modeling agent and heat stabilizer migrate into dialyzate and bring harm to the health of patient；The non-PVC plastic infusion bag is
Co-extrusion film and produced in the form of " double width film ", non-PVC plastic infusion bag in itself, non-PVC plastic infusion bag and chemical feed pipe and
Non- PVC plastic infusion bag welding position sealing even uniform, leaving no air bubbles inside, is kept away in itself with woven hose using being welded to connect
Exempt from non-PVC film material and make the phenomenon that leakage easily occurs when soft bag contains Large Copacity preparation.
As a kind of preferred embodiment, the gripping mechanism has a 3-5, and the gripping mechanism is clip, lock, saturating
One or more in gelatin, double faced adhesive tape, VELCRO.By gripping mechanism by transfusion catheter and waste pipe disk into circle point
It is not fixed, prevents it from scattering, is easy to storage and the packaging of transfusion catheter and waste pipe, gripping mechanism is easily opened, when
When the product is used, transfusion catheter and waste pipe is facilitated to unfold to itself original length, to facilitate peritonaeum saturating
Analysis.
As a kind of preferred embodiment, the prescription of the peritoneal dialysis solution is：Glucose 10-60g, sodium chloride 1-
10g, calcium chloride 0-5g, magnesium chloride 0-5g, sodium lactate 1-10g, appropriate water for injection, full dose 1000mL, pH value 4.5-
5.5.This peritoneal dialysis solution pH stable of the present invention, more conforms to the physiological ph of human body, and glucose degradation products are few, special
It is not that the hazardous decomposition products such as 5 methyl furfural are few, is beneficial to human body long-term use.
As a kind of preferred embodiment, the preparation technology of the peritoneal dialysis solution is：Into with container, temperature is added
Spend the recipe quantity fresh water for injection of the 70-90% for 40-70 DEG C, added successively according to prescription glucose, sodium chloride, calcium chloride,
Magnesium chloride, sodium lactate, stir fully dissolving 10-20min；The water for injection of 40-70 DEG C of addition stirs 15- to prescription full dose
25min, watery hydrochloric acid is added to adjust pH to 4.5-5.5；Sampling, examine, assay meets product or inspection of semifinished product standard, through pre-
It is filling in non-PVC plastic infusion bag after filtering and end-filtration.The preparation technology operation of this peritoneal dialysis solution of the present invention
Simply, mild condition, easy to control, production efficiency is high；Raw material sources are wide, cheap and easy to get, and cost is low, reduce the economy of patient
Burden.
As a kind of preferred embodiment, the volume of the peritoneal dialysis liquid bag is 1000-3000mL.It is of the invention special
It is suitable for containing the preparation of Large Copacity, particularly more than 1000mL capacity, overcomes the flexible package that existing non-PVC film material makes
The problem of when containing Large Copacity preparation leakage easily occurs for bag.
As a kind of preferred embodiment, the corner of the non-PVC plastic infusion bag is set for fillet, the non-PVC
The bag side of plastic infusion bag and the heat sealing strength at bag bottom are 30-45N/15mm, the heat on the bag top of the non-PVC plastic infusion bag
Conjunction intensity is 40-50N/15mm.The non-PVC plastic infusion bag that fillet is set can avoid the corner scratch patient of infusion bag；This
It can fully ensure that when vanning transport and low latitude are fallen, the phenomenon of leakage does not occur for the product, and ensure to weld under kind heat sealing strength
Socket part position even uniform.
A kind of production method of non-PVC-soft-bag-packaged peritoneal dialysis liquid product of the present invention, it is mainly by following
What technical scheme was realized：Comprise the following steps：（1）The making of non-PVC plastic infusion bag：The double films of negated PVC plastic, are placed in
In bag template, 2 mouth pipes are added in its side, respectively chemical feed pipe and woven hose carry out pressurization welding, pressure 8-12N,
Film welding temperature is 130-155 DEG C, weld interval 2-6s, and mouth pipe preheating temperature is 150-165 DEG C, preheating time 1-4s,
Mouth pipe welding temperature is 140-160 DEG C, weld interval 2-5s, after bag success, cutting, obtains non-PVC plastic infusion bag；（2）
Dialyzate it is filling：Peritoneal dialysis dialyzate is taken, it is filling to step by chemical feed pipe or woven hose（1）The non-PVC plastic of gained
In infusion bag, it is filling finish after, cover dosing valve and easy folding plug respectively, obtain head product bag；Then, medicine is connected on woven hose
Fluid catheter, liquid medicine catheter lower end connect Y-connector, are connected waste pipe on Y-connector with the symmetrical one end of liquid medicine catheter, and Y connects
The other end connection protective cap of device is connect, by liquid medicine catheter and waste pipe disk into a diameter of 10-15cm circle, and using card
Tight device is fixed, and obtains semi-finished product；（3）By step（2）The semi-packed product of gained are positioned in sterile outer bag, in 110-
At 125 DEG C, sterilizing, sterilization time 5-30min, product is obtained.
The non-PVC plastic infusion bag of the present invention is produced in the form of " double width film ", and double films are not separated before bag, therefore,
Fully ensure that the inside of infusion bag is not contaminated, ensure that its wholesomeness and security, non-PVC plastic film belongs to environmentally friendly material
Material, production, use, recovery do not produce toxin；Between this pair of film and between film and chemical feed pipe, between film and woven hose
Using being welded to connect, by the control of specific welding procedure, fully ensure that the non-PVC plastic infusion bag is containing Large Copacity
The phenomenon of leakage will not occur during preparation, packaging safety, avoid wasting.It is straight after the completion of the non-PVC plastic infusion bag bag of the present invention
Filling peritoneal dialysis solution is connect, then, connection liquid medicine catheter, Y-connector, waste pipe and waste fluid bag, and using sterile outer
Bag is packed, and by sterilizing, and is made.
As a kind of preferred embodiment, the head product bag also includes print steps, and the print steps are：Pass through
Heating, the method for pressurization make pigment peel ply and the stripping of colour band base material on colour band, reverses direction, with non-PVC plastic infusion bag
The attachment of outer surface sublimating and dyeing combine, to stamp the information of product on the outer surface of non-PVC plastic infusion bag.The present invention exists
The outer surface of non-PVC plastic infusion bag directly stamps the information of product, is easy to identify, printing is convenient, these information be not easy by
Rub off, fully ensured that the integrality of the information of product.
As a kind of preferred embodiment, the step（1）In, pressure 10N, film welding temperature is 135-150 DEG C,
Weld interval is 3-4s, and pipe preheating temperature is 155-160 DEG C, preheating time 2-3s, and pipe welding temperature is 145-155 DEG C, weldering
It is 3-4s to connect the time.Welding pressure is fixed value, and general welding pressure control is in 10N, fully adjustment welding temperature and welding
Between, weld strength can be further improved, saves weld interval, improves production efficiency.
As a kind of preferred embodiment, the step（1）In, for double film roll systems in film roll, film roll is placed into film frame
On, and be fixed by Pneumatic expanded axle, the rolling or stopping of film roll are driven by motor, double films are controlled using balancing pole
The even running during transport, double films are made to run to bag template.Double films are fed by film roll, in mould bases and pneumatically
It is fixed in the presence of tension shaft, controls running by motor driver running situation, and using balancing pole, fully
It ensure that the smooth steady feed of double films.
Beneficial effects of the present invention：The present invention contains dialyzate using non-PVC plastic infusion bag, avoids PVC packaging bags
Harm to patient, non-PVC plastic infusion bag are produced in the form of " double width film ", and double films are not separated before bag, fully ensure that
The inside of infusion bag is not contaminated, and ensure that its wholesomeness and security；Non- PVC plastic infusion bag in itself, non-PVC plastic
Infusion bag is used with woven hose with chemical feed pipe and non-PVC plastic infusion bag and is welded to connect, welding position sealing even uniform,
Leaving no air bubbles inside, ensure the product vanning transport and low latitude fall when will not leakage, avoid non-PVC film material make soft bag contain
The phenomenon of leakage easily occurs when filling Large Copacity preparation；Non- PVC plastic infusion bag is set using fillet, avoids the corner of infusion bag
Scratch patient；The present invention is full-featured, and easy to use, economical and practical, the heat sealing strength at bag side and bag bottom is 30-45N/15mm,
The heat sealing strength on bag top is 40-50 N/15mm, and in vanning transport and 1.5 meters of low latitude drop test, leakage rate is less than
0.2%。
Brief description of the drawings
Fig. 1 is the planar structure schematic diagram of one embodiment of the invention；
In figure：1- dialyzate bags；2- chemical feed pipes；3- woven hoses；4- liquid medicine catheters；5-Y type connectors；6- protective caps；7- waste liquids
Conduit；8- waste fluid bags.
Embodiment
Technical scheme is clearly and completely described below in conjunction with the specific embodiment of the present invention, shown
So, described embodiment is only the part of the embodiment of the present invention, rather than whole embodiments.Based in the present invention
Embodiment, the every other embodiment that those of ordinary skill in the art are obtained under the premise of creative work is not made, all
Belong to the scope of protection of the invention.
A kind of non-PVC-soft-bag-packaged peritoneal dialysis liquid product of the present invention, the peritoneal dialysis liquid product include packaging
System, the packaging system include peritoneal dialysis liquid bag, liquid medicine catheter, waste pipe, Y-connector, waste fluid bag and protective cap,
The peritoneal dialysis liquid bag is provided with sterile outer bag built with peritoneal dialysis solution, the outside of the packaging system；The peritonaeum is saturating
The bottom of analysis liquid bag is connected with the Y-connector by the liquid medicine catheter, and the other both ends of the Y-connector connect successively
The protective cap and the waste pipe are connected to, the end of the waste pipe is connected with the waste fluid bag；The peritoneal dialysis
Liquid bag is non-PVC plastic infusion bag, and the non-PVC plastic infusion bag is the co-extrusion film produced in the form of double width film, described non-
PVC plastic infusion bag is provided with chemical feed pipe and woven hose, and the chemical feed pipe is provided with dosing valve, and the woven hose is provided with easy to break
Plug；The non-PVC plastic infusion bag is welded to connect with the chemical feed pipe, the non-PVC plastic infusion bag and the woven hose
To be welded to connect, the liquid medicine catheter can disk into a diameter of 10-15cm circle, the liquid medicine catheter is provided with gripping mechanism,
The waste pipe also can disk into a diameter of 10-15cm circle, also be provided with gripping mechanism on the waste pipe.
Specifically, the gripping mechanism has 3-5, and the gripping mechanism is clip, lock, transparent adhesive tape, double faced adhesive tape, magic
One or more in patch.
Preferably, the prescription of the peritoneal dialysis solution is：Glucose 10-60g, sodium chloride 1-10g, calcium chloride 0-5g, chlorine
Change magnesium 0-5g, sodium lactate 1-10g, appropriate water for injection, full dose 1000mL, pH value 4.5-5.5.
It is further preferred that the preparation technology of the peritoneal dialysis solution is：Into with container, addition temperature is 40-70
DEG C 70-90% recipe quantity fresh water for injection, add glucose, sodium chloride, calcium chloride, magnesium chloride, breast successively according to prescription
Sour sodium, stir fully dissolving 10-20min；The water for injection of 40-70 DEG C of addition stirs 15-25min to prescription full dose, adds dilute
Salt acid for adjusting pH is to 4.5-5.5；Sampling, examine, assay meets product or inspection of semifinished product standard, through pre-filtering and terminal
It is filling in non-PVC plastic infusion bag after filtering.
Specifically, the volume of the peritoneal dialysis liquid bag is 1000-3000mL.
Further, the corner of the non-PVC plastic infusion bag is set for fillet, the bag of the non-PVC plastic infusion bag
The heat sealing strength at side and bag bottom is 30-45N/15mm, and the heat sealing strength on the bag top of the non-PVC plastic infusion bag is 40-
50N/15mm。
A kind of production method of non-PVC-soft-bag-packaged peritoneal dialysis liquid product of the present invention, comprises the following steps：（1）
The making of non-PVC plastic infusion bag：The double films of negated PVC plastic, are placed in bag template, 2 mouth pipes are added in its side, respectively
For chemical feed pipe and woven hose, pressurization welding, pressure 8-12N are carried out, film welding temperature is 130-155 DEG C, weld interval 2-
6s, mouth pipe preheating temperature are 150-165 DEG C, preheating time 1-4s, and mouth pipe welding temperature is 140-160 DEG C, and weld interval is
2-5s, after bag success, cutting, obtain non-PVC plastic infusion bag；（2）Dialyzate it is filling：Peritoneal dialysis dialyzate is taken, is led to
Cross chemical feed pipe or woven hose is filling to step（1）In the non-PVC plastic infusion bag of gained, it is filling finish after, cover dosing respectively
Valve and easy folding plug, obtain head product bag；Then, liquid medicine catheter, liquid medicine catheter lower end connection Y-connector are connected on woven hose, Y connects
Connect and be connected waste pipe on device with the symmetrical one end of liquid medicine catheter, the other end of Y-connector connection protective cap, by liquid medicine catheter and
Waste pipe disk and is fixed using gripping mechanism into a diameter of 10-15cm circle, obtains semi-finished product；（3）By step
（2）The semi-packed product of gained are positioned in sterile outer bag, at 110-125 DEG C, sterilizing, sterilization time 5-30min, must be produced
Product.
Preferably, the head product bag also includes print steps, and the print steps are：Method by heating, pressurizeing
The pigment peel ply on colour band is set to be peeled off with colour band base material, reverses direction, the outer surface sublimating and dyeing with non-PVC plastic infusion bag
Attachment combines, to stamp the information of product on the outer surface of non-PVC plastic infusion bag.
Specifically, the step（1）In, pressure 10N, film welding temperature is 135-150 DEG C, weld interval 3-4s,
Pipe preheating temperature is 155-160 DEG C, preheating time 2-3s, and pipe welding temperature is 145-155 DEG C, weld interval 3-4s.
Further, the step（1）In, in film roll, film roll is placed on film frame double film roll systems, and by Pneumatic expanded
Axle is fixed, and the rolling or stopping of film roll are driven by motor, controls double films to be put down during transport using balancing pole
Steady operation, double films are made to run to bag template.
Embodiment one
A kind of production method of non-PVC-soft-bag-packaged peritoneal dialysis liquid product of the present invention is as follows：
（1）The making of non-PVC plastic infusion bag
Double width film is placed on film frame, film is fixed by Pneumatic expanded axle, a motor drives the rolling and stopping of film roll,
One root long power rod is used as balancing pole to control film even running during transport, 2 tunics is run at bag, wherein side
Add 2 mouth pipes, heat time-pressure-temperature is adjusted in weld by bag template, wherein pressure value is fixed as 10N, film weldering
When connecing, the welding temperature of upper and lower plates is respectively 150,145 DEG C, and certainly, the welding temperature of upper and lower plates can also be identical, weld interval
For 3s, mouth pipe preheating temperature is 160 DEG C, preheating time 2s, and mouth pipe welding temperature is 155 DEG C, weld interval 3s, bag into
After work(, cutting, non-PVC plastic infusion bag is obtained, it is standby；
（2）Prepare peritoneal dialysis solution
A, raw material is weighed according to following formula：
Glucose (C6H12O6·H2O) 15g
Sodium chloride 5.6g
Calcium chloride (CaCl2·2H2O) 0.26g
Magnesium chloride (MgCl2·6H2O) 0.15g
Sodium lactate 5.0g
Appropriate water for injection
Full dose 1000mL
B, peritoneal dialysis solution is prepared according to following technique：
Into with container, the 70% recipe quantity fresh water for injection that temperature is 40 DEG C is added, is added successively according to above-mentioned prescription
Glucose, sodium chloride, calcium chloride, magnesium chloride, sodium lactate, stir fully dissolving 10min；The water for injection of 40 DEG C of addition is to prescription
Full dose, and 15min is stirred, add watery hydrochloric acid to adjust pH to 4.5；Sampled assay meets product inspection of semifinished product standard, in advance
Filtering and end-filtration, it is filling in above-mentioned non-PVC plastic infusion bag；
（3）It is filling finish after, cover dosing valve and easy folding plug respectively, obtain head product bag；Then, decoction is connected on woven hose
Conduit, liquid medicine catheter lower end connect Y-connector, waste pipe, Y connections are connected with the symmetrical one end of liquid medicine catheter on Y-connector
The other end connection protective cap of device, by liquid medicine catheter and waste pipe disk into a diameter of 10cm circle, liquid medicine catheter and useless
Fluid catheter respectively has 3 bonding points, and gripping mechanism is provided with bonding point, and gripping mechanism is clip, lock, transparent adhesive tape, double faced adhesive tape, evil spirit
One or more in art patch, obtain semi-finished product；
（4）Above-mentioned semi-finished product are positioned in sterile outer bag, at 115 DEG C, sterilizing, sterilization time 30min, obtain product.
Embodiment two
The production method of another non-PVC-soft-bag-packaged peritoneal dialysis liquid product of the present invention is as follows：
（1）The making of non-PVC plastic infusion bag
The double films of negated PVC plastic, are placed in bag template, and 2 mouth pipes, respectively chemical feed pipe and woven hose are added in its side,
Pressurization welding is carried out, pressure 10N, when film welds, the welding temperature of upper and lower plates distinguishes 140 DEG C, 135 DEG C, weld interval 4s,
Mouth pipe preheating temperature is 155 DEG C, preheating time 3s, and mouth pipe welding temperature is 145 DEG C, weld interval 4s, after bag success,
Cutting, obtains non-PVC plastic infusion bag, standby；
（2）Prepare peritoneal dialysis solution
A, raw material is weighed according to following formula：
Glucose (C6H12O6·H2O) 25g
Sodium chloride 5.6g
Calcium chloride (CaCl2·2H2O) 0.26g
Magnesium chloride (MgCl2·6H2O) 0.15g
Sodium lactate 5.0g
Appropriate water for injection
Full dose 1000mL
B, peritoneal dialysis solution is prepared according to following technique：
Into with container, the 90% recipe quantity fresh water for injection that temperature is 70 DEG C is added, grape is added successively according to prescription
Sugar, sodium chloride, calcium chloride, magnesium chloride, sodium lactate, stir fully dissolving 20min；The water for injection of 60 DEG C of addition is complete to prescription
Amount, and 25min is stirred, add watery hydrochloric acid to adjust pH to 5.5；Sampled assay meets product inspection of semifinished product standard, pre- mistake
Filter and end-filtration, it is filling in above-mentioned non-PVC plastic infusion bag；
（3）It is filling finish after, cover dosing valve and easy folding plug respectively, obtain head product bag；By head product bag by heating, pressurizeing
Method pigment peel ply on colour band is peeled off with colour band base material, reverses direction, the outer surface liter with non-PVC plastic infusion bag
China's dyeing attachment combines, and to stamp the information of product on the outer surface of non-PVC plastic infusion bag, completes print steps；
（5）Then, liquid medicine catheter is connected on woven hose, liquid medicine catheter lower end connects Y-connector, led on Y-connector with decoction
Manage symmetrical one end connection waste pipe, the other end connection protective cap of Y-connector, by liquid medicine catheter and waste pipe disk into
A diameter of 15cm circle, liquid medicine catheter and waste pipe respectively have 5 bonding points, are provided with double faced adhesive tape at bonding point, obtain semi-finished product；
（6）Above-mentioned semi-finished product are positioned in sterile outer bag, at 115 DEG C, sterilizing, sterilization time 30min, obtain product.
Refering to accompanying drawing 1, non-PVC-soft-bag-packaged peritoneal dialysis liquid product obtained by embodiments of the invention one and embodiment two
Include packaging system, packaging system includes peritoneal dialysis liquid bag 1, liquid medicine catheter 4, waste pipe 7, Y-connector 5, waste liquid
Bag 8 and protective cap 6, peritoneal dialysis liquid bag 1 are provided with sterile outer bag built with peritoneal dialysis solution, the outside of packaging system, in order to
For purpose of brevity, outer bag not shown in Fig. 1；The bottom of peritoneal dialysis liquid bag 1 is connected with Y-connector 5, Y by liquid medicine catheter 4
The other both ends of type connector 5 are connected with protective cap 6 and waste pipe 7 in turn, and the end of waste pipe 7 is connected with waste fluid bag 8；
Peritoneal dialysis liquid bag 1 is non-PVC plastic infusion bag, and non-PVC plastic infusion bag is the co-extrusion film produced in the form of double width film, non-
PVC plastic infusion bag is provided with chemical feed pipe 2 and woven hose 3, and chemical feed pipe 2 is provided with dosing valve, and woven hose 3 is provided with easy folding plug；
Non- PVC plastic infusion bag is welded to connect with chemical feed pipe 2, and non-PVC plastic infusion bag with woven hose 3 also to be welded to connect, lead by decoction
Pipe 4 can disk into a diameter of 10-15cm circle, liquid medicine catheter 4 is provided with gripping mechanism, waste pipe 7 also can disk into a diameter of
10-15cm circle, gripping mechanism also is provided with waste pipe 7, for simplicity, gripping mechanism not shown in Fig. 1.
By embodiment one and the non-PVC-soft-bag-packaged peritoneal dialysis liquid product of gained of embodiment two and existing non-PVC bags
Fill soft bag（Control sample）Heat sealing strength performance test experiment, transport simulation experiment and low latitude drop test, experiment knot are carried out respectively
Fruit is as shown in table 1, as can be seen from Table 1：The non-PVC plastic infusion bag of the present invention, welding position even uniform, bubble-free；Its
The heat sealing strength of bag side, bag bottom and bag top is obviously higher than control sample, and it is in vanning transport and 1.5 meters of low latitude drop test
In, the bag number of its leakage is also significantly less than control sample, its leakage rate be 0.1%, 0.2%, this well below control sample 0.8%.
The performance test results of 1 product of the present invention of table
Beneficial effects of the present invention：The present invention contains dialyzate using non-PVC plastic infusion bag, avoids PVC packaging bags to suffering from
The harm of person, non-PVC plastic infusion bag are produced in the form of " double width film ", and double films are not separated before bag, fully ensured that defeated
The inside of liquid bag is not contaminated, and ensure that its wholesomeness and security；Non- PVC plastic infusion bag in itself, non-PVC plastic transfusion
Bag is used with woven hose with chemical feed pipe and non-PVC plastic infusion bag and is welded to connect, and welding position sealing even uniform is internal
Bubble-free, ensure the product when vanning transport and low latitude are fallen will not leakage, avoid non-PVC film material make soft bag contain it is big
The phenomenon of leakage easily occurs during capacity preparation；Non- PVC plastic infusion bag is set using fillet, avoids the corner scratch of infusion bag
Patient；The present invention is full-featured, easy to use, economical and practical, and the heat sealing strength at bag side and bag bottom is 30-45N/15mm, bag top
Heat sealing strength be 40-50N/15mm, in vanning transport and 1.5 meters of low latitude drop test, leakage rate is less than 0.2%.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention
God any modification, equivalent substitution and improvements made etc., should be included in the scope of the protection with principle.
Claims (10)
- A kind of 1. non-PVC-soft-bag-packaged peritoneal dialysis liquid product, it is characterised in that：The peritoneal dialysis liquid product includes packaging System, the packaging system include peritoneal dialysis liquid bag, liquid medicine catheter, waste pipe, Y-connector, waste fluid bag and protective cap, The peritoneal dialysis liquid bag is provided with sterile outer bag built with peritoneal dialysis solution, the outside of the packaging system；The bottom of the peritoneal dialysis liquid bag is connected with the Y-connector by the liquid medicine catheter, the Y-connector Other both ends are connected with the protective cap and the waste pipe in turn, and the end of the waste pipe is connected with the waste liquid Bag；The peritoneal dialysis liquid bag is non-PVC plastic infusion bag, and the non-PVC plastic infusion bag is to be produced in the form of double width film Co-extrusion film, the non-PVC plastic infusion bag is provided with chemical feed pipe and woven hose, and the chemical feed pipe is provided with dosing valve, described Woven hose is provided with easy folding plug；The non-PVC plastic infusion bag is welded to connect with the chemical feed pipe, the non-PVC plastic infusion bag and the woven hose To be welded to connect, the liquid medicine catheter can disk into a diameter of 10-15cm circle, the liquid medicine catheter is provided with gripping mechanism, The waste pipe also can disk into a diameter of 10-15cm circle, also be provided with gripping mechanism on the waste pipe.
- 2. non-PVC-soft-bag-packaged peritoneal dialysis liquid product according to claim 1, it is characterised in that：The gripping mechanism has 3-5, and the gripping mechanism is one kind in clip, lock, transparent adhesive tape, double faced adhesive tape, VELCRO It is or several.
- 3. non-PVC-soft-bag-packaged peritoneal dialysis liquid product according to claim 1, it is characterised in that：The prescription of the peritoneal dialysis solution is：Glucose 10-60g, sodium chloride 1-10g, calcium chloride 0-5g, magnesium chloride 0-5g, breast Sour sodium 1-10g, appropriate water for injection, full dose 1000mL.
- 4. non-PVC-soft-bag-packaged peritoneal dialysis liquid product according to claim 3, it is characterised in that：The preparation technology of the peritoneal dialysis solution is：Into with container, the recipe quantity for the 70-90% that temperature is 40-70 DEG C is added Fresh water for injection, add glucose, sodium chloride, calcium chloride, magnesium chloride, sodium lactate successively according to prescription, stir fully dissolving 10-20min；The water for injection of 40-70 DEG C of addition stirs 15-25min to prescription full dose, adds watery hydrochloric acid to adjust pH to 4.5- 5.5；Sampling, examine, assay meets product or inspection of semifinished product standard, filling in non-after pre-filtering and end-filtration In PVC plastic infusion bag.
- 5. non-PVC-soft-bag-packaged peritoneal dialysis liquid product according to claim 1, it is characterised in that：The volume of the peritoneal dialysis liquid bag is 1000-3000mL.
- 6. non-PVC-soft-bag-packaged peritoneal dialysis liquid product according to claim 1, it is characterised in that：The corner of the non-PVC plastic infusion bag is set for fillet, the heat seal of the bag side and bag bottom of the non-PVC plastic infusion bag Intensity is 30-45N/15mm, and the heat sealing strength on the bag top of the non-PVC plastic infusion bag is 40-50N/15mm.
- 7. the production method of the non-PVC-soft-bag-packaged peritoneal dialysis liquid product according to claim 1-6 any one, its It is characterised by, comprises the following steps：（1）The making of non-PVC plastic infusion bag：The double films of negated PVC plastic, are placed in bag template, and 2 mouths are added in its side Pipe, respectively chemical feed pipe and woven hose, pressurization welding, pressure 8-12N are carried out, film welding temperature is 130-155 DEG C, during welding Between be 2-6s, mouth pipe preheating temperature is 150-165 DEG C, preheating time 1-4s, and mouth pipe welding temperature is 140-160 DEG C, welding Time is 2-5s, after bag success, cutting, obtains non-PVC plastic infusion bag；（2）Dialyzate it is filling：Peritoneal dialysis dialyzate is taken, it is filling to step by chemical feed pipe or infusion port（1）Gained is non- In PVC plastic infusion bag, it is filling finish after, cover dosing valve and easy folding plug respectively, obtain head product bag；Then, in woven hose Upper connection liquid medicine catheter, liquid medicine catheter lower end connection Y-connector, is connected waste liquid on Y-connector with the symmetrical one end of liquid medicine catheter Conduit, the other end connection protective cap of Y-connector, by liquid medicine catheter and waste pipe disk into a diameter of 10-15cm circle, And be fixed using gripping mechanism, obtain semi-finished product；（3）By step（2）The semi-packed product of gained are positioned in sterile outer bag, at 110-125 DEG C, sterilizing, and sterilization time For 5-30min, product is obtained.
- 8. the production method of non-PVC-soft-bag-packaged peritoneal dialysis liquid product according to claim 7, it is characterised in that：The head product bag also includes print steps, and the print steps are：Make the face on colour band by the method for heating, pressurizeing Expect that peel ply is peeled off with colour band base material, reverses direction, the outer surface sublimating and dyeing attachment with non-PVC plastic infusion bag combines, with The information of product is stamped on the outer surface of non-PVC plastic infusion bag.
- 9. the production method of non-PVC-soft-bag-packaged peritoneal dialysis liquid product according to claim 7, it is characterised in that：The step（1）In, pressure 10N, film welding temperature is 135-150 DEG C, weld interval 3-4s, and pipe preheating temperature is 155-160 DEG C, preheating time 2-3s, pipe welding temperature is 145-155 DEG C, weld interval 3-4s.
- 10. the production method of non-PVC-soft-bag-packaged peritoneal dialysis liquid product according to claim 9, it is characterised in that：The step（1）In, in film roll, film roll is placed on film frame double film roll systems, and is fixed by Pneumatic expanded axle, is led to The rolling or stopping of motor driving film roll are crossed, double film even runnings during transport are controlled using balancing pole, makes double films In operation to bag template.
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| CN107554877B (en) | 2019-12-24 |
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Effective date of registration: 20230323 Address after: 276800 No. 39, Fuyang Road, Shandong, Rizhao City Patentee after: HUAREN PHARMACEUTICAL (RIZHAO) Co.,Ltd. Address before: 266101 No. 187 Zhuzhou Road, Laoshan District, Qingdao, Shandong. Patentee before: HUAREN PHARMACEUTICAL Co.,Ltd. |