Sterile liquid dressing, sterile liquid dressing product and preparation method of sterile liquid dressing product

Abstract

The invention relates to the technical field of medical instruments, and discloses a sterile liquid dressing, a sterile liquid dressing product and a preparation method of the sterile liquid dressing, and the sterile liquid dressing is prepared from the following components by taking the total mass of the liquid dressing as 100wt%: 0.1 wt%-3wt% of sodium carboxymethyl cellulose, 0.5 wt%-5wt% of glycerol and 0.1 wt%-1wt% of hyaluronic acid. According to the invention, a liquid pad which is not easy to disperse is formed before endoscopic excision or stripping for early cancer or precancerous lesions such as polyp, intraepithelial neoplasia and the like of the digestive tract wall, the boundary of the lesions is well exposed, and treatment is facilitated; after the focus is cut off, wound covering protection, hemostasis and tiny damage repair are facilitated.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a sterile liquid dressing, a sterile liquid dressing product and a preparation method thereof. Background Art

[0002] In modern medical practice, due to the particularity of the lesions on the wall of the digestive tract, a sterile liquid dressing is required to be injected submucosally before cutting to form a local bulge. It shows a clear lesion boundary for easy treatment; and after cutting, it can cover the wound surface, which plays an important role in hemostasis, repairing minor damage and preventing wound adhesion. At present, physiological saline is often added with indigo carmine and other colorants for injection in clinical practice, but due to the rapid diffusion, it cannot form an effective bulge for a long time, and it needs to be injected repeatedly during treatment. It also cannot provide the corresponding hemostasis and effective wound coverage functions, which is not conducive to rapid wound healing. Summary of the invention

[0003] In view of the above-mentioned technical deficiencies, the technical problem to be solved by the present invention is to provide a sterile liquid dressing, a sterile liquid dressing product and a preparation method thereof, aiming to solve the technical problems that traditional liquid dressings cannot effectively help polyps bulge and define boundaries before polyp cutting and do not have sufficient hemostasis, wound healing and anti-adhesion functions.

[0004] To solve the above technical problems, the present invention adopts the following technical solution: The present invention provides a sterile liquid dressing, comprising: based on the total mass of the liquid dressing as 100wt%, the liquid dressing is composed of the following components: 0.1wt%~3wt% of sodium carboxymethyl cellulose, 0.5wt%~5wt% of glycerol, and 0.1wt%~1wt% of hyaluronic acid.

[0005] A sterile liquid dressing product, comprising a glass bottle or a plastic bottle and the sterile liquid dressing as claimed in claim 1 contained in the glass bottle or the plastic bottle.

[0006] A method for preparing a sterile liquid dressing comprises the following steps: S1. Add 40% purified water or water for injection to the weighed sodium carboxymethyl cellulose, and add weighed glycerol and stir to obtain a solution; S2, weigh hyaluronic acid, sprinkle it evenly on the solution obtained in step S1, and add the remaining amount of purified water or water for injection; S3, performing ultrasonic treatment at 5-10° C. for 20 minutes to obtain a treated mixture; S4. Packaging and sterilizing the treated mixture to obtain the sterile liquid dressing product.

[0007] Furthermore, in step S1: Use a mechanical stirrer to stir at room temperature at a speed of 300-500 r / min for 15-20 minutes until the sodium carboxymethyl cellulose is completely dissolved to form a uniform solution.

[0008] Furthermore, in step S4: The mixture obtained in step S3 is filtered by membrane filtration or plate laminar flow filtration under pressure; Use an automatic filling machine to dispense liquid dressings into pre-sterilized glass or plastic bottles; After the subpackaging is completed, seal it immediately; The packaged products are finally sterilized by gamma ray irradiation at a dose of 25-30 kGy, or dry heat sterilization at 121° for 15 minutes or 170°~340° for 45 minutes, or by 0.22um filtration sterilization to finally obtain sterile liquid dressings.

[0009] The beneficial effects of the present invention are as follows: the present invention forms a non-diffusible liquid pad for early cancer or precancerous lesions of the digestive tract wall such as polyps, intraepithelial neoplasia, etc. before endoscopic resection or peeling, thereby exposing the lesion boundary well and facilitating treatment; after the lesion is removed, it is beneficial for wound coverage protection, hemostasis and repair of minor damage. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0011] Figure 1 A schematic flow chart of a method for preparing a sterile liquid dressing provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0012] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Example

[0013] This embodiment provides a sterile liquid dressing, comprising: based on the total mass of the liquid dressing being 100wt%, the liquid dressing is composed of the following components: 0.1wt% to 3wt% of sodium carboxymethyl cellulose, 0.5wt% to 5wt% of glycerol, and 0.1wt% to 1wt% of hyaluronic acid. It should be noted that carboxymethyl fiber is the main component of absorbable hemostatic gauze, and according to its characteristics, it can be spun into flakes and made into cloth to obtain an absorbable hemostatic gauze. Example

[0014] This embodiment provides a sterile liquid dressing product, which consists of a glass bottle or a plastic bottle and the sterile liquid dressing provided in Embodiment 1 contained in the glass bottle or the plastic bottle. Example

[0015] Based on Examples 1 and 2, Figure 1 As shown, this embodiment provides a method for preparing a sterile liquid dressing, comprising the following steps: S1. Set the total mass of the liquid dressing to 100 g, weigh 0.5 g of sodium carboxymethyl cellulose, 2 g of glycerol, 0.5 g of hyaluronic acid and the remaining 97 g of purified water or water for injection; add 40 g of purified water and 2 g of glycerol to a container containing 0.5 g of sodium carboxymethyl cellulose, and stir the mixture at a speed of 400 r / min using a mechanical stirrer for about 18 minutes until the sodium carboxymethyl cellulose is completely dissolved to form a uniform solution.

[0016] S2. Sprinkle 0.5 g of hyaluronic acid evenly on the surface of the solution, add the remaining purified water or water for injection, and stir gently for about 5 minutes to allow the hyaluronic acid to be completely dispersed in the solution, while trying to avoid the generation of foam.

[0017] S3, transferring the obtained mixed solution into a container suitable for ultrasonic treatment, and performing ultrasonic treatment at 5-10° C. for 20 minutes to obtain a treated mixture; S4. Pressurize the mixture obtained in step S3 and filter it through membrane filtration or plate laminar flow filtration; use an automatic filling machine to pack the liquid dressing into pre-sterilized glass bottles or plastic bottles; seal the bottles immediately after the packing is completed; perform final sterilization on the packed products by gamma ray irradiation sterilization with a dose of 25-30 kGy, or dry heat sterilization at 121° for 15 minutes or 170°~340° for 45 minutes, or sterilization by 0.22um filtration. This product is not suitable for gas sterilization, and finally obtain a sterile liquid dressing. Example

[0018] This embodiment is the fourth embodiment of the present invention. This embodiment is different from the third embodiment in that it provides a verification test for a sterile liquid dressing to verify and illustrate the technical effects adopted in this method.

[0019] In this embodiment, the experiment is divided into two groups, the liquid dressing of the present invention is used as the experimental group, and the traditional liquid dressing is used as the control group. A total of 30 polyp models and 60 experimental animals are selected, with 30 animals in each group, and each experimental step is repeated three times independently; in a simulated surgical environment, the present embodiment injects the corresponding liquid dressing into the polyp model and the experimental animal respectively, and records the effect after injection; specifically, the effect of the liquid dressing of the present invention on the polyp protrusion is evaluated by observing the height of the bulge in the polyp area, and the hemostatic effect is first tested on the experimental animals, and the hemostatic effect is evaluated by measuring and recording the amount of bleeding and bleeding time after injection; secondly, the wound is regularly observed, and the healing time and healing quality score are recorded to evaluate the wound healing; finally, feedback from patients using the liquid dressing of the present invention and the traditional liquid dressing is collected, and satisfaction scores are performed. A total of 120 patient feedback questionnaires are collected, with 60 in each group. The specific results are shown in Table 1: Table 1: Comparison results table.

[0020] index Liquid dressing of the present invention Traditional liquid dressings Polyp protrusion effect Prominent bulge with clear borders The bulge is not obvious and the boundary is fuzzy Polyp height after injection (mm) 3.5 ± 0.2 1.8 ± 0.3 Hemostatic effect 70% reduction in bleeding 40% reduction in bleeding Mean bleeding time (seconds) 15 ± 3 30 ± 5 Wound healing time (days) 7 ± 1 10 ± 2 Healing quality score (1-10 points) 9.2 ± 0.5 7.5 ± 0.6 Anti-adhesion effect No obvious adhesion Obvious adhesion Patient satisfaction score (1-10 points) 9.0 ± 0.4 7.0 ± 0.5 The experimental results in Table 1 show that, firstly, when the liquid dressing of the present invention is used, the height of the polyp is increased by about 94%, and the polyp is significantly raised with clear boundaries, indicating that the present invention can effectively help the polyp to rise and clearly define the surgical boundary; secondly, in terms of hemostatic effect, the amount of bleeding is reduced by 70%, which is 75% higher than that of the traditional liquid dressing, and the average bleeding time is shortened by 50%; the wound healing time is shortened by about 30%, and the healing quality score is improved by about 23%. Finally, the postoperative adhesion situation is also significantly improved, the adhesion score is reduced by about 70%, and the patient satisfaction is improved by about 29%. It can be seen that the liquid dressing of the present invention has better polyp raising effect, hemostatic effect and anti-adhesion effect than the traditional liquid dressing.

[0021] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or replace some of the technical features therein by equivalents. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A sterile liquid dressing, characterized in that: include: Taking the total mass of the liquid dressing as 100wt%, the liquid dressing consists of the following components: 0.1wt% to 3wt% of sodium carboxymethyl cellulose, 0.5wt% to 5wt% of glycerol, and 0.1wt% to 1wt% of hyaluronic acid.

2. A sterile liquid dressing product, characterized in that: The invention consists of a glass bottle or a plastic bottle and the sterile liquid dressing as claimed in claim 1 contained in the glass bottle or the plastic bottle.

3. A method for preparing a sterile liquid dressing, characterized in that: The following steps are involved: S1. Add 40% purified water or water for injection to the weighed sodium carboxymethyl cellulose, and add weighed glycerol and stir to obtain a solution; S2, weigh hyaluronic acid, sprinkle it evenly on the solution obtained in step S1, and add the remaining amount of purified water or water for injection; S3, performing ultrasonic treatment at 5-10° C. for 20 minutes to obtain a treated mixture; S4. Packaging and sterilizing the treated mixture to obtain the sterile liquid dressing product.

4. The preparation method according to claim 3, characterized in that: In step S1: Use a mechanical stirrer to stir at room temperature at a speed of 300-500 r / min for 15-20 minutes until the sodium carboxymethyl cellulose is completely dissolved to form a uniform solution.

5. The preparation method according to claim 3, characterized in that: In step S4: The mixture obtained in step S3 is filtered by membrane filtration or plate laminar flow filtration under pressure; Use an automatic filling machine to dispense liquid dressings into pre-sterilized glass or plastic bottles; After the subpackaging is completed, seal it immediately; The packaged products are finally sterilized by gamma ray irradiation at a dose of 25-30 kGy, or dry heat sterilization at 121° for 15 minutes or 170°~340° for 45 minutes, or by 0.22um filtration sterilization to finally obtain sterile liquid dressings.

Images