CN101015501A - Injection composition of fat milk, amino acid and glucose packed with three-cavity bag and preparing method thereof - Google Patents
Injection composition of fat milk, amino acid and glucose packed with three-cavity bag and preparing method thereof Download PDFInfo
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- CN101015501A CN101015501A CN 200710020197 CN200710020197A CN101015501A CN 101015501 A CN101015501 A CN 101015501A CN 200710020197 CN200710020197 CN 200710020197 CN 200710020197 A CN200710020197 A CN 200710020197A CN 101015501 A CN101015501 A CN 101015501A
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Abstract
The invention discloses an injection composition packaged in a three-cavity bag. The three cavities separated by diaphragm are respectively filled with fattiness milk injection, compound amino acid injection, and glucose injection. The using method is crimping each cavity in turns, or divulging the isolating bar in each cavity to mix the injections for venoclysis so as to avoid the venture of microorganism and particulates pollution in traditional mix processing. The mix processing can be carried out under any environmental condition which qualifies the small hospital without aseptic preparation condition to use the nutrition, highly reduce the untoward reaction such as transfusion heater response, sanguis infection, and blood poisoning due to traditional mix processing.
Description
Technical field
The invention discloses a kind of compositions of fat milk, aminoacid and glucose injection of three chamber bag independent packagings and the preparation method of this injecta composition.
Background technology
Fat, protein and sugar are three class basic nutrition materials of human body requirements amount maximum.Maybe can't satisfy when absorbing enough above-mentioned nutrient substance in the human gastrointestinal tract functional defect, must provide in the mode of venous transfusion.Therefore, fat emulsion injection, Amino Acid Compound Injection and glucose injection are widely used for clinical in fat, protein and sugar to be provided respectively, Here it is so-called parenteral nutrition.On nutrient metabolism mechanism, the utilization of these three kinds of nutrients interdepends, and from physiology, has taken in fat, protein and sugar during the human body dietary intake simultaneously.Therefore, theory and practice has all proved simultaneously to human vein input fat milk, aminoacid and glucose, meet most human physiological metabolism's needs, especially when needs life-time service parenteral nutrition, to keeping the balance of each nutrient in the human body, keeping normal human physiological functions all has very important meaning.In clinical practice, realization fat emulsion injection, Amino Acid Compound Injection and glucose injection are imported the mode of human body simultaneously for before use these three kinds of products being poured in the specially designed aseptic plastic bag by mixing duct, and the infusion port by aseptic plastic bag after mixing is imported human body.The greatest drawback of this infusion model is to need to adopt a mixing tube that has four syringe needles, the plug that three syringe needles are wherein passed three kinds of products to be mixed respectively enters in the medicinal liquid, the 4th syringe needle inserts mixed bag, and medicinal liquid flows via a conduit in the mixed bag, mix homogeneously.Obviously, because whole mixed process is manual operations, repeatedly the puncture behavior has destroyed the sealing of product, makes mistakes slightly, is easy to cause contamination by micro to product, thereby brings serious consequences such as infusion reaction, blood infection, septicemia to the patient.For this reason, large hospital is set up special aseptic preparation chamber usually, is used for carrying out under aseptic condition married operation.Yet even adopted aseptic technique, the probability of contaminating microorganisms is also more than one thousandth.In addition, construction, the maintenance cost of aseptic preparation chamber are quite high, and non-middle and small hospital and economically underdeveloped area can afford to bear, and have hindered mixing infusion model ground to a great extent and have promoted.Another shortcoming of this hybrid mode is repeatedly to puncture plug, produces a large amount of plug microgranules inevitably, enters to stop up blood capillary behind the blood easily, causes the microcirculation thromboembolism.
Summary of the invention
The object of the present invention is to provide sealing system a kind of suitability for industrialized production, that can under the condition of complete closed, not destroy product, can the mixing-in fat breast, fat milk, aminoacid and the glucose injection of the packed with three-cavity bag of aminoacid and glucose solution.
Another object of the present invention is to provide a kind of preparation method of above-mentioned injection.
According to technical scheme provided by the invention, pack into independently respectively in three chambers that described injection adopts barrier film to separate fat emulsion injection, Amino Acid Compound Injection and glucose injection, wherein the main component of fat emulsion injection is to contain 150-250 gram purification soybean oil in every 1000ml solution; The main component of glucose injection is that every 1000ml contains 100-120 gram Dextrose Monohydrate; The main component of Amino Acid Compound Injection is that every 1000ml contains the described material of following Amino Acid Compound Injection component list:
The Amino Acid Compound Injection component list
Component content
L-alanine 2.55-3.45g
Glycine 1.79-2.42g
L-arginase 12 .80-3.80g
L-aspartic acid 3.48-4.72g
L-glutamic acid 7.65-10.35g
L-histidine 2.04-2.76g
L-isoleucine 3.32-4.48g
L-leucine 4.50-6.10g
L-lysine hydrochloride 4.16-5.64g
L-methionine 1.62-2.18g
L-phenylalanine 4.68-6.32g
L-proline 6.88-9.32g
L-serine 6.38-8.62g
L-threonine 2.55-3.45g
L-tryptophan 0.85-1.15g
L-tyrosine 0.425-0.575g
L-valine 3.66-4.94g
L-cysteine hydrochloride 0.123-0.167g
Two hydration calcium chloride 0.313-0.423g
Bitter salt 0.314-0.426g
Potassium chloride 0.319-0.431g
Potassium hydroxide 0.714-0.966g
Sodium hydroxide 1.70-2.30g
Sodium pyrosulfite 0.25-0.34g
Sodium glycerophosphate 6.21-8.40g
Surplus is a water for injection.
The refined lecithin that also contains every 1000ml 11-13 gram in the described fat emulsion injection, the anhydrous glycerol of 20-24 gram and energy are with the sodium hydroxide of this injection pH regulator to 7.5-8.5.
This is a kind of fat milk, amino acid and glucose injection of packed with three-cavity bag.Be respectively charged into fat emulsion injection, Amino Acid Compound Injection and glucose injection in three chambers that it adopts barrier film to separate.Only need during use firmly to push each chamber successively, or tear the isolating bar between each chamber, can give the human vein infusion immediately three kinds of injection mixings.The volume of three chamber herb liquids can have plurality of specifications, to adapt to different patients' metabolic demand amount.
The packaging bag that product of the present invention adopts divides inner bag and outer bag, is made by the overlay of two kinds of multiple structures respectively.Inner bag is used for liquid drug.Inner bag is separated to form three chambers by hot pressing, can tolerate long-term contact of oils and fats, aminoacid and glucose solution and chemical reaction does not take place, and does not also have any substance dissolves in above-mentioned three kinds of solution.These three kinds of medicinal liquids are respectively charged in three chambers.The inner bag integral body that installs medicinal liquid and seal is packed in the outer bag.Outer bag has splendid physical barriers effect to oxygen, carbon dioxide and other gas, can stop penetrating of these gases, guarantees the stability of product between sterilization and storage life.Inner bag can both tolerate 121 degrees centigrade high temperature sterilize with outer bag.Finish packaged products and put into 121 degrees centigrade heat water-spraying's formula steriliser sterilization with thorough killing microorganisms.Inner bag stand a certain size with the vertical pulling force of strip of paper used for sealing the time can open, content is mixed mutually.Mixed liquor can guarantee the probability of contaminating microorganisms be lower than 1,000,000/.
The fat milk of above-mentioned packed with three-cavity bag, amino acid and glucose injection liquid and preparation method thereof are as follows:
Step 1: bag;
Get the inner bag plastic foil, press forming and connect filling exit on the bag hot press;
Get outer bag and use plastic foil, press forming on the bag hot press is reserved on one side and is opened wide;
Step 2: dosing;
A, fat emulsion injection preparation
Get purification soybean oil, refined lecithin, anhydrous glycerol, sodium hydroxide and water for injection;
Soybean oil is heated to about 80 ℃, adds refined lecithin under the strong agitation, continue to stir until dissolving, this is an oil phase;
In water for injection, add anhydrous glycerol, stirring and dissolving, this is a water;
Oil phase is slowly added intensively stirred aqueous phase, continue strong agitation, this is a colostrum;
Get sodium hydroxide solution, splash into Ruzhong just, regulate pH to 7.5-8.5;
With colostrum through the homogenize of high pressure homogenize machine, homogenize pressure 400-800kg/cm
2, for several times, obtain even Emulsion repeatedly, make fat emulsion injection.
B, Amino Acid Compound Injection preparation
Prepare each raw material by above-mentioned " Amino Acid Compound Injection component list ";
Above-mentioned raw materials is added one by one in advance again and remove in 60-90 ℃ the water for injection of oxygen, be stirred to dissolving under nitrogen protection, dissolved oxygen concentration must not be higher than 100ppm in the control medicinal liquid;
C, glucose injection preparation
Get Dextrose Monohydrate and be dissolved in the water for injection, the glucose injection that makes;
Step 3: the outer bag of fill, sealing and dress
The fat emulsion injection, Amino Acid Compound Injection and the glucose injection that have prepared are connected on the filling machine that three pipelines and filling element arranged by liquid medicine filter respectively, this filling machine is equipped with evacuation-inflated with nitrogen system, medicinal liquid metering system, heated sealant system, finish to internal bag evacuation-inflated with nitrogen, quality of liquid medicine metering and functions such as loading amount control, inner bag sealing respectively, regulate the fill volume of each medicinal liquid as required, ready made inner bag is loaded onto filling machine, fill and sealing, pouring process carries out under nitrogen protection;
The inner bag that embedding is good is packed outer bag into, adds oxygen absorbent between inside and outside bag, by having the oxygen between inside and outside bag to the heat sealing machine of outer bag evacuation-inflated with nitrogen function is removed and is sealed;
Step 4: sterilization
Sterilizing installation is a superheated water cyclic spraying steriliser, packaged product is tiled on the shelf of steriliser, to sterilize with the recirculated water pressurized, heated to high temperature and spray on the product, product was at high temperature kept 12-18 minute, thoroughly to kill the microorganism in the product, reach the effect of sterilization.
The invention has the beneficial effects as follows:
Can thoroughly avoid the conventional hybrid operation easily to cause the risk of product microorganism and particle contamination, and can under any environmental condition, carry out married operation, make the middle and small hospital that does not possess aseptic preparation condition also can use the parenteral nutrition that meets the human nutrition metabolic characteristic easily, can bring huge interests to the patient undoubtedly, greatly reduce serious adverse reactions such as transfusion heat source response that conventional hybrid operation causes because of easy contaminating microorganisms, blood infection, septicemia.
The medicinal liquid component that this product is adorned is:
1, fat emulsion injection.The every 1000ml of this fat emulsion injection contains the pure soy bean of 150-250 gram through silica gel adsorption place to go polar impurity, 11-13 gram refine yolk lecithin, and 20-24 restrains anhydrous glycerol, and the sodium hydroxide adjusting pH that contains trace is 6-9.
2, Amino Acid Compound Injection.This Amino Acid Compound Injection contains 18 seed amino acids and potassium, sodium, calcium, magnesium ion, sodium glycerophosphate, and containing acetate in minute, to regulate pH be 5-7.Contain concrete the composition among every 1000ml:
| Composition | Content |
| The L-alanine | 2.55-3.45g |
| Glycine | 1.79-2.42g |
| The L-arginine | 2.80-3.80g |
| The L-aspartic acid | 3.48-4.72g |
| L-glutamic acid | 7.65-10.35g |
| The L-histidine | 2.04-2.76g |
| The L-isoleucine | 3.32-4.48g |
| The L-leucine | 4.50-6.10g |
| The L-lysine hydrochloride | 4.16-5.64g |
| The L-methionine | 1.62-2.18g |
| The L-phenylalanine | 4.68-6.32g |
| The L-proline | 6.88-9.32g |
| The L-serine | 6.38-8.62g |
| The L-threonine | 2.55-3.45g |
| The L-tryptophan | 0.85-1.15g |
| L-tyrosine | 0.425-0.575g |
| The L-valine | 3.66-4.94g |
| The L-cysteine hydrochloride | 0.123-0.167g |
| Two hydration calcium chloride | 0.313-0.423g |
| Bitter salt | 0.314-0.426g |
| Potassium chloride | 0.319-0.431g |
| Potassium hydroxide | 0.714-0.966g |
| Sodium hydroxide | 1.70-2.30g |
| Sodium pyrosulfite | 0.25-0.34g |
| Sodium glycerophosphate | 6.21-8.40g |
| Water for injection | 902-940g |
3, glucose injection.The every 1000ml of this glucose injection contains Dextrose Monohydrate 100-120 gram.
The specific embodiment
Below in conjunction with specific embodiment the present invention is further described.
Embodiment one
Step 1, bag.
Get the inner bag plastic foil, press forming and connect filling exit on the bag hot press.Get outer bag and use plastic foil, press forming on the bag hot press is reserved on one side and is opened wide.
Step 2, dosing.On different dosing apparatus, prepare fat emulsion injection, Amino Acid Compound Injection and glucose injection respectively.
1) fat emulsion injection preparation
Get purification soybean oil 200 grams, refined lecithin: 12 grams, anhydrous glycerol: 22 grams, sodium hydroxide: an amount of, water for injection: 750 grams.
Soybean oil 200 grams are heated to about 80 ℃, add refined lecithin 12 grams under the strong agitation, continue to stir until dissolving, this is an oil phase.
In 750 gram waters for injection, add 22 gram anhydrous glycerols, stirring and dissolving, this is a water.
Oil phase is slowly added intensively stirred aqueous phase, continued strong agitation 10 minutes, this is a colostrum.
Get sodium hydroxide solution, splash into Ruzhong just, regulate pH to 7.5-8.5.
With colostrum through the homogenize of high pressure homogenize machine, homogenize pressure 400-800kg/cm
2, homogenize is 6 times repeatedly, obtains even Emulsion.
2) Amino Acid Compound Injection
Take off and state each raw material, L-alanine: 2.55g, glycine: 1.79g, L-arginine: 2.80g, L-aspartic acid: 3.48g, L-glutamic acid: 7.65g, L-histidine: 2.04g, L-isoleucine: 3.32g, L-leucine: 4.50g, L-lysine hydrochloride: 4.16g, L-methionine: 1.62g, L-phenylalanine: 4.68g, L-proline: 6.88g, L-serine: 6.38g, L-threonine: 2.55g, L-tryptophan: 0.85g, L-tyrosine: 0.425g, L-valine: 3.66g, L-cysteine hydrochloride: 0.123g, two hydration calcium chloride: 0.313g, bitter salt: 0.314g, potassium chloride: 0.319g, potassium hydroxide: 0.714g, sodium hydroxide: 1.70g, sodium pyrosulfite: 0.25g, sodium glycerophosphate: 6.21g.
Above-mentioned raw materials added in advance one by one remove in 60-90 ℃ the water for injection of oxygen, be made into the 1000ml injection, under nitrogen protection, be stirred to dissolving.Dissolved oxygen concentration must not be higher than 100ppm in the medicinal liquid.
3) glucose injection
Get glucose 110 grams, be dissolved in the 920 gram waters for injection, promptly.
The outer bag of step 3 fill, sealing and dress
The fat emulsion injection, Amino Acid Compound Injection and the glucose injection that have prepared are connected on the filling machine that three pipelines and filling element arranged by liquid medicine filter respectively.This filling machine is equipped with evacuation-inflated with nitrogen system, medicinal liquid metering system, heated sealant system, finishes to internal bag evacuation-inflated with nitrogen, quality of liquid medicine metering and functions such as loading amount control, inner bag sealing respectively.Regulate the fill volume of each medicinal liquid as required.Ready made inner bag is loaded onto filling machine, fill and sealing.Pouring process carries out under nitrogen protection.
The inner bag that embedding is good is packed outer bag into, adds oxygen absorbent between inside and outside bag.By having the oxygen between inside and outside bag is removed and sealed to the heat sealing machine of outer bag evacuation-inflated with nitrogen function.
The step 4 sterilization
Sterilizing installation is a superheated water cyclic spraying steriliser.Packaged product is tiled on the shelf of steriliser, will sterilize with recirculated water pressurized, heated to 121 degree centigrade and sprays on the product.Product was kept 12-18 minute down at 121 degrees centigrade,, reach the effect of sterilization thoroughly to kill the microorganism in the product.
Embodiment two
Take off and state each raw material, L-alanine: 3.45g, glycine: 2.42g; L-arginine: 3.80g; L-aspartic acid: 4.72g, L-glutamic acid: 10.35g, L-histidine: 2.76g; L-isoleucine: 4.48g; L-leucine: 6.10g, L-lysine hydrochloride: 5.64g, L-methionine: 2.18g; L-phenylalanine: 6.32g; L-proline: 9.32g, L-serine: 8.62g, L-threonine: 3.45g; L-tryptophan: 1.15g; L-tyrosine: 0.575g, L-valine: 4.94g, L-cysteine hydrochloride: 0.167g; two hydration calcium chloride: 0.423g; bitter salt: 0.426g, potassium chloride: 0.431g, potassium hydroxide: 0.966g; sodium hydroxide: 2.30g; sodium pyrosulfite: 0.34g, sodium glycerophosphate: 8.40g adds above-mentioned raw materials one by one in advance except that in 60-90 ℃ the water for injection of oxygen; be made into the 1000ml injection, under nitrogen protection, be stirred to dissolving.Dissolved oxygen concentration must not be higher than 100ppm in the medicinal liquid.
All the other steps, prescription are identical with embodiment one.
Embodiment three
Step 2, dosing; 2) Amino Acid Compound Injection adopts following intermediate value prescription, and all the other are identical with embodiment one.
Take off and state each raw material, L-alanine: 3.00g, glycine: 2.105g; L-arginine: 3.30g; L-aspartic acid: 4.10g, L-glutamic acid: 9.00g, L-histidine: 2.40g; L-isoleucine: 3.90g; L-leucine: 5.30g, L-lysine hydrochloride: 4.90g, L-methionine: 1.90g; L-phenylalanine: 5.50g; L-proline: 8.10g, L-serine: 7.50g, L-threonine: 3.00g; L-tryptophan: 1.00g; L-tyrosine: 0.500g, L-valine: 4.30g, L-cysteine hydrochloride: 0.145g; two hydration calcium chloride: 0.372g; bitter salt: 0.370g, potassium chloride: 0.375g, potassium hydroxide: 0.840g; sodium hydroxide: 2.00g; sodium pyrosulfite: 0.295g, sodium glycerophosphate: 7.305g adds above-mentioned raw materials one by one in advance except that in 60-90 ℃ the water for injection of oxygen; be made into the 1000ml injection, under nitrogen protection, be stirred to dissolving.Dissolved oxygen concentration must not be higher than 100ppm in the medicinal liquid.
All the other steps, prescription are identical with embodiment one.
Embodiment four
Step 1, bag.
Get the inner bag plastic foil, press forming and connect filling exit on the bag hot press.Get outer bag and use plastic foil, press forming on the bag hot press is reserved on one side and is opened wide.
Step 2, dosing.On different dosing apparatus, prepare fat emulsion injection, Amino Acid Compound Injection and glucose injection respectively.
1) fat emulsion injection preparation
Get purification soybean oil 150 grams, refined lecithin: 12 grams, anhydrous glycerol: 22 grams, sodium hydroxide: an amount of, water for injection: 800 grams.
Soybean oil 150 grams are heated to about 80 ℃, add refined lecithin 12 grams under the strong agitation, continue to stir until dissolving, this is an oil phase.
In 800 gram waters for injection, add 22 gram anhydrous glycerols, stirring and dissolving, this is a water.
Oil phase is slowly added intensively stirred aqueous phase, continued strong agitation 10 minutes, this is a colostrum.
Get sodium hydroxide solution, splash into Ruzhong just, regulate pH to 7.5-8.5.
With colostrum through the homogenize of high pressure homogenize machine, homogenize pressure 400-800kg/cm
2, homogenize is 6 times repeatedly, obtains even Emulsion.
2) Amino Acid Compound Injection
Take off and state each raw material, L-alanine: 2.55g, glycine: 1.79g, L-arginine: 2.80g, L-aspartic acid: 3.48g, L-glutamic acid: 7.65g, L-histidine: 2.04g, L-isoleucine: 3.32g, L-leucine: 4.50g, L-lysine hydrochloride: 4.16g, L-methionine: 1.62g, L-phenylalanine: 4.68g, L-proline: 6.88g, L-serine: 6.38g, L-threonine: 2.55g, L-tryptophan: 0.85g, L-tyrosine: 0.425g, L-valine: 3.66g, L-cysteine hydrochloride: 0.123g, two hydration calcium chloride: 0.313g, bitter salt: 0.314g, potassium chloride: 0.319g, potassium hydroxide: 0.714g, sodium hydroxide: 1.70g, sodium pyrosulfite: 0.25g, sodium glycerophosphate: 6.21g.
Above-mentioned raw materials added in advance one by one remove in 60-90 ℃ the water for injection of oxygen, be made into the 1000ml injection, under nitrogen protection, be stirred to dissolving.Dissolved oxygen concentration must not be higher than 100ppm in the medicinal liquid.
3) glucose injection
Get glucose 110 grams, be dissolved in the 920 gram waters for injection, promptly.
The outer bag of step 3 fill, sealing and dress
The fat emulsion injection, Amino Acid Compound Injection and the glucose injection that have prepared are connected on the filling machine that three pipelines and filling element arranged by liquid medicine filter respectively.This filling machine is equipped with evacuation-inflated with nitrogen system, medicinal liquid metering system, heated sealant system, finishes to internal bag evacuation-inflated with nitrogen, quality of liquid medicine metering and functions such as loading amount control, inner bag sealing respectively.Regulate the fill volume of each medicinal liquid as required.Ready made inner bag is loaded onto filling machine, fill and sealing.Pouring process carries out under nitrogen protection.
The inner bag that embedding is good is packed outer bag into, adds oxygen absorbent between inside and outside bag.By having the oxygen between inside and outside bag is removed and sealed to the heat sealing machine of outer bag evacuation-inflated with nitrogen function.
The step 4 sterilization
Sterilizing installation is a superheated water cyclic spraying steriliser.Packaged product is tiled on the shelf of steriliser, will sterilize with recirculated water pressurized, heated to 121 degree centigrade and sprays on the product.Product was kept 12-18 minute down at 121 degrees centigrade,, reach the effect of sterilization thoroughly to kill the microorganism in the product.
Embodiment five
Step 1, bag.
Get the inner bag plastic foil, press forming and connect filling exit on the bag hot press.Get outer bag and use plastic foil, press forming on the bag hot press is reserved on one side and is opened wide.
Step 2, dosing.On different dosing apparatus, prepare fat emulsion injection, Amino Acid Compound Injection and glucose injection respectively.
1) fat emulsion injection preparation
Get purification soybean oil 250 grams, refined lecithin: 12 grams, anhydrous glycerol: 22 grams, sodium hydroxide: an amount of, water for injection: 700 grams.
Soybean oil 250 grams are heated to about 80 ℃, add refined lecithin 12 grams under the strong agitation, continue to stir until dissolving, this is an oil phase.
In 700 gram waters for injection, add 22 gram anhydrous glycerols, stirring and dissolving, this is a water.
Oil phase is slowly added intensively stirred aqueous phase, continued strong agitation 10 minutes, this is a colostrum.
Get sodium hydroxide solution, splash into Ruzhong just, regulate pH to 7.5-8.5.
With colostrum through the homogenize of high pressure homogenize machine, homogenize pressure 400-800kg/cm
2, homogenize is 6 times repeatedly, obtains even Emulsion.
2) Amino Acid Compound Injection
Take off and state each raw material, L-alanine: 2.55g, glycine: 1.79g, L-arginine: 2.80g, L-aspartic acid: 3.48g, L-glutamic acid: 7.65g, L-histidine: 2.04g, L-isoleucine: 3.32g, L-leucine: 4.50g, L-lysine hydrochloride: 4.16g, L-methionine: 1.62g, L-phenylalanine: 4.68g, L-proline: 6.88g, L-serine: 6.38g, L-threonine: 2.55g, L-tryptophan: 0.85g, L-tyrosine: 0.425g, L-valine: 3.66g, L-cysteine hydrochloride: 0.123g, two hydration calcium chloride: 0.313g, bitter salt: 0.314g, potassium chloride: 0.319g, potassium hydroxide: 0.714g, sodium hydroxide: 1.70g, sodium pyrosulfite: 0.25g, sodium glycerophosphate: 6.21g.
Above-mentioned raw materials added in advance one by one remove in 60-90 ℃ the water for injection of oxygen, be made into the 1000ml injection, under nitrogen protection, be stirred to dissolving.Dissolved oxygen concentration must not be higher than 100ppm in the medicinal liquid.
3) glucose injection
Get glucose 110 grams, be dissolved in the 920 gram waters for injection, promptly.
The outer bag of step 3 fill, sealing and dress
The fat emulsion injection, Amino Acid Compound Injection and the glucose injection that have prepared are connected on the filling machine that three pipelines and filling element arranged by liquid medicine filter respectively.This filling machine is equipped with evacuation-inflated with nitrogen system, medicinal liquid metering system, heated sealant system, finishes to internal bag evacuation-inflated with nitrogen, quality of liquid medicine metering and functions such as loading amount control, inner bag sealing respectively.Regulate the fill volume of each medicinal liquid as required.Ready made inner bag is loaded onto filling machine, fill and sealing.Pouring process carries out under nitrogen protection.
The inner bag that embedding is good is packed outer bag into, adds oxygen absorbent between inside and outside bag.By having the oxygen between inside and outside bag is removed and sealed to the heat sealing machine of outer bag evacuation-inflated with nitrogen function.
The step 4 sterilization
Sterilizing installation is a superheated water cyclic spraying steriliser.Packaged product is tiled on the shelf of steriliser, will sterilize with recirculated water pressurized, heated to 121 degree centigrade and sprays on the product.Product was kept 12-18 minute down at 121 degrees centigrade,, reach the effect of sterilization thoroughly to kill the microorganism in the product.
Embodiment six
Step 1, bag.
Get the inner bag plastic foil, press forming and connect filling exit on the bag hot press.Get outer bag and use plastic foil, press forming on the bag hot press is reserved on one side and is opened wide.
Step 2, dosing.On different dosing apparatus, prepare fat emulsion injection, Amino Acid Compound Injection and glucose injection respectively.
1) fat emulsion injection preparation
Get purification soybean oil 200 grams, refined lecithin: 12 grams, anhydrous glycerol: 22 grams, sodium hydroxide: an amount of, water for injection: 750 grams.
Soybean oil 200 grams are heated to about 80 ℃, add refined lecithin 12 grams under the strong agitation, continue to stir until dissolving, this is an oil phase.
In 750 gram waters for injection, add 22 gram anhydrous glycerols, stirring and dissolving, this is a water.
Oil phase is slowly added intensively stirred aqueous phase, continued strong agitation 10 minutes, this is a colostrum.
Get sodium hydroxide solution, splash into Ruzhong just, regulate pH to 7.5-8.5.
With colostrum through the homogenize of high pressure homogenize machine, homogenize pressure 400-800kg/cm
2, homogenize is 6 times repeatedly, obtains even Emulsion.
2) Amino Acid Compound Injection
Take off and state each raw material, L-alanine: 2.55g, glycine: 1.79g, L-arginine: 2.80g, L-aspartic acid: 3.48g, L-glutamic acid: 7.65g, L-histidine: 2.04g, L-isoleucine: 3.32g, L-leucine: 4.50g, L-lysine hydrochloride: 4.16g, L-methionine: 1.62g, L-phenylalanine: 4.68g, L-proline: 6.88g, L-serine: 6.38g, L-threonine: 2.55g, L-tryptophan: 0.85g, L-tyrosine: 0.425g, L-valine: 3.66g, L-cysteine hydrochloride: 0.123g, two hydration calcium chloride: 0.313g, bitter salt: 0.314g, potassium chloride: 0.319g, potassium hydroxide: 0.714g, sodium hydroxide: 1.70g, sodium pyrosulfite: 0.25g, sodium glycerophosphate: 6.21g.
Above-mentioned raw materials added in advance one by one remove in 60-90 ℃ the water for injection of oxygen, be made into the 1000ml injection, under nitrogen protection, be stirred to dissolving.Dissolved oxygen concentration must not be higher than 100ppm in the medicinal liquid.
3) glucose injection
Get glucose 100 grams, be dissolved in the 930 gram waters for injection, promptly.
The outer bag of step 3 fill, sealing and dress
The fat emulsion injection, Amino Acid Compound Injection and the glucose injection that have prepared are connected on the filling machine that three pipelines and filling element arranged by liquid medicine filter respectively.This filling machine is equipped with evacuation-inflated with nitrogen system, medicinal liquid metering system, heated sealant system, finishes to internal bag evacuation-inflated with nitrogen, quality of liquid medicine metering and functions such as loading amount control, inner bag sealing respectively.Regulate the fill volume of each medicinal liquid as required.Ready made inner bag is loaded onto filling machine, fill and sealing.Pouring process carries out under nitrogen protection.
The inner bag that embedding is good is packed outer bag into, adds oxygen absorbent between inside and outside bag.By having the oxygen between inside and outside bag is removed and sealed to the heat sealing machine of outer bag evacuation-inflated with nitrogen function.
The step 4 sterilization
Sterilizing installation is a superheated water cyclic spraying steriliser.Packaged product is tiled on the shelf of steriliser, will sterilize with recirculated water pressurized, heated to 121 degree centigrade and sprays on the product.Product was kept 12-18 minute down at 121 degrees centigrade,, reach the effect of sterilization thoroughly to kill the microorganism in the product.
Embodiment seven
Step 1, bag.
Get the inner bag plastic foil, press forming and connect filling exit on the bag hot press.Get outer bag and use plastic foil, press forming on the bag hot press is reserved on one side and is opened wide.
Step 2, dosing.On different dosing apparatus, prepare fat emulsion injection, Amino Acid Compound Injection and glucose injection respectively.
1) fat emulsion injection preparation
Get purification soybean oil 200 grams, refined lecithin: 12 grams, anhydrous glycerol: 22 grams, sodium hydroxide: an amount of, water for injection: 750 grams.
Soybean oil 200 grams are heated to about 80 ℃, add refined lecithin 12 grams under the strong agitation, continue to stir until dissolving, this is an oil phase.
In 750 gram waters for injection, add 22 gram anhydrous glycerols, stirring and dissolving, this is a water.
Oil phase is slowly added intensively stirred aqueous phase, continued strong agitation 10 minutes, this is a colostrum.
Get sodium hydroxide solution, splash into Ruzhong just, regulate pH to 7.5-8.5.
With colostrum through the homogenize of high pressure homogenize machine, homogenize pressure 400-800kg/cm
2, homogenize is 6 times repeatedly, obtains even Emulsion.
2) Amino Acid Compound Injection
Take off and state each raw material, L-alanine: 2.55g, glycine: 1.79g, L-arginine: 2.80g, L-aspartic acid: 3.48g, L-glutamic acid: 7.65g, L-histidine: 2.04g, L-isoleucine: 3.32g, L-leucine: 4.50g, L-lysine hydrochloride: 4.16g, L-methionine: 1.62g, L-phenylalanine: 4.68g, L-proline: 6.88g, L-serine: 6.38g, L-threonine: 2.55g, L-tryptophan: 0.85g, L-tyrosine: 0.425g, L-valine: 3.66g, L-cysteine hydrochloride: 0.123g, two hydration calcium chloride: 0.313g, bitter salt: 0.314g, potassium chloride: 0.319g, potassium hydroxide: 0.714g, sodium hydroxide: 1.70g, sodium pyrosulfite: 0.25g, sodium glycerophosphate: 6.21g.
Above-mentioned raw materials added in advance one by one remove in 60-90 ℃ the water for injection of oxygen, be made into the 1000ml injection, under nitrogen protection, be stirred to dissolving.Dissolved oxygen concentration must not be higher than 100ppm in the medicinal liquid.
3) glucose injection
Get glucose 120 grams, be dissolved in the 910 gram waters for injection, promptly.
The outer bag of step 3 fill, sealing and dress
The fat emulsion injection, Amino Acid Compound Injection and the glucose injection that have prepared are connected on the filling machine that three pipelines and filling element arranged by liquid medicine filter respectively.This filling machine is equipped with evacuation-inflated with nitrogen system, medicinal liquid metering system, heated sealant system, finishes to internal bag evacuation-inflated with nitrogen, quality of liquid medicine metering and functions such as loading amount control, inner bag sealing respectively.Regulate the fill volume of each medicinal liquid as required.Ready made inner bag is loaded onto filling machine, fill and sealing.Pouring process carries out under nitrogen protection.
The inner bag that embedding is good is packed outer bag into, adds oxygen absorbent between inside and outside bag.By having the oxygen between inside and outside bag is removed and sealed to the heat sealing machine of outer bag evacuation-inflated with nitrogen function.
The step 4 sterilization
Sterilizing installation is a superheated water cyclic spraying steriliser.Packaged product is tiled on the shelf of steriliser, will sterilize with recirculated water pressurized, heated to 121 degree centigrade and sprays on the product.Product was kept 12-18 minute down at 121 degrees centigrade,, reach the effect of sterilization thoroughly to kill the microorganism in the product.
Claims (3)
1, a kind of fat milk of packed with three-cavity bag, aminoacid and glucose injection, it is characterized in that: pack into independently respectively in three chambers that it adopts barrier film to separate fat emulsion injection, Amino Acid Compound Injection and glucose injection, wherein the main component of fat emulsion injection is that every 1000ml contains 150-250 gram purification soybean oil; The main component of glucose injection is that every 1000ml contains 100-120 gram Dextrose Monohydrate; The main component of Amino Acid Compound Injection is that every 1000ml contains following substances:
Component content
L-alanine 2.55-3.45g
Glycine 1.79-2.42g
L-arginase 12 .80-3.80g
L-aspartic acid 3.48-4.72g
L-glutamic acid 7.65-10.35g
L-histidine 2.04-2.76g
L-isoleucine 3.32-4.48g
L-leucine 4.50-6.10g
L-lysine hydrochloride 4.16-5.64g
L-methionine 1.62-2.18g
L-phenylalanine 4.68-6.32g
L-proline 6.88-9.32g
L-serine 6.38-8.62g
L-threonine 2.55-3.45g
L-tryptophan 0.85-1.15g
L-tyrosine 0.425-0.575g
L-valine 3.66-4.94g
L-cysteine hydrochloride 0.123-0.167g
Two hydration calcium chloride 0.313-0.423g
Bitter salt 0.314-0.426g
Potassium chloride 0.319-0.431g
Potassium hydroxide 0.714-0.966g
Sodium hydroxide 1.70-2.30g
Sodium pyrosulfite 0.25-0.34g
Sodium glycerophosphate 6.21-8.40g
Surplus is a water for injection.
2, the fat milk of packed with three-cavity bag as claimed in claim 1, aminoacid and glucose injection, it is characterized in that: contain the refined lecithin of 11-13 gram in every 1000ml fat emulsion injection, the anhydrous glycerol of 20-24 gram and energy are with the sodium hydroxide of this injection pH regulator to 7.5-8.5.
3, the preparation method of the fat milk of packed with three-cavity bag, aminoacid and glucose injection is as follows according to claim 1:
Step 1: bag;
Get the inner bag plastic foil, press forming and connect filling exit on the bag hot press;
Get outer bag and use plastic foil, press forming on the bag hot press is reserved on one side and is opened wide; Step 2: dosing;
A, fat emulsion injection preparation;
Get purification soybean oil, refined lecithin, anhydrous glycerol, sodium hydroxide and water for injection;
Soybean oil is heated to about 80 ℃, adds refined lecithin under the strong agitation, continue to stir until dissolving, this is an oil phase;
In water for injection, add anhydrous glycerol, stirring and dissolving, this is a water;
Oil phase is slowly added intensively stirred aqueous phase, continue strong agitation, this is a colostrum;
Get sodium hydroxide solution, splash into Ruzhong just, regulate pH to 7.5-8.5;
With colostrum through the homogenize of high pressure homogenize machine, homogenize pressure 400-800kg/cm
2, for several times, obtain even Emulsion repeatedly, make every 1000ml solution and contain 150-250 gram purification soybean oil, 11-13 restrains refined lecithin, the fat emulsion injection of 20-24 gram anhydrous glycerol;
B, Amino Acid Compound Injection preparation;
Prepare following each raw material;
Content among the every 1000ml of composition
L-alanine 2.55-3.45g
Glycine 1.79-2.42g
L-arginase 12 .80-3.80g
L-aspartic acid 3.48-4.72g
L-glutamic acid 7.65-10.35g
L-histidine 2.04-2.76g
L-isoleucine 3.32-4.48g
L-leucine 4.50-6.10g
L-lysine hydrochloride 4.16-5.64g
L-methionine 1.62-2.18g
L-phenylalanine 4.68-6.32g
L-proline 6.88-9.32g
L-serine 6.38-8.62g
L-threonine 2.55-3.45g
L-tryptophan 0.85-1.15g
L-tyrosine 0.425-0.575g
L-valine 3.66-4.94g
L-cysteine hydrochloride 0.123-0.167g
Two hydration calcium chloride 0.313-0.423g
Bitter salt 0.314-0.426g
Potassium chloride 0.319-0.431g
Potassium hydroxide 0.714-0.966g
Sodium hydroxide 1.70-2.30g
Sodium pyrosulfite 0.25-0.34g
Sodium glycerophosphate 6.21-8.40g
Surplus is a water for injection;
Mentioned component content on request added in advance one by one remove in 60-90 ℃ the water for injection of oxygen, be stirred to dissolving under nitrogen protection, dissolved oxygen concentration must not be higher than 100ppm in the control medicinal liquid;
C, glucose injection preparation;
Get Dextrose Monohydrate and be dissolved in the water for injection, make the glucose injection that every 1000ml solution contains 100-120 gram Dextrose Monohydrate;
Step 3: the outer bag of fill, sealing and dress
The fat emulsion injection, Amino Acid Compound Injection and the glucose injection that have prepared are connected on the filling machine that three pipelines and filling element arranged by liquid medicine filter respectively, this filling machine is equipped with evacuation-inflated with nitrogen system, medicinal liquid metering system, heated sealant system, finish to internal bag evacuation-inflated with nitrogen, quality of liquid medicine metering and functions such as loading amount control, inner bag sealing respectively, regulate the fill volume of each medicinal liquid as required, ready made inner bag is loaded onto filling machine, fill and sealing, pouring process carries out under nitrogen protection;
The inner bag that embedding is good is packed outer bag into, adds oxygen absorbent between inside and outside bag, by having the oxygen between inside and outside bag to the heat sealing machine of outer bag evacuation-inflated with nitrogen function is removed and is sealed;
Step 4: sterilization
Sterilizing installation is a superheated water cyclic spraying steriliser, packaged product is tiled on the shelf of steriliser, to sterilize with the recirculated water pressurized, heated to high temperature and spray on the product, product was at high temperature kept 12-18 minute, thoroughly to kill the microorganism in the product, reach the effect of sterilization.
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Address after: 214092, No. 16, Zhabei Road, Mashan, Binhu District, Jiangsu, Wuxi Patentee after: Fresenius Cabi Huarui Pharmaceutical Co. Ltd. Address before: 214092, No. 16, Zhabei Road, Mashan, Binhu District, Jiangsu, Wuxi Patentee before: Sino-Swed Pharmaceutical Co., Ltd. |
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