Biocolloid liquid for cleaning non-chronic wound surface and preparation method of biocolloid liquid

By adding carboxylated glucosan sodium, polyglucosamine carboxylate and sulfosilicate to the wound repair colloid fluid, the pH value and dynamic viscosity are controlled, and the problem of insufficient stability of existing colloid fluids during acute wound treatment is solved. It achieves rapid hemostasis, promotion of healing and antibacterial effects.

CN119386260AInactive Publication Date: 2025-02-07HAINAN ZHONGSEN BIOTECH CO LTD
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Patent Information

Application Number
CN202411570754.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-11-05
Publication Date
2025-02-07
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

The existing wound repair colloid fluid is insufficient in the treatment of non-chronic wounds, especially acute wounds, and cannot meet the pH requirements of rapid cleaning, disinfection, hemostasis and suture treatments, affecting wound healing and safety.

Method used

Provide a non-chronic wound cleaning biocolloid liquid containing carboxylic acid sodium, polyglucosamine carboxylate, sulfosiligo peptide and normal saline. The pH value is controlled at 4.5-7.5 and the dynamic viscosity is 1.18mPa·s- Within the range of 3.00mPa·s, ensure good stability under different environmental conditions.

Benefits of technology

In non-chronic wounds, especially acute wound treatment, this biocolloid fluid has the effects of rapid hemostasis, promotion of healing, prevention of adhesions, auxiliary repair and antibacterial treatment, solving the stability and pH requirements during wound treatment and improving the wound treatment Safety and efficiency of healing.

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Abstract

The invention belongs to the field of medical dressings, and particularly relates to a biocolloid liquid for cleaning non-chronic wounds, the biocolloid liquid comprises sodium carboxyamino glucosan, sodium polyglucosamine carboxylate, thioglycopeptide and normal saline, is colorless or slightly yellow clear slightly viscous liquid, and is free of suspended solids and precipitates, and the biocolloid liquid can be used for cleaning non-chronic wounds. Wherein the sodium carboxyamino-glucosamine polysaccharide is glycosaminoglycan with the polymerization degree of 50-500 and containing carboxyl and amino groups, and the cytotoxic reaction of the biocolloid solution is not greater than level 2 by selectively controlling the pH value, the dynamic viscosity, the content of the sodium carboxyamino-glucosamine polysaccharide, the protein content, the heavy metal content and the like of the biocolloid solution; and moreover, flocculation and aging of colloidal fluid are avoided during treatment, and the excellent effect of timely treatment in application scenes such as cleaning and disinfection of non-chronic wounds is effectively ensured.
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Description

Technical Field

[0001] The invention belongs to the field of medical dressings, and specifically relates to a biocolloid liquid for cleaning non-chronic wounds and a preparation method thereof. The biocolloid liquid is mainly composed of a chitosan derivative (carboxymethyl chitosan) and purified water, is a colorless or slightly yellow clear slightly viscous liquid, has no suspended matter and precipitation, and is usually used for cleaning, disinfection and other treatments of non-chronic wounds. Background Art

[0002] Wound healing refers to the process in which local tissues are repaired through regeneration, repair, and reconstruction after tissue loss caused by an injury factor. Wounds are divided into acute wounds and chronic wounds according to the healing time. Non-chronic wounds usually refer to those wounds that do not take too long to heal and can generally heal within a few days or weeks. The typical symptoms of this type of wound include but are not limited to the following: Pain: The wound may be accompanied by varying degrees of pain, especially in the early stages. Redness and swelling: The skin around the wound may become red and swollen, which is the body's natural inflammatory response to injury. Secretion: The wound may have secretions, such as blood, pus, or other body fluids. The color, texture, and smell of these secretions may vary depending on the type of infection. Scabbing: As the wound heals, scabs may form, which is a natural way for the body to protect the wound. Itching: During the healing process, itching may be felt around the wound, which is a manifestation of new skin growth and recovery of nerve endings. Functional limitations: If the wound is located in a joint or other active part, it may temporarily affect the function of the part. Granulation tissue formation: During the healing process, fresh granulation tissue may form at the bottom of the wound, which is an important sign of healing. Wound shrinkage: Over time, the wound will gradually shrink and eventually heal.

[0003] There are many factors that affect wound healing, including systemic factors such as age, nutrition, tobacco and alcohol, potential or concomitant diseases, and psychological state, as well as local factors such as foreign bodies, infection, blood supply, humidity, pressure, friction, and shear force. In the 1970s, the pH value of the wound microenvironment was proposed as another local factor affecting wound healing and gradually received attention. The pH of the wound microenvironment is the acidity and alkalinity of the local exudate of the wound. The pH value of the normal skin surface is 4.0-6.0, and the pH value of wounds at different depths and locations is different. Sharpe et al. believed that the deeper the burn wound, the higher the pH value. Schreml et al. emphasized that the pH value of the wound changes from the center to the periphery in a gradient, with the center being higher (about 7.4) and the edge being lower (about 6.5). At present, the specific mechanism of pH value in the healing process of acute and chronic wounds is still unclear, but it is generally accepted that an acidic microenvironment can promote wound healing. In 2015, Jones et al. summarized the fluctuations in pH during the healing process of acute and chronic wounds: the pH of acute and chronic wounds will have a short downward trend in the early stage of inflammation, and then the pH of acute wounds will gradually increase as the wound heals, and reach a peak value when the granulation tissue growth is completed, becoming alkaline. After epithelialization begins, the pH value drops rapidly to the slightly acidic pH of the normal epidermis. In 2016, Mou Tianyi proposed in "Changes in pH Values ​​of Acute and Chronic Wounds and Wound Healing" that the pH of normal skin fluctuates between 4.80-5.70; the pH of acute non-infected wounds fluctuates between 6.60-7.90; the pH of acute infected wounds fluctuates between 6.60-8.30; the pH of chronic wounds fluctuates between 7.50-8.70; the pH of chronic wounds infected with Staphylococcus aureus: 7.82±0.11; the pH of chronic wounds infected with Escherichia coli: 7.63±0.06; the pH of chronic wounds infected with Pseudomonas aeruginosa: 8.50±0.05; the pH of chronic wounds infected with Klebsiella pneumoniae: 8.00±0.05; the pH of chronic wounds tends to decrease after debridement (P<0.05); the pH of acute infected wounds decreases after debridement and dressing change (P<0.05). It shows that the wound has different pH values ​​at different healing periods; acute wounds and chronic wounds have different pH fluctuation ranges, and different bacterial infections in chronic wounds have different pH values; the pH value change trends of the microenvironment of acute and chronic wounds are different: when the acute wound heals, the pH value of the wound gradually evolves towards acidification, and the acidic environment may help the wound healing, while the microenvironment of the chronic wound will continue to fluctuate in the alkaline environment.

[0004] During the healing process after surgery, tissue adhesion is inevitable due to the exudation of tissue fluid around the incision and the proliferation of fibrous tissue. Postoperative adhesion not only affects the surgical effect, but also causes serious postoperative complications. Studies have shown that the adhesion formation process first begins with the formation of fibrin mass, which is gradually replaced by granulation tissue (mainly fibroblasts and macrophages), and finally forms a fibrous band to cause adhesion. Blood clots are the main form of fibrin mass, so good postoperative hemostasis is crucial to prevent adhesion. In vitro experiments have shown that chitosan derivatives can significantly shorten the bleeding time of tissue wounds and have good coagulation properties. The reason for this is that CMCS is an amphoteric polyelectrolyte. In the solution, the amino group can be protonated to generate cations, and the carboxyl group can be ionized to generate anions. The two ions work together to accelerate the coagulation process and shorten the coagulation time. Infection is also one of the factors that induce postoperative adhesion. Bacteria have different adhesion-causing abilities. For example, Escherichia coli can induce the infiltration of fibrin molecules and leukocytes, resulting in more extensive adhesions. Antibiotics are often used clinically to control surgical area infection and reduce the occurrence of adhesions. Chitosan derivatives have good local antibacterial activity and thus have the effect of reducing postoperative adhesion. Due to large-area skin defects caused by burns, ulcers or other reasons, artificial skin, collagen membranes (sponges) and the like are often used clinically to cover the wound surface to reduce the loss of tissue fluid and protein, reduce bacterial invasion of the wound surface, and promote wound healing. However, these materials have the disadvantages of poor tissue compatibility, low mechanical strength, and no antibacterial activity. Chitosan derivatives have good biocompatibility, antibacterial properties, and can promote the growth of fibroblasts, and are suitable as wound dressing materials.

[0005] The known wound repair colloid liquid is not stable enough. Due to environmental changes such as pH changes, it often produces aging phenomena such as spontaneous flocculation, and at the same time affects its bactericidal effect. Changes in the pH of the wound environment will also cause flocculation and aging of the polymer colloid liquid. The environment used for the colloid liquid for wound repair changes (such as pH 6.5-8.5 during wound healing or after infection), which causes flocculation and aging of the colloid liquid, which will greatly affect the stability of the colloid liquid and reduce its wound repair and antibacterial effects, seriously restricting the application of the colloid liquid. CN201410073108 In order to solve such problems, a colloid liquid for wound repair and a preparation method thereof are provided, the colloid liquid contains the following components in weight percentage: 0.5-5% sodium carboxyaminoglucan, 0.1-0.5% cyclodextrin, 0.1-0.5% accelerator, and the rest is saline, based on the total weight of the colloid liquid. The colloid liquid has excellent stability under various environmental conditions, especially at pH values ​​(6.5-8.5) when the wound is in the healing process or after infection, so it has a wide range of applications, good antibacterial effect, can promote wound repair, is safe and reliable, and is easy to use. However, the wound repair colloid liquid solves the problem of solution stability during wound repair. It cannot meet the pH value requirements for immediate cleaning, disinfection, hemostasis, suture, etc. of non-chronic wounds, especially acute wounds, which is not conducive to the rapid treatment and later recovery of non-chronic wounds, especially acute wounds. Modern wound healing theory points out that the ammonia produced by the decomposition of urease in the wound by the slough and microorganisms forms tissue toxins in an alkaline environment and affects the healing of the wound, but such toxicity does not occur when the pH value is low. In addition, alkalosis can also cause the tissue to be in an oxygen-deficient state, which is not conducive to wound healing. The pH value of ordinary people's skin and wounds after healing is about 5, and the pH value may rise to 6.5-8.5 during the healing process or after infection. Summary of the invention

[0006] In order to solve the timeliness problem required for the treatment of non-chronic wounds, the pH value requirements for cleaning, disinfection, hemostasis, suturing and other treatments are met when non-chronic wounds, especially acute wounds, are immediately treated, which is conducive to the rapid treatment and later recovery of non-chronic wounds, especially acute wounds. The present invention provides a biocolloid liquid for cleaning non-chronic wounds, which includes sodium carboxyaminoglucosan, sodium polyglucosamine carboxylate, sulphoglycopeptide and physiological saline, etc. The product is sterile, a colorless or slightly yellow clear slightly viscous liquid, without suspended matter and precipitation. The sodium carboxyaminoglucosan described in the biocolloid liquid is an amino polysaccharide containing carboxylamino groups with a polymerization degree of 50-500, the sodium polyglucosamine carboxylate is obtained by extracting glycopeptides from the duodenum or gastric mucosa of pigs and undergoing sulfonation treatment, and the sulphoglycopeptide has good antibacterial activity and can form a protective film on the wound surface, which can protect the normal biological activity of the tissue and promote the repair of epithelial, mucosal and tissue wounds. When using it for wound treatment, no flocculation and aging of the colloid liquid will occur to affect the treatment effect. Furthermore, the pH value of the biocolloid liquid is controlled in the range of 4.5-7.5, preferably in the range of 4.7-7, and more preferably in the range of 5-6.4; further, the dynamic viscosity of the biocolloid liquid is 1.18mPa·s-3.00mPa·s, preferably 1.35mPa·s-2.73mPa·s, and more preferably 1.85mPa·s-2.57mPa·s; further, the protein content in the biocolloid liquid should be ≤10μg / mL; further, the heavy metal content is ≤10μg / mL, and the cytotoxic reaction is not greater than level 2. The biocolloid liquid is usually used for timely cleaning, disinfection, hemostasis, suturing and other treatments of non-chronic wounds, especially acute wounds. During the treatment, the colloid liquid will not flocculate and age, which will affect the treatment effect. Appropriate dressings are covered as needed to protect the wound, prevent infection and promote healing. It can remove necrotic tissue, prevent bacteria from invading the wound, and does not irritate the wound and surrounding tissues.

[0007] The biocolloid liquid for cleaning non-chronic wounds of the present invention has obvious clinical effects of promoting healing, stopping bleeding, inhibiting bacteria, controlling exudation, and reducing scar formation when cleaning, disinfecting, stopping bleeding, suturing, etc. of various non-chronic wounds, especially acute wounds in time. Specifically, the present invention is realized by the following technical schemes: In the first aspect, the present invention provides a biocolloid liquid for cleaning non-chronic wounds, and the biocolloid liquid is made of the following raw materials by weight percentage: 0.1%-3% sodium carboxyaminoglucosan, 0.5%-3.5% sodium polyaminoglucosamine carboxylate, 1%-3% thioglycopeptide, and physiological saline is added to 100%. The biocolloid liquid has the effects of rapid hemostasis, promoting healing, preventing adhesion, assisting repair and inhibiting bacteria when cleaning, disinfecting, stopping bleeding, suturing, etc. of non-chronic wounds, especially acute wounds in time. As an optional way, in the above-mentioned biocolloid liquid, the biocolloid liquid is made of the following raw materials by weight percentage: 0.5%-2% sodium carboxyaminoglucan, 1%-3% sodium polyglucosamine carboxylate, 1.5%-2.5% sulphoglycopeptide, and normal saline is added to 100%. As an optional way, in the above-mentioned biocolloid liquid, the biocolloid liquid is made of the following raw materials by weight percentage: 0.8%-1.5% sodium carboxyaminoglucan, 1.3%-2% sodium polyglucosamine carboxylate, 1.8%-2.3% sulphoglycopeptide, and normal saline is added to 100%. As an optional way, in the above-mentioned biocolloid liquid, the biocolloid liquid is made of the following raw materials by weight percentage: 1% sodium carboxyaminoglucan, 1.5% sodium polyglucosamine carboxylate, 2% sulphoglycopeptide, and normal saline is added to 100%.

[0008] In the second aspect, the present invention provides a method for preparing the biocolloid liquid described in the first aspect, comprising the following steps: Step 1: weigh various raw materials except physiological saline in the formula amount, add them to the liquid preparation tank, and add physiological saline to 100% for standby use; Step 2: stir the solution obtained in step 1 at a speed of 800-1000rpm, place it for 7 hours, and filter it with a filter element to obtain a clarified solution for standby use; Step 3: fill the clarified solution obtained in step 2 into a soft bag or a glass bottle according to the required specifications and seal it to obtain a primary product for standby use; Step 4: sterilize the primary product obtained in step 3, and package it after sterilization. Preferably, the packaging model can be bottled or soft bag, and the specifications are 5ml, 8ml, 10ml, 20ml, 50ml, 60ml, 80ml, 100ml, 200ml, and 250ml. The top of the bottled product is an easy-pull cover handle. Push it up 180 degrees with your thumb at the arrow, and then rotate it to the right to separate the aluminum tie cover. For products in soft bags, simply cut off the tube opening and they are ready for use.

[0009] In the third aspect, the present invention provides the use of the biocolloid liquid described in the first aspect or the biocolloid liquid prepared by the preparation method described in the second aspect in the preparation of functional surgical flushing dressings. As an optional mode, in the above-mentioned use, the functional surgical flushing dressing has the effects of rapid hemostasis, promoting healing, preventing adhesion, auxiliary repair and antibacterial, and is suitable for various surgical flushing, irrigation, cleaning, wound surface, mucosa and skin treatment and repair, and can play a lubricating isolation and biological barrier role for tissue wound surface, mucosa, and skin, effectively preventing bleeding and having antibacterial effects. Specifically, surgical field treatment can be performed, and the biocolloid liquid can be infiltrated with a sterile syringe or sterile absorbent cotton gauze to moisten and protect the surgical field wound surface and incision, and the remaining biocolloid liquid can be used to flush the local area, and the excess residual liquid can be sucked out to resist infection, relieve pain, and reduce the occurrence of postoperative adhesion. The general flushing amount is 50 to 250 ml. Postoperative suture wound treatment can be performed, postoperative suture wounds are rinsed with the biocolloid liquid, and wounds are covered with products such as self-adhesive or non-adhesive sterile gauze, which can resist infection, relieve pain, inhibit scars, and promote rapid wound healing. It can be used for burns, scalds, and frostbite treatment. If there is a large amount of secretion, first debride the wound, then cover the wound with 3 layers of sterile cotton yarn soaked in the biocolloid liquid and bandage it, and change the dressing once every 1 to 3 days. It is also possible to cover the local (half exposed) with a single layer of soaked cotton yarn, and then moisten the local with a syringe or sprayer, 1 to 3 times / day, if necessary, many times. It can be used to treat unhealthy granulation wounds. For those that are gray, atrophic, and have many secretions, wet the sterile cotton yarn with the biocolloid liquid, and change the dressing once every 1 to 3 days, until the granulation particles are red, tender and full, and skin grafting can be performed when bleeding is touched. It can be used to treat skin grafts and donor areas. After skin grafting or skin harvesting, the skin grafts and donor areas are covered with 4 to 6 layers of sterile gauze soaked with the biocolloid liquid, and then pressure bandaged with a sterile gauze pad. For large skin flap transplantation, the recipient area is wetted with 4 to 6 layers of sterile gauze soaked with the biocolloid liquid at least 1 to 3 days before transplantation, and is changed once a day. After transplantation, 4 to 6 layers of sterile cotton gauze soaked with the biocolloid liquid are covered and bandaged with a cotton pad. It can be used to treat mesothelial serosa, articular surfaces, tendons, and sheath tissues, and the biocolloid liquid is sprayed, flushed, irrigated, lubricated, or covered with gauze soaked with the biocolloid liquid to protect the tissue wound surface. The dosage is 50 to 250 ml at a time. It can be used to treat bad breath, gingivitis, and oral ulcers. The biocolloid liquid is used to rinse the mouth twice a day, 20 to 30 ml each time. If the biocolloid liquid is contained in the mouth for 5 minutes, the effect is better. It can be used on the body and face. It can be applied or wet-compressed for facial acne, dermatitis, skin discomfort before or after makeup, and local itching. The wet compress lasts for 10 to 20 minutes each time, which can make the skin smooth and healthy. As an optional method, in the above-mentioned use, the functional surgical flushing dressing is used for direct flushing or covering, applying or wet compressing the wound surface after soaking with a sterile dressing.

[0010] It should be understood that within the scope of the present invention, each technical feature specifically described in the present invention can be combined with each other to form a new or preferred technical solution. The present invention has good safety, biocompatibility, hemostasis and repair performance relative to the prior art, and has excellent antibacterial activity. The inventor unexpectedly found in the research process that the combination of carboxyaminoglucosan sodium, polyglucosamine carboxylate sodium, and sulphoglycopeptide in a specific dosage ratio has an unexpected synergistic effect. Compared with the use of carboxyaminoglucosan sodium biocolloid liquid alone, the use of polyglucosamine carboxylate sodium biocolloid liquid, sulphoglycopeptide flushing liquid and saline alone has excellent technical effects in terms of flushing effect, antibacterial effect, adverse reactions, biocompatibility, moisturizing performance, hemostasis performance, and repair effect. When it is used for non-chronic wounds, especially acute wounds, it is promptly cleaned, disinfected, hemostatic, sutured, etc., and has the effects of rapid hemostasis, promoting healing, preventing adhesion, auxiliary repair and antibacterial, which solves the shortcomings of the functional surgical flushing dressing currently used in clinical practice, and has very high technical advancement and clinical practical value. DETAILED DESCRIPTION

[0011] The present invention is further described below with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the scope of the present invention. If specific techniques or conditions are not specified in the embodiments, they are carried out according to the techniques or conditions described in the literature in this field, or according to the product instructions. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased through regular channels.

[0012] The experimental methods in the following examples are conventional methods unless otherwise specified. The experimental materials used in the following examples are commercially available products unless otherwise specified.

[0013] Example 1

[0014] A biocolloid liquid for cleaning non-chronic wounds is prepared from the following raw materials by weight percentage: 1% sodium carboxyaminoglucosan, 1.5% sodium polyglucosamine carboxylate, 2% thioglycopeptide, and normal saline added to 100%. The sodium carboxyaminoglucosan is an aminopolysaccharide containing carboxyamino groups with a polymerization degree of 50-500.

[0015] The preparation method of the biological colloid liquid comprises the following steps: step 1: weighing various raw materials except physiological saline in a formula amount, adding them into a liquid preparation tank, and adding physiological saline to 100% for standby; step 2: stirring the solution obtained in step 1 at a rotation speed of 900 rpm, leaving it for 7 hours, and filtering it with a filter element to obtain a clarified solution for standby; step 3: filling the clarified solution obtained in step 2 into a soft bag or a glass bottle according to the required specifications and sealing it to obtain a primary product for standby; step 4: sterilizing the primary product obtained in step 3, and packaging it after sterilization.

[0016] Embodiment 2-8

[0017]

[0018] The raw materials used in Examples 2-8, such as sodium carboxyaminoglucosamine polysaccharide, sodium polyglucosamine carboxylate, and thioglycopeptide, are the same as those in Example 1, and the preparation method is also basically the same as that in Example 1.

[0019] Comparative Example 1

[0020] A biocolloid liquid for cleaning non-chronic wounds is prepared from the following raw materials by weight percentage: 1% sodium carboxyaminoglucan polysaccharide and physiological saline to 100%. The sodium carboxyaminoglucan polysaccharide is an amino polysaccharide containing carboxyamino groups with a polymerization degree of 50-500.

[0021] The sodium carboxyaminoglucosan used in Comparative Example 1 is the same as that in Example 1, except that sodium carboxyaminoglucosan and thioglycopeptide are not included. The preparation method of Comparative Example 1 is the same as that in Example 1.

[0022] Comparative Example 2

[0023] A hemostatic and repairing biocolloid liquid is prepared from the following raw materials by weight percentage: 1.5% sodium polyglucosamine carboxylate, and physiological saline to 100%. The preparation method of comparative example 2 is the same as that of example 1 except that sodium polyglucosamine carboxylate and thioglycopeptide are not included.

[0024] Comparative Example 3

[0025] A biocolloid liquid for cleaning non-chronic wounds is prepared from the following raw materials by weight percentage: 1% sodium carboxyaminoglucosan, 1.5% sodium polyglucosamine carboxylate, and normal saline to 100%. The preparation method of comparative example 3 is the same as that of example 1 except that sulphadopeptide is not included.

[0026] Comparative Example 4

[0027] A biocolloid liquid for cleaning non-chronic wounds is prepared from the following raw materials by weight percentage: 1% sodium carboxyglucosamine polysaccharide, 2% thioglycopeptide, and normal saline to 100%. The preparation method of comparative example 4 is the same as that of example 1 except that sodium carboxyglucosamine polysaccharide is not included.

[0028] Comparative Example 5

[0029] A biocolloid liquid for cleaning non-chronic wounds is prepared from the following raw materials by weight percentage: 1.5% sodium polyglucosamine carboxylate, 2% thioglycopeptide, and normal saline to 100%. The preparation method of comparative example 5 is the same as that of example 1 except that sodium polyglucosamine carboxylate is not included.

[0030] Effect Example: Stability Test

[0031] The colloidal liquid obtained in Example 1 was tested for stability at the same time as Comparative Example 1: the pH value of the colloidal liquid was changed, and the stability change of the colloidal liquid was observed after standing for 24 hours; the colloidal liquid was left standing for 24 hours at 25°C and 5°C, and the stability change of the colloidal liquid was observed (the experiment described the stability results of the colloidal liquid as three grades: A, B and C. Grade A means good dispersion without obvious flocculation; Grade B means slight flocculation visible to the naked eye, and Grade C means obvious flocculation). The stability results are shown in Table 1 below. Controlled at 4.5-7.5, preferably 4.7-7, and more preferably 5-6.4 Table 1: Stability results

[0032]

[0033] From the above results, it can be seen that the colloidal liquid of Example 1 of the present invention is left standing for 24 hours at a pH value below 7, and its stability grade is A, while the colloidal liquids in Comparative Examples 1-5 are left standing for 24 hours after the pH environment changes to a pH value above 5, and their stability grades are further reduced to B or C. Therefore, at the conventional pH value (pH=5) of human skin and wounds after healing and at the pH value (pH=6.4-7.5) during the wound healing process or after infection, the stability grade of the colloidal liquid of the present invention is better than the colloidal liquids of Comparative Examples 1-5, and when the use environment changes to the pH value during the wound healing process or after infection, the stability superiority of the colloidal liquid of Example 1 of the present invention relative to Comparative Example 1 is more significant.

[0034] In addition, after standing for 24 hours at room temperature, the stability grade of the colloidal liquid of Example 1 of the present invention is A, while the stability grade of the colloidal liquid in Comparative Examples 1-5 is B. When the ambient temperature changes to 5°C, the stability grade of the colloidal liquid of Example 1 of the present invention is still A, while the grade of the colloidal liquid in Comparative Example 1 is further reduced to C. It can be seen that at room temperature and at the changed ambient temperature (e.g., 5°C), the stability grade of the colloidal liquid of the present invention is better than that of the colloidal liquid in Comparative Examples 1-5, and when the ambient temperature changes, the stability superiority of the colloidal liquid of Example 1 of the present invention relative to Comparative Examples 1-5 is more significant.

[0035] The present invention respectively conducted conventional animal skin irritation test, skin sensitization test and in vitro cytotoxicity test on the biocolloid liquid for cleaning non-chronic wounds prepared in Examples 1-8 and Comparative Examples 1-5. The results showed that the biocolloid liquid for cleaning non-chronic wounds of the present invention is safe and non-toxic.

[0036] In summary, the biocolloid liquid for cleaning non-chronic wounds of the present invention not only has good safety, biocompatibility, hemostasis and repair performance, but also has excellent antibacterial activity.

[0037] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A biocolloidal liquid for cleaning non-chronic wounds, comprising sodium carboxyaminoglucosan, sodium polyglucosamine carboxylate, thioglycopeptide and normal saline, and being a colorless or slightly yellow clear slightly viscous liquid without suspended matter and precipitation, wherein the sodium carboxyaminoglucosan is an amino polysaccharide containing a carboxylamino group with a polymerization degree of 50-500, the protein content in the biocolloidal liquid is ≤10 μg / mL, the heavy metal content is ≤10 μg / mL, and the cytotoxic reaction is not greater than grade 2.

2. The biocolloid liquid as claimed in claim 1 is made of the following raw materials in weight percentage: 0.1%-3% sodium carboxyaminoglucosan, 0.5%-3.5% sodium polyglucosamine carboxylate, 1%-3% thioglycopeptide, and physiological saline to 100%.

3. The biocolloid liquid as claimed in claim 1 or 2, which is made of the following raw materials in weight percentage: 0.5%-2% sodium carboxyaminoglucosan, 1%-3% sodium polyglucosamine carboxylate, 1.5%-2.5% thioglycopeptide, and physiological saline to 100%.

4. The biocolloid liquid according to any one of claims 1 to 3, which is made of the following raw materials in weight percentage: 1% sodium carboxyaminoglucosan, 1.5% sodium polyglucosamine carboxylate, 2% thioglycopeptide, and physiological saline added to 100%.

5. The biocolloid liquid according to any one of claims 1 to 4, which is made of the following raw materials by weight percentage: pH value is in the range of 4.5-7.5, preferably in the range of 4.7-7, more preferably in the range of 5-6.

4.

6. The biocolloid liquid according to any one of claims 1 to 5, having a dynamic viscosity of 1.18 mPa·s-3.00 mPa·s, preferably 1.35 mPa·s-2.73 mPa·s, and more preferably 1.85 mPa·s-2.57 mPa·s.

7. The method for preparing the biocolloid liquid according to any one of claims 1 to 6, comprising the following steps: Step 1: Weigh various raw materials except physiological saline in the formula amount, add them into a liquid preparation tank, and add physiological saline to 100% for later use; Step 2: Stir the solution obtained in step 1 at a speed of 800-1000 rpm, leave it for 7 hours, and filter it with a filter element to obtain a clarified solution for later use; Step 3: Fill the clarified solution obtained in step 2 into a soft bag or a glass bottle according to the required specifications and seal it to obtain a primary product for later use; Step 4: Sterilize the primary product obtained in step 3, and package it after sterilization.

8. The method for preparing a biocolloid liquid as claimed in claim 7, wherein the packaging model can be bottled or soft bagged, and the specifications are 5ml, 8ml, 10ml, 20ml, 50ml, 60ml, 80ml, 100ml, 200ml, and 250ml.

9. Use of the biocolloid liquid according to any one of claims 1 to 6 or the biocolloid liquid prepared by the preparation method according to claim 7 or 8 in preparing a functional surgical flushing dressing.

Citation Information

Patent Citations

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