TWI785756B - Multi-stage release dressing - Google Patents

Abstract

The disclosure is to provide a multi-stage release dressing. The present multi-stage release dressing comprises a body with a wound-contact surface, wherein the wound-contact surface comprises an 35% to 65% immediate-release active hydrocolloid and a 65% to 35% sustained-release active hydrocolloid, and the immediate-release active hydrocolloid and the sustained-release active hydrocolloid extends from the wound-contact surface to the body, wherein the immediate-release active hydrocolloid and the sustained-release active hydrocolloid account for 35% to 65% and 65% to 35% of the total weight of the body. The present multi-stage release dressing has a multi-stage liquid absorption to control the release profile of the active ingredient, thereby providing the stable release of the active ingredient at an effective concentration for a long period.

Description

multi-stage release dressing

The disclosure relates to a multi-stage release dressing, in particular to a multi-stage release dressing with multi-stage liquid absorption efficiency to control the release curve of the active ingredient, and provide a long-term stable release of the effective concentration of the active ingredient.

Wound healing is a dynamic and complex process, which can be roughly divided into three stages: inflammatory period, proliferative period, and maturation and remodeling period. Each stage requires a suitable environment to promote recovery, and dressings can be used as an aid according to the pathological condition. In addition to traditional dressings that temporarily cover and protect wounds, new dressings that prevent wound dehydration, promote healing, and resist bacterial penetration are important clinical development projects in modern medicine. They can promote angiogenesis and connective tissue synthesis, and help wounds Tissue gas exchange, maintaining proper tissue temperature to improve blood flow, preventing bacterial growth, or providing debridement are all functions that new dressings are expected to impart.

Dressing bases are usually synthetic polymers and are available in the form of films, foams, hydrogels, and hydrocolloids. In order to achieve the above healing function, hydrolyzable active substances can be added to the dressing matrix. For example, in the prior art, by adding sodium hydrogen sulfide (NaHS), the dressing can produce blood vessels that relax blood vessels and inhibit vascular smooth muscle cells after absorbing the secretion of wound tissue fluid. Proliferation, induction of vascular smooth muscle cell apoptosis, promotion of microvascular endothelial cell proliferation, anti-inflammatory and anti-oxidative effects of the active ingredient hydrogen sulfide (H ₂ S) gas; or by adding sodium percarbonate (SPO), calcium peroxide Peroxides such as (CaO ₂ ) and magnesium peroxide (MgO ₂ ) enable the dressing to secrete the active ingredient oxygen after absorbing wound tissue fluid, and achieve the effect of helping collagen deposition to promote wound tissue remodeling and induce angiogenesis. Among them, the decomposition rate of the hydrolyzable active substance will determine the release rate of the active ingredient.

However, the decomposition speed of the hydrolyzable active substance is limited by the single liquid absorption efficiency of the dressing matrix, so the dressing may contain the active ingredient with a fast release rate, but cannot release the sustained effect, or the active ingredient release rate is slow, and the dressing may not release the active ingredient slowly. The release concentration at the initial stage of application did not reach the effective concentration.

Moreover, for dressings containing more than one hydrolyzable active substance at the same time, the release curve of each active substance cannot be adjusted with the wound healing stage due to the single liquid absorption efficiency of the dressing matrix, so as to provide the most suitable healing conditions.

Therefore, there is still a need for a dressing with multi-stage liquid absorption efficiency to control the release curve of the active ingredient and provide a long-term stable release of the effective concentration of the active ingredient.

The present disclosure provides a novel multi-segment release dressing. The disclosed multi-stage release dressing has multi-stage liquid absorption efficiency to control the release curve of the active ingredient, and can release the effective concentration of the active ingredient stably for a long time to promote continuous wound healing.

The multi-stage release dressing of the present disclosure comprises a body, the body has a wound contact surface, wherein the wound contact surface contains 35% to 65% of the immediate release active hydrocolloid and 65% to 35% of the sustained release active hydrocolloid, and the immediate release active The hydrocolloid and the slow-release active hydrocolloid extend from the wound contact surface to the body, wherein the quick-release active hydrocolloid and the slow-release active hydrocolloid account for 35% to 65% and 65% to 35% of the total body weight respectively.

In one embodiment of the present disclosure, the immediate-release active hydrocolloid comprises 45 to 60 parts by weight of a hydrophilic polymer, 35 to 55 parts by weight of an elastomer compound, 3 to 7 parts by weight of a first hydrolyzable active substance, and 0.1 to 5 parts by weight of surfactant.

In one embodiment of the present disclosure, the sustained-release active hydrocolloid includes 40-60 parts by weight of a hydrophilic polymer, 40-55 parts by weight of an elastomer compound, and 4-10 parts by weight of a second hydrolyzable active substance.

According to one embodiment of the present disclosure, in the immediate-release active hydrocolloid or sustained-release active hydrocolloid, the hydrophilic polymer is selected from sodium carboxymethylcellulose, hydroxyethyl cellulose, sodium alginate, gelatin, The group consisting of pectin, carboxymethyl chitosan, guar gum, locust bean gum, collagen, karaya gum, and combinations thereof.

According to an embodiment of the present disclosure, in the immediate-release active hydrocolloid or the sustained-release active hydrocolloid, the elastomer compound includes an elastomer, a tackifier, and an extender.

According to an embodiment of the present disclosure, the content of the aforementioned elastomer may be 15-35 parts by weight, the content of the aforementioned tackifier may be 40-80 parts by weight, and the content of the aforementioned extender may be 2-20 parts by weight.

According to one embodiment of the present disclosure, the aforementioned elastic system is selected from styrene-isoprene-styrene (SIS) copolymer, styrene-butadiene-styrene (SBS) copolymer, styrene-( The group consisting of ethylene-butylene)-styrene (SEBS) copolymer, styrene-(ethylene-propylene)-styrene (SEPS) copolymer and combinations thereof.

According to an embodiment of the present disclosure, the aforementioned tackifier is selected from the group consisting of rosin resin, terpene resin, C5 petroleum resin, C9 petroleum resin, high-purity dicyclopentadiene (H-DCPD) and combinations thereof group.

According to an embodiment of the present disclosure, the aforementioned spreading agent is selected from the group consisting of mineral oil, liquid paraffin, castor oil, dibutyl phthalate, lanolin, naphthenic oil and combinations thereof.

According to an embodiment of the present disclosure, the aforementioned surfactant is polysorbate 80, polysorbate 20, polysorbate 60 or polysorbate 40.

According to an embodiment of the present disclosure, the aforementioned first hydrolyzable active substance is peroxide or sodium hydrosulfide.

According to an embodiment of the present disclosure, the aforementioned second hydrolyzable active substance is peroxide or sodium hydrosulfide.

In another embodiment of the present disclosure, the multi-stage release dressing may further include 0.2 to 2 parts by weight of antioxidant.

In another embodiment of the present disclosure, the aforementioned antioxidants may be hindered phenols, thiosynergists, secondary aromatic amines or phosphites.

The disclosure above is intended to provide a simplified summary of the disclosure to enable readers to have a basic understanding of the disclosure. This disclosure is not a complete overview of the disclosure, and it is not intended to point out key/critical elements of the embodiments of the disclosure or to define the scope of the disclosure. After referring to the following embodiments, those with ordinary knowledge in the technical field to which the present disclosure belongs can easily understand the basic spirit of the present disclosure as well as the technical means and implementation aspects adopted in the present disclosure.

In order to make the description of the content of the disclosure more detailed and complete, the following provides an illustrative description of the implementation and specific embodiments of the disclosure; but this is not the only way to implement or use the specific embodiments of the disclosure. The various embodiments disclosed below can be combined or replaced with each other when beneficial, and other embodiments can also be added to one embodiment, without further description or illustration.

The advantages, features and technical methods achieved by the present disclosure will be described in more detail with reference to exemplary embodiments to make it easier to understand, and the present disclosure may be implemented in different forms, so it should not be construed as being limited to the embodiments stated here On the contrary, for those with ordinary knowledge in the technical field, the provided embodiments will make this disclosure more thorough, comprehensive and completely convey the scope of this disclosure, and this disclosure will only be limited by the scope of the appended patent application definition.

And unless otherwise defined, all the terms (including technical and scientific terms) and proper nouns used in the following text are essentially the same as those generally understood by those skilled in the art to which this disclosure belongs, and for example, the commonly used Those terms defined in the dictionary should be understood as having meanings consistent with the contents of the relevant fields, and will not be interpreted in an overly idealized or overly formal meaning unless clearly defined in the following.

The object of the present disclosure is to provide a multi-stage release dressing comprising a body, wherein the body has a wound contacting surface, wherein the wound contacting surface comprises 35% to 65% immediate release active hydrocolloid and 65% to 35% sustained release active hydrocolloid , and the quick-release active hydrocolloid and the slow-release active hydrocolloid extend from the wound contact surface to the body, wherein the quick-release active hydrocolloid and the slow-release active hydrocolloid account for 35% to 65% and 65% to 35% of the total weight of the body, respectively. %between. The disclosed multi-stage release dressing has multi-stage liquid absorption efficiency to control the release curve of the active ingredient, and can release the effective concentration of the active ingredient stably for a long time to promote continuous wound healing. When the wound contacting surface contains too little or too much immediate-release active hydrocolloid or sustained-release active hydrocolloid, the initial liquid absorption of the immediate-release active hydrocolloid or sustained-release active hydrocolloid will be too low or too high. When the total weight of the quick-release active hydrocolloid or slow-release active hydrocolloid is too low or too high, the total liquid absorption of the quick-release active hydrocolloid or slow-release active hydrocolloid will be too low or too high. The unsatisfactory liquid absorption efficiency such as total liquid absorption or initial liquid absorption of immediate-release active hydrocolloids or sustained-release active hydrocolloids makes it difficult to maintain a suitable release curve for active ingredients, and multi-stage release dressings cannot release effective concentrations stably for a long time active ingredients.

In one embodiment of the multi-stage release dressing of the present disclosure, the immediate-release active hydrocolloid comprises 45 to 60 parts by weight of a hydrophilic polymer, 35 to 55 parts by weight of an elastomer compound, and 3 to 7 parts by weight of the first Hydrolyzable active substances, and 0.1 to 5 parts by weight of surfactant.

In one embodiment of the multi-stage release dressing of the present disclosure, the sustained-release active hydrocolloid includes 40 to 60 parts by weight of a hydrophilic polymer, 40 to 55 parts by weight of an elastomer compound, and 4 to 10 parts by weight of a Two hydrolyzable active substances.

The hydrophilic polymer can absorb liquid without swelling because of its hydrophilic group and three-dimensional cross-linked structure, so it can provide active hydrocolloids with the function of absorbing wound exudate well. Suitable hydrophilic polymers can be natural, semi-synthetic or synthetic hydrophilic polymers. Natural hydrophilic macromolecules may, for example, include polysaccharide macromolecules and protein or polypeptide macromolecules, such as pectin, pectin, acacia gum, guar gum, agar, starch, xanthan gum, dextran, albumin, casein protein etc. Semi-synthetic hydrophilic polymers can include, for example, carboxymethylcellulose, sodium carboxymethylcellulose, methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, methylhydroxypropyl Cellulose, sodium alginate, carboxymethyl starch, etc. Synthetic hydrophilic polymers may, for example, include polyvinyl alcohol, polyvinylpyrrolidone, acrylic polymers (such as polyacrylic acid and polyacrylamide), polyethylene glycol, polyvinyl methyl ether, and the like. In one preferred embodiment of the multi-stage release dressing of the present disclosure, the hydrophilic polymer of the immediate-release active hydrocolloid or the sustained-release active hydrocolloid can be sodium carboxymethylcellulose, hydroxyethylcellulose, sodium alginate, At least one or a combination of gelatin, pectin, carboxymethyl chitosan, guar gum, locust bean gum, collagen, and karaya gum, but not limited thereto. When the amount of hydrophilic polymer added is too much, the liquid absorption rate of the hydrocolloid may be too high, so that the hydrolysis rate of the hydrolyzable active substance is too fast, and the sustained release cannot be achieved. When the amount of hydrophilic polymer added is too small, the liquid absorption rate of the hydrocolloid may be too low, so that the hydrolysis rate of the hydrolyzable active substance is too slow, and the release concentration at the initial stage of dressing application does not reach the effective concentration.

The addition of the elastomer compound makes the hydrocolloid formable and has sufficient mechanical strength, and its hydrophobicity can coat the hydrolyzable active substance in the hydrocolloid, which can avoid the rapid hydrolysis of the hydrolyzable active substance, so it can slow down and regulate the release of the active ingredient rate. In one embodiment of the present disclosure, the elastomer compound may include an elastomer, a tackifier, and an extender.

The main function of the elastomer is to provide the mechanical strength of the main body of the hydrocolloid, and to coat the hydrophobicity of the hydrolyzable active substance. Suitable elastomers may for example be styrene-isoprene-styrene (SIS) copolymers, styrene-butadiene-styrene (SBS) copolymers, styrene-(ethylene-butylene)-styrene (SEBS) copolymer, styrene-(ethylene-propylene)-styrene (SEPS) copolymer, or combinations thereof, but not limited thereto.

Viscosifiers are used to further adjust the viscosity of the hydrocolloid. A suitable tackifier may be at least one of rosin resin, terpene resin, C5 petroleum resin, C9 petroleum resin, and high-purity dicyclopentadiene (H-DCPD) or a combination thereof.

Extenders can provide viscosity control and/or wetting. A suitable extender may be at least one of mineral oil, liquid paraffin, castor oil, dibutyl phthalate, lanolin and naphthenic oil or a combination thereof.

In an embodiment of the present disclosure, the elastomer of the elastomer composite may be 15 to 35 parts by weight, the tackifier may be 40 to 80 parts by weight, and the extender may be 2 to 20 parts by weight.

The hydrolyzable active substance absorbs wound exudate and is hydrolyzed to release active ingredients that promote wound healing, such as known peroxides, sodium hydrosulfide, hydrolyzed collagen, hyaluronic acid, and ascorbic acid (ascorbic acid), niacin, nicotinamide, arbutin or chlorhexidine acetate, but not limited thereto. In a preferred embodiment of the multi-stage release dressing of the present disclosure, the first hydrolyzable active substance is peroxide or sodium hydrosulfide. In a preferred embodiment of the multi-stage release dressing of the present disclosure, the second hydrolyzable active substance is peroxide or sodium hydrosulfide.

With the addition of a surfactant, the hydrophilic group at one end of the immediate-release active hydrocolloid can fully infiltrate the immediate-release active hydrocolloid after contacting the wound, further triggering the swelling of the hydrophilic polymer in the immediate-release active hydrocolloid and Quickly absorbs exudate. In one embodiment of the multi-stage release dressing of the present disclosure, the surfactant of the immediate-release active hydrocolloid can be polysorbate 80, polysorbate 20, polysorbate 60 or polysorbate 40. When the amount of the surfactant added is too high, the liquid absorption rate of the immediate-release active hydrocolloid may be too fast, and the first hydrolyzable substance may be degraded too quickly. When the addition amount of the surfactant is too small, the liquid absorption rate of the immediate-release active hydrocolloid may be too slow, so that the first hydrolyzable substance cannot be decomposed and the active ingredient can be released to an effective concentration at the initial stage of dressing application. In the process of absorbing wound exudate after the multi-stage release dressing of the present disclosure is applied, the liquid absorption rate of the immediate-release active hydrocolloid can be greater than or equal to 0.3 g/g･hr within 8 hours, and the liquid absorption rate can be less than 0.02 g after 24 hours /g･hr; The absorption rate of the relative slow-release active hydrocolloid can be less than 0.125 g/g･hr within 24 hours, and the absorption rate can be greater than 0.02 g/g･hr after 24 hours.

In another embodiment of the multi-stage release dressing of the present disclosure, the hydrocolloid may optionally further contain 0.2 to 2 parts by weight of an antioxidant to avoid property changes caused by aging of the elastomer. Suitable antioxidants may be hindered phenols, thiosynergists, phosphites or secondary aromatic amines.

The multi-segment release dressing of the present disclosure is further described below through diagrams. As shown in the perspective view of Figure 1A, the multi-stage release dressing 10 comprises a body 100 having a wound contacting surface 110, wherein the wound contacting surface 110 comprises an immediate release active hydrocolloid 101 and a sustained release active hydrocolloid 102, and the immediate release The active hydrocolloid 101 and the slow-release active hydrocolloid 102 extend from the wound contact surface 110 to the main body 100 . The depths d1 and d2 of the immediate-release active hydrocolloid 101 and the sustained-release active hydrocolloid 102 extending from the wound contact surface 110 to the body 100 according to the embodiment of the present disclosure are not limited, and can be based on the target thickness s of the body 100, and The quick-release active hydrocolloid 101 and the sustained-release active hydrocolloid 102 are set between 35% and 65% and 65% to 35% of the total weight of the body 100 respectively. Please refer to Figure 1B, the quick-release active hydrocolloid 101 and The depths of the slow-release active hydrocolloids 102 respectively extending from the wound contact surface 110 to the main body 100 can also be, for example but not limited to, d1' and d2' as shown in FIG. 1B.

Next, please refer to Fig. 2A to Fig. 2C together. The method for distributing the immediate-release active hydrocolloid 101 and the sustained-release active hydrocolloid 102 on the wound contact surface 110 according to the embodiment of the present disclosure is not limited, and can be arbitrarily determined. Wound contact surface 110 comprises 35% to 65% immediate release active hydrocolloid 101 and 65% to 35% slow release active hydrocolloid 102 arranged in proportion, such as but not limited to the wound contact surface as shown in Fig. 1A 110, the quick-release active hydrocolloid 101 is interlacedly distributed in the slow-release active hydrocolloid 102 in a dot shape, or the wound contact surface 210 as shown in Figure 2A, and the quick-release active hydrocolloid 201 is interlacedly distributed in the sustained-release active In the hydrocolloid 202, or the wound contact surface 210' as shown in Figure 2B, the immediate-release active hydrocolloid 201' is radially distributed in the slow-release active hydrocolloid 202', or the wound as shown in Figure 2C In contact with the surface 210 ″, the immediate-release active hydrocolloid 201 ″ is distributed in the slow-release active hydrocolloid 202 ″ in a ring shape. According to other embodiments of the present disclosure, the distribution method of the immediate-release active hydrocolloid 101 and the sustained-release active hydrocolloid 102 on the wound contact surface 110 can also be as shown in Figure 1A and Figure 2A to Figure 2C. Combinations and variations of distribution methods.

In addition, there is no limit to the relative interlacing mode of the immediate-release active hydrocolloid 101 and the sustained-release active hydrocolloid 102 in the multi-stage release dressing 10 according to the embodiment of the present disclosure. In the release dressing 10, the immediate-release active hydrocolloid 101 is distributed in the slow-release active hydrocolloid 102 in a relative staggered manner, or as shown in Figure 3, the slow-release active hydrocolloid 302 is distributed in the immediate-release active hydrocolloid in the multi-stage release dressing 30 301 Wherein this kind of relative staggering mode is opposite to Fig. 1A. In the multi-stage release dressing 10 according to other embodiments of the present disclosure, the relative distribution of the immediate-release active hydrocolloid 101 and the sustained-release active hydrocolloid 102 can also be in a relative staggered manner as shown in FIG. 2A to FIG. 2C opposite and change.

The manufacturing method of the multi-stage release dressing disclosed in the present disclosure may include preparing the fast-acting active hydrocolloid and the slow-acting active hydrocolloid separately, and cutting them after laminating them. In the cut multi-segment release dressing, the wound contact surface contains 35% to 65% immediate release active hydrocolloid and 65% to 35% slow release active hydrocolloid. The quick-acting active hydrocolloid can be prepared by mixing the aforementioned elastomer, tackifier and spreading agent at a temperature between 100°C and 200°C to form an elastomer composite. After mixing evenly, add the hydrophilic polymer, the first hydrolyzable active substance and the surfactant, and heat at a temperature between 100°C and 150°C for 15 minutes to 45 minutes to obtain a quick-acting active hydrocolloid Material. In a preferred embodiment of the present disclosure, the immediate-release active hydrocolloid comprises 45 to 60 parts by weight of a hydrophilic polymer, 35 to 55 parts by weight of an elastomer compound, and 3 to 7 parts by weight of a first hydrolyzable active substance and 0.1 to 5 parts by weight of a surfactant.

The slow-acting active hydrocolloid can be prepared by mixing the aforementioned elastomer, tackifier and spreading agent at a temperature between 100°C and 200°C to form an elastomer composite. After mixing evenly, add the hydrophilic polymer and the second hydrolyzable active substance, and heat at a temperature between 100°C and 150°C for 15 minutes to 45 minutes to obtain a quick-acting active hydrocolloid material. In a preferred embodiment of the present disclosure, the sustained-release active hydrocolloid comprises 40 to 60 parts by weight of a hydrophilic polymer, 40 to 55 parts by weight of an elastomeric compound, and 4 to 10 parts by weight of a second hydrolyzable active substance.

Then, inject the above-mentioned quick-release active hydrocolloid material and slow-release active hydrocolloid material into the molding mold and heat-press molding to form the quick-release active hydrocolloid and the slow-release active hydrocolloid. The hot pressing temperature can be, for example, between 50°C and 100°C.

According to the distribution method and target ratio of the immediate-release active hydrocolloid and the slow-release active hydrocolloid in the wound contact surface of the multi-stage release dressing, the formed immediate-release active hydrocolloid and the slow-release active hydrocolloid are stacked, and directly along the stacking axis. Hot-pressed into blocks or bundled toward the axis, then hot-pressed and fixed and cut into sheets parallel to the stacking axis to form a multi-stage release dressing with interlaced distribution of immediate-release active hydrocolloids and slow-release active hydrocolloids. The hot pressing temperature can be, for example, between 50°C and 100°C.

The following examples are used to further illustrate the present disclosure, but the present disclosure is not limited thereto.

Example

Example 1

Take 26 grams of styrene-isoprene-styrene copolymer (Kraton D1161, available from Kraton Polymers Japan Ltd., Japan), 62 grams of C5/C9 copolymer resin (Wingtack 86, available from Total Petrochemicals & Refining USA , Inc., U.S.) and 10 grams of mineral oil (Kaydol White Mineral Oil, purchased from Sonneborn, LLC, U.S.) were stirred at 150° C. for 60 minutes under a nitrogen atmosphere to form elastomer composite A.

Get 43.4 grams of elastomer compound A and 1 gram of hindered phenol tetrakis (3,5-di-tert-butyl-4-hydroxyl) pentaerythritol phenylpropionate (Chinox 1010, purchased from Double Bond Chemicals, Taiwan) at 180 ° C was stirred for 60 minutes under a nitrogen atmosphere, then cooled to 120°C, added 50 grams of sodium carboxymethyl cellulose, 5 grams of sodium percarbonate and 0.5 grams of surfactant Tween 80, stirred for 10 minutes and poured In the mold, it is hot-pressed at 90°C to form a quick-release active hydrocolloid.

Get 44 grams of elastomer compound A and 1 gram of hindered phenol tetrakis (3,5-di-tert-butyl-4-hydroxyl) pentaerythritol phenylpropionate (Chinox 1010, purchased from Double Bond Chemicals, Taiwan) at 180 ° C C stirred under nitrogen atmosphere for 60 minutes, then cooled to 120°C, added 50 grams of sodium carboxymethylcellulose, 5 grams of sodium percarbonate and 1 gram of sodium hydrosulfide, stirred for 10 minutes and poured into the mold Heat press molding at 90°C to form a slow-release active hydrocolloid.

The immediate-release active hydrocolloids and the slow-release active hydrocolloids were stacked staggeredly, and after hot-pressing and laminating the composite hydrocolloids along the direction of the stacking axis at 100°C, the composite hydrocolloids were cut into sheets parallel to the stacking axis, and A multi-segment release dressing is formed, the multi-segment release dressing comprises a body, and the body has a wound contact surface in which the immediate-release active hydrocolloid is interlacedly distributed in the slow-release active hydrocolloid. The wound contact surface contains 50% immediate-release active hydrocolloid and 50% sustained-release active hydrocolloid, and the immediate-release active hydrocolloid and sustained-release active hydrocolloid account for 60% and 40% of the total body weight respectively.

Example 2

The steps and materials of Example 2 are the same as in Example 1 to form a multi-stage release dressing, except that 42 grams of Elastomer Complex A is used to replace 43.4 grams of Elastomer Complex A and 2 grams of surfactant Tween for immediate release of the active hydrocolloid 80 replaces 0.5 grams of surfactant Tween 80, and the slow-release active hydrocolloid uses 40 grams of sodium carboxymethylcellulose to replace 50 grams of sodium carboxymethylcellulose and 54 grams of elastomer compound A to replace 44 grams of Elastomeric compound A.

Formed multi-stage release dressing, wherein the wound contact surface comprises 60% immediate-release active hydrocolloid and 40% sustained-release active hydrocolloid, and the immediate-release active hydrocolloid and sustained-release active hydrocolloid account for 50% and 50% of the total body weight respectively. 50%.

Example 3

The steps and materials of Example 3 are the same as in Example 1 to form a multi-stage release dressing, except that 44.38 grams of Elastomer Complex A is used to replace 43.4 grams of Elastomer Complex A and 4.12 grams of Sodium Percarbonate is used to replace the immediate-release active hydrocolloid 5 grams of sodium percarbonate, and the slow-release active hydrocolloid uses 42.42 grams of sodium carboxymethylcellulose instead of 50 grams of sodium carboxymethylcellulose, and 48.58 grams of elastomeric compound A instead of 44 grams of elastomeric compound A and 8 grams of sodium percarbonate instead of 5 grams of sodium percarbonate.

Formed multi-stage release dressing, wherein the wound contact surface comprises 40% immediate-release active hydrocolloid and 60% sustained-release active hydrocolloid, and the immediate-release active hydrocolloid and sustained-release active hydrocolloid account for 40% and 40% of the total body weight respectively. 60%.

Then, the multi-segment release dressings formed in Examples 1 to 3 were tested for liquid absorption characteristics and oxygen release concentration according to the following methods, and the test results are listed in Table 1.

Liquid absorption test

Get the active hydrocolloid prepared in Examples 1 to 4, weigh its weight with a four-digit balance to obtain its dry weight. Afterwards, soak the active hydrocolloid in phosphate buffered saline (PBS) at a constant temperature of 23±2°C. And 120 hours, the active hydrocolloid was taken out and its weight was weighed to obtain its wet weight after absorbing liquid. And according to the following formula, the average liquid absorption rate and liquid absorption ratio are obtained:

Average liquid absorption rate within 24 hours (g/g･hr)=(wet weight after 24 hours of liquid absorption (g)-dry weight (g))/(dry weight (g)*24(hr));

Average liquid absorption rate within 24 to 48 hours (g/g･hr) = (wet weight after 48 hours of liquid absorption (g) - wet weight after 24 hours of liquid absorption (g))/(after 24 hours of liquid absorption wet weight(g)*24(hr));

Absorption ratio = (wet weight after absorbing liquid at each test time point - dry weight)/(dry weight);

And, when the change range between the liquid absorption rate at one test time point and the liquid absorption rate at the next test time point is less than 1%, the test time point is regarded as the liquid absorption saturation time.

Oxygen release concentration test

The active hydrocolloids prepared in Examples 1 to 4 were soaked in phosphate-buffered saline at a constant temperature of 23 ± 2°C, and were taken out after 8, 24, 48, and 72 hours at each test time point, and were tested with Dissolved oxygen meter (instrument name 550A, manufactured by YSI, USA) measures the dissolved oxygen in the soaking solution, which is the oxygen release concentration of the active hydrocolloid at each test time point. Table 1: the test result of embodiment 1-3 Example 1 Example 2 Example 3 immediate release active hydrocolloid slow release active hydrocolloid immediate release active hydrocolloid slow release active hydrocolloid immediate release active hydrocolloid slow release active hydrocolloid Average liquid absorption rate within 24 hours (g/g･hr) 0.354 0.102 0.406 0.005 0.317 0.012 Average liquid absorption rate within 24 to 48 hours (g/g･hr) 0 0.065 0 0.024 0 0.031 Absorption saturation time (hours) twenty four 48 twenty four >120 8 >120 Oxygen release concentration at 8 hours (mg/L) 17 10 13 10 15 9.7 Oxygen release concentration in 24 hours (mg/L) 14.5 15 12 10.2 14 14 Oxygen release concentration at 48 hours (mg/L) 10.5 15 10 11 12.5 15.5 Oxygen release concentration at 72 hours (mg/L) 9.2 13 10 13.3 11 15.3

The prepared multi-stage release dressing of Examples 1 to 3, because of the quick-release active hydrocolloid with a higher liquid absorption rate in 24 hours, can quickly release the oxygen of sufficient effective concentration within 24 hours, and within 24 hours to After 48 hours, the absorption rate of the slow-release active hydrocolloid increases to increase the oxygen release concentration, so that the multi-stage release dressing can achieve the function of having multi-stage liquid absorption efficiency and stably releasing the effective concentration of oxygen for a long time.

Although this disclosure has been disclosed as above with the embodiment, it is not intended to limit this disclosure. Anyone who is familiar with this technology can make various changes and modifications without departing from the spirit and scope of this disclosure. Therefore, the protection of this disclosure The scope shall be defined by the appended patent application scope.

10, 10', 30: multi-segment release dressing 100: Ontology 101, 201, 201', 201", 301: immediate release active hydrocolloid 102, 202, 202', 202", 302: slow-release active hydrocolloid 110, 210, 210', 210": wound contact surface s: the thickness of the body d1, d1': Depth extending from the wound contact surface to the body of the immediate-release active hydrocolloid d2, d2': Depth extending from the wound contact surface to the main body of the sustained-release active hydrocolloid

Figures 1A to 1B are drawn according to the embodiments of the present disclosure, including the multi-stage release of the immediate release active hydrocolloid 101, 101' and the slow release active hydrocolloid 102, 102' extending from the wound contact surface 110 to the body 100 Perspective view of dressing 10, 10'.

Figures 2A to 2C show the immediate-release active hydrocolloids 201, 201', 201'' and sustained-release active hydrocolloids 201, 201', 201'' on wound contact surfaces 210, 210', 210'' in a multi-stage release dressing according to another embodiment of the present disclosure. Schematic diagram of distribution of active hydrocolloids 202, 202', 202''.

FIG. 3 is a three-dimensional perspective view of a multi-stage release dressing 30 comprising an immediate-release active hydrocolloid 301 and a slow-release active hydrocolloid 302 according to another embodiment of the present disclosure.

Domestic deposit information (please note in order of depositor, date, and number) none Overseas storage information (please note in order of storage country, institution, date, and number) none

10: Multi-stage release dressing

100: Ontology

101: Immediate release active hydrocolloid

102: Slow-release active hydrocolloid

110: wound contact surface

s: the thickness of the body

d1: Depth extending from the wound contact surface to the body of the immediate-release active hydrocolloid

d2: Depth extending from the wound contact surface to the main body of the sustained-release active hydrocolloid

Claims (14)

A multi-segment release dressing comprising: a body having a wound contacting surface, wherein the wound contacting surface comprises 35% to 65% of an immediate-release active hydrocolloid and 65% to 35% of a sustained-release active hydrocolloid, and the immediate-release active hydrocolloid and the sustained-release active hydrocolloid are contacted by the wound The surface extends toward the body, wherein the quick-release active hydrocolloid and the sustained-release active hydrocolloid account for 35% to 65% and 65% to 35% of the total weight of the body, respectively. The multi-stage release dressing as described in claim 1, wherein the quick-release active hydrocolloid comprises: 45 to 60 parts by weight of a hydrophilic polymer; 35 to 55 parts by weight of elastomeric compound; 3 to 7 parts by weight of the first hydrolyzable active substance; and 0.1 to 5 parts by weight of a surfactant. The multi-stage release dressing as described in claim 1, wherein the slow-release active hydrocolloid comprises: 40 to 60 parts by weight of a hydrophilic polymer; 40 to 55 parts by weight of an elastomeric compound; and 4 to 10 parts by weight of the second hydrolyzable active substance. The multi-stage release dressing as described in claim 2 or 3, wherein the hydrophilic polymer is selected from sodium carboxymethyl cellulose, hydroxyethyl cellulose, sodium alginate, gelatin, pectin, carboxymethyl shell The group consisting of polysaccharides, guar gum, locust bean gum, collagen, karaya gum, and combinations thereof. The multi-stage release dressing as described in claim 2 or 3, wherein the elastomeric compound comprises: an elastic body; a tackifier; and an extender. The multi-stage release dressing as described in claim 5, wherein the content of the elastomer is between 15 and 35 parts by weight, the content of the tackifier is between 40 and 80 parts by weight, and the content of the spreading agent is between Between 2 and 20 parts by weight. The multi-stage release dressing as described in claim 5, wherein the elastic system is selected from the group consisting of styrene-isoprene-styrene (SIS) copolymer, styrene-butadiene-styrene (SBS) copolymer, The group consisting of styrene-(ethylene-butylene)-styrene (SEBS) copolymer, styrene-(ethylene-propylene)-styrene (SEPS) copolymer and combinations thereof. The multistage release dressing as described in claim item 5, wherein the tackifier is selected from rosin resin, terpene resin, C5 petroleum resin, C9 petroleum resin, high-purity dicyclopentadiene (H-DCPD) and its The group formed by the combination. The multi-stage release dressing as claimed in item 5, wherein the spreading agent is selected from the group consisting of mineral oil, liquid paraffin, castor oil, dibutyl phthalate, lanolin, naphthenic oil and combinations thereof Group. The multi-stage release dressing as claimed in item 2, wherein the surfactant is polysorbate 80, polysorbate 20, polysorbate 60 or polysorbate 40. The multi-stage release dressing as claimed in claim 2, wherein the first hydrolyzable active substance is peroxide or sodium hydrosulfide. The multi-stage release dressing as claimed in claim 3, wherein the second hydrolyzable active substance is peroxide or sodium hydrosulfide. The multi-stage release dressing as claimed in claim 1, wherein the multi-stage release dressing further comprises 0.2 to 2 parts by weight of an antioxidant. The multi-stage release dressing as claimed in claim 9, wherein the antioxidant is hindered phenol, thiosynergists, phosphites or secondary aromatic amines.

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