CN107261188A - A kind of hyaluronic acid dressing and its production technology - Google Patents
A kind of hyaluronic acid dressing and its production technology Download PDFInfo
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- CN107261188A CN107261188A CN201710585924.6A CN201710585924A CN107261188A CN 107261188 A CN107261188 A CN 107261188A CN 201710585924 A CN201710585924 A CN 201710585924A CN 107261188 A CN107261188 A CN 107261188A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/28—Polysaccharides or their derivatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/44—Medicaments
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/23—Carbohydrates
- A61L2300/232—Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
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Abstract
The invention discloses a kind of hyaluronic acid dressing, including packaging material, membrane material and sodium hyaluronate solution, the sodium hyaluronate solution and membrane material are located in packaging material, the sodium hyaluronate solution is adsorbed in membrane material, the concentration of Sodium Hyaluronate is 0.01mg/ml~10.0mg/ml in the sodium hyaluronate solution, the Sodium Hyaluronate includes high molecular weight sodium hyaluronate, middle-molecular-weihydroxyethyl Sodium Hyaluronate and low molecular weight sodium hyaluronate, and the molecular weight of the high molecular weight sodium hyaluronate is 1.8 × 106More than, the molecular weight of the middle-molecular-weihydroxyethyl Sodium Hyaluronate is 2.0 × 105~4.0 × 105, the molecular weight of the low molecular weight sodium hyaluronate is 1.0 × 104Below.A kind of hyaluronic acid dressing that the present invention is provided, moistening effect is good, promotes wound healing.Invention additionally discloses a kind of production technology of hyaluronic acid dressing.
Description
Technical field
The present invention relates to pharmaceutical technology field, specifically, be related to a kind of hyaluronic acid dressing for promoting wound healing and
Its production technology.
Background technology
Preferable dressing should typically possess following functions：Wound is set to keep stationary temperature；One need to be kept with wound facing face
Fixed humidity；Unnecessary exudate can be absorbed；Possesses good permeability；Microorganism, particulates emission can be prevented and other are harmful
Substances Pollution wound；Wound will not be damaged when removing dressing.And these characteristics also exactly by offer dryness be cured by surface of a wound care product
The traditional dressing in cyclization border enters the main cause for turning to the high-end dressing for providing Moist healing environment.Although currently without any one
Class dressing can solve the problems, such as the wound of different surface of a wound different times simultaneously, but initiative dressing is due to promotion wound
Chemotaxis, the expression of protease inhibition mitigate the influence wound such as apoptosis burden physiology, biochemical character, directly facilitate and heal
The characteristic of journey, the advantage for healing stage wound with highly significant is served more and more important in surface of a wound repair process
Effect.
Sodium Hyaluronate（HA）Also known as sodium hyaluronate, it is a kind of biological polyoses, itself is exactly the main component of skin histology
One of, the Sodium Hyaluronate containing abundance in skin is to maintain one of key factor of skin health, is used as current nature to send out
The best material of existing moisture retention, because it has unique physicochemical property and good biocompatibility.At present medical science,
Serve and be widely applied in terms of biomaterial.
Skin wound healing is a very complicated process, is related to various kinds of cell and secretory product extracellular matrix is carried out
Rebuild and regenerate.It mainly includes 3 big critical stages：Inflammation, propagation and reconstruction phase.HA participates in each stage：It is long in inflammatory phase
Chain HA synthesis increase, its water imbibition causes the expansion of surface of a wound surrounding tissue, produced suitable for many of cell migration to injury
Permeability framework, and the migration of neutrophil leucocyte can be suppressed, reduce inflammation reaction.Proliferation period, short chain HA（Containing 6~20 monose）Can
Promote migration of fibroblast cells to wound tissue, fibroblast produces collagen and glycosaminoglycan（GAG）, build newly extracellular
Matrix（ECM）；HA may additionally facilitate propagation and the migration of angiogenesis and keratinocyte.Reconstruction phase, HA promotes normal and disease
The cicatrization of rationality.In a word, in wound healing, there is very important effect in each period to HA.
Existing market product is generally prepared by the hyaluronic acid of unimodal molecular weight, it is impossible to take into account high molecular weight hyaluronic acid and low
Multiple effect of the molecular weight hyaluronic acid to wound healing.
The content of the invention
The present invention a wherein purpose be to provide a kind of hyaluronic acid dressing, moistening effect is good, promote wound healing.
The technical scheme that hyaluronic acid dressing disclosed by the invention is used is：A kind of hyaluronic acid dressing, including packaging material,
Membrane material and sodium hyaluronate solution, the sodium hyaluronate solution and membrane material are located in packaging material, and the sodium hyaluronate solution is inhaled
Invest in membrane material, the concentration of matter acid sodium is 0.01mg/ml~10.0mg/ml, the hyalomitome in the sodium hyaluronate solution
Sour sodium includes high molecular weight sodium hyaluronate, middle-molecular-weihydroxyethyl Sodium Hyaluronate and low molecular weight sodium hyaluronate, the macromolecule
The molecular weight for measuring Sodium Hyaluronate is 1.8 × 106More than, the molecular weight of the middle-molecular-weihydroxyethyl Sodium Hyaluronate is 2.0 × 105~
4.0×105, the molecular weight of the low molecular weight sodium hyaluronate is 1.0 × 104Below.
Preferably, the concentration of the Sodium Hyaluronate is 1mg/ml~2mg/ml.
Preferably, the high molecular weight sodium hyaluronate, middle-molecular-weihydroxyethyl Sodium Hyaluronate and low molecule amount are transparent
The mass ratio of matter acid sodium is 1：（0.01~100）：（0.01~100）.
Preferably, the high molecular weight sodium hyaluronate, middle-molecular-weihydroxyethyl Sodium Hyaluronate and low molecule amount are transparent
The mass ratio of matter acid sodium is 1.2：1：1.
Preferably, the membrane material is non-woven fabrics, silk fabric, pectin fiber cloth or other biocompatible materialses.
Preferably, the packaging material is Polythene Bag or or aluminium foil bag.
The beneficial effect of hyaluronic acid dressing disclosed by the invention is：The HA of different relative molecular weights has different biologies
Activity and using effect, polymer hyaluronic acid sodium can hinder bacterium and harmful substance in skin surface formation biological protection film
Gear is outside；Middle numerator sodium hyaluronate can pin the moisture of 200 times of own wt, permanent moisturizing；Micromolecule hyaluronic acid sodium can
Corium is penetrated into, increases blood circulation, promotes skin-nourishing absorption to accelerate skin healing speed.It is disclosed by the invention
The sour dressing of bright matter, moisturizing and can accelerate skin healing speed, promote propagation and the differentiation of epidermal cell, prevention and maintenance skin are damaged
Wound.
Another object of the present invention is to provide a kind of production technology of hyaluronic acid dressing.
The technical scheme that the production technology of hyaluronic acid dressing disclosed by the invention is used is:
A kind of production technology of hyaluronic acid dressing, comprises the following steps：
Configure sodium hyaluronate solution；
Filtration sterilization；
The local laminar flow laminar region in ten thousand grades of bottling departments is delivered to by sterile pipes；
Membrane material is fitted into three-layer sealed packaging bag, 25KGy-45 KGy irradiation sterilizations, from general 100,000 grades of areas of area, Wan Jiqu,
Local laminar flow laminar region is put into bottle placer notch, often enters next stage and removes one layer of packaging bag；
In environment under the local laminar flow laminar region protection of ten thousand grades of bottling departments, by the sodium hyaluronate solution after filtration sterilization with
And the filling sealing in packaging material of membrane material after irradiated sterilizing.
Preferably, sodium hyaluronate solution uses the degerming mode of secondary filtration during filtration sterilization, preposition
Coarse filtration film is 0.45 μm, and rearmounted refined filtration film is 0.22 μm.
Preferably, sodium hyaluronate solution temperature during filtration sterilization is 30 DEG C to 80 DEG C.
The beneficial effect of the production technology of hyaluronic acid dressing disclosed by the invention is：Production efficiency is high and has well
Aseptic result.
Embodiment
The present invention is further elaborated and illustrated with reference to specific embodiment：A kind of hyaluronic acid dressing, including bag
Material, membrane material and sodium hyaluronate solution, the membrane material are non-woven fabrics, silk fabric, pectin fiber cloth or other biocompatibility materials
Material, the packaging material is Polythene Bag, and the sodium hyaluronate solution and membrane material are sealed in packaging material, the sodium hyaluronate solution
It is adsorbed in membrane material, the concentration of Sodium Hyaluronate is 0.01mg/ml~10.0mg/ml in the sodium hyaluronate solution, preferably
1mg/ml~2mg/ml, it is saturating that the hyaluronic acid sodium includes the sour sodium of HMW matter, middle-molecular-weihydroxyethyl Sodium Hyaluronate and low molecule amount
The sour sodium of bright matter, the molecular weight of the high molecular weight sodium hyaluronate is 1.8 × 106More than, the middle-molecular-weihydroxyethyl Sodium Hyaluronate
Molecular weight be 2.0 × 105~4.0 × 105, the molecular weight of the low molecular weight sodium hyaluronate is 1.0 × 104Hereinafter, it is described
The mass ratio of high molecular weight sodium hyaluronate, middle-molecular-weihydroxyethyl Sodium Hyaluronate and low molecular weight sodium hyaluronate is 1：（0.01~
100）：（0.01~100）, preferably 1.2：1：1.
A kind of production technology of hyaluronic acid dressing, comprises the following steps：
Configure the concentration of Sodium Hyaluronate in transparent sodium hyaluronate solution, sodium hyaluronate solution for 0.01mg/ml~
10.0mg/ml；
Filtration sterilization, using the degerming mode of secondary filtration, preposition coarse filtration film is 0.45 μm, and rearmounted refined filtration film is 0.22 μm, transparent
Temperature when matter acid sodium solution is filtered is 30 DEG C to 80 DEG C；
The local laminar flow laminar region in ten thousand grades of bottling departments is delivered to by sterile pipes；
Membrane material is fitted into three-layer sealed packaging bag, 25KGy-45 KGy irradiation sterilizations, from general 100,000 grades of areas of area, Wan Jiqu,
Local laminar flow laminar region is put into bottle placer notch, often enters next stage and removes one layer of packaging bag；
In environment under the local laminar flow laminar region protection of ten thousand grades of bottling departments, by the sodium hyaluronate solution after filtration sterilization with
And the filling sealing in packaging material of membrane material after irradiated sterilizing.
Embodiment 1：High, medium and low molecular weight hyaluronic acid sodium is pressed 1.2：1：1 ratio is added in Agitation Tank, hyalomitome
The concentration of sour sodium is 1.6mg/ml.80 DEG C are heated to, insulated and stirred is after 20 minutes, when expecting that body is down to 60 DEG C, through automatic liquid matching
System secondary filtration sterilizes, wherein preposition coarse filtration film is 0.45 μm, rearmounted refined filtration film is 0.22 μm, and the stoste after filtration sterilization is straight
Connect sterile pipes and transport the local laminar flow laminar region into ten thousand grades of bottling departments.
Membrane material should be put into packaging bag seal three layers, after 25KGy-45 KGy irradiation sterilizations, through general area, 100,000 grades
Area, Wan Jiqu, the order of local laminar flow laminar region are put into bottle placer notch, when often into next stage, all should remove one layer of packaging
Bag.
The membrane material after transparent sodium hyaluronate solution and irradiated sterilizing after filtration sterilization, in the office of ten thousand grades of bottling departments
It is filling in gnotobasis under the laminar flow protection of hundred grades of portion to be sealed in packaging material.
Embodiment 2：High, medium and low molecular weight hyaluronic acid sodium is pressed 1.2:1：1 ratio is added in Agitation Tank, transparent
The concentration of matter acid sodium is 1.6mg/ml.80 DEG C are heated to, after insulation homogeneous is stirred 20 minutes, directly through two grades of automatic liquid mixing system
Filtration sterilization, wherein preposition coarse filtration film is 0.45 μm, rearmounted refined filtration film is 0.22 μm, the sodium hyaluronate solution after filtration sterilization
The local laminar flow laminar region into ten thousand grades of bottling departments is transported by sterile pipes.
Membrane material, which should be put into packaging bag, seals three layers, after 25KGy-45KGy irradiation sterilizations, through general area, 100,000 grades of areas,
Ten thousand grades of areas, orders of local laminar flow laminar region are put into bottle placer notch, when often into next stage, all should remove one layer of packaging bag,
When often entering next stage, one layer of packaging bag all should be removed.
The membrane material after transparent sodium hyaluronate solution and irradiated sterilizing after filtration sterilization, in the office of ten thousand grades of bottling departments
It is filling in gnotobasis under the laminar flow protection of hundred grades of portion to be sealed in packaging material.
Embodiment 3：High, medium and low molecular weight hyaluronic acid sodium is pressed 1.2:1：1 ratio is added in Agitation Tank, transparent
The concentration of matter acid sodium is 1.6mg/ml.80 DEG C, after homogeneous is stirred 20 minutes are heated to, when expecting that body is down to 30 DEG C, through matching somebody with somebody automatically
Liquid system secondary filtration sterilizes, wherein preposition coarse filtration film is 0.45 μm, rearmounted refined filtration film is 0.22 μm, the stoste after filtration sterilization
The local laminar flow laminar region into ten thousand grades of bottling departments is directly transported by sterile pipes.
Membrane material, which should be put into packaging bag, seals three layers, after 25KGy-45KGy irradiation sterilizations, through general area, 100,000 grades of areas,
Ten thousand grades of areas, orders of local laminar flow laminar region are put into bottle placer notch, when often into next stage, all should remove one layer of packaging bag,
When often entering next stage, one layer of packaging bag all should be removed.
The membrane material after transparent sodium hyaluronate solution and irradiated sterilizing after filtration sterilization, in the office of ten thousand grades of bottling departments
It is filling in gnotobasis under the laminar flow protection of hundred grades of portion to be sealed in packaging material.
Embodiment 4：High, medium and low molecular weight hyaluronic acid sodium is pressed 100:1：1 ratio is added in Agitation Tank, transparent
The concentration of matter acid sodium is 1.6mg/ml.80 DEG C are heated to, insulated and stirred is after 20 minutes, when expecting that body is down to 60 DEG C, through matching somebody with somebody automatically
Liquid system secondary filtration sterilizes, wherein preposition coarse filtration film is 0.45 μm, rearmounted refined filtration film is 0.22 μm, the stoste after filtration sterilization
The local laminar flow laminar region into ten thousand grades of bottling departments is directly transported by sterile pipes.
Membrane material, which should be put into packaging bag, seals three layers, after 25KGy-45KGy irradiation sterilizations, through general area, 100,000 grades of areas,
Ten thousand grades of areas, orders of local laminar flow laminar region are put into bottle placer notch, when often into next stage, all should remove one layer of packaging bag,
When often entering next stage, one layer of packaging bag all should be removed.
The membrane material after transparent sodium hyaluronate solution and irradiated sterilizing after filtration sterilization, in the office of ten thousand grades of bottling departments
It is filling in gnotobasis under the laminar flow protection of hundred grades of portion to be sealed in packaging material.
Embodiment 5：High, medium and low molecular weight hyaluronic acid sodium is pressed 1:100：1 ratio is added in Agitation Tank, transparent
The concentration of matter acid sodium is 1.6mg/ml.80 DEG C are heated to, insulated and stirred is after 20 minutes, when expecting that body is down to 60 DEG C, through matching somebody with somebody automatically
Liquid system secondary filtration sterilizes, wherein preposition coarse filtration film is 0.45 μm, rearmounted refined filtration film is 0.22 μm, the stoste after filtration sterilization
The local laminar flow laminar region into ten thousand grades of bottling departments is directly transported by sterile pipes.
Membrane material, which should be put into packaging bag, seals three layers, after 25KGy-45KGy irradiation sterilizations, through general area, 100,000 grades of areas,
Ten thousand grades of areas, orders of local laminar flow laminar region are put into bottle placer notch, when often into next stage, all should remove one layer of packaging bag,
When often entering next stage, one layer of packaging bag all should be removed.
The membrane material after transparent sodium hyaluronate solution and irradiated sterilizing after filtration sterilization, in the office of ten thousand grades of bottling departments
It is filling in gnotobasis under the laminar flow protection of hundred grades of portion to be sealed in packaging material.
Embodiment 6：High, medium and low molecular weight hyaluronic acid sodium is pressed 1:1：100 ratio is added in Agitation Tank, transparent
The concentration of matter acid sodium is 1.6mg/ml.80 DEG C are heated to, insulated and stirred is after 20 minutes, when expecting that body is down to 60 DEG C, through matching somebody with somebody automatically
Liquid system secondary filtration sterilizes, wherein preposition coarse filtration film is 0.45 μm, rearmounted refined filtration film is 0.22 μm, the stoste after filtration sterilization
The local laminar flow laminar region into ten thousand grades of bottling departments is directly transported by sterile pipes.
Membrane material, which should be put into packaging bag, seals three layers, after 25KGy-45KGy irradiation sterilizations, through general area, 100,000 grades of areas,
Ten thousand grades of areas, orders of local laminar flow laminar region are put into bottle placer notch, when often into next stage, all should remove one layer of packaging bag,
When often entering next stage, one layer of packaging bag all should be removed.
The membrane material after transparent sodium hyaluronate solution and irradiated sterilizing after filtration sterilization, in the office of ten thousand grades of bottling departments
It is filling in gnotobasis under the laminar flow protection of hundred grades of portion to be sealed in packaging material.
Embodiment 7：High, medium and low molecular weight hyaluronic acid sodium is pressed 1.2:1：1 ratio is added in Agitation Tank, transparent
The concentration of matter acid sodium is 0.01mg/ml.80 DEG C are heated to, insulated and stirred is after 20 minutes, when expecting that body is down to 60 DEG C, through matching somebody with somebody automatically
Liquid system secondary filtration sterilizes, wherein preposition coarse filtration film is 0.45 μm, rearmounted refined filtration film is 0.22 μm, the stoste after filtration sterilization
The local laminar flow laminar region into ten thousand grades of bottling departments is directly transported by sterile pipes.
Membrane material, which should be put into packaging bag, seals three layers, after 25KGy-45KGy irradiation sterilizations, through general area, 100,000 grades of areas,
Ten thousand grades of areas, orders of local laminar flow laminar region are put into bottle placer notch, when often into next stage, all should remove one layer of packaging bag,
When often entering next stage, one layer of packaging bag all should be removed.
The membrane material after transparent sodium hyaluronate solution and irradiated sterilizing after filtration sterilization, in the office of ten thousand grades of bottling departments
It is filling in gnotobasis under the laminar flow protection of hundred grades of portion to be sealed in packaging material.
Embodiment 8：High, medium and low molecular weight hyaluronic acid sodium is pressed 1.2:1：1 ratio is added in Agitation Tank, transparent
The concentration of matter acid sodium is 10mg/ml.80 DEG C are heated to, insulated and stirred is after 20 minutes, when expecting that body is down to 60 DEG C, through automatic liquid matching
System secondary filtration sterilizes, wherein preposition coarse filtration film is 0.45 μm, rearmounted refined filtration film is 0.22 μm, and the stoste after filtration sterilization is straight
Connect sterile pipes and transport the local laminar flow laminar region into ten thousand grades of bottling departments.
Membrane material, which should be put into packaging bag, seals three layers, after 25KGy-45KGy irradiation sterilizations, through general area, 100,000 grades of areas,
Ten thousand grades of areas, orders of local laminar flow laminar region are put into bottle placer notch, when often into next stage, all should remove one layer of packaging bag,
When often entering next stage, one layer of packaging bag all should be removed.
The membrane material after transparent sodium hyaluronate solution and irradiated sterilizing after filtration sterilization, in the office of ten thousand grades of bottling departments
It is filling in gnotobasis under the laminar flow protection of hundred grades of portion to be sealed in packaging material.
Embodiment 9：High, medium and low molecular weight hyaluronic acid sodium is pressed 1.2:1：1 ratio is added in Agitation Tank, transparent
The concentration of matter acid sodium is 1.0mg/ml.80 DEG C are heated to, insulated and stirred is after 20 minutes, when expecting that body is down to 60 DEG C, through matching somebody with somebody automatically
Liquid system secondary filtration sterilizes, wherein preposition coarse filtration film is 0.45 μm, rearmounted refined filtration film is 0.22 μm, the stoste after filtration sterilization
The local laminar flow laminar region into ten thousand grades of bottling departments is directly transported by sterile pipes.
Membrane material, which should be put into packaging bag, seals three layers, after 25KGy-45KGy irradiation sterilizations, through general area, 100,000 grades of areas,
Ten thousand grades of areas, orders of local laminar flow laminar region are put into bottle placer notch, when often into next stage, all should remove one layer of packaging bag,
When often entering next stage, one layer of packaging bag all should be removed.
The membrane material after transparent sodium hyaluronate solution and irradiated sterilizing after filtration sterilization, in the office of ten thousand grades of bottling departments
It is filling in gnotobasis under the laminar flow protection of hundred grades of portion to be sealed in packaging material.
Embodiment 10：High, medium and low molecular weight hyaluronic acid sodium is pressed 1.2:1：1 ratio is added in Agitation Tank, transparent
The concentration of matter acid sodium is 2.0mg/ml.80 DEG C are heated to, insulated and stirred is after 20 minutes, when expecting that body is down to 60 DEG C, through matching somebody with somebody automatically
Liquid system secondary filtration sterilizes, wherein preposition coarse filtration film is 0.45 μm, rearmounted refined filtration film is 0.22 μm, the stoste after filtration sterilization
The local laminar flow laminar region into ten thousand grades of bottling departments is directly transported by sterile pipes.
Membrane material, which should be put into packaging bag, seals three layers, after 25KGy-45KGy irradiation sterilizations, through general area, 100,000 grades of areas,
Ten thousand grades of areas, orders of local laminar flow laminar region are put into bottle placer notch, when often into next stage, all should remove one layer of packaging bag,
When often entering next stage, one layer of packaging bag all should be removed.
The membrane material after transparent sodium hyaluronate solution and irradiated sterilizing after filtration sterilization, in the office of ten thousand grades of bottling departments
It is filling in gnotobasis under the laminar flow protection of hundred grades of portion to be sealed in packaging material.
Embodiment compares
| Embodiment | The rate of filtration | Hyaluronic acid sodium content after filtering（mg/ml） | Aseptic | Biocompatibility | Film forming |
| 1 | 1000ml/min | 1.49 | It is sterile | It is good | It is good |
| 2 | 1110ml/min | 1.50 | It is sterile | It is good | It is good |
| 3 | 355ml/min | 1.49 | It is sterile | It is good | It is good |
| 4 | 300ml/min | 1.29 | It is sterile | It is good | Very well |
| 5 | 1080ml/min | 1.57 | It is sterile | It is good | Difference |
| 6 | 1140ml/min | 1.57 | It is sterile | It is good | Difference |
| 7 | 1860 ml/min | 0.009 | It is sterile | It is good | Nothing |
| 8 | 180 ml/min | 9.15 | It is sterile | It is good | It is very good |
| 9 | 1265 ml/min | 0.925 | It is sterile | It is good | It is poor |
| 10 | 675 ml/min | 1.75 | It is sterile | It is good | It is good |
In summary, it can be seen from embodiment 1-3, when temperature is 60 DEG C or so, the stoste rate of filtration is very fast, can meet reality
Border batch production needs, when temperature maintains 80 DEG C, and the rate of filtration has certain increase, but maintains higher temperature to be relatively stranded
Difficulty, will also result in energy waste；When filtration temperature is relatively low, the rate of filtration is remarkably decreased, and is unfavorable for mass producing needs, because
This, solution temperature is at 50-70 DEG C, and filtration sterilization is proper.
Compared according to embodiment 2 with embodiment 4-6 and understood, transparent polymer amount matter acid sodium content is higher, saturating after filtering
The sour sodium total content of bright matter is lower, and loss late is about the 20% of the sour sodium content of HMW matter, and the rate of filtration also can by compared with
Big influence.But, when HMW matter acid sodium content is too low, the film forming of its product is poor, it is impossible to meet the design of product
Need, therefore, the ratio of the Sodium Hyaluronate of high, medium and low molecular weight is preferably 1：1：1, while in view of the transparent of HMW
The loss late of matter acid sodium, increases by 20% addition, i.e., 1.2 on this basis:1:1.
Compared according to embodiment 2 with embodiment 7-10 and understood, under identical process conditions, and high, medium and low molecular weight
Sodium Hyaluronate proportioning is identical, when the concentration of Sodium Hyaluronate in sodium hyaluronate solution is 0.01mg/ml, such as embodiment 7,
Film forming is essentially nothing；When the concentration of Sodium Hyaluronate in sodium hyaluronate solution is 10mg/ml, the mistake filtering velocity of embodiment 8
Spend rapid drawdown, it is impossible to meet production needs；When the concentration of Sodium Hyaluronate in sodium hyaluronate solution is 1mg/ml, embodiment 9
Film forming it is poor；The indices of embodiment 10 and embodiment 2 are essentially identical, but raw material addition increases, and causes to be produced into
This increase, therefore, the concentration of Sodium Hyaluronate can meet requirement for 1.6mg/ml.
Further to verify the effect for the promotion wound healing that the Sodium Hyaluronate of high, medium and low molecular weight is rationally produced with liquid
Really, the present invention also have chosen product prepared by embodiment 2, embodiment 7, embodiment 8, embodiment 10, be tested using double blind random,
40 light moderate trauma patient is randomly divided into three groups, every group of 10 people use the said goods in continuous 5 days, concrete condition is as follows：It is real
A trial effect is applied to compare
| Embodiment | Skin sense | Moisture retention | Wound healing number after 5 days | Wound healing rate |
| 2 | It is good | It is good | 9 | 90% |
| 7 | It is too dilute | Difference | 2 | 20% |
| 8 | It is somewhat thick, it is too glutinous after applying | Very well | 10 | 100% |
| 10 | It is good | It is good | 9 | 90% |
Summary trial effect comparative result understands that hyaluronic acid sodium content is higher, and the effect to wound healing is more obvious, but
When being too high levels, it can also cause sense organ uncomfortable, have harmful effect to the experience on probation of patient, may result in the resistance of patient
Psychology.Therefore, embodiment 2 and embodiment 10 can both reach the effect of wound healing, also there is preferable experience sense.
Finally it should be noted that the above embodiments are merely illustrative of the technical solutions of the present invention, rather than to present invention guarantor
The limitation of scope is protected, although being explained with reference to preferred embodiment to the present invention, one of ordinary skill in the art should
Work as understanding, technical scheme can be modified or equivalent substitution, without departing from the reality of technical solution of the present invention
Matter and scope.
Claims (9)
1. a kind of hyaluronic acid dressing, including packaging material, membrane material and sodium hyaluronate solution, the sodium hyaluronate solution and membrane material
In packaging material, the sodium hyaluronate solution is adsorbed in membrane material, it is characterised in that matter acid in the sodium hyaluronate solution
The concentration of sodium is 0.01mg/ml~10.0mg/ml, and it is transparent that the sour sodium of the matter includes high molecular weight sodium hyaluronate, middle-molecular-weihydroxyethyl
Matter acid sodium and low molecular weight sodium hyaluronate, the molecular weight of the high molecular weight sodium hyaluronate is 1.8 × 106More than, it is described
The molecular weight of middle-molecular-weihydroxyethyl Sodium Hyaluronate is 2.0 × 105~4.0 × 105, the molecular weight of the low molecular weight sodium hyaluronate
For 1.0 × 104Below.
2. hyaluronic acid dressing as claimed in claim 1, it is characterised in that the concentration of the sour sodium of the matter is 1mg/ml~2mg/
ml。
3. hyaluronic acid dressing as claimed in claim 1, it is characterised in that the high molecular weight sodium hyaluronate, middle molecule
The mass ratio for measuring Sodium Hyaluronate and low molecular weight sodium hyaluronate is 1：（0.01~100）：（0.01~100）.
4. hyaluronic acid dressing as claimed in claim 3, it is characterised in that the high molecular weight sodium hyaluronate, middle molecule
The mass ratio for measuring Sodium Hyaluronate and low molecular weight sodium hyaluronate is 1.2：1：1.
5. the hyaluronic acid dressing as described in any one of Claims 1-4, it is characterised in that the membrane material is non-woven fabrics, silk
The material of cloth, pectin fiber cloth or other good biocompatibilities.
6. hyaluronic acid dressing as claimed in claim 5, it is characterised in that the packaging material is Polythene Bag or aluminium foil bag.
7. the production technology of a kind of hyaluronic acid dressing as described in claim 1-6, it is characterised in that comprise the following steps：
Configure sodium hyaluronate solution；
Filtration sterilization；
The local laminar flow laminar region in ten thousand grades of bottling departments is delivered to by sterile pipes；
Membrane material is fitted into three-layer sealed packaging bag, 25KGy-45 KGy irradiation sterilizations, from general 100,000 grades of areas of area, Wan Jiqu,
Local laminar flow laminar region is put into bottle placer notch, often enters next stage and removes one layer of packaging bag；
In environment under the local laminar flow laminar region protection of ten thousand grades of bottling departments, by the sodium hyaluronate solution after filtration sterilization with
And the filling sealing in packaging material of membrane material after irradiated sterilizing.
8. the production technology of hyaluronic acid dressing as claimed in claim 7, it is characterised in that the sodium hyaluronate solution exists
The degerming mode of secondary filtration is used during filtration sterilization, preposition coarse filtration film is 0.45 μm, and rearmounted refined filtration film is 0.22 μm.
9. the production technology of hyaluronic acid dressing as claimed in claim 7, it is characterised in that the sodium hyaluronate solution exists
Temperature is 30 DEG C to 80 DEG C during filtration sterilization.
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