CN202314359U - Novel double-chamber transfusion bag for packaging amino acid and glucose injection - Google Patents
Novel double-chamber transfusion bag for packaging amino acid and glucose injection Download PDFInfo
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- CN202314359U CN202314359U CN2011202705738U CN201120270573U CN202314359U CN 202314359 U CN202314359 U CN 202314359U CN 2011202705738 U CN2011202705738 U CN 2011202705738U CN 201120270573 U CN201120270573 U CN 201120270573U CN 202314359 U CN202314359 U CN 202314359U
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- transfusion bag
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- bag
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Links
- 238000004806 packaging method and process Methods 0.000 title claims abstract description 15
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Chemical compound OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 title claims abstract description 12
- 150000001413 amino acids Chemical class 0.000 title claims abstract description 11
- 229940093181 glucose injection Drugs 0.000 title claims abstract description 9
- RSWGJHLUYNHPMX-UHFFFAOYSA-N Abietic-Saeure Natural products C12CCC(C(C)C)=CC2=CCC2C1(C)CCCC2(C)C(O)=O RSWGJHLUYNHPMX-UHFFFAOYSA-N 0.000 claims abstract description 43
- KHPCPRHQVVSZAH-HUOMCSJISA-N Rosin Natural products O(C/C=C/c1ccccc1)[C@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 KHPCPRHQVVSZAH-HUOMCSJISA-N 0.000 claims abstract description 43
- KHPCPRHQVVSZAH-UHFFFAOYSA-N trans-cinnamyl beta-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OCC=CC1=CC=CC=C1 KHPCPRHQVVSZAH-UHFFFAOYSA-N 0.000 claims abstract description 43
- 235000001014 amino acid Nutrition 0.000 claims description 7
- 230000010412 perfusion Effects 0.000 claims description 6
- 238000007731 hot pressing Methods 0.000 claims description 4
- 239000012530 fluid Substances 0.000 claims description 2
- 238000010348 incorporation Methods 0.000 claims 1
- 239000007788 liquid Substances 0.000 abstract description 33
- 238000000034 method Methods 0.000 abstract description 30
- 239000003814 drug Substances 0.000 abstract description 12
- 238000002156 mixing Methods 0.000 abstract description 5
- 238000003860 storage Methods 0.000 abstract description 3
- 239000002245 particle Substances 0.000 abstract description 2
- 206010011409 Cross infection Diseases 0.000 abstract 1
- 206010029803 Nosocomial infection Diseases 0.000 abstract 1
- 238000012360 testing method Methods 0.000 description 33
- 238000007789 sealing Methods 0.000 description 14
- 230000001954 sterilising effect Effects 0.000 description 13
- 238000002360 preparation method Methods 0.000 description 11
- 238000001802 infusion Methods 0.000 description 10
- 229910052751 metal Inorganic materials 0.000 description 10
- 238000004659 sterilization and disinfection Methods 0.000 description 10
- NLKNQRATVPKPDG-UHFFFAOYSA-M potassium iodide Chemical compound [K+].[I-] NLKNQRATVPKPDG-UHFFFAOYSA-M 0.000 description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 9
- -1 polypropylene Polymers 0.000 description 8
- 239000000243 solution Substances 0.000 description 7
- 239000004743 Polypropylene Substances 0.000 description 6
- 229920001577 copolymer Polymers 0.000 description 6
- 229920001155 polypropylene Polymers 0.000 description 6
- 230000008569 process Effects 0.000 description 6
- 239000012490 blank solution Substances 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 238000005516 engineering process Methods 0.000 description 5
- 239000000463 material Substances 0.000 description 5
- 239000004033 plastic Substances 0.000 description 5
- 229920003023 plastic Polymers 0.000 description 5
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 description 4
- 238000007689 inspection Methods 0.000 description 4
- 239000002184 metal Substances 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 238000010521 absorption reaction Methods 0.000 description 3
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 239000008103 glucose Substances 0.000 description 3
- 238000010438 heat treatment Methods 0.000 description 3
- 229940090044 injection Drugs 0.000 description 3
- 238000002347 injection Methods 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 238000003780 insertion Methods 0.000 description 3
- 230000037431 insertion Effects 0.000 description 3
- 230000009191 jumping Effects 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- 239000005022 packaging material Substances 0.000 description 3
- 230000002980 postoperative effect Effects 0.000 description 3
- 238000004448 titration Methods 0.000 description 3
- 238000003466 welding Methods 0.000 description 3
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 description 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- QIVBCDIJIAJPQS-VIFPVBQESA-N L-tryptophane Chemical compound C1=CC=C2C(C[C@H](N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-VIFPVBQESA-N 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 2
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 2
- QIVBCDIJIAJPQS-UHFFFAOYSA-N Tryptophan Natural products C1=CC=C2C(CC(N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-UHFFFAOYSA-N 0.000 description 2
- 206010052428 Wound Diseases 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 235000019270 ammonium chloride Nutrition 0.000 description 2
- 238000003321 atomic absorption spectrophotometry Methods 0.000 description 2
- 238000000151 deposition Methods 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 239000003792 electrolyte Substances 0.000 description 2
- 239000002158 endotoxin Substances 0.000 description 2
- 238000013401 experimental design Methods 0.000 description 2
- 239000006260 foam Substances 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 230000005484 gravity Effects 0.000 description 2
- 239000003978 infusion fluid Substances 0.000 description 2
- 239000004531 microgranule Substances 0.000 description 2
- 230000000474 nursing effect Effects 0.000 description 2
- 238000012856 packing Methods 0.000 description 2
- 239000013618 particulate matter Substances 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 239000012085 test solution Substances 0.000 description 2
- 238000002834 transmittance Methods 0.000 description 2
- 238000000870 ultraviolet spectroscopy Methods 0.000 description 2
- 239000008215 water for injection Substances 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- QGZKDVFQNNGYKY-UHFFFAOYSA-O Ammonium Chemical compound [NH4+] QGZKDVFQNNGYKY-UHFFFAOYSA-O 0.000 description 1
- VYZAMTAEIAYCRO-UHFFFAOYSA-N Chromium Chemical compound [Cr] VYZAMTAEIAYCRO-UHFFFAOYSA-N 0.000 description 1
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 1
- JPVYNHNXODAKFH-UHFFFAOYSA-N Cu2+ Chemical compound [Cu+2] JPVYNHNXODAKFH-UHFFFAOYSA-N 0.000 description 1
- 206010013786 Dry skin Diseases 0.000 description 1
- 206010018691 Granuloma Diseases 0.000 description 1
- 208000032420 Latent Infection Diseases 0.000 description 1
- 208000002720 Malnutrition Diseases 0.000 description 1
- 206010058046 Post procedural complication Diseases 0.000 description 1
- 208000035965 Postoperative Complications Diseases 0.000 description 1
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 1
- 208000037656 Respiratory Sounds Diseases 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- ATJFFYVFTNAWJD-UHFFFAOYSA-N Tin Chemical compound [Sn] ATJFFYVFTNAWJD-UHFFFAOYSA-N 0.000 description 1
- 239000008351 acetate buffer Substances 0.000 description 1
- REDXJYDRNCIFBQ-UHFFFAOYSA-N aluminium(3+) Chemical compound [Al+3] REDXJYDRNCIFBQ-UHFFFAOYSA-N 0.000 description 1
- 229910021529 ammonia Inorganic materials 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- ALBRKUHVWDVWRO-UHFFFAOYSA-N bagrosin Chemical compound C=1C=C2C=CC3=CC=CC=C3C2=CC=1C1(C)NC(=O)NC1=O ALBRKUHVWDVWRO-UHFFFAOYSA-N 0.000 description 1
- 229950006958 bagrosin Drugs 0.000 description 1
- 229910052788 barium Inorganic materials 0.000 description 1
- DSAJWYNOEDNPEQ-UHFFFAOYSA-N barium atom Chemical compound [Ba] DSAJWYNOEDNPEQ-UHFFFAOYSA-N 0.000 description 1
- 229910001422 barium ion Inorganic materials 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 229910052793 cadmium Inorganic materials 0.000 description 1
- BDOSMKKIYDKNTQ-UHFFFAOYSA-N cadmium atom Chemical compound [Cd] BDOSMKKIYDKNTQ-UHFFFAOYSA-N 0.000 description 1
- WLZRMCYVCSSEQC-UHFFFAOYSA-N cadmium(2+) Chemical compound [Cd+2] WLZRMCYVCSSEQC-UHFFFAOYSA-N 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 229910052804 chromium Inorganic materials 0.000 description 1
- 239000011651 chromium Substances 0.000 description 1
- 229910001430 chromium ion Inorganic materials 0.000 description 1
- 238000005352 clarification Methods 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 229910052802 copper Inorganic materials 0.000 description 1
- 239000010949 copper Substances 0.000 description 1
- 229910001431 copper ion Inorganic materials 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 208000037771 disease arising from reactivation of latent virus Diseases 0.000 description 1
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- 229910001385 heavy metal Inorganic materials 0.000 description 1
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- 230000000968 intestinal effect Effects 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- RVPVRDXYQKGNMQ-UHFFFAOYSA-N lead(2+) Chemical compound [Pb+2] RVPVRDXYQKGNMQ-UHFFFAOYSA-N 0.000 description 1
- 239000006193 liquid solution Substances 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 230000001071 malnutrition Effects 0.000 description 1
- 235000000824 malnutrition Nutrition 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000011259 mixed solution Substances 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 208000015380 nutritional deficiency disease Diseases 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 239000012476 oxidizable substance Substances 0.000 description 1
- 235000016236 parenteral nutrition Nutrition 0.000 description 1
- 235000010603 pastilles Nutrition 0.000 description 1
- 235000018102 proteins Nutrition 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 description 1
- 235000019345 sodium thiosulphate Nutrition 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 229910001432 tin ion Inorganic materials 0.000 description 1
- 235000021476 total parenteral nutrition Nutrition 0.000 description 1
- 238000009423 ventilation Methods 0.000 description 1
- 238000012800 visualization Methods 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- 230000029663 wound healing Effects 0.000 description 1
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- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
The utility model belongs to the technical field of medicine, and in particular to a three-layer coextrusion double-chamber transfusion bag. A novel double-chamber transfusion bag for packaging amino acid and glucose injection is formed through hot press, a rosin joint interval is formed between double chambers through a hot press method, and the interval has a function of isolating medicine liquid in the double chambers during storage and transportation of transfusion liquid and can be conveniently opened by exerting certain external force when the transfusion liquid is used to enable the two chambers to be communicated, so that the medicine liquid in the double chambers can be mixed. The novel double-chamber transfusion bag for packaging the amino acid and glucose injection avoids mixing misoperation easy to happen during normal transfusion mixing, reduces the problems of particles generated by puncture, cross infection and the like, and improves stability of transfusion. The transfusion liquid packaged by the novel double-chamber transfusion bag for packaging the amino acid and glucose injection meets the requirements of safe, fast and convenient transfusion treatment.
Description
Technical field
This utility model belongs to medical technical field, is specifically related to a kind of three-layer co-extruded double-chamber transfusion bag that is used to pack the parenteral nutrition product.
Background technology
Since 1931 had had venous transfusion, infusion treatment had become one of common, the most general clinical therapeutic modality.The infusion solutions packaged form mainly passed through in development with the next stage: the vial infusion solutions---plastic bottle infusion solutions---PVC big soft infusion bag---non-PVC-soft-bag infusion solutions.Three-layer co-extruded double-chamber transfusion bag is exactly the usually said soft bag of immediate dispensing infusion.
Can open easily in order to ensure the sealing of rosin joint in sterilization and the storage transportation and when using; Requirement to packaging material, production equipment and technology is very high; How to guarantee that product rosin joint in storage, transportation does not ftracture; Can open rosin joint and apply suitable pressure before use, make the medicament mixed of two chambers become a major criterion weighing the double-chamber transfusion bag quality.
Present total parenteral nutrition transfusion all is that different types of transfusion is filled in the big mixed bag generally; Generally have operating room, can reduce the probability of pollution, but can not guarantee thoroughly that medicinal liquid is not contaminated in Grade III Class A hospital; But in basic hospital, generally do not possess mixing condition; Can increase the pollution probability during preparation, have the drug safety problem, cofabrication process is loaded down with trivial details.
The gastrointestinal procedures patient is because the influence of factors such as operation wound, the preceding inspection of art, intestinal preparation and the early stage fasting of postoperative; Postoperative regular meeting causes protein and heat malnutrition; Therefore postoperative in time replenishes an amount of aminoacid, glucose and electrolyte, supplies with for nitrogen that guarantees body and energy, keeps the stable and organ function of organismic internal environment; Reduce the generation of post-operative complication, promote that wound healing is significant.
The enforcement of this utility model can make things convenient for clinical use, reduces and pollutes probability, improves the quality stability of aminoacid glucose injection.
Summary of the invention
Clinical for ease use; Reduce and pollute probability and the stability of improving infusion preparation; This utility model provides a kind of new double-chamber transfusion bag that is used to pack the aminoacid glucose injection, it is characterized in that: comprise 2 compartments (1) and (2), between 2 compartments, having at interval, (3) separate it; 2 compartments respectively have the path (4) of a perfusion fluid; One side compartment (1) is through path (4) perfusion 500 ml solns, and opposite side compartment (2) is through path (4) perfusion 500 ml solns, and path (4) is parallel with interval (3).
When using clinically, face, the rosin joint at interval (3) is opened, 2 compartments (1) and (2) are connected, thereby the solution of two Room is mixed with the preceding extruding transfusion bag of passing through.
Above-mentioned double-chamber transfusion bag, its main body is processed through hot pressing by three-layer co-extruded film for transfusion, and in the wherein three-layer co-extruded film for transfusion, outer membrane is made up of polypropylene, styrene-ethylene-butylene copolymer; Mesopelagic layer is made up of polypropylene, polyethylene, styrene-ethylene-butylene copolymer; Inner layer film is made up of polypropylene, styrene-ethylene-butylene copolymer.
The main body of above-mentioned double-chamber transfusion bag is processed through hot pressing by three-layer co-extruded film for transfusion, and wherein co-squeeze film for transfusion derives from the three-layer co-extruded film for transfusion product (registration certificate number: advance medicated bag word J20060015) of PolyCine GmbH company customization.
Above-mentioned double-chamber transfusion bag; Wherein said transfusion bag is processed through hot-press method, and between two compartments, forms (3) at interval through the heating rosin joint, and the width of its interval (3) is 0.3-2.0 centimetre; Be preferably 0.5-2.0 centimetre, more preferably 0.8-1.5 centimetre.
Above-mentioned double-chamber transfusion bag; In the wherein said hot-press method, the parameter of rosin joint is: temperature 120-130 ℃, and 0.1-3 second weld interval; The parameter of welded is: temperature 130-160 ℃; 0.1-3 second weld interval, path (4) with the welding parameter of compartment (1), (2) is: temperature 130-160 ℃, and 0.1-3 second weld interval; In the preferred hot-press method; The parameter of rosin joint is: temperature 120-130 ℃; 0.5-2 second weld interval, the parameter of welded is: temperature 130-160 ℃, and 0.5-2.5 second weld interval; The welding parameter of path (4) and compartment (1), (2) is: temperature 130-160 ℃, and 1.0-2.5 second weld interval.
Above-mentioned double-chamber transfusion bag, wherein the real weldering position intensity of double-chamber transfusion bag is measured according to the method for complex pocket in the heat sealing strength algoscopy (YBB00122003), and the meansigma methods at real weldering position all is not less than 20N/15mm; Rosin joint position intensity is measured according to the method for complex pocket in the heat sealing strength algoscopy (YBB00122003), and the meansigma methods at rosin joint position is 5-12N/15mm.
The transverse width of the outer margin contour of above-mentioned double-chamber transfusion bag is 25-30 centimetre, and the longitudinal length of outer margin contour is 25-40 centimetre.
Above-mentioned double-chamber transfusion bag is characterized in that also having an outer packaging bag that it is sealed in the outside of said double-chamber transfusion bag.
Above-mentioned double-chamber transfusion bag, the material that it is characterized in that said outer packaging bag is metal or plastics.
A kind of in green, blue, red, black or the clear, colorless of above-mentioned double-chamber transfusion bag, the color that it is characterized in that said outer packaging bag.
Quantitatively consisting of of the aminoacid glucose injection that this utility model relates to:
During clinical use with 2 bags of mixing, through intravenous drip to patient's administration.
The sterilization method of above-mentioned double-chamber transfusion bag adopts the heating means sterilization.
Full nutrition transfusion contains each seed amino acid, glucose and various electrolyte, and wherein Mei Lade (Maillard) reaction can take place for glucose and tryptophan, and compatibility is unstable.The key of double-chamber transfusion bag is a rosin joint, and this rosin joint is strict when depositing usually isolates two chambers, and under certain external force, is opening when using, and two Room are communicated.Linear change does not take place with external force with regard to requiring its material mechanical character in this, and strip of paper used for sealing generally should be identical with packaging material, so adopt non-PVC composite membrane just to become optimum selection.
When clinical transfusion is treated; Usually can 1-3 kind medicine be added in the basic transfusion; And in process for preparation, because of puncture with mix and the transfusion physicochemical property to be changed all can produce a large amount of particulate matters, microgranule gets into and can stop up blood capillary behind the human body and form thrombosis and granuloma; Process for preparation also mispairing and germ contamination might occur, increases nursing staff's labor intensity, increases to have the dangerous pricking wound occurrence probability of latent infection, is unfavorable for nursing staff's occupational safety; And process for preparation is consuming time, is unfavorable for patient's first aid medication.Two chambers bag of this utility model can reduce microgranule or because the pollution risk that medicament mixed causes that causes because of puncture effectively.
What above technology obtained is qualified two chambers bag, can medicinal liquid be filled into respectively in 2 compartments then, and the sealing of jumping a queue, heat sterilization, both.The double-chamber transfusion bag of this utility model adopts the outer packaging bag of metal or plastic material to seal, and remains in cleaning, ventilation.The double-chamber transfusion bag steady quality of this utility model, meet clinically safety, rapidly, be convenient to use requirement, the infusion treatment when especially being fit to wartime, disaster also is beneficial to the drug safety that guarantees the medical condition backward areas people, is worth development to be promoted.
Description of drawings
The sketch map of the double-chamber transfusion bag of Fig. 1 this utility model.
Preparation technology's flow chart of the double-chamber transfusion bag of Fig. 2 this utility model.
The specific embodiment
In order better to understand the method for this utility model, further set forth this utility model and advantage thereof through embodiment and experimental evidence below.
The preparation technology of the double-chamber transfusion bag of this utility model
| Embodiment | The parameter of rosin joint | The parameter of welded | The welding parameter of path (4) and compartment (1), (2) | The width of (3) at interval | The material of three-layer co-extruded film for transfusion |
| Embodiment 1 | 120 ℃, 0.1 second | 130 ℃, 0.1 second | 130 ℃, 0.1 second | 2.0 centimetre | * |
| Embodiment 2 | 120 ℃, 0.5 second | 130 ℃, 0.5 second | 130 ℃, 0.1 second | 1.5 centimetre | * |
| Embodiment 3 | 120 ℃, 2.0 seconds | 130 ℃, 2.5 seconds | 130 ℃, 0.5 second | 0.8 centimetre | * |
| Embodiment 4 | 120 ℃, 3.0 seconds | 130 ℃, 3.0 seconds | 130 ℃, 3.0 seconds | 0.3 centimetre | * |
| Embodiment 5 | 125 ℃, 0.1 second | 140 ℃, 0.1 second | 140 ℃, 0.1 second | 2.0 centimetre | * |
| Embodiment 6 | 125 ℃, 0.5 second | 140 ℃, 0.5 second | 140 ℃, 0.5 second | 1.5 centimetre | * |
| Embodiment 7 | 125 ℃, 2.0 seconds | 140 ℃, 2.5 seconds | 140 ℃, 2.5 seconds | 0.8 centimetre | * |
| Embodiment 8 | 125 ℃, 3.0 seconds | 140 ℃, 3.0 seconds | 140 ℃, 3.0 seconds | 0.5 centimetre | * |
| Embodiment 9 | 130 ℃, 0.1 second | 150 ℃, 0.1 second | 150 ℃, 0.1 second | 2.0 centimetre | * |
| Embodiment 10 | 130 ℃, 0.5 second | 150 ℃, 0.5 second | 150 ℃, 0.5 second | 0.8 centimetre | * |
| Embodiment 11 | 130 ℃, 2.0 seconds | 150 ℃, 2.5 seconds | 150 ℃, 2.5 seconds | 0.8 centimetre | * |
| Embodiment 12 | 130 ℃, 3.0 seconds | 150 ℃, 3.0 seconds | 150 ℃, 3.0 seconds | 0.3 centimetre | * |
| Embodiment 13 | 130 ℃, 0.1 second | 160 ℃, 0.1 second | 160 ℃, 0.1 second | 2.0 centimetre | * |
| Embodiment 14 | 130 ℃, 0.5 second | 160 ℃, 0.5 second | 160 ℃, 0.5 second | 1.5 centimetre | * |
| Embodiment 15 | 130 ℃, 2.0 seconds | 160 ℃, 2.5 seconds | 160 ℃, 2.5 seconds | 0.8 centimetre | * |
| Embodiment 16 | 130 ℃, 3.0 seconds | 160 ℃, 3.0 seconds | 160 ℃, 3.0 seconds | 0.5 centimetre | * |
| Embodiment 17 | 120 ℃, 0.1 second | 130 ℃, 0.1 second | 130 ℃, 0.1 second | 2.0 centimetre | ** |
| Embodiment 18 | 120 ℃, 0.5 second | 130 ℃, 0.5 second | 130 ℃, 0.5 second | 1.5 centimetre | ** |
| Embodiment 19 | 120 ℃, 2.0 seconds | 130 ℃, 2.5 seconds | 130 ℃, 2.5 seconds | 0.8 centimetre | ** |
| Embodiment 20 | 120 ℃, 3.0 seconds | 130 ℃, 3.0 seconds | 130 ℃, 3.0 seconds | 0.5 centimetre | ** |
| Embodiment 21 | 125 ℃, 0.1 second | 140 ℃, 0.1 second | 140 ℃, 0.1 second | 2.0 centimetre | ** |
| Embodiment 22 | 125 ℃, 0.5 second | 140 ℃, 0.5 second | 140 ℃, 0.5 second | 1.5 centimetre | ** |
| Embodiment 23 | 125 ℃, 2.0 seconds | 140 ℃, 2.5 seconds | 140 ℃, 2.5 seconds | 0.8 centimetre | ** |
| Embodiment 24 | 125 ℃, 3.0 seconds | 140 ℃, 3.0 seconds | 140 ℃, 3.0 seconds | 0.5 centimetre | ** |
| Embodiment 25 | 130 ℃, 0.1 second | 150 ℃, 0.1 second | 150 ℃, 0.1 second | 2.0 centimetre | ** |
| Embodiment 26 | 130 ℃, 0.5 second | 150 ℃, 0.5 second | 150 ℃, 0.5 second | 1.5 centimetre | ** |
| Embodiment 27 | 130 ℃, 2.0 seconds | 150 ℃, 2.5 seconds | 150 ℃, 2.5 seconds | 0.8 centimetre | ** |
| Embodiment 28 | 130 ℃, 3.0 seconds | 150 ℃, 3.0 seconds | 150 ℃, 3.0 seconds | 0.3 centimetre | ** |
| Embodiment 29 | 130 ℃, 0.1 second | 160 ℃, 0.1 second | 160 ℃, 0.1 second | 2.0 centimetre | ** |
| Embodiment 30 | 130 ℃, 0.5 second | 160 ℃, 0.5 second | 160 ℃, 0.5 second | 1.5 centimetre | ** |
| Embodiment 31 | 130 ℃, 2.0 seconds | 160 ℃, 2.5 seconds | 160 ℃, 2.5 seconds | 0.8 centimetre | ** |
| Embodiment 32 | 130 ℃, 3.0 seconds | 160 ℃, 3.0 seconds | 160 ℃, 3.0 seconds | 0.5 centimetre | ** |
*: in the three-layer co-extruded film for transfusion, outer membrane is made up of polypropylene, styrene-ethylene-butylene copolymer; Mesopelagic layer is made up of polypropylene, polyethylene, styrene-ethylene-butylene copolymer; Inner layer film is made up of polypropylene, styrene-ethylene-butylene copolymer.
*: three-layer co-extruded film for transfusion derives from the three-layer co-extruded film for transfusion (registration certificate number: advance medicated bag word J20060015) of PolyCine GmbH company.
Experimental example 1-outward appearance detects
Get each 10 of the embodiment 1-32 of this utility model, face range estimation at the bright place of available light respectively, all transparent, bright and clean, do not have a macroscopic foreign body.Mouth interface tube place does not have crackle, crack, hole, painted embedding thing and deposition of foreign material.
Experimental example 2-differentiates
(1) microscopic features: get each 10 of the embodiment 1-32 of this utility model, be cut into suitable thickness respectively, put microscopically and observe, three layers of cross section clear display.
(2) real weldering intensity: get the embodiment 1-32 of this utility model, measure according to the method for complex pocket in the heat sealing strength algoscopy (YBB00122003) respectively, the meansigma methods at each heat seal position all is not less than 20N/15mm.
(3) rosin joint intensity: get the embodiment 1-32 of this utility model, measure according to the method for complex pocket in the heat sealing strength algoscopy (YBB00122003) respectively, the meansigma methods at each heat seal position is (5N-12N)/15mm.
The experimental example 3-compatibility test of sterilizing
Get each 100 of the embodiment 1-32 of this utility model, fill proportioning medicinal liquid respectively, and seal.Adopt moist hear heat test (standard sterilization F
0The value>=8, like 121 ℃ of moist heat sterilizations, 15 minutes) sterilization after, carry out following test:
1. thermal adaptability:
Get 10 in above-mentioned sample; In-25 ℃ ± 2 ℃ condition held 24 hours, under 50 ℃ ± 2 ℃ condition, continue then to place 24 hours, again 23 ℃ ± 2 ℃ condition held 24 hours; At last sample is placed between the two parallel plates; Bear the intrinsic pressure of 67KPa, kept 10 minutes, no liquid spills.
2. anti-drop
Get 10 in above-mentioned sample; In-25 ℃ ± 2 ℃ condition held 24 hours, under 50 ℃ ± 2 ℃ condition, continue then to place 24 hours, again 23 ℃ ± 2 ℃ condition held 24 hours; Press the falling height of table 1 at last; It is fallen respectively on the inflexible smooth surface of a hard, do not break and leak, and the heat-sealing sealing coat does not have breakage.
Table 1 falling height
| Sign capacity (ml) | Falling height (m) |
| 500-500 | 1.00 |
| 500-500 | 0.75 |
| 500-500 | 0.50 |
| 500-500 | 0.25 |
3. transparency
Get 10 in above-mentioned sample, other gets one in empty bag, and the level number of packing into is No. 4 a turbidity standard, as the contrast bag; Under black background, with 2000lx-3000lx irradiation (avoiding exposure experiment personnel's eyes), visualization can be distinguished with the contrast bag with electric filament lamp.
4. particulate matter
Get 10 in above-mentioned sample; The interval of opening between two chambers is mixed solution; Measure according to the method under infusion bottle and the transfusion bag item in the particulate matter algoscopy (YBB00272004) of packaging material, the population of particle diameter >=5,10,25 μ m is lower than 100,20,2/ml respectively.
5. puncture force
Get 10 of the transfusion bag of this utility model; With the perforator that meets disposable infusion set gravity liquid infusing type standard (GB8368-2005); Site of puncture with the speed of 200mm/min ± 20mm/min puncture transfusion bag; The puncture force of plastics perforator is lower than 100N, and the puncture force of metal puncture device is lower than 80N.
The retentivity of perforator and the impermeability of insertion point
Get 10 double-chamber transfusion bags; Firmly extruding opens intermediary rosin joint bar, with meeting disposable infusion set; The insertion point of the perforator puncture transfusion bag of gravity liquid infusing type standard (GB8368-2005); Pull up perforator with the speed of 200mm/min ± 20mm/min then, the separating force of plastics perforator is not less than 5.0N, and the separating force of metal puncture device is not less than 1.0N.After extracting perforator, transfusion bag is placed between the two parallel plates again, apply the intrinsic pressure of 20kpa, kept 15 seconds, the insertion point does not have leak of liquid.
6. the sealing of injection point
Get 10 double-chamber transfusion bags, firmly extruding is opened intermediary rosin joint bar; Use external diameter as the entry needle puncture and injection of medicine point of 0.6mm and kept 15 seconds, extract entry needle after, then bag is placed between the two parallel plates; Apply the intrinsic pressure of 20kpa, kept 15 seconds, injection point does not leak.
7. light transmittance
Get the smooth position of the transfusion bag of this utility model; Be cut into the section of 5 0.9cm * 4cm, put into absorption cell along the incident illumination vertical direction respectively, topped up with water; And with water as blank; According to ultraviolet visible spectrophotometry (two appendix IV of Chinese Pharmacopoeia version in 2005 A), measure light transmittance at the 450nm place, all be not less than 75%.
8. residue on ignition
Get 1 of the transfusion bag of this utility model, shred, precision takes by weighing 5.0g, places the crucible of constant weight.Be heated to 100 ℃ of dryings 1 hour, and in 550 ℃ of ignition to constant weight, left over residue and be lower than 0.05% again.After getting residue under the residue on ignition item and adding hydrochloric acid (1 → 2) 25ml dissolving, measure according to atomic absorption spectrophotometry (two appendix IV of Chinese Pharmacopoeia version in 2005 D),
Copper is measured in the 324.8nm wavelength, is lower than 3/1000000ths;
Cadmium is measured in the 228.8nm wavelength, is lower than 3/1000000ths;
Chromium is measured in the 357.9nm wavelength, is lower than 3/1000000ths;
Plumbous in 217.0nm wavelength mensuration, be lower than 3/1000000ths;
Stannum is measured in the 286.3nm wavelength, is lower than 3/1000000ths;
Barium is measured in the 553.6nm wavelength, is lower than 3/1000000ths.
The drug release test of the blank transfusion bag of experimental example 4-this utility model
Get the smooth part (internal surface area 600cm2) of the blank transfusion bag (no medicinal liquid is filled) of the embodiment 1-32 of this utility model, be cut into the fritter of 5cm * 0.5cm, use water washing; After the drying at room temperature, place the conical flask of 500ml, add water 200ml; Sealing was put in the autoclave sterilizer, in 121 ℃ of heating 30 minutes; Put and be chilled to room temperature, as test liquid; Water intaking as blank solution, is carried out following test with the method operation in addition:
1. clarity: get test liquid, measure, the solution clarification according to clarity inspection technique (two appendix IX of Chinese Pharmacopoeia version in 2005 B); As showing muddy, compare with No. 2 turbidity standards, denseer.
2. color: get test liquid, inspection (two appendix IX of Chinese Pharmacopoeia version in 2005 A) in accordance with the law, solution is colourless.
3. foam stability test: get test liquid 5ml, place in the tool plug test tube (internal diameter 15mm, highly about 200mm), shaken 3min, the foam of generation disappears in 3min.
4.pH value: get test liquid 20ml, add Klorvess Liquid (1 → 1000) 1ml, measure according to pH value algoscopy (two appendix VI of Chinese Pharmacopoeia version in 2005 H), pH value is 5.0-7.0.
5. ultraviolet absorptivity: getting test liquid, is contrast with the blank solution.According to ultraviolet visible spectrophotometry (two appendix IV of Chinese Pharmacopoeia version in 2005 A), in the scope interscan of wavelength 220-350nm.Obtained the maximum absorption between 220-240nm is lower than 0.08; Obtained the maximum absorption between 241-350nm is lower than 0.05.
6. non-volatile matter: get test liquid 50ml, put in the evaporating dish of constant weight, water bath method, and be dried to constant weight at 105 ℃.Make blank correction with blank solution, leave over residue and be lower than 2.5mg.
7. readily oxidizable substance: precision is measured test liquid 20ml, and accurate permanganate titration liquid (0.002mol/L) 10ml and the dilution heat of sulfuric acid 10.0ml of adding heats little boiling 3 minutes, is cooled to room temperature.Add the 0.1g potassium iodide, to light brown, add the titration of 5 starch indicator solution continued again to colourless with sodium thiosulfate volumetric solution (0.01mol/L) titration.Carry out blank assay simultaneously, the difference that experimental liquid and blank solution consume volumetric solution is lower than 1.5ml.
8. ammonium ion: get test liquid 50ml, add alkaline test solution of mercuric potassium iodide 2ml, placed 15 minutes; Like colour developing,, add contrast liquor ratio that blank solution 46ml and alkaline test solution of mercuric potassium iodide 2ml process, darker with ammonium chloride solution (get ammonium chloride 31.5mg, add no ammonia and make dissolving in right amount and be diluted to 1000ml) 4.0ml.（0.00008%）
9. barium ions: it is an amount of to get test liquid, measures down according to the metallic element item, be lower than 1,000,000/.
10. copper ion: it is an amount of to get test liquid, measures down according to the metallic element item, be lower than 1,000,000/.
11. cadmium ion: it is an amount of to get test liquid, measures down according to the metallic element item, is lower than 1/10000000th.
12. lead ion: it is an amount of to get test liquid, measures down according to the metallic element item, be lower than 1,000,000/.
13. tin ion: it is an amount of to get test liquid, measures down according to the metallic element item, is lower than 1/10000000th.
14. chromium ion: it is an amount of to get test liquid, measures down according to the metallic element item, be lower than 1,000,000/.
15. aluminium ion: it is an amount of to get test liquid, measures in the wavelength of 309.3nm according to atomic absorption spectrophotometry (two appendix IV of Chinese Pharmacopoeia version in 2005 D), is lower than 1,000,000/zero point zero five.
16. heavy metal: precision is measured test liquid 20ml, adds acetate buffer (pH3.5) 2ml, inspection (two appendix VIII of Chinese Pharmacopoeia version in 2005 H, first method) in accordance with the law, be lower than 1,000,000/.
Experimental example 5-detection of bacterial endotoxin
Get each 10 of the blank transfusion bag of the embodiment 1-32 of this utility model, add the apirogen water of sign capacity, behind the envelope, place autoclave sterilizer, in 121 ℃ ± 2 ℃ sterilizations 30 minutes, put cold, as experimental liquid.Gel method (two appendix XI of Chinese Pharmacopoeia version in 2005 E method 1) according to bacterial endotoxins test is measured, and is lower than 0.25EU/ml.
Experimental example 6-rosin joint and real weldering intensity detection
The requirement of strength sample of rosin joint in the process of storing transportation except can bearing certain pressure, anti-drop and rosin joint do not ftracture and damages; Also desired strength can not be too big; Clinician or nurse can open the rosin joint extruding with suitable strength, are convenient to the mixing of two chambers bag transfusion, convenient clinical use.
Get each 10 of the blank transfusion bag of the embodiment 1-32 of this utility model, measure according to the method for complex pocket in the heat sealing strength algoscopy (YBB00122003) respectively, the meansigma methods at each heat seal position is 5-12N/15mm.
Wherein, the formulation of rosin joint low intensity limit ensures that according to being anti-drop test data finished product under the commercially available back condition, in loading and unloading and transportation, can not produce damaged situation because of the external force effect; In clinical use, the opening operation of two chambers bag rosin joint makes things convenient for, uses compliance to be foundation well with finished product in the formulation of the rosin joint intensity upper limit.For working out the bound scope of rosin joint intensity, we have designed a series of tests and have drawn reasonable parameter.
Rosin joint low intensity limit EXPERIMENTAL DESIGN: open Bag Making Machine, adjustment heat-seal temperature and slit width are produced a collection of double-chamber transfusion bag; Through the intercepting of rosin joint position being carried out the tensile force test, rosin joint intensity is respectively 3-4N, 5-6N, and each specification bag of each parameter area is no less than 100; Get above-mentioned sample, according to different specifications fill water for injection, after jumping a queue; Sterilising temp according to finished product is sterilized; Get sample after the sterilization in-25 ℃ ± 2 ℃ condition held 24 hours, under 50 ℃ ± 2 ℃ condition, continue then to place 24 hours, again 23 ℃ ± 2 ℃ condition held 24 hours; Whether drop on the inflexible smooth surface of a hard from the height of 0.75m respectively at last, observing double-chamber transfusion bag has and breaks and leak.
Result of the test: rosin joint intensity is the sample of 3-4N, and falling the middle rosin joint in back has generation to squeeze situation about opening, and rosin joint intensity is the sample of 5-6N, not breaks after falling or crowded opening.Considering has certain difference between the different batches film, for guaranteeing in the finished product transportation damaged situation not to take place, the lower limit of rosin joint intensity is decided to be 5N.
Rosin joint heat sealing strength upper limit EXPERIMENTAL DESIGN: open Bag Making Machine, adjustment heat-seal temperature and slit width are produced a collection of double-chamber transfusion bag; Through the intercepting of rosin joint position being carried out the tensile force test, rosin joint intensity is respectively 8-10N, 10-12N, 12-14N, and each parameter area bag is no less than 200; Get above-mentioned sample, according to different specifications fill water for injection, after jumping a queue; Sterilising temp according to finished product is sterilized, and the sample of getting after the sterilization makes an experiment.
Select 10 of female employees at random at workshop, 5 of male employees are divided into 3 groups according to the power of hand strength, every group 5 people, and everyone is no less than 10 bags by the test specimen of getting different rosin joint intensity, with the two chambers of hands extruding bag, sees whether two intermediary rosin joints of chamber bag can be opened.
Result of the test: with strength from weak to strong ordering, rosin joint intensity is the test specimen of 8-10N and 10-12N, the member of 3 groups all can with the hands push out rosin joint, and shows with rosin joint intensity and strengthen, the operating pressure of opening rosin joint strengthens, difficulty increases; Rosin joint intensity is the test specimen of 12-14N, preceding 2 group memberships had surpass half the strength weak person can not the smooth opening rosin joint, the 3rd group membership opens rosin joint also has certain degree of difficulty.Considering between the film of different batches has certain difference, for convenient clinical use, with being defined as 12N on the rosin joint intensity.
Experimental example 7-outer packaging bag is to the sex investigation of preparation stabilization
Get each 5 of the pastille transfusion finished products of the embodiment 1-32 of this utility model; Under 25 ℃, the condition of relative humidity 45%; Form to adopt or not adopt the outer packaging bag sealing keeps sample; Measure the relative percentage composition of the relatively poor relatively tryptophan of stability, investigate the influence of outer package preparation stability.
* relatively there were significant differences with no outer packaging bag, and there were significant differences for # and the colourless comparison of non-PVC
Can reach a conclusion through this experiment: outer packaging bag is to the effect of being significantly improved of the stability of drug in the double-chamber transfusion bag that is poured in this utility model, and coloured outer packaging bag is more obvious to the improvement effect of preparation stability.
Claims (8)
1. the double-chamber transfusion bag of aminoacid glucose injection is packed in new being used to; It is characterized in that: comprise 2 compartments (1) and (2); Between 2 compartments, have interval (3) that it is separated, 2 compartments respectively have the path (4) of a perfusion fluid, and a side compartment (1) is through path (4) perfusion 500 ml solns; Opposite side compartment (2) is through path (4) perfusion 500 ml solns, and path (4) is parallel with interval (3).
2. double-chamber transfusion bag according to claim 1; The main body that it is characterized in that said double-chamber transfusion bag is processed through hot pressing by three-layer co-extruded film for transfusion, and it number is the three-layer co-extruded film for transfusion of medicated bag word J20060015 into that wherein three-layer co-extruded film for transfusion derives from PolyCine GmbH certificate of incorporation.
3. double-chamber transfusion bag according to claim 1 and 2 is characterized in that having formed rosin joint (3) at interval through hot pressing between said compartment (1) and (2), and the width of its interval (3) is 0.3-2.0 centimetre.
4. double-chamber transfusion bag according to claim 4 is characterized in that the width at the interval (3) between its compartment is 0.5-2.0 centimetre.
5. double-chamber transfusion bag according to claim 5 is characterized in that the width at the interval (3) between its compartment is 0.8-1.5 centimetre.
6. double-chamber transfusion bag according to claim 1 and 2, the transverse width that it is characterized in that the outer margin contour of said double-chamber transfusion bag is 25-30 centimetre, the longitudinal length of outer margin contour is 25-40 centimetre.
7. double-chamber transfusion bag according to claim 1 and 2 is characterized in that also having an outer packaging bag that it is sealed in the outside of said double-chamber transfusion bag.
8. a kind of in green, blue, red, black or the clear, colorless of double-chamber transfusion bag according to claim 7, the color that it is characterized in that said outer packaging bag.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2011202705738U CN202314359U (en) | 2011-07-28 | 2011-07-28 | Novel double-chamber transfusion bag for packaging amino acid and glucose injection |
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|---|---|---|---|
| CN2011202705738U CN202314359U (en) | 2011-07-28 | 2011-07-28 | Novel double-chamber transfusion bag for packaging amino acid and glucose injection |
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| CN202314359U true CN202314359U (en) | 2012-07-11 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102755252A (en) * | 2011-07-28 | 2012-10-31 | 辽宁海思科制药有限公司 | New dual-chamber transfusion bag for packaging amino acid and glucose injection |
| CN115743676A (en) * | 2022-11-24 | 2023-03-07 | 楚天科技股份有限公司 | Multi-chamber bag making process |
-
2011
- 2011-07-28 CN CN2011202705738U patent/CN202314359U/en not_active Expired - Lifetime
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102755252A (en) * | 2011-07-28 | 2012-10-31 | 辽宁海思科制药有限公司 | New dual-chamber transfusion bag for packaging amino acid and glucose injection |
| CN115743676A (en) * | 2022-11-24 | 2023-03-07 | 楚天科技股份有限公司 | Multi-chamber bag making process |
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Granted publication date: 20120711 |