CN113855849A - Dressing composition and preparation method and application thereof - Google Patents

Dressing composition and preparation method and application thereof Download PDF

Info

Publication number
CN113855849A
CN113855849A CN202010615094.9A CN202010615094A CN113855849A CN 113855849 A CN113855849 A CN 113855849A CN 202010615094 A CN202010615094 A CN 202010615094A CN 113855849 A CN113855849 A CN 113855849A
Authority
CN
China
Prior art keywords
dressing
dressing composition
sodium hyaluronate
water
wound
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
CN202010615094.9A
Other languages
Chinese (zh)
Inventor
赵海光
李静
薛秀生
阿斯根
徐倩
王文新
徐勇猛
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fu Langfu Hangzhou Biological Technology Co ltd
Original Assignee
Fu Langfu Hangzhou Biological Technology 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
Publication date
Application filed by Fu Langfu Hangzhou Biological Technology Co ltd filed Critical Fu Langfu Hangzhou Biological Technology Co ltd
Priority to CN202010615094.9A priority Critical patent/CN113855849A/en
Publication of CN113855849A publication Critical patent/CN113855849A/en
Pending legal-status Critical Current

Links

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
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0023Polysaccharides
    • 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/20Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing organic 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/24Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/26Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/28Polysaccharides or their derivatives
    • 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • 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
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/46Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
    • 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
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0014Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0019Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061Use of materials characterised by their function or physical properties
    • 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
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061Use of materials characterised by their function or physical properties
    • A61L26/008Hydrogels or hydrocolloids

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Materials Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention relates to a dressing composition and a preparation method and application thereof, in particular to a dressing composition prepared by using hyaluronic acid (sodium), cross-linked hyaluronic acid (sodium) and polylactic acid-glycolic acid copolymer as a skeleton, and a preparation method and application thereof.

Description

Dressing composition and preparation method and application thereof
Technical Field
The invention belongs to the technical field of biomedical engineering, and particularly relates to a dressing composition and a preparation method and application thereof, in particular to a dressing composition prepared by using hyaluronic acid (sodium), cross-linked hyaluronic acid (sodium) and PLGA as a skeleton, and a preparation method and application thereof.
Background
Traditional medical dressings, including cotton gauze, non-woven fabrics etc. when being used for the face of wound, though have advantages such as the material is easily obtained, simple manufacture, low price, still have obvious shortcoming: the absorption capacity is small, namely the wound surface exudate is large, and the wound surface exudate needs to be frequently replaced; the permeability is too high, so that the wound surface is easy to dehydrate or be polluted by external dust; dressing adhesion wound surface brings pain of dressing change, potential secondary wound and inapplicability to treatment of difficult-to-heal wound surfaces such as ulcer and the like. The traditional medical dressing is used for healing wounds, the theoretical basis is a dry healing theory, the traditional medical view is that the wound healing needs the action of a dry environment and oxygen, the wound is clean and favorable for healing, and therefore the traditional gauze dressing and the like or directly exposed wounds are all based on the dry healing theory. However, dry healing therapy faces a variety of problems in the treatment of chronic wounds that are difficult to resolve, such as the formation of dry, hard and thick scabs in necrotic tissue, possible accumulation of pus and fluid under the scab, potential and unsmooth drainage of sinus tracts, necrosis of exposed bones and tendons, and the like. In addition, against the theory of dry healing: the oxygen utilization of human beings requires the oxygen and action of hemoglobin, and atmospheric oxygen is not directly available to wounds.
The theory of moist healing is that under the aseptic condition, the closed dressing and/or the liquid medicine are used to maintain the environment and the temperature of the wound which are suitable for moistening, which is beneficial to the formation of epithelial cells of the wound surface and promotes the growth of granulation tissues and the healing of the wound surface. The medical hydrogel or hydrocolloid dressing is used for healing of a wound surface, is mainly based on a wet healing theory, namely, the medical hydrogel or hydrocolloid dressing accelerates the healing of the wound surface while providing a wet environment, covering and protecting the wound surface and absorbing seepage of the wound surface, but is generally not suitable for wounds with more seepage, fragile surrounding skin or infected wounds.
Currently, dressings based on the theory of wet healing and available on the market include: 1. the hydrogel dressing is a water-activated colloidal ointment or gel, is mainly suitable for partial and full-skin injured wounds and yellow slough or black necrotic wounds, can enable the wounds to generate hydration, provides an ideal moist environment, promotes autolysis of necrotic tissues, accelerates wound healing, and has the effect of filling the wounds. The disadvantage is that it has no barrier function and can not prevent the invasion of the surrounding bacteria; the skin around the wound is easily soaked when the ointment is applied. 2. The hydrocolloid dressing is suitable for wounds with damaged superficial and partial cortex and wounds with small to medium exudation. The product is mainly characterized by comprising hydrophilic particles and hydrophobic polymers, can absorb a small to medium amount of wound exudate, forms a moist wound healing environment, does not tear new granulation tissues, promotes the synthesis of epithelial cell collagen, accelerates the growth of microvessels, and prevents the invasion of external bacteria. The disadvantages include: it is not suitable for wounds with much exudation, wounds with weak peripheral skin due to potential peripheral skin damage at the time of peeling, wounds which are not claimed to be used for deep potential, and the like. 3. The alginate dressing takes alginic acid fiber in ocean as a main raw material, and is mainly suitable for medium to large-amount exudation wounds and mild bleeding wounds. The product is characterized in that the product can absorb the seepage amount 17-20 times of the weight of the product, calcium ion exchange between the colloid and the wound surface can quickly stop bleeding of the wound, and the platelet is absorbed to promote the generation of blood clots, thereby playing a role in blood coagulation. The disadvantage is that it is not suitable for dry wounds and generally needs to be used with other dressings. 4. The foam dressing is suitable for most wounds, and the product is characterized by being capable of absorbing a large amount of middle-to-large-amount seepage liquid, low in permeability, capable of keeping the wound surface moist for a long time, capable of preventing granulation tissue from being edematous, free of soaking surrounding skin, convenient to use and good in compliance. It has some drawbacks: when the wound dressing is used for a low-exudation wound surface, the self debridement process is not facilitated, the wound surface cannot be observed due to opaqueness, and the use cost is relatively high. 5. The ion dressing is suitable for wound infected with purulent secretion and features that the dressing contains silver or silver compound, and the silver ion has antibacterial and antiphlogistic functions and the released silver ion has antiphlogistic and bactericidal functions. However, the ion dressing has the following disadvantages: the products on the market have no capability of absorbing seepage, are easy to cause coloring on wounds, can cause silver ion allergy, and have potential risk of damaging liver and kidney after long-term use.
Biocompatible polymers have many important physiological functions, and common biocompatible polymers include: polysaccharides, proteins, synthetic polymers, and the like. Natural hyaluronic acid is a natural heteropolysaccharide composed of alternating units of D-glucuronic acid and N-acetyl-D-glucosamine, first extracted from the vitreous of bovine eyes in 1934 by professor Karl Mayer, and has since been found to be widely present in connective tissues of humans and other vertebrates, such as the intercellular spaces, tissues of the motor joints, umbilical cord, skin, cartilage, blood vessel walls, synovial fluid, and comb, all of which contain hyaluronic acid. Hyaluronic acid is usually present in the form of a sodium salt in the physiological state of the human body. The sodium hyaluronate and the gel thereof are widely applied in the fields of orthopedics, gynecology, orthopedics and the like, and can also be used as an ophthalmic preparation carrier or directly used as an ophthalmic preparation for ophthalmic surgery, namely the sodium hyaluronate products also have important application in the ophthalmic surgery. Sodium hyaluronate is also an important component of joint synovial fluid and cartilage. Although natural hyaluronic acid or its sodium salt has a wide application field and definite application advantages, natural hyaluronic acid or its sodium salt also has definite disadvantages. The method comprises the following steps: short half-life in vivo; poor stability and easy degradation; has the disadvantage of being too hydrophilic. In order to overcome the above-mentioned disadvantages of natural hyaluronic acid or its sodium salt, common means employed in the prior art are chemical modification and intermolecular crosslinking, i.e. formation of chemically modified hyaluronic acid and crosslinked hyaluronic acid. The hyaluronic acid sold in the market at present is mainly prepared by extracting from animal tissues and can also be prepared by a microbial fermentation mode; the chemically modified hyaluronic acid and the cross-linked hyaluronic acid are generally prepared by chemical synthesis modification based on the source of the existing hyaluronic acid.
Polylactic acid-glycolic acid copolymer, abbreviated as PLGA in English, is an important biodegradable high molecular material, can be used in the medical treatment or pharmacy field, because have advantages such as non-toxic safe, good biocompatibility and degradation property controllable, it is an ideal material for preparing microballoons in the pharmacy field, and has already been approved by the US FDA to be used for preparing carriers for microspheres for injection, the products that have been successfully marketed or developed and matured at present include octreotide sustained-release microballoons for injection, leuprorelin sustained-release microballoons for injection, triptorelin sustained-release microballoons for injection, etc. Although PLGA is used as a pharmaceutical adjuvant to be well applied in the fields of microspheres for injection and the like, no mature research and development example is found in the prior art when PLGA is used for preparing medical devices, particularly medical wound dressings. The biodegradable performance advantages of PLGA are reflected in: the degradation products are lactic acid and glycolic acid, and the two degradation products are byproducts of human metabolic pathways, so that no toxic or side effect on human bodies is generated when PLGA is applied to the composition of medical materials or biological materials.
The external dressing managed according to medical instruments in China has a wide application range. Chronic venous ulcers are the most severe and refractory complication of Chronic Venous Insufficiency (CVI) of the lower extremities, with a total incidence of about 0.4% to 1.3% in the population. Venous ulcers are reported in about 12% to 14% of CVI patients, and the most important aspect of venous ulcer treatment is the prevention of ulcer formation. Dressing therapy may be used as an advantageous or alternative therapy for the clinical treatment of venous ulcers.
The medical hydrocolloid or hydrogel dressing in the market at present mainly uses functional components such as chitosan, sodium alginate, silver ions and the like, the products have poor wound healing promotion capability, the anti-inflammation, hemostasis and pain relieving effects are not obvious, the safety needs to be reevaluated, particularly, the treatment effect time for various chronic body surface wounds including ulcer, diabetic foot, lower limb venous/arterial ulcer, pressure sore, burn, scald and other wounds cannot enable patients to reach satisfaction, the treatment process can cause the patients to feel painful, and the compliance of the patients is influenced.
Disclosure of Invention
In view of the above circumstances, the present invention aims to provide a medical dressing composition, a preparation method and an application thereof, aiming at the defects of various hydrogel dressings or hydrocolloid dressings based on the wet healing theory in the prior art, the dressing composition has the effects of lasting moisture retention, rapid, lasting and effective absorption of wound exudate, antibiosis and anti-inflammation, acceleration of healing of various acute and chronic wounds, adhesion prevention, difficult formation of dry scab, avoidance of secondary injury during dressing change, reduction of dressing change frequency, and reduction of scar generation on the basis. Is suitable for various wounds, especially wounds with no more than moderate exudation, including but not limited to body surface ulcer, diabetic foot, lower limb venous/arterial ulcer, pressure sore, burn, scald, etc.
According to one aspect of the present invention, there is provided a dressing composition comprising, in weight percent:
Figure BDA0002563475980000041
Figure BDA0002563475980000051
in a preferred embodiment, the dressing composition comprises, in weight percent:
Figure BDA0002563475980000052
it will be appreciated by those skilled in the art that the dressing composition of the present invention may further comprise a suitable amount of a pH adjusting agent, if necessary. Preferable pH adjusting agents include triethanolamine, acetic acid, and the like. Preferably, the dressing composition of the invention has a pH of 6.0 to 7.0, most preferably 6.5. + -. 0.1.
According to the invention, hyaluronic acid and/or sodium hyaluronate may be either commercially available or homemade, preferably, the weight average molecular weight thereof may range from 10k Da to 400k Da; further preferably, the weight average molecular weight ranges from 200k Da to 400k Da; more preferably, it has a weight-average molecular weight ranging between 250 and 350k Da; most preferably, the weight average molecular weight is in the range of 290-310 kDa.
According to the invention, the cross-linked hyaluronic acid and/or the cross-linked sodium hyaluronate may be either commercially available or self-made, preferably, the weight average molecular weight thereof may range from 1000k Da to 3000k Da; further preferably, the weight average molecular weight ranges from 1500k Da to 2500 Da; more preferably, the weight average molecular weight ranges between 1800k Da to 2200k Da; most preferably, the weight average molecular weight may range between 1900k Da and 2100k Da.
According to the present invention, it is preferable that the ratio of lactic acid to glycolic acid in the polylactic acid-glycolic acid copolymer is 50: 50; preferably, the weight average molecular weight of the polylactic acid-glycolic acid copolymer may range between 10000Da to 20000 Da. It will be appreciated by those skilled in the art that small amounts, for example up to 20%, of other types of polylactic acid-glycolic acid copolymers may be incorporated, for example polylactic acid-glycolic acid copolymers with a ratio of lactic acid to glycolic acid of 25:75 or 75: 25.
In the dressing composition, hyaluronic acid and/or sodium hyaluronate, cross-linked hyaluronic acid and/or cross-linked sodium hyaluronate and polylactic acid-glycolic acid copolymer are used as skeleton components to support the whole dressing composition together, so that materials such as natural fibers, artificial fibers, biodegradable fibers and the like can be avoided, the dressing composition has excellent biocompatibility, and particularly, due to the fact that the skeleton components are used and matched with other components, the dressing composition can achieve the effects of keeping moisture for a long time, absorbing wound exudate quickly, durably and effectively, resisting bacteria and diminishing inflammation, accelerating healing of various acute and chronic wounds and the like, and can reduce generation of scars.
According to the invention, the poloxamer is preferably poloxamer 407.
According to the invention, carbomer is preferably carbomer 941.
It will be understood by those skilled in the art that the dressing composition of the present invention may also contain an appropriate amount of a substance having anti-inflammatory activity, including but not limited to chemically synthesized drugs and/or plant extracts, etc., and may also contain an appropriate amount of various active substances known in the art to be beneficial for wound healing.
According to another aspect of the present invention, there is provided a method of preparing the dressing composition described above, comprising the steps of:
(1) dissolving polylactic acid-glycolic acid copolymer in solvent such as ethyl acetate to obtain solution; placing hyaluronic acid and/or sodium hyaluronate and cross-linked hyaluronic acid and/or cross-linked sodium hyaluronate in water, and stirring until homogenization; mixing homogenized liquid of sodium hyaluronate and/or sodium hyaluronate and crosslinked hyaluronic acid and/or crosslinked sodium hyaluronate with solution of polylactic acid-glycolic acid copolymer, and stirring until homogenization; adjusting the pH to 6.5-7.5, preferably 7 + -0.1; removing the organic solvent and part of the water, e.g. to a water content of not more than 10%, e.g. freeze drying until the water content is not more than 10%; grinding to particle size below 1000 μm, preferably 10 μm-300 μm to obtain skeleton material;
it will be appreciated by those skilled in the art that, in the above step (1), when preparing a homogenized solution of hyaluronic acid and/or sodium hyaluronate, and cross-linked hyaluronic acid and/or cross-linked sodium hyaluronate, heating may be carried out appropriately, for example, to 50-70 ℃, preferably 55-65 ℃; when the homogenized mixture of sodium hyaluronate and/or sodium hyaluronate and crosslinked hyaluronic acid and/or crosslinked sodium hyaluronate is mixed with the solution of polylactic acid-glycolic acid copolymer, it may be heated to 50-70 deg.C, preferably 55-65 deg.C.
(2) Dissolving propylene glycol in water, adding poloxamer and carbomer, stirring until homogenization, and standing to fully swell to obtain a mixed solution I;
it will be appreciated by those skilled in the art that in step (2) above, heating may be suitably carried out, for example to a temperature of from 40 to 60℃, preferably from 45 to 55℃.
(3) Preparing a mixed solution II containing a framework material, benzyl alcohol, ethanol and water;
(4) after mixing mixture I and mixture II, the pH is adjusted to 6.0-7.0, preferably 6.5 ± 0.1, and all or part of the ethanol and part of the water is removed, e.g. by air drying, until the water content does not exceed 25%, preferably 5-25%, most preferably 15-25%.
The dressing composition can be used alone or coated on other medical materials such as medical gauze and medical plastic films. For example, the dressing composition of the present invention may be applied directly to a wound site of a patient, or coated on other medical materials; the dressing composition of the present invention can also be processed into various shapes such as a sheet, a plug, etc. for use alone or in combination with other medical materials.
According to another aspect of the present invention there is provided a dressing composition prepared by the above process.
According to another aspect of the present invention, there is provided a dressing comprising the dressing composition described above.
According to another aspect of the invention, the present invention provides the use of a dressing composition as described above in the manufacture of a dressing.
Compared with the prior art, the invention has the beneficial effects that:
1. the invention firstly provides a skeleton component of a medical dressing prepared by mixing hyaluronic acid and/or sodium hyaluronate, cross-linked hyaluronic acid and/or cross-linked sodium hyaluronate with polylactic acid-glycolic acid copolymer, which has excellent water absorption, can effectively absorb seepage, can be connected into a sticky film after absorbing moisture or liquid, is attached to the surface of a wound, and is beneficial to the treatment of amorphous wound or wound with small surface and deeper inside the wound.
2. The dressing disclosed by the invention can maintain the moist healing environment of the wound on the basis of effectively absorbing seepage, promote the ordered growth of granulation and epithelial tissues, accelerate the healing of the wound, reduce the formation of scars, and is high in safety and free of irritation.
Detailed Description
The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, it should be understood that various changes or modifications can be made by those skilled in the art after reading the description of the present invention, and such equivalents also fall within the scope of the invention.
Preparation example 1 preparation of a medical dressing scaffold Material
Dissolving PLGA (model 50-50, weight average molecular weight 15000Da)2.2g in ethyl acetate to obtain PLGA solution;
9.3g of cross-linked sodium hyaluronate (with a weight-average molecular weight of 2000k Da) and 0.95g of sodium hyaluronate (with a weight-average molecular weight of 300k Da) are taken, put into a proper amount of water and stirred at 60 +/-5 ℃ until homogenization is achieved;
adding PLGA solution into the homogenized solution of cross-linked sodium hyaluronate and sodium hyaluronate under the condition of stirring at 60 +/-5 ℃, stirring until homogenization, adjusting the pH to be about 7 by using triethanolamine and/or acetic acid, freeze-drying until the water content is within 10%, and grinding the obtained freeze-dried product into fine powder which is sieved by a 60-mesh sieve, thereby obtaining A13.5g of the medical dressing framework material. Wherein the content of the cross-linked sodium hyaluronate is about 68.9%, the content of the sodium hyaluronate is about 7.0%, the content of the PLGA is about 16.3%, and the water content is about 7.8%.
Preparation example 2 preparation of framework Material for medical dressing
Dissolving PLGA (model 50-50, weight average molecular weight 15000Da)2.45g in ethyl acetate to obtain PLGA solution;
taking 11.75g of cross-linked sodium hyaluronate (with a weight-average molecular weight of 2000k Da) and 0.96g of sodium hyaluronate (with a weight-average molecular weight of 300k Da), putting the cross-linked sodium hyaluronate and the sodium hyaluronate into a proper amount of water, and stirring the mixture at 60 +/-5 ℃ until homogenization;
adding PLGA solution into the homogenized solution of cross-linked sodium hyaluronate and sodium hyaluronate under the condition of stirring at 60 +/-5 ℃, stirring until homogenization, adjusting the pH to be about 7 by using triethanolamine and/or acetic acid, freeze-drying until the water content is within 10%, and grinding the obtained freeze-dried product into fine powder which is sieved by a 80-mesh sieve, thereby obtaining 16.5g of medical dressing framework material B16. Wherein the content of the cross-linked sodium hyaluronate is about 71.2%, the content of the sodium hyaluronate is about 5.8%, the content of the PLGA is about 14.8%, and the water content is about 8.2%.
Example 1 preparation of medical hydrogel dressing 1 with scaffold Material A of preparation example 1
Dissolving 6.25g of propylene glycol in a proper amount of water, adding 1.25g of poloxamer 407 and 1.25g of carbomer 941 into the propylene glycol under the condition of stirring at 50 +/-2 ℃, stirring until homogenization is carried out, and standing for 6 hours to fully swell the mixture to obtain a mixed solution I;
preparing a mixed solution II containing 1.6g of ethanol, 0.25g of benzyl alcohol, 5.0g of the powder of the framework material A prepared in preparation example 1 and an appropriate amount of water;
and (3) mixing the mixed solution I and the mixed solution II, adjusting the pH to 6.5 +/-0.1 by using triethanolamine and/or acetic acid, and airing until the water content is not more than 25%, and simultaneously volatilizing part of ethanol to obtain 17.7g of the medical hydrogel dressing. Wherein, the content of the cross-linked sodium hyaluronate in the framework material A is about 19.5%, the content of the sodium hyaluronate is about 2.0%, the content of the PLGA is about 4.6%, the content of the poloxamer 407 is about 7.1%, the content of the carbomer 941 is about 7.1%, the content of the propylene glycol is about 35.3%, the content of the benzyl alcohol is about 1.4%, the content of the ethanol is about 0.3%, and the water content is about 22.7%.
Example 2 preparation of medical hydrogel dressing 2 with scaffold material B of preparation example 2
Dissolving 5.0g of propylene glycol in a proper amount of water, adding 2.5g of poloxamer 407 and 0.5g of carbomer 941 into the propylene glycol under the condition of stirring at 50 +/-2 ℃, stirring until homogenization is carried out, and standing for 6 hours to fully swell the mixture to obtain a mixed solution I;
preparing a mixed solution II containing 4g of ethanol, 0.5g of benzyl alcohol, 6.25g of the powder of the framework material B prepared in preparation example 2 and a proper amount of water;
and (3) mixing the mixed solution I and the mixed solution II, adjusting the pH to 6.5 +/-0.1 by using triethanolamine and/or acetic acid, and airing until the water content is not more than 25%, and simultaneously volatilizing part of ethanol to obtain 19.0g of the medical hydrogel dressing. Wherein, the content of the cross-linked sodium hyaluronate in the framework material B is about 23.4%, the content of the sodium hyaluronate is about 1.9%, the content of the PLGA is about 4.9%, the content of the poloxamer 407 is about 13.2%, the content of the carbomer 941 is about 2.6%, the content of the propylene glycol is about 26.3%, the content of the benzyl alcohol is about 2.6%, the content of the ethanol is about 0.3%, and the water content is about 24.8%.
Example 3 bacteriostatic Effect of the medical dressings of examples 1-2
In vitro antibacterial tests were conducted on the dressings prepared in examples 1-2, commercially available dressing products (comparative example 1, trade name: Kangfuer debridement adhesive, Kangle-Bao Chinese medical supplies Co., Ltd.), the dressing prepared by mixing the components of example 1 except the skeleton material A (comparative example 2), and a negative control (PBS solution) with reference to the specifications of the test method in appendix C of GB/T15979-2002 hygienic Standard for Disposable sanitary articles.
Test bacteria: staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans.
The test method comprises the following steps: the concentration of the above test bacteria was 104-105cfu/g of bacterial suspension. 0.1mL of the bacterial suspension was uniformly applied to a sheet (2.0 cm. times.3.0 cm, thickness 0.1cm) of the dressing prepared in example 1-2 and the dressing of comparative example 1-2 for 20min, and then the sample was put into 5.0mL of PBS solution, mixing well, adding 0.1mL of bacterial suspension into 5.6mL of PBS solution in the negative control group, fully mixing, respectively taking 0.5mL of each component, placing into a sterile plate, pouring 30mL of nutrient agar culture medium (staphylococcus aureus, escherichia coli and pseudomonas aeruginosa) or improved martin agar culture medium (candida albicans), rotating the plate, fully mixing, placing into a 37 +/-2 ℃ incubator (staphylococcus aureus, escherichia coli and pseudomonas aeruginosa) for culturing for 24 hours or a 2 +/-2 ℃ incubator (candida albicans) for culturing for 72 hours, observing the result, calculating the colony number, and calculating the bacteriostasis rate according to the following formula:
bacteriostasis rate (number of colonies in negative control group-number of colonies in each group)/number of colonies in negative control group
When the bacteriostasis rate is more than or equal to 50% and less than 90%, the tested dressing has bacteriostasis; when the bacteriostasis rate is more than or equal to 90 percent, the test dressing has stronger bacteriostasis.
As shown in Table 1, it can be seen from the data in Table 1 that the dressings of examples 1-2 according to the present invention have superior bacteriostatic activity to the commercially available dressing (comparative example 1) and also to the dressing of example 1 prepared by mixing the components other than the framework material A (comparative example 2).
TABLE 1 results of comparative tests on bacteriostatic effect
Figure BDA0002563475980000111
Example 4 Effect of the medical dressings of examples 1-2
The effect of the medical dressing prepared in example 1-2 in promoting wound healing was examined by wound healing test.
The specific test method is as follows:
test animals: new Zealand white rabbits with the body weight of 1.8 Kg-2.5 Kg are selected and randomly grouped, the observation time points are 3d, 5d, 10d and 15d respectively, and 13 new Zealand white rabbits are selected at each time point. The method comprises the steps of shearing the back of a New Zealand white rabbit 24-72 hours before a test, and then carrying out depilatory treatment by using depilatory cream. The white rabbit is anesthetized by intravenous injection at the ear margin by using 2.0 percent sodium pentobarbital solution according to the amount of 1.0mL/Kg, hot water at 80 ℃ is used for scalding for 10s, the back of the white rabbit is scalded from I degree to shallow II degree, the size is 2.0cm multiplied by 2.0cm, 3 parts on the left side and the right side are in a symmetrical state, and the interval of 6 parts of the scalded needs to reach 2.0cm or more than 2.0 cm.
After 1 day of scald, the medical dressings prepared in examples 1-2 are respectively covered on one scald part on the back of each white rabbit, and the scald parts are respectively used as example group 1 and example group 2; a commercially available dressing product (trade name: Kanghuier debridement adhesive, Kangle Bao Chinese medical supplies Co., Ltd.) was respectively covered on one scald part of the back of each white rabbit as a control group 1; the dressings prepared by mixing the components except the framework material A in the example 1 are respectively covered on one scald part on the back of each white rabbit to serve as a control group 2; common medical gauze covers one scald part on the back of each white rabbit respectively to serve as a control group 3; the last scalded part of the back of each rabbit was treated with only sterilization without dressing, and served as control group 4. The healing rate of the wound was calculated at each sampling time point.
The calculation method of the wound healing rate is as follows: the surface of wound is first traced on translucent paper, then the paper is used as template, and the hard paper with homogeneous texture is cut into the same size, and then weighed with balance, and the mass of the hard paper is used to indirectly express the size of the surface of wound. The wound healing rate was calculated according to the following formula, and the average wound healing rate of 13 rabbits was calculated:
wound healing rate (%) (original wound area-non-healed wound area)/original wound area.
The results of the test are shown in table 2, from which the results of the mean healing rate of the surfaces were created: the scald wound surfaces of the example groups 1-2, which are molded by New Zealand white rabbits, are obviously superior to the control group 1 in the healing effectiveness of the wound surfaces, and have significant differences, namely the medical dressing prepared by the invention has obvious advantages compared with similar products sold on the market; the scald wound surfaces of the example groups 1-2, which are molded by New Zealand white rabbits, are obviously superior to the control groups 2 and 3 in the healing effectiveness of the wound surfaces, and have obvious difference, namely, the medical dressing prepared by the invention has obvious advantages compared with dressings prepared by other components without framework materials and common medical gauze dressings; the example groups 1-2 also had significant advantages in the effectiveness of wound healing compared to the control group 4.
TABLE 2 wound healing test results
Number of days of sampling 3d 5d 10d 15d
Example set 1 Average rate of healing of wound 28.1% 49.2% 80.5% 94.3%
Example group 2 Average rate of healing of wound 29.4% 50.7% 82.0% 93.9%
Control group 1 Average rate of healing of wound 19.4% 37.9% 76.3% 79.1%
Control group 2 Average rate of healing of wound 17.5% 33.8% 61.4% 71.9%
Control group 3 Average rate of healing of wound 16.0% 31.2% 60.3% 73.6%
Control group 4 Average rate of healing of wound 7.9% 20.3% 40.6% 64.1%
The embodiments of the present invention have been described above. However, the present invention is not limited to the above embodiment. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (10)

1. A dressing composition comprising, in weight percent:
Figure FDA0002563475970000011
2. the dressing composition of claim 1, comprising, in weight percent:
Figure FDA0002563475970000012
3. a dressing composition according to claim 1 or 2, wherein the pH of the dressing composition is from 6.0 to 7.0, most preferably 6.5 ± 0.1.
4. A dressing composition according to any one of claims 1 to 3, wherein the weight average molecular weight of the hyaluronic acid and/or sodium hyaluronate is between 10 and 400k Da; preferably between 200 and 400k Da; more preferably between 250-350 k Da; most preferably between 290 and 310k Da.
5. A dressing composition according to any one of claims 1 to 4, wherein the cross-linked hyaluronic acid and/or the cross-linked sodium hyaluronate has a weight average molecular weight between 1000 and 3000 kDa; preferably between 1500k Da and 2500 Da; more preferably between 1800k Da and 2200k Da; most preferably between 1900k Da and 2100k Da.
6. The dressing composition of any one of claims 1 to 5, wherein the polylactic acid-glycolic acid copolymer has a ratio of lactic acid to glycolic acid of 50: 50; preferably, the weight average molecular weight of the polylactic acid-glycolic acid copolymer is between 10000Da and 20000 Da.
7. The dressing composition of any one of claims 1-6, wherein the poloxamer is poloxamer 407; preferably, the carbomer is carbomer 941.
8. A method of preparing a dressing composition according to any one of claims 1 to 7, comprising the steps of:
(1) dissolving polylactic acid-glycolic acid copolymer in solvent such as ethyl acetate to obtain solution; placing hyaluronic acid and/or sodium hyaluronate and cross-linked hyaluronic acid and/or cross-linked sodium hyaluronate in water, and stirring until homogenization; mixing homogenized liquid of sodium hyaluronate and/or sodium hyaluronate and crosslinked hyaluronic acid and/or crosslinked sodium hyaluronate with solution of polylactic acid-glycolic acid copolymer, and stirring until homogenization; adjusting the pH to 6.5-7.5, preferably 7 + -0.1; removing the organic solvent and part of the water, e.g. to a water content of not more than 10%, e.g. freeze drying until the water content is not more than 10%; grinding to particle size below 1000 μm, preferably 10 μm-300 μm to obtain skeleton material;
(2) dissolving propylene glycol in water, adding poloxamer and carbomer, stirring until homogenization, and standing to fully swell to obtain a mixed solution I;
(3) preparing a mixed solution II containing a framework material, benzyl alcohol, ethanol and water;
(4) after mixing mixture I and mixture II, the pH is adjusted to 6.0-7.0, preferably 6.5 ± 0.1, and all or part of the ethanol and part of the water is removed, e.g. by air drying, until the water content does not exceed 25%, preferably 5-25%, most preferably 15-25%.
9. A dressing comprising a dressing composition according to any one of claims 1 to 7.
10. Use of a dressing composition according to any one of claims 1 to 7 in the manufacture of a dressing.
CN202010615094.9A 2020-06-30 2020-06-30 Dressing composition and preparation method and application thereof Pending CN113855849A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202010615094.9A CN113855849A (en) 2020-06-30 2020-06-30 Dressing composition and preparation method and application thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202010615094.9A CN113855849A (en) 2020-06-30 2020-06-30 Dressing composition and preparation method and application thereof

Publications (1)

Publication Number Publication Date
CN113855849A true CN113855849A (en) 2021-12-31

Family

ID=78981318

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202010615094.9A Pending CN113855849A (en) 2020-06-30 2020-06-30 Dressing composition and preparation method and application thereof

Country Status (1)

Country Link
CN (1) CN113855849A (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114306721A (en) * 2022-01-12 2022-04-12 河北卫崭医疗科技有限公司 Waterproof and breathable foam dressing and preparation method thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101313915A (en) * 2007-05-30 2008-12-03 北京泰克美科技有限公司 Application of hyaluronic acid and its salt, crosslinked hyaluronic acid and its salt in preparing medicament for treating or preventing sea-soaking injury
EP2647649A1 (en) * 2012-04-04 2013-10-09 Andreas Witt Hyaluronic acid gel, method for producing the hyaluronic acid gel and medical product with the hyaluronic acid gel
CN104873535A (en) * 2015-05-15 2015-09-02 厦门迅朗生物技术有限公司 Anti-adhering liquid of polylactic acid-hydroxyacetic acid copolymer and preparation method thereof
US20160175342A1 (en) * 2013-08-09 2016-06-23 Genbiotech Continuous release compositions made from hyaluronic acid, and therapeutic applications of same

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101313915A (en) * 2007-05-30 2008-12-03 北京泰克美科技有限公司 Application of hyaluronic acid and its salt, crosslinked hyaluronic acid and its salt in preparing medicament for treating or preventing sea-soaking injury
EP2647649A1 (en) * 2012-04-04 2013-10-09 Andreas Witt Hyaluronic acid gel, method for producing the hyaluronic acid gel and medical product with the hyaluronic acid gel
US20160175342A1 (en) * 2013-08-09 2016-06-23 Genbiotech Continuous release compositions made from hyaluronic acid, and therapeutic applications of same
CN104873535A (en) * 2015-05-15 2015-09-02 厦门迅朗生物技术有限公司 Anti-adhering liquid of polylactic acid-hydroxyacetic acid copolymer and preparation method thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
冯寿全, 上海科学技术出版社 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114306721A (en) * 2022-01-12 2022-04-12 河北卫崭医疗科技有限公司 Waterproof and breathable foam dressing and preparation method thereof

Similar Documents

Publication Publication Date Title
Moraes et al. Bacterial cellulose/collagen hydrogel for wound healing
CN108014366B (en) Marine biological material composite hydrogel dressing and preparation method thereof
AU636686B2 (en) Wound gel compositions and methods of using them
Sheokand et al. Natural polymers used in the dressing materials for wound healing: Past, present and future
Shyna et al. A nonadherent chitosan-polyvinyl alcohol absorbent wound dressing prepared via controlled freeze-dry technology
Khorasani et al. The effects of Aloe Vera cream on split-thickness skin graft donor site management: a randomized, blinded, placebo-controlled study
Ghadi et al. Microparticulate polymers and hydrogels for wound healing
CN107185031A (en) A kind of medical dressing with bioactivity and preparation method thereof
Zahra et al. Exploring the recent developments of alginate silk fibroin material for hydrogel wound dressing: a review
CN111481735A (en) Medical antibacterial wound-protecting hydrogel dressing and preparation method thereof
Shi et al. Recent progresses of collagen dressings for chronic skin wound healing
CN104840428A (en) Hyaluronic acid-chitosan microsphere carrying epidermal growth factor and preparation method and application of hyaluronic acid-chitosan microsphere
CN111073001A (en) Amphoteric glucan hydrogel and application thereof
CN114917403A (en) Mussel-like mucin gel as well as preparation method and application thereof
CN112891615B (en) Liquid adhesive bandage and preparation method thereof
RU2699362C2 (en) Composition based on cerium dioxide nanoparticles and brown algae polysaccharides for treating wounds
CN113855849A (en) Dressing composition and preparation method and application thereof
CN104984383A (en) Novel hydrogel dressing for treating burn wound and preparation method thereof
Nqoro et al. Alginate-based wound dressings for skin healing and regeneration
CN109432483B (en) Medical dressing for accelerating wound healing and preparation method and application thereof
Bhoopathy et al. A comprehensive review on natural therapeutics for Wound Treatment
RU2284824C1 (en) Surgical antiseptic glue "argacol"
CN105688271A (en) Propolis dressing for healing wounds and preparation method of propolis dressing
CN113855850A (en) Dressing composition and preparation method and application thereof
Sikka et al. Modern developments in burn wound dressing

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
RJ01 Rejection of invention patent application after publication
RJ01 Rejection of invention patent application after publication

Application publication date: 20211231