CN101874772A - Preparation process for soft bag injection and product - Google Patents
Preparation process for soft bag injection and product Download PDFInfo
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- CN101874772A CN101874772A CN2010101861847A CN201010186184A CN101874772A CN 101874772 A CN101874772 A CN 101874772A CN 2010101861847 A CN2010101861847 A CN 2010101861847A CN 201010186184 A CN201010186184 A CN 201010186184A CN 101874772 A CN101874772 A CN 101874772A
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Abstract
The invention provides a preparation process for a soft bag injection and a product. The preparation process is characterized by comprising the following steps of: (1) preparing the injection; (2) performing oxygen-free encapsulation; and (3) sterilizing the product. During the oxygen-free encapsulation, the obtained injection is filtered by a filter and is filled into an inner soft bag, and the soft bag is vacuumed, filled with a nitrogen gas and plugged; an outer plastic bag is arranged outside the inner bag package; and a space between the inner bag and the outer bag is vacuumed and filled with the nitrogen gas and an oxygen inhalant is added into the space. The preparation process has the advantages of simplicity and convenient operation. Under the condition that no auxiliary material, such as an antioxidant and the like, is added, the injection is rarely oxidized and decomposed to form peroxides or the peroxides are not decomposed continuously to produce harmful substances, such as aldehyde, ketone and the like. The soft bag injection product has high stability and can prevent the oxidation or decomposition of oxidizable or decomposable ingredients in the soft bag product so as to reduce the decomposition and the production of the harmful substances.
Description
Technical field
The present invention relates generally to the packaging field of medicine, food and chemical products, is preparation technology of a kind of soft bag injection and products thereof specifically.
Background technology
In the past, auxotype injection such as fat milk class, amino acids injection etc., in production and storage process, can produce harmful catabolite because of oxidation, decomposition, and cause the content of active component in the medicinal liquid to descend, can form peroxide because of oxidation as fat milk, or peroxide continues to decompose materials such as producing deleterious aldehyde, ketone.
Owing to above reason, clinical general recommendations takes necessary means to reduce the generation of oxidation in the auxotype injection, catabolite.Corresponding measure comprises: 1. in auxotype injection production use, use lucifuge paper to make the reservoir bag and the infusion pipeline lucifuge of injection.Add trace element or at last when 2. preparing from other approach infusion.3. an amount of vitamin that adds with antioxidation.4. discharge the air in the transfusion bag before preparation finishes as far as possible.But these measures all are the measures during at clinical use, can not fundamentally reduce the generation of peroxide decomposition product.
In addition, for preventing the peroxidating of lipomul, usually the packing of lipomul all is based on the good vial of closure, though but vial can reduce the peroxidating problem of lipomul in storage process, but because it belongs to open transfusion, in infusion process, need to introduce air, have certain hidden danger.
Summary of the invention
The preparation technology who the purpose of this invention is to provide a kind of soft bag injection is not adding under the situation of adjuvants such as antioxidant, makes the auxotype injection oxidation seldom occur, is decomposed to form peroxide or materials such as the deleterious aldehyde of peroxide continuation decomposition generation, ketone.Its technology is simple, and is easy to operate.A kind of soft bag injection is provided, and good stability of products prevents easily oxidation in the soft bag product, easily decomposes the oxidation or the decomposition of composition, thereby the decomposition that has reduced further harmful substance produces.
The objective of the invention is to be achieved through the following technical solutions: a kind of preparation technology of soft bag injection is characterized in that preparation technology may further comprise the steps:
(1) preparation of injection;
(2) anaerobic fill;
(3) product sterilization;
In the anaerobic filling process: the gained injection through filter filter pack in soft bag, charge into nitrogen behind the evacuation and jump a queue; Adding in inner bag packing increases the outer bag of plastics, inner bag with outside bag between charge into nitrogen behind the evacuation, and adding oxygen inhalant.
To improvement of the technical scheme: soft bag be soft bag of the plastics used always as medical container in described, comprise polyethylene, polypropylene, polrvinyl chloride, friendship plastic of poly vinyl acetate copolymer, ethene-alpha-olefin copolymer, above-mentioned mixture of polymers and contain the soft bag that the laminate of above-mentioned polymer is made that the outer bag of described plastics be outer bag of the high-barrier plastics of choke, resistance oxygen.
To further improvement in the technical proposal: described injection is that amino acid injection, aminoacid glucose injection, medium and long chain fat emulsion injection, long chain fat emulsion injection, aminoacid fat emulsion injection or other contain amino acid whose injection.
To further improvement in the technical proposal: injection products evacuation and inflated with nitrogen operation are repeated once at least.
To further improvement in the technical proposal: the injection in the described inner bag is a medium and long chain fat emulsion injection, inner bag and outside add the oxygen inhalant between the bag after, inner bag and outside evacuation after 0.1 second～20 seconds between the bag, charged into nitrogen 0.1 second～20 seconds, seal, promptly get the soft bag injection product.
A kind of soft bag injection product is characterized in that, described injection through filter filter pack in the soft bag, charge into nitrogen behind the evacuation and jump a queue; Adding in inner bag packing increases the outer bag of plastics, inner bag with outside bag between charge into nitrogen behind the evacuation, and adding oxygen inhalant.
To improvement of the technical scheme: soft bag be soft bag of the plastics used always as medical container in described, comprise polyethylene, polypropylene, polrvinyl chloride, friendship plastic of poly vinyl acetate copolymer, ethene-alpha-olefin copolymer, above-mentioned mixture of polymers and contain the soft bag that the laminate of above-mentioned polymer is made that the outer bag of described plastics be outer bag of the high-barrier plastics of choke, resistance oxygen.
To further improvement in the technical proposal: described injection is that amino acid injection, aminoacid glucose injection, medium and long chain fat emulsion injection, long chain fat emulsion injection, aminoacid fat emulsion injection or other contain amino acid whose injection.
The present invention compared with prior art has following advantage and good effect:
The present invention is by bag outside the high-barrier plastics that increase choke resistance oxygen soft bag injection product (inner bag) outside (outside bag), charging into an amount of nitrogen again behind the evacuation between inside and outside bag, and adding oxygen inhalant, can eliminate the detrimental effect of oxygen to the injection drug system, from then on suppressed the auxotype injection and produced peroxide, or peroxide continues to decompose materials such as producing deleterious aldehyde, ketone at heat sterilization and lay up period generation oxidation Decomposition.
The specific embodiment
The preparation technology's of a kind of soft bag injection of the present invention embodiment, packaging facilities: inflated type vacuum packer, packaging product: the soft bag of medium and long chain fat emulsion injection product.
Preparation technology may further comprise the steps:
(1) preparation of injection;
(2) anaerobic fill;
(3) product sterilization;
In the anaerobic filling process: the gained injection through filter filter pack in soft bag, charge into nitrogen behind the evacuation and jump a queue; Adding in inner bag packing increases the outer bag of plastics, inner bag with outside bag between charge into nitrogen behind the evacuation, and adding oxygen inhalant.
Soft bag is the soft bag of using always as medical container of plastics in described, comprise polyethylene, polypropylene, polrvinyl chloride, friendship plastic of poly vinyl acetate copolymer, ethene-alpha-olefin copolymer, above-mentioned mixture of polymers and contain the soft bag that the laminate of above-mentioned polymer is made that the outer bag of described plastics be outer bag of the high-barrier plastics of choke, resistance oxygen.
Above-mentioned injection also can be amino acid injection, aminoacid glucose injection, medium and long chain fat emulsion injection, long chain fat emulsion injection, aminoacid fat emulsion injection or other contains amino acid whose injection.
Injection in the described inner bag is a medium and long chain fat emulsion injection, inner bag and outside add the oxygen inhalant between the bag after, inner bag with outside bag between evacuation after 0.1 second～20 seconds, charged into nitrogen 0.1 second～20 seconds, seal, promptly get the soft bag injection product.Above-mentioned injection products some need evacuation and inflated with nitrogen operation to repeat more than twice or twice.
A kind of soft bag injection product embodiments that adopts above-mentioned preparation technology to produce, with medium and long chain fat emulsion injection through filter filter pack in the soft bag, charge into nitrogen behind the evacuation and jump a queue; Adding in inner bag packing increases the outer bag of plastics, inner bag with outside bag between charge into nitrogen behind the evacuation, and adding oxygen inhalant.Soft bag is a non-PVC-soft-bag in described, and the outer bag of described plastics is the outer bag of high-barrier plastics of choke, resistance oxygen.Above-mentioned injection is that amino acid injection, aminoacid glucose injection, medium and long chain fat emulsion injection, long chain fat emulsion injection, aminoacid fat emulsion injection or other contain amino acid whose injection.
After adding medium and long chain fat emulsion injection soft bag product (inner bag) and oxygen inhalant in the bag outside air-locked high-barrier plastics (outside bag), evacuation charged into nitrogen 0.1 second～20 seconds after 0.1 second～20 seconds between inside and outside bag, sealed, promptly.
Testing result:
Generally by detecting the peroxide value index of medicinal liquid, the continuation catabolite of peroxide can be by detecting the anisidine value index of medicinal liquid for peroxide in the medium and long chain fat emulsion injection.Not by process of the present invention, do not pack the outer bag of high-barrier plastics after promptly producing, or the outer bag of packing high-barrier plastics but not evacuation do not charge into the lipomul of nitrogen, its anisidine value is respectively 3.2 and 2.8.The middle long-chain fat milk product peroxide value of producing by the present invention can be controlled in the 0.1mmol/L, and anisidine value can be controlled in 1.5.
The present invention is applicable to the packed in flexible pouchy product of all auxotype injection or easy oxidation, all can use in a plurality of fields such as medicine, food, chemical productss.It is not adding under the situation of adjuvants such as antioxidant, reduced easily oxidation in the soft bag product to greatest extent, easily decomposed the oxidation or the decomposition of composition, thereby the decomposition that has reduced further harmful substance produces.Applicable product thereof such as amino acid injection (3A) in field of medicaments, amino acid injection (9A), amino acid injection (18A), aminoacid glucose injection, medium and long chain fat emulsion injection, long chain fat emulsion injection, aminoacid fat emulsion injection etc.
The oil-in-water type fat breast of fat emulsion injection as packed in flexible pouchy of the present invention for making with the emulsifying agent chyle fat.
The fat that is applicable to Emulsion of the present invention can be as the oil ﹠ fat of origin of heat (energy source) in any high alimentation of being everlasting, comprising: various plants oil, as Oleum Glycines, Oleum Gossypii semen, safflower oil, Semen Maydis oil, cocos nucifera oil, Oleum Perillae, Storax oil, Semen Lini wet goods; Fish oil is as pilchard oil, cod-liver oil etc.; Chain fatty acid triglycerides (LCT) as the essential fatty acid source; And carbon number is generally the MCT Oil (MCT) of 8-10.In addition, described fat also comprises the triglyceride of chemistry definition, 1-Caulis et Folium Lini acyl group-1 for example, 3-two caprylyl glycerol, 2-Caulis et Folium Lini acyl group-1,3-didecyl acylglycerol etc.These materials can use separately, also can use with.
Certainly, above-mentioned explanation is not to be restriction to invention, the present invention also be not limited to above-mentioned for example, those skilled in the art, the variation of making in essential scope of the present invention, remodeling, interpolation or replacement also should belong to protection scope of the present invention.
Claims (8)
1. the preparation technology of a soft bag injection is characterized in that preparation technology may further comprise the steps:
(1) preparation of injection;
(2) anaerobic fill;
(3) product sterilization;
In the anaerobic filling process: the gained injection through filter filter pack in soft bag, charge into nitrogen behind the evacuation and jump a queue; Adding in inner bag packing increases the outer bag of plastics, inner bag with outside bag between charge into nitrogen behind the evacuation, and adding oxygen inhalant.
2. according to the preparation technology of the described soft bag injection of claim 1, it is characterized in that the plastics soft bag of described interior soft bag for using always as medical container, comprise polyethylene, polypropylene, polrvinyl chloride, friendship plastic of poly vinyl acetate copolymer, ethene-alpha-olefin copolymer, above-mentioned mixture of polymers and contain the soft bag that the laminate of above-mentioned polymer is made that the outer bag of described plastics be outer bag of the high-barrier plastics of choke, resistance oxygen.
3. according to the preparation technology of claim 1 or 2 described soft bag injections, it is characterized in that described injection is that amino acid injection, aminoacid glucose injection, medium and long chain fat emulsion injection, long chain fat emulsion injection, aminoacid fat emulsion injection or other contain amino acid whose injection.
4. according to the preparation technology of claim 1 or 2 described soft bag injections, it is characterized in that injection products evacuation and inflated with nitrogen operation are repeated once at least.
5. according to the preparation technology of claim 1 or 2 described soft bag injections, it is characterized in that the injection in the described inner bag is a medium and long chain fat emulsion injection, inner bag and outside add the oxygen inhalant between the bag after, inner bag and outside evacuation after 0.1 second～20 seconds between the bag, charged into nitrogen 0.1 second～20 seconds, seal, promptly get the soft bag injection product.
6. a soft bag injection product is characterized in that, described injection through filter filter pack in the soft bag, charge into nitrogen behind the evacuation and jump a queue; Adding in inner bag packing increases the outer bag of plastics, inner bag with outside bag between charge into nitrogen behind the evacuation, and adding oxygen inhalant.
7. according to the described soft bag injection product of claim 6, it is characterized in that, soft bag is the soft bag of using always as medical container of plastics in described, comprise polyethylene, polypropylene, polrvinyl chloride, friendship plastic of poly vinyl acetate copolymer, ethene-alpha-olefin copolymer, above-mentioned mixture of polymers and contain the soft bag that the laminate of above-mentioned polymer is made that the outer bag of described plastics be outer bag of the high-barrier plastics of choke, resistance oxygen.
8. according to claim 6 or 7 described soft bag injection products, it is characterized in that described injection is that amino acid injection, aminoacid glucose injection, medium and long chain fat emulsion injection, long chain fat emulsion injection, aminoacid fat emulsion injection or other contain amino acid whose injection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101861847A CN101874772A (en) | 2010-05-31 | 2010-05-31 | Preparation process for soft bag injection and product |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101861847A CN101874772A (en) | 2010-05-31 | 2010-05-31 | Preparation process for soft bag injection and product |
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| CN101874772A true CN101874772A (en) | 2010-11-03 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN2010101861847A Pending CN101874772A (en) | 2010-05-31 | 2010-05-31 | Preparation process for soft bag injection and product |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103431996A (en) * | 2013-08-30 | 2013-12-11 | 山东华鲁制药有限公司 | Transfusion plastic container for containing medicine liquid |
| CN104224760A (en) * | 2013-06-20 | 2014-12-24 | 上海信谊金朱药业有限公司 | Preparation method of salbutamol sulfate aerosol inhalation solution |
| CN104434517A (en) * | 2014-10-10 | 2015-03-25 | 西安京西双鹤药业有限公司 | Double-layer aseptic package, packaging method and sterility test method for large volume injections |
| CN107405254A (en) * | 2015-01-30 | 2017-11-28 | 普罗诺瓦生物医药挪威公司 | Nutrition device |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101033030A (en) * | 2007-04-13 | 2007-09-12 | 西安力邦制药有限公司 | Application of nontoxic composite aluminum foil for exterior package of PVC or non-PVC soft packed transfusion agent |
| CN101461756A (en) * | 2007-12-17 | 2009-06-24 | 丽珠集团利民制药厂 | Medicine liquid flexible package and method for packing the same |
-
2010
- 2010-05-31 CN CN2010101861847A patent/CN101874772A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101033030A (en) * | 2007-04-13 | 2007-09-12 | 西安力邦制药有限公司 | Application of nontoxic composite aluminum foil for exterior package of PVC or non-PVC soft packed transfusion agent |
| CN101461756A (en) * | 2007-12-17 | 2009-06-24 | 丽珠集团利民制药厂 | Medicine liquid flexible package and method for packing the same |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104224760A (en) * | 2013-06-20 | 2014-12-24 | 上海信谊金朱药业有限公司 | Preparation method of salbutamol sulfate aerosol inhalation solution |
| CN103431996A (en) * | 2013-08-30 | 2013-12-11 | 山东华鲁制药有限公司 | Transfusion plastic container for containing medicine liquid |
| CN104434517A (en) * | 2014-10-10 | 2015-03-25 | 西安京西双鹤药业有限公司 | Double-layer aseptic package, packaging method and sterility test method for large volume injections |
| CN107405254A (en) * | 2015-01-30 | 2017-11-28 | 普罗诺瓦生物医药挪威公司 | Nutrition device |
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Application publication date: 20101103 |