JP2843957B2 - Ointment patch - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to an ointment patch.

[0002]

2. Description of the Related Art When an ointment is painful due to burns, trauma, inflammation of the skin surface and deep part, and application of an ointment to the skin, a conventional technique is to apply a certain amount of the ointment to gauze, cloth or the like. A method of applying to an affected part and fixing it with a tape has been used.

However, in this method, it takes time to apply the ointment to gauze or the like, it is difficult to apply the ointment uniformly, it is difficult to precisely administer a fixed amount, There is a problem that the fixation of gauze and the like may not be performed properly, and the development of an ointment patch has been desired.

[0004] Unlike a cataplasm where a drug is sufficiently held on a support, in an ointment patch, when the separation layer is peeled off when applied to an affected area, the ointment adheres to the separation layer, so that a certain amount of drug is applied. It cannot be applied and is difficult to use as a medical patch.

In order to solve such a problem, an ointment patch using a special sheet-like separation layer which is hard to adhere to the ointment when peeled off and which is soft or stretchable has been proposed (JP-A-4-257516). Gazette).

However, in this patch, the adhesion of the ointment to the separation layer can be prevented by a special sheet, but since the sheet is peeled off during use, the adhesion of the ointment cannot be prevented. That is, it has a drawback that it is difficult to make an ointment having ordinary appropriate hardness and consistency into a patch form.

[0007]

SUMMARY OF THE INVENTION An object of the present invention is to provide an ointment patch in which a certain amount of an ointment can be applied uniformly and easily to an affected part.

[0008]

Means for Solving the Problems The present inventor has conducted intensive studies in view of the above-mentioned problems of the prior art, and as a result, by disposing an intermediate layer between an ointment layer and a separation layer, the ointment main component has been reduced. It has been found that an ointment patch is obtained in which the ointment does not adhere to the separation layer while allowing penetration into the affected area.

The present invention relates to an ointment patch (hereinafter referred to as "first ointment") comprising a support layer, an ointment layer, an intermediate layer and a separation layer, and comprising a support layer, an ointment layer, an intermediate layer and a separation layer arranged in this order.
Invention).

The present invention also includes a support layer, a porous layer in which an ointment is impregnated in a porous substance, and a separation layer. The support layer, a porous layer in which the ointment is impregnated in the porous substance, An ointment patch (hereinafter referred to as “second ointment”) having a separation layer arranged in this order.
Invention).

The present invention further provides an ointment layer on a part of one surface of the support layer, and the whole or a part of the non-ointment-coated portion of the support layer on the surface is surrounded by the ointment layer. An object of the present invention is to provide a bonded ointment patch (hereinafter referred to as a third invention).

Further, the present invention provides an ointment patch (hereinafter referred to as an ointment patch) comprising an ointment layer disposed on one surface of a support layer, and a covering portion surrounding the ointment layer in a state of not contacting the ointment layer. , A fourth invention).

First, the first invention will be described (see FIG. 2).

As the ointment of the present invention, conventionally known ointments are widely used, and specific examples thereof include oily ointments, emulsion ointments, and water-soluble ointments. Exalbe ointment, boala ointment, boala cream are preferred. Is mentioned. The drug applied to the ointment is not particularly limited, but may be an analgesic, antipruritic, astringent, anti-inflammatory agent, a purulent disease agent, a burn treatment agent, a parasitic skin disease agent, an antitumor agent. And topical therapeutic agents such as antibiotics and systemic therapeutic agents such as vasodilators. The thickness of the ointment layer is not particularly limited, but is usually about 0.1 to 3.0 mm.

The ointment used in the present invention has a yield value in a spreadability test of 500 to 100,000 dyn / cm ^2.
Degree, preferably 1,000 to 10,000 dyn / c
m ² .

In the present invention, the term "intermediate layer" means a layer which prevents the ointment from adhering to the separation layer and allows the ointment to diffuse outside through the intermediate layer.

The intermediate layer is a non-woven fabric, a woven fabric, a knitted fabric, a film or the like having a porous or a plurality of openings, and is made of a material such as polyolefin such as nylon, polyethylene and polypropylene, and polyethylene terephthalate. Examples include natural fibers such as polyester, polyvinylidene chloride, cotton, and hemp, pulp, polyvinyl chloride, rayon, and the like, and a mixture of two or more of these may be used. The opening may be formed by hot air or by punching.

Examples of the intermediate layer include a mesh sheet, a nonwoven fabric sheet, a paper sheet, and a gauze. The formation of the holes in the intermediate layer may be regular or irregular.

The thickness of the intermediate layer varies depending on conditions such as the type and thickness of the ointment, but is usually about 0.01 to 3.0 mm, preferably about 0.05 to 2.0 mm.

The diameter of the porous intermediate layer when converted to a circular shape varies depending on the type and thickness of the ointment, but is usually about 0.1 to 5000 μm, preferably 5 to 2000 μm. It is about. The porosity of the intermediate layer is usually about 1 to 95%, preferably 5 to 60%.
It is about.

The separation layer of the present invention is intended to prevent contamination as a pharmaceutical and to prevent quality change and instability due to drying of the ointment due to contact of the intermediate layer with external air and drying. May be a film, a molded article having a fixed shape, or the like. The thickness of the separation layer is about 5 to 5000 μm.
It is about 000 μm. The material of the separation layer is a material obtained by laminating or coating a separation agent such as silicon on paper, a polyolefin such as polyethylene or polypropylene, a polyester such as polyethylene terephthalate,
Examples include nylon, cellophane, polystyrene, polyvinylidene chloride, and polyvinyl chloride. The separation layer is adhered to the support at the non-ointment attachment portion of the support. The bonding is performed by a commonly used pressure-sensitive adhesive such as an acrylic or rubber-based pressure-sensitive adhesive or a method of caulking with pressure.
A cutout may be provided in the separation layer to facilitate separation.

For the support layer of the present invention, a known support as a patch can be widely used and is not particularly limited. For example, a film made of urethane, polyolefin, polyester, nylon, etc. For example, a resin or rubber-based pressure-sensitive adhesive is uniformly applied, and the thickness thereof is about 0.01 to 2000 μm.

The support layer of the present invention may be made of a nonwoven fabric such as polyester, rayon, polyolefin, nylon or the like, a knitted fabric,
Gauze, woven fabric such as lint cloth, absorbent cotton, paper or other intervening layer may be formed by fixing the film to the above-mentioned film with an acrylic or rubber-based adhesive, without using the above-mentioned film, an acrylic-based Alternatively, it may be formed by applying a rubber-based adhesive. Their thickness is about 0.1 to 5 mm.

According to the first invention, the ointment adhering to the separation layer is 5% or less of the total ointment.

Next, the second invention will be described (see FIG. 3).

The support layer, ointment and separation layer are the same as in the first invention.

The porous material is a non-woven fabric, a woven fabric, a knitted fabric, or the like having an opening in addition to a normal porous material, and the latter materials include polyolefins such as nylon, polyethylene and polypropylene, and polyethylene terephthalate. Polyester such as latex, polyvinylidene chloride, those with natural fiber such as cotton, pulp, polyvinyl chloride,
Rayon and the like.

The above-mentioned impregnation means not only the case where an ointment is held on the surface or inside of a porous material, but also the case where a porous material is laminated and an ointment is held between them, or the case where a porous material and an ointment are held. The concept includes a case where the agents are simply mixed, and includes everything that includes a porous substance and an ointment and prevents the ointment from adhering to the separation layer.

The ratio of the ointment to the porous substance in the porous layer is defined as 100% by weight of the total of the ointment and the porous substance: about 1 to 90:99 to 10%, preferably about 20%.
~ 60: about 80 to 40%.

The above-mentioned intermediate layer (for example, a mesh sheet) may be further provided between the porous layer and the separation layer.

Next, the third invention will be described (see FIGS. 4 and 5).

The support layer and the ointment are the same as in the first invention.

The ointment is placed on the support layer. In one embodiment, the ointment is placed in a central portion of the support except for the peripheral portion, and is folded in two so as to join the peripheral portions to which the adhesive is attached (see FIG. 4). By folding back the support in this way, even if a part or all of the separation layer is omitted, contamination of the ointment can be prevented, and quality change and instability due to contact between the ointment and external air can be suppressed. Even if there is no intermediate layer, the applied amount of the ointment can be kept constant.

An acrylic or rubber adhesive may be applied to the entire surface of the non-ointment-coated portion, or the adhesive may be applied only to a part thereof. The bonding of the non-ointment-coated portion having an adhesive may be directly combined with the non-ointment-coated portion having another adhesive, but it is preferable that a separation layer similar to the above is interposed between the non-ointment-coated portions. As the material and the thickness of the separation layer, the same as those in the first invention can be used.

The non-ointment-coated portion may be joined by joining the two ointment patches as shown in FIG.

In another embodiment, the arrangement of the ointment is
A non-ointment area is provided at the center of the support as shown in FIG. 5,
It can be folded from both sides.

The ointment patch of the third aspect of the present invention includes any form of ointment patch as long as the ointment is hermetically sealed by folding back and the contact between the ointment and external air is prevented. is there.

In the ointment patch of the third invention, an intermediate layer similar to the above may be provided on the ointment layer. This case is preferable because the surface of the ointment becomes more uniform by the action of the intermediate layer.

Next, the fourth invention will be described (see FIG. 6).

The support layer and the ointment are the same as in the first invention.

In the fourth invention, the shape of the covering portion is not particularly limited as long as the covering portion and the ointment layer do not directly contact each other. For example, the covering portion may have an arcuate shape covering the support layer or a box-like shape. . Further, the covering portion may cover the entire support layer, or may cover a part of the support layer including the ointment layer.
When the covering portion covers the entire support layer, the non-ointment placement surface of the support layer is fixed to the covering portion in a detachable manner, or the intermediate layer (for example, a mesh sheet) is provided on the surface of the ointment layer. It may be further formed so that little or no ointment adheres to the coating. When the covering part covers only a part of the support layer, the covering part is fixed to the support layer.

The covering section may have a plurality of storage chambers and may store ointment patches in a stacked state.

Examples of the material of the covering portion include, but are not limited to, plastics, polyolefins such as nylon, polyethylene and polypropylene, polyesters such as polyethylene terephthalate, polyvinylidene chloride, polyvinyl chloride and the like.

The fixing of the covering portion to the support layer can be performed by caulking with an adhesive or high pressure.

[0045]

The ointment patch of the present invention has a substantially constant amount of ointment when used, and can be used as a pharmaceutical.

Since the ointment patch of the first invention has the intermediate layer, the main ingredient of the ointment hardly disperses to the skin through the intermediate layer. On the other hand, by controlling the material of the intermediate layer and the size of the pores, it is possible to control the diffusion of the drug to the skin, and it is also possible to obtain a long-lasting preparation.

In the ointment patch of the second invention, the ointment is impregnated with the porous substance, so that the ointment can be prevented from adhering to the separation layer when the separation layer is separated during use.

The ointment patch of the third aspect of the present invention does not require a separation layer, so that the manufacturing process is simplified, and there is no need to separate the separation layer during use. Also, there is no ointment loss.

Since the ointment patch of the fourth invention has a coating surrounding the ointment layer, a certain amount of the ointment can be applied even when separating the coating from the support layer during use. it can.

The ointment patches of the first to third inventions are used as medical preparations having a certain amount of drug, with little ointment adhering to the separation layer or the coating even when pressure is applied to the patch. It is possible. As a result, it has become possible to easily apply the ointment to an affected area, which has conventionally been cumbersome and difficult to apply in a uniform and fixed amount. Further, by appropriately selecting the material of the intermediate layer, the size of the pores, the thickness, and the like, an ointment supply amount equivalent to that when the ointment was directly applied to the skin could be secured.

In the conventional ointment, the ointment and the clothes may come into contact after administration to the affected area and the ointment may adhere to the clothes. However, the ointment patch of the present invention does not have such a problem. Since all are used for treatment, a certain therapeutic effect can be secured for a long time.

In particular, when an intermediate layer is provided, only a small amount of ointment remains on the skin when the applied patch is peeled off, so that it does not stain the clothes, and the labor for wiping is also reduced. No need.

[0053]

EXAMPLES Examples of the present invention will be specifically described below, but the present invention is not limited to these examples.

[0054]

EXPERIMENTAL EXAMPLE 1 Ointment patches A without a mesh sheet layer as an intermediate layer shown in FIG. 1 and ointment patches B-1 and B-2 having a mesh sheet layer of the present invention shown in FIG. Ointment applied amount 200mg, 300
mg and 600 mg / 9 cm ² in three stages, and after applying the load shown in Table 2, the release film as a separation layer was removed. Then, the amount of the ointment attached to the release film was measured, and the state of the surface of the ointment patch preparation was observed. Each test was repeated three times and the mean and standard deviation were calculated.

A steroid ointment was used as the ointment.
As a support, a urethane-based pressure-sensitive adhesive film (registered trademark: Katereep) was used. A 100 μm-thick polyethylene film was used as the intermediate layer mesh sheet, and a 200 μm-thick release film was used as the separation layer.
A μm polyethylene film was used. The nonwoven fabric used as the support was made of polyester and had a thickness of:
It was 1.00 mm and the basis weight was 100 g / m ² .

The results are shown in Tables 1 and 2.

[0057]

[Table 1]

[0058]

[Table 2]

Incidentally, the ointment adhesion rate in Table 2 was calculated by the following formula and expressed as an average value ± standard deviation: ointment adhesion rate = (amount of ointment applied / amount of ointment applied) × 100
(%) From the results in Table 2, the following became clear.

The ointment patch A without a mesh sheet layer is
As the amount of ointment applied increased, the amount of ointment adhering to the release film increased, and the amount of adhesion to the release film was 2 to 19% of the total ointment amount. Moreover, since the ointment strongly adhered to the release film, irregularities were formed on the ointment surface.

On the other hand, in the ointment patches B-1 and B-2 of the present invention having a mesh sheet layer, the amount of ointment slightly varies depending on the opening ratio, pore diameter, material and thickness of the mesh sheet. Compared with ointment patch A, the difference was significantly smaller, and there was no or slight difference depending on the amount of ointment applied and weight. Further, the ointment was uniformly held on the mesh sheet.

[0062]

EXPERIMENTAL EXAMPLE 2 In the same manner as in Experimental Example 1, an ointment patch A and ointment patches B-1 and B-2 were prepared by applying a fixed amount of a steroid ointment to a nonwoven fabric having a fixed area. Each was subjected to a release test at 37 ° C. for 4 hours using Franz cells. Here, as the test conditions, an isotonic phosphate buffer solution was used for the test solution on the receiver side, and a membrane filter (pore size: 1.0 μm) was used for the release control membrane. It was quantified according to the high performance liquid chromatography method of the revised Japanese Pharmacopoeia General Test Method, Section 4. This test was repeated three times. Table 3 shows the results
Shown in

[0063]

Table 3 Ointment patch Amount of active drug release 4 hours after the start of test (μg / cm ² ) A 135.4 ± 15.2 B-1 125.3 ± 44.0 B-2 54.2 ± 17.0 In Table 3, the value of the active drug release amount was expressed as a mean value ± standard deviation.

As a result of Table 3, the ointment patch B-
In No. 1, the provision of the intermediate layer did not inhibit the release of the main ingredient of the ointment, that is, did not inhibit the diffusion into the skin. Further, ointment patch B-2 shows a significant release control effect on ointment patch A, the opening ratio of the mesh sheet, pore size,
By adjusting the material and thickness, the possibility of formulation and control according to the design purpose was shown.

[0065]

Example 1 A urethane-based pressure-sensitive adhesive film (registered trademark: Catelip A) was used as a support, and the basis weight was 100 g / m2.
² , thickness is about 1.0mm, 50% modulus is 0.5
Using a polyester nonwoven fabric of で 1 (kg / 5 cm), a steroid ointment was uniformly applied to the surface with a constant thickness. This was adhered to the adhesive film with the ointment applied side facing out. Further, the pore size was 0.41 m on the ointment applied side.
m, and a diamond-shaped mesh sheet having a hole interval of 0.8 mm was bonded. At this time, the ointment application area was made small so as not to protrude from the nonwoven fabric, and the nonwoven fabric was made smaller than the adhesive film. Further, the mesh sheet was made the same size as the pressure-sensitive adhesive film so that these laminations could be fixed. Finally, the outside of the mesh sheet was bonded with a release film of the same size as this (see FIG. 2). This is put in an aluminum bag, sealed by heat sealing, and
Stored for days. The ointment adhesion rate to the release film during use was as good as 0.87%.

[0066]

Example 2 A support layer was formed by attaching a polyester nonwoven fabric having a thickness of 1.16 mm, a basis weight of 80 g / m ² and a size of 10 cm × 14 cm to a urethane-based adhesive film having a thickness of 2 μm and a size of 15 cm × 18 cm. . A uniform steroid ointment layer with a thickness of 1.0 m on the upper surface of the nonwoven fabric of the support layer
The layers were laminated so that the total amount was 10 g at m. Further, as an intermediate layer, a polyester mesh sheet having a pore diameter of 1.66 mm, a porosity of 49.1%, a pore arrangement of rhombic shape and a size of 11 cm × 15 cm is laminated so as to cover the ointment layer. Size 15cm x 1 as separation layer (liner layer)
8 cm of silicon paper was stuck so as to fit the adhesive film.

[0067]

EXAMPLE 3 A support layer was formed by attaching a nonwoven polyester nonwoven fabric having a thickness of 1.05 mm, a basis weight of 110 g / m ² and a size of 10 cm × 14 cm to a urethane-based adhesive film having a thickness of 3 μm and a size of 15 cm × 18 cm. . A uniform ointment layer having a thickness of 0.7 mm and a total amount of 7 g was laminated on the upper surface of the nonwoven fabric of the support layer, and this was folded inward from the center. The application area of the ointment is 9 cm x 13 cm, and 2
At the time of folding, the ointment was prevented from protruding from the nonwoven fabric (see FIG. 4).

[0068]

Example 4 A rayon nonwoven fabric having a thickness of 0.5 mm, a basis weight of 35 g / m ² and a size of 10 cm × 14 cm was used as a support layer. A uniform borer ointment layer having a thickness of 0.35 mm and a total amount of 3.5 g was laminated on the upper surface of the nonwoven fabric of the support layer. Further, as an intermediate layer, a polyester mesh sheet having a pore diameter of 0.52 mm, an opening ratio of 5.3%, and a pore arrangement of 11 cm × 15 cm in a lattice pattern is laminated so as to cover the ointment layer, and this is inward from the center. Folded in two. At this time,
The application area of the ointment was 9 cm × 13 cm, and the ointment was prevented from protruding from the nonwoven fabric when folded in two.

[0069]

Example 5 A urethane adhesive film having a thickness of 100 μm and a size of 9 cm ² was applied with a basis weight of 100 g / m ² , a thickness of about 1.0 mm, and a 50% modulus of 0.5 to 1 (kg / 5).
cm) A laminate of a polyolefin nonwoven fabric having a size of 8.5 cm ² was used as a support layer. 25
The steroid ointment stored at ° C was uniformly applied with a thickness of 0.7 mm, and an ointment layer was laminated. Further, an intermediate layer of a diamond-shaped pattern having a hole diameter of 0.41 mm and a hole interval of 0.8 mm and a size of 9 cm, that is, a mesh sheet was bonded to the ointment application surface.
At this time, the ointment application area was made small so that the ointment did not protrude from the nonwoven fabric, so that these layers could be fixed. Finally, a silicone paper having the same size as the urethane adhesive film was attached to obtain an ointment patch. This ointment patch was placed in an aluminum bag, sealed by heat sealing, and stored. The ointment adhesion rate to the liner layer (separation layer) during use of the obtained ointment patch was as low as 0.87%.

[Brief description of the drawings]

FIG. 1 shows a conventional ointment patch without a mesh sheet layer.

FIG. 2 shows the ointment patch of the first invention having a mesh sheet layer.

FIG. 3 shows an ointment patch of the second invention having a porous layer obtained by impregnating a porous substance with an ointment.

FIG. 4 shows the ointment patch of the third invention having a two-fold structure.

FIG. 5 shows an ointment patch of the third invention having a structure folded back from both ends.

FIG. 6 shows the ointment patch of the fourth invention in which the ointment patch is hermetically sealed in a case.

FIG. 7 shows an embodiment in which in the ointment patch of the first invention, a separation layer is omitted by combining mesh sheet layers.

[0029]

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Ointment patch 2 Support layer 2a Adhesive film 2b Cloth 3 Ointment layer 4 Separation layer 5 Intermediate layer 6 Porous layer 7 Coating part

────────────────────────────────────────────────── ─── Continuing on the front page (72) Inventor Hiroshi Takei 2700-8 Hinatsu-cho, Hikone City, Shiga Prefecture (72) Katsumi Hirose 937-37, Kamigo Notogawa-cho, Kanzaki-gun, Shiga Prefecture -257516 (JP, A) Japanese Utility Model Showa 57-17614 (JP, U) Japanese Utility Model Application 1-104122 (JP, U) Japanese Patent Publication No. 49-48233 (JP, B1) (58) Fields surveyed (Int. . ^6, DB name) A61K 9/70

Claims (4)

(57) [Claims] 1. A support layer, an ointment layer comprises an intermediate layer and the separation layer, and a support layer, an ointment layer made by arranging the intermediate layer and the separation layer in this order, an intermediate layer separating the separation layer Apply to skin
The ointment adheres to the separation layer by the action of the intermediate layer.
Ointment patches that can be controlled . 2. A support layer, comprising a porous layer in which an ointment is impregnated in a porous substance and a separation layer, wherein the support layer, the porous layer in which the ointment is impregnated in the porous substance, and a separation layer are formed by Ointment is oily or ointment or emulsion ointment
Agent, the porous substance is nylon, polyolefin,
Polyester, polyvinylidene chloride, rayon, cotton, hemp
Consist of natural fibers, such as pulp and polyvinyl chloride
Selected from the group, separating the separation layer and applying the porous layer to the skin
The ointment to the separating layer by the action of the porous material
An ointment patch that can control wearing . 3. An ointment layer is provided at the center of one surface of the support layer.
And an intermediate layer is laminated on the ointment layer.
A coating portion is provided on the coating portion, and a pair of the intermediate layer and the coating portion are provided.
Ointment patches prepared by superimposing . 4. An ointment layer is provided at the center of one surface of the support layer.
And the intermediate layer is placed on the ointment layer.
Provide a coating part on the ointment coating part, and
Foldable ointment patch .