CN105030815A - Operation flushing fluid and preparation method of operation flushing fluid - Google Patents
Operation flushing fluid and preparation method of operation flushing fluid Download PDFInfo
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- CN105030815A CN105030815A CN201510483179.5A CN201510483179A CN105030815A CN 105030815 A CN105030815 A CN 105030815A CN 201510483179 A CN201510483179 A CN 201510483179A CN 105030815 A CN105030815 A CN 105030815A
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Abstract
The invention discloses operation flushing fluid and a preparation method of the operation flushing fluid. The operation flushing fluid uses carboxyl chitosan and sodium alginate as active ingredients, and uses polyphosphate as an ion mediating agent and a permeation pressure regulating agent. The operation flushing fluid has a bleeding stopping function, and also has a wound healing prompting function, an anti-inflammatory function and an anti-effusion function. The preparation method of the operation flushing fluid provided by the invention comprises four steps including preparation of a carboxyl chitosan interlinking solution, preparation of a sodium alginate interlinking solution, compounding, permeability regulation, filtration and sterilization of the carboxyl chitosan interlinking solution and the sodium alginate interlinking solution. The preparation method has the advantages that the carboxyl chitosan and the sodium alginate which are difficult to co-exist in the same system are compounded into the operation flushing fluid; and the original characteristics of each ingredient can be maintained.
Description
Technical field
The present invention relates to medical drugs, furthermore, relate to a kind of surgical flush fluid and method for making thereof.
Technical background
Operation, refers to the treatment such as excision, stitching that doctor carries out patient body with medical apparatus and instruments.Object cures or diagnoses the illness, as removed pathological tissues, repairing damage, transplant organ, improving the function and morphology etc. of body.Operation can cause damage, hemorrhage etc., postoperatively occurs various complication.At present, in operation, the modes such as hemostasis by compression, electric coagulation hemostasis, hemostasis by ligation, topical remedy or biological product hemostasis are generally adopted to stop blooding.And the hemostasis of performing the operation in prior art is stopped blooding to main blood vessel often, and generally too can not pursue hemostasis for branch vessel and trickle blood vessel.Simultaneously, in the process of operation, need to guarantee that visual area is clear, be beneficial to carrying out of operation, the wound surface formed after operation, as other wounds, there is inflammation, infection, sepage, healing etc. physiological activity, in repair process, need experience three courses equally, i.e. the local inflammation stage of reaction, cell proliferation and differentiation and granulation phase, tissue reconstruction stage.
At present, be extensively normal saline or ringer's solution by the flushing liquor used in operation, but this and so on flushing liquor both without obvious anthemorrhagic performance, also without the performance promoting wound healing preferably.Therefore, prior art can not provide one both to have hemostasia effect, has again promotion wound healing, the surgical flush fluid of antiinflammatory, exudation.
Alginate jelly, also known as sodium alginate, Sodium Alginate, algin sodium, is the polymer of β-anhydrous dextrorotation mannan aldehydic acid sodium, it is a kind of natural polysaccharide, can at coagulation forming in acid or divalent metal saline solution, its molecular structure is linear type simultaneously, has the characteristic making fiber.When after sodium alginate and contacting blood, soluble sodium salt is dissolved, and band stickiness, can block blood flow; Meanwhile, the sodium ion in sodium alginate and the calcium ion in blood carry out ion exchange, become insoluble calcium phosphate and maintain its network structure, with the carrying out that can accelerate Coagulation test after contacting blood further, thus form fibrin very soon, reach blood coagulation object; And sodium alginate also has promotion wound healing effect.
Using carboxyl chitosan is the soluble derivative of chitosan, and being a kind of poly-aminocarboxylated polysaccharide, is also a kind of polyampholyte.Itself is nontoxic, nonirritant, without challeng, be the good biomaterial of a kind of histocompatibility.And the formation of granulation and tissue can also be promoted, there is effect of antiinflammatory exudation, flushing or the soak of the wound of animal large area opening can be used for.Cosmetics, fresh-keeping, medical etc. in have multiple application.
In prior art, carrying out ionomer majority to alginate jelly and these two kinds of materials of using carboxyl chitosan is come by calcium ion or other chemical cross-linking agents, and hydrogel or microsphere are prepared in utilization.If form the angle of formula from using carboxyl chitosan and sodium alginate by cross-linking patterns, only have 2 sections of more close patents or patent application document, they are No. 200910060490.3 " carboxymethyl chitosan/oxidized sodium alginate self-crosslinking antibacterial hydrogel materials ", 201110325859.6 " a kind of preparation methoies with the chitosan compound nano/micron capsule of nucleocapsid structure " respectively.What wherein No. 200910060490.3 " carboxymethyl chitosan/oxidized sodium alginate self-crosslinking antibacterial hydrogel material " set forth is that oxidized sodium alginate forms aldehyde radical thus carries out chemical crosslinking with carboxymethyl chitosan; 201110325859.6 " a kind of preparation methoies with the chitosan compound nano/micron capsule of nucleocapsid structure " then obtain sodium tripolyphosphate-chitosan solution by sodium tripolyphosphate cross-linked chitosan, then are mixed into carboxymethyl chitosan and carry out polymer agglomerates and obtain chitosan nano/micron capsule.
Therefore do not exist in prior art and in the solution using carboxyl chitosan and sodium alginate are carried out by the polyphosphoric acids radical ion in polyphosphate the technology that physical crosslinking forms isotonic solution.
Summary of the invention
Using carboxyl chitosan and sodium alginate are carried out physical crosslinking by the polyphosphoric acids radical ion in polyphosphate and form isotonic solution thus provide one both to have hemostatic function by the present invention in the solution, wound healing can be promoted again, surgical flush fluid of antiinflammatory, exudation and preparation method thereof.
For achieving the above object, technical scheme of the present invention is achieved in that
The invention discloses a kind of surgical flush fluid, it for active component, take polyphosphate as ion mediation agent and osmotic pressure regulator with using carboxyl chitosan and sodium alginate, and its composition quality formula is as follows:
Alternatively, described polyphosphate is sodium salt, potassium salt or ammonium salt, or their combination.
The invention also discloses a kind of preparation method of surgical flush fluid, the method comprises:
(1) load weighted using carboxyl chitosan is put into purified water to dissolve, then temperature of liquid is controlled, between 50 DEG C ~ 80 DEG C, add polyphosphate and stir, make polyphosphate dissolve also mix homogeneously and obtain using carboxyl chitosan crosslinker solution, for subsequent use;
(2) load weighted sodium alginate is put into purified water to dissolve, then temperature of liquid is controlled, between 50 DEG C ~ 80 DEG C, add polyphosphate and stir, make polyphosphate dissolve also mix homogeneously and obtain sodium alginate cross-linking solution, for subsequent use;
(3) at the temperature of 50 DEG C ~ 80 DEG C, any one limit in above-mentioned using carboxyl chitosan crosslinker solution and sodium alginate cross-linking solution is stirred in the another kind that limit to join with the speed being no more than 50 ml/min in using carboxyl chitosan crosslinker solution and sodium alginate cross-linking solution with the speed being not less than 50 revs/min and obtains combination solution, continue to stir combination solution more than 30 minutes with this understanding, then combination solution osmotic pressure is regulated, until combination solution osmotic pressure is between 280mOsm/L ~ 320mOsm/L with polyphosphate;
By the combination solution prepared in (3) by filter element carry out filtering and impurity removing degerming after, in temperature higher than 115 DEG C, carry out moist heat sterilization under the condition of F0 >=8 and namely obtain surgical flush fluid of the present invention.
From above-mentioned, the present invention this with using carboxyl chitosan and sodium alginate for active component, the surgical flush fluid formed for ion mediation agent and osmotic pressure regulator with polyphosphate had both had hemostatic function, can promote wound healing again, antiinflammatory, exudation.Preparation, the preparation of sodium alginate cross-linking solution, using carboxyl chitosan crosslinker solution and sodium alginate cross-linking solution composite and adjusting comprising using carboxyl chitosan crosslinker solution of the present invention is oozed, the method for making of filtration sterilization four step can provide described surgical flush fluid.
Detailed description of the invention
Core concept of the present invention is: adopt Technology of the present invention, by the preparation of using carboxyl chitosan crosslinker solution, the preparation of sodium alginate cross-linking solution, composite and the tune of using carboxyl chitosan crosslinker solution and sodium alginate cross-linking solution oozes, filtration sterilization four step, and be the using carboxyl chitosan that ion mediation agent and osmotic pressure regulator will be difficult to coexist in same system originally with polyphosphate, sodium alginate is re-dubbed surgical flush fluid, surgical flush fluid of the present invention can retain an original characteristic of component, surgical flush fluid of the present invention is had can stop blooding, wound healing can be promoted again, antiinflammatory, the multi-efficiency of exudation.
For making the object, technical solutions and advantages of the present invention clearly, will be described in further detail embodiment of the present invention by embodiment below.
By the surgical flush fluid of following technique according to the formulated embodiment of the present invention 1-3 of table one (table one is the formula of embodiment of the present invention 1-3):
Load weighted using carboxyl chitosan is put into purified water dissolve, then temperature of liquid is controlled, between 50 DEG C ~ 80 DEG C, add polyphosphate and stir, make polyphosphate dissolve also mix homogeneously and obtain using carboxyl chitosan crosslinker solution, for subsequent use.
Load weighted sodium alginate is put into purified water dissolve, then temperature of liquid is controlled, between 50 DEG C ~ 80 DEG C, add polyphosphate and stir, make polyphosphate dissolve also mix homogeneously and obtain sodium alginate cross-linking solution, for subsequent use.
At the temperature of 50 DEG C ~ 80 DEG C, limit is stirred with the speed of 120 revs/min in above-mentioned sodium alginate cross-linking solution limit to join in using carboxyl chitosan crosslinker solution (also limit can be stirred with the speed of 120 revs/min in above-mentioned using carboxyl chitosan crosslinker solution limit join in appeal sodium alginate cross-linking solution with the speed of 10 ml/min) with the speed of 10 ml/min and obtain combination solution, continue to stir combination solution 30 minutes with this understanding, sampling, detect and regulate combination solution osmotic pressure with polyphosphate, until combination solution osmotic pressure is between 280mOsm/L ~ 320mOsm/L.
By the above-mentioned combination solution prepared by the filter element of 0.45um and 0.22um carry out filtering and impurity removing degerming after, in temperature higher than 115 DEG C, carry out moist heat sterilization under the condition of F0 >=8 and namely obtain surgical flush fluid of the present invention.
In embodiment of the present invention 1-3, using carboxyl chitosan a kind ofly has biological activity and the water soluble amino polysaccharide of range of viscosities between 10mpas ~ 80mpas, can promote that burning soup hinders wound healing, there is antiinflammatory exudation effect, in surgical flush fluid, play wound surface reparation, antiinflammatory exudation function.
In embodiment of the present invention 1-3, sodium alginate provides the hemostatic function of surgical flush fluid of the present invention, but also has promotion wound healing effect.
[table]
The formula of embodiment of the present invention 1-3
By the surgical flush fluid prepared in embodiment of the present invention 1-3, (Jiangsu Qi Likang skin pharmaceutcal corporation, Ltd produces with normal saline, wound haemostatic membrane, lot number 11122302,15ml/ bottle) together for the hemostasis irrigation tests of rabbit surface wound Hemorrhage Model, the equal retest of all tests 10 times, haemostatic effect statistical result is as table two.Table two is the surface wound haemostatic effect contrast table of the made surgical flush fluid of embodiment of the present invention 1-3 and normal saline and wound haemostatic membrane, known by this table, haemostatic effect and the wound haemostatic membrane of surgical flush fluid of the present invention are more or less the same, and all exceed about 1 times than the anthemorrhagic performance of normal saline.
Namely the surgical flush fluid prepared by special process of the present invention can realize the compatible of each component, maintains again the original function of each component, one can be provided both to have hemostatic function, can promote wound healing again, the surgical flush fluid of antiinflammatory, exudation.
[table two]
The surface wound haemostatic effect contrast table of the made surgical flush fluid of embodiment of the present invention 1-3 and normal saline and wound haemostatic membrane
| Group | Testing time | The average bleeding time (second) |
| Embodiment 1 | 10 | 85.72±15.16 |
| Embodiment 2 | 10 | 86.25±15.16 |
| Embodiment 3 | 10 | 85.36±15.16 |
| Normal saline | 10 | 161.00±44.62 |
| Wound haemostatic membrane | 10 | 85.00±29.14 |
In sum, the present invention this with using carboxyl chitosan and sodium alginate for active component, the surgical flush fluid formed for ion mediation agent and osmotic pressure regulator with polyphosphate both had hemostatic function, can promote wound healing again, antiinflammatory, exudation.Namely surgical flush fluid of the present invention can realize the compatible of each component, maintains again the original function of each component.Preparation, the preparation of sodium alginate cross-linking solution, using carboxyl chitosan crosslinker solution and sodium alginate cross-linking solution composite and adjusting comprising using carboxyl chitosan crosslinker solution of the present invention is oozed, the method for making of filtration sterilization four step can provide described surgical flush fluid.
The foregoing is only preferred embodiment of the present invention, be not intended to limit protection scope of the present invention.All any amendments done within the spirit and principles in the present invention, equivalent replacement, improvement etc., be all included in protection scope of the present invention.
Claims (3)
1. a surgical flush fluid, it is characterized in that described surgical flush fluid with using carboxyl chitosan and sodium alginate for active component, take polyphosphate as ion mediation agent and osmotic pressure regulator, and its composition quality formula is as follows:
2. surgical flush fluid as claimed in claim 1, is characterized in that described polyphosphate is sodium salt, potassium salt or ammonium salt, or their combination.
3., as the preparation method of any one surgical flush fluid in claim 1-2, it is characterized in that this preparation method comprises:
(1) load weighted using carboxyl chitosan is put into purified water to dissolve, then temperature of liquid is controlled, between 50 DEG C ~ 80 DEG C, add polyphosphate and stir, make polyphosphate dissolve also mix homogeneously and obtain using carboxyl chitosan crosslinker solution, for subsequent use;
(2) load weighted sodium alginate is put into purified water to dissolve, then temperature of liquid is controlled, between 50 DEG C ~ 80 DEG C, add polyphosphate and stir, make polyphosphate dissolve also mix homogeneously and obtain sodium alginate cross-linking solution, for subsequent use;
(3) at the temperature of 50 DEG C ~ 80 DEG C, any one limit in above-mentioned using carboxyl chitosan crosslinker solution and sodium alginate cross-linking solution is stirred in the another kind that limit to join with the speed being no more than 50 ml/min in using carboxyl chitosan crosslinker solution and sodium alginate cross-linking solution with the speed being not less than 50 revs/min and obtains combination solution, continue to stir combination solution more than 30 minutes with this understanding, then combination solution osmotic pressure is regulated, until combination solution osmotic pressure is between 280mOsm/L ~ 320mOsm/L with polyphosphate;
By the combination solution prepared in (3) by filter element carry out filtering and impurity removing degerming after, in temperature higher than 115 DEG C, carry out moist heat sterilization under the condition of F0 >=8 and namely obtain surgical flush fluid of the present invention.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108653825A (en) * | 2018-06-09 | 2018-10-16 | 江苏海尔滋生物科技有限公司 | Cutting lavation fluid film and preparation method thereof |
| CN110882412A (en) * | 2019-12-10 | 2020-03-17 | 杨鑫 | Antibacterial and anti-inflammatory medical gel and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103930133A (en) * | 2011-11-13 | 2014-07-16 | 桑那瑞斯公司 | In-situ cross-linkable polymeric compositions and methods thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103930133A (en) * | 2011-11-13 | 2014-07-16 | 桑那瑞斯公司 | In-situ cross-linkable polymeric compositions and methods thereof |
Non-Patent Citations (1)
| Title |
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| 石凉等: "壳聚糖止血材料及最新研究进展", 《蚕业科学》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108653825A (en) * | 2018-06-09 | 2018-10-16 | 江苏海尔滋生物科技有限公司 | Cutting lavation fluid film and preparation method thereof |
| CN110882412A (en) * | 2019-12-10 | 2020-03-17 | 杨鑫 | Antibacterial and anti-inflammatory medical gel and preparation method thereof |
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Denomination of invention: Operation flushing fluid and preparation method of operation flushing fluid Effective date of registration: 20191212 Granted publication date: 20190315 Pledgee: Bank of Guiyang, Limited by Share Ltd directly under the sub branch Pledgor: Guizhou Yangsheng Medical Instrument Co., Ltd. Registration number: Y2019520000014 |