CN116196466A - Mussel mucin cream dressing and preparation method thereof - Google Patents

Mussel mucin cream dressing and preparation method thereof Download PDF

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Publication number
CN116196466A
CN116196466A CN202310256158.4A CN202310256158A CN116196466A CN 116196466 A CN116196466 A CN 116196466A CN 202310256158 A CN202310256158 A CN 202310256158A CN 116196466 A CN116196466 A CN 116196466A
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China
Prior art keywords
mussel mucin
cream
oil phase
phase
cream dressing
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CN202310256158.4A
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Chinese (zh)
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王毅
乔保坤
崔雪君
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Xi'an Denos Medical Technology Co ltd
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Xi'an Denos Medical Technology Co ltd
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    • 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
    • A61L26/0028Polypeptides; Proteins; Degradation products thereof
    • A61L26/0047Specific proteins or polypeptides not covered by groups A61L26/0033 - A61L26/0042
    • 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
    • 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
    • A61L26/0066Medicaments; Biocides
    • 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412Tissue-regenerating or healing or proliferative agents
    • 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602Type of release, e.g. controlled, sustained, slow
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The application relates to the technical field of chemistry and provides a mussel mucin cream dressing and a preparation method thereof. The preparation method comprises the following steps: obtaining mussel mucin, oily matrix, sodium hyaluronate, silk fibroin and pH regulator in a preset mass percentage; after mussel mucin is dissolved in purified water and heated to 80+/-5 ℃, a pH regulator is added into the mussel mucin, and the pH value is regulated to a preset range; adding sodium hyaluronate and silk fibroin into mussel mucin, and fully stirring to serve as a water phase for standby; heating the oily matrix to 75-90 ℃ to serve as an oil phase for standby; adding the oil phase into the water phase, and stirring the oil phase and the water phase by a stirring device until the oil phase and the water phase are uniformly mixed, thus obtaining the mussel mucin cream dressing of the oil-in-water system. The oil-in-water system changes the storage condition of the product from special refrigeration or freezing storage into conventional normal-temperature storage, saves the storage and storage cost and is more convenient to use.

Description

Mussel mucin cream dressing and preparation method thereof
Technical Field
The application relates to the technical field of chemistry, in particular to a mussel mucin cream dressing and a preparation method thereof.
Background
Mussel mucin has high molecular characteristics, is rich in dopa groups and has a large number of positive charges, can effectively promote wound healing, has high biocompatibility and low cytotoxicity, and has a very high application prospect.
When mussel mucin is prepared into products such as dressing, the mussel mucin needs to be sterilized. However, mussel mucin is easily oxidized and crosslinked due to its very active intramolecular dopa groups, thus losing its associated function. The traditional irradiation sterilization mode can cause protein degradation or oxidation crosslinking precipitation, so that a mussel mucin dressing which can be stably sterilized and stored at normal temperature is urgently needed.
Disclosure of Invention
The application aims at overcoming the defects in the prior art, and provides a mussel mucin cream dressing and a preparation method thereof, so as to solve the problem that the mussel mucin is degraded or separated out due to the traditional sterilization process.
In order to achieve the above purpose, the technical scheme adopted in the application is as follows:
in a first aspect, the present application provides a method for preparing a mussel mucin cream dressing, comprising:
obtaining mussel mucin, oily matrix, sodium hyaluronate, silk fibroin and pH regulator in a preset mass percentage; after mussel mucin is dissolved in purified water and heated to 80+/-5 ℃, a pH regulator is added into the mussel mucin, and the pH value is regulated to a preset range; adding sodium hyaluronate and silk fibroin into mussel mucin, and fully stirring to serve as a water phase for standby; heating the oily matrix to 75-90 ℃ to serve as an oil phase for standby; adding the oil phase into the water phase, and stirring the oil phase and the water phase by a stirring device until the oil phase and the water phase are uniformly mixed to obtain the mussel mucin cream dressing.
The beneficial effects of this application are: the mussel mucin cream dressing prepared by the preparation method of the mussel mucin cream dressing is cream of an oil-in-water system, and can solve the problem that dopa groups contained in mussel mucin are easy to oxidize. The oil-in-water system can avoid unstable and layered phenomena of the product after the traditional wet heat sterilization. And the oil-in-water system can effectively avoid degradation of protein molecules in the storage period, and the product can be stored at normal temperature. The storage condition of the product is changed from special refrigeration or freezing storage to conventional normal-temperature storage, the storage and storage cost is saved, and the use is more convenient.
In some embodiments, the preset mass percent comprises: the mass percentage of mussel mucin is 3% -8%; the mass percentage of the oily matrix is 5% -20%; the mass percentage of the sodium hyaluronate is 6-16%; the mass percentage of silk fibroin is 1% -5%; the balance being purified water.
In some embodiments, after obtaining the mussel mucin cream dressing, further comprising: and (3) filling after the mussel mucin cream dressing is reduced to a preset temperature, and sterilizing the filled mussel mucin cream dressing to obtain the sterile mussel mucin cream dressing.
In some embodiments, the mussel mucin cream is a cream of an oil-in-water system.
In some embodiments, the predetermined range of pH values includes: 3.0-4.2.
In some embodiments, stirring the oil phase and the water phase by a stirring device until the oil phase and the water phase are uniformly mixed comprises: stirring the oil phase and the water phase at 1000-1500r/min for 5-20min by a stirring device.
In some embodiments, the oleaginous base comprises at least one of cetostearyl alcohol, glyceryl monostearate, glyceryl stearate, polyether-10 behenate, polyether-25 behenate and a C10-C30 alkyl acrylate cross-linked polymer.
In some embodiments, the pH adjuster comprises at least one of citric acid, boric acid, acetic acid, phosphoric acid, hydrochloric acid, triethanolamine, sodium hydroxide, and potassium hydroxide.
In a second aspect, the present application provides a mussel mucin cream dressing comprising: mussel mucin, oily matrix, sodium hyaluronate, silk fibroin and pH regulator.
In some embodiments, the mussel mucin is 3% -8% by mass; the mass percentage of the oily matrix is 5% -20%; the mass percentage of the sodium hyaluronate is 6-16%; the mass percentage of silk fibroin is 1% -5%; the balance being purified water.
The advantageous effects of the second aspect can be referred to in the first aspect.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered limiting the scope, and that other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
Fig. 1 shows a mussel mucin cream dressing prepared in example 1 in the preparation method of the mussel mucin cream dressing provided in the present application;
fig. 2 shows a mussel mucin cream dressing prepared in comparative example 2 in the preparation method of the mussel mucin cream dressing provided in the present application;
fig. 3 shows a mussel mucin cream dressing prepared in comparative example 5 in the preparation method of the mussel mucin cream dressing provided in the present application;
fig. 4 shows an electrophoresis pattern of the mussel mucin cream dressing prepared by the preparation method of the mussel mucin cream dressing provided by the application.
Detailed Description
For the purposes of making the objects, technical solutions and advantages of the present application more apparent, the technical solutions of the present application will be clearly and completely described below by means of examples, with reference to the accompanying drawings, and it is apparent that the described examples are some, but not all, examples of the present application.
It is noted that all percentages, fractions and ratios are calculated on the total mass of the composition of the invention, unless otherwise indicated. All of the mass of the ingredients listed, unless otherwise indicated, are given to the active substance content and therefore they do not include solvents or by-products that may be included in commercially available materials. The term "mass percent" herein may be represented by the symbol "%".
All molecular weights herein are weight average molecular weights expressed in daltons, unless indicated otherwise.
All formulations and tests herein take place in an environment of 25 ℃, unless otherwise indicated.
The terms "comprising," "including," "containing," "having," or other variations thereof herein are intended to cover a non-closed inclusion, without distinguishing between them. The term "comprising" means that other steps and ingredients may be added that do not affect the end result. The term "comprising" also includes the terms "consisting of …" and "consisting essentially of …". The compositions and methods/processes of the present invention comprise, consist of, and consist essentially of the essential elements and limitations described herein, as well as additional or optional ingredients, components, steps, or limitations of any of the embodiments described herein. The terms "efficacy," "performance," "effect," "efficacy" are not differentiated herein and will not be explained one by one.
The dressing is a medical product for protecting the wound surface and promoting the healing of the wound surface. The dressing prepared from mussel mucin has high molecular characteristics, is rich in dopa groups and has a large number of positive charges, can effectively promote wound healing, and has high biocompatibility and low cytotoxicity, so that the dressing has a very high application prospect.
But also because the dopa groups in the molecule are very active, they are easily oxidized and crosslinked to lose the relevant functions, and proteins can be precipitated from the solution due to the oxidized and crosslinked. The traditional irradiation sterilization mode can cause protein degradation or oxidation crosslinking precipitation, so that a mussel mucin dressing which can be stably sterilized and stored at normal temperature is urgently needed.
In this regard, the present application provides a method of preparing a recombinant mussel mucin cream dressing comprising: obtaining mussel mucin, oily matrix, sodium hyaluronate, silk fibroin and pH regulator in a preset mass percentage; after mussel mucin is dissolved in purified water and heated to 80+/-5 ℃, a pH regulator is added into the mussel mucin, and the pH value is regulated to a preset range; adding sodium hyaluronate and silk fibroin into mussel mucin, and fully stirring to serve as a water phase for standby; heating the oily matrix to 75-90 ℃ to serve as an oil phase for standby; adding the oil phase into the water phase, and stirring the oil phase and the water phase by a stirring device until the oil phase and the water phase are uniformly mixed to obtain the mussel mucin cream dressing.
Wherein, the oil phase matrix is heated to 75-90 ℃ to ensure the grease to be completely melted.
In some embodiments, the mussel mucin may be recombinant mussel mucin or naturally extracted. As an example, when recombinant mussel mucin is used, the recombinant mussel mucin may be of fp-151 type, which is genetically recombinant. The fp-151 type recombinant mussel mucin is a recombinant protein composed of 6 MAP1 type (fp-1) decapeptide repeats of MAP5 type (fp-5) at the C-terminal and N-terminal. The preparation of the recombinant mussel mucin can be carried out by stirring the mussel mucin freeze-dried sponge in purified water until the mussel mucin freeze-dried sponge is completely dissolved, and heating the mussel mucin to 80+/-5 ℃ to obtain the recombinant mussel mucin.
The mussel mucin cream dressing prepared by the preparation method of the mussel mucin cream dressing provided by the embodiment is cream of an oil-in-water system, and can solve the problem that dopa groups contained in mussel mucin are easy to oxidize. The oil-in-water system can avoid unstable and layered phenomena of the product after the traditional wet heat sterilization. And the oil-in-water system can effectively avoid degradation of protein molecules in the storage period, and the product can be stored at normal temperature. The storage condition of the product is changed from special refrigeration or freezing storage to conventional normal-temperature storage, the storage and storage cost is saved, and the use is more convenient.
In some embodiments, the preset mass percent comprises: the mass percentage of mussel mucin is 3% -8%; the mass percentage of the oily matrix is 5% -20%; the mass percentage of the sodium hyaluronate is 6-16%; the mass percentage of silk fibroin is 1% -5%, and the balance is purified water.
In some embodiments, after obtaining the mussel mucin cream dressing, further comprising: and (3) filling after the mussel mucin cream dressing is reduced to a preset temperature, and sterilizing the filled mussel mucin cream dressing to obtain the sterile mussel mucin cream dressing.
The sterilization treatment of the filled mussel mucin cream dressing can keep the filled mussel mucin cream dressing for 9-30 minutes at the temperature of more than 121 ℃ so as to realize the sterilization treatment of the mussel mucin cream dressing.
Because the mussel mucin cream dressing provided by the embodiment utilizes the amphoteric characteristic of mussel mucin to obtain an oil-in-water system, the phenomenon that oil-water layering easily occurs in high-temperature sterilization of traditional cream dressing is avoided, and the product is kept in an original state after the product is subjected to moist heat sterilization treatment, so that a novel sterilization mode is provided for the sterile cream dressing.
The mussel mucin emulsifiable paste prepared by the invention is an oil-in-water emulsifiable paste. The microscopic spherical liquid drops formed by the oil-in-water system reduce the contact between oxygen in the air and recombinant mussel mucin to a certain extent, so that the oxidation crosslinking is prevented, and on the other hand, the microscopic spherical liquid drops reduce the intermolecular interaction force of mussels and the intermolecular oxidation crosslinking, so that the protein crosslinking precipitation is effectively prevented, and the protein stability is improved.
In some embodiments, the predetermined range of pH values includes: 3.0-4.2.
In some embodiments, the pH adjuster comprises at least one of citric acid, boric acid, acetic acid, phosphoric acid, hydrochloric acid, triethanolamine, sodium hydroxide, and potassium hydroxide.
In some embodiments, stirring the oil phase and the water phase by a stirring device until the oil phase and the water phase are uniformly mixed comprises: stirring the oil phase and the water phase at 1000-1500r/min for 5-20min by a stirring device.
In some embodiments, the oleaginous base comprises at least one of cetostearyl alcohol, glyceryl monostearate, glyceryl stearate, polyether-10 behenate, polyether-25 behenate and a C10-C30 alkyl acrylate cross-linked polymer.
The application also provides a mussel mucin cream dressing. The mussel mucin cream dressing can be prepared by a preparation method of the mussel mucin cream dressing.
In some embodiments, the mussel mucin cream dressing comprises: mussel mucin, oily matrix, sodium hyaluronate, silk fibroin and pH regulator.
In some embodiments, the mussel mucin is 3% -8% by mass; the mass percentage of the oily matrix is 5% -20%; the mass percentage of the sodium hyaluronate is 6-16%; the mass percentage of silk fibroin is 1% -5%; the balance being purified water.
The mussel mucin cream dressing in this example includes mussel mucin and sodium hyaluronate and silk fibroin. The three substances form a reticular structure which can play a good role in drug slow release and provide an administration way for oil-soluble functional raw materials.
The method of preparing the mussel mucin cream dressing is further described below by way of examples and comparative examples.
Example 1
In this embodiment, the mussel mucin accounts for 5% by mass, the oily matrix comprises 3% by mass of glyceryl monostearate, 5% by mass of cetostearyl alcohol, 10% by mass of sodium hyaluronate, and 3% by mass of silk fibroin. The preparation method comprises the following steps of:
(1) 5% mussel mucin freeze-dried sponge is stirred in purified water to dissolve completely and heated to 80 ℃.
(2) Adding a pH regulator to adjust the pH to 4.0.
(3) Adding 10% of sodium hyaluronate and 3% of silk fibroin, and fully stirring to serve as a water phase for standby.
(4) 3% of glyceryl monostearate and 5% of cetostearyl alcohol are heated to 80 ℃ until the solid grease is completely dissolved and used as an oil phase for standby.
(5) Adding the oil phase into the water phase, stirring at high speed of 1000r/min for 10min until the oil phase is completely and uniformly mixed, cooling to normal temperature, and filling.
(6) And (5) after filling, carrying out damp-heat sterilization on the product in a high-pressure steam sterilization cabinet to obtain the sterile recombinant mussel mucin cream dressing.
Example 2
In this embodiment, the mussel mucin accounts for 8% by mass, the oily matrix comprises 20% by mass of cetostearyl alcohol, 16% by mass of sodium hyaluronate and 5% by mass of silk fibroin. The preparation method comprises the following steps of:
(1) 8% mussel mucin freeze-dried sponge is stirred and dissolved completely in purified water and heated to 85 ℃.
(2) The pH was adjusted to 4.2 by adding a pH adjustor.
(3) Adding 16% of sodium hyaluronate and 5% of silk fibroin, and stirring thoroughly to obtain water phase for use.
(4) Heating 20% cetostearyl alcohol to 90 ℃ until the solid grease is completely dissolved, and taking the solid grease as an oil phase for standby.
(5) Adding the oil phase into the water phase, stirring at a high speed of 1500r/min for 20min until the oil phase is completely and uniformly mixed, cooling to normal temperature, and filling.
(6) And (5) after filling, carrying out damp-heat sterilization on the product in a high-pressure steam sterilization cabinet to obtain the sterile recombinant mussel mucin cream dressing.
Example 3
In the embodiment, the mussel mucin accounts for 3% by mass, the oily matrix comprises 5% by mass of behenyl polyether-25, 6% by mass of sodium hyaluronate and 1% by mass of silk fibroin. The preparation method comprises the following steps of:
(1) 3% mussel mucin freeze-dried sponge is stirred in purified water to dissolve completely and heated to 75 ℃.
(2) Adding a pH regulator to adjust the pH to 3.0.
(3) Adding sodium hyaluronate 6% and silk fibroin 1%, stirring thoroughly, and taking as water phase for use.
(4) 5% of behenyl alcohol polyether-25 is heated to 75 ℃ until the solid grease is completely dissolved and is used as an oil phase for standby.
(5) Adding the oil phase into the water phase, stirring at high speed of 1000r/min for 5min until the oil phase is completely and uniformly mixed, cooling to normal temperature, and filling.
(6) And (5) after filling, carrying out damp-heat sterilization on the product in a high-pressure steam sterilization cabinet to obtain the sterile recombinant mussel mucin cream dressing.
Comparative example 1
The raw materials and the mass percentages of the raw materials used in this comparative example were the same as in example 1, but differ from example 1 in that the order of addition of the raw materials was adjusted, specifically as follows:
(1) Adding 10% of sodium hyaluronate and 3% of silk fibroin into purified water, stirring for full dissolution, and heating to 80 ℃.
(2) Adding a pH regulator to adjust the pH to 4.0.
(3) Adding 5% mussel mucin freeze-dried sponge, and stirring thoroughly to obtain water phase for use.
(4) 3% of glyceryl monostearate and 5% of cetostearyl alcohol are heated to 80 ℃ until the solid grease is completely dissolved and used as an oil phase for standby.
(5) Adding the oil phase into the water phase, stirring at high speed of 1000r/min for 10min until the oil phase is completely and uniformly mixed, cooling to normal temperature, and filling.
(6) And (5) after filling, carrying out damp-heat sterilization on the product in a high-pressure steam sterilization cabinet to obtain the sterile recombinant mussel mucin cream dressing.
Comparative example 2
In the comparative example, the addition ratio of the raw materials is not within the range of the mass percentages provided in the application, and specifically comprises the following steps:
the mussel mucin accounts for 2% by mass, the oily matrix comprises 1% by mass of glyceryl monostearate, 2% by mass of cetostearyl alcohol, 3% by mass of sodium hyaluronate and 0.5% by mass of silk fibroin. The preparation method comprises the following steps of:
(1) 2% mussel mucin freeze-dried sponge is stirred and dissolved completely in purified water and heated to 80 ℃.
(2) Adding a pH regulator to adjust the pH to 6.0.
(3) Adding 3% of sodium hyaluronate and 0.5% of silk fibroin, and stirring thoroughly to obtain water phase for use.
(4) Heating 1% of glyceryl monostearate and 2% of cetostearyl alcohol to 80 ℃ until the solid grease is completely dissolved, and taking the mixture as an oil phase for standby.
(5) Adding the oil phase into the water phase, stirring at high speed of 1000r/min for 10min until the oil phase is completely and uniformly mixed, cooling to normal temperature, and filling.
(6) And (5) after filling, carrying out damp-heat sterilization on the product in a high-pressure steam sterilization cabinet to obtain the sterile recombinant mussel mucin cream dressing.
Comparative example 3
The comparative example differs from example 1 in that the raw materials used do not include silk fibroin, and the mass percentages of the remaining raw materials are the same as example 1, specifically as follows:
weighing the raw material components according to a proportion.
(1) 5% mussel mucin freeze-dried sponge is stirred in purified water to dissolve completely and heated to 80 ℃.
(2) Adding a pH regulator to adjust the pH to 4.0.
(3) Adding 10% sodium hyaluronate, stirring thoroughly, and taking as water phase for use.
(4) 3% of glyceryl monostearate and 5% of cetostearyl alcohol are heated to 80 ℃ until the solid grease is completely dissolved and used as an oil phase for standby.
(5) Adding the oil phase into the water phase, stirring at high speed of 1000r/min for 10min until the oil phase is completely and uniformly mixed, cooling to normal temperature, and filling.
(6) And (3) carrying out damp-heat sterilization on the product in a high-pressure steam sterilization cabinet after filling, thus obtaining the sterile recombinant mussel mucin cream dressing.
Comparative example 4
The comparative example is different from example 1 in that the raw materials used do not include sodium hyaluronate, and the mass percentages of the remaining raw materials are the same as example 1, specifically as follows:
weighing the raw material components according to a proportion.
(1) 5% mussel mucin freeze-dried sponge is stirred in purified water to dissolve completely and heated to 80 ℃.
(2) Adding a pH regulator to adjust the pH to 4.0.
(3) Adding 3% of silk fibroin, and stirring thoroughly to obtain water phase for use.
(4) 3% of glyceryl monostearate and 5% of cetostearyl alcohol are heated to 80 ℃ until the solid grease is completely dissolved and used as an oil phase for standby.
(5) Adding the oil phase into the water phase, stirring at high speed of 1000r/min for 10min until the oil phase is completely and uniformly mixed, cooling to normal temperature, and filling.
(6) And (5) after filling, carrying out damp-heat sterilization on the product in a high-pressure steam sterilization cabinet to obtain the sterile recombinant mussel mucin cream dressing.
Comparative example 5
The comparative example is different from example 1 in that only the oil phase is heated in the preparation process, the water phase is prepared at normal temperature, and the mass percentages and the process of the rest raw materials are the same as those of example 1, and the specific steps are as follows:
(1) And (3) stirring and dissolving 5% mussel mucin freeze-dried sponge in purified water at normal temperature.
(2) Adding a pH regulator to adjust the pH to 4.0.
(3) Adding 10% of sodium hyaluronate and 3% of silk fibroin, and fully stirring to serve as a water phase for standby.
(4) 3% of glyceryl monostearate and 5% of cetostearyl alcohol are heated to 80 ℃ until the solid grease is completely dissolved and used as an oil phase for standby.
(5) Adding the oil phase into the water phase, stirring at high speed of 1000r/min for 10min until the oil phase is completely and uniformly mixed, cooling to normal temperature, and filling.
(6) And (5) after filling, carrying out damp-heat sterilization on the product in a high-pressure steam sterilization cabinet to obtain the sterile recombinant mussel mucin cream dressing.
The results show that the water phase is prepared at normal temperature, and after the oil phase is added, the oil phase can be partially coagulated, so that the formed cream has non-uniform components and solid particles, and is not beneficial to product stability.
Fig. 1 shows a mussel mucin cream dressing prepared by example 1 in the preparation method of the mussel mucin cream dressing provided by the present application, fig. 2 shows a mussel mucin cream dressing prepared by comparative example 2 in the preparation method of the mussel mucin cream dressing provided by the present application, and fig. 3 shows a mussel mucin cream dressing prepared by comparative example 5 in the preparation method of the mussel mucin cream dressing provided by the present application.
From fig. 1, 2 and 3, it can be determined that when the mass percentages of the raw materials in the preparation method of the mussel mucin cream dressing are out of the ranges provided in the present application, or are not heated at the preset temperature, a shaped mussel mucin cream dressing cannot be obtained.
The stability test was performed on each of the above examples and comparative examples, and it was observed whether or not the examples 1, 2, 3 and comparative examples 1, 2, 3, 4, 5 were delaminated by centrifugation at 3000r/min for 30min after sterilization. Whether delamination or anti-coarsening occurs at 50 ℃ for 24 hours and at-18 ℃ for 24 hours is shown in Table 1:
TABLE 1
Figure BDA0004129705190000131
Fig. 4 shows an electrophoresis pattern of the mussel mucin cream dressing prepared by the preparation method of the mussel mucin cream dressing provided by the application.
Taking mussel mucin cream dressing prepared in example 1 as an example. The mussel mucin cream dressing was divided into 6 parts, one part of which was not sterilized, and the other five parts were respectively subjected to moist heat sterilization, 5K irradiation sterilization, 10K irradiation sterilization, 15K irradiation sterilization and 20K irradiation sterilization. Then an electrophoresis test was performed.
Referring to fig. 4, it can be seen from fig. 4 that the protein bands after the heat-moisture sterilization are almost the same as before the sterilization, indicating that the heat-moisture sterilized protein is not significantly degraded. And the protein is completely degraded and is disabled after irradiation sterilization at different doses.
The invention provides a sterile product capable of protecting stable protein, which ensures the integrity of protein molecules, promotes wound healing and brings good news to patients after medical arts.
In the foregoing embodiments, the descriptions of the embodiments are emphasized, and in part, not described or illustrated in any particular embodiment, reference is made to the related descriptions of other embodiments.
The above embodiments are only for illustrating the technical solution of the present application, and are not limiting thereof; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present application, and are intended to be included in the scope of the present application.

Claims (10)

1. A method of preparing a mussel mucin cream dressing, the method comprising:
obtaining mussel mucin, oily matrix, sodium hyaluronate, silk fibroin and pH regulator in a preset mass percentage;
after the mussel mucin is dissolved in purified water and heated to 80+/-5 ℃, adding a pH regulator into the mussel mucin, and adjusting the pH value to a preset range;
adding sodium hyaluronate and silk fibroin into the mussel mucin, and fully stirring to serve as a water phase for standby;
heating the oily matrix to 75-90 ℃ to serve as an oil phase for standby;
adding the oil phase into the water phase, and stirring the oil phase and the water phase through a stirring device until the oil phase and the water phase are uniformly mixed, so as to obtain the mussel mucin cream dressing.
2. The method of claim 1, wherein the predetermined mass percent comprises:
the mass percentage of the mussel mucin is 3% -8%;
the mass percentage of the oily matrix is 5% -20%;
the mass percentage of the sodium hyaluronate is 6% -16%;
the mass percentage of the silk fibroin is 1% -5%;
the balance being purified water.
3. The method according to claim 1 or 2, further comprising, after said obtaining a mussel mucin cream dressing:
and (3) filling the mussel mucin cream dressing after the mussel mucin cream dressing is reduced to a preset temperature, and sterilizing the filled mussel mucin cream dressing to obtain the sterile mussel mucin cream dressing.
4. A method according to claim 3, wherein the mussel mucin cream is a cream of an oil-in-water system.
5. A method according to claim 3, wherein the predetermined range of pH values comprises: 3.0-4.2.
6. A method according to claim 3, wherein agitating the oil phase and the aqueous phase by an agitating device until the oil phase and the aqueous phase are uniformly mixed comprises:
stirring the oil phase and the water phase for 5-20min at 1000-1500r/min by a stirring device.
7. A method according to claim 3, wherein the oily base comprises at least one of cetostearyl alcohol, glyceryl monostearate, glyceryl stearate, polyether-10 behenate, polyether-25 behenate and a C10-C30 alkyl acrylate cross-linked polymer.
8. The method of claim 3, wherein the pH adjuster comprises at least one of citric acid, boric acid, acetic acid, phosphoric acid, hydrochloric acid, triethanolamine, sodium hydroxide, and potassium hydroxide.
9. A mussel mucin cream dressing, characterized in that the mussel mucin cream dressing comprises:
mussel mucin, oily matrix, sodium hyaluronate, silk fibroin and pH regulator.
10. The mussel mucin cream dressing according to claim 9, wherein the mussel mucin is 3-8% by mass;
the mass percentage of the oily matrix is 5% -20%;
the mass percentage of the sodium hyaluronate is 6% -16%;
the mass percentage of the silk fibroin is 1% -5%;
the balance being purified water.
CN202310256158.4A 2023-03-16 2023-03-16 Mussel mucin cream dressing and preparation method thereof Pending CN116196466A (en)

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