CN202376452U - Novel three-chamber transfusion bag used for packaging medium-long-chain fat emulsion, 16 amino acids and 16% dextrose injection - Google Patents
Novel three-chamber transfusion bag used for packaging medium-long-chain fat emulsion, 16 amino acids and 16% dextrose injection Download PDFInfo
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- CN202376452U CN202376452U CN2011202705761U CN201120270576U CN202376452U CN 202376452 U CN202376452 U CN 202376452U CN 2011202705761 U CN2011202705761 U CN 2011202705761U CN 201120270576 U CN201120270576 U CN 201120270576U CN 202376452 U CN202376452 U CN 202376452U
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Abstract
The utility model belongs to the medical technical field, and to be specific, relates to a novel three-chamber transfusion bag used for packaging medium-long-chain fat emulsion, 16 amino acids and 16% dextrose injection. The three-chamber transfusion bag provided in the utility model comprises a first separation chamber, a second separation chamber, and a third separation chamber. A spacing is disposed between the first separation chamber and the second separation chamber in order to isolate the two chambers from each other, and a spacing is disposed between the second separation chamber and the third separation chamber in order to isolate the two chambers from each other. Each of the three separation chambers is provided with a channel used for injecting liquid, and the chambers can respectively use the channel to inject 250ml fat emulsion injection in the first separation chamber, to inject 500ml amino acid injection in the second separation chamber, and to inject 500ml dextrose injection into the third separation chamber, and the channels are parallel to the spacings. By using the novel three-chamber transfusion bag 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 three-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 three chamber infusion bags that are used to pack the parenteral nutrition product.
Background technology
Parenteral nutrition mainly is applicable to gastrointestinal function obstacle or depleted patient, is through the required nutritional factors of intravenous route supply patient, mainly comprises heat carbohydrate, lipomul, aminoacid, vitamin, electrolyte and trace element.From the organism metabolism angle, two big fundamentals of synthetic protein are the energy and nitrogenous source, and are indispensable.The former provides synthetic power at (mainly being glucose and fat), and latter's (essential amino acids) then is the raw material of synthetic protein.Have only the heat material of working as and nitrogen substance to import simultaneously and comprise electrolyte, vitamin etc., just possibly make anabolism be in optimum state.
Because patient needs the multiple material of infusion simultaneously; Therefore the rational method of parenteral nutrition is to use " All-In-One "; Be about to various nutrient substance, scientifically mixed configuration is in same container to comprise fat milk, aminoacid, glucose and trace element etc., and infusion is given the patient simultaneously.Total parenteral nutrition (TPN) is a new notion.TPN is meant and outside gastrointestinal tract, supplies with the required whole nutritional labelings of patient; Comprise enough heats, several amino acids, essential fatty acid, multivitamin and electrolyte and trace element; Make patient can not take in and absorb bear severe trauma or complicated operation again after, still can keep good nutriture.
Middle long chain fat emulsion/aminoacid/glucose injection is made up of 3 bag liquids.The 1st bag comprises 250 milliliters of middle long-chain fat acid injections, wherein contains soybean oil 25.0 grams, medium chain triglyceride 25.0 grams, glycerol 6.25 grams, Ovum Gallus domesticus Flavus lecithin 3.0 grams.The 2nd bag comprises 500 milliliters of amino acid injections, wherein contains isoleucine 2.34 grams, leucine 3.13 grams, lysine hydrochloride 2.84 grams, methionine 1.96 grams; Phenylalanine-3,4-quinone .51 gram, threonine 1.82 grams, tryptophan 0.57 gram, valine 2.60 grams, arginase 12 .70 gram; Histidine monohydrochloride monohydrate 1.69 grams, alanine 4.85 grams, Aspartic Acid 1.50 grams, glutamic acid 3.50 grams; Glycine 1.65 grams, proline 3 .40 gram, serine 3.00 grams, sodium chloride 1.081 grams; The 3rd bag comprises 500 milliliters of glucose injections, wherein contains glucose 88.0 grams.
In the indication of long chain fat emulsion/aminoacid/glucose injection be: be used for can not or functional defect or the patient that absorbed nourishment by taboo per os/intestinal, the daily required energy of parenteral alimentation, essential fatty acid, aminoacid and electrolyte are provided.
In the hospital at home, the input of parenteral nutrition is through the administration of many bottles of infusion modes, is about to bottled total parenteral nutrition-aminoacid, glucose and fat milk and links up by placed in-line mode and import, and this is unscientific in fact.Many bottles in turn infusion has not only brought to medical personnel and has changed the trouble that bottle, constantly inspection, adjustment drip speed repeatedly, main is to patient also brought infection chance to increase, effectively nutritional labeling is difficult to more problems such as good utilisation.
Three chamber infusion bags of this utility model are contained in different drug in the different compartments, pass through extruding three Room bags during use, just can be with the medicament mixed in each compartment together.The enforcement of this utility model can make things convenient for clinical use, reduces and pollutes probability, the quality stability of long chain fat emulsion/aminoacid in the raising/glucose injection.
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 three chamber infusion bags that are used for packing long chain fat emulsion, 16 seed amino acids and 16% glucose injection; This transfusion bag comprises first compartment (1), second compartment (2) and the 3rd compartment (3), and (4) separate it having at interval between first compartment (1) and second compartment (2) and between second compartment (2) and the 3rd compartment (3) respectively, and three compartments respectively have the path (5) of a perfusion fluid; Three compartments pour into 250 milliliters of fat emulsion injections through path (5) to first compartment (1) respectively; To 500 milliliters of amino acid injections of second compartment (2) perfusion, to 500 milliliters of glucose injections of the 3rd compartment (3) perfusion, path (5) is parallel with interval (4).
When using clinically, face, the rosin joint at interval (4) is opened, 3 first compartments (1), second compartment (2) and the 3rd compartment (3) are connected, thereby the medicinal liquid in three Room is mixed with the preceding extruding transfusion bag of passing through.
Three above-mentioned chamber infusion bags, 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 by polypropylene, and styrene-ethylene-butadiene block copolymer is formed (7.5%); Mesopelagic layer is by polypropylene, polyethylene, and styrene-ethylene-butadiene block copolymer is formed (85%); Inner layer film is formed (7.5%) by polypropylene.
Three above-mentioned chamber infusion bags, its main body is processed through hot pressing by three-layer co-extruded film for transfusion, and wherein three-layer co-extruded film for transfusion derives from PolyCine GmbH company, and wherein the outer membrane source is the film material (7.5%) of numbering CFA 100; The mesopelagic layer source is the film material (85%) of numbering BFX 101; The inner layer film source is the film material (7.5%) of numbering BFX 284.
The percent of above-mentioned film is thickness parameter, i.e. ratio in each comfortable gross thickness of trilamellar membrane.
Three above-mentioned chamber infusion bags; Wherein said transfusion bag is processed through hot-press method, and between each compartment, forms (4) at interval through the heating rosin joint, and the width of its interval (4) is 0.3-2.0 centimetre; Be preferably 0.5-2.0 centimetre, more preferably 0.8-1.5 centimetre.
Three above-mentioned chamber infusion bags, the parameter of the rosin joint in the wherein said hot pressing is: temperature 120-140 ℃, 0.5-3 second weld interval; The parameter of said real weldering is: temperature 130-160 ℃, and 0.5-3 second weld interval; The parameter of said path (4) and first compartment (1), second compartment (2), the 3rd compartment (3) welding is: temperature 130-160 ℃, and 0.5-3 second weld interval.
Preferably, the parameter of rosin joint is in the said hot pressing: temperature 125-135 ℃, and 1-2 second weld interval; The parameter of said real weldering is: temperature 140-150 ℃, and 1-2 second weld interval; The welding parameter of said path (4) and first compartment (1), second compartment (2), (3) is: temperature 140-150 ℃, and 1-2 second weld interval.
Three above-mentioned chamber infusion bags, wherein the real weldering position intensity of three chamber infusion bags is measured according to the method for complex pocket in the heat sealing strength algoscopy (YBB00122003), and the meansigma methods at each heat seal position all is not less than 25N/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 each heat seal position is 8-18N/15mm.
Three above-mentioned chamber infusion bags, the transverse width of its outer margin contour are 25-30 centimetre, and the longitudinal length of outer margin contour is 25-40 centimetre.
Three above-mentioned chamber infusion bags, its outside outer packaging bag in addition seals it.
Three above-mentioned chamber infusion bags, wherein the material of outer packaging bag is metal or plastics.
Three above-mentioned chamber infusion bags, wherein the color of outer packaging bag is a kind of in green, blue, red, black or the clear, colorless.
Be placed with oxygen absorbent between the three above-mentioned chamber infusion bags, itself and said outer packaging bag.In this utility model, long-chain fat acid injection during first compartment (1) pours into 250 milliliters through path (4) wherein contains soybean oil 25.0 grams, medium chain triglyceride 25.0 grams; Glycerol 6.25 grams, Ovum Gallus domesticus Flavus lecithin 3.0 gram second compartments (2) wherein contain isoleucine 2.34 grams through 500 milliliters of amino acid injections of path (4) perfusion, leucine 3.13 grams; Lysine hydrochloride 2.84 grams, methionine 1.96 grams, phenylalanine-3,4-quinone .51 gram, threonine 1.82 grams; Tryptophan 0.57 gram, valine 2.60 grams, arginase 12 .70 gram, histidine monohydrochloride monohydrate 1.69 grams; Alanine 4.85 grams, Aspartic Acid 1.50 grams, glutamic acid 3.50 grams, glycine 1.65 grams; Proline 3 .40 gram, serine 3.00 grams, sodium chloride 1.081 grams; The 3rd compartment (3) wherein contains glucose 88.0 grams through 500 milliliters of glucose injections of path (4) perfusion.
Three above-mentioned chamber infusion bags, its sterilization method adopt 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 three chamber infusion bags is rosin joints, and this rosin joint is at strict medicinal liquid of isolating in three compartments of storage, when transportation, and under certain external force, is opening when using, and three 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.The three Room bags 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 three qualified chamber infusion bags, can medicinal liquid be filled into respectively in 3 compartments then, and the sealing of jumping a queue, heat sterilization promptly gets.Three chamber infusion bags of this utility model adopt the outer packaging bag of metal or plastic material to seal, and between three chamber infusion bags and outer packaging bag, are placed with oxygen absorbent, remain in cleaning, ventilation.The three chamber infusion bag steady qualities 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 three chamber infusion bags of Fig. 1 this utility model
Preparation technology's flow chart of three chamber infusion bags of Fig. 2 this utility model
The specific embodiment
In order better to understand this utility model, further set forth this utility model and advantage thereof through embodiment and experimental evidence below.
The preparation technology of three chamber infusion bags of this utility model
*: in the three-layer co-extruded film for transfusion, outer membrane is by polypropylene, and styrene-ethylene-butadiene block copolymer is formed (7.5%); Mesopelagic layer is by polypropylene, polyethylene, and styrene-ethylene-butadiene block copolymer is formed (85%); Inner layer film is formed (7.5%) by polypropylene.
*: wherein three-layer co-extruded film for transfusion derives from PolyCine GmbH company, and wherein the outer membrane source is numbering CFA 100 (7.5%); The mesopelagic layer source is numbering BFX 101 (85%); The inner layer film source is numbering BFX 284 (7.5%).
The percent of above-mentioned film is thickness parameter, i.e. ratio in each comfortable gross thickness of trilamellar membrane.
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 (milliliter) | Falling height (m) |
| 250-500-500 | 1.00 |
| 250-500-500 | 0.75 |
| 250-500-500 | 0.50 |
| 250-500-500 | 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 the illumination irradiation (avoid exposure experiment personnel's eyes) of electric filament lamp with 2000lx-3000lx, visualization can be distinguished with the contrast bag.。
4. particulate matter
Get 10 in above-mentioned sample; The interval of opening between three Room 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/milliliter 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 (GB8368-2005) standard; Site of puncture with the speed puncture transfusion bag of 200mm/ minute ± 20mm/ minute; 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 three chamber infusion bags; Firmly extruding; Intermediary rosin joint bar (at interval) is opened,, pulled up perforator with the speed of 200mm/ minute ± 20mm/ minute then with the insertion point of the perforator puncture transfusion bag that meets disposable infusion set gravity liquid infusing type (GB8368-2005) standard; 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 three chamber infusion bags, firmly extruding is opened intermediary rosin joint bar (at interval); Use external diameter as the entry needle puncture and injection of medicine point of 0.6mm and kept 15 seconds, extract entry needle after, 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 5.0 grams, 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 25 milliliters of dissolvings of hydrochloric acid (1 → 2), 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 500 milliliters conical flask, add 200 milliliters in water; 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 5 milliliters of test liquids, place in the tool plug test tube (internal diameter 15mm, highly about 200mm), shaken 3 minutes, the foam of generation disappeared in 3 minutes.
4.pH value: get 20 milliliters of test liquids, add Klorvess Liquid (1 → 1000) 1 milliliter, 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 50 milliliters of test liquids, 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 2.5 milligrams.
7. readily oxidizable substance: precision is measured 20 milliliters of test liquids, and accurate 10 milliliters of permanganate titration liquid (0.002mol/L) and 10.0 milliliters of the dilution heat of sulfuric acid of adding heats little boiling 3 minutes, is cooled to room temperature.Add 0.1 gram 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 1.5 milliliters.
8. ammonium ion: get 50 milliliters of test liquids, add 2 milliliters of alkaline test solution of mercuric potassium iodide, placed 15 minutes; Like colour developing, with 4.0 milliliters of ammonium chloride solutions (get 31.5 milligrams of ammonium chloride, add no ammonia and make dissolving in right amount and be diluted to 1000 milliliters), add 46 milliliters of contrast liquor ratios of processing with 2 milliliters of alkaline test solution of mercuric potassium iodide of blank solution, there is not darker (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 20 milliliters of test liquids, adds 2 milliliters of acetate buffers (pH3.5), 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 the 0.25EU/ milliliter.
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 three Room bag transfusions, 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 8-18N/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 three Room bag rosin joints 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 three chamber infusion bags; Through the intercepting of rosin joint position being carried out the tensile force test, rosin joint intensity is respectively 5-6N, and 7-8N, each specification bag of each parameter area are 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 three chamber infusion bags has and breaks and leak.
Result of the test: rosin joint intensity is the sample of 5-6N, and falling the middle rosin joint in back has the crowded situation about opening that takes place, and rosin joint intensity is not broken after falling or crowded opening greater than the sample of 8-10 N.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 8N.
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 three chamber infusion bags, 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, 14-16N, 16-18N; Each parameter area bag of 18-20N is no less than 200, gets above-mentioned sample, according to different specifications fill water for injection; After jumping a queue, sterilize according to the sterilising temp of finished product, 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, pushes three Room bags with hands, sees whether the intermediary rosin joint of three Room bags can be opened.
Result of the test: with strength from weak to strong ordering, rosin joint intensity is 8-10N, 10-12N, 12-14N, 14-16N; The test specimen of 16-18N, the member of 3 groups all can with the hands push out rosin joint, and demonstration strengthens with rosin joint intensity; The operating pressure of opening rosin joint strengthens, and difficulty increases.Rosin joint intensity is the test specimen of 18-20N, 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 18N 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 Aspartic Acid, 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 stability of drug effect of being significantly improved in three chamber infusion bags that are poured in this utility model, and coloured outer packaging bag is more obvious to the improvement effect of preparation stability.
Claims (8)
1. three chamber infusion bags of long chain fat emulsion, 16 seed amino acids and 16% glucose injection are packed in new being used for; It is characterized in that: comprise first compartment (1), second compartment (2) and the 3rd compartment (3); (4) separate it having at interval between first compartment (1) and second compartment (2) and between second compartment (2) and the 3rd compartment (3) respectively; Three compartments respectively have the path (5) of a perfusion fluid; Three compartments pour into 250 milliliters of fat emulsion injections through path (5) to first compartment (1) respectively; To 500 milliliters of amino acid injections of second compartment (2) perfusion, to 500 milliliters of glucose injections of the 3rd compartment (3) perfusion, path (5) is parallel with interval (4).
2. according to claim 1 described three chamber infusion bag; It is characterized in that forming rosin joint (4) at interval through hot pressing between said first compartment (1) and second compartment (2) and between second compartment (2) and the 3rd compartment (3), the width of its interval (4) is 0.3-2.0 centimetre.
3. three chamber infusion bags according to claim 2 is characterized in that the width at the interval (4) between its compartment is 0.5-2.0 centimetre.
4. three chamber infusion bags according to claim 3 is characterized in that the width at the interval (4) between its compartment is 0.8-1.5 centimetre.
5. according to each described three chamber infusion bags of claim 1-4, the transverse width that it is characterized in that the outer margin contour of said three chamber infusion bags is 25-30 centimetre, and the longitudinal length of outer margin contour is 25-40 centimetre.
6. according to each described three chamber infusion bags of claim 1-4, it is characterized in that also having an outer packaging bag that it is sealed in the outside of said three chamber infusion bags.
7. three chamber infusion bags according to claim 6, the material that it is characterized in that said outer packaging bag is metal or plastics.
8. a kind of in green, blue, red, black or the clear, colorless of three chamber infusion bags according to claim 6, the color that it is characterized in that said outer packaging bag.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011202705761U CN202376452U (en) | 2011-07-28 | 2011-07-28 | Novel three-chamber transfusion bag used for packaging medium-long-chain fat emulsion, 16 amino acids and 16% dextrose injection |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011202705761U CN202376452U (en) | 2011-07-28 | 2011-07-28 | Novel three-chamber transfusion bag used for packaging medium-long-chain fat emulsion, 16 amino acids and 16% dextrose injection |
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| Publication Number | Publication Date |
|---|---|
| CN202376452U true CN202376452U (en) | 2012-08-15 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2011202705761U Expired - Lifetime CN202376452U (en) | 2011-07-28 | 2011-07-28 | Novel three-chamber transfusion bag used for packaging medium-long-chain fat emulsion, 16 amino acids and 16% dextrose injection |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN202376452U (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103720741A (en) * | 2014-01-07 | 2014-04-16 | 辽宁海思科制药有限公司 | Medium-and-long-chain fat emulsion/amino acid (16)/glucose (16 percent) composition for injection |
| CN103735607A (en) * | 2014-01-07 | 2014-04-23 | 辽宁海思科制药有限公司 | Novel injection composition for packaging fat emulsion and amino acid (17) glucose (11 percent) |
-
2011
- 2011-07-28 CN CN2011202705761U patent/CN202376452U/en not_active Expired - Lifetime
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103720741A (en) * | 2014-01-07 | 2014-04-16 | 辽宁海思科制药有限公司 | Medium-and-long-chain fat emulsion/amino acid (16)/glucose (16 percent) composition for injection |
| CN103735607A (en) * | 2014-01-07 | 2014-04-23 | 辽宁海思科制药有限公司 | Novel injection composition for packaging fat emulsion and amino acid (17) glucose (11 percent) |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CX01 | Expiry of patent term | ||
| CX01 | Expiry of patent term |
Granted publication date: 20120815 |