Hydrocolloid dressing and preparation method thereof

Abstract

The invention relates to the technical field of medical materials, in particular to a hydrocolloid dressing and a preparation method thereof.The hydrocolloid dressing comprises a base film, a functional layer and release paper which are sequentially stacked; the functional layer is prepared from the following raw material components in parts by weight: 15 to 45 parts of sodium carboxymethyl cellulose; 1-5 parts of an aluminum-containing hemostatic; 3-20 parts of an alkaline antibacterial agent; and 30-70 parts of a viscous substance. According to the hydrocolloid dressing provided by the invention, through the synergistic effect of the aluminum-containing hemostatic agent and the alkaline antibacterial agent in the functional layer, the hemostatic performance of the hydrocolloid dressing is improved, and meanwhile, the hydrocolloid dressing is beneficial to protecting a wound, inhibiting microorganism growth at the wound and promoting wound healing.

Description

Technical Field

[0001] The invention relates to the technical field of medical materials, and in particular to a hydrocolloid dressing and a preparation method thereof. Background Art

[0002] Hydrocolloid dressings are a new type of wound dressing developed under the guidance of the moist healing principle. They are made by mixing elastic polymer hydrogel with synthetic rubber and adhesive. The most common gel in hydrocolloid dressings is carboxymethyl cellulose, which can be firmly adhered to the skin at the edge of the wound and can swell 12 times after absorbing exudate.

[0003] Hydrocolloid dressings can be used to treat a variety of different wounds, such as pressure sores and venous ulcers, and are particularly effective for chronic, difficult-to-heal wounds. The absorbency and viscosity of hydrocolloids enable them to meet the basic requirements of an ideal dressing, namely, protecting the wound, providing a suitable environment to promote wound healing, and being easy to remove without damaging new tissue.

[0004] Although the hydrocolloid dressings currently on the market have the functions of absorbing exudate, providing a moist environment and preventing adhesion, their hemostatic performance is poor; therefore, how to improve the hemostatic performance of hydrocolloid dressings is a technical problem that urgently needs to be solved. Summary of the invention

[0005] In order to solve the problem of poor hemostatic performance of hydrocolloid dressings in the prior art, the present invention provides a hydrocolloid dressing. The hydrocolloid dressing improves its hemostatic and antibacterial properties while ensuring the absorbency and appropriate viscosity of the hydrocolloid dressing through the synergistic effect of an aluminum-containing hemostatic agent, an antibacterial agent and sodium carboxymethyl cellulose, thereby solving the problem of poor hemostatic performance of hydrocolloid dressings in the prior art.

[0006] The technical solution adopted by the present invention to solve its technical problem is:

[0007] A hydrocolloid dressing comprises a base film, a functional layer and a release paper which are stacked in sequence; the raw materials of the functional layer comprise the following components in parts by weight:

[0008]

[0009] Optionally, the aluminum-containing hemostatic agent is selected from at least one of aluminum chloride and alum.

[0010] Optionally, the alkaline antibacterial agent is sodium bicarbonate.

[0011] Optionally, the adhesive is hot melt adhesive.

[0012] Optionally, the base film is a polyurethane film.

[0013] Another object of the present invention is to provide a method for preparing the hydrocolloid dressing as described above, comprising the following steps:

[0014] S1: preparing a functional mixture according to the formula amount using sodium carboxymethyl cellulose, aluminum-containing hemostatic agent, alkaline antibacterial agent, and adhesive as raw materials;

[0015] S2: applying the functional mixture onto a base film and applying release paper to obtain a hydrocolloid dressing.

[0016] Optionally, step S1 includes the following process:

[0017] S11: mixing the aluminum-containing hemostatic agent and the alkaline antibacterial agent according to the formula amount to obtain a hemostatic antibacterial agent;

[0018] S12: adding the sodium carboxymethyl cellulose and the viscous substance to the hemostatic antibacterial agent in sequence to obtain the functional mixture.

[0019] Optionally, the pH value of the hemostatic antibacterial agent ranges from 6.5 to 8.5.

[0020] The beneficial effects of the present invention are:

[0021] The hydrocolloid dressing provided by the present invention improves the hemostatic performance of the hydrocolloid dressing through the synergistic effect of the aluminum-containing hemostatic agent and the alkaline antibacterial agent in the functional layer, helps to protect the wound, inhibit the growth of microorganisms in the wound, and promote wound healing. DETAILED DESCRIPTION

[0022] The present invention is now further described in detail. The embodiments described below are exemplary and intended to be used to explain the present invention, but cannot be understood as limiting the present invention. All other embodiments obtained by ordinary technicians in this field without creative work based on the embodiments of the present invention belong to the scope of protection of the present invention.

[0023] In order to solve the problem of poor hemostatic performance of hydrocolloid dressings in the prior art, the present invention provides a hydrocolloid dressing, which comprises a base film, a functional layer and a release paper stacked in sequence; the raw materials of the functional layer include the following components in parts by weight:

[0024] 15-45 parts of sodium carboxymethyl cellulose;

[0025] 1-5 parts of aluminum-containing hemostatic agent;

[0026] 3-20 parts of alkaline antibacterial agent;

[0027] 30-70 parts of sticky material.

[0028] In order to ensure the hemostatic performance of the hydrocolloid dressing, the present invention introduces an aluminum-containing hemostat into the functional layer, wherein the aluminum-containing hemostat can precipitate and coagulate proteins, thereby achieving hemostasis; since the aqueous solution of the aluminum-containing hemostat is acidic, in order to avoid irritation to the wound and skin, an alkaline antibacterial agent is further introduced, which not only imparts antibacterial properties to the hydrocolloid dressing, but also synergizes with the aluminum-containing hemostat to provide a suitable environment for promoting wound healing. While achieving hemostasis, it protects the wound, inhibits the growth of microorganisms in the wound, reduces irritation to the wound and skin, and promotes wound healing.

[0029] The hydrocolloid dressing provided by the present invention improves the hemostatic performance of the hydrocolloid dressing through the synergistic effect of the aluminum-containing hemostatic agent and the alkaline antibacterial agent in the functional layer, helps to protect the wound, inhibit the growth of microorganisms in the wound, and promote wound healing.

[0030] Specifically, the present invention preferably comprises an aluminum-containing hemostatic agent selected from at least one of aluminum chloride and alum; and preferably the alkaline antibacterial agent is sodium bicarbonate.

[0031] Specifically, aluminum chloride is an inorganic compound that can quickly stop bleeding. It is a salt of strong acid and weak base. The pH of the solution is about 4. Direct application to the wound will cause irritation to the wound and skin while stopping bleeding; alum can coagulate protein and thus stop bleeding. Its aqueous solution is also acidic, and generally the pH is less than 7. When used directly, the higher the concentration, the stronger the acidity, which will cause irritation to the wound and skin; sodium bicarbonate applied directly to the wound can cause burns and irritation; the present invention creatively combines aluminum chloride or alum with sodium bicarbonate for use. Through compounding, while ensuring the hemostatic performance of the hydrocolloid dressing and improving the antibacterial performance, it avoids irritation to the wound and skin, protects the wound, provides a suitable environment for wound healing, and promotes wound healing.

[0032] Furthermore, in the present invention, the preferred adhesive is a hot melt adhesive, and further preferred the adhesive is a polyisobutylene medical hot melt adhesive; and the preferred base film is a polyurethane film.

[0033] The hydrocolloid dressing provided by the present invention can astringe, stop bleeding and resist bacteria. It is not only suitable for the treatment of chronic wounds such as bedsores and venous ulcers, but also can be used for the treatment of acute bleeding small wounds, protecting wounds, providing a suitable environment for promoting wound healing, inhibiting the growth of wound microorganisms and reducing irritation.

[0034] Another object of the present invention is to provide a method for preparing the hydrocolloid dressing as described above, the method comprising the following steps:

[0035] S1: preparing a functional mixture according to the formula amount using sodium carboxymethyl cellulose, aluminum-containing hemostatic agent, alkaline antibacterial agent, and adhesive as raw materials;

[0036] S2: Apply the functional mixture onto the base film and apply release paper to obtain a hydrocolloid dressing.

[0037] When the adhesive is a hot melt adhesive, it is preferred to heat the adhesive to melt at 130-150° C. and then mix it with other raw materials.

[0038] The preparation method of the hydrocolloid dressing provided by the present invention improves the hemostatic performance of the hydrocolloid dressing, inhibits the growth of microorganisms in the wound, and promotes wound healing through the synergistic effect of the aluminum-containing hemostatic agent and the alkaline antibacterial agent in the functional mixture.

[0039] Furthermore, in order to take into account the hemostatic performance, antibacterial performance and wound healing performance of the hydrocolloid dressing, the preferred step S1 of the present invention includes the following process:

[0040] S11: mixing the aluminum-containing hemostatic agent and the alkaline antibacterial agent according to the formula amount to obtain a hemostatic antibacterial agent;

[0041] S12: According to the formula, sodium carboxymethyl cellulose and a sticky substance are added to the hemostatic antibacterial agent in sequence, preferably the sticky substance is heated and melted at 130-150°C and then added to obtain a functional mixture; in this step, preferably the amount of the hemostatic antibacterial agent added is 5-25 parts, the amount of sodium carboxymethyl cellulose added is 15-45 parts, and the amount of the sticky substance added is 30-70 parts.

[0042] Specifically, in order to avoid irritation to wounds and skin and promote wound healing, the pH value range of the hemostatic antibacterial agent of the present invention is preferably 6.5-8.5, and further preferably, when the aluminum-containing hemostatic agent is aluminum chloride and the alkaline antibacterial agent is sodium bicarbonate, the mass ratio of aluminum chloride to sodium bicarbonate is 1-5 parts, and the amount of sodium bicarbonate added is 3-20 parts; when the aluminum-containing hemostatic agent is alum and the alkaline antibacterial agent is sodium bicarbonate, the amount of alum added is 1-5 parts, and the amount of sodium bicarbonate added is 5-20 parts in parts by weight.

[0043] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, specific embodiments of the present invention are described in detail below.

[0044] Example 1

[0045] This embodiment provides a method for preparing a hydrocolloid dressing, comprising the following steps:

[0046] S11: Mix 3 parts of aluminum chloride and 17 parts of sodium bicarbonate by weight to obtain a hemostatic antibacterial agent;

[0047] S12: adding 35 parts of sodium carboxymethyl cellulose to 20 parts of the hemostatic antibacterial agent, mixing evenly, and then adding 60 parts of polyisobutylene medical hot melt adhesive melted at 140° C., mixing evenly, to obtain a functional mixture;

[0048] S2: Apply the functional mixture onto the base film and apply release paper to obtain a hydrocolloid dressing.

[0049] Example 2

[0050] This embodiment provides a method for preparing a hydrocolloid dressing, comprising the following steps:

[0051] S11: Mix 2 parts of alum and 8 parts of sodium bicarbonate by weight to obtain a hemostatic antibacterial agent;

[0052] S12: adding 35 parts of sodium carboxymethyl cellulose to 10 parts of the hemostatic antibacterial agent, mixing evenly, and then adding 60 parts of polyisobutylene medical hot melt adhesive melted at 140° C., mixing evenly, to obtain a functional mixture;

[0053] S2: Apply the functional mixture onto the base film and apply release paper to obtain a hydrocolloid dressing.

[0054] Example 3

[0055] This embodiment provides a method for preparing a hydrocolloid dressing, comprising the following steps:

[0056] S11: Mix 5 parts of aluminum chloride and 20 parts of sodium bicarbonate by weight to obtain a hemostatic antibacterial agent;

[0057] S12: adding 45 parts of sodium carboxymethyl cellulose to 25 parts of the hemostatic antibacterial agent, mixing evenly, and then adding 40 parts of polyisobutylene medical hot melt adhesive melted at 140° C., mixing evenly, to obtain a functional mixture;

[0058] S2: Apply the functional mixture onto the base film and apply release paper to obtain a hydrocolloid dressing.

[0059] Comparative Example 1

[0060] This comparative example provides a method for preparing a hydrocolloid dressing, comprising the following steps:

[0061] S1: adding 60 parts of polyisobutylene medical hot melt adhesive melted at 140° C. to 35 parts of sodium carboxymethyl cellulose by weight, and mixing them evenly to obtain a functional mixture;

[0062] S2: Apply the functional mixture onto the base film and apply release paper to obtain a hydrocolloid dressing.

[0063] Comparative Example 2

[0064] This comparative example provides a method for preparing a hydrocolloid dressing, comprising the following steps:

[0065] S1: According to the weight ratio, 35 parts of sodium carboxymethyl cellulose are added to 3 parts of aluminum chloride, and the mixture is evenly mixed. Then, 60 parts of polyisobutylene medical hot melt adhesive melted at 140° C. are added, and the mixture is evenly mixed to obtain a functional mixture;

[0066] S2: Apply the functional mixture onto the base film and apply release paper to obtain a hydrocolloid dressing.

[0067] Comparative Example 3

[0068] This comparative example provides a method for preparing a hydrocolloid dressing, comprising the following steps:

[0069] S1: According to the weight ratio, 35 parts of sodium carboxymethyl cellulose are added to 17 parts of sodium bicarbonate, and the mixture is evenly mixed. Then, 60 parts of polyisobutylene medical hot melt adhesive melted at 140° C. are added, and the mixture is evenly mixed to obtain a functional mixture;

[0070] S2: Apply the functional mixture onto the base film and apply release paper to obtain a hydrocolloid dressing.

[0071] Comparative Example 4

[0072] This comparative example provides a method for preparing a hydrocolloid dressing, comprising the following steps:

[0073] S11: Mix 3 parts of aluminum chloride and 17 parts of nano zinc oxide according to weight to obtain a hemostatic antibacterial agent;

[0074] S12: adding 35 parts of sodium carboxymethyl cellulose to 20 parts of the hemostatic antibacterial agent, mixing evenly, and then adding 60 parts of polyisobutylene medical hot melt adhesive melted at 140° C., mixing evenly, to obtain a functional mixture;

[0075] S2: Apply the functional mixture onto the base film and apply release paper to obtain a hydrocolloid dressing.

[0076] Comparative Example 5

[0077] This comparative example provides a method for preparing a hydrocolloid dressing, comprising the following steps:

[0078] S11: Mix 3 parts of nano calcium oxide and 17 parts of sodium bicarbonate by weight to obtain a hemostatic antibacterial agent;

[0079] S12: adding 35 parts of sodium carboxymethyl cellulose to 20 parts of the hemostatic antibacterial agent, mixing evenly, and then adding 60 parts of polyisobutylene medical hot melt adhesive melted at 140° C., mixing evenly, to obtain a functional mixture;

[0080] S2: Apply the functional mixture onto the base film and apply release paper to obtain a hydrocolloid dressing.

[0081] The hemostatic performance, antibacterial performance and wound healing promotion of the hydrocolloid dressings prepared in the above embodiments and comparative examples were tested, and the testing method is as follows:

[0082] Hemostasis and wound healing performance: 24 rats were selected and fed under the same conditions for half a month. Wounds were prepared under anesthesia and aseptic conditions. Wounds of the same depth and size were selected, and the dressings prepared in Examples 1-3 and Comparative Examples 1-5 were placed on the wounds. Three parallel samples were made for each dressing, and the hemostasis time was measured. After the measurement, the dressing was not taken out, and a secondary dressing was directly performed. The wound healing area was checked regularly, and the healing rate was calculated.

[0083] Antibacterial properties: The inhibition zone method is used to detect whether it has antibacterial properties. TSA plate culture medium is added with Staphylococcus aureus liquid, and the hydrocolloid dressing disc is placed in it for culture to observe whether an inhibition zone appears around the disc.

[0084] The test results are shown in Table 1:

[0085] Table 1

[0086]

[0087]

[0088] It can be seen from the data in the above table that the hydrocolloid dressings prepared in various embodiments of the present invention have excellent hemostatic and antibacterial properties, and are helpful in promoting wound healing.

[0089] The difference between Comparative Example 1 and Example 1 is that no aluminum-containing hemostatic agent and alkaline antibacterial agent are added to the functional layer; the prepared hydrocolloid dressing has poor hemostatic property, no antibacterial property, and slow wound healing.

[0090] The difference between Comparative Example 2 and Example 1 is that no alkaline antibacterial agent is added to the functional layer; the prepared hydrocolloid dressing has good hemostatic properties and certain antibacterial properties, but the wound heals slowly because the alkaline antibacterial agent irritates the wound.

[0091] The difference between Comparative Example 3 and Example 1 is that no aluminum-containing hemostatic agent is added to the functional layer; although the prepared hydrocolloid dressing has certain hemostatic and antibacterial properties, the wound heals slowly.

[0092] The difference between Comparative Example 4 and Example 1 is that the alkaline antibacterial agent in the functional layer is replaced with zinc oxide; the wound healing of the prepared hydrocolloid dressing is significantly slower than that of Example 1.

[0093] The difference between Comparative Example 5 and Example 1 is that the aluminum-containing hemostatic agent in the functional layer is replaced by calcium oxide; the prepared hydrocolloid dressing not only has poor hemostatic properties, but also significantly slows down wound healing.

[0094] Based on the above ideal embodiments of the present invention, the relevant staff can make various changes and modifications without departing from the technical concept of the present invention through the above description. The technical scope of the present invention is not limited to the contents of the specification, and its technical scope must be determined according to the scope of the claims.

Claims

1. A hydrocolloid dressing, characterized in that: It comprises a base film, a functional layer and a release paper which are stacked in sequence; the raw materials of the functional layer include the following components in parts by weight:

2. The hydrocolloid dressing according to claim 1, characterized in that The aluminum-containing hemostatic agent is selected from at least one of aluminum chloride and alum.

3. The hydrocolloid dressing according to claim 1, characterized in that The alkaline antibacterial agent is sodium bicarbonate.

4. The hydrocolloid dressing according to claim 1, characterized in that The sticky substance is hot melt adhesive.

5. The hydrocolloid dressing according to any one of claims 1 to 4, characterized in that: The base film is a polyurethane film.

6. A method for preparing the hydrocolloid dressing according to any one of claims 1 to 5, characterized in that: The steps include: S1: preparing a functional mixture according to the formula amount using sodium carboxymethyl cellulose, aluminum-containing hemostatic agent, alkaline antibacterial agent, and adhesive as raw materials; S2: applying the functional mixture onto a base film and applying release paper to obtain a hydrocolloid dressing.

7. The method for preparing the hydrocolloid dressing according to claim 6, characterized in that: Step S1 includes the following process: S11: mixing the aluminum-containing hemostatic agent and the alkaline antibacterial agent according to the formula amount to obtain a hemostatic antibacterial agent; S12: adding the sodium carboxymethyl cellulose and the viscous substance to the hemostatic antibacterial agent in sequence to obtain the functional mixture.

8. The method for preparing the hydrocolloid dressing according to claim 7, characterized in that: The pH value of the hemostatic antibacterial agent ranges from 6.5 to 8.5.

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