JP2926914B2 - Patch for treating skin diseases and method for producing the same - Google Patents
Patch for treating skin diseases and method for producing the sameInfo
- Publication number
- JP2926914B2 JP2926914B2 JP17657990A JP17657990A JP2926914B2 JP 2926914 B2 JP2926914 B2 JP 2926914B2 JP 17657990 A JP17657990 A JP 17657990A JP 17657990 A JP17657990 A JP 17657990A JP 2926914 B2 JP2926914 B2 JP 2926914B2
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- ointment
- patch
- yield value
- dyne
- weight
- Prior art date
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Description
【発明の詳細な説明】 〔産業上の利用分野〕 本発明は、患者の苦痛を和らげ、施療の効率を高める
皮膚疾患治療用の貼付剤及びその製造法に関する。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.
軟膏剤は外用医薬として種々の用途に応用されている
が、皮膚疾患治療用の軟膏含有貼付剤は未だ開発されて
いない。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.
軟膏剤は患者局所に塗布する場合、指で局所に触れる
と患者が痛みを訴えるため、使用しづらいという欠点が
あるほか、大きい患部面では軟膏を全面に均一塗布する
のに時間がかかるという不便もある。さらに、軟膏剤は
塗布した後、塗布面をガーゼ、脱脂綿、油紙等で被覆し
て衣服への付着を予防する必要があり、施療者にとって
は手間がかかると言う不満もあった。そこで予め軟膏を
塗布した貼付剤の開発が望まれていた。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.
本発明は、上記事項に基づいてなされたもので、その
目的とするところは、軟膏剤の上記難点を克服し、患者
の苦痛をやわらげると共に、施療の効率を高めることに
ある。しかし、軟膏剤は本来軟らかく製造されているた
め、貼付剤にすることは通常困難であった。このため本
発明者らは軟らかい軟膏剤を貼付剤化する方法を鋭意検
討した結果、本発明を完成した。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.
すなわち、本発明は下記(1)〜(4)から成るもの
である。That is, the present invention comprises the following (1) to (4).
(1)支持体、軟膏の展延性が10℃の降伏値で30,000〜
100,000dyne/cm2,36℃の降伏値で2,000〜20,000dyne/cm
2である支持体に接して形成される軟膏層及び膏体を保
護する保護ライナーを含んでなる皮膚疾患治療用貼付
剤。(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)軟膏の有効成分がリゾチームである前記(1)記
載の皮膚疾患治療用貼付剤。(2) The patch for treating skin diseases according to (1), wherein the active ingredient of the ointment is lysozyme.
(3)支持体に展延性が10℃の降伏値で30,000〜100,00
0dyne/cm2,36℃の降伏値で2,000〜20,000dyne/cm2の軟
膏を塗布又は展延し、これを水、生理食塩液もしくは水
溶性消毒液で湿潤化した布又は紙から選ばれる保護ライ
ナーで保護することを特徴とする皮膚疾患治療用貼付剤
の製造法。(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.
本発明に用いられる、展延性が10℃の降伏値で30,000
〜100,000dyne/cm2、36℃の降伏値で2,000〜20,000dyne
/cm2の軟膏は、乳剤性軟膏で油中水型のものがよい。こ
のような軟膏の性質は大部分が軟膏の基剤の性質により
決まる。基剤は流動パラフィン、オクチルドデカノール
などの室温で液状のもの、サラシミツロウ、ステアリル
アルコール、セタノール、白色ワセリンなどの室温で固
形のものの中から適宜組み合せて用いればよい。この
際、室温で液状のものの配合量は多いほど軟膏は軟らか
く(すなわち展延性が大きく)なることを配慮する。基
剤の構成成分数は多いため、上記の特性を示す軟膏の成
分及び配合量は試行錯誤的に実験を繰り返すことにより
幾通りも見出しうる。例えば流動パラフィン25〜40%、
サラシミツロウ7〜13%、セタノール2〜4%(いずれ
も軟膏当りの重量%)を含む基剤がよい。軟膏には基剤
のほかに、モノステアリン酸ソルビタン、ポリオキシエ
チレンセチルエーテル等の乳化剤、ステアリン酸アルミ
ニウム等の安定剤、パラオキシ安息香酸メチル等の保存
剤、リン酸水素ナトリウム等のpH調整剤、それに主薬
(有効成分)及び適量の精製水が配合される。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.
軟膏の製造は日本薬局方製剤総則軟膏剤の項に準じ行
うことができる。基剤、一部の乳化剤及び安定剤は加温
して融解し、混和し、約75℃に保ち、これに水溶性の安
定剤及び乳化剤を水に溶かし、約75℃に加温したのち添
加し、かき混ぜる。適当な温度に冷却したのち、主薬
(有効成分)を加え、かき混ぜ全質均等化して軟膏(医
薬用バルク)とする。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).
主薬(有効成分)としては特に限定されないが、例え
ばリゾチーム、プラスミン、ブロメライン、上皮細胞生
長因子(EGF)、カリクレイン等が挙げられる。The main drug (active ingredient) is not particularly limited, but includes, for example, lysozyme, plasmin, bromelain, epidermal growth factor (EGF), kallikrein, and the like.
なお降伏値はスプレッドメータ法により、次式により
求めたものである。The yield value was obtained by the following equation using the spread meter method.
降伏値=11960GV/πD3 (ここでGはガラス板の重量(g)、Vは試料の量(cm
3)、Dは試料の広がりが止ったときの直径(cm)を示
す。) 本発明の支持体は局所面への均一な密着性を第一に考
慮して、柔軟性のある綿、スフ、化学繊維からなる織
布、不織布や軟質塩化ビニル、ポリエチレン、ポリウレ
タン等のフィルムあるいは発泡体シートが適当である。
特に、通気性を兼ね備えた綿、スフ、セルロース等から
なる織布あるいは不織布が良い。これらの材質は、さら
に、人体への密着性をよくするため、伸縮性とドレープ
性をもたせることもできる。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.
膏体を保護するための保護ライナーとしては、処理剤
で処理し、軟膏からの剥離性を良くした布又は紙等があ
る。また、プラスチックフィルム、プラスチックシー
ト、発泡体、それらをエンボス加工したもの等を用いる
こともできる。処理剤としては、水、生理食塩液、水溶
性消毒液等があり、これらを含浸し湿潤化させた布又は
紙は軟膏に対する剥離性がよい。また、処理剤中に軟膏
の水相に含まれる薬剤濃度と同程度の濃度の薬剤を含有
させることで保護ライナーへの薬剤の移行を防止するこ
ともできる。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.
支持体への軟膏の展延、塗布は、室温以下、好ましく
は15℃以下の温度で、通常のドクターナイフ法、Tダイ
法、ロールコート法などにより行うと良い。軟膏の塗布
厚さは0.5〜5mmが適当であるが、治療効果を十分に発現
させるには、1mm以上にするのが好ましい。また、人体
への適用時の作業性を考慮して、貼付剤の辺縁2〜4mm
は軟膏を塗布しない状態に保持しても良い。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.
貼付剤の大きさは特に制限されないが、種々の大きさ
の用途に応じられるよう、A6〜A3版の大きさとするのが
好ましい。これら貼付剤は、アルミ接着フィルム等でつ
くられた密封容器に入れて使用時まで保管される。ま
た、保管温度は2〜10℃が好ましい。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.
軟膏の展延性が、10℃の降伏値で30,000〜100,000dyn
e/cm2であることは、本発明品の製造時又は保管時(約1
0℃)に軟膏が適当な硬さをもつことを意味し、製造時
では作業性が良く冷蔵保存から取り出して使用する際に
は、膏体からの保護ライナーの剥離性が良くなる理由と
なる。また軟膏の展延性が、36℃の降伏値で2,000〜20,
000dyne/cm2であることは、その温度で軟膏が適当な軟
らかさをもつことを意味し、本発明品が実際に患部に貼
付された時に軟膏が体温で温められ、軟らかくなり、そ
の結果治療効果を上げ、あるいは使用感が良くなる理由
となる。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.
次に製剤例及び実験例により更に具体的に説明する。 Next, the present invention will be described more specifically with reference to formulation examples and experimental examples.
(製剤例) 流動パラフィン35重量部、オクチルドデカノール5重
量部、ステアリン酸アルミニウム1重量部、固形パラフ
ィン1重量部、白色ワセリン5重量部、鯨ロウ4重量
部、ポリオキシエチレンセチルエーテル1重量部、ステ
アリルアルコール2重量部、セタノール3重量部、及び
サラシミツロウ7重量部を加熱して融解し、混和し、約
75℃に保ち、これにモノステアリン酸ソルビタン5重量
部、D−ソルビトール3重量部、及び精製水10重量部を
加え、約75℃に保温しながらかき混ぜ、約45℃に冷却
し、塩化リゾチーム5重量部を適量の精製水に溶かして
加え、かき混ぜてリゾチーム軟膏(医薬用バルク)とし
た。この軟膏の展延性をスプレッドメータ法で測定する
と、10℃における降伏値は44,580dyne/cm2、36℃におけ
る降伏値は3,420dyne/cm2であった。(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 .
支持体に綿織布を、保護ライナーに含水紙を用い、A6
版大の綿織布に辺縁部位の3mmを除いて、ナイフカッタ
ー法で8℃に保冷した上記軟膏を厚さ3mmに塗布した。
その上面を含水紙で被覆し、これをアルミパック封入し
て製剤とした。そののち2〜5℃の冷蔵庫内に保管し
た。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.
(実験例) 本発明の貼付剤の効果を確認するため、上記製剤例で
作成した貼付剤を試料として、切傷治療実験を行った。(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.
ウイスター系雄ラットの背部被毛を電気バリカン及び
脱毛剤で脱毛した。エーテル麻酔下に背部皮膚の左右の
2か所をカッターで切り、25〜30mm切傷を2個作成し
た。切傷の中央を手術用糸で縫合した。抜糸は3日後に
行った。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.
左右の切傷のうち一方には本発明の貼付剤を適当な大
きさに裁断し、ライナーを剥離して貼付した。他の一方
にはなにも貼付しないで放置した。支持体に粘着したリ
ゾチーム軟膏は体温により十分軟らかくなり、傷面を完
全に被覆できた。貼付剤の交換は1日1回、毎日行っ
た。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.
4日後にラットを放血、致死させて皮膚を剥離し、切
傷の癒合程度をレオメータで測定した。その成績を第1
表に示した。本発明の貼付剤は、創耐張力が大きく、明
らかな切傷治癒効果が認められた。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.
〔発明の効果〕 軟膏の投与量は貼付剤の大きさにより容易かつ確実に
定まるので、患部の大きさなどに応じ、所定の大きさの
貼付剤を選んで貼付すれば良い。そのため本発明は、患
者の苦痛を和らげ、施療の効率を高める効果がある。 [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.
───────────────────────────────────────────────────── フロントページの続き (72)発明者 入江 大祐 茨城県日立市東町4丁目13番1号 日立 化成工業株式会社山崎工場内 (72)発明者 深澤 一也 茨城県日立市東町4丁目13番1号 日立 化成工業株式会社山崎工場内 (56)参考文献 特開 昭63−203612(JP,A) 特開 昭63−156727(JP,A) 特公 昭49−48233(JP,B1) (58)調査した分野(Int.Cl.6,DB名) A61K 9/70 ──────────────────────────────────────────────────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)
0,000〜100,000dyne/cm2,36℃の降伏値で2,000〜20,000
dyne/cm2である支持体に接して形成される軟膏層及び膏
体を保護する保護ライナーを含んでなる皮膚疾患治療用
貼付剤。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.
1記載の皮膚疾患治療用貼付剤。2. The patch according to claim 1, wherein the active ingredient of the ointment is lysozyme.
100,000dyne/cm2,36℃の降伏値で2,000〜20,000dyne/cm
2の軟膏を塗布又は展延し、これを水、生理食塩液もし
くは水溶性消毒液で湿潤化した布又は紙から選ばれる保
護ライナーで保護することを特徴とする皮膚疾患治療用
貼付剤の製造法。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.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP19212389 | 1989-07-25 | ||
JP1-192123 | 1989-07-25 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH03130215A JPH03130215A (en) | 1991-06-04 |
JP2926914B2 true JP2926914B2 (en) | 1999-07-28 |
Family
ID=16286058
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP17657990A Expired - Fee Related JP2926914B2 (en) | 1989-07-25 | 1990-07-04 | Patch for treating skin diseases and method for producing the same |
Country Status (1)
Country | Link |
---|---|
JP (1) | JP2926914B2 (en) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH04145019A (en) * | 1990-10-02 | 1992-05-19 | Dia Seiyaku Kk | Poultice containing lysozyme chloride |
KR100369366B1 (en) * | 2000-12-28 | 2003-02-05 | 우 찬 한 | A transferring device for fruit |
US7202066B2 (en) * | 2002-01-29 | 2007-04-10 | Carrington Laboratories, Inc. | Combination of a growth factor and a protease enzyme |
JP4705667B2 (en) * | 2008-07-28 | 2011-06-22 | 住友建機株式会社 | Paving material gate mechanism of charging feeder |
-
1990
- 1990-07-04 JP JP17657990A patent/JP2926914B2/en not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
JPH03130215A (en) | 1991-06-04 |
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