CN108653825A - Cutting lavation fluid film and preparation method thereof - Google Patents

Cutting lavation fluid film and preparation method thereof Download PDF

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Publication number
CN108653825A
CN108653825A CN201810590531.9A CN201810590531A CN108653825A CN 108653825 A CN108653825 A CN 108653825A CN 201810590531 A CN201810590531 A CN 201810590531A CN 108653825 A CN108653825 A CN 108653825A
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CN
China
Prior art keywords
injection
water
cutting
wound
solution
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201810590531.9A
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Chinese (zh)
Inventor
胡军
胡静雯
胡梦
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Jiangsu Haierzi Biotechnology Co Ltd
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Jiangsu Haierzi Biotechnology Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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Application filed by Jiangsu Haierzi Biotechnology Co Ltd filed Critical Jiangsu Haierzi Biotechnology Co Ltd
Priority to CN201810590531.9A priority Critical patent/CN108653825A/en
Publication of CN108653825A publication Critical patent/CN108653825A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • A61L31/042Polysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • A61L31/043Proteins; Polypeptides; Degradation products thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/04Materials for stopping bleeding

Abstract

The invention discloses a kind of cutting lavation fluid films with broad-spectrum antiseptic and anastalsis, by following raw material and its mass percentage composition:Sodium alginate 0.1~6.0%, mould 50 100ppm of FE biologies, glycine 0.1%~5% add water for injection or purified water to enough.Present invention is mainly used for fit through urethra, bladder progress prostate vaporization resectoscope, gynemetrics's Resection hysteroscope carries out the cleaning of the electrocision surface of a wound and rinses, it keeps surgical field of view clear and is rinsed suitable for the skin and mucosas damage superficial surface of a wound debridement such as radioactivity, acute injury and surgical cut wound, form isolating and protecting.Exudation is reduced with hemostasis.

Description

Cutting lavation fluid film and preparation method thereof
Technical field
The present invention relates to cutting lavation fluid films and preparation method thereof, belong to medical instrument dressing and biological medicine class neck Domain.
Background technology
Hyperplasia of prostate is elderly men disease, with the continuous improvement of the extension living standard of average human life, The incidence of benign prostatic hyperplasis is also increasing rapidly, has seriously affected daily life and the physical and mental health of gerontal patient. Transurethral resection of prostate operation is the satisfied operation method of current treatment hyperplasia of prostate.Transurethral prostatic electroresection A It is Minimally Invasive Surgery, few intercurrent disease small with wound compared with extracing open surgery with traditional hyperplasia of prostate, and technology is grasped Make the features such as simple;Small for the surgical risk of high-risk gerontal patient, postoperative surgical complication significantly reduces;Improve trouble The postoperative life quality of person;The operation of urethra resection of prostate is the Minimally Invasive Surgery newly carried out in recent years.
The operation of urethra resection of prostate is generally carried out, and various hysteroscopes used in art, surgical instrument use are to electric conductivity There is strict demand, standby to ensure safety and patient comfort in surgical procedure, while also to keep surgical field of view clear.It is especially right Prostate vaporization resectoscope is carried out in urethra, bladder, is rushed for the surface of a wound cleaning when gynemetrics's Resection hysteroscope carries out electrocision It washes, keeps surgical field of view clearly particularly necessary.For requiring washing wound surface liquid both to require debridement effect, keep visual area clear Again have hemostasis, reduce exudation and it is postoperative its surface of a wound formed isolation protection film promote wound healing.Simultaneously for etc. Conductivity is required to want low in safe range using flushing liquor in ion and non-plasma vaporization electric excision mirror surgical procedure.Face at present It is raw although the isotonic physiological saline that bed uses can play cleaning action but not have anti-inflammatory, hemostasis and wound healing Reason brine is conductive ion solution, for that can not be used in non-plasma vaporization electric excision mirror surgical procedure, and clinic is made It is easy to form knot in the surface of a wound although mannitol is used for non-conductive but mannitol in non-plasma vaporization electric excision mirror surgical procedure Crystalline substance, influences that visual area is clear, which does not have anti-inflammatory, hemostasis and wound healing yet, easily causes postoperative hemorrhage, sense Dye and adhesion and it is not easy healing complications.
Therefore, invention is a kind of solves clinically particularly to need about flushing liquor deficiency in vaporization electric excision mirror operation at present.It is right Shorten operating time, improves surgical effect and be of great significance.
Invention content
In order to overcome the above-mentioned deficiencies of the prior art, present invention is mainly used for fit through urethra, bladder progress prostate Vaporization electric excision mirror, gynemetrics's Resection hysteroscope carry out the cleaning of the electrocision surface of a wound and rinse, keep surgical field of view clear and be suitable for The skin and mucosas damage superficial surface of a wound debridement such as radioactivity, acute injury and surgical cut wound is rinsed, and isolating and protecting is formed.With only Blood reduces exudation.To shortening operating time, improves surgical effect and be of great significance.
Invention cutting irrigating solution FE biologies are mould to be had bactericidal effect and penetrates bacterial membrane;Bacterial membrane is generally bacterial secretory Object polysaccharide and calcareous organic salt long time sedimentation and cavity mucous membrane surface, general antibiotic medicine is difficult to penetrate;FE biologies are mould can It penetrates bacterial membrane and kills bacterium and virus.Especially to treatment prostatitis is with obvious effects and uterine neck and urethral wall because bacterial membrane every From function influence therapeutic effect.
The present invention is achieved through the following technical solutions, a kind of cutting lavation fluid film, each component and its mass fraction For:
Sodium alginate 0.1%~6.0%;
The mould 50ppm-100ppm of FE biologies;
Glycine 0.1%~5%;
Add water for injection or purified water to enough.
As cutting lavation fluid film of the present invention, the sodium alginate is water soluble algae acid sodium.
The alginate with haemostatic effect, with anti-radiation line and ionising radiation effect, with good filming, Isolation protection film is formed in human skin mucous membrane surface.
The FE biologies are mould to be had bactericidal effect and penetrates bacterial membrane;Bacterial membrane is generally bacterial secretory object polysaccharide and calcium Matter organic salt long time sedimentation and cavity mucous membrane surface, general drug is difficult to penetrate;The mould bacterial membrane that can penetrate of FE biologies is killed carefully Bacterium and virus.
The glycine is as adjusting osmotic pressure substance;On the one hand have antibiotic property, on the other hand the product requirement not Conductive, glycine does not have ionic compound property, and adjusting osmotic pressure using it solves the product without electric conductivity.
The preparation method of cutting lavation fluid film, it is characterised in that:It is characterized in that:It is prepared as follows:
Step 1)Sodium alginate is dissolved in water for injection or purified water, obtains solution 1., spare;
Step 2)Glycine is dissolved in after being sufficiently stirred dissolving in water for injection or purified water, adds FE biologies and mould be sufficiently stirred It is uniformly dissolved rear obtained solution 2., it is spare;
Step 3)It is sufficiently stirred 1. 2. solution is mixed with solution after, phosphate buffer solution is added dropwise and adjusts PH to 4.5-7.5, boils After 30 minutes, water for injection is added to enough;
Step 4)By step 3)The liquid bulk film of gained obtains finished product after suction filtration, refined filtration, sterile filling.
The present invention ensures safety and patient comfort in surgical procedure, keeps surgical field of view clear;Solve washing wound surface liquid tool Have debridement effect simultaneously, and with hemostasis, reduce exudation and it is postoperative its surface of a wound formed isolation protection film promote wound repair be cured It closes;Use flushing liquor that conductivity is required to want low in safety simultaneously in plasma and non-plasma vaporization electric excision mirror surgical procedure In range.Although overcoming the isotonic physiological saline for solving current Clinical practice that can play cleaning action but not having anti-inflammatory, stop Blood and wound healing, but physiological saline be conductive ion solution, in non-plasma vaporization electric excision mirror surgical procedure not Technically deficiency can be used, although also solving to perform the operation for the mannitol of Clinical practice for non-plasma vaporization electric excision mirror Non-conductive but mannitol is easy to be formed in the surface of a wound and crystallize in journey, and it is clear to influence visual area, which does not have anti-inflammatory, hemostasis yet And wound healing, it easily causes postoperative hemorrhage, infection and adhesion and to be not easy healing complications technically insufficient.
The mechanism of action of the present invention is as follows:
1, antibacterial action
1.1, physical biological barrier:Antibacterial sodium alginate is high-molecular compound, and there is certain viscosity easily to form biomembrane, A kind of biological glued membrane is formed in skin and mucous membrane rapidly, skin and mucosa is made to be isolated to prevent pathogenic bacteria from growing with extraneous bacterium, Play physical biological barrier anti-infectious function.
1.2 penetrate bacterial membrane:FE biologies are mould to be had bactericidal effect and penetrates bacterial membrane.Bacterial membrane is generally bacterial secretory Object polysaccharide and calcareous organic salt long time sedimentation and cavity mucous membrane surface, general drug is difficult to penetrate.FE biologies are mould can be penetrated carefully Mycoderm kills bacterium and virus.
1.3 ionic surface active agents act on:Sodium alginate, which is high-molecular compound, has ionic surface active agent property pole It easily forms micelle to bear since electrostatic attraction acts on higher, a pile positive charge can be attracted around micelle, some is positive and negative It cancels out each other, but still forms high positive charge group around micelle.Since bacterial micro-organism passes through coulomb masterpiece with negative electrical charge Bacteria wall is wrapped up with bacterial adsorption around micelle, to be formed to a kind of biomembrane.Bacterial cell ectendotrophy substance is blocked to turn Fortune.The eubolism for interfering bacterium, to inhibit bacterial growth.
2, anastalsis:Sodium alginate molecule is a kind of measurements of the chest, waist and hips helicoidal structure high-molecular compound.It can be by erythrocyte Simultaneously wherein, the water soluble colloid of sodium alginate is in body local wound, the threadiness having using itself for network with platelet aggregation Fibrin is crisscross, during capable of effectively knitting haemocyte net, makes to form normal fibrin blood clot, in threadiness Good haemostatic effect is played under fibrin double action.
3. non-conductive:Glycine is as adjusting osmotic pressure substance;On the one hand there is antibiotic property, on the other hand the product is wanted Ask do not have electric conductivity, glycine do not have ionic compound property, using its adjust osmotic pressure solve the product do not have lead Electrically.
The physical and chemical index of products obtained therefrom is:
1, appearance is light yellow clear liquid
2, light transmittance >=95%
3, pH value 4.5-7.5
4, dynamic viscosity >=3mpas
5, conductivity is not more than 10us/cm
6, osmotic pressure is isotonic
7, bacterial endotoxin≤0.5Eu/ml
8, content of beary metal≤0.001%
The bio-safety performance index of this product:
1, acute systemic toxicity, result are:Practical nontoxic grade
2, cell toxicity test, result are:1 grade
3, priming experiments without
4, intradermal irritation test without
5, vaginal mucosa irritation test is negative.
Above-mentioned biological property index is detected by specified inspection body of country, standard compliant relevant regulations.
The beneficial effects of the invention are as follows:It is produced by above-mentioned preparation process and method a kind of with broad-spectrum antibacterial action Cutting lavation fluid film, be suitable for radioactivity, acute injury and surgical cut wound etc. skin and mucosas damage superficial surface of a wound debridement It rinses, forms isolating and protecting.Exudation is reduced with hemostasis.It is mainly used for fitting through urethra, bladder progress prostate vaporization electricity Mirror is cut, gynemetrics's Resection hysteroscope carries out the cleaning of the electrocision surface of a wound and rinses, and keeps surgical field of view clear.Non-toxic to human body, It is nonirritant, without sensitivity response and with anti-inflammatory analgetic, antibacterial, hemostasis, promote the surface of a wound quickly heal, fill up technical field one Blank not will produce drug resistance.
Specific implementation mode
The present invention is described in further detail with reference to example.It will be apparent to those skilled in the art that embodiment is to explain The claimed content of the present invention, is not construed as the specific restriction to protection domain.
Embodiment 1
Cutting lavation fluid film, each raw material composition and its mass percent are:
Sodium alginate 0.2%
The mould 50ppm-100ppm of FE biologies
Glycine 1.5%
Add water for injection 98.3%
The preparation method of the cutting lavation fluid film, is prepared as follows:
Step 1)Sodium alginate is dissolved in water for injection, obtains solution 1., spare;
Step 2)Glycine is dissolved in after being sufficiently stirred dissolving in water for injection, adds biological mould are sufficiently stirred of FE and be uniformly dissolved Obtained solution is 2., spare afterwards;
Step 3)It is sufficiently stirred 1. 2. solution is mixed with solution after, phosphate buffer solution is added dropwise and adjusts PH to 4.5, boils 30 points Water for injection is added to enough in Zhong Hou;
Step 4)By step 3)The liquid bulk film of gained obtains finished product after suction filtration, refined filtration, sterile filling.
Embodiment 2
Cutting lavation fluid film, each raw material composition and its mass percent are:
Sodium alginate 0.5%
The mould 50ppm-100ppm of FE biologies
Glycine 2.0%
Add water for injection 97.5%
The preparation method of the cutting lavation fluid film, is prepared as follows:
Step 1)Sodium alginate is dissolved in water for injection, obtains solution 1., spare;
Step 2)Glycine is dissolved in after being sufficiently stirred dissolving in water for injection, adds biological mould are sufficiently stirred of FE and be uniformly dissolved Obtained solution is 2., spare afterwards;
Step 3)It is sufficiently stirred 1. 2. solution is mixed with solution after, phosphate buffer solution is added dropwise and adjusts PH to 6.0, boils 30 points Water for injection is added to enough in Zhong Hou;
Step 4)By step 3)The liquid bulk film of gained obtains finished product after suction filtration, refined filtration, sterile filling.
Embodiment 3
Cutting lavation fluid film, each raw material composition and its mass percent are:
Sodium alginate 1.0%;
The mould 50ppm-100ppm of FE biologies;
Glycine 3.0%;
Add water for injection 96%;
The preparation method of the cutting lavation fluid film, is prepared as follows:
Step 1)Sodium alginate is dissolved in water for injection, obtains solution 1., spare;
Step 2)Glycine is dissolved in after being sufficiently stirred dissolving in water for injection, adds biological mould are sufficiently stirred of FE and be uniformly dissolved Obtained solution is 2., spare afterwards;
Step 3)It is sufficiently stirred 1. 2. solution is mixed with solution after, phosphate buffer solution is added dropwise and adjusts PH to 7.5, boils 30 points Water for injection is added to enough in Zhong Hou;
Step 4)By step 3)The liquid bulk film of gained obtains finished product after suction filtration, refined filtration, sterile filling.

Claims (2)

1. a kind of cutting lavation fluid film, it is characterised in that:Each component and its mass fraction are:
Sodium alginate 0.1%~6.0%;
The mould 50ppm-100ppm of FE biologies;
Glycine 0.1%~5%;
Add water for injection or purified water to enough.
2. a kind of preparation method of cutting lavation fluid film as described in claim 1, it is characterised in that:It carries out as follows It prepares:
Step 1)Sodium alginate is dissolved in water for injection or purified water, obtains solution 1., spare;
Step 2)Glycine is dissolved in after being sufficiently stirred dissolving in water for injection or purified water, adds FE biologies and mould be sufficiently stirred It is uniformly dissolved rear obtained solution 2., it is spare;
Step 3)It is sufficiently stirred 1. 2. solution is mixed with solution after, phosphate buffer solution is added dropwise and adjusts PH to 4.5-7.5, boils After 30 minutes, water for injection is added to enough;
Step 4)By step 3)The liquid bulk film of gained obtains finished product after suction filtration, refined filtration, sterile filling.
CN201810590531.9A 2018-06-09 2018-06-09 Cutting lavation fluid film and preparation method thereof Pending CN108653825A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201810590531.9A CN108653825A (en) 2018-06-09 2018-06-09 Cutting lavation fluid film and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201810590531.9A CN108653825A (en) 2018-06-09 2018-06-09 Cutting lavation fluid film and preparation method thereof

Publications (1)

Publication Number Publication Date
CN108653825A true CN108653825A (en) 2018-10-16

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1499964A (en) * 2001-03-30 2004-05-26 Aga Irrigating fluid
CN1672688A (en) * 2004-03-24 2005-09-28 阴法义 Medical composite chitinamine gel
CN1850108A (en) * 2006-05-12 2006-10-25 胡军 Medical hemostasis anti-adhesive irrigation solution
CN103977449A (en) * 2014-06-04 2014-08-13 张巍 Blended liquid hemostatic composite material and preparation method thereof
CN105030815A (en) * 2015-08-10 2015-11-11 贵州扬生医用器材有限公司 Operation flushing fluid and preparation method of operation flushing fluid

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1499964A (en) * 2001-03-30 2004-05-26 Aga Irrigating fluid
CN1672688A (en) * 2004-03-24 2005-09-28 阴法义 Medical composite chitinamine gel
CN1850108A (en) * 2006-05-12 2006-10-25 胡军 Medical hemostasis anti-adhesive irrigation solution
CN103977449A (en) * 2014-06-04 2014-08-13 张巍 Blended liquid hemostatic composite material and preparation method thereof
CN105030815A (en) * 2015-08-10 2015-11-11 贵州扬生医用器材有限公司 Operation flushing fluid and preparation method of operation flushing fluid

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
中国企业评价协会编: "《中国企业自主创新评价报告 2014》", 28 February 2015, 中国发展出版社 *
师海波主编: "《最新临床药物手册 第4版》", 30 October 2016, 辽宁科学技术出版社 *

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Application publication date: 20181016