WO2012043052A1 - Solution chirurgicale nettoyante - Google Patents
Solution chirurgicale nettoyante Download PDFInfo
- Publication number
- WO2012043052A1 WO2012043052A1 PCT/JP2011/067396 JP2011067396W WO2012043052A1 WO 2012043052 A1 WO2012043052 A1 WO 2012043052A1 JP 2011067396 W JP2011067396 W JP 2011067396W WO 2012043052 A1 WO2012043052 A1 WO 2012043052A1
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- WO
- WIPO (PCT)
- Prior art keywords
- surgical field
- bacteria
- surgical
- mass
- solution
- Prior art date
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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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
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/02—Local antiseptics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
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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
Definitions
- the present invention relates to an operative field cleaning solution.
- Surgical site infection occurs by the following three mechanisms. 1) Bacteria are mixed into the operative field, abdominal cavity and chest cavity during surgery. 2) The number of remaining bacteria cannot be sufficiently reduced due to insufficient washing after surgery. 3) Bacteria grow in the surgical field and become manifest as infections. The frequency of surgical site infection varies depending on the surgical procedure and the location of the surgical field, but is most frequently caused by intestinal bacterial exposure through gastrointestinal incision in digestive surgery. However, surgical site infections occur with a certain frequency in all surgical procedures, and once they occur, they not only show severe symptoms, but also increase treatment costs and lengthen patient stay. This results in undesirable results for both the patient and the hospital.
- Patent Document 1 describes a cleaning bag containing physiological saline.
- Non-patent Document 1 Glycine, sodium acetate, ⁇ -polylysine, pH adjuster, lysozyme, medium chain fatty acid polyglycerin ester and other emulsifiers are used as shelf life improvers. These preservatives are safe to eat (Non-patent Document 1). It has never been examined whether these food preservatives can be used as irrigation solution in the surgical field.
- an object of the present invention is to solve the above problems and provide a surgical field cleaning solution for cleaning the surgical field. More specifically, the present invention provides a surgical field cleaning solution for cleaning the surgical field, which prevents surgical site infection and does not inhibit postoperative healing.
- a surgical field cleaning solution for cleaning a surgical field which is an aqueous solution containing a bacteriostatic agent, having an osmotic pressure of 230 to 340 mOsm, and cultivating superficial skin bacteria or intestinal bacteria at 37 ° C. for 48 hours.
- Surgery solution that suppresses growth without killing bacteria.
- a surgical field cleaning liquid storage container in which the surgical field cleaning liquid according to any one of (1) to (4) is stored in a storage container made of a soft thermoplastic resin and sterilized.
- a surgical-field-cleaning-liquid storage container package in which a storage container made of a soft thermoplastic resin storing the surgical-field cleaning liquid is stored in a heat-resistant packaging material and sterilized.
- the growth of bacteria in the surgical field after washing can be suppressed, the occurrence of surgical site infection can be prevented, and postoperative healing is not inhibited.
- the surgical field cleaning liquid of the present invention is stored in a storage container made of a soft thermoplastic resin and sterilized, the entire container containing the surgical field cleaning liquid is sterilized, so the content liquid is put in another container. Since it can be used in the operative field without transfer, the procedure can be simplified and the operation time can be shortened.
- FIG. 1 is a plan view of the surgical field cleaning liquid storage container of the present invention.
- the surgical field cleaning solution of the present invention is an aqueous solution for cleaning the surgical field at the time of surgery.
- Human or animal surgery is a treatment that invades the living body and controls wounds or diseases, and includes excision, formation, transplantation, examination, etc., and skin incision, laparotomy, thoracotomy in surgery and cardiac surgery.
- Surgery, laparoscopic surgery, thoracoscopic surgery, arthroscopic surgery and orthopedic surgery are exemplified, but not limited thereto.
- a surgical field is a living part that has been invaded by surgery, including the abdominal cavity, thoracic cavity, joint cavity, organs, skin, bones, joints, parts in contact with muscles, connective tissue, peritoneum, omentum, etc. It is not limited to.
- the surgical field is usually exposed to the outside air due to tissue, blood, and bodily fluids, and is exposed to bacterial infection and contamination by blood, bodily fluids, bodily substances, and diseased sites.
- Bacteria causing surgical site infections vary depending on the surgical site, and in the gastrointestinal surgery with the highest frequency of surgical site infection, gram-negative Escherichia coli, Pseudomonas aeruginosa and gram-positive enterococci are the cause. .
- the causative bacteria of the surgical site infection include both gram positive bacteria and gram negative bacteria.
- the present invention is an operative field cleaning solution for cleaning an operative field, an aqueous solution containing a bacteriostatic agent, having an osmotic pressure of 230 to 340 mOsm, and culturing superficial skin bacteria or enteric bacteria at 37 ° C. for 48 hours.
- the surgical field washing liquid suppresses the growth without killing the bacteria.
- immunity was recovered 48 hours after the operation, but there is no idea that this was used as a criterion for determining the surgical field washing solution.
- the surgical field cleaning liquid of the present invention adjusted according to this standard is highly useful.
- suppressing the growth without killing the bacteria not only suppresses the death of Escherichia coli and the release of endotoxins and cytokines, but also the infection of the bacteria becomes impossible to control with the lowered immunity. It means to suppress the growth to the level that occurs.
- bacteriostatic agent substances having a bacteriostatic effect that suppress growth without killing bacteria
- sorbic acid glycine, protamine, and polylysine. It has been known that these substances have a bacteriostatic effect, but it has not been known whether they can be used as an operative field washing solution that has an effect of preventing infection at a surgical site and not inhibiting postoperative healing.
- the surgical field cleaning solution of the present invention has an effect of preventing surgical site infection and not inhibiting postoperative healing, and is particularly excellent for cleaning the abdominal cavity.
- the surgical field washing solution preferably has a pH of 6 to 9, more preferably a pH of 6.5 to 8.3, and an osmotic pressure of 230 to 340 mOsm, preferably 258 to 316 mOsm.
- the pH and osmotic pressure are close to those of organs, tissues, mucous membranes, skin, and cells, and there are no obstacles due to touching the tissues.
- the concentration of the substance that inhibits the growth of bacteria contained in the surgical field washing solution is preferably 0.5 to 2.5% by mass, more preferably 1.0% to 2.0% by mass for glycine. is there. If the concentration is less than 0.5% by mass, bacterial growth cannot be suppressed. If the concentration exceeds 2.5% by mass, the osmotic pressure is increased and the tissue is damaged. Substances that inhibit the growth of bacteria may be used alone or in combination with substances that inhibit the growth of two or more bacteria.
- sodium chloride or phosphate may be added to adjust the osmotic pressure.
- concentration of sodium chloride is preferably 0.01 to 0.9% by mass, more preferably 0.03 to 0.7% by mass.
- the surgical field cleaning solution of the present invention preferably does not contain chemical substances other than sorbic acid, glycine, protamine, polylysine, sodium chloride and phosphate. This is because if unnecessary chemical substances are included, substances unnecessary for the living body remain in the body after washing. In particular, it is more preferable not to contain substances other than glycine and sodium chloride.
- E. coli is turbid in 1 platinum ear liquid medium and cultured overnight at 37 ° C. to make a stock solution. 100 ⁇ L of this stock solution is added to 3 mL of physiological saline or 3 mL of the surgical field washing solution of the present invention, and cultured at 37 ° C. for 48 hours. The cultured sample is diluted 100000 times with RO water, and 100 ⁇ L each is added to an agar medium. Sowing. Count the number of colonies after 3 days. A state in which colonies increase with physiological saline is defined as a state in which Escherichia coli is seen to grow.
- the surgical field washing solution of the present invention has a smaller number of colonies than physiological saline, preferably 5 or less, more preferably 1 or less.
- the state in which the growth of E. coli is suppressed but not killed indicates a state in which colonies increase after 96 hours when culturing is continued without adding a new surgical field washing solution.
- the surgical field cleaning liquid is contained in a storage container made of a soft thermoplastic resin.
- the container containing the surgical field cleaning solution is preferably sterilized.
- the sterilization method is not limited, any of chemical sterilization, radiation sterilization, and heat sterilization may be used, but heat sterilization in an autoclave is preferable because a large amount of sterilization can be performed at low cost.
- a commonly used infusion bag can be used as the storage container.
- the surgical field cleaning liquid storage container 10 has a container main body 1 formed of a soft thermoplastic resin and a cleaning liquid discharge port 2 provided with an opening.
- the peripheral part of the container body 1 is sealed to form a sealing part 12.
- the sealing portion is sealed by resin thermal fusion.
- the opening of the cleaning liquid discharge port 2 is covered with a member such as a film material provided with a tab 22 so as to be peeled off, and the cap 21 is configured to open by peeling off the member.
- the container body 1 is a portion for storing the cleaning liquid, and the shape near the opening of the cleaning liquid discharge port 2 is the inclined portion 6 because the surgical field cleaning liquid can be easily discharged.
- a hole 8 that can be used when the container body 1 is suspended or a plurality of containers are used in the sealing part 12 at the peripheral edge of the inclined part 6 is opened to the left and right.
- the side opposite to the cleaning liquid discharge port 2 is the bottom of the container body 1, and the peripheral edge is sealed to form a sealing portion 12.
- it is a heat-sealed sealing portion in which a resin sheet is heat-sealed.
- the hanging part 4 which is a hole part which can be used when the container main body 1 is hung and used is opened left and right.
- the container body 1 is manufactured by heat-sealing a soft thermoplastic resin sheet except for a portion where an accessory member such as the cleaning liquid discharge port 2 is provided.
- the container body 1 and the cleaning liquid discharge port 2 are both integrally formed from a soft thermoplastic resin.
- the container body 1 stores the above-described surgical field cleaning liquid of the present invention and is discharged from the cleaning liquid discharge port 2.
- the soft thermoplastic resin sheet which is a material for forming the container body 1 of the present invention, is preferably a soft thermoplastic resin sheet molded into a cylindrical shape by an inflation molding method.
- the container body may be a blow molded product of a soft thermoplastic resin.
- it may be used as a retort pouch (a food container for retort sterilization), a standing pouch, or the like.
- the volume of the container body varies depending on the surgical field and the like, but is generally preferably 100 mL to 2000 mL, and more preferably 500 mL to 1000 mL.
- the container body 1 preferably has a water vapor barrier property.
- the water vapor permeability is preferably 50 g / m 2 ⁇ 24 hrs ⁇ 40 ° C. ⁇ 90% RH or less, and more preferably 10 g / m 2 ⁇ 24 hrs ⁇ 40 ° C. ⁇ 90% RH or less. More preferably, it is 1 g / m 2 ⁇ 24 hrs ⁇ 40 ° C. ⁇ 90% RH or less.
- This water vapor permeability is measured by the method described in JISK7129 (Method A). Since the container main body 1 has the water vapor barrier property, the evaporation of moisture from the inside of the surgical field cleaning liquid storage container can be prevented.
- the concentration, pH and osmotic pressure of the bacteriostatic agent stored inside can be kept stable for a long period of time.
- superficial skin bacteria or intestinal bacteria are cultured at 37 ° C for 48 hours, the bacteria are killed.
- the characteristics of the surgical field washing solution of the present invention that suppresses the proliferation are stably maintained for a long time.
- the soft thermoplastic resin material forming the container body 1 include polyolefins such as polyethylene and polypropylene. Furthermore, styrene-based thermoplastic elastomers such as styrene-butadiene copolymer, styrene-ethylene-butylene-styrene block copolymer, styrene-isoprene-styrene block copolymer, ethylene-propylene copolymer, ethylene- A soft resin obtained by blending and softening an olefinic thermoplastic elastomer such as a butene copolymer or a propylene- ⁇ -olefin copolymer can be given.
- polyolefins such as polyethylene and polypropylene.
- styrene-based thermoplastic elastomers such as styrene-butadiene copolymer, styrene-ethylene-butylene-styrene block
- the material constituting the container body is preferably 500 MPa or less, preferably 50 to 300 MPa in terms of tensile modulus, from the viewpoints of ease of handling, liquid dischargeability, and the like.
- the container body 1 may have a single-layer structure (single-layer body) made of the material as described above, and a plurality of layers (particularly layers of different materials) are stacked for various purposes. It may be a multilayer laminate. In the case of a multilayer laminate, a plurality of resin layers may be stacked, or a metal layer may be stacked on at least one resin layer. In the case where a plurality of resin layers are stacked, the advantages of the respective resins can be obtained together. For example, the impact resistance of the container body 1 can be improved, or blocking resistance and gas barrier properties can be imparted. it can. In the case of a metal layer, the gas barrier property and light shielding property of the container body 1 can be improved.
- the gas barrier property and water vapor barrier property can be improved, and a light shielding property can be imparted.
- an oxide such as titanium oxide, aluminum oxide, and silicon oxide.
- the present invention is characterized in that the surgical field cleaning liquid is stored in a storage container made of a soft thermoplastic resin and sterilized, and further, the storage container may be stored in a heat-resistant packaging material and sterilized. . If the outside of the medical container is also sterilized, the surgical field cleaning solution can be poured directly from the storage container into the surgical field without transferring the surgical field cleaning solution to another container during use. In addition, since it is molded from a soft thermoplastic resin, it is easy to grasp and easy to pour the surgical field washing liquid. It can also be produced aseptically by aseptic filling. Furthermore, these can also be packaged with a packaging material.
- EXAMPLES The present invention will be described below with reference to examples, but the present invention is not limited to these examples.
- ⁇ Experimental example 1 Escherichia coli (ATCC 25922) previously cultured in an agar medium was turbid in 1 platinum ear liquid medium and cultured overnight at 37 ° C. to obtain a stock solution.
- glycine and sodium acetate are dissolved in RO water (reverse osmosis membrane-treated pure water) to prepare a 2% by mass glycine aqueous solution and a 2% by mass sodium acetate aqueous solution, combined with physiological saline (Terumo), pH and The osmotic pressure was measured.
- RO water reverse osmosis membrane-treated pure water
- ⁇ Experimental example 2> Dissolve glycine in RO water to prepare 0.3 wt%, 0.5 wt%, 1 wt%, 2 wt%, 3 wt% glycine aqueous solution. Sodium chloride was added so that the pressure was 290 mOsm. Further, Escherichia coli (ATCC 25922) previously cultured in an agar medium was turbid in 1 platinum ear liquid medium and cultured overnight at 37 ° C. to obtain a stock solution.
- the use of the aqueous glycine solution having the concentration of the present invention as an operative field washing solution has an effect of preventing surgical site infection and not inhibiting postoperative healing.
- Sodium acetate is dissolved in RO water to prepare 0.3 mass%, 0.5 mass%, 1.0 mass%, 2.0 mass%, and 3.0 mass% aqueous sodium acetate solutions, respectively.
- Sodium chloride was added so that the osmotic pressure was 290 mOsm.
- Escherichia coli ATCC 25922 previously cultured in an agar medium was turbid in 1 platinum ear liquid medium and cultured overnight at 37 ° C. to obtain a stock solution. 100 ⁇ L of this stock solution was added to 3 mL of physiological saline, and 3 mL of prepared 0.1 mass%, 0.3 mass%, 0.5 mass%, 1 mass%, 2 mass%, 3 mass% sodium acetate aqueous solution, respectively.
- Glycine was dissolved in RO water to prepare a 1% by mass aqueous glycine solution, and an aqueous sodium acetate solution was added so that the sodium acetate concentration was 0.1% by mass. Further, sodium chloride was added so that the osmotic pressure was 290 mOsm. Further, Escherichia coli (ATCC 25922) previously cultured in an agar medium was turbid in 1 platinum ear liquid medium and cultured overnight at 37 ° C. to obtain a stock solution. 100 ⁇ L of this stock solution was added to 3 mL of this solution and cultured at 37 ° C. for 48 hours.
- the cultured sample was diluted 100000 times with RO water, and 100 ⁇ L each was seeded on an agar medium. After culturing at 37 ° C., the number of colonies was counted after 3 days. The results are shown in Table 4. In the glycine / sodium acetate aqueous solution, the number of colonies was further increased as compared with the glycine aqueous solution, indicating that the growth of E. coli was promoted.
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Abstract
La présente invention concerne une solution chirurgicale nettoyante qui, étant une solution aqueuse contenant un agent bactériostatique, présente une pression osmotique allant de 230 à 340 mOsm. Après la culture de bactéries sur une surface de peau ou dans des intestins pendant 48 heures à 370 °C, l'on observe que la solution chirurgicale nettoyante inhibe la croissance de celles-ci mais ne les tue pas. La solution chirurgicale nettoyante de la présente invention empêche le site chirurgical de s'infecter et n'inhibe pas la guérison post-opératoire.
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JP6247421B1 (ja) * | 2017-07-20 | 2017-12-13 | 日本細菌検査株式会社 | 菌輸送液及び菌輸送方法 |
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JPH0196123A (ja) * | 1987-10-08 | 1989-04-14 | Sangi:Kk | 抗歯周症剤 |
JP2009532049A (ja) * | 2006-04-06 | 2009-09-10 | ピュラック バイオケム ビー.ブイ. | 抗微生物性調製物 |
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JPH0196123A (ja) * | 1987-10-08 | 1989-04-14 | Sangi:Kk | 抗歯周症剤 |
JP2009532049A (ja) * | 2006-04-06 | 2009-09-10 | ピュラック バイオケム ビー.ブイ. | 抗微生物性調製物 |
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AKIRA SHIBUYA: "Shokuhin no Kagakuteki Hozon Gijutsu 10 3) Himochi Kojozai ni yoru Hozon Gijutsu (4) Glycine", JOURNAL OF ANTIBACTERIAL AND ANTIFUNGAL AGENTS, vol. 37, no. 11, 2009, JAPAN, pages 847 - 856 * |
SHIGEHARU OIE: "Surgical Site Infection (SSI) 6. Shodoku-ho no Kihon", SURGERY FRONTIER, vol. 11, no. 4, 2004, pages 362 - 368 * |
TATSUHIKO SATO ET AL.: "Shujutsu-yo Kusuri no Tsukaikata 1. Shodokuyaku", PRACTICAL OPHTHALMOLOGY, vol. 23, 2008, pages 404 - 405 * |
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JP6247421B1 (ja) * | 2017-07-20 | 2017-12-13 | 日本細菌検査株式会社 | 菌輸送液及び菌輸送方法 |
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