CN202376453U - Novel package of double-chamber transfusion bag of parenteral nutrition injection - Google Patents
Novel package of double-chamber transfusion bag of parenteral nutrition injection Download PDFInfo
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- CN202376453U CN202376453U CN2011202705776U CN201120270577U CN202376453U CN 202376453 U CN202376453 U CN 202376453U CN 2011202705776 U CN2011202705776 U CN 2011202705776U CN 201120270577 U CN201120270577 U CN 201120270577U CN 202376453 U CN202376453 U CN 202376453U
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Abstract
The utility model belongs to the medical technical field, to be specific, relates to a three-layer co-extrusion double-chamber transfusion bag. The double-chamber transfusion bag provided in the utility model can be produced by hot pressing, and a false welding spacing can be formed between the double chambers by using the hot press method. The spacing can be used to isolate the injection in the double chambers during storage and transport of the transfusion liquid, and the spacing can be conveniently opened by applying a certain external force during the use of the transfusion liquid, the double chambers can be communicated, and then the transfusion liquid in the double chambers can be mixed. By using the novel package provided in the utility model, the maloperation during the mixing of common transfusion liquid can be prevented, problems such as particles generated by the puncture and cross contamination by the mixture can be reduced, and the stability of transfusion can be improved. The transfusion liquid packaged by the double-chamber bag provided in the utility model can satisfy the clinical requirements of safe, rapid, 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.
The parenteral nutrition injection that this utility model relates to is made up of 2 bag liquids, and the 1st bag comprises 200 milliliters of Freamines, wherein contain: isoleucine 1.120 grams, alanine 1.240 grams; Tryptophan 0.260 gram, leucine 2.500 grams, proline 0.660 gram, valine 0.900 gram; Lysine acetate 2.480 grams, Aspartic Acid 0.760 gram, arginine 1.580 grams, methionine 0.700 gram; Glycine 2.140 grams, histidine 1.200 grams, phenylalanine 1.870 grams, cysteine 0.200 gram; Serine 0.440 gram, threonine 1.300 grams, glutamic acid 1.300 grams and tyrosine 0.070 gram.The 2nd bag comprises 800 milliliters of 15% glucose solutions that contain inorganic salt, wherein contains: anhydrous glucose 120.0 grams, sodium chloride 2.920 grams, potassium acetate 2.160 grams, potassium dihydrogen phosphate 1.088 grams, magnesium sulfate 0.740 gram, calcium gluconate (C
12H
22CaO
14H
2O) 1.792 grams and zinc sulfate (ZnSO
47H
2O) 5.752 milligrams.
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 clinical indication of parenteral nutrition injection (25) is: for can not or fully per os and/or the patient who absorbs nourishment through gastrointestinal and those need the patient of central vein nutrition, these article can be used as the nutritional preparation of patient's supplementing water, electrolyte, aminoacid and heat.Its usage and dosage is intravenous drip.At treatment beginning and carbohydrate tolerance unknown or when having reduced as initial liquid, perhaps as the patient because morbidity causes that carbohydrate tolerance descends and when needing the restriction glucose to take in conduct keep liquid.Open sealing coat during use, make two bag liquids be mixed and made into initial liquid or keep liquid.
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 parenteral nutrition injection (25).
The utility model content
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 parenteral nutrition 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 800 ml solns, and opposite side compartment (2) is through path (4) perfusion 200 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 customed product (registration certificate number: advance medicated bag word J20060015) of PolyCine GmbH company.
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 ℃, and 0.5-2 second weld interval; The parameter of welded is: temperature 130-160 ℃; 0.5-2.5 second weld interval, path (4) with the welding parameter of 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.
In this utility model, compartment (1) wherein contains through path (4) perfusion 800 ml water solution: anhydrous glucose 120.0 grams, sodium chloride 2.920 grams, potassium acetate 2.160 grams, potassium dihydrogen phosphate 1.088 grams, magnesium sulfate 0.740 gram, calcium gluconate (C
12H
22CaO
14H
2O) 1.792 grams and zinc sulfate (ZnSO
47H
2O) 5.752 milligrams; Compartment (2) wherein contains through path (4) perfusion 200 ml water solution: isoleucine 1.120 grams, alanine 1.240 grams, tryptophan 0.260 gram; Leucine 2.500 grams, proline 0.660 gram, valine 0.900 gram, lysine acetate 2.480 grams; Aspartic Acid 0.760 gram, arginine 1.580 grams, methionine 0.700 gram, glycine 2.140 grams; Histidine 1.200 grams, phenylalanine 1.870 grams, cysteine 0.200 gram; Serine 0.440 gram, threonine 1.300 grams, glutamic acid 1.300 grams and tyrosine 0.070 gram.
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
*: 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 special-purpose film (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) |
| 800-200 | 1.00 |
| 800-200 | 0.75 |
| 800-200 | 0.50 |
| 800-200 | 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 relatively poor relatively tryptophan of stability and the relative percentage composition of cysteine, 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 parenteral nutrition 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 800 ml solns; Opposite side compartment (2) is through path (4) perfusion 200 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. according to any described double-chamber transfusion bag of claim 1-2, it is characterized in that having formed rosin joint (3) at interval through hot pressing between said compartment (1) and (2), 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. according to any described double-chamber transfusion bag of claim 1-2, the transverse width that it is characterized in that the outer margin contour of said double-chamber transfusion bag is 25-30 centimetre, and the longitudinal length of outer margin contour is 25-40 centimetre.
7. according to any described double-chamber transfusion bag of claim 1-2, it 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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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103610693A (en) * | 2013-12-03 | 2014-03-05 | 辽宁海思科制药有限公司 | Parenteral nutrition injection composition |
| CN111658667A (en) * | 2020-07-16 | 2020-09-15 | 华仁药业股份有限公司 | Preparation method of double-chamber bag-packaged cerebrospinal fluid for operation |
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2011
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103610693A (en) * | 2013-12-03 | 2014-03-05 | 辽宁海思科制药有限公司 | Parenteral nutrition injection composition |
| CN103610693B (en) * | 2013-12-03 | 2015-12-30 | 辽宁海思科制药有限公司 | A kind of parenteral nutrition injection composition |
| CN111658667A (en) * | 2020-07-16 | 2020-09-15 | 华仁药业股份有限公司 | Preparation method of double-chamber bag-packaged cerebrospinal fluid for operation |
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