Wound repair dressing containing ectoine and preparation method thereof

Abstract

The present invention discloses a wound repair dressing containing ectoine and a preparation method thereof. The preparation method of the wound repair dressing containing ectoine comprises the following steps: chitosan and sodium carboxymethyl starch are added to an ε-polylysine aqueous solution to obtain a first phase; ectoine is added to a soybean lecithin aqueous solution, and then glycerol and rosehip oil are added to obtain a second phase; the first phase and the second phase are mixed and homogenized to form an emulsion; and the emulsion is dried. The wound repair dressing containing ectoine of the present invention provides a long-lasting and effective wound repair solution. The ectoine in the microcapsule can be continuously released to ensure that the wound is in contact with the repair component for a long time, thereby accelerating the healing process. The stable encapsulation of the microcapsule protects the ectoine from the external environment and prolongs its effectiveness.

Description

Technical Field

[0001] The invention relates to a repair dressing, in particular to an ectoine-containing wound repair dressing and a preparation method thereof. Background Art

[0002] In modern medicine, wound repair is becoming increasingly important, especially for complex, chronic or difficult-to-heal wounds. Although traditional dressings perform well in terms of physical protection, they often lack bioactive ingredients that can accelerate wound healing. With advances in biomaterials science and drug delivery technology, researchers have begun to focus on how to effectively integrate bioactive ingredients into dressings.

[0003] Ecdoin, a proven effective skin repair ingredient, has attracted attention for its potential in wound treatment. However, there are still challenges in effectively integrating ecdoin into dressings, especially in maintaining its stability and achieving its controlled release. These challenges include how to maintain its stability without reducing the efficacy of ecdoin, and how to design dressings so that ecdoin can be released into the wound at the appropriate time and dose. Furthermore, in order to enhance the therapeutic effect of dressings, researchers are also exploring how to optimize the local release of ecdoin through innovative drug delivery systems, such as microencapsulation technology. The development of this technology not only helps to improve the therapeutic effect, but also significantly improves patient comfort and wound healing speed. Therefore, the development of a new type of ecdoin-containing dressing that can combine the dual advantages of physical protection and bioactive ingredients is of great clinical significance for modern wound treatment. Summary of the invention

[0004] The technical problem to be solved by the present invention is to provide a wound repair dressing containing ectoine and a preparation method thereof.

[0005] Specifically, the technical solution of the present invention is:

[0006] The present invention provides a method for preparing a wound repair dressing containing ectoine, comprising the following steps:

[0007] Chitosan and sodium carboxymethyl starch are added to the ε-polylysine aqueous solution to obtain the first phase;

[0008] Ecdoin is added to the aqueous solution of soybean lecithin, and then glycerol and rosehip oil are added to obtain a second phase;

[0009] The first phase and the second phase are mixed and homogenized to form an emulsion;

[0010] The emulsion is dried to obtain the wound repair dressing containing ectoine, and the wound repair dressing containing ectoine is ectoine-containing microcapsules.

[0011] Preferably, a method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0012] Step 1: chitosan and sodium carboxymethyl starch are added to a 0.6-1.2 wt% ε-polylysine aqueous solution, and mixed evenly at 40-60° C. to obtain a first phase;

[0013] Step 2: Add ectoine to a 4-6wt% soy lecithin aqueous solution, then add glycerol and rosehip oil, mix evenly at 40-60° C. to obtain a second phase;

[0014] Step 3: The first phase and the second phase are mixed and homogenized to form an emulsion;

[0015] Step 4: Dry the emulsion to obtain a wound repair dressing. The wound repair dressing contains ectoine microcapsules.

[0016] Preferably, the step 3 is to mix the first phase and the second phase, control the pressure to 10-15 MPa, maintain the rotation speed at 1000-2000 r / min, and homogenize for 10-20 min.

[0017] Preferably, the step 4 is to vacuum dry or spray dry the emulsion.

[0018] Preferably, the mass ratio of chitosan, sodium carboxymethyl starch, ε-polylysine, soybean lecithin, glycerol, rosehip oil and ectoine is (4-12):(2-10):(0.05-0.5):(0.5-4):(0.3-3):(0.5-5):1.

[0019] Preferably, the mass ratio of chitosan, sodium carboxymethyl starch, ε-polylysine, soybean lecithin, glycerol, rosehip oil and ectoine is (6-10):(4-8):(0.1-0.3):(1-3):(0.5-2):(1-3):1.

[0020] Preferably, a method for preparing a wound repair dressing containing ectoine further comprises dispersing the ectoine microcapsules into a carbomer aqueous solution to form a gel, that is, the wound repair dressing is a gel.

[0021] The present invention also provides a wound repair dressing containing ectoine, which is prepared by the above method.

[0022] The wound repair dressing containing ectoine of the present invention provides a long-lasting and effective wound repair solution. The ectoine in the microcapsules can be released continuously, ensuring that the wound is in contact with the repair components for a long time, thereby accelerating the healing process. The stable encapsulation of the microcapsules protects the ectoine from the external environment and prolongs its effectiveness. The gel matrix is ​​easy to apply and is suitable for wounds of different shapes and sizes, while providing moisturizing and comfort, enhancing the user experience. Overall, this innovative dressing improves the efficiency of wound repair while also ensuring the convenience and comfort of application. DETAILED DESCRIPTION

[0023] A method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0024] Step 1: chitosan and sodium carboxymethyl starch are added to a 0.6-1.2 wt % ε-polylysine aqueous solution, and mixed evenly at 40-60° C. to obtain a first phase.

[0025] In step 1, chitosan and sodium carboxymethyl starch are added to an aqueous solution containing ε-polylysine and mixed evenly at a temperature of 40-60°C to form the first phase. The main function of this step is to create the shell of the microcapsule. Chitosan and sodium carboxymethyl starch provide the basis of the microcapsule structure. ε-polylysine, as a natural cross-linking agent, helps to enhance the bond between the two materials and improve the mechanical strength and stability of the microcapsule. Through this process, a strong and controllable shell is formed, which provides a good foundation for the subsequent encapsulation of active ingredients.

[0026] Step 2: Add ectoine to a 4-6wt% soy lecithin aqueous solution, then add glycerol and rosehip oil, mix evenly at 40-60°C to obtain a second phase.

[0027] In step 2, Ecdoin is first added to a 4-6wt% soy lecithin aqueous solution. This step is mainly used to evenly disperse Ecdoin in a water-based medium. Next, glycerin and rosehip oil are added to form an oil-water emulsion. Glycerin, as a hydrophilic carrier, helps to stabilize and increase the viscosity of the aqueous phase, while rosehip oil provides the necessary oil phase to increase the repair and protection properties of the microcapsules. These ingredients are mixed at 40-60°C to ensure that soy lecithin can effectively emulsify the oil phase and the aqueous phase to form a uniform and stable emulsion, which provides a basis for the internal structure of the microcapsules and the encapsulation of active ingredients.

[0028] Step 3: Mix the first phase and the second phase, control the pressure to 10-15 MPa, maintain the rotation speed at 1000-2000 r / min, and homogenize for 10-20 min to form an emulsion.

[0029] In step 3, the first phase (aqueous solution containing chitosan, sodium carboxymethyl starch and ε-polylysine) is mixed with the second phase (emulsion containing ectoine, soybean lecithin, glycerol and rosehip oil) and forms an emulsion through a homogenization process. The core function of this step is to use the high-speed stirring and shear force of the homogenizer to achieve a delicate and uniform mixing of the oil and water phases, thereby effectively encapsulating active ingredients such as ectoine and rosehip oil inside the microcapsule. During the homogenization process, soybean lecithin plays a key role as an emulsifier, helping to stabilize the emulsion and ensure the quality and subsequent stability of the microcapsules.

[0030] Step 4: vacuum drying or spray drying the emulsion to obtain ectoine-containing microcapsules.

[0031] In step 4, the emulsion formed by homogenization is dried to remove the moisture therein and solidify to form microcapsules containing ectoine. This step can be carried out by vacuum drying or spray drying. Vacuum drying reduces the boiling point of water by reducing the pressure, thereby removing moisture under mild conditions, which is suitable for heat-sensitive substances. Spray drying forms tiny droplets by spraying the emulsion at high speed, which quickly evaporates the water and is suitable for large-scale production. Regardless of the drying method used, the ultimate goal is to obtain dry and stable microcapsules, which encapsulate the active ingredients for use in wound repair dressings.

[0032] The mass ratio of the chitosan, sodium carboxymethyl starch, ε-polylysine, soybean lecithin, glycerol, rosehip oil and ectoine is (4-12):(2-10):(0.05-0.5):(0.5-4):(0.3-3):(0.5-5):1.

[0033] Chitosan is a linear polysaccharide composed of alternating N-acetylglucosamine and glucosamine units. The abundant hydroxyl and amino groups in its molecular structure endow it with excellent film-forming properties and biocompatibility. These hydroxyl and amino groups enable chitosan to effectively cross-link with molecules such as polyacids, thereby enhancing the stability of microcapsules in pharmaceutical applications.

[0034] Sodium carboxymethyl starch improves water solubility and chemical stability through carboxymethyl groups. After combining with chitosan, it enhances the overall structural stability of microcapsules and improves the effectiveness of drug carriers. The chemical modification characteristics of sodium carboxymethyl starch make it an ideal material to adjust drug release rate and enhance the application performance of microcapsules, especially for wound repair dressings.

[0035] ε-polylysine plays a vital role as an effective cross-linking agent in the present invention. Its molecular structure contains multiple amino groups, which can undergo cross-linking reactions with functional groups in chitosan and sodium carboxymethyl starch. This cross-linking increases the mechanical strength and structural stability of the microcapsule, making it more stable during the drug delivery process, and can effectively protect and control the release of the active ingredient encapsulated inside, ectoine.

[0036] Soy lecithin plays a key role as an emulsifier in the present invention. Due to its molecular structure with a hydrophilic head group and a hydrophobic tail, soybean lecithin can effectively combine the oil phase (such as rosehip oil) and water to form a stable oil-water emulsion. This ability is particularly important for the stable encapsulation of microcapsules, especially in complex systems containing water-soluble and oil-soluble components. By stabilizing the oil-water interface, soybean lecithin ensures that the active ingredients (such as ectoine) can be evenly dispersed and stably encapsulated in the microcapsules, thereby improving the overall effectiveness and applicability of the microcapsules.

[0037] As a polyol with a trihydroxy structure, glycerin not only effectively stabilizes the water phase and increases the moisturizing effect of the overall preparation, but also acts as a hydrophilic carrier in the microcapsules, which helps to improve the stability and controlled release effect of the active ingredient Ecdoin, thereby enhancing the efficacy of the microcapsules.

[0038] Rosehip oil plays a vital role in the present invention. It is rich in unsaturated fatty acids, which not only provides the necessary oil phase for the microcapsules, but also significantly enhances the repair and protection properties of the microcapsules. Due to its excellent effect in scar repair, rosehip oil is considered to be one of the best oils, making it particularly effective in treating skin damage and improving skin health.

[0039] Ecdoin, as a small molecule amino acid derivative, has significant skin repair function. It can be stably encapsulated in microcapsules, protecting it from external factors while ensuring its gradual and continuous release to the wound surface. The structure of Ecdoin enables it to effectively interact with skin cells, promote cell regeneration and repair damaged tissues. These characteristics make it show high therapeutic potential in the treatment of various skin injuries, especially in accelerating wound healing and reducing scar formation.

[0040] Preferably, a method for preparing a wound repair dressing containing ectoine further comprises dispersing the ectoine microcapsules into a carbomer aqueous solution to form a gel. The wound repair dressing is a gel.

[0041] The present invention also provides a wound repair dressing containing ectoine, which is prepared by the above method.

[0042] The ectoine microcapsules of the present invention have significant advantages, especially in promoting wound repair. As an effective repair component, ectoine can achieve sustained release when encapsulated in microcapsules, thereby improving the therapeutic effect. This sustained release mechanism helps to maintain a stable drug concentration on the wound surface and promote more effective healing. At the same time, microcapsule technology protects ectoine from damage by the external environment, enhances its stability, and prolongs its effectiveness. These characteristics of microcapsules make it an ideal drug delivery system in wound repair.

[0043] The gel of the present invention is made by dispersing ectoine microcapsules in a carbomer aqueous solution, and has multiple advantages. First, the use of microcapsules can achieve the sustained release of ectoine, thereby providing a lasting wound repair effect. Secondly, the gel matrix protects the microcapsules, increases the stability of the active ingredients, and prolongs the shelf life of the product. Furthermore, the gel-like dressing is easy to apply, suitable for irregular wounds, and improves the convenience of use. In addition, the gel can provide a suitable moist environment for the wound, which helps to promote wound healing.

[0044] In the examples and comparative examples of the present invention, chitosan is water-soluble chitosan 3000, food grade, purchased from Anhui Yuanzheng Bioengineering Co., Ltd. Sodium carboxymethyl starch, purchased from Shandong Pingju Biotechnology Co., Ltd., food grade, content 99%.

[0045] Embodiment 1:

[0046] A method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0047] Step 1: chitosan and sodium carboxymethyl starch are added to a 0.9 wt % ε-polylysine aqueous solution, and mixed evenly at 50° C. to obtain a first phase.

[0048] Step 2: Add ectoine to a 5 wt % soybean lecithin aqueous solution, then add glycerol and rosehip oil, mix well at 50° C. to obtain a second phase.

[0049] Step 3: Mix the first phase and the second phase, control the pressure to 12 MPa, maintain the speed at 1500 r / min, and homogenize for 15 min to form an emulsion.

[0050] Step 4: vacuum drying the emulsion, with specific parameters as follows: temperature 45° C., vacuum degree 80 mbar, until the sample is completely dry, and finally obtaining ectoine-containing microcapsules.

[0051] The mass ratio of the chitosan, sodium carboxymethyl starch, ε-polylysine, soybean lecithin, glycerol, rosehip oil and ectoine is 8:6:0.2:2:2:3:1.

[0052] Comparative Example 1:

[0053] A method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0054] Step 1: chitosan is added to a 0.9 wt % ε-polylysine aqueous solution and mixed evenly at 50° C. to obtain a first phase.

[0055] Step 2: Add ectoine to a 5 wt % soybean lecithin aqueous solution, then add glycerol and rosehip oil, mix well at 50° C. to obtain a second phase.

[0056] Step 3: Mix the first phase and the second phase, control the pressure to 12 MPa, maintain the speed at 1500 r / min, and homogenize for 15 min to form an emulsion.

[0057] Step 4: vacuum drying the emulsion, with specific parameters as follows: temperature 45° C., vacuum degree 80 mbar, until the sample is completely dry, and finally obtaining ectoine-containing microcapsules.

[0058] The mass ratio of the chitosan, ε-polylysine, soybean lecithin, glycerol, rosehip oil and ectoine is 14:0.2:2:2:3:1.

[0059] Comparative Example 2:

[0060] A method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0061] Step 1: Sodium carboxymethyl starch is added to a 0.9 wt% ε-polylysine aqueous solution, and mixed evenly at 50° C. to obtain a first phase.

[0062] Step 2: Add ectoine to a 5 wt % soybean lecithin aqueous solution, then add glycerol and rosehip oil, mix well at 50° C. to obtain a second phase.

[0063] Step 3: Mix the first phase and the second phase, control the pressure to 12 MPa, maintain the speed at 1500 r / min, and homogenize for 15 min to form an emulsion.

[0064] Step 4: vacuum drying the emulsion, with specific parameters as follows: temperature 45° C., vacuum degree 80 mbar, until the sample is completely dry, and finally obtaining ectoine-containing microcapsules.

[0065] The mass ratio of the sodium carboxymethyl starch, ε-polylysine, soybean lecithin, glycerol, rosehip oil and ectoine is 14:0.2:2:2:3:1.

[0066] Comparative Example 3:

[0067] A method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0068] Step 1: chitosan and sodium carboxymethyl starch are added into a 0.9 wt % calcium chloride aqueous solution, and mixed evenly at 50° C. to obtain a first phase.

[0069] Step 2: Add ectoine to a 5 wt % soybean lecithin aqueous solution, then add glycerol and rosehip oil, mix well at 50° C. to obtain a second phase.

[0070] Step 3: Mix the first phase and the second phase, control the pressure to 12 MPa, maintain the speed at 1500 r / min, and homogenize for 15 min to form an emulsion.

[0071] Step 4: vacuum drying the emulsion, with specific parameters as follows: temperature 45° C., vacuum degree 80 mbar, until the sample is completely dry, and finally obtaining ectoine-containing microcapsules.

[0072] The mass ratio of the chitosan, sodium carboxymethyl starch, calcium chloride, soybean lecithin, glycerol, rosehip oil and ectoine is 8:6:0.2:2:2:3:1.

[0073] Comparative Example 4:

[0074] A method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0075] Step 1: chitosan and sodium carboxymethyl starch are added to a 0.9 wt % sodium tripolyphosphate aqueous solution, and mixed evenly at 50° C. to obtain a first phase.

[0076] Step 2: Add ectoine to a 5 wt % soybean lecithin aqueous solution, then add glycerol and rosehip oil, mix well at 50° C. to obtain a second phase.

[0077] Step 3: Mix the first phase and the second phase, control the pressure to 12 MPa, maintain the speed at 1500 r / min, and homogenize for 15 min to form an emulsion.

[0078] Step 4: vacuum drying the emulsion, with specific parameters as follows: temperature 45° C., vacuum degree 80 mbar, until the sample is completely dry, and finally obtaining ectoine-containing microcapsules.

[0079] The mass ratio of the chitosan, sodium carboxymethyl starch, sodium tripolyphosphate, soybean lecithin, glycerol, rosehip oil and ectoine is 8:6:0.2:2:2:3:1.

[0080] Comparative Example 5:

[0081] A method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0082] Step 1: chitosan and sodium carboxymethyl starch are added to a 0.9 wt % aqueous solution of genipin (CAS No.: 6902-77-8), mixed at 50° C. to obtain a first phase.

[0083] Step 2: Add ectoine to a 5 wt % soybean lecithin aqueous solution, then add glycerol and rosehip oil, mix well at 50° C. to obtain a second phase.

[0084] Step 3: Mix the first phase and the second phase, control the pressure to 12 MPa, maintain the speed at 1500 r / min, and homogenize for 15 min to form an emulsion.

[0085] Step 4: vacuum drying the emulsion, with specific parameters as follows: temperature 45° C., vacuum degree 80 mbar, until the sample is completely dry, and finally obtaining ectoine-containing microcapsules.

[0086] The mass ratio of the chitosan, sodium carboxymethyl starch, genipin, soybean lecithin, glycerol, rosehip oil and ectoine is 8:6:0.2:2:2:3:1.

[0087] Comparative Example 6:

[0088] A method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0089] Step 1: chitosan and sodium carboxymethyl starch are added to a 0.9 wt % tannic acid aqueous solution, and mixed evenly at 50° C. to obtain a first phase.

[0090] Step 2: Add ectoine to a 5 wt % soybean lecithin aqueous solution, then add glycerol and rosehip oil, mix well at 50° C. to obtain a second phase.

[0091] Step 3: Mix the first phase and the second phase, control the pressure to 12 MPa, maintain the speed at 1500 r / min, and homogenize for 15 min to form an emulsion.

[0092] Step 4: vacuum drying the emulsion, with specific parameters as follows: temperature 45° C., vacuum degree 80 mbar, until the sample is completely dry, and finally obtaining ectoine-containing microcapsules.

[0093] The mass ratio of the chitosan, sodium carboxymethyl starch, tannic acid, soybean lecithin, glycerol, rosehip oil and ectoine is 8:6:0.2:2:2:3:1.

[0094] Comparative Example 7:

[0095] A method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0096] Step 1: chitosan and sodium carboxymethyl starch are added to a 0.9 wt % ε-polylysine aqueous solution, and mixed evenly at 50° C. to obtain a first phase.

[0097] Step 2: Add ectoine to a 5 wt % aqueous solution of glyceryl monostearate, then add glycerol and rosehip oil, mix well at 50° C. to obtain a second phase.

[0098] Step 3: Mix the first phase and the second phase, control the pressure to 12 MPa, maintain the speed at 1500 r / min, and homogenize for 15 min to form an emulsion.

[0099] Step 4: vacuum drying the emulsion, with specific parameters as follows: temperature 45° C., vacuum degree 80 mbar, until the sample is completely dry, and finally obtaining ectoine-containing microcapsules.

[0100] The mass ratio of the chitosan, sodium carboxymethyl starch, ε-polylysine, glyceryl monostearate, glycerol, rosehip oil and ectoine is 8:6:0.2:2:2:3:1.

[0101] Comparative Example 8:

[0102] A method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0103] Step 1: chitosan and sodium carboxymethyl starch are added to a 0.9 wt % ε-polylysine aqueous solution, and mixed evenly at 50° C. to obtain a first phase.

[0104] Step 2: Add ectoine to a 5 wt % soybean lecithin aqueous solution, then add rosehip oil, mix evenly at 50° C. to obtain a second phase.

[0105] Step 3: Mix the first phase and the second phase, control the pressure to 12 MPa, maintain the speed at 1500 r / min, and homogenize for 15 min to form an emulsion.

[0106] Step 4: vacuum drying the emulsion, with specific parameters as follows: temperature 45° C., vacuum degree 80 mbar, until the sample is completely dry, and finally obtaining ectoine-containing microcapsules.

[0107] The mass ratio of the chitosan, sodium carboxymethyl starch, ε-polylysine, soybean lecithin, rosehip oil and ectoine is 8:6:0.2:2:3:1.

[0108] Comparative Example 9:

[0109] A method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0110] Step 1: chitosan and sodium carboxymethyl starch are added to a 0.9 wt % ε-polylysine aqueous solution, and mixed evenly at 50° C. to obtain a first phase.

[0111] Step 2: Add ectoine to a 5 wt % soybean lecithin aqueous solution, then add glycerol and sunflower oil, mix well at 50° C. to obtain a second phase.

[0112] Step 3: Mix the first phase and the second phase, control the pressure to 12 MPa, maintain the speed at 1500 r / min, and homogenize for 15 min to form an emulsion.

[0113] Step 4: vacuum drying the emulsion, with specific parameters as follows: temperature 45° C., vacuum degree 80 mbar, until the sample is completely dry, and finally obtaining ectoine-containing microcapsules.

[0114] The mass ratio of the chitosan, sodium carboxymethyl starch, ε-polylysine, soybean lecithin, glycerol, sunflower oil and ectoine is 8:6:0.2:2:2:3:1.

[0115] Comparative Example 10:

[0116] A method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0117] Step 1: chitosan and sodium carboxymethyl starch are added to a 0.9 wt % ε-polylysine aqueous solution, and mixed evenly at 50° C. to obtain a first phase.

[0118] Step 2: Add ectoine to a 5 wt% soy lecithin aqueous solution, then add glycerol and olive oil, mix well at 50° C. to obtain a second phase.

[0119] Step 3: Mix the first phase and the second phase, control the pressure to 12 MPa, maintain the speed at 1500 r / min, and homogenize for 15 min to form an emulsion.

[0120] Step 4: vacuum drying the emulsion, with specific parameters as follows: temperature 45° C., vacuum degree 80 mbar, until the sample is completely dry, and finally obtaining ectoine-containing microcapsules.

[0121] The mass ratio of the chitosan, sodium carboxymethyl starch, ε-polylysine, soybean lecithin, glycerol, olive oil and ectoine is 8:6:0.2:2:2:3:1.

[0122] Comparative Example 11:

[0123] A method for preparing a wound repair dressing containing ectoine comprises the following steps:

[0124] Step 1: chitosan is added into a 0.9 wt % tannic acid aqueous solution and mixed evenly at 50° C. to obtain a first phase.

[0125] Step 2: Add ectoine to a 5 wt % aqueous solution of glyceryl monostearate, then add glycerol and olive oil, mix well at 50° C. to obtain a second phase.

[0126] Step 3: Mix the first phase and the second phase, control the pressure to 12 MPa, maintain the speed at 1500 r / min, and homogenize for 15 min to form an emulsion.

[0127] Step 4: vacuum drying the emulsion, with specific parameters as follows: temperature 45° C., vacuum degree 80 mbar, until the sample is completely dry, and finally obtaining ectoine-containing microcapsules.

[0128] The mass ratio of the chitosan, tannic acid, glyceryl monostearate, glycerol, olive oil and ectoine is 14:0.2:2:2:3:1.

[0129] Application examples:

[0130] 25 parts by weight of the microcapsules prepared in the embodiment or comparative example are uniformly dispersed in 75 parts by weight of a 2 wt% Carbomer 940 aqueous solution to prepare an ectoine-containing wound repair dressing, ectoine gel.

[0131] Among them, the ectoine gel of application example 1 corresponds to the microcapsules of embodiment 1; the ectoine gels of comparative application examples 1-11 correspond to the microcapsules of comparative examples 1-11 respectively.

[0132] Ecdoin gel of Application Example 1 of the present invention:

[0133] Scope of application: Drain moisture from the wound to provide a moist environment to promote wound healing. Used for covering small wounds, abrasions, cuts and other non-chronic wounds.

[0134] Directions for use: For topical use, 3 times a day, 15 days as a course of treatment, or as directed by a doctor.

[0135] Contraindications: 1. Those who are allergic to external ectoine products are prohibited from using this product. 2. This product is prohibited from use if its properties change.

[0136] This product cannot be used to cover chronic wounds (such as venous ulcers, arterial ulcers, diabetic foot ulcers and other chronic wounds).

[0137] Test Example 1:

[0138] In order to evaluate the stability of the microcapsules, the following method was used: First, 5 grams of microcapsules were mixed with 95 grams of deionized water at 45°C and stirred at 200 rpm for 30 minutes to form a uniform emulsion. Next, the mixture was allowed to cool naturally to 30°C and maintained at this temperature, then allowed to stand and the timing was started. The emulsion was observed every 30 minutes, and the time point when stratification occurred was recorded. The shorter the time for stratification to occur, the poorer the stability of the microcapsules; on the contrary, if the stratification time is longer, it indicates that the microcapsules have better stability. This method can effectively evaluate the stability and durability of microcapsules in an aqueous environment.

[0139] Table 1: Microcapsule stability test table

[0140] Time of stratification, hours Example 1 206.0 Comparative Example 1 178.5 Comparative Example 2 161.5 Comparative Example 3 159.0 Comparative Example 4 155.5 Comparative Example 5 153.5 Comparative Example 6 148.0 Comparative Example 7 171.0 Comparative Example 8 66.0 Comparative Example 9 167.5 Comparative Example 10 163.0 Comparative Example 11 98.5

[0141] Comparing Example 1 with Comparative Examples 1-2, the performance of chitosan and sodium carboxymethyl starch as capsule wall materials is significantly better than that of a single wall material. In Example 1, the choice of chitosan and sodium carboxymethyl starch as microcapsule wall materials has significant advantages. Chitosan provides structural stability and good film-forming properties, while sodium carboxymethyl starch increases the elasticity and toughness of the microcapsules. The combination of these two materials not only improves the physical stability of the microcapsules, but also enhances their functionality as drug carriers. The addition of sodium carboxymethyl starch makes the microcapsules perform better in controlling drug release and enhancing drug protection. Compared with single material wall materials, this combination exhibits superior overall performance.

[0142] In Example 1 and Comparative Examples 3-6, the use of different cross-linking agents leads to significant differences in effect. Example 1 uses ε-polylysine as a cross-linking agent, while Comparative Examples 3-6 use calcium chloride, sodium tripolyphosphate, genipin and tannic acid, respectively. ε-Polylysine provides higher efficiency and stability during the cross-linking process, strengthens the overall structure of the microcapsules, and thus gives the microcapsules better stability and sustained drug release ability. In contrast, other cross-linking agents may fail to achieve the same effect due to differences in chemical structure or cross-linking efficiency, affecting the stability and drug release performance of the microcapsules.

[0143] In Example 1 and Comparative Example 7, the use of different emulsifiers (soy lecithin and glyceryl monostearate) resulted in significant differences in the effects. Soy lecithin, as an emulsifier in Example 1, provided a more efficient emulsification due to its unique chemical structure, and promoted the stable mixing of the oil-water phase, thereby forming a more uniform and stable microcapsule. However, glyceryl monostearate may not be as good as soybean lecithin in terms of emulsification efficiency or stability, affecting the overall stability of the microcapsule and the drug release effect. Therefore, the selection of emulsifiers is crucial to ensure the quality and performance of microcapsules.

[0144] In Example 1 and Comparative Example 8, the absence of glycerol leads to a significant decrease in performance. Glycerol, as a hydrophilic carrier, plays a role in increasing the stability of the water phase and the moisturizing effect in the preparation of microcapsules. It also helps to disperse and stably release the drugs in the microcapsules. In Comparative Example 8, the absence of glycerol may lead to instability of the water phase of the microcapsules, affecting the effective encapsulation and controlled release of the drugs, thereby reducing the overall performance of the microcapsules. Therefore, the addition of glycerol is very critical for maintaining the stability of the microcapsules and improving the drug release effect.

[0145] In Example 1 and Comparative Examples 9-10, different types of oils (rosehip oil, sunflower oil and olive oil) have significant effects on the performance of microcapsules. Rosehip oil is rich in unsaturated fatty acids and natural nutrients, which helps to improve the repair and protection properties of microcapsules. Although sunflower oil and olive oil also contain healthy fatty acids, their ingredients and properties are different from rosehip oil, and they may not be as effective as rosehip oil in promoting the stability of microcapsules and drug release. Therefore, the choice of oil directly affects the overall performance and application effect of microcapsules.

[0146] Test Example 2:

[0147] According to GB / T16886.1-2011 Biological Evaluation of Medical Devices and GB / T16886.5-2017 and

[0148] GB / T16886.10-2017, biological evaluation test was carried out on the ectoine gel prepared in Example 1.

[0149] Test results of this product:

[0150] (1) Demonstrate no cytotoxicity and prove no harmful effects on cell tissues;

[0151] (2) It does not induce skin sensitization, indicating that the product has good biocompatibility with skin tissue;

[0152] (3) No irritation reaction was observed in the intradermal irritation test in mice, indicating that the product has good intradermal safety.

[0153] (4) These results collectively indicate that this product performs well in terms of biological safety and is suitable for use in the medical device field.

[0154] Test Example 3:

[0155] In this test, a wound repair dressing containing Ecdoin, Ecdoin gel, was applied to the wounds of rabbits to observe its repair effect. 120 healthy rabbits weighing about 2.5±0.2kg were used and divided into 12 groups, with 10 rabbits in each group. Before the experiment, the rabbits were anesthetized and their back skin was cleaned. Subsequently, a 4×4cm superficial abrasion was made on the back, and different dressings were applied to the wounds respectively. Apply twice a day, morning and evening, 0.5 grams each time, until the wound is completely healed. By recording the healing and infection of the rabbit wounds, the wound healing rate is calculated as follows: (original wound area-unhealed wound area) ÷ original wound area × 100%.

[0156] Table 2: Wound repair performance test table

[0157] 7-day wound healing rate, % Scar after wound healing Application Example 1 93.8 Almost no scars Comparative application example 1 90.4 Almost no scars Comparative Application Example 2 88.2 Almost no scars Comparative Application Example 3 87.7 Almost no scars Comparative Application Example 4 87.6 Almost no scars Comparative Application Example 5 83.1 Almost no scars Comparative Application Example 6 82.9 Almost no scars Comparative Application Example 7 89.6 Almost no scars Comparative Application Example 8 74.4 Minor scars Comparative Application Example 9 89.3 Almost no scars Comparative Application Example 10 89.1 Almost no scars Comparative Application Example 11 78.2 Minor scars

[0158] Comparing Application Example 1 with Comparative Application Examples 9-10, the application of rosehip oil in Example 1 shows excellent effects, which is mainly due to its rich unsaturated fatty acids and natural nutrients. These ingredients help promote wound healing, improve the stability of microcapsules, and effectively control drug release, thereby accelerating the wound repair process. Therefore, when designing wound repair dressings containing ectoine, choosing a suitable oil component, such as rosehip oil, is crucial to improving the overall therapeutic effect.

Claims

1. A method for preparing a wound repair dressing containing ectoine, characterized in that: The steps include: Step 1: chitosan and sodium carboxymethyl starch are added to a 0.6-1.2 wt% ε-polylysine aqueous solution, and mixed evenly at 40-60° C. to obtain a first phase; Step 2: Add ectoine to a 4-6wt% soy lecithin aqueous solution, then add glycerol and rosehip oil, mix evenly at 40-60° C. to obtain a second phase; Step 3: The first phase and the second phase are mixed and homogenized to form an emulsion; Step 4: drying the emulsion; The mass ratio of the chitosan, sodium carboxymethyl starch, ε-polylysine, soybean lecithin, glycerol, rosehip oil and ectoine is (4-12):(2-10):(0.05-0.5):(0.5-4):(0.3-3):(0.5-5):

1.

2. A method for preparing a wound repair dressing containing ectoine as claimed in claim 1, characterized in that: The step 3 is to mix the first phase and the second phase, control the pressure to 10-15 MPa, maintain the rotation speed at 1000-2000 r / min, and homogenize for 10-20 min.

3. A method for preparing a wound repair dressing containing ectoine as claimed in claim 1, characterized in that: The step 4 is to vacuum dry or spray dry the emulsion.

4. A method for preparing a wound repair dressing containing ectoine as claimed in claim 1, characterized in that: The mass ratio of chitosan, sodium carboxymethyl starch, ε-polylysine, soybean lecithin, glycerol, rosehip oil and ectoine is (6-10):(4-8):(0.1-0.3):(1-3):(0.5-2):(1-3):

1.

5. The method for preparing a wound repair dressing containing ectoine as claimed in claim 1, characterized in that: The method also includes dispersing the ectoine-containing microcapsules into a carbomer aqueous solution.

6. A wound repair dressing containing ectoine, characterized in that: The method is prepared by any one of claims 1 to 5.