COVERING FILM, SYSTEM COMPRISING SAME, AND USAGE METHOD AND APPLICATION THEREFOR

Abstract

A medical covering film and system, and a usage method and an application therefor. The medical covering film comprises a barrier film layer (10), an adsorption layer (20), and a reticular adhesive layer (30), one side of the adsorption layer (20) being composited on the barrier film layer (10), and the reticular adhesive layer (30) being composited on the other side of the adsorption layer (20); the area of an adhesive-free region (31) of the reticular adhesive layer (30) occupies 10% or more of the total area of the reticular adhesive layer (30), but not 100%. The present medical covering film can fix a preparation to the affected skin very well, is not easily squeezed off the target skin area by external force, and can maintain the moisture in the preparation very well.

Claims

1. A covering film, wherein, the covering film comprises a barrier film layer and an adsorption layer; the covering film further comprises one or more selected from the group consisting of reticular adhesive layer and cross-linking agent; one side of the adsorption layer is composited on the barrier film, and when the covering film comprises the reticular adhesive layer, the reticular adhesive layer is composited on the other side of the adsorption layer.

2. The covering film according to claim 1, wherein, the covering film is a medical covering film.

3. The covering film according to claim 1, wherein, the covering film contains a cross-linking agent.

4. The covering film according to claim 1, wherein, the covering film further comprises a reticular adhesive layer, one side of the adsorption layer is composited on the barrier film, and the reticular adhesive layer is composited on the other side of the adsorption layer; the area of the adhesive-free region of the reticular adhesive layer occupies 10% or more of the total area of the reticular adhesive layer, but not 100%.

5. The covering film according to claim 1, wherein, the material of the barrier film of the barrier film layer is polyethylene film, ethylene-vinyl acetate copolymer film or polyurethane film; or, the adsorption layer is a material capable of adsorbing or retaining a water-containing semi-solid preparation; or, the adhesive region of the reticular adhesive layer is an adhesive net composed of one or more selected from the group consisting of curves and straight lines; or, the thickness of the reticular adhesive layer is 0.01 mm-0.75 mm; or, the adhesive region of the reticular adhesive layer is an adhesive net composed of a set of parallel longitude lines and a set of parallel latitude lines; or, the adhesive of the reticular adhesive layer is a medical pressure-sensitive adhesive that is insoluble in water; or, one side of the adsorption layer is adhered to the barrier film layer by adhesive, or composited on the barrier film layer by hot pressing; the reticular adhesive layer is adhered to the other side of the adsorption layer by using spray coating method; or, the area of the adhesive-free region of the reticular adhesive layer occupies 30% or more of the total area of the reticular adhesive layer.

6. The covering film according to claim 1, wherein, the length stretch rate of the covering film in all directions is more than 10%.

7. A system for fixing a preparation on the skin, wherein, the system comprises the covering film according to claim 1 and a preparation layer for coating on the affected skin; the covering film is used to cover the affected skin coated with the preparation layer in a way that the reticular adhesive layer orients towards the affected skin; the central region of the reticular adhesive layer is used for contacting the preparation layer; the edge region of the reticular adhesive layer is used to adhere to the skin area beyond the affected skin or the preparation layer, so as to fix the preparation layer on the affected skin or the skin beyond the affected skin, and the preparation layer is completely enclosed in a closed space composed of the medical covering film and the skin beyond the affected skin or the skin.

8. A system for fixing the preparation on the skin, wherein, the system comprises the covering film according to claim 1; wherein, the covering film comprises a barrier film layer and an adsorption layer, but does not comprise a reticular adhesive layer; the cross-linking agent is dispersed in the material of the adsorption layer; the system also comprises a preparation layer for coating on the affected skin; wherein, the preparation contains one or more selected from the group consisting of an adhesive agent and a cross-linkable substance.

9. The system according to claim 7, wherein, the preparation is a water-containing semi-solid preparation.

10. A usage method of the covering film according to claim 1, wherein, the usage method comprises the following steps: applying a preparation on the central region of the reticular adhesive layer of the covering film, so that the edge region of the reticular adhesive layer is not coated by the preparation, to obtain the covering film with a preparation layer; then covering the covering film with the preparation layer on the affected skin, and making the preparation layer in contact with the affected skin, the edge region is adhered to the skin beyond the affected skin or the skin not covered by the preparation layer, so as to fix the preparation layer on the affected skin or the skin beyond the affected skin, and the preparation layer is completely enclosed in a closed space composed of the covering film and the skin or the skin beyond the affected skin.

11. The usage method of the covering film according to claim 10, wherein, the usage method comprises the following steps: the covering film is covered on the affected skin coated with the preparation layer and surrounding skin in a way that the reticular adhesive layer orients towards the affected skin, the central region of the reticular adhesive layer contacts the preparation layer, the edge region of the reticular adhesive layer adheres to the skin beyond the affected skin or the skin not covered by the preparation layer, so as to fix the preparation layer on the affected skin or the skin beyond the affected skin, and the preparation layer is completely enclosed in a closed space composed of the covering film and the skin beyond the affected skin or the skin.

12. The usage method of the covering film according to claim 10, wherein, the length of the outer edge of the covering film away from the water-containing semi-solid preparation layer or the outer edge of the preparation layer is more than 5 mm.

13. A method for treating herpes zoster pain, post-herpetic nerve damage pain, neuroma pain, phantom limb pain, diabetic peripheral neuralgia, joint pain, osteoarthritis pain, back pain, pain caused by gout, pain caused by soft tissue injury, postoperative incision pain, pain of broken skin caused by disease or trauma, burn pain or pain during burn scab removal in a subject in need thereof, comprising: applying the covering film according to claim 1 with a preparation layer to the subject.

14. A usage method of the system according to claim 7 for fixing the preparation on the skin, wherein, the preparation is applied to the affected skin to form a preparation layer; and the covering film is covered on the preparation layer, let the cross-linking agent and the cross-linkable substance undergo a cross-linking reaction to solidify the preparation layer.

15. A system for fixing the preparation on the skin, wherein, the system comprises the covering film according to claim 1; wherein, the covering film comprises a barrier film layer, an adsorption layer, and a reticular adhesive layer; a cross-linking agent is dispersed in the material of the adsorption layer; the system also comprises a preparation layer for coating on the affected skin; wherein, the preparation contains one or more selected from the group consisting of an adhesive agent and a cross-linkable substance.

16. The system according to claim 15, wherein, the preparation contains a cross-linkable substance and the covering film contains a corresponding cross-linking agent; or, the preparation contains a cross-linkable substance and the covering film contains a corresponding cross-linking agent.

17. The system according to claim 16, wherein, the cross-linkable substance is polyvinyl alcohol, and the corresponding cross-linking agent is sodium borate; or, the cross-linkable substance is polyvinylpyrrolidone, and the corresponding cross-linking agent is N,N′-methylenebisacrylamide.

18. The covering film according to claim 3, wherein, the cross-linking agent is dispersed in the material of the adsorption layer; or, the covering film contains a cross-linking agent higher than 0.01 mg/per square centimeter; or, the cross-linking agent is a substance containing boron element, glutaraldehyde, glyoxal, maleic acid, citric acid, trisodium trimetaphosphate, sodium hexametaphosphate, dianhydride, succinic acid, sulfosuccinic acid, or N,N′-methylenebisacrylamide.

19. The covering film according to claim 5, wherein, the adsorption layer is a non-woven fabric; or, the thickness of the reticular adhesive layer is 0.05 mm-0.75 mm; or, the longitude lines and the latitude lines are perpendicular to each other; or, the adhesive of the reticular adhesive layer is one or more selected from the group consisting of silicone pressure-sensitive adhesive and acrylic pressure-sensitive adhesive; or, the area of the adhesive-free region of the reticular adhesive layer occupies 70% or more of the total area of the reticular adhesive layer.

20. The system according to claim 8, wherein, the preparation contains a cross-linkable substance and the covering film contains a corresponding cross-linking agent.

21. The system according to claim 20, wherein, the cross-linkable substance is polyvinyl alcohol, and the corresponding cross-linking agent is sodium borate; or, the cross-linkable substance is polyvinylpyrrolidone, and the corresponding cross-linking agent is N,N′-methylenebisacrylamide.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0058] FIG. 1 is a schematic diagram of the structure of each layer of the medical covering film of Examples 1-6;

[0059] FIG. 2 is a schematic diagram of the structure of the medical covering film of Examples 1-6;

[0060] FIG. 3 is a top view of the medical covering film coated with a water-containing semi-solid preparation layer;

[0061] FIG. 4 is a cross-sectional view of the medical covering film covering a water-containing semi-solid preparation layer in Application Examples 1˜4 in the state of usage;

[0062] FIG. 5 is a schematic diagram of the structure of the medical covering film of Example 7.

DESCRIPTION OF REFERENCE SIGNS IN THE DRAWINGS

[0063] barrier film layer 10 [0064] adsorption layer 20 [0065] non-woven fabric layer containing sodium borate 201 [0066] reticular adhesive layer 30 [0067] adhesive-free region 31 [0068] adhesive region 32 [0069] water-containing semi-solid preparation layer 40

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0070] The present disclosure will be further explained below by means of examples, but the present disclosure is not limited to the scope of the described examples. In the following examples, the experimental methods without specific conditions are selected according to conventional methods and conditions, or according to the commodity specifications.

TABLE-US-00001 TABLE 1 material and structural parameters of the medical covering film for each example Example Components 1 2 3 4 5 6 7 Barrier Material polyethylene EVA film polyurethane polyurethane polyethylene polyurethane polyethylene film layer film film film film film film 10 Adsorption Material non- non- non- non- non- non- non- layer 20 woven woven woven woven woven woven woven fabric fabric fabric fabric fabric fabric fabric Reticular Type of silicone acrylic silicone acrylic silicone acrylic silicone adhesive adhesive pressure- pressure- pressure- pressure- pressure- pressure- pressure- layer 30 sensitive sensitive sensitive sensitive sensitive sensitive sensitive adhesive adhesive adhesive adhesive adhesive adhesive adhesive Thickness 0.25 mm 0.05 mm 0.5 mm 0.1 mm 0.75 mm 0.75 mm 0.025 mm Width of 0.5 0.5 0.5 0.5 0.5 1 0.5 longitude line/mm Width of 0.5 0.5 0.5 0.5 0.5 1 0.5 latitude line/mm Side 0.23 0.60 1.20 2.60 4 9 0.23 length a/ mm Proportion 10% 30% 50% 70% 64% 81% 10% b

[0071] In Table 1, the side length a refers to the side length of each square constituting the adhesive-free region 31; proportion b refers to the proportion of the area of the adhesive-free region 31 to the total area of the reticular adhesive layer 30.

[0072] The raw materials of the water-containing semi-solid preparation (Formulation A, B, C, D) used in the following examples are shown in the following table, and the preparation method thereof is to mix the components evenly.

TABLE-US-00002 TABLE 2 the raw materials of Formulation A Mass percentage or Components molar concentration Lidocaine 5 wt % Disodium hydrogen phosphate 0.094 mol/L Sodium dihydrogen phosphate 0.006 mol/L Xanthan gum 4 wt % Sodium hydroxide 0.08 wt % Water Added to 100 wt %

TABLE-US-00003 TABLE 3 the raw materials of Formulation B Mass percentage or Components molar concentration Lidocaine 8 wt % Disodium hydrogen phosphate 0.094 mol/L Sodium dihydrogen phosphate 0.006 mol/L Sodium hydroxide 0.08 wt % Hydroxyethyl cellulose 3 wt % Glycerin 15 wt % Water Added to 100 wt %

TABLE-US-00004 TABLE 4 the raw materials of Formulation C Components Mass percentage Diclofenac sodium 2 wt % Ethanol 20 wt % Hydroxyethyl cellulose 3 wt % Glycerin 15 wt % Water Added to 100 wt %

TABLE-US-00005 TABLE 5 the raw materials of Formulation D Components Mass percentage Xanthan gum 2 wt % Hydroxyethyl cellulose 3 wt % Glycerin 35 wt % Water Added to 100 wt %

TABLE-US-00006 TABLE 6 the raw materials of Formulation F Mass percentage or Components molar concentration Bupivacaine 8 wt % Disodium hydrogen phosphate 0.094 mol/L Sodium dihydrogen phosphate 0.006 mol/L Sodium hydroxide 0.08 wt % Hydroxyethyl cellulose 3 wt % Polyvinyl alcohol 10 wt % Water Added to 100 wt %

TABLE-US-00007 TABLE 7 the raw materials of Formulation G Components Mass percentage Diclofenac sodium 2 wt % Ethanol 20 wt % Hydroxyethyl cellulose 3 wt % Polyvinyl alcohol 5 wt % Water Added to 100 wt %

Examples 1-7

[0073] The medical covering film as shown in FIG. 1 and FIG. 2, the medical covering film comprises a barrier film layer 10, an adsorption layer 20, and a reticular adhesive layer 30, the adsorption layer 20 is composited on the barrier film layer 10, and the reticular adhesive layer 30 is composited on the adsorption layer 20.

[0074] Wherein, the reticular adhesive layer 30 is composed of a set of parallel longitude lines and a set of parallel latitude lines, the longitude lines and the latitude lines are perpendicular to each other, and the distance between two adjacent longitude lines is equal to the distance between two adjacent latitude lines. The longitude lines and the latitude lines on the reticular adhesive layer 30 constitute the adhesive region 32, and the other regions on the reticular adhesive layer 30 except for the longitude lines and latitude lines constitute adhesive-free region 31.

[0075] Wherein, the adsorption layer 20 is adhered to the barrier film layer 10 by adhesive, and the reticular adhesive layer 30 is adhered to the adsorption layer 20 by spray coating method.

[0076] Wherein, the material of the barrier film layer 10 and the material of the adsorption layer 20, the type of the adhesive of the reticular adhesive layer 30, the thickness of the reticular adhesive layer 30, the proportion of the area of the adhesive-free region 31 of the reticular adhesive layer 30 to the total area of the reticular adhesive layer 30 are shown in Table 1.

Example 8

[0077] A Medical Covering Film and a Water-Containing Semi-Solid Preparation

[0078] In this example, the raw materials of the water-containing semi-solid preparation (Formulation E) used are shown in the following table, and the preparation method thereof is to mix the components evenly.

TABLE-US-00008 TABLE 8 the raw materials of the Formulation E Components Mass percentage Lidocaine    5% Polyvinyl alcohol  7.5% Sodium hydroxide 0.64% Xanthan gum  1.6% Water Added to 100 wt %

[0079] The material and structural parameters of the medical covering film are the same as those in Example 1. Additionally, the non-woven fabric contains 0.2 mg of sodium borate, 1 mg of glycerin, and 1 mg of maltodextrin per square centimeter (as shown in FIG. 5). When the medical covering film is covered on a layer of the Formulation E applied to the affected skin, the sodium borate in the medical covering film diffuses into the preparation layer and undergoes cross-linking reaction with the polyvinyl alcohol in the preparation layer, solidifying and adhering Formulation E to the medical covering film. In this way, when the scheduled administration time is over, the medical covering film can be removed and Formulation E that has been solidified and adhered to the medical covering film can be removed simultaneously. In this way, there is no residual water-containing semi-solid preparation on the skin, so the patient does not need to wash the skin.

Application Example 1

[0080] The usage method of the medical covering film of the Example 4 is as following: as shown in FIG. 3, a layer of Formulation A with a thickness of 2 mm was applied on a 10 cm×10 cm of the reticular adhesive layer 30 of the medical covering film of Example 4, and Formulation A covered a 6 cm×6 cm of region of the central region of the reticular adhesive layer 30. This medical covering film with the Formulation A adhered to the skin on the back of a human subject, the Formulation A and the 2 cm wide of edge region around the reticular adhesive layer 30 were directly contacted the skin, the edge region of the reticular adhesive layer 30 formed a flat square closed space with the skin, the 6 cm×6 cm of the Formulation A layer (that is, the water-containing semi-solid preparation layer 40 shown in FIG. 4) in the middle was enclosed in this closed space, forming the state shown in FIG. 4. Part of Formulation A in the closed space was absorbed by the middle non-woven fabric layer through adhesive-free region 31 of the reticular adhesive layer 30, thereby being fixed in place.

[0081] Technical effect: the medical covering film can fix Formulation A on the affected skin during usage very well, the preparation is not easy to be squeezed off the target skin area by an external force, and can maintain the moisture in Formulation A very well. The skin covered by the Formulation A was anesthetized after about 90 minutes, and the Formulation A was removed from the skin 24 hours after the start of medication. The skin covered by the Formulation A was still anesthetized when the Formulation A was removed and one hour after the removal.

Application Example 2

[0082] The usage method of the medical covering film of the Example 5 is as following: the patient's back skin had been suffering from postherpetic neuralgia for more than 8 years. The affected skin was a rectangle of about 15 cm×30 cm. A roll of 20 cm wide and 200 cm long medical covering film of Example 5 was cut for 35 cm long to obtain a piece of 20 cm×35 cm of the medical covering film. As shown in FIG. 3, Formulation A was applied on a 16 cm×31 cm of region of the central region of the reticular adhesive layer 30 to form a layer with a thickness of 1 mm. The affected skin was covered with this medical covering film with Formulation A, so that the affected skin was completely covered by Formulation A. The 2 cm wide edge region of around the reticular adhesive layer 30 directly contacted the skin, and formed a flat rectangle closed space with the skin. The 16 cm×31 cm of Formulation A layer (that is, the water-containing semi-solid preparation layer 40 shown in FIG. 4) in the middle was enclosed in this closed space, forming the state shown in FIG. 4. Part of Formulation A in the closed space was adsorbed by the middle non-woven fabric layer through adhesive-free region 31 of the reticular adhesive layer 30, thereby being fixed in place.

[0083] Technical effect: After about 90 minutes, the patient's pain began to decrease significantly. The patient kept Formulation A and medical covering film on the skin for 18 hours. During the 18-hour medication period, the medical covering film maintained the moisture in Formulation A very well, and Formulation A was not removed from the original application place during her daily activities and sleep, because most of the local anesthetic preparation layer was adsorbed by the non-woven fabric layer at the original application place. In the next few months, she repeatedly used the Formulation A and B in the same way, and both achieved similar satisfactory results.

Application Example 3

[0084] The usage method of the medical covering film of the Example 3 is as following: in order to reduce the pain caused by knee osteoarthritis, the medical staff applied a layer of the Formulation C on the knee joint of the patient to form a 15 cm wide loop around the knee joint, and the Formulation C was covered with the medical covering film of Example 3 (the edge region of the medical covering film, which is not in contact with the formulation, fixed the medical covering film and the formulation on the skin), Formulation C (the water-containing semi-solid preparation 40 shown in FIG. 4) was enclosed in a closed space composed of the medical covering film and the skin. The combination of this covering film and the Formulation C was kept on the patient's knee joint 16 hours a day and used every day.

[0085] Technical effect: the anti-inflammatory drug diclofenac sodium in Formulation C was absorbed through the skin into the joint tissues. After two to three days, the patient felt a marked relief of pain. This is because the covering film prevented the evaporation of moisture in the formulation during the 16-hour application. Moreover, the stretchability of the covering film in all directions made the movement of the patient's joints unrestricted. The medical covering film can fix Formulation C to the affected skin during usage very well, the preparation is not easily squeezed off the target skin area by an external force, and the covering film can maintain the moisture in Formulation C very well.

Application Example 4

[0086] A person's skin on the elbow is very dry. The medical staff applies the Formulation D with a thickness of about 2 mm to the dry skin, and covers the Formulation D with the medical covering film of Example 1-6 (the edge region of the medical covering film, which is not in contact with the formulation, fixes the medical covering film and the formulation on the skin), Formulation D (the water-containing semi-solid preparation 40 shown in FIG. 4) is enclosed in a closed space composed of the medical covering film and the skin, forming the state shown in FIG. 4.

[0087] Technical effect: the medical covering film can fix Formulation D which contains moisture and glycerin and other moisturizing components to the affected skin during usage very well, Formulation D is not easily squeezed off the target skin area by an external force, and can maintain the moisture in the Formulation D very well. The patient keeps Formulation D on the skin for 18 hours. This patient repeats the above-mentioned skin moisturizing procedure once a day, and the effect is very satisfactory.

Application Example 5

[0088] The usage method of the medical covering film of the Example 8 is as following: in order to reduce the pain caused by knee osteoarthritis, the medical staff applies a layer of Formulation G on the knee joint of the patient to form a 15 cm wide loop around the knee joint, and the Formulation G is covered with the medical covering film of Example 8 (the edge region of the medical covering film that does not contact the formulation fixed the medical covering film and the formulation on the skin), Formulation G (the water-containing semi-solid preparation 40 shown in FIG. 4) is enclosed in a closed space composed of the medical covering film and the skin. The combination of this covering film and Formulation G is kept on the patient's knee joint 16 hours a day and used every day. Because Formulation G contains polyvinyl alcohol and the adsorption layer of the medical covering film contains sodium borate. When the medical covering film covers Formulation G layer, sodium borate diffuses into the formulation layer and undergoes cross-linking reaction with the polyvinyl alcohol inside, solidifying and adhering Formulation G to the medical covering film. In this way, when the covering film is removed, Formulation G layer can be removed simultaneously, leaving no residual Formulation G on the skin.

[0089] Technical effect: The anti-inflammatory drug diclofenac sodium in Formulation G is absorbed through the skin into the joint tissues. After two to three days, the patient feels a marked relief of pain. This is because the covering film prevents the evaporation of moisture in the formulation during the 16-hour application. Moreover, the stretchability of the covering film in all directions makes the movement of the patient's joints without limitation. The medical covering film can fix the Formulation G to the affected skin during usage very well, Formulation D is not easily squeezed off the target skin area by external force, and the medical covering film can maintain the moisture in Formulation G very well.

[0090] Although the specific embodiments of the present disclosure are described above, those skilled in the art should understand that these are only illustrative examples, the scope of protection of the present disclosure is limited by the attached claims. Those skilled in the art can make various changes or modifications to these embodiments without deviating from the principle and essence of the present disclosure, but these changes and modifications all fall within the scope of protection of the present disclosure.