CN105770970A - Compound polysaccharide anti-hemorrhagic thin film and preparation method thereof - Google Patents
Compound polysaccharide anti-hemorrhagic thin film and preparation method thereof Download PDFInfo
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- 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
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- A61L15/40—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing ingredients of undetermined constitution or reaction products thereof, e.g. plant or animal extracts
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- 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
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- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
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- A61L15/42—Use of materials characterised by their function or physical properties
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- A—HUMAN NECESSITIES
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- 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
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- 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
- A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents
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- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/04—Materials for stopping bleeding
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Abstract
The invention discloses a compound polysaccharide anti-hemorrhagic thin film and a preparation method thereof.The thin film is prepared from, by mass, 10-20 parts of chitosan, 2-8 parts of glucose, 3-6 parts of methylcellulose, 1-5 parts of gelatin, 4-7 parts of pectin, 4-7 parts of sodium trimetaphosphate, 8-20 parts of polyhydric alcohols, 5-8 parts of agar, 2-8 parts of sorbic acid, 5-10 parts of sodium alginate, 3-6 parts of panax notoginseng, 1-3 parts of sodium fumarate and 2-5 parts of sanguisorba officinalis.A polysaccharide serves as a matrix, proper anti-hemorrhagic components and auxiliaries are added, and the film-shaped anti-hemorrhagic material is prepared.Compared with conventional powder or spray, the film-shaped anti-hemorrhagic material can stop bleeding in two aspects synchronously.In the early time of bleeding, the film body is similar to tourniquet and can quickly stop bleeding, the anti-hemorrhagic components in the film synchronously stop bleeding at the same time, and the thin film has dual anti-hemorrhagic functions, greatly shortens bleeding time and is obvious in anti-hemorrhagic effect and convenient to use.
Description
Technical field
The invention belongs to hemostatic material in medical use technical field, be specifically related to a kind of complex polysaccharide hemostasis thin film and preparation method thereof.
Background technology
The hemorrhage first cause being always up trauma patient death.At present, the hemorrhage effective control device of large artery trunks is only rested on operating-table, but for field or acute injury bleeding patients, it is sent on the road of rescue room and has missed best treatment time due to severe loss of blood after hemorrhage often, therefore, how the very first time efficiently control hemorrhage become current the most challenging, be also most important work.Compare the method that the surgical operation traditional with some controls hemostasis, have recently emerged the hemostatic material of some advanced persons and examination thorn may be used for field hemostasis or emergency survival hemostasis.Oxidized cellulose, Fibrin Glue and rubber polymer thorn etc. have been used as trying punishment in local hemostasis;And molecular sieve and chitosan are manufactured experimently as the local hemostasis of latest generation, its effect and safety are among everybody is studying at present;The restructuring activation blood coagulation VII factor (FVIIa) be occur recently for the optimal hemostasis agents of wound hemostasis, but by many group STOCHASTIC CONTROL experiments, the safety of wounded patient is needed to investigate by it.
Traditional hemostatic fashion mainly ties, press and dressing etc., main hemostasia products has first-aid kit, four-tailed bandage, hemostatic gauze, tourniquet and binder etc., these hemostatic materials can stop blooding in very short time and give treatment to patient, it is control hemorrhage main method, but in use or use after can there is great defect, be therefore extremely limited when clinical practice.Such as, sewing hemostasis is very effective for the wound hemorrhage of soft tissue and big blood vessel, but the haemostatic effect for the parenchymal viscera that fragility is relatively big and blood flow is abundant is very undesirable, and very easily cause pinprick or the hemorrhagic tissue injury of breach, thus having influence on the normal function of the parenchymal viscera such as kidney, brain;Blood capillary is pressed by pressing haemostatic with needing lasting several tens minutes, promotes platelet to assemble, and is control the small-sized the most direct hemorrhage hemostatic fashion of body surface, but but very undesirable for slightly substantial amounts of hemorrhage haemostatic effect.Tourniquet there is also a lot of defect in the process used: if tourniquet is improper to treatment of wounds or does not have correct taking the time and pressure, it is possible to can cause pain near wound, nerve injury, even cause tissue necrosis etc. time serious；Tourniquet is for some special and relatively common wounds, and the wound hemostasis effect such as such as in irregular shape, deep, narrow, arteriorrhexis is bad;Tourniquet is easier to come off, and causes secondary hemorrhage;The reaction that the use of tourniquet can bring out surgical wound surface surrounding soft tissue is congested, and oxygen content is decreased obviously.Visible, traditional hemostatic material can not meet modem surgical safe haemostasis and urgent trauma hemostasis clinical demand, and the weak point of these hemostatic fashion needs other novel hemostatic materials to make up.
Summary of the invention
The present invention provides a kind of complex polysaccharide hemostasis thin film and preparation method thereof, complex polysaccharide of the present invention hemostasis thin film, suitable hemostatic compositions and auxiliary agent is added with polysaccharide for substrate, preparation film-like hemostatic material, film body composition possesses good hemostatic function, compared with conventional powder or spray, membranaceous hemostatic material can synchronize hemostasis from two aspects, and hemorrhage early stage, film body is similar to tourniquet, can quick-acting haemostatic powder, hemostatic compositions in film synchronizes hemostasis, double-hemostasis function function simultaneously, substantially reduces the bleeding time, haemostatic effect is obvious, and easy to use.
To achieve these goals, the technical solution used in the present invention is:
Complex polysaccharide hemostasis thin film, component and each constituent mass number are as follows: chitosan 10 ~ 20 parts, glucose 2 ~ 8 parts, methylcellulose 3 ~ 6 parts, 1 ~ 5 part of gelatin, pectin 4 ~ 7 parts, sodium trimetaphosphate 4 ~ 7 parts, polyhydric alcohol 8 ~ 20 parts, 5 ~ 8 parts of agar, sorbic acid 2 ~ 8 parts, sodium alginate 5 ~ 10 parts, Radix Notoginseng 3 ~ 6 parts, fumaric acid sodium 1 ~ 3 part, Radix Sanguisorbae 2 ~ 5 parts.
Described polyhydric alcohol is glycerol or butanediol.
Described complex polysaccharide hemostasis thin film, component and each constituent mass number are preferably as follows: chitosan 12 ~ 18 parts, glucose 4 ~ 6 parts, methylcellulose 4 ~ 5 parts, 2 ~ 4 parts of gelatin, pectin 5 ~ 6 parts, sodium trimetaphosphate 5 ~ 6 parts, polyhydric alcohol 10 ~ 16 parts, 6 ~ 7 parts of agar, sorbic acid 4 ~ 6 parts, sodium alginate 6 ~ 8 parts, Radix Notoginseng 4 ~ 5 parts, fumaric acid sodium 2 ~ 3 parts, Radix Sanguisorbae 3 ~ 4 parts.
Described complex polysaccharide hemostasis thin film, component and each constituent mass number are preferably as follows: chitosan 16 parts, glucose 5 parts, methylcellulose 4.5 parts, 3 parts of gelatin, pectin 5.6 parts, sodium trimetaphosphate 5.5 parts, polyhydric alcohol 13 parts, 6.5 parts of agar, sorbic acid 5 parts, sodium alginate 7 parts, Radix Notoginseng 4.5 parts, fumaric acid sodium 2.5 parts, Radix Sanguisorbae 3.5 parts.
The preparation method of described complex polysaccharide hemostasis thin film, comprises the steps:
1) chitosan, glucose, methylcellulose and sodium alginate are mixed in mass parts ratio, add polyhydric alcohol, be warming up to 80 ~ 100 DEG C, stir 30 ~ 60min, be subsequently adding sorbic acid and continue stirring 10 ~ 18min, obtain mixed sugar liquid；
2) by gelatin, pectin, agar, fumaric acid sodium, sodium trimetaphosphate, Radix Notoginseng and Radix Sanguisorbae mix homogeneously, joining in the mixed sugar liquid of step 1), heating, to 70 ~ 80 DEG C, is stirred 40 ~ 80min, is obtained polysaccharide membrane liquid；
3) by step 2) polysaccharide membrane liquid pour mask on glass plate of obtaining, 50 ~ 70 DEG C dry, take off film, obtain complex polysaccharide hemostasis thin film.
Step 1) is warming up to 90 DEG C, stirs 45min, be subsequently adding sorbic acid and continue stirring 13min.
Step 2) in heating to 75 DEG C, stir 60min.
In step 3), baking temperature is 60 DEG C.
Beneficial effect:
Complex polysaccharide provided by the invention hemostasis thin film, adds suitable hemostatic compositions and auxiliary agent, prepares film-like hemostatic material with polysaccharide for substrate, film body composition possesses good hemostatic function, and compared with conventional powder or spray, membranaceous hemostatic material can synchronize hemostasis from two aspects, hemorrhage early stage, film body is similar to tourniquet, can quick-acting haemostatic powder, simultaneously the hemostatic compositions in film synchronizes hemostasis, double-hemostasis function function, substantially reducing the bleeding time, haemostatic effect is obvious, and easy to use.
Detailed description of the invention
Embodiment 1
Complex polysaccharide hemostasis thin film, component and each constituent mass number are as follows: chitosan 10 parts, glucose 2 parts, methylcellulose 3 parts, 1 part of gelatin, pectin 4 parts, sodium trimetaphosphate 4 parts, polyhydric alcohol glycerol 8 parts, 5 parts of agar, sorbic acid 2 parts, sodium alginate 5 parts, Radix Notoginseng 3 parts, fumaric acid sodium 1 part, Radix Sanguisorbae 2 parts.
Preparation method, comprises the steps:
1) chitosan, glucose, methylcellulose and sodium alginate are mixed in mass parts ratio, add polyhydric alcohol, be warming up to 90 DEG C, stir 45min, be subsequently adding sorbic acid and continue stirring 13min, obtain mixed sugar liquid；
2) by gelatin, pectin, agar, fumaric acid sodium, sodium trimetaphosphate, Radix Notoginseng and Radix Sanguisorbae mix homogeneously, joining in the mixed sugar liquid of step 1), heating, to 75 DEG C, is stirred 60min, is obtained polysaccharide membrane liquid；
3) by step 2) polysaccharide membrane liquid pour mask on glass plate of obtaining, 60 DEG C dry, take off film, obtain complex polysaccharide hemostasis thin film.
Embodiment 2
Complex polysaccharide hemostasis thin film, component and each constituent mass number are as follows: chitosan 20 parts, glucose 8 parts, methylcellulose 6 parts, 5 parts of gelatin, pectin 7 parts, sodium trimetaphosphate 7 parts, polyhydric alcohol glycerol 20 parts, 8 parts of agar, sorbic acid 8 parts, sodium alginate 10 parts, Radix Notoginseng 6 parts, fumaric acid sodium 3 parts, Radix Sanguisorbae 5 parts.
Preparation method, comprises the steps:
1) chitosan, glucose, methylcellulose and sodium alginate are mixed in mass parts ratio, add polyhydric alcohol, be warming up to 90 DEG C, stir 45min, be subsequently adding sorbic acid and continue stirring 13min, obtain mixed sugar liquid；
2) by gelatin, pectin, agar, fumaric acid sodium, sodium trimetaphosphate, Radix Notoginseng and Radix Sanguisorbae mix homogeneously, joining in the mixed sugar liquid of step 1), heating, to 75 DEG C, is stirred 60min, is obtained polysaccharide membrane liquid；
3) by step 2) polysaccharide membrane liquid pour mask on glass plate of obtaining, 60 DEG C dry, take off film, obtain complex polysaccharide hemostasis thin film.
Embodiment 3
Complex polysaccharide hemostasis thin film, component and each constituent mass number are as follows: chitosan 12 parts, glucose 4 parts, methylcellulose 4 parts, 2 parts of gelatin, pectin 5 parts, sodium trimetaphosphate 5 parts, polyhydric alcohol glycerol 10 parts, 6 parts of agar, sorbic acid 4 parts, sodium alginate 6 parts, Radix Notoginseng 4 parts, fumaric acid sodium 2 parts, Radix Sanguisorbae 3 parts.
Preparation method, comprises the steps:
1) chitosan, glucose, methylcellulose and sodium alginate are mixed in mass parts ratio, add polyhydric alcohol, be warming up to 90 DEG C, stir 45min, be subsequently adding sorbic acid and continue stirring 13min, obtain mixed sugar liquid；
2) by gelatin, pectin, agar, fumaric acid sodium, sodium trimetaphosphate, Radix Notoginseng and Radix Sanguisorbae mix homogeneously, joining in the mixed sugar liquid of step 1), heating, to 75 DEG C, is stirred 60min, is obtained polysaccharide membrane liquid；
3) by step 2) polysaccharide membrane liquid pour mask on glass plate of obtaining, 60 DEG C dry, take off film, obtain complex polysaccharide hemostasis thin film.
Embodiment 4
Complex polysaccharide hemostasis thin film, component and each constituent mass number are as follows: chitosan 18 parts, glucose 6 parts, methylcellulose 5 parts, 4 parts of gelatin, pectin 6 parts, sodium trimetaphosphate 6 parts, polyhydric alcohol glycerol 16 parts, 7 parts of agar, sorbic acid 6 parts, sodium alginate 8 parts, Radix Notoginseng 5 parts, fumaric acid sodium 3 parts, Radix Sanguisorbae 4 parts.
Preparation method, comprises the steps:
1) chitosan, glucose, methylcellulose and sodium alginate are mixed in mass parts ratio, add polyhydric alcohol, be warming up to 90 DEG C, stir 45min, be subsequently adding sorbic acid and continue stirring 13min, obtain mixed sugar liquid；
2) by gelatin, pectin, agar, fumaric acid sodium, sodium trimetaphosphate, Radix Notoginseng and Radix Sanguisorbae mix homogeneously, joining in the mixed sugar liquid of step 1), heating, to 75 DEG C, is stirred 60min, is obtained polysaccharide membrane liquid；
3) by step 2) polysaccharide membrane liquid pour mask on glass plate of obtaining, 60 DEG C dry, take off film, obtain complex polysaccharide hemostasis thin film.
Embodiment 5
Complex polysaccharide hemostasis thin film, component and each constituent mass number are as follows: chitosan 16 parts, glucose 5 parts, methylcellulose 4.5 parts, 3 parts of gelatin, pectin 5.6 parts, sodium trimetaphosphate 5.5 parts, polyhydric alcohol butanediol 13 parts, 6.5 parts of agar, sorbic acid 5 parts, sodium alginate 7 parts, Radix Notoginseng 4.5 parts, fumaric acid sodium 2.5 parts, Radix Sanguisorbae 3.5 parts.
Preparation method, comprises the steps:
1) chitosan, glucose, methylcellulose and sodium alginate are mixed in mass parts ratio, add polyhydric alcohol, be warming up to 90 DEG C, stir 45min, be subsequently adding sorbic acid and continue stirring 13min, obtain mixed sugar liquid；
2) by gelatin, pectin, agar, fumaric acid sodium, sodium trimetaphosphate, Radix Notoginseng and Radix Sanguisorbae mix homogeneously, joining in the mixed sugar liquid of step 1), heating, to 75 DEG C, is stirred 60min, is obtained polysaccharide membrane liquid；
3) by step 2) polysaccharide membrane liquid pour mask on glass plate of obtaining, 60 DEG C dry, take off film, obtain complex polysaccharide hemostasis thin film.
Reference examples 1
The present embodiment is identical with the component of embodiment 5 and preparation method, differs only in, without Radix Notoginseng and Radix Sanguisorbae.
Reference examples 2:
The present embodiment is identical with the component of embodiment 5 and preparation method, differs only in, without glucose and fructose.
The mensuration of the BCI index of hemostatic material and comparing
People's whole blood that 100 μ L contain anticoagulant ACD (2.5% ACD, 10 μ L) adds in a little container；Secondly the CaCl2 solution (0.2mol/L) of 20 μ L is joined and blood carries out preliminary blood coagulation, then the sample that weight is 0.03g is poured in small container and covered into blood, more above-mentioned beaker is put into cultivation 10min in 37 DEG C of incubators;Afterwards 25ml deionized water is poured slowly in beaker along walls of beaker, does not destroy the blood solidified as far as possible, this beaker is inserted 5min in 37 DEG C of constant temperature digital display water bath chaders;Finally take out beaker and stand 5min, take out the liquid in a small amount of beaker afterwards on ultraviolet spectrophotometer, measure its absorbance at 542nm place.The BCI value of sample calculates such as formula:
Not BCI=100* (liquid absorbance at 542nm place after sample stops blooding)/(not adding the liquid of the sample absorbance at 542nm place), hemostatic capability and the BCI value of material are inversely proportional to, namely BCI value is more low, and the anthemorrhagic performance of material is more good.
The BCI index of comparing embodiment 1 ~ 5, reference examples 1 ~ 2 and commercially available YUNNAN BAIYAO, result is shown in Table 1.
Table 1:
Surface wound hemostasis trial:
Take healthy rabbits 30, male and female half and half, body weight 2.3～2.8kg.Being randomly divided into 5 groups by sex, body weight, often group 6, male and female half and half, be respectively as follows: model control group, embodiment 1 ~ 5, reference examples 1 ~ 2 and YUNNAN BAIYAO group.First with depilatory to family's rabbit back depilation, with 1% pentobarbital sodium 30mg/kg auricular vein injecting anesthetic rabbit after 24h.No. 7 syringe needle are used to scratch in depilation peeling skin " # ", with substantially hemorrhage for degree.Being full of after wound surface until blood, stop blooding to the complex polysaccharide of wound parcel embodiment 1 ~ 5, reference examples 1 ~ 2 respectively immediately thin film and coating YUNNAN BAIYAO, to wound surface is completely covered, model control group is left intact.Observing the hemorrhage of wound every 30s, dip in suction gently with filter paper bar until blood no longer oozes out, namely no longer speckle with till blood on filter paper bar, record required time is the bleeding time.Stopping blooding not yet more than 15min, pressing haemostatic, the bleeding time is in 15min.Result is in Table 2.
Table 2:
Claims (8)
1. complex polysaccharide hemostasis thin film, it is characterised in that component and each constituent mass number are as follows: chitosan 10 ~ 20 parts, glucose 2 ~ 8 parts, methylcellulose 3 ~ 6 parts, 1 ~ 5 part of gelatin, pectin 4 ~ 7 parts, sodium trimetaphosphate 4 ~ 7 parts, polyhydric alcohol 8 ~ 20 parts, 5 ~ 8 parts of agar, sorbic acid 2 ~ 8 parts, sodium alginate 5 ~ 10 parts, Radix Notoginseng 3 ~ 6 parts, fumaric acid sodium 1 ~ 3 part, Radix Sanguisorbae 2 ~ 5 parts.
2. complex polysaccharide according to claim 1 hemostasis thin film, it is characterised in that: described polyhydric alcohol is glycerol or butanediol.
3. complex polysaccharide according to claim 1 hemostasis thin film, it is characterised in that component and each constituent mass number are as follows: chitosan 12 ~ 18 parts, glucose 4 ~ 6 parts, methylcellulose 4 ~ 5 parts, 2 ~ 4 parts of gelatin, pectin 5 ~ 6 parts, sodium trimetaphosphate 5 ~ 6 parts, polyhydric alcohol 10 ~ 16 parts, 6 ~ 7 parts of agar, sorbic acid 4 ~ 6 parts, sodium alginate 6 ~ 8 parts, Radix Notoginseng 4 ~ 5 parts, fumaric acid sodium 2 ~ 3 parts, Radix Sanguisorbae 3 ~ 4 parts.
4. complex polysaccharide according to claim 1 hemostasis thin film, it is characterised in that component and each constituent mass number are as follows: chitosan 16 parts, glucose 5 parts, methylcellulose 4.5 parts, 3 parts of gelatin, pectin 5.6 parts, sodium trimetaphosphate 5.5 parts, polyhydric alcohol 13 parts, 6.5 parts of agar, sorbic acid 5 parts, sodium alginate 7 parts, Radix Notoginseng 4.5 parts, fumaric acid sodium 2.5 parts, Radix Sanguisorbae 3.5 parts.
5. the preparation method of complex polysaccharide hemostasis thin film described in claim 1, it is characterised in that comprise the steps:
1) chitosan, glucose, methylcellulose and sodium alginate are mixed in mass parts ratio, add polyhydric alcohol, be warming up to 80 ~ 100 DEG C, stir 30 ~ 60min, be subsequently adding sorbic acid and continue stirring 10 ~ 18min, obtain mixed sugar liquid；
2) by gelatin, pectin, agar, fumaric acid sodium, sodium trimetaphosphate, Radix Notoginseng and Radix Sanguisorbae mix homogeneously, joining in the mixed sugar liquid of step 1), heating, to 70 ~ 80 DEG C, is stirred 40 ~ 80min, is obtained polysaccharide membrane liquid；
3) by step 2) polysaccharide membrane liquid pour mask on glass plate of obtaining, 50 ~ 70 DEG C dry, take off film, obtain complex polysaccharide hemostasis thin film.
6. according to claim 5 complex polysaccharide hemostasis thin film preparation method, it is characterised in that: step 1) is warming up to 90 DEG C, stir 45min, be subsequently adding sorbic acid continue stirring 13min.
7. according to claim 5 complex polysaccharide hemostasis thin film preparation method, it is characterised in that: step 2) in heating to 75 DEG C, stir 60min.
8. according to claim 5 complex polysaccharide hemostasis thin film preparation method, it is characterised in that: in step 3), baking temperature is 60 DEG C.
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| CN108014361A (en) * | 2018-02-07 | 2018-05-11 | 苏州元禾医疗器械有限公司 | A kind of wound dressing |
| WO2019112701A1 (en) * | 2017-12-07 | 2019-06-13 | Massachusetts Institute Of Technology | Sensitization of bacterial cells to quinolone antibiotics |
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