JP2926914B2 - Patch for treating skin diseases and method for producing the same - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a patch for treating a skin disease which relieves a patient's pain and improves treatment efficiency, and a method for producing the same.

[Conventional technology]

Ointments have been applied to various uses as external medicines, but ointment-containing patches for the treatment of skin diseases have not yet been developed.

[Problems to be solved by the invention]

When applying ointments to the topical area of the patient, it is difficult to use the ointment because the patient complains of pain when touching the area with the finger.In addition, it is inconvenient that it takes time to apply the ointment uniformly over the entire affected area. There is also. Furthermore, after the ointment is applied, it is necessary to cover the applied surface with gauze, absorbent cotton, oil paper, or the like to prevent the ointment from adhering to clothes, and there is also a dissatisfaction that the practitioner takes time and effort. Therefore, development of a patch to which an ointment has been applied in advance has been desired.

The present invention has been made based on the above-mentioned matters, and an object of the present invention is to overcome the above-mentioned drawbacks of an ointment, relieve a patient's pain, and increase the efficiency of treatment. However, since an ointment was originally manufactured softly, it was usually difficult to make it into a patch. Therefore, the inventors of the present invention have intensively studied a method for converting a soft ointment into a patch, and have completed the present invention.

[Means for solving the problem]

That is, the present invention comprises the following (1) to (4).

(1) The spreadability of the support and ointment is 30,000-yield value at 10 ° C.
100,000 dyne / cm ² , 2,000-20,000 dyne / cm at a yield value of 36 ° C
^{2. A} patch for treating a skin disease, comprising the ointment layer formed in contact with the support and the protective liner for protecting the ointment, which is ² .

(2) The patch for treating skin diseases according to (1), wherein the active ingredient of the ointment is lysozyme.

(3) The support has a ductility of 30,000 to 100,00 at a yield value of 10 ° C.
0 dyne / cm ² , 2,000 to 20,000 dyne / cm ² ointment is applied or spread at a yield value of 36 ° C., which is selected from a cloth or paper moistened with water, saline or a water-soluble disinfectant. A method for producing a patch for treating skin diseases, wherein the patch is protected with a liner.

The ductility used in the present invention is 30,000 at a yield value of 10 ° C.
2,000~20,000dyne in ~100,000dyne / cm ^2, 36 yield value of ℃
The ointment of / cm ² is preferably an emulsion ointment and a water-in-oil type. The properties of such ointments are largely determined by the nature of the base of the ointment. The base may be appropriately combined from a liquid at room temperature such as liquid paraffin and octyldodecanol, and a solid at room temperature such as beeswax, stearyl alcohol, cetanol and white petrolatum. At this time, it is considered that the ointment becomes softer (that is, the spreadability is larger) as the amount of the liquid at room temperature increases. Since the number of constituent components of the base is large, the components and amounts of the ointment having the above-mentioned properties can be found in various ways by repeating experiments by trial and error. For example, liquid paraffin 25-40%,
A base containing 7 to 13% of beeswax and 2 to 4% of cetanol (all by weight per ointment) is preferred. In addition to the base in the ointment, sorbitan monostearate, emulsifiers such as polyoxyethylene cetyl ether, stabilizers such as aluminum stearate, preservatives such as methyl parahydroxybenzoate, pH adjusters such as sodium hydrogen phosphate, The main drug (active ingredient) and an appropriate amount of purified water are added thereto.

The ointment can be manufactured according to the Japanese Pharmacopoeia Preparation General Ointment. The base, some emulsifiers and stabilizers are heated and melted, mixed and kept at about 75 ° C, and the water-soluble stabilizers and emulsifiers are dissolved in water, heated to about 75 ° C and added. And stir. After cooling to an appropriate temperature, the base drug (active ingredient) is added, and the mixture is stirred to equalize the quality of the whole to form an ointment (pharmaceutical bulk).

The main drug (active ingredient) is not particularly limited, but includes, for example, lysozyme, plasmin, bromelain, epidermal growth factor (EGF), kallikrein, and the like.

The yield value was obtained by the following equation using the spread meter method.

Yield value = 11960 GV / πD ³ (where G is the weight (g) of the glass plate, V is the amount of the sample (cm)
³ ), D indicates the diameter (cm) when the spread of the sample stops. The support of the present invention is made of a flexible woven fabric, nonwoven fabric, soft vinyl chloride, polyethylene, polyurethane, or other film made of cotton, cloth, or synthetic fiber in consideration of the uniform adhesion to a local surface. Alternatively, a foam sheet is suitable.
In particular, a woven or non-woven fabric made of cotton, staple, cellulose or the like having air permeability is preferable. These materials can also have elasticity and drape to improve the adhesion to the human body.

Examples of the protective liner for protecting the plaster include cloth or paper treated with a treating agent to improve the releasability from the ointment. Further, a plastic film, a plastic sheet, a foam, an embossed material thereof, or the like can also be used. Examples of the treatment agent include water, physiological saline, water-soluble disinfectant, and the like, and the cloth or paper impregnated and moistened with these has good releasability from ointment. In addition, it is possible to prevent the transfer of the drug to the protective liner by including the drug in the treatment agent at the same concentration as the drug concentration contained in the aqueous phase of the ointment.

The spreading and application of the ointment to the support may be performed at room temperature or lower, preferably at 15 ° C. or lower, by a usual doctor knife method, T-die method, roll coating method, or the like. The coating thickness of the ointment is suitably 0.5 to 5 mm, but it is preferably 1 mm or more in order to sufficiently exhibit the therapeutic effect. In addition, in consideration of workability at the time of application to the human body, the margin of the patch is 2 to 4 mm
May be kept in a state where the ointment is not applied.

The size of the patch is not particularly limited, but is preferably A6 to A3 size so that it can be used for various sizes. These patches are stored in a sealed container made of an aluminum adhesive film or the like until use. The storage temperature is preferably 2 to 10C.

[Action]

The spreadability of the ointment is 30,000-100,000 dyn at a yield value of 10 ° C
e / cm ² means that the product of the present invention is manufactured or stored (about 1
0 ° C) means that the ointment has an appropriate hardness, which is a reason why the workability is good at the time of production and the releasability of the protective liner from the ointment is good when used after removal from refrigerated storage . The spreadability of the ointment is 2,000 to 20, with a yield value of 36 ° C.
000dyne / cm ² means that the ointment has appropriate softness at that temperature, and when the product of the present invention is actually applied to the affected area, the ointment is warmed at body temperature and becomes soft, and as a result This is the reason why the effect is improved or the usability is improved.

〔Example〕

 Next, the present invention will be described more specifically with reference to formulation examples and experimental examples.

(Formulation example) 35 parts by weight of liquid paraffin, 5 parts by weight of octyl dodecanol, 1 part by weight of aluminum stearate, 1 part by weight of solid paraffin, 5 parts by weight of white petrolatum, 4 parts by weight of spermaceti, 1 part by weight of polyoxyethylene cetyl ether , 2 parts by weight of stearyl alcohol, 3 parts by weight of cetanol and 7 parts by weight of beeswax are melted by heating, mixed,
Keep at 75 ° C, add 5 parts by weight of sorbitan monostearate, 3 parts by weight of D-sorbitol, and 10 parts by weight of purified water, stir while keeping the temperature at about 75 ° C, cool to about 45 ° C, and add lysozyme chloride 5 parts by weight. A part by weight was dissolved in an appropriate amount of purified water and added, followed by stirring to obtain a lysozyme ointment (pharmaceutical bulk). When the spreadability of this ointment was measured by a spread meter method, the yield value at 10 ° C was 44,580 dyne / cm ² , and the yield value at 36 ° C was 3,420 dyne / cm ² .

Use cotton woven fabric for the support, wet paper for the protective liner, A6
The above-mentioned ointment kept at 8 ° C. by a knife cutter method was applied to a thickness of 3 mm on a plate-sized cotton woven fabric except for 3 mm at the peripheral portion.
The upper surface was covered with water-containing paper, and this was sealed in an aluminum pack to prepare a preparation. Thereafter, it was stored in a refrigerator at 2 to 5 ° C.

(Experimental Example) In order to confirm the effect of the patch of the present invention, a cut treatment experiment was performed using the patch prepared in the above formulation example as a sample.

The hair on the back of male Wistar rats was depilated with an electric clipper and a hair remover. Under ether anesthesia, two places on the left and right sides of the back skin were cut with a cutter, and two 25-30 mm cuts were made. The center of the incision was sutured with surgical thread. Thread removal was performed three days later.

The patch of the present invention was cut into an appropriate size on one of the left and right cuts, and the liner was peeled off and applied. The other was left unattached. The lysozyme ointment adhered to the support became sufficiently soft by body temperature, and could completely cover the wound surface. The patch was changed once a day, every day.

Four days later, the rats were exsanguinated and sacrificed, the skin was peeled off, and the degree of healing of the cut was measured with a rheometer. First grade
It is shown in the table. The patch of the present invention had high wound resistance and a clear cut healing effect.

[Effects of the Invention] Since the dose of the ointment is easily and reliably determined by the size of the patch, a patch having a predetermined size may be selected and applied according to the size of the affected part. Therefore, the present invention has the effect of relieving the patient's pain and increasing the efficiency of treatment.

──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventor Daisuke Irie 4- 13-1, Higashicho, Hitachi City, Ibaraki Prefecture Inside the Yamazaki Plant of Hitachi Chemical Co., Ltd. (72) Inventor Kazuya Fukasawa 4-13 Higashicho, Hitachi City, Ibaraki Prefecture No. 1 Inside the Yamazaki Plant of Hitachi Chemical Co., Ltd. (56) References JP-A-63-203612 (JP, A) JP-A-63-156727 (JP, A) JP-B-49-48233 (JP, B1) (58) ) Surveyed field (Int.Cl. ⁶ , DB name) A61K 9/70

Claims (3)

(57) [Claims] 1. The spreadability of a support or an ointment is 3 at a yield value of 10 ° C.
2,000 to 20,000 with a yield value of 0,000 to 100,000 dyne / cm ² and 36 ° C
A patch for treating a skin disease, comprising an ointment layer formed in contact with a support having a dyne / cm ² and a protective liner for protecting the ointment. 2. The patch according to claim 1, wherein the active ingredient of the ointment is lysozyme. 3. The support has a ductility of from 30,000 at a yield value of 10 ° C.
100,000 dyne / cm ² , 2,000-20,000 dyne / cm at a yield value of 36 ° C
^2. Production of a patch for the treatment of skin diseases, characterized by applying or spreading the ointment ² and protecting it with a protective liner selected from cloth or paper moistened with water, physiological saline or a water-soluble disinfectant. Law.