Anorectal dressing with healing promoting function

Abstract

The invention relates to an anorectal dressing with lubricating and healing promoting functions. The anorectal dressing comprises a dressing body made of polyurethane foam, the composite coating is coated on at least part of the surface of the dressing body; the composite coating comprises a bioactive component; the bioactive component comprises alginate, bletilla striata polysaccharide and a hemostatic and anti-inflammatory component selected from phyllostachys sieboldii saponin, tranexamic acid or a combination of phyllostachys sieboldii saponin and tranexamic acid. By compounding the functional coating on the surface, multiple effects of lubrication, hemostasis, anti-inflammation and wound healing promotion are achieved, so that the experience of a patient is improved, postoperative recovery is accelerated, the postoperative recovery is fast, and the effect is more stable, safer and more effective.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a dressing for postoperative care of anorectal wounds or wounds caused by anorectal diseases, and its preparation method. Background Technology

[0002] In proctology clinics, after treating hemorrhoids, anal fistulas, anal fissures, and other conditions, dressings are often used to compress and support the wound to stop bleeding and promote healing. Traditionally, these dressings are made by doctors manually folding gauze and soaking it in medicated solution. These dressings lack ventilation channels, which can easily cause local bloating and discomfort for patients. Furthermore, their function is limited, mainly providing physical compression and fluid absorption. In the existing technology, there are already anorectal dressings made with hydrophilic polyurethane foam as the matrix, such as the anorectal dressing and its manufacturing method, and the dressing rod submitted by the applicant in CN202310577302.4. This dressing rod is elastic, lightweight, absorbent, porous, soft, and easily deformable and resilient. A silicone oil layer is coated on the body of the anorectal dressing rod to reduce friction between the body and the anus. A push rod is used to push the body into the anus, making it easy to insert the dressing rod into the anorectal area. Several ventilation holes are opened in the arc-shaped insertion part to facilitate the patient to expel intestinal gas. It has the advantages of being soft, absorbent and non-sticky, and maintaining a moist environment. However, conventional silicone oil lubricants only play a role in reducing friction and focus on the physical properties of the material. They have weak biological functions in promoting wound hemostasis, anti-inflammation, and accelerating tissue regeneration, and cannot produce a positive therapeutic effect on wound healing. Therefore, developing a new type of anorectal dressing that combines a good insertion experience, physical support performance, and multiple active therapeutic functions (hemostasis, anti-inflammation, and healing promotion) would be a better choice. Summary of the Invention

[0003] This invention aims to at least solve one of the technical problems existing in the prior art. To this end, this invention proposes an anorectal dressing with lubricating and healing-promoting functions, comprising: a dressing body made of polyurethane foam; and a composite coating applied to at least a portion of the surface of the dressing body; the composite coating containing bioactive components; the bioactive components including alginate, Bletilla striata polysaccharide, and hemostatic and anti-inflammatory components selected from Paris polyphylla saponins, tranexamic acid, or combinations thereof.

[0004] Furthermore, the composite coating exists in the form of a dry film, which can be re-dissolved and release active ingredients upon contact with water or wound exudate.

[0005] Furthermore, based on the dry weight of the composite coating, the content of Bletilla striata polysaccharide is 0.4 to 2.0 parts, and the content of alginate is 1.1 to 2.2 parts.

[0006] Furthermore, based on the dry weight of the composite coating, the content of Paris saponins is 0.043 parts to 0.43 parts.

[0007] Furthermore, based on the dry weight of the composite coating, the content of tranexamic acid is 0 to 2.7 parts.

[0008] Furthermore, the alginate is sodium alginate, which is partially or wholly replaced by polymannuronic oligosaccharides with a degree of polymerization of 5 to 20.

[0009] Furthermore, the surface viscosity of the composite coating after dissolving in water is 2000-2500 mm² / s.

[0010] In addition, the present invention also provides a method for preparing the above-mentioned anorectal dressing, comprising the following steps: Preparing the rectal dressing body: Providing a molded and cleaned polyurethane foam dressing body; S1. Preparation of coating solution: Dissolve alginate and / or polymannuronic oligosaccharide, Bletilla striata polysaccharide, and one or two components selected from Paris polyphylla saponins and tranexamic acid in deionized water, mix evenly, and obtain coating solution; S2. Coating: Immersing at least the front end portion of the dressing body into the coating liquid, causing the coating liquid to be absorbed onto its surface; S3. Drying and sterilization: The coated dressing body is removed, dried to cure the coating into a dry film, and then sterilized to obtain the anorectal dressing.

[0011] This invention provides a hemostatic dressing with a healing-promoting function, a further improvement on the hemostatic dressing described in applicant CN202310577302.4. While maintaining the advantages of the polyurethane foam matrix, it achieves multiple effects—lubrication, hemostasis, anti-inflammation, and promoting wound healing—through a surface composite functional coating, thereby improving patient experience and accelerating postoperative recovery. Compared with the prior art, this invention has the following significant advantages: Faster postoperative recovery: The composite coating created in this invention organically combines physical lubrication with multiple bioactive properties such as hemostasis, anti-inflammation, and healing promotion. Its effect surpasses that of traditional single-function dressings or simple lubricating coatings, resulting in faster and shorter postoperative recovery.

[0012] More stable effects: The selected active ingredients exhibit significant synergistic effects, resulting in more stable efficacy. Alginate (especially low-polymerization polymannuronic oligosaccharides) and Bletilla striata polysaccharides work together to promote epithelial cell growth and granulation tissue formation; Paris polyphylla saponins effectively inhibit key inflammatory factors (such as TNF-α and IL-1β), reducing swelling; tranexamic acid enhances hemostasis. This compound formulation intervenes in multiple aspects of anorectal wound healing.

[0013] Excellent user experience: The dry coating makes the dressing easy to store and handle, and it becomes instantly lubricated upon contact with water during use, greatly reducing friction and pain during insertion. The porous structure of the foam matrix itself facilitates air release and relieves bloating.

[0014] Safe and effective: It mainly uses natural polysaccharides and known safe and effective active ingredients, has good biocompatibility, does not irritate the wound, and can actively create a microenvironment conducive to healing.

[0015] Simple process: The preparation method is simple and easy to scale up. The functional coating can be firmly loaded by dip coating and drying. Detailed Implementation

[0016] The present invention will be further described below with reference to specific embodiments, but the scope of protection of the present invention is not limited thereto.

[0017] This embodiment of an anorectal dressing with lubricating and healing functions includes: a dressing body made of polyurethane foam; and a composite coating applied to at least a portion of the surface of the dressing body in the form of a dry film, which can be re-dissolved and release active ingredients upon contact with water or wound exudate; the composite coating contains bioactive components; the bioactive components include alginate, Bletilla striata polysaccharide, and hemostatic and anti-inflammatory components selected from Paris polyphylla saponins, tranexamic acid, or combinations thereof, wherein, based on the dry weight of the composite coating, the content of Bletilla striata polysaccharide is 0.4 to 2.0 parts, the content of alginate is 1.1 to 2.2 parts, the content of Paris polyphylla saponins is 0.043 to 0.43 parts, and the content of tranexamic acid is 0 to 2.7 parts.

[0018] The alginate is low-viscosity sodium alginate, which is partially or wholly replaced by polymannuronic oligosaccharides with a degree of polymerization of 5 to 20.

[0019] The method for preparing the above-mentioned rectal dressing in this embodiment includes the following steps: Preparation stage: Matrix treatment, using hydrophilic polyether prepolymer, chain extender, bioactive substance cyclodextrin β inclusion complex, surfactant composition, water, etc. to foam and mold columnar hydrophilic polyurethane foam body, after washing with purified water, pre-drying at 50℃ for use. S1, Preparation of coating solution: (1) Weigh out 10 sets of the following components: Low-viscosity sodium alginate, polymannuronic oligosaccharides with a degree of polymerization of 5-20, Bletilla striata polysaccharide extract powder (polysaccharide content ≥95 parts), Paris polyphylla alcohol extract (main components: Paris saponins I, II, VI, VII, content 1.3%, density 0.82 g / ml), tranexamic acid. The specific content of each component is shown in the table below (coating solution ingredient list).

[0020] (2) Dissolve the above raw materials in 100ml of deionized water and stir until completely dissolved to obtain a uniform coating solution; S2. Coating: Immerse at least about 2 / 3 of the front end of the dressing body into the coating liquid for 10 seconds to ensure full wetting and allow the coating liquid to be absorbed onto its surface; S3. Drying and sterilization: The coated dressing body is taken out and dried in a 60°C hot air circulating oven for 4 hours to dry the coating into a film. Then, it is sterilized with ethylene oxide or cobalt-60 to obtain the anorectal dressing of this embodiment.

[0021] Coating liquid ingredient list experimental group Low viscosity sodium alginate (unit: g) Polymannuron oligosaccharides (unit: g) Bletilla striata polysaccharide extract dry powder (unit: g) Alcoholic extract of Paris polyphylla (unit: ml) Tranexamic acid (unit: g) Deionized water (unit: ml) 1 2.2 0.0 0.4 4.0 0 100 2 1.8 0.2 0.6 8.0 0.3 100 3 1.4 0.5 0.8 16.0 0.6 100 4 1.0 0.8 1.0 20.0 0.9 100 5 1.0 1.2 1.2 24.0 1.2 100 6 0.8 1.0 1.4 28.0 1.5 100 7 0.6 0.8 1.6 32.0 1.8 100 8 0.4 0.7 1.8 36.0 2.1 100 9 0.2 1.6 2.0 38.0 2.4 100 10 0.0 2.2 2.0 40.0 2.7 100 Comparative Example Using the same polyurethane foam matrix as in the above embodiments, the surface was coated only with a 5% polyvinyl alcohol (PVA) aqueous solution as a lubricating layer, and dried and sterilized using the same process to obtain the control dressing.

[0022] Effect verification experiment: In vitro cell (human keratinocyte HaCaT) proliferation experiments (e.g., CCK-8 assay) revealed that, compared to the comparative PVA extract, the experimental groups (Examples 1-10) showed significantly higher cell numbers in the coating extracts compared to the control group, with a highly statistically significant difference (p<0.01), significantly promoting cell proliferation. The dressings containing Paris polyphylla saponins in the Example 10 experimental groups exhibited a significant inhibitory effect on LPS-induced TNF-α secretion by macrophages in anti-inflammatory factor detection. Cell proliferation was even faster after replacing sodium alginate with polymannuron oligosaccharides. Animal skin defect models showed that wounds treated with the dressings of this invention healed faster, with milder inflammatory responses and more abundant granulation tissue growth.

[0023] Application method: In clinical use, a small amount of sterile water or saline solution is applied to the tip of the dressing of this invention. The composite coating on the surface quickly dissolves to form a lubricating layer, allowing for easy and painless insertion into the anorectal wound. Subsequently, the bioactive components in the coating continue to act on the wound, exerting a comprehensive therapeutic effect of hemostasis, anti-inflammation, and promoting healing.

[0024] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A rectal dressing with healing-promoting function, characterized in that, include: A dressing body made of polyurethane foam; and a composite coating applied to at least a portion of the surface of the dressing body; The composite coating contains bioactive components; the bioactive components include alginate, Bletilla striata polysaccharide, and one or two selected from Paris polyphylla saponins and tranexamic acid.

2. The rectal dressing according to claim 1, characterized in that, The composite coating exists in the form of a dry film.

3. The rectal dressing according to claim 1 or 2, characterized in that, Based on the dry weight of the composite coating, the content of Bletilla striata polysaccharide is 0.4 parts to 2.0 parts, and the content of alginate is 1.1 parts to 2.2 parts.

4. The rectal dressing according to claim 3, characterized in that, The content of Paris saponins is 0.043 to 0.43 parts based on the dry weight of the composite coating.

5. The rectal dressing according to claim 3, characterized in that, The content of tranexamic acid is 0 to 2.7 parts based on the dry weight of the composite coating.

6. The rectal dressing according to claim 1, characterized in that, The alginate is sodium alginate, which is partially or wholly replaced by polymannuronic oligosaccharides with a degree of polymerization of 5 to 20.

7. The rectal dressing according to claim 1, characterized in that, The surface viscosity of the composite coating after dissolving in water is 2000-2500 mm² / s.

8. A method for preparing the rectal dressing as described in any one of claims 1-7, characterized in that, Includes the following steps: S1. Preparation of coating solution: Dissolve alginate and / or polymannuronic oligosaccharide, Bletilla striata polysaccharide, and one or two components selected from Paris polyphylla saponins and tranexamic acid in deionized water and mix thoroughly; S2. Immerse at least a portion of the polyurethane foam dressing body in the coating liquid; S3. Remove and dry to allow the coating to dry into a film, then sterilize.

9. The method according to claim 8, characterized in that, In step S3, the coating is dried in a 60°C hot air circulating oven for 4 hours to cure it into a dry film, and then sterilized using ethylene oxide or cobalt 60.

10. The method according to claim 8, characterized in that, The polyurethane foam dressing body is a hydrophilic polyurethane foam body that has been molded, foamed, and cleaned.