WO2016093412A1 - Éponge de gélatine contenant une solution de tampon de phosphate (pbs) ou un tampon de phosphate et appliquée à une chimio-embolisation artérielle transcathéter, et son procédé de préparation - Google Patents

Éponge de gélatine contenant une solution de tampon de phosphate (pbs) ou un tampon de phosphate et appliquée à une chimio-embolisation artérielle transcathéter, et son procédé de préparation Download PDF

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Publication number
WO2016093412A1
WO2016093412A1 PCT/KR2014/012414 KR2014012414W WO2016093412A1 WO 2016093412 A1 WO2016093412 A1 WO 2016093412A1 KR 2014012414 W KR2014012414 W KR 2014012414W WO 2016093412 A1 WO2016093412 A1 WO 2016093412A1
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WO
WIPO (PCT)
Prior art keywords
phosphate buffer
gelatin sponge
pbs
buffer solution
sponge
Prior art date
Application number
PCT/KR2014/012414
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English (en)
Korean (ko)
Inventor
손지우
Original Assignee
주식회사 에이치제이메디칼
주식회사 엔스메디칼
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.)
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Publication date
Application filed by 주식회사 에이치제이메디칼, 주식회사 엔스메디칼 filed Critical 주식회사 에이치제이메디칼
Publication of WO2016093412A1 publication Critical patent/WO2016093412A1/fr

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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
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/36—Surgical swabs, e.g. for absorbency or packing body cavities during surgery
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
    • A61L24/0036—Porous materials, e.g. foams or sponges
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/10—Polypeptides; Proteins
    • A61L24/104—Gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/36—Materials or treatment for tissue regeneration for embolization or occlusion, e.g. vaso-occlusive compositions or devices

Definitions

  • the present invention relates to a gelatin sponge containing a phosphate buffer solution (PBS) or a phosphate buffer (Phosphate Buffer) applied to carotid artery embolization and a method for preparing the same, and more specifically, a phosphate buffer solution (PBS) at 4 ° C. to 37 ° C. ) Or immersing the gelatin sponge in a phosphate buffer (Phosphate Buffer) for 3 to 12 hours, and the gelatin sponge in which the ginseng buffer buffer (PBS) or the phosphate buffer (Phosphate Buffer) is precipitated -10 ° C to -35 ° C.
  • PBS phosphate buffer solution
  • Phosphate Buffer phosphate buffer
  • the crushed gelatin sponge is delivered to the hospital in a sterilized vial bottle, a phosphate buffer solution or a phosphate buffer solution, and then delivered to a hospital, followed by physiological saline, distilled water and anticancer.
  • the gelatin sponge and a method comprising (Phosphate Buffer) applied to the carotid artery embolization chemical configured to be used as a liver cancer therapeutic agent As it will be bonded to each other input of the phosphate buffer solution (PBS) or a phosphate buffer, the gelatin sponge and a method comprising (Phosphate Buffer) applied to the carotid artery embolization chemical configured to be used as a liver cancer therapeutic agent.
  • liver cancer is one of the most common cancers in the world, especially in men.
  • liver cancer The main causes of liver cancer are chronic hepatitis caused by the hepatitis B virus and chronic hepatitis caused by the hepatitis C virus, and as a result of chronic hepatitis caused by these viruses, hepatic cirrhosis occurs and liver cancer develops as long-term inflammation progresses.
  • liver cancer chronic liver diseases such as alcoholic liver disease or liver damage caused by toxins such as aflatoxin may all cause liver cancer.
  • liver cancer is very fast, so early screening is important.
  • surgical removal of the cancerous tissue method of transarterial chemoembolzation, and percutaneous ethanol injection And radiofrequency thermal ablation to kill cancer cells, but these methods are not effective when the size of liver cancer is too large, large blood vessels are involved, or cancer has spread to other organs. There are disadvantages.
  • liver cancer treatment includes liver resection, liver transplantation, and local therapy (high-frequency rupture, topical, alcohol injection) .However, more than 50% of patients with hepatocellular carcinoma are diagnosed at advanced stage or advanced cirrhosis. Embolization, targeted therapy anticancer agent. The role of non- radical treatment, such as external radiation therapy, is also important.
  • liver cancer using drug-releasing microspheres which is a new carotid artery treatment among the carotid artery embolization, which is a part of the treatment of non-basement liver cancer.
  • drug-releasing microspheres are embolization materials that combine 100-700 ⁇ m microspheres with anticancer drugs to treat liver cancer using the hepatic artery.
  • Existing drug-releasing microspheres are permanent embolic substances in the form of beads made of polyvynil alcohol. As hepatic blood vessels are severely damaged and hepatic blood vessels are permanently blocked, hepatic cancer with high recurrence rate is increased when chemoembolization is attempted.
  • hepatic artery damage is small and the hepatic blood vessels are not permanently blocked, and if relapses, chemoembolization can be attempted again using the hepatic artery.
  • phosphate buffer solution applied to carotid artery chemoembolization, which is configured to treat liver cancer by using hepatic artery as embolic material by combining anticancer agent with gelatin sponge embolism material or It relates to a gelatin sponge containing a phosphate buffer (Phosphate Buffer) and a preparation method thereof.
  • PBS phosphate buffer solution
  • a process of immersing gelatin sponge in a phosphate buffer solution (PBS) or phosphate buffer (PBS) or phosphate buffer at 4 ° C. to 37 ° C. for 3 to 12 hours, and the ginseng buffer solution (PBS) or phosphate A process of freeze-drying the gelatin sponge on which the Phosphate Buffer is precipitated for 30 minutes to 16 hours at a temperature condition of -10 ° C to -35 ° C, grinding the freeze-dried gelatin sponge, and the pulverized gelatin sponge After separating into 10 ⁇ 100 ⁇ m, 100 ⁇ 300 ⁇ m, 300 ⁇ 500 ⁇ m, 500 ⁇ 700 ⁇ m size, respectively, disinfected vials, phosphate buffer solution, phosphate buffer solution in the packaging container in any one of the hospital After delivery to physiological saline, distilled water and anticancer agents are added to each other and combined with each other to contain a phosphate buffer solution (PBS) or phosphate buffer (PBS) or phosphate buffer
  • the present invention is a microsphere that is broken down in the body, when injected into the liver for the treatment of liver cancer, the microspheres are broken down in the body after a period of time, during this period to prevent blood supplied to the hypervascularized malignant tumor and local to the tumor
  • drugs are continuously delivered to the tumor (Drug Delivery) to reduce side effects due to the influx of systemic blood flow of anticancer drugs and to increase tumor response.
  • liver cancer patients with high recurrence rate need to be re-treated, there is an effect that can be performed chemoembolization using drug-release microspheres again.
  • 1 is a work flow diagram schematically showing the work process of the present invention.
  • Figure 2 is a perspective view showing the gelatin sponge which is the main part of the present invention.
  • Figure 3 (a) is a perspective view schematically showing a state in which the main portion of the present invention gelatin sponge immersed in phosphate buffer solution (PBS).
  • PBS phosphate buffer solution
  • Figure 3 (b) is a perspective view schematically showing a state in which the main portion of the present invention gelatin sponge immersed in a phosphate buffer (Phosphate Buffer).
  • Figure 4 is a perspective view showing a state in which the crushed gelatin sponge immersed in phosphate buffer (PBS) or phosphate buffer (Phosphate Buffer) that is the main part of the present invention, and then crushed into powder.
  • PBS phosphate buffer
  • Phosphate Buffer phosphate buffer
  • Figure 5 is a perspective view of the packaged in a vial bottle in a state that is crushed into a powder after cooling the gelatin sponge which is the main part of the present invention.
  • Figure 6 is a perspective view schematically showing a state in which physiological saline or distilled water and an anticancer agent are coupled to a gelatin sponge stored in a vial bottle which is a main part of the present invention.
  • the present invention forms a gelatin sponge 10 containing a phosphate buffer solution (PBS) 20 or a phosphate buffer (Phosphate Buffer) 30 to be applied to carotid artery embolization as shown in FIGS. Done.
  • PBS phosphate buffer solution
  • Phosphate Buffer phosphate buffer
  • the gelatin sponge 10 is impregnated with a phosphate buffer solution (PBS) 20 or a phosphate buffer (Phosphate Buffer) 30 of 4 °C ⁇ 37 °C is subjected to a process of immersion for 3 to 12 hours.
  • PBS phosphate buffer solution
  • Phosphate Buffer phosphate buffer
  • the gelatin sponge 10 in which the ginseng salt buffer solution (PBS) 20 or the phosphate buffer (Phosphate Buffer) 30 is precipitated is frozen at -10 ° C to -35 ° C for 30 minutes to 16 hours.
  • the gelatin sponge 10 in which the ginseng salt buffer solution (PBS) 20 or the phosphate buffer (Phosphate Buffer) 30 is precipitated is minus ⁇ 10 ° C. to ⁇ 35 ° C.
  • PBS ginseng salt buffer solution
  • Phosphate Buffer phosphate buffer
  • crushed gelatin sponge (10) is separated through a mesh (not shown) to the specifications of 10 ⁇ 100 ⁇ m, 100 ⁇ 300 ⁇ m, 300 ⁇ 500 ⁇ m, 500 ⁇ 700 ⁇ m, respectively, sterilized vial bottle It will go through the packaging process.
  • the present invention may be packaged after immersing and freezing the gelatin sponge 10 in the phosphate buffer solution 20 or the phosphate buffer (Phosphate Buffer) (30), after the grinding and drying operation.
  • PBS phosphate buffer solution
  • Phosphate Buffer phosphate buffer
  • the gelatin sponge 10 pulverized according to the standard is delivered to the hospital in the packaging container in any one of the sterilized vial bottle or phosphate buffer solution, phosphate buffer solution, physiological saline, distilled water and anticancer drugs are combined with each other It can be used as a treatment for liver cancer.
  • the gelatin sponge 10 in which the phosphate buffer solution (PBS) 20 or the phosphate buffer (Phosphate Buffer) 30 is deposited is dehumidified, nitrogen dried, cold air dried, vacuum dried, or natural dried in addition to the freeze drying method. Any one can be dried.
  • the present invention can be combined with the anti-cancer drug gelatin embolic material to treat liver cancer by using the hepatic artery as an embolic material.
  • microsphere that breaks down in the body when injected into the liver for the treatment of liver cancer
  • drugs are continuously delivered to the tumor, thereby reducing side effects due to the influx of systemic blood flow of anticancer drugs and increasing tumor response.
  • PBS phosphate buffer solution
  • Phosphate buffer phosphate buffer
  • the pulverized gelatin sponge was separated into sizes of 10 to 100 ⁇ m, 100 to 300 ⁇ m, 300 to 500 ⁇ m, and 500 to 700 ⁇ m by using a mesh, and then the sterilized vial bottle or the crushed gelatin sponge was used as a phosphate buffer solution. It may be made through a fourth process of delivering to the hospital in the packaging container state contained in any one of the phosphate buffer solution.
  • Another working process of the present invention is as follows.
  • PBS phosphate buffer solution
  • Phosphate buffer phosphate buffer
  • the ginseng buffer buffer (PBS) (20) or phosphate buffer (Phosphate Buffer) (30) precipitated gelatin sponge was freeze-dried for 16 to 48 hours at -10 °C ⁇ -35 °C temperature conditions 0% ⁇ 10
  • the second step of having a moisture of%
  • the crushed gelatin sponge is separated into sizes of 10 to 100 ⁇ m, 100 to 300 ⁇ m, 300 to 500 ⁇ m, and 500 to 700 ⁇ m using a mesh, and then packaged in sterile vial bottles, or pulverized.
  • the gelatin sponge can be made through a fourth process of delivering to the hospital in the packaging container state contained in any one of the phosphate buffer solution, phosphate buffer solution.
  • the present invention can freeze by immersing the gelatin sponge in a phosphate buffer solution or phosphate buffer (Phosphate Buffer) through the above-described process, after grinding and drying operation, to obtain a packaged product.
  • a phosphate buffer solution or phosphate buffer Phosphate Buffer
  • the gelatin sponge 10 in which the phosphate buffer solution (PBS) 20 or the phosphate buffer (Phosphate Buffer) 30 is deposited is dehumidified, nitrogen dried, cold air dried, vacuum dried, or natural dried in addition to the freeze drying method. Any one can be dried.
  • Another working process of the present invention is as follows.
  • the standardized gelatin sponge may be immersed in phosphate buffer solution (PBS) 20 or phosphate buffer (Phosphate Buffer) 30 at 4 ° C. to 37 ° C. for 3 to 12 hours, and then the anticancer agent may be combined.
  • PBS phosphate buffer solution
  • Phosphate Buffer phosphate buffer
  • the gelatin sponge 10 pulverized by the standard is delivered to the hospital packaging container contained in any one of the sterilized vial bottle or phosphate buffer solution, phosphate buffer solution, physiological saline, distilled water and an anticancer agent is coupled to each other Will be used as a liver cancer treatment.
  • the present invention is a microsphere that is decomposed in the body, and when injected into the liver for the treatment of liver cancer, the microspheres are decomposed in the body after a certain period of time.
  • drug release microspheres are decomposed in a local manner, drugs are continuously delivered to the tumor (Drug Delivery) to reduce side effects due to systemic blood flow of anticancer drugs and to increase tumor response.
  • liver cancer patients with high recurrence rate need to be re-treated, there is an effect that can be performed chemoembolization using drug-release microspheres again.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Materials Engineering (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medical Informatics (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La présente invention concerne une éponge de gélatine contenant une solution de tampon de phosphate (PBS) ou un tampon de phosphate et appliquée à une chimio-embolisation artérielle transcathéter, et son procédé de préparation et, plus spécifiquement, une éponge de gélatine contenant une solution de tampon de phosphate (PBS) ou un tampon de phosphate et appliquée à une chimio-embolisation artérielle transcathéter, et son procédé de préparation, le procédé comprenant : une étape consistant à immerger une éponge de gélatine dans une solution de tampon de phosphate (PBS) ou un tampon de phosphate à 4-37 °C pendant 3 à 12 heures; une étape consistant à lyophiliser l'éponge de gélatine, qui est imprégnée avec la solution de tampon de phosphate (PBS) ou le tampon de phosphate, à une condition de température de -10 °C à -35 °C pendant 30 minutes à 16 heures; une étape consistant à pulvériser l'éponge de gélatine lyophilisée; une étape consistant à séparer l'éponge de gélatine pulvérisée en dimensions de 10-100 μm, 100-300 μm, 300-500 µm et 500-700 μm, respectivement. Une fois que l'éponge de gélatine pulvérisée est transférée à un hôpital tout en étant maintenue dans des flacons désinfectés, ou dans des récipients d'emballage dans lesquels l'éponge de gélatine pulvérisée est stockée dans n'importe quelle solution de tampon de phosphate et d'un tampon de phosphate, l'éponge de gélatine pulvérisée étant liée à une solution saline physiologique, de l'eau distillée, et à un agent anticancéreux, qui sont introduits dans cette dernière pour une utilisation comme agent thérapeutique contre le cancer du foie.
PCT/KR2014/012414 2014-12-10 2014-12-16 Éponge de gélatine contenant une solution de tampon de phosphate (pbs) ou un tampon de phosphate et appliquée à une chimio-embolisation artérielle transcathéter, et son procédé de préparation WO2016093412A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20140177234 2014-12-10
KR10-2014-0177234 2014-12-10

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WO2016093412A1 true WO2016093412A1 (fr) 2016-06-16

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220111112A1 (en) * 2020-01-09 2022-04-14 Ethicon, Inc. Flexible Gelatin Sealant Dressing with Reactive Components

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20030097620A (ko) * 1993-07-19 2003-12-31 더 유니버시티 오브 브리티쉬 콜롬비아 항맥관형성 조성물, 당해 조성물로 피복된 스텐트 및 당해스텐트의 제조방법

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20030097620A (ko) * 1993-07-19 2003-12-31 더 유니버시티 오브 브리티쉬 콜롬비아 항맥관형성 조성물, 당해 조성물로 피복된 스텐트 및 당해스텐트의 제조방법

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
BAKER, STEVEN GERALD: "In Vitro Elution of Analgesic Medications from an Absorbable Gelatin Sponge", MICHIGAN STATE UNIVERSITY, MASTER'S THESIS, 2011 *
BANICH, JC ET AL.: "Chemoattraction of CD 34+ Progenitor Cells and Dendritic Cells to the Site of Tumor Excision as the First Step of an Immunotherapeutic Approach to Target Residual Tumor Cells", J. IMMUNOTHER., vol. 26, no. 1, January 2003 (2003-01-01), pages 31 - 40 *
SUN, WEI ET AL.: "Hemostatic Absorbable Gelatin Sponge Loaded with 5-fluorouracil for Treatment of Tumors", INT. J NANOMEDICINE, vol. 8, 2013, pages 1499 - 1506 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220111112A1 (en) * 2020-01-09 2022-04-14 Ethicon, Inc. Flexible Gelatin Sealant Dressing with Reactive Components

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