CN100387238C - Medical hemostasis anti-adhesive irrigation solution - Google Patents
Medical hemostasis anti-adhesive irrigation solution Download PDFInfo
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- CN100387238C CN100387238C CNB200610040441XA CN200610040441A CN100387238C CN 100387238 C CN100387238 C CN 100387238C CN B200610040441X A CNB200610040441X A CN B200610040441XA CN 200610040441 A CN200610040441 A CN 200610040441A CN 100387238 C CN100387238 C CN 100387238C
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The present invention discloses a medical hemostasis adhesive prevention irrigation solution used in a preoperative period, which belongs to a high polymer biologic material with the functions of hemostasis, antibiosis and adhesive prevention for a surgery preoperative period. The present invention has the preventive function of preventing implantation metastasis caused by tumor cells of films scattered in human body cavities in vivo in tumor operation in a tumor surgical operation aspect. The present invention uses injection water as a carrier, and uses non-water-soluble chitosan or water-soluble chitosan or carboxymethyl chitosan as major raw materials, and then, substance used for regulating osmotic pressure, such as NaCl or mannitol or glycine are used as auxiliary materials matched with the major raw materials to prepare the medical hemostasis adhesive prevention irrigation solution. The present invention has nontoxicity, no irritability and no hypersusceptibility on human bodies, and has high biodegradability and good effects on the hemostasis, the antibiosis and the adhesive prevention.
Description
Technical field
The present invention relates to a kind of surgery and enclose surgical flush fluid, particularly a kind of surgery encloses that operation uses can stop blooding, antibiotic, a kind of polymeric biomaterial flushing liquor of preventing the postoperative tissue adhesion.
Background technology
Run through and all adopt flushing liquor flushing open operation wound in the various operations of surgery.The flushing liquor of present clinical use is traditional normal saline, and conventional normal saline can not be effectively antibiotic, hemostasis, the prevention tissue adhesion, promotes wound healing, can not suppress the implantation metastasis that occurs because of the tumor cell adhesion that is scattered in the operation.
Summary of the invention
The purpose of this invention is to provide a kind of surgery and enclose the hemostasis anti-adhesive irrigation solution that operation is used, can reduce postoperative tissue adhesion, have hemostasis, antibiotic, promotion wound healing, thereby reduce antibiotic use amount, suppress the growth of tumor cell, prevent the implantation metastasis of cancerous cell on the cavity inner membrance.
The present invention realizes with following technical scheme: a kind of medical hemostasis anti-adhesive irrigation solution, it is characterized in that with water for injection being carrier, the chitosan or the carboxymethyl chitosan that contain hemostatic and antibacterial, anti effect in the flushing liquor, content range is at 0.1%-0.8%, contain and regulate osmotic pressure electrolyte sodium chloride 0.6%-0.9%, all the other are water for injection.
Described chitosan is water solublity or water-insoluble chitosan or carboxymethyl chitosan.
The material of described conciliation osmotic pressure also can be mannitol or glycine, and its content scope of application is: mannitol is 3.0%-5.0%, and glycine is 1.0%-2.0%.
By dissolving blended method, it is prepared into the water white colloidal sol shape liquid that a kind of grade is oozed sterilization, have antibiotic, stop blooding, promote wound healing, prevent the postoperative tissue adhesion, suppress the effect that tumor cell shifts, be the polymeric biomaterial flushing liquor of a new generation.
Medical hemostasis anti-adhesive of the present invention towards the mechanism of action of liquid is:
1. anastalsis: sloughed the positive charge that exposes on N-acetyl group, the amino in the chitosan molecule; can adsorb the negative charge that erythrocyte itself had and make its coagulation; the water soluble colloid of chitosan is in the body local wound simultaneously; the linear fiber albumen that utilization itself has is crisscross; during effectively the hemocyte net being knitted; make to have formed normal fibrin blood clot, under positive charge and linear fiber albumen dual function, play good haemostatic effect.
2. antibacterial action: because the positive charge effect in the chitosan molecule, disturbed the metabolism of bacterial cell outer wall, effect by coulomb absorption with bacterial adherence together, stop diffusion, and resisted bacterial growth, the polymeric membrane of chitosan solution formation has simultaneously stoped nutrient substance to transmit in antibacterial, plays good antibacterial effect under this dual function.
3. promote the wound healing effect: promote wound healing active function power to be the concentration height of Fructus Vitis viniferae amine, because glucamine is the main component on the chitosan molecule chain, and its hemostasis, pain relieving, antibacterial action, these effects all have positive effect for wound healing.
4. anti effect: because chitosan has hemostasis and biological barrier effect, can promote epithelial cell and vascular endothelial cell growth, can be suppressed to fibroblast growth by selectivity, thereby reduced the collagen fiber source, reach prevention and alleviate the purpose of adhesion, under the situation that does not influence the normal structure healing, prevent the tissue adhesion effectively.
5. because the chitosan molecule surface has positive charge, and the cancerous cell surface has negative charge, both are by the adsorption of coulomb, cancerous cell is adsorbed in the chitosan surface, prevents diffusion and the growth of anticancer, the homergy of interfere with cancer cells, thus kill cancerous cell.With the sodium chloride brine in this product cancerous cell is had swelling action, thus destruction of cancer cells, and then reach and prevent cancerous cell mucosa implantation metastasis in body cavity.
The preparation method of above-mentioned flushing liquor is:
(A) non-soluble chitosan is dissolved in (water for injection 100ml adds the 1ml glacial acetic acid) in the dilute acetic acid solution, fully swelling until dissolve fully solution (1) or directly be dissolved in water-soluble chitosan or carboxymethyl chitosan in the water for injection, get solution (1), standby;
(B) substance dissolves that will reconcile osmotic pressure in water for injection solution (2), standby;
(C) with the activated carbon of solution (1) and solution (2) mixing back adding 0.01%, heated and boiled adds water for injection to capacity after about 30 minutes;
(D) solution with step (C) gained gets finished product after disinfection with high pressure steam behind sucking filtration, fine straining, the sterile filling is sterilized.
The physical and chemical index of products obtained therefrom meets the requirement of the Pharmacopoeia of the People's Republic of China about flushing liquor.
Concrete test result is:
1, outward appearance is a colourless transparent liquid;
2, light transmittance 〉=95%;
3, pH value 5.5-6.5;
4, dynamic viscosity 〉=100mpas;
5, bacterial endotoxin (every milliliter)≤0.5EU;
6, content of beary metal is (with P
bCalculate)≤0.001%.
The following biological property index of this product all meets the regulation of product standard.
1, acute general toxicity test, actual nontoxic level
2, cell toxicity test should be not more than 1 grade
3, sensitization experiment, no sensitivity response
4, Intradermal irritation test, the nonirritant reaction
5, short term subcutaneous Implantation Test, no lump and do not have inflammatory reaction
6, eye irritant test, the nonirritant reaction
7, Ames experiment, feminine gender
8, the hemolysis rate test≤8%
The invention has the beneficial effects as follows: the hemostasis of enclosing operation that produces by above-mentioned preparation technology and method, antibiotic, prevent tissue adhesion's flushing liquor, be to the human body avirulence, nonirritant, no sensitivity response and have pain relieving, antibiotic, hemostasis, promote the wound surface quickly-healing, prevent the postoperative tissue adhesion, significantly reduced the infection that operation causes, the tissue adhesion, significantly reduced antibiotic use amount, reduced the misery that the tissue adhesion brought that the patient causes because of operation, in clinical use, be specially adapted to the hemostasis of peri-operation period, antibiotic, prevent the antibiotic flushing of tissue adhesion and mobility's wound, be used to wash open wound or cavity.Owing to, be specially adapted to the prevention tissue adhesion's of various surgical operation peri-operation periods flushing to non-stimulated, the no sensitization of human body.As:
1, antibacterial anti hemorrhagic prevents the postoperative tissue adhesion.Be used for postoperative irrigation such as abdominal operation postoperative such as intestinal adhesion, intestinal perforation operation.
2, be used for gynecological's postoperative irrigation and fallopian tube recanalization surgery washing.
3, be used for the flushing of bone surgery postoperative, as: the postoperative irrigation of operation such as osteoarthrosis chamber and microsurgery, thus the tissue adhesion of osteoarthrosis, tendon prevented.
4, the postoperative anti flushing of Urology Surgery, as: the postoperative irrigation of bladder, operation on prostate.、
5, ophthalmologic operation: if any the anti flushing of ophthalmologic operation postoperative.
6, Department of B urn: be used for the flushing of burn wound, prevent adhesion, the infection of wound tissue, promote the quickly-healing of wound surface.
7, the postoperative irrigation of surgical oncology operation, one side promotes the wound healing of damaged tissue, prevents the tissue adhesion, the cancerous cell implantation metastasis of being scattered in preventing from the other hand to perform the operation.
8, other surgical operation: wash as surgical operation post-operation adhesion preventings such as neurosurgery.
9, the wound surface of the open wound that causes of mobility's wound or tract flushing.
10, the ulcer wound surface flushing that causes of bedsore wound and diabetes promotes the healing of wound surface.
The specific embodiment
Be described in further detail the present invention below in conjunction with embodiment.
Example 1:
Raw material: water-insoluble chitosan 0.5%
Sodium chloride 0.75%
Water for injection 98.75%
Preparation method:
1, water-insoluble chitosan is dissolved in the dilute acetic acid solution (every 100ml water for injection adds the glacial acetic acid of 1ml) solution (1), standby;
2, sodium chloride is dissolved in the water for injection, makes solution (2);
3, above-mentioned two kinds of solution are mixed the activated carbon of back adding 0.1%, heated and boiled 30 minutes adds water for injection again to capacity;
4, with above-mentioned prepared solution process sucking filtration, fine straining, sterile filling,, obtain finished product in 115 ℃ of high-pressure steam sterilizations sterilizations 30 minutes.
Example 2:
Raw material: water-soluble chitosan 0.5%
Sodium chloride 0.75%
Water for injection 98.75%
Preparation method:
1, water-soluble chitosan is dissolved in the water for injection, gets solution (1), standby;
2, sodium chloride is dissolved in the water for injection, makes solution (2);
3, above-mentioned two kinds of solution are mixed the activated carbon of back adding 0.1%, heated and boiled 30 minutes adds water for injection again to capacity;
4, with above-mentioned prepared solution process sucking filtration, fine straining, sterile filling, the high-pressure steam sterilization sterilization is 30 minutes under 115 ℃ of temperature, obtains finished product.
Embodiment 3:
Raw material: carboxymethyl chitosan 0.5%
Sodium chloride 0.75%
Water for injection 98.75%
Preparation method:
1, carboxymethyl chitosan is dissolved in the water for injection, gets solution (1), standby;
2, sodium chloride is dissolved in the water for injection, makes solution (2);
3, above-mentioned two kinds of solution are mixed the activated carbon of back adding 0.1%, heated and boiled 30 minutes adds water for injection again to capacity;
4, with above-mentioned prepared solution process sucking filtration, fine straining, sterile filling, the high-pressure steam sterilization sterilization is 30 minutes under 115 ℃ of temperature, obtains finished product.
Embodiment 4:
Raw material: water-insoluble chitosan 0.5%
Mannitol 4%
Water for injection 95.7%
Preparation method:
1, water-insoluble chitosan is dissolved in the dilute acetic acid solution (every 100ml water for injection adds the glacial acetic acid of 1ml) solution (1), standby;
2, mannitol is dissolved in the water for injection, makes solution (2);
3, above-mentioned two kinds of solution are mixed the activated carbon of back adding 0.1%, heated and boiled 30 minutes adds water for injection again to capacity;
4, with above-mentioned prepared solution process sucking filtration, fine straining, sterile filling, the high-pressure steam sterilization sterilization is 30 minutes under 115 ℃ of temperature, obtains finished product.
Embodiment 5:
Raw material: water-soluble chitosan 0.5%
Mannitol 4%
Water for injection 95.7%
Preparation method:
1, water-soluble chitosan is dissolved in the water for injection solution (1), standby;
2, mannitol is dissolved in the water for injection, makes solution (2);
3, above-mentioned two kinds of solution are mixed the activated carbon of back adding 0.1%, heated and boiled 30 minutes adds water for injection again to capacity;
4, with above-mentioned prepared solution process sucking filtration, fine straining, sterile filling, the high-pressure steam sterilization sterilization is 30 minutes under 115 ℃ of temperature, obtains finished product.
Embodiment 6:
Raw material: carboxymethyl chitosan 0.5%
Mannitol 4%
Water for injection 95.7%
Preparation method:
1, carboxymethyl chitosan is dissolved in the water for injection solution (1), standby;
2, mannitol is dissolved in the water for injection, makes solution (2);
3, above-mentioned two kinds of solution are mixed the activated carbon of back adding 0.1%, heated and boiled 30 minutes adds water for injection again to capacity;
4, with above-mentioned prepared solution process sucking filtration, fine straining, sterile filling, the high-pressure steam sterilization sterilization is 30 minutes under 115 ℃ of temperature, obtains finished product.
Embodiment 7:
Raw material: water-insoluble chitosan 0.5%
Glycine 1.5%
Water for injection 98%
Preparation method:
1, water-insoluble chitosan is dissolved in the dilute acetic acid solution (every 100ml water for injection adds the glacial acetic acid of 1ml) solution (1), standby;
2, glycine is dissolved in the water for injection, makes solution (2);
3, above-mentioned two kinds of solution are mixed the activated carbon of back adding 0.1%, heated and boiled 30 minutes adds water for injection again to capacity;
4, with above-mentioned prepared solution process sucking filtration, fine straining, sterile filling, the high-pressure steam sterilization sterilization is 30 minutes under 115 ℃ of temperature, obtains finished product.
Embodiment 8:
Raw material: water-soluble chitosan 0.5%
Glycine 1.5%
Water for injection 98%
Preparation method:
1, water-soluble chitosan is dissolved in the water for injection solution (1), standby;
2, glycine is dissolved in the water for injection, makes solution (2);
3, above-mentioned two kinds of solution are mixed the activated carbon of back adding 0.1%, heated and boiled 30 minutes adds water for injection again to capacity;
4, with above-mentioned prepared solution process sucking filtration, fine straining, sterile filling, the high-pressure steam sterilization sterilization is 30 minutes under 115 ℃ of temperature, obtains finished product.
Embodiment 9:
Raw material: carboxymethyl chitosan 0.5%
Glycine 1.5%
Water for injection 98%
Preparation method:
1, carboxymethyl chitosan is dissolved in the water for injection solution (1), standby;
2, glycine is dissolved in the water for injection, makes solution (2);
3, above-mentioned two kinds of solution are mixed the activated carbon of back adding 0.1%, heated and boiled 30 minutes adds water for injection again to capacity;
4, with above-mentioned prepared solution process sucking filtration, fine straining, sterile filling, the high-pressure steam sterilization sterilization is 30 minutes under 115 ℃ of temperature, obtains finished product.
Above-mentioned 9 embodiment products obtained therefroms, its physical and chemical index all meets the requirement of the Pharmacopoeia of the People's Republic of China about flushing liquor after testing.The biological property index all meets the regulation of product standard.
Claims (2)
1. a surgery encloses the medical hemostasis anti-adhesive irrigation solution that operation is used, it is characterized in that it be with the chitosan and the material of reconciling osmotic pressure be material dissolution in water for injection, make etc. ooze the polymeric biomaterial flushing liquor of sterilization, its chitosan is water-insoluble or water solublity, and the material of regulating osmotic pressure is sodium chloride or mannitol or glycine; The content percentage by weight of each component is:
Chitosan: 0.1-0.8%
Regulate the material of osmotic pressure: sodium chloride 0.6-0.9%
Or mannitol 3.0-5.0%
Or glycine 1.0-2.0%
Water for injection: surplus.
2. the preparation method of the described medical hemostasis anti-adhesive irrigation solution of claim 1 is characterized in that, specifically comprises the steps:
(A) non-water-soluble chitosan is dissolved in rare glacial acetic acid solution, its ratio is to add the 1ml glacial acetic acid in the 100ml water for injection, fully soaks swelling, until dissolving fully, obtain solution 1., or directly be dissolved in water-soluble chitosan in the water for injection, obtain solution 1., standby;
(B) will regulate the material sodium chloride of osmotic pressure or mannitol or glycine directly be dissolved in the water for injection solution 2., standby;
(C) 2. 1. solution being mixed the back with solution adds 0.1% activated carbon heated and boiled and adds water for injection after 30 minutes to capacity;
(D) solution with step (C) gained gets finished product behind sterilization under the high steam behind sucking filtration, fine straining, the sterile filling.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB200610040441XA CN100387238C (en) | 2006-05-12 | 2006-05-12 | Medical hemostasis anti-adhesive irrigation solution |
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|---|---|---|---|
| CNB200610040441XA CN100387238C (en) | 2006-05-12 | 2006-05-12 | Medical hemostasis anti-adhesive irrigation solution |
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| CN1850108A CN1850108A (en) | 2006-10-25 |
| CN100387238C true CN100387238C (en) | 2008-05-14 |
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| CN101961505A (en) * | 2010-09-28 | 2011-02-02 | 北京纺织科学研究所 | Methods for preparing medical anti-adhesion hemostatic material and medical anti-adhesion hemostatic washing fluid |
| CN102755663A (en) * | 2012-07-31 | 2012-10-31 | 贵州扬生医用器材有限公司 | Formula of medical biocolloid solution and preparation method thereof |
| CN103041441A (en) * | 2012-08-02 | 2013-04-17 | 贵州扬生医用器材有限公司 | Application method of medical biocolloid liquid |
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| CN105147721A (en) * | 2015-08-28 | 2015-12-16 | 施康培医疗科技（武汉）有限公司 | Antibacterial cleaning agent and application method thereof |
| CN105326786A (en) * | 2015-11-09 | 2016-02-17 | 合肥九研医药科技开发有限公司 | Nasal irrigant composition and preparation method thereof |
| 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 |
| CN108744026A (en) * | 2018-06-09 | 2018-11-06 | 江苏海尔滋生物科技有限公司 | Instant-matching type chitin polysaccharide frozen dried powder |
| CN109394678A (en) * | 2018-10-15 | 2019-03-01 | 安徽徽科生物工程技术有限公司 | Tissue irrigating solutions and its application in the medical field |
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| US20040127461A1 (en) * | 2000-04-21 | 2004-07-01 | Adjuvant Pharmaceuticals, Llc | Water soluble, randomly substituted partial N-, partial O-acetylated chitosan, preserving compositions containing chitosan, and processes for making thereof |
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