JPH07126158A - Topical formulation containing crotamiton - Google Patents
Topical formulation containing crotamitonInfo
- Publication number
- JPH07126158A JPH07126158A JP5269280A JP26928093A JPH07126158A JP H07126158 A JPH07126158 A JP H07126158A JP 5269280 A JP5269280 A JP 5269280A JP 26928093 A JP26928093 A JP 26928093A JP H07126158 A JPH07126158 A JP H07126158A
- Authority
- JP
- Japan
- Prior art keywords
- weight
- parts
- crotamiton
- external preparation
- formulation containing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
(57)【要約】
【目的】 クロタミトンを高濃度に配合することにより
鎮痒効果を高め、かつクロタミトンの経時的な変色を抑
え、商品価値を高めた外用剤を提供する。
【構成】 クロタミトン、ピロ亜硫酸ナトリウム、エデ
ト酸ナトリウム及びジブチルヒドロキシトルエンを配合
した外用剤。(57) [Summary] [Purpose] To provide an external preparation having a high commercial value by increasing the antipruritic effect by suppressing the discoloration of crotamiton by mixing crotamiton in a high concentration. [Composition] An external preparation containing crotamiton, sodium pyrosulfite, sodium edetate and dibutylhydroxytoluene.
Description
【0001】[0001]
【産業上の利用分野】本発明は鎮痒剤としてクロタミト
ンを配合した外用剤に関する。TECHNICAL FIELD The present invention relates to an external preparation containing crotamiton as an antipruritic agent.
【0002】[0002]
【従来の技術】皮膚疾患において例えば水虫・たむしな
どの随伴症状や虫刺され等の蚤痒感を軽減する目的で、
クロタミトン等の鎮痒剤を配合した外用剤が使用されて
いる。効果的に蚤痒感を軽減するためには、クロタミト
ンの配合比を高めることが好ましい。2. Description of the Related Art In skin diseases, for example, for the purpose of reducing the accompanying symptoms such as athlete's foot, beetle and the itchiness such as insect bites,
External preparations containing antipruritic agents such as crotamiton are used. In order to effectively reduce the itchiness, it is preferable to increase the mixing ratio of crotamiton.
【0003】[0003]
【発明が解決しようとする課題】しかしクロタミトンを
高濃度に配合した場合、経時的に製剤の変色が認めら
れ、商品価値の著しい低下が問題となっていた。本発明
の目的は、クロタミトンを高濃度に配合することにより
鎮痒効果を高め、かつクロタミトンの経時的な変色を抑
え、商品価値を高めた外用剤を提供することにある。However, when crotamiton is blended in a high concentration, discoloration of the preparation is observed with the passage of time, and there has been a problem of a marked decrease in commercial value. An object of the present invention is to provide an external preparation having a high commercial value by increasing the antipruritic effect by suppressing the discoloration of crotamiton over time by incorporating crotamiton in a high concentration.
【0004】[0004]
【課題を解決するための手段】本発明者らは、前記目的
を達成すべく鋭意研究を進めた結果、クロタミトンにピ
ロ亜硫酸ナトリウム、エデト酸ナトリウム(以下、ED
TA−2Naと略称する。)及びジブチルヒドロキシト
ルエン(以下、BHTと略称する。)を配合することに
より、調製した外用剤における経時的なクロタミトンの
変色を抑えることができることを見いだし、本発明を完
成した。Means for Solving the Problems As a result of intensive studies to achieve the above object, the present inventors have found that crotamiton has sodium pyrosulfite and sodium edetate (hereinafter, ED).
It is abbreviated as TA-2Na. ) And dibutylhydroxytoluene (hereinafter, abbreviated as BHT) are blended, it was found that the discoloration of crotamiton with time in the prepared external preparation can be suppressed, and the present invention was completed.
【0005】すなわち、本発明はクロタミトン、ピロ亜
硫酸ナトリウム、EDTAー2Na及びBHTを配合し
た外用剤である。本発明において、クロタミトンの配合
量は製剤全量の10〜20重量%、ピロ亜硫酸ナトリウ
ムの配合量は製剤全量の0.05〜0.3重量%、ED
TA−2Naの配合量は製剤全量の0.05〜0.2重
量%、BHTの配合量は製剤全量の0.01〜0.2重
量%である。That is, the present invention is an external preparation containing crotamiton, sodium pyrosulfite, EDTA-2Na and BHT. In the present invention, the content of crotamiton is 10 to 20% by weight of the total preparation, the content of sodium pyrosulfite is 0.05 to 0.3% by weight of the total preparation, and ED
The blending amount of TA-2Na is 0.05 to 0.2 wt% of the total amount of the preparation, and the blending amount of BHT is 0.01 to 0.2 wt% of the total amount of the preparation.
【0006】本発明の外用剤は、通常用いられる方法
(例えば第12改正日本薬局方に規定する方法など)に
従って調製することができる。その剤形としては、軟
膏、クリーム剤、ゲル剤、チンキ剤、液剤を挙げること
ができる。The external preparation of the present invention can be prepared according to a commonly used method (for example, the method defined in the 12th revised Japanese Pharmacopoeia). Examples of the dosage form include ointments, creams, gels, tinctures, and liquids.
【0007】本発明の外用剤には、必要に応じて、抗真
菌剤(例えば、硝酸ミコナゾール、トルナフテート、ク
ロトリマゾールなど)、抗ヒスタミン剤(例えば、塩酸
ジフェンヒドラミン、塩酸イソチペンジル、マレイン酸
クロルフェニラミンなど)、抗炎症剤(例えば、グリチ
ルレチン酸、グリチルリチン酸ジカリウムなど)、局所
麻酔剤(例えば、塩酸ジブカイン、リドカイン、塩酸リ
ドカインなど)、界面活性剤(例えば、ポリオキシエチ
レンソルビタンモノステアレート、ソルビタンモノステ
アレートなど)、清涼化剤(例えば、メントール、カン
フルなど)、ゲル化剤、中和剤、pH調製剤、溶媒、油
成分及び高分子などの通常外用剤に配合される成分を本
発明の効果を損なわない範囲で加えることができる。The external preparations of the present invention include, if necessary, antifungal agents (eg, miconazole nitrate, tolnaftate, clotrimazole, etc.), antihistamines (eg, diphenhydramine hydrochloride, isothipendyl hydrochloride, chlorpheniramine maleate, etc.). , Anti-inflammatory agents (eg, glycyrrhetinic acid, dipotassium glycyrrhizinate), local anesthetics (eg, dibucaine hydrochloride, lidocaine, lidocaine hydrochloride), surfactants (eg, polyoxyethylene sorbitan monostearate, sorbitan monostearate) Etc.), a cooling agent (for example, menthol, camphor, etc.), a gelling agent, a neutralizing agent, a pH adjusting agent, a solvent, an oil component, and a component that is usually added to an external preparation such as a polymer to obtain the effect of the present invention. It can be added within a range that does not impair it.
【0008】[0008]
【発明の効果】本発明により、鎮痒効果を高め、かつク
ロタミトンの経時的な変色を抑えて商品価値を高めたク
ロタミトン配合外用剤を提供することが可能となった。INDUSTRIAL APPLICABILITY According to the present invention, it becomes possible to provide a crotamiton-containing external preparation which has an improved antipruritic effect and suppresses discoloration of crotamiton over time, and has an increased commercial value.
【0009】[0009]
【実施例】以下、実施例及び試験例を挙げて、本発明を
さらに詳細に説明する。試験例 [クロタミトン含有製剤の経時的外観観察] (1)被験試料の調製 被験試料を40℃,相対湿度75%で6ヶ月間及び室温
で1年間保存し、外観変化を肉眼判定により評価した。
なお、被験試料は表1に示す処方を攪拌、溶解して均一
にすることにより調製した。表1に被験試料の処方及び
試験結果を示す。EXAMPLES The present invention will be described in more detail below with reference to examples and test examples. Test Example [Observation of appearance of crotamiton-containing preparation over time] (1) Preparation of test sample The test sample was stored at 40 ° C and 75% relative humidity for 6 months and at room temperature for 1 year, and the change in appearance was evaluated by the naked eye.
The test sample was prepared by stirring and dissolving the formulation shown in Table 1 to homogenize it. Table 1 shows the formulation of the test sample and the test results.
【0010】[0010]
【表1】 [Table 1]
【0011】実施例1 クロタミトン10重量部、硝酸ミコナゾール1重量部、
リドカイン2重量部、ポリソルベート60 5重量部、
プロピレングリコール10重量部、グリセリンモノステ
アレート20重量部、アジピン酸ジイソプロピル2重量
部、尿素3重量部、ピロ亜硫酸ナトリウム0.15重量
部、EDTA−2Na0.1重量部、BHT0.05重
量部及び精製水46.7重量部を加温溶解し、ホモミキ
サーを用いて乳化し、クリーム剤を得た。Example 1 10 parts by weight of crotamiton, 1 part by weight of miconazole nitrate,
2 parts by weight of lidocaine, 5 parts by weight of polysorbate 60,
Propylene glycol 10 parts by weight, glycerin monostearate 20 parts by weight, diisopropyl adipate 2 parts by weight, urea 3 parts by weight, sodium pyrosulfite 0.15 parts by weight, EDTA-2Na 0.1 parts by weight, BHT 0.05 parts by weight and purification 46.7 parts by weight of water was dissolved by heating and emulsified using a homomixer to obtain a cream.
【0012】実施例2 クロタミトン15重量部、塩酸イソチペンジル0.75
重量部、リドカイン2重量部、メントール2重量部、グ
リチルリチン酸ジカリウム0.5重量部、ピロ亜硫酸ナ
トリウム0.15重量部、EDTA−2Na0.1重量
部、BHT0.05重量部、ポリエチレングリコール−
300 10重量部、カルボキシビニルポリマー0.5
重量部、エチルアルコール45重量部及び精製水18.
45重量部を攪拌溶解し、ジイソパノールアミン0.5
重量部を添加しゲル剤を得た。Example 2 15 parts by weight of crotamiton and 0.75 of isothipendyl hydrochloride.
Parts by weight, lidocaine 2 parts by weight, menthol 2 parts by weight, dipotassium glycyrrhizinate 0.5 parts by weight, sodium pyrosulfite 0.15 parts by weight, EDTA-2Na 0.1 parts by weight, BHT 0.05 parts by weight, polyethylene glycol-
300 10 parts by weight, carboxyvinyl polymer 0.5
Parts by weight, 45 parts by weight of ethyl alcohol and purified water 18.
Dissolve 45 parts by weight with stirring and add 0.5 parts of diisopropanolamine.
A part by weight was added to obtain a gel agent.
【0013】実施例3 クロタミトン10重量部、硝酸ミコナゾール1重量部、
リドカイン2重量部、グリチルリチン酸ジカリウム0.
5重量部、エチルセルロース0.2重量部、ピロ亜硫酸
ナトリウム0.15重量部、EDTA−2Na0.1重
量部、BHT0.05重量部、エチルアルコール83重
量部及び精製水3重量部を攪拌溶解し、チンキ剤を得
た。Example 3 10 parts by weight of crotamiton, 1 part by weight of miconazole nitrate,
2 parts by weight of lidocaine, dipotassium glycyrrhizinate 0.
5 parts by weight, 0.2 parts by weight of ethyl cellulose, 0.15 parts by weight of sodium pyrosulfite, 0.1 parts by weight of EDTA-2Na, 0.05 parts by weight of BHT, 83 parts by weight of ethyl alcohol and 3 parts by weight of purified water were dissolved with stirring. I got a tincture.
【0014】[0014]
───────────────────────────────────────────────────── フロントページの続き (51)Int.Cl.6 識別記号 庁内整理番号 FI 技術表示箇所 A61K 47/10 J 47/18 J (72)発明者 田中 重男 東京都豊島区高田3丁目24番1号 大正製 薬株式会社内 (72)発明者 漆崎 文男 東京都豊島区高田3丁目24番1号 大正製 薬株式会社内─────────────────────────────────────────────────── ─── Continuation of the front page (51) Int.Cl. 6 Identification number Reference number within the agency FI technical display location A61K 47/10 J 47/18 J (72) Inventor Shigeo Tanaka 3-24 Takada, Toshima-ku, Tokyo No. 1 Taisho Pharmaceutical Co., Ltd. (72) Inventor Fumio Urushizaki 3-24-1, Takada, Toshima-ku, Tokyo Taisho Pharmaceutical Co., Ltd.
Claims (1)
エデト酸ナトリウム及びジブチルヒドロキシトルエンを
配合した外用剤。1. Crotamiton, sodium pyrosulfite,
An external preparation containing sodium edetate and dibutylhydroxytoluene.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP26928093A JP3608209B2 (en) | 1993-10-27 | 1993-10-27 | Crotamiton combination external preparation |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP26928093A JP3608209B2 (en) | 1993-10-27 | 1993-10-27 | Crotamiton combination external preparation |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH07126158A true JPH07126158A (en) | 1995-05-16 |
JP3608209B2 JP3608209B2 (en) | 2005-01-05 |
Family
ID=17470161
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP26928093A Expired - Lifetime JP3608209B2 (en) | 1993-10-27 | 1993-10-27 | Crotamiton combination external preparation |
Country Status (1)
Country | Link |
---|---|
JP (1) | JP3608209B2 (en) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2001064165A (en) * | 1999-08-27 | 2001-03-13 | Eisai Co Ltd | Skin liquid preparation for external use containing crotamiton |
JP2003321347A (en) * | 2002-05-07 | 2003-11-11 | Rohto Pharmaceut Co Ltd | Gel ointment |
JP2005239683A (en) * | 2004-02-27 | 2005-09-08 | Taisho Pharmaceut Co Ltd | Ophthalmic agent |
WO2008038807A1 (en) * | 2006-09-29 | 2008-04-03 | Kobayashi Pharmaceutical Co., Ltd. | External composition for skin |
WO2008038806A1 (en) * | 2006-09-29 | 2008-04-03 | Kobayashi Pharmaceutical Co., Ltd. | Antipruritic agent |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090175810A1 (en) | 2008-01-03 | 2009-07-09 | Gareth Winckle | Compositions and methods for treating diseases of the nail |
US8039494B1 (en) | 2010-07-08 | 2011-10-18 | Dow Pharmaceutical Sciences, Inc. | Compositions and methods for treating diseases of the nail |
EP3052487B1 (en) | 2013-10-03 | 2018-09-05 | Dow Pharmaceutical Sciences, Inc. | Stabilized efinaconazole compositions |
KR102612453B1 (en) | 2013-11-22 | 2023-12-08 | 다우 파마슈티컬 사이언시즈, 인코포레이티드 | Anti-infective methods, compositions, and devices |
-
1993
- 1993-10-27 JP JP26928093A patent/JP3608209B2/en not_active Expired - Lifetime
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2001064165A (en) * | 1999-08-27 | 2001-03-13 | Eisai Co Ltd | Skin liquid preparation for external use containing crotamiton |
JP4521899B2 (en) * | 1999-08-27 | 2010-08-11 | エーザイ・アール・アンド・ディー・マネジメント株式会社 | Clotamiton-containing skin external solution |
JP2003321347A (en) * | 2002-05-07 | 2003-11-11 | Rohto Pharmaceut Co Ltd | Gel ointment |
JP4549006B2 (en) * | 2002-05-07 | 2010-09-22 | ロート製薬株式会社 | Gel ointment |
JP2005239683A (en) * | 2004-02-27 | 2005-09-08 | Taisho Pharmaceut Co Ltd | Ophthalmic agent |
WO2008038807A1 (en) * | 2006-09-29 | 2008-04-03 | Kobayashi Pharmaceutical Co., Ltd. | External composition for skin |
WO2008038806A1 (en) * | 2006-09-29 | 2008-04-03 | Kobayashi Pharmaceutical Co., Ltd. | Antipruritic agent |
JP2008088094A (en) * | 2006-09-29 | 2008-04-17 | Kobayashi Pharmaceut Co Ltd | Antipruritic agent |
JP2008088100A (en) * | 2006-09-29 | 2008-04-17 | Kobayashi Pharmaceut Co Ltd | Skin care composition |
Also Published As
Publication number | Publication date |
---|---|
JP3608209B2 (en) | 2005-01-05 |
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