Medical degumming cleaning agent for protecting skin and preparation method of medical degumming cleaning agent

Abstract

The composition is an emulsion formed by mixing an oil phase and a water phase. The oil phase comprises squalane and cyclic siloxane, the water phase takes water as a solvent and comprises a surfactant and polyhydric alcohol, and the surfactant consists of decyl glucoside and cocamidopropyl betaine in a weight ratio of (1: 1)-(2: 1). The composition disclosed by the invention is applied to the medical instrument (such as an adhesive tape, a tension reducing device, an operation dressing and the like) adhered to the skin, and then the medical instrument is stripped from the skin. Through verification, the acting force for stripping the medical instrument is remarkably reduced, compared with three commercially available adhesive removers, the stripping force is also remarkably reduced by nearly one time, the irritation to the skin is slight and is equivalent to normal saline, adhesive residues on the surface of the skin can be mildly removed, and side effects caused by traditional solvent products to the skin are avoided.

Description

Technical Field

[0001] The invention relates to a composition for cleaning, in particular to a composition for cleaning adhesive medical products from the skin, which is beneficial for protecting the skin, and a method for preparing the composition. Background Art

[0002] In the process of medical care, adhesive medical products such as adhesive tapes, tension reducers and surgical dressings are widely used in wound care, drug delivery and fluid management. However, the process of replacing these products often requires them to be removed from the skin surface before re-pasting new products. The removal process of these products is not only often accompanied by skin pain, but also often leaves adhesive residues on the skin surface, which can cause skin irritation or even allergic reactions. What's worse, repeated replacement can lead to wounds or skin damage. These problems are particularly prominent in long-term users and patients with sensitive skin. Therefore, safely and effectively reducing product viscosity and removing residual adhesives on the skin has become one of the problems that need to be solved in this field.

[0003] Currently, commonly used medical adhesive removers usually do not take into account that the skin is in a sensitive and damaged state after long-term use of adhesive products such as tension-reducing tapes and pressure-sensitive adhesives. Although ethanol is conducive to adhesive removal and has a significant effect in removing adhesives, the high dosage leads to further damage to the skin barrier. Therefore, in order to overcome these defects, a milder adhesive remover with good skin compatibility is needed clinically. Summary of the invention

[0004] An object of the present invention is to provide a composition which can be used as a cleanser to facilitate the removal of medical adhesives from the skin.

[0005] Another object of the present invention is to provide a composition which can be used as a cleaning agent to facilitate the removal of medical adhesives from the skin.

[0006] Another object of the present invention is to provide a composition which can be used as a cleaning agent to act on medical adhesives to reduce the adhesion between the adhesives and the skin, thereby reducing the force required to peel the medical adhesives from the skin and improving skin pain.

[0007] Another object of the present invention is to provide a composition which can be used as a cleaning agent to act on medical adhesives, thereby increasing the bonding strength between the adhesive and the base fabric and weakening the bonding strength with the skin, making the medical adhesive easier to peel off from the skin and no longer leaving adhesive on the skin, thereby protecting the epidermis and improving skin allergic reactions.

[0008] A composition, which is an emulsion formed by mixing an oil phase and an aqueous phase, wherein the weight ratio of the oil phase to the aqueous phase is 2 to 4:5, wherein:

[0009] The oil phase includes squalane and cyclic siloxane in a weight ratio of 1:5-7;

[0010] The aqueous phase uses water as a solvent, and includes a surfactant (e.g., a concentration of 19 wt% to 24 wt%) and a polyol (e.g., a concentration of 5 wt% to 10 wt%, especially 8 wt%).

[0011] The surfactant is composed of decyl glucoside and cocamidopropyl betaine, and the weight ratio is 1:1 to 2:1, especially 2:1;

[0012] Polyols such as, but not limited to, propylene glycol and glycerol can be used alone or in combination in the present invention.

[0013] Cyclic siloxanes such as, but not limited to, decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) are suitable for use in the present invention alone or in combination.

[0014] The composition of the present invention also contains vitamin E, which is beneficial to increase the bonding force between the viscose and the base fabric and weaken the bonding force between the base fabric and the skin. The amount used is 1wt% to 3wt%, specifically 1wt%, 2wt% and 3wt%.

[0015] The composition of the present invention further adds one or more of olive oil and coconut oil into the oil phase to reduce the amount of squalane used accordingly, thereby effectively reducing the cost of the composition, but the weight ratio of squalane to cyclic siloxane is not less than 1:10.

[0016] The composition of the present invention further adds isopropanol to the water phase at a concentration of 10wt% to 16wt%, especially 10wt%, 11wt% and 12wt%, which facilitates the composition to contact the viscose through the base fabric and enhances the bonding effect between the viscose and the base fabric.

[0017] The composition of the present invention is prepared as follows:

[0018] After the oil phase is heated to 40℃±0.5℃ and mixed evenly, add the water phase and continue mixing to form a uniform emulsion.

[0019] In order to increase the bonding force between the viscose and the base fabric and weaken the bonding force between the base fabric and the skin, the composition of the present invention is prepared by first heating the oil phase to 40°C ± 0.5°C and mixing it, then adding the water phase and continuing to mix, during which vitamin E is added to finally form a uniform emulsion.

[0020] After applying the composition of the present invention to medical devices (such as adhesive tape, tension reducer and surgical dressing, etc.) attached to the skin, the medical devices are then peeled off the skin. It has been verified that the force of peeling off the medical devices is significantly reduced. Compared with three commercially available adhesive removers, the peeling force is also significantly reduced by nearly 1 times, and the irritation to the skin is mild, which is equivalent to normal saline. It can be seen that the composition of the present invention can not only gently remove the adhesive residue on the skin surface, avoiding the side effects of traditional solvent products on the skin, but also soothe the skin and promote barrier repair while removing the adhesive. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 These are bright field photos of the skin irritation test on various groups of animals to which the composition of Example 1 was applied;

[0022] Figure 2 These are bright field photographs of the skin of each group of animals to which the composition of Example 1 was applied after multiple stimulation tests. DETAILED DESCRIPTION

[0023] The technical solution of the present invention is described in detail below with reference to the accompanying drawings. The embodiments of the present invention are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention is described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that the technical solution of the invention can be modified or replaced by equivalents without departing from the spirit and scope of the technical solution of the present invention, which should be included in the scope of the claims of the present invention.

[0024] Example 1 Preparation of the composition

[0025] First heat the oil phase to 40℃±0.5℃ and mix well, then add the water phase and continue mixing. During this time, add vitamin E to finally form a uniform emulsion.

[0026] Take 5g of squalane, 30g of cyclic siloxane (D5 or D6), 2g of vitamin E, 10g of decyl glucoside, 5g of cocamidopropyl betaine, 7g of isopropyl alcohol, 3g of propylene glycol, 2g of glycerin, and 36g of pure water. Prepare the oil phase and the water phase respectively according to the above method, and then mix them. Vitamin E is added during the process to form a stable emulsion, which is recorded as: Emulsion Example 1.

[0027] Take 5g of squalane, 30g of cyclic siloxane (D5 or D6), 2g of vitamin E, 8g of octyl glucoside, 4g of cocamidopropyl betaine, 10g of isopropyl alcohol, 3g of propylene glycol, 2g of glycerin, and 36g of pure water. Prepare the oil phase and the water phase respectively according to the above method, and then mix them. Vitamin E is added during the process to form a stable emulsion, which is recorded as: Emulsion Example 2.

[0028] Take 5g of squalane, 35g of cyclic siloxane (D5 or D6), 2g of vitamin E, 8g of octyl glucoside, 4g of cocamidopropyl betaine, 5g of isopropyl alcohol, 3g of propylene glycol, 2g of glycerol, and 36g of pure water. Prepare the oil phase and the water phase respectively according to the above method, and then mix them. Vitamin E is added during the process to form a stable emulsion, which is recorded as: Emulsion Example 3.

[0029] Example 2 Peel Force Test

[0030] Comparison test of parameters and performance of the embodiment with existing commercial medical adhesive removers The national standard GB / T2792-2014 adhesive tape peel strength method was adopted to test the same tension-reducing tape without using a commercial medical adhesive remover, using three emulsions prepared in Example 1 once, and using three commercial medical adhesive removers (recorded as: Comparative Example 1, Comparative Example 2 and Comparative Example 3) once, and the 90° peel strength was tested. The results are shown in Table 1 below.

[0031] Table 1

[0032]

[0033]

[0034] As can be seen from Table 1, the three emulsions prepared in Example 1 all significantly reduced the peeling force. Compared with the three commercially available adhesive removers, the emulsion 1 was particularly significant, further reducing the peeling force by nearly 1 times.

[0035] Example 3 Skin irritation verification

[0036] According to the national standard GB / T 16886.23 Biological evaluation of medical devices: irritation and skin sensitization test method, the irritation of the emulsion prepared in Example 1 to the skin was compared with that of physiological saline.

[0037] The skin irritation of lotion example 1 and saline was tested on the skin of 4 rabbit animal models. The results are detailed in Figure 1 The single contact time of the repeated contact experiment is 4 hours, observation is 24 hours, and the last contact observation is 72 hours, with a total of 6 contacts, see Figure 2 .

[0038] The experimental results show that compared with saline, emulsion example 1 has no obvious skin reaction after single stimulation, as shown in Table 2 below, and very slight skin reaction (0-0.4) can be seen after repeated stimulation, mainly manifested as very slight erythema (barely visible), and no obvious skin erythema and swelling. During the experiment, the highest score of skin irritation reaction was very slight erythema, which was occasionally seen in repeated contact experiments.

[0039] Table 2

[0040]

[0041] The emulsion provided in the embodiment of the present invention successfully removes the adhesive and has a slight irritation to the skin, which is equivalent to normal saline, and avoids the side effects of traditional solvent products on the skin.

Claims

1. A composition, characterized in that An emulsion formed by mixing an oil phase and an aqueous phase, wherein the ratio of the oil phase to the aqueous phase is 2:5 to 4:5 by weight; The oil phase includes squalane and cyclic siloxane in a weight ratio of 1:5-7; The aqueous phase uses water as solvent and includes surfactants and polyols; The surfactant consists of decyl glucoside and cocamidopropyl betaine in a weight ratio of 1:1 to 2:

1.

2. The composition according to claim 1, characterized in that The polyol concentration is 5wt% to 10wt%, and is selected from one or more of propylene glycol and glycerol.

3. The composition according to claim 1, characterized in that The cyclic siloxane is selected from one or more of decamethylcyclopentasiloxane and dodecamethylcyclohexasiloxane.

4. The composition according to claim 1, characterized in that Vitamin E is also added.

5. The composition according to claim 4, characterized in that The dosage of vitamin E is 1wt% to 3wt%.

6. The composition according to claim 1, characterized in that Isopropanol is also added to the aqueous phase.

7. The composition according to claim 6, characterized in that The concentration of the isopropanol is 10wt% to 16wt%.

8. The composition according to claim 1, characterized in that The concentration of the surfactant is 19wt% to 24wt%.

9. A method for preparing the composition according to claim 1, characterized in that The oil phase is heated to 40°C ± 0.5°C and mixed, and then the water phase is added and mixed continuously to form a uniform emulsion.

10. The method according to claim 9, characterized in that After vitamin E is added during the continuous mixing, a uniform emulsion is finally formed, wherein the amount of vitamin E is 1 wt% to 3 wt%.

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