JPH0260340B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION (a) Field of Industrial Application This invention relates to a bandage suitable for use on wounds, its materials and manufacturing method.

Open-work ointments, such as tulle gras (sometimes called Vaseline gauze)
BACKGROUND OF THE INVENTION Bandages constructed from watermarked supports have been used for many years to bandage wounds. Soft paraffin Tulgra received West German published patent No.
Disclosed in No. 2805248. Tulugura is usually provided in a sterile pouch. That Tsurugura is
The paper prevents the pouch from adhering to the walls of the pouch (or from adhering the slippers to each other when there is more than one slippery grain in the pouch). Remove the Tulugura from the pouch, remove the paper from the Vaseline, and apply it to the wound. This operation often results in a loss of petrolatum and, if the turgrain has been loaded with a drug, loss of that drug. Clearly, it would be desirable to be able to avoid using materials such as paper to protect the bandages of ointment-impregnated open-work supports such as Tulgra. here,
It has been found that the use of dissolvable films eliminates the need to remove protective materials as described above.

The invention therefore provides a bandage consisting of an open-worked support impregnated with an ointment having a protective material on both sides, characterized in that the protective material is a water-soluble film.

Suitable ointment-impregnated open-work supports include:
Any of those commonly used in the art for impregnated gauze bandages are included. Such bandages can be either hydrophobic ointments or hydrophilic ointments that do not contain water.

A preferred example of the open-work support impregnated with ointment is the above-mentioned turrugula.
Suitable turgular dressings according to the invention are gauze, such as Leno gauze impregnated with a petrolatum-based ointment. Usually Warisen-based ointments are pharmaceutical grade white or yellow Warisen jelly optionally containing other ingredients such as surfactants. Waricene-based ointments consisting of a mixture of soft paraffin and lanolin are also suitable.

A preferred dressing is a sterile dressing. This sterile dressing is suitably packaged in a germ-resistant pack, such as a pouch. Appropriate packs and sterilization methods are as described below.

As another aspect, the present invention provides a sterile bandage comprising a tulle gel, a protective material located on both sides of the tungsten, and a pouch enclosing the tungsten and the protective material, characterized in that the protective material is a water-soluble film. .

To use, open the pouch, take out the protective material and place it on the wound. The protective material then dissolves into the fluid released from the wound and its surroundings, and the turgray is then free to carry out its normal functions.

It is particularly preferred that both sides of the turrugula have a protective body in the form of a water-soluble film.

The film is composed of pharmaceutically acceptable water-soluble materials such as polyvinyl alcohol, methylcellulose, ethylcellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, polyvinylpyrrolidone, alginate, etc., and mixtures thereof.

A particularly suitable film is composed of polyvinyl alcohol. As used herein, the term polyvinyl alcohol includes polyvinyl alcohol and partially acetylated polyvinyl alcohol. This film is preferably made of polyvinyl alcohol in which 10 to 33% of the hydroxyl groups are acetylated, more preferably 15 to 25% of the hydroxyl groups are acetylated, and preferably 15 to 25% of the hydroxyl groups are acetylated.
It is a film consisting of 10-22% acetylated polyvinyl alcohol.

Suitable polyvinyl alcohol used in this invention has a molecular weight of 15,000 to 120,000, more suitably 20,000 to 100,000, preferably 25,000 to 85,000.
It has a molecular weight of

A preferred polyvinyl alcohol is Goshenol GL05 manufactured by Nippon Gosei Co., Ltd. and available from British Traders and Shippers Limited. Goseenol GL05 has a molecular weight of 30,000 and a hydrolysis rate of 87-89%.

Water-soluble films generally contain 1-50% plasticizer, more commonly 5-40% plasticizer,
It suitably contains 8-30% plasticizer, preferably 10-25%.

The plasticizers used in this film are usually water,
alcohol or a mixture thereof. The film often contains up to 25% water, more commonly 1-20%, usually 2-10% water. The alcohols used are usually di- or trihydroxy compounds such as ethylene glycol, propylene glycol, tetramethylene glycol, glycerin, and the like. Suitable alcohols include propylene glycol and glycerin, of which glycerin is usually preferred. This film often contains 1-25% alcohol, more commonly 1-20%, preferably 8-15%.
Contains alcohol.

Suitable water-soluble films for use as protective materials in the bandages of this invention have a weight per unit area of 10 to 125 g/m ² , preferably a weight per unit area of 15 to 50 g/m ² . The water-soluble polymer may be a film having a substantially uniform thickness or having multiple thin regions. Suitable such films have a thickness of 10-125μ, with the preferred thickness being
It is 12.5~50μ.

A preferred water-soluble film is a polyvinyl alcohol (Gosenol GL05) film about 25 microns thick with 5-15% by weight glycerin plasticizer.

Advantageously, the water-soluble film has thinner regions to aid in dispersion of the film in water. Such thin regions are preferably in the form of depressions arranged in a uniform pattern on one or both sides of the film. Suitable indentations include grooves that are intersecting sets of interconnecting, eg, straight, parallel grooves, and discrete indentations having geometrical forms, such as triangular, rectangular, circular, and the like.

A suitable water-soluble film having a thin region is known as Hi-Selon C type film manufactured by Nippon Gosei Co., Ltd. and supplied by British Traders and Shippers Limited. There is. Hi-Selon C type film has a hydrolysis rate of 87-89% and a molecular weight of
It is an embossed film of water-soluble polyvinyl alcohol of 44,000 to 72,000. The film is plasticized with a humectant-type plasticizer such as polyethylene glycol and has an equilibrium moisture content of 8% at 20°C and 65% relative humidity. Hi-Selon C type film has an embossed pattern of approximately 16 balanced straight grooves per cm in both the vertical and horizontal directions, and the grooves intersect at 90° angles to form a square grid pattern.

Suitable water-soluble films with thin regions have a weight per unit area of approximately 24 g/m ² and between 5 and 15
A film of polyvinyl alcohol (Gohsenol GL05) containing % glycerin by weight and having a uniform pattern of triangular depressions on one side.

The ointment of the bandage of this invention can optionally contain drugs. Suitable drugs include silver sulfadiazine, chlorhexidine acetate and povidone iodine.

The drugs used are usually locally effective therapeutic agents. A particular group of therapeutic agents used in this invention are anti-infective agents that can be used topically. Such drugs include salts such as the gluconate, acetate, and hydrochloride salts of chlorhexidine; silver salts such as silver sulfadiazine; iodophors such as polyvinylpyrrolidone iodine; benzalkonium chloride or other topical Contains acceptable antimicrobial agents. Such drugs also include salts of fusidic acid such as the sodium salt; salts such as the sulfate or hydrochloride salts of neomycin and other topical antibiotics.

Preferably the drug is in powder form. The average particle size of suitable powders is between 1 and 500μ, preferably between 2 and 300μ,
For example, it is 5 to 250μ.

Suitable povidone iodine powders are grades 30/06/ and 17/12 manufactured by BASF and currently available from Blagden Chemicals Limited.

Powders of grade 30/06 have an average particle size of 200μ, an average molecular weight of 40,000, an effective _I2 content of 9-12%.

Grade 17/12 powders have a particle size of less than 150 microns, an average molecular weight of approximately 12,000, and an effective _I2 content of 9
~12%.

These grades of povidone iodine powders with average particle sizes as low as 10 microns are also suitable.

The preferred chlorhexidine acetate powder is
It has an average particle size of 10μ.

Suitable silver sulfadiazine powder is 2-5μ
It has an average particle size of

Usually the drug is present at 0.1% to 25% by weight of the ointment, and usually from 0.4% to 15% by weight of the ointment.

In another aspect, the present invention provides a method of making a bandage of the present invention comprising placing a water-soluble film on both sides of an ointment-impregnated open-work support.

Ointment-impregnated mesh fabrics can be manufactured in the usual manner.

It is convenient to laminate the water-soluble film to both sides of the ointment-impregnated open-work support in a continuous process to form a continuous strip and then cut the strip into appropriately sized bandages.

The sterile dressing of this invention is an ointment-impregnated open-
It can be manufactured by placing a water-soluble film on both sides of a workpiece support, such as turgrain, sealing the dressing in a germ-resistant pack, such as a pouch, and then sterilizing the pouch and contents.

Films of suitable water-soluble polymers can be made by hot melt extrusion or by casting the polymer onto a release surface or the like. Polyvinyl alcohol films are prepared by applying a 4-35% by weight aqueous solution of the polymer onto polyethylene-coated paper by conventional methods, such as a doctor blade over a flat bed coating head. It can be easily manufactured by casting the film on a glass plate and then drying it in an oven at 85°C. A suitable polyethylene coated paper is Stellarize 15 manufactured by Sterling Coated Papers Limited.
(Steralese15) is known.

Suitable water-soluble films with thin areas can be produced by casting a solution or hot melt of the polymer in contact with a surface having a pattern of raised areas. These films can also be made by embossing the film with a surface having a similar pattern.

A suitable method for producing such a film is one consisting of casting an aqueous polymer solution in contact with a sheet embossed with a uniform pattern of raised areas.

A preferred method for producing polyvinyl alcohol films with thin regions is to prepare an aqueous solution of polyvinyl alcohol (30% by weight Gohsenol GL05) containing a plasticizer (5-15% by weight glycerol).
A sheet embossed with a uniform pattern of protruding triangles by a doctor blade on a flat bed coating head (polyethylene film type 04514 embossing code 14,
(obtained from AOE Plastics Gm bH).

Since treatment with ethylene oxide in the conventional manner is the preferred sterilization method, the pouches used are most preferably made of paper or some other ethylene oxide permeable material. On the other hand, pouches can be made of heat-sealable aluminum foil laminates. Suitable heat-sealable aluminum foil laminates, such as paper/aluminum foil/ethylene vinyl acetate/lacquer laminates, are
Available from DRG Flexible Packaging Limited.

Suitable sterilization methods for aluminum foil laminate pouches include gamma irradiation.

The use of a water-soluble film protectant in the bandage of the present invention, which does not require removal, avoids the loss of ointment that occurs when the protectant is removed from a conventional bandage. Therefore, the weight per unit area of the ointment impregnated into the open-work support of the bandage of the present invention is that of a conventional bandage (typically 250 g/m ² ).
Even if the amount is less than that, the efficiency of the bandage will not be compromised.

The open-work support of the bandage of this invention is
An impregnation weight per unit area of 100 to 190 g/m ² is suitable, an impregnation weight per unit area of 120 to 170 g/m ² is preferred.

This invention will be explained in the following examples.

Example 1 Ten pieces of leno gauze impregnated with Vaseline jelly
A cm wide strip is placed on a 20μ thick polyvinyl alcohol film (Hi-Selon C type embossed film) with a width and length of 100 cm, and then a further 10 cm wide and long polyvinyl alcohol film is placed on top of it. to form a laminate with impregnated gauze placed between the two layers of film.
The laminated strips were then cut into 10 cm x 10 cm bandages, packed into individually sealed aluminum foil pouches, and sterilized by gamma irradiation (2.5 megarads) in the conventional manner.

Example 2 In a manner similar to Example 1, a Tulgurah bandage loaded with the drug of this invention was prepared containing 0.525% by weight of chlorhexidine acetate (a micronized powder commercially available from ICI Pharmaceuticals Limited). 150-200 of Vaseline Jelly (British Pharmacopoeia)
g/m ² by impregnating Leno gauze.

Example 3 Vaseline jelly (British Pharmacopoeia) containing a surfactant (0.1% by weight Tween 60) and povidone iodine powder (6% by weight grade 30/06, available from Blagden Chemicals Limited).
A 10 cm wide strip of Leno gauze impregnated with 160 g/m ² ) is placed on a 10 cm wide strip of embossed polyvinyl alcohol film (24 g/m ² ), then on top of the impregnated layer, the embossed A similar strip of polyvinyl alcohol film was placed to make a laminate.

This embossed polyvinyl alcohol film was prepared by applying an aqueous solution of Gohsenol GL05 (30% by weight) containing glycerin (5% by weight) to an embossed polyethylene film (grade
04514, Emboss Code 14, AOE Plastics
GmbH) by means of a blade on a flat bed coating head, and then this cast film is
Produced by drying in an oven at 70-80°C.

The laminated strips were then cut into 10 cm x 10 cm bandages, packed into individually sealed aluminum foil pouches, and sterilized by gamma irradiation in the conventional manner.

This aluminum foil pouch is paper (40g/
m ² )/aluminum foil (24g/m ² )/ethylene vinyl acetate (23g/m ² , Surlyn 1652)
A front foil made of a laminate bonded with
Heat-sealable peelable lacquer (25g/m ² ,
It was manufactured by heat sealing the edges with similarly constructed pack aluminum foil coated with DRG Flexible Packaging Limited (available from DRG Flexible Packaging Limited).

Wound treatment test The bandage of Example 3 was applied to partially thick wounds (2.5 cm
2.5 cm). The water-soluble protectant of these bandages dissolved in 1.5 minutes on contact with wound exudate. When the wound area was inspected over a three-month period, the healing status and healing process of the wound were compared with that of a regular Turugra bandage (Jelonet manufactured by T.G. Smith & Nephew Limited). As a result, there was no substantial change.

Claims (1)

[Claims] 1. Ointment-impregnated open with protective material on both sides.
Consists of a work support (support with watermark structure),
A bandage characterized in that the protective material is a water-soluble film. 2. The bandage of claim 1, wherein the ointment-impregnated open-work support is Tulugra. 3. The bandage of claim 1, which is sterilized in a sealed germ-resistant pack. 4. A bandage according to any one of claims 1 to 3, wherein the water-soluble film has thin areas that aid in dispersion of the film in water. 5. Bandage according to any one of claims 1 to 4, wherein the water-soluble film has a weight per unit area of 15 to 50 g/ ^m2 . 6. The bandage according to any one of claims 1 to 5, wherein the water-soluble film is a polyvinyl alcohol film in which 10 to 22% of the hydroxyl groups are acetylated. 7. A bandage according to claim 6, wherein the polyvinyl alcohol has from 1 to 20% by weight of an alcoholic plasticizer. 8. A dressing according to any one of claims 1 to 7, wherein the ointment contains a topically acceptable antimicrobial agent. 9. The bandage of claim 8, wherein the antimicrobial agent is present in the ointment at 0.4-15% by weight. 10. The bandage according to claim 8, wherein the antibacterial agent is a chlorhexidine salt. 11. The bandage according to claim 8, wherein the antibacterial agent is polyvinylpyrrolidone iodine. 12 Ointment on open-work support, 120~
12. A bandage according to claim 1, impregnated with a weight per unit area of 170 g/m ^<2> . 13. An ointment-impregnated open-work support comprising a water-soluble film on both sides of an ointment-impregnated open-work support, characterized in that the protective material is a water-soluble film, and having a protection material on both sides. A manufacturing method for a bandage consisting of a structural support.