CN114748674A - Embolism microsphere preloaded with medicine and processing method thereof - Google Patents

Embolism microsphere preloaded with medicine and processing method thereof Download PDF

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Publication number
CN114748674A
CN114748674A CN202210405007.6A CN202210405007A CN114748674A CN 114748674 A CN114748674 A CN 114748674A CN 202210405007 A CN202210405007 A CN 202210405007A CN 114748674 A CN114748674 A CN 114748674A
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preloaded
medicine
microsphere
macromolecular material
small balls
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盛晓波
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Shanghai Fangrun Interventional Instrument Co ltd
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Shanghai Fangrun Interventional Instrument Co ltd
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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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/06—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • 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
    • A61L24/0015—Medicaments; Biocides
    • 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
    • A61L24/0042—Materials resorbable by the body
    • 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
    • A61L24/046—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602—Type of release, e.g. controlled, sustained, slow
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/62—Encapsulated active agents, e.g. emulsified droplets
    • A61L2300/622—Microcapsules

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention discloses an embolism microsphere preloaded with medicine, which is formed by polymerizing a biological macromolecular material with elasticity, a functional macromolecular material with biodegradability and medicine. The invention also provides a processing method of the embolism microsphere with the preloaded medicine. The embolism microsphere preloaded with the medicine provided by the invention has the advantages that the microsphere is fully mixed with the medicine, the medicine loading is high, the degradable macromolecular material is degraded to generate carbon dioxide and water, the shell structure is supported, and the embolism effect is continuously realized.

Description

Embolism microsphere preloaded with medicine and processing method thereof
Technical Field
The invention relates to the technical field of medical materials, in particular to an embolism microsphere preloaded with medicine and a processing method thereof.
Background
Interventional therapy is a minimally invasive medical technology under the guidance of image equipment, transcatheter vascular embolization is an important technology of interventional therapy, and the transcatheter vascular embolization is increasingly widely applied to the field of interventional radiotherapy due to the advantages of minimally invasive performance, whole-course image guidance, selective target vessel insertion technology, accurate positioning and the like. The artificial synthetic embolism material carrying the anti-tumor drug is injected into the blood vessel through the catheter by the catheter vascular embolization, so that the blood vessel is blocked, the blood supply of the blood vessel to the tumor part is blocked, and the anti-tumor drug is released, and the key is to select a proper embolization agent.
At present, the embolization materials used in clinic mainly include embolization materials which can not carry medicine, such as gelatin sponge particles, polyvinyl alcohol (PVA), Embosphere, and embolization microspheres which can carry medicine, such as DC-Bead, Gal raw microspheres, Hepasphere microspheres, etc. For some degradable embolic microspheres, the microspheres degrade after drug release and do not continue to embolize.
Therefore, those skilled in the art are dedicated to provide an embolization microsphere preloaded with a drug and a method for manufacturing the embolization microsphere, so as to solve the problem that the embolization microsphere cannot play an embolization role after being degraded with the drug.
Disclosure of Invention
In view of the defects in the prior art, the technical problem to be solved by the present invention is to provide an embolization microsphere preloaded with drug, which can continue to embolize after the drug is degraded, and a method for processing the same.
In order to achieve the aim, the invention provides a medicine preloading embolism microsphere which is formed by polymerizing a biological macromolecular material with elasticity, a functional macromolecular material with biodegradability and a medicine.
Further, the biological macromolecular material with elasticity comprises sodium polyacrylate vinyl alcohol, polyvinyl alcohol and polyethylene glycol.
Further, the functional macromolecular material with biodegradability comprises polycarboxylic acid glycolic acid copolymer and polycaprolactone.
Further, the medicament comprises adriamycin, irinotecan and doxorubicin.
Furthermore, the particle size of the degradable microsphere particles is 1-5 μm.
The invention also provides a method for processing the embolism microsphere with preloaded medicine, which comprises the following steps:
dissolving the biodegradable functionalized macromolecular material by using an organic solvent to form a dissolving solution;
adding the medicine into the dissolving solution, and dissolving to form viscous liquid;
injecting the viscous liquid into the water solution of the biomacromolecule material with elasticity;
magnetically stirring the aqueous solution to generate small balls;
sucking out the small balls through a suction device;
and putting the small balls into saline water to fully solidify the small balls.
Further, the organic solvent is dichloromethane, and the mass ratio of the organic solvent to the biodegradable functionalized macromolecular material is (99-70): (1-30).
Further, the concentration of the medicine is 5-50 mg/ml.
Further, the concentration of the aqueous solution of the bio-macromolecular material with elasticity is 10-30%.
Further, the temperature of the brine is 4 ℃, and the concentration of the brine is 5-10%.
In the method, the magnetic stirring time is 5-10 min.
The invention has at least the following beneficial technical effects:
according to the embolism microsphere preloaded with the medicine, the microsphere is fully mixed with the medicine, so that the medicine loading capacity is high; the medicine is loaded on the nuclear structure, and the generated embolism microsphere has smooth surface and is easy to be transported in blood vessels; carbon dioxide and water are generated when the degradable biological macromolecular material is degraded, and the shell structure can be supported by the carbon dioxide to continuously play a role in embolism.
The conception, the specific structure and the technical effects of the present invention will be further described with reference to the accompanying drawings to fully understand the objects, the features and the effects of the present invention.
Drawings
FIG. 1 is a schematic illustration of the process for manufacturing drug preloaded embolic microspheres of the present invention.
Detailed Description
The following describes preferred embodiments of the present invention to make the technical contents thereof clearer and easier to understand. The present invention may be embodied in many different forms of embodiments and the scope of the invention is not limited to the embodiments set forth herein.
In the drawings, structurally identical elements are represented by like reference numerals, and structurally or functionally similar elements are represented by like reference numerals throughout the several views. The size and thickness of each component shown in the drawings are arbitrarily illustrated, and the present invention is not limited to the size and thickness of each component. The thickness of the components may be exaggerated where appropriate in the figures to improve clarity.
The invention provides an embolism microsphere with preloaded medicine, which is formed by polymerizing a biological macromolecular material with elasticity, a functional macromolecular material with biodegradability and active medicine.
The elastic biological macromolecular material is soft and has changeable structure, and can be sodium polyacrylate vinyl alcohol, polyvinyl alcohol (PVA) and polyethylene glycol (PEG). The polyethylene glycol has high hydrophilicity, can change the biological distribution behavior and the solubility of the medicament in aqueous solution, has protective effect on the medicament modified by the polyethylene glycol, reduces the enzymolysis of the medicament, and increases the biocompatibility of the modified carrier; polyvinyl alcohol is an extremely safe high molecular organic matter and has good biocompatibility.
The biodegradable functional macromolecular material can be slowly degraded, and can be polylactic-co-glycolic acid (PLGA) and Polycaprolactone (PCL). Wherein, PLGA is a high molecular copolymer polymerized by lactic acid and glycollic acid according to a certain proportion, contains more terminal hydroxyl and carboxyl, can be used for the crosslinking of amino-containing substances, and is a good drug carrier; the PLGA has good biodegradability in the temperature range of 20-42 ℃, and has no toxic or side effect on human bodies; the PLGA microsphere controlled release system has good biological characteristics, no accumulation in vivo after long-term use, and can delay the release time of the drug, thereby being a good drug controlled release system. The PCL has good biodegradability, biocompatibility and nontoxicity, can be degraded to generate carbon dioxide and water, and can be completely degraded in natural environment within 6-12 months.
The active drug of the embodiment can be adriamycin, irinotecan and doxorubicin, and can be released to tumor parts of blood vessels to realize the treatment effect.
In the embodiment, a shell-core structure is formed by a biological macromolecular material with elasticity and a functional macromolecular material with biodegradability, the active drug is positioned in a core part, and the active drug is slowly released into a blood vessel; meanwhile, the functional macromolecular material with biodegradability is degraded to generate carbon dioxide and water, and the carbon dioxide gas supports the biological macromolecular material with elasticity of the shell layer to continue to play a role in embolism. The diameter of the embolism microsphere prepared by the embodiment is 1-5 μm.
The invention also provides a processing method of the embolism microsphere with preloaded medicine, as shown in figure 1, the processing method of the invention comprises the following steps:
dissolving the biodegradable functionalized macromolecular material by using an organic solvent to form a dissolving solution;
adding the active drug into the dissolving solution, and dissolving to form viscous liquid;
injecting the viscous liquid into the water solution of the biomacromolecule material with elasticity;
magnetically stirring the aqueous solution to generate small balls;
sucking out the small balls through a suction device;
and putting the small balls into saline water to fully solidify the small balls.
The embolism microsphere prepared by the method has the advantages of full mixing of the microsphere and the medicament, high medicament loading, smooth surface of the microsphere and easy transportation in blood vessels.
The invention also specifically discloses the following embodiments.
Example 1
Mixing dichloromethane and PLGA according to a volume ratio of 90:10 to dissolve the PLGA in the dichloromethane to form a dissolved solution;
adding adriamycin serving as an active medicament into the dissolved solution to prepare viscous liquid, wherein the content of the adriamycin in the viscous liquid is 20 mg/ml;
taking 10ml of viscous liquid, and adding the viscous liquid into 20ml of PEG (polyethylene glycol) aqueous solution with the mass concentration of 10%;
stirring for 5min by magnetic force to generate small balls by the PEG, the PLGA and the active medicine;
the small balls are pumped out through a pumping device;
placing into 100ml of saline water with the temperature of 4 ℃ and the mass concentration of 5% to fully solidify the small balls.
The diameter of the embolization microspheres made in this example was about 2.5 μm.
Example 2
Mixing dichloromethane and PCL in a volume ratio of 75:25 to dissolve the PCL in the dichloromethane to form a dissolved solution;
adding irinotecan serving as an active medicament into the dissolved solution to prepare viscous liquid, wherein the content of the irinotecan in the viscous liquid is 45 mg/ml;
taking 10ml of viscous liquid, and adding the viscous liquid into 40ml of PVA water solution with the mass concentration of 25%;
stirring for 10min by magnetic force to generate small balls by the PVA, the PCL and the active drug;
the small balls are pumped out through a pumping device;
placing into 100ml saline water with 4 deg.C and 10% mass concentration to solidify the small ball completely.
The diameter of the embolization microspheres made in this example was about 4.5 μm.
The foregoing detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, those skilled in the art can make logical analysis, reasoning or limited experiments based on the present invention.

Claims (10)

1. The embolism microsphere with the preloaded medicine is characterized by being formed by polymerizing a biological macromolecular material with elasticity, a functional macromolecular material with biodegradability and the medicine.
2. The preloaded embolization microsphere of claim 1, wherein the elastic biomacromolecule material comprises sodium polyacrylate, vinyl alcohol, polyethylene glycol.
3. The preloaded pharmaceutical embolic microsphere of claim 1, wherein said biodegradable functionalized macromolecular material comprises a polycarboxylic acid glycolic acid copolymer, polycaprolactone.
4. The preloaded pharmaceutical embolic microsphere of claim 1, wherein said drug comprises doxorubicin, irinotecan, doxorubicin.
5. The preloaded pharmaceutical embolic microsphere of claim 1, wherein said degradable microsphere particles have a particle size of 1 to 5 μm.
6. The method of processing preloaded pharmaceutical embolic microspheres of any of claims 1-5, wherein said method comprises the steps of:
dissolving the biodegradable functionalized macromolecular material by using an organic solvent to form a dissolving solution;
adding the medicine into the dissolving solution, and dissolving to form viscous liquid;
injecting the viscous liquid into the water solution of the biomacromolecule material with elasticity;
magnetically stirring the aqueous solution to generate small balls;
sucking out the small balls through a suction device;
and putting the small balls into saline water to fully solidify the small balls.
7. The method for processing embolization microspheres preloaded with drugs according to claim 6, wherein the organic solvent is dichloromethane, and the mass ratio of the organic solvent to the functionalized macromolecular biodegradable material is (99-70): (1-30).
8. The method of claim 6, wherein the drug is present in a concentration of 5 to 50 mg/ml.
9. The method of claim 6, wherein the concentration of the aqueous solution of the elastic biopolymer material is 10-30%.
10. The method of claim 6 wherein the saline is at a temperature of 4 ℃ and the saline concentration is 5-10%.
CN202210405007.6A 2022-04-18 2022-04-18 Embolism microsphere preloaded with medicine and processing method thereof Pending CN114748674A (en)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100021550A1 (en) * 2007-01-12 2010-01-28 Yanfang Li Radiopaque biodegradable vascular embolic microspheres
US20130195988A1 (en) * 2010-09-08 2013-08-01 Shanghai Cancer Institute Vascular embolization gelling agent for sustained release of drugs for treating tumors and method for preparing the same
CN103877625A (en) * 2014-03-05 2014-06-25 同济大学 PLGA (poly(lactic-co-glycolic acid))/bletilla composite microsphere for embolism and preparation method thereof
CN107049984A (en) * 2017-03-14 2017-08-18 武汉理工大学 A kind of preparation method for carrying taxol polylactic-co-glycolic acid microballoon
CN108721684A (en) * 2018-05-31 2018-11-02 山东省科学院能源研究所 Hud typed prepackage chemotherapeutics embolism microball of one kind and preparation method thereof
US20190192438A1 (en) * 2017-12-22 2019-06-27 Shandong Rientech Medical Technology Co.,Ltd Method for preparing degradable drug-loaded microsphere for embolization, and product obtained therefrom

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100021550A1 (en) * 2007-01-12 2010-01-28 Yanfang Li Radiopaque biodegradable vascular embolic microspheres
US20130195988A1 (en) * 2010-09-08 2013-08-01 Shanghai Cancer Institute Vascular embolization gelling agent for sustained release of drugs for treating tumors and method for preparing the same
CN103877625A (en) * 2014-03-05 2014-06-25 同济大学 PLGA (poly(lactic-co-glycolic acid))/bletilla composite microsphere for embolism and preparation method thereof
CN107049984A (en) * 2017-03-14 2017-08-18 武汉理工大学 A kind of preparation method for carrying taxol polylactic-co-glycolic acid microballoon
US20190192438A1 (en) * 2017-12-22 2019-06-27 Shandong Rientech Medical Technology Co.,Ltd Method for preparing degradable drug-loaded microsphere for embolization, and product obtained therefrom
CN108721684A (en) * 2018-05-31 2018-11-02 山东省科学院能源研究所 Hud typed prepackage chemotherapeutics embolism microball of one kind and preparation method thereof

Non-Patent Citations (1)

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Title
赵鑫: "可生物降解材料微球的研究进展", 《广东轻工职业技术学院学报》 *

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