CN-121987661-A - Water-soluble supermolecule ternary complex, external preparation, preparation method and application thereof

CN121987661ACN 121987661 ACN121987661 ACN 121987661ACN-121987661-A

Abstract

The invention discloses a water-soluble supermolecule ternary complex, an external preparation, a preparation method and application thereof, wherein the water-soluble supermolecule ternary complex is formed by compounding carboxymethyl chitosan, beta-glucan and ectoin according to the mass ratio of (1-3): (0.2-1.5). The carboxymethyl chitosan and the beta-glucan are entangled through hydrogen bonds and electrostatic action to construct a three-dimensional network skeleton, the ectoin and the carboxymethyl chitosan are dynamically electrostatically crosslinked to enhance the network cohesion and crosslinking density, and the ectoin and the beta-glucan are fused through a hydration layer to realize stable connection; the three components cooperate to form a supermolecule system with stable structure and dynamic reversibility, so that the supermolecule system still keeps structural integrity and stable performance under the conditions of high temperature and high pressure. The ternary complex is used for preparing the external preparation, can realize high-temperature high-pressure sterilization, can effectively avoid infection risk, has stable performance, is suitable for sensitive skin states such as eczema and the like, and has good practical value and economic value.

Inventors

JIN YU
XU LIN
XU NIANQIN
Chang Ruixuan
XU SONGQUAN
LIU MOUZHI
CAO JINGJING
DAI CHAO

Assignees

南京天纵易康生物科技股份有限公司

Dates

Publication Date: 20260508
Application Date: 20260127

Claims (10)

1. A water-soluble supermolecule ternary complex is characterized by being formed by compounding carboxymethyl chitosan, beta-glucan and exendin in a mass ratio of (1-3) (0.2-1.5), wherein the molecular weight of the carboxymethyl chitosan is 1-500 kDa, and the molecular weight of the beta-glucan is 2000-5000 kDa.
2. The water-soluble supermolecule ternary complex according to claim 1, wherein the mass ratio of carboxymethyl chitosan, beta-glucan and ectoin is 2.5:1:1, the molecular weight of carboxymethyl chitosan is 1-100 kDa, and the molecular weight of beta-glucan is 2000-2500 kDa.
3. A method for preparing a water-soluble supramolecular ternary complex according to claim 1 or 2, comprising the steps of: 1) Weighing carboxymethyl chitosan, adding into PBS buffer solution under stirring, and continuously stirring at room temperature until the carboxymethyl chitosan is completely dissolved to form clear and transparent carboxymethyl chitosan solution for later use; 2) Weighing beta-glucan, adding purified water, stirring under heating until the beta-glucan is completely dissolved, and cooling to obtain beta-glucan solution for later use; 3) Weighing exendin, adding purified water, and stirring until the exendin is completely dissolved to obtain an exendin solution for later use; 4) Under the heating condition, dropwise adding the beta-glucan solution prepared in the step 2) into the carboxymethyl chitosan solution prepared in the step 1), stirring while dropwise adding, and keeping the temperature and stirring for a period of time after dropwise adding to obtain carboxymethyl chitosan-beta-glucan binary mixed solution; 5) Maintaining heating conditions, dropwise adding the ectoin solution prepared in the step 3) into the carboxymethyl chitosan-beta-glucan binary complex mixed solution obtained in the step 4), continuously preserving heat and stirring for a period of time after the dropwise adding is finished, and then standing for treatment to obtain carboxymethyl chitosan-beta-glucan-ectoin ternary mixed solution; 6) And 5) carrying out ultrasonic treatment on the carboxymethyl chitosan-beta-glucan-ectoin ternary mixed solution obtained in the step 5) to obtain the water-soluble supermolecule ternary complex of carboxymethyl chitosan, beta-glucan and ectoin ternary complex.
4. The method for preparing a water-soluble supramolecular ternary complex according to claim 3, wherein in step 1), the mass and volume concentration of the carboxymethyl chitosan solution is 2% -6%, the pH is 7-7.5, in step 2), the mass and volume concentration of the beta-glucan solution is 1.5% -5.0%, and in step 3), the mass and volume concentration of the escin solution is 5% -10%.
5. The method for preparing the water-soluble supermolecule ternary complex according to claim 3, wherein in the step 4), the temperature of the heating condition is controlled to be 35-45 ℃, the dripping speed of the beta-glucan solution is controlled to be 1-2 mL/min, the heat preservation time after the dripping is 15-25 min, and the whole stirring speed is controlled to be 200-400 rpm.
6. The method for preparing the water-soluble supermolecule ternary complex according to claim 3, wherein in the step 5), the temperature of the heating condition is controlled to be 35-45 ℃, the dripping speed of the ectoin solution is controlled to be 0.5-1 ml/min, the heat preservation time after the dripping is 10-20 min, the whole stirring speed is controlled to be 100-200 rpm, and the standing time is controlled to be 1.5-2.5 h.
7. The method for preparing a water-soluble supramolecular ternary complex according to claim 3, wherein in step 6), the ultrasonic treatment is carried out under the conditions of 15-20 ℃ of temperature, 90-110W of power, 35-45 kHz of frequency and 2-10 min of treatment time.
8. The external preparation for treating eczema is characterized by comprising the following components in percentage by mass: The water-soluble supermolecule ternary complex according to claim 1 or 2, wherein the water-soluble supermolecule ternary complex is 10-30%, 2-6% Of humectant, 0.4-0.8% Of thickener, 3-8% Of an emollient, 3-8% Of an emulsifying agent, 4-6% Of a sealing grease, The balance being water; wherein the thickener is selected from one or more of carbomer homopolymer, carbomer copolymer, acrylic ester copolymer, xanthan gum, cellulose and its derivatives, and sodium polyacrylate; The emulsifier is a mixture of tween 20 and span 60, and the mass ratio of tween 20 to span 60 is (2-4) (1-4).
9. The external preparation according to claim 8, wherein the preparation method of the external preparation comprises the following steps: a) Preparing a water phase, namely mixing a humectant, a thickener and purified water, heating to 75-85 ℃, and stirring until the mixture is completely dissolved to obtain the water phase for later use; B) Preparing an oil phase, namely mixing an emollient, an emulsifier and closed grease, heating to 75-85 ℃, and stirring until the mixture is completely dissolved to obtain the oil phase for later use; c) Adding the oil phase prepared in the step B) into the water phase prepared in the step A), homogenizing for 3-5 min to obtain a preparation emulsion system for later use; D) Introducing a supermolecule ternary complex, namely controlling the temperature of the emulsion system of the preparation prepared in the step C), adding the water-soluble supermolecule ternary complex as claimed in claim 1 or 2, and uniformly stirring to obtain an external emulsion; E) And D) carrying out damp heat sterilization, namely carrying out high-temperature high-pressure damp heat sterilization on the external emulsion prepared in the step D) to obtain an external preparation product.
10. The method for preparing an external preparation according to claim 9, wherein in the step D), the supermolecule ternary complex is introduced, specifically, the temperature of a preparation emulsion system is controlled to be 45-55 ℃, the water-soluble supermolecule ternary complex is slowly introduced at a speed of 1-3% of the total mass/min, and the stirring speed in the whole process is controlled to be 200-500 rpm; in the step E), the high-temperature high-pressure wet heat sterilization condition is that the temperature is 105-121 ℃, the pressure is 0.02-0.15 MPa, and the treatment is 25-60 min.

Description

Water-soluble supermolecule ternary complex, external preparation, preparation method and application thereof Technical Field The invention belongs to the technical field of biology, and particularly relates to a water-soluble supermolecule ternary complex, an external preparation, a preparation method and application thereof. Background Eczema is a common and complex skin disease, has high incidence rate in the global scope, and is statistically plagued by rash in about 10-20% of children and 1-3% of adults in the global. Research shows that eczema is essentially an immune-mediated inflammatory skin disease, the immune environment of a patient suffering from eczema is abnormal, when the skin barrier function is damaged, bacterial, fungal and virus infections are extremely easy to cause symptoms such as skin erythema, pimple, blister, erosion and exudation, severe itching is caused, particularly, the itching is often aggravated at night, the sleep of the patient is seriously disturbed, and long-term scratching can also cause skin damage and infection, further aggravate illness, form malignant circulation and seriously influence the life quality of the patient. Currently, there are numerous drugs for eczema treatment, including glucocorticoids, immunosuppressants, traditional Chinese medicine preparations and the like. Because hormone medicines have side effects such as skin atrophy, pigmentation, telangiectasis and the like in long-term use, immunosuppressants have the problems of increased infection risk, liver and kidney function damage and the like, and compared with traditional Chinese medicine treatment, traditional Chinese medicine treatment is relatively safe, and becomes the research and development focus of functional preparations for treating eczema. For example, chinese patent application CN118453748A discloses a preparation for removing eczema and a preparation method thereof, extracts of more than ten specific plants such as purslane, golden chamomile, cortex phellodendri and the like are used as anti-allergic components and antibacterial anti-inflammatory components for eczema treatment, and the composition for preventing acute eczema of infants is disclosed in another patent application CN117752742A, and is prepared from more than ten Chinese herbal medicines such as liquorice, scutellaria baicalensis, radix sileris, pinellia ternate and the like and is used for preventing acute eczema of infants. However, the medicine prepared by compounding the plant extracts is influenced by factors such as raw material production places, extraction processes and the like, the product purity and the quality are large in batch-to-batch variability, standardized control is difficult, and the treatment effect is difficult to ensure clearly. In addition, the action mechanism of the plant extract compound drug is complex and difficult to be clarified, and the long-term use of the plant extract compound drug possibly causes unknown damage to the body. Carboxymethyl chitosan (CMCS) is prepared by introducing carboxymethyl groups on amino groups or hydroxyl groups of natural polysaccharide chitosan molecules through chemical modification, has an inhibitory effect on various bacteria and fungi, and is widely applied in the field of biological medicine. For example, chinese patent document CN103893640B discloses a chitosan infant biomedical antibacterial liquid and a preparation method thereof, and the chitosan infant biomedical antibacterial liquid is prepared by compounding various plant extracts such as baikal skullcap root, amur corktree bark, glabrous greenbrier rhizome and the like with modified chitosan, and is suitable for treating infection of small-area skin and mucous membrane wound surfaces, burns, scalds and the like. However, the backbone of CMCS is formed by β - (1→4) glycosidic linkages, which break down under high temperature and high pressure, and decompose, resulting in a decrease in viscosity, a decrease in binding ability and penetration ability with bacterial membranes, and a decrease in bacteriostatic activity; therefore, CMCS-containing products are not sterilized at high temperature and high pressure, CMCS main chain is broken due to irradiation sterilization, CMCS solution has high viscosity and is difficult to filter sterilization, and therefore, most of preparations containing CMCS on the market are provided in a non-sterile form, and for eczema treatment, pathogenic bacteria infection cannot be effectively controlled, and the treatment effect is affected. Beta-glucan is a natural high molecular polysaccharide formed by connecting D-glucose through beta-glycosidic bond, and the main sources of the beta-glucan comprise yeast/fungi, grains, bacteria and the like. Among them, yeast/fungus-derived beta-glucan has been reported to have an immunomodulatory effect, and has been attracting attention in the fields of immunoadjuvants, antitumor adjuvant therapy, wound healing, antiinfection, and th