KR20050078679A - 록소프로펜 이나 록소프로펜 나트륨염을 함유한 진통제의카타플라스마제 조성물 및 그 제조방법 - Google Patents
록소프로펜 이나 록소프로펜 나트륨염을 함유한 진통제의카타플라스마제 조성물 및 그 제조방법 Download PDFInfo
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- KR20050078679A KR20050078679A KR1020040006405A KR20040006405A KR20050078679A KR 20050078679 A KR20050078679 A KR 20050078679A KR 1020040006405 A KR1020040006405 A KR 1020040006405A KR 20040006405 A KR20040006405 A KR 20040006405A KR 20050078679 A KR20050078679 A KR 20050078679A
- Authority
- KR
- South Korea
- Prior art keywords
- acid
- roxofene
- cataplasma
- sodium
- salt
- Prior art date
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- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A—HUMAN NECESSITIES
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Abstract
Description
Claims (15)
- 록소프로펜 및 록소프로펜 나트륨 염을 유효성분으로 함유하는 습포제(cataplasm).
- 제 1항에 있어서,록소프로펜염 습포제(카타플라스마) 총량에 대한 배합비율은 1 내지 25 중량%, 바람직하게는 1.5 내지 20 중량%, 더욱 바람직하게는 2 내지 15 중량%인 것을 특징으로 하는 록소프로펜염 함유 습포제(카타플라스마).
- 제 1항에 있어서,수용성 고분자, 보습제, 수분, 흡수촉진제, 부형제, 자극완화제, 약효보조제 및 pH 조정제로 구성되는 군에서 하나 이상 선택되는 것이 더 함유되는 것을 특징으로 하는 함유 습포제(카타플라스마).
- 제 3항에 있어서,수용성 고분자는 젤라틴(gelatin)·히알루론산(hyaluronic acid) 또는 그의 염, 콜라겐(collagen), 잔사 고무, 아카시아 고무, 구어 고무, 카라기산, 아르긴산(alginic acid), 아르긴산나트륨(sodium alginate), 한천(agar), 아라비아 고무, 토라간 고무, 카라야 고무, 펙틴(pectin) 및 녹말 중에서 선택되는 천연 고분자; 메틸셀룰로스(methyl cellulose), 에틸셀룰로스(ethyl cellulose), 히드록시에틸셀룰로스(hydroxy ethyl cellulose), 카르복시메틸셀룰로스나트륨(sodium carboxy methyl cellulose), 가용성 녹말(soluble starch), 카르복시메틸녹말 (carboxylmethyl starch) 및 디알데히드 녹말(dialdehyde starch) 중에서 선택되는 반합성 고분자; 또는 폴리비닐알코올(polyvinyl alcohol), 폴리비닐피롤리돈 (polyvinyl pyrollidone), 폴리비닐아크릴레이트(polyacrylate), 폴리아크릴산 (polyacrylic acid), 폴리아크릴산나트륨(sodium polyacrylate), 폴리아크릴산 공중합체(polyacrylic acid copolymer, 카르복시비닐폴리 등), 폴리에틸렌 옥사이드(polyethylene oxide), 메틸비닐에테르-무수말레산 공중합체(methyl vinylether-anhydrousmaleic acid copolymer) 및 이소부틸렌-무수말레인산 공중합체(iosbutylene-anhydrousmaleic acid copolymer),메타아크릴산-아크릴산부틸 공중합체, 이소부틸렌-무수말레인산 공중합체 중에서 선택되는 합성 고분자인 것을 특징으로 하는 디클로페낙염 함유 습포제(카타플라스마).
- 제 4항에 있어서,수용성 고분자는 습포제(카타플라스마)의 총량에 대해서 1 내지 50 중량%인 것을 특징으로 하는 록소프로펜염 함유 습포제(카타플라스마).
- 제 3항에 있어서,보습제는 글리세린(glycerine), 프로필렌 글리콜(propylene glycol), 소르비톨(sorbitol), 에틸렌글리콜(ethylene glycol), 디에틸렌글리콜(diethylene glycol), 폴리에틸렌글리콜(polyethylene glycol), 폴리프로필렌글리콜 (polypropylene glycol) 및 1,3-부틸렌글리콜(1,3-butylene glycol)이 단독 또는 2종 이상 혼합된 것을 특징으로 하는 록소프로펜 염 함유 습포제(카타플라스마).
- 제 6항에 있어서,보습제는 습포제(카타플라스마)의 총량에 대해서 3 내지 60 중량%인 것을 특징으로 하는 록소프로펜염 함유 습포제(카타플라스마).
- 제 3항에 있어서,수분(정제수)은 습포제(카타플라스마)의 총량에 대해서 10 내지 80 중량%인 것을 특징으로 하는 록소프로펜염 함유 습포제(카타플라스마).
- 제 3항에 있어서,부형제는 고령토, 황토, 숯, 산화아연, 티탄, 활석, 벤토나이트 및 함수규산 알루미늄으로 이루어진 충진제 그룹으로부터 선택되거나; 치몰(thimol), 메틸파라벤(methylparabene), 염화벤자르코늄(benzalkonium chloride) 및 에틸파라벤(ethylparabene)으로 이루어진 방부제 그룹으로부터 선택되거나; 아스코르빈산(ascorbic acid), 스테아르산에스테르, 에테르산2나트륨,피로아황산나트륨, 디부틸히드록시 톨루엔(dibutylhydroxy toluene), 부틸히드록시아리솔 (butylhydroxy arisol) 및 몰식자산에스테르으로 이루어진 항산화제 그룹으로부터 선택되거나; 소르비탄지방산에스테르, 글리세린지방산에스테르, 폴리에틸렌글리콜지방산에스테르, 폴리옥시에틸렌소르비탄 지방산 에스테르 및 폴리옥시에텔린알킬에테르로 이루어진 유화제 그룹으로부터 선택되거나; 살리실산페닐, 살리실산글리콜, 파라아미노벤조산메틸, 2-히드록시-4-메톡시벤조페놀, 2.2'-디히드록시-4.4'-디메톡시벤조페논 및 2-히드록시-4-메톡시벤조페놀-5-술폰산으로 이루어진 자외선 흡수제 그룹으로부터 선택되거나; 염화칼슘·탄산칼슘·염화마그네슘 등의 알카리토류금속, 칼리명반·암모니아명반·,다가금속염, 예를들면·수산화알루미늄,황산알루미늄,아세트산알루미늄,규산알루미늄 등의 알루미늄 화합물, 수산화마그네슘, 황산마그네슘, 초산마그네슘 등과 같은 마그네슘 화합물, 수산화칼슘, 탄산칼슘, 염화칼슘, 글루콘산칼슘, 칼슘 락테이트, 판토텐산칼슘 등의 칼슘화합물, 알루미늄 마그네슘 규소화합물, 황산알루미늄 칼륨 또는 기타 칼슘, 마그네슘, 알루미늄과 같은 중금속을 함유하는 제산제, 포르말린·글리옥사졸·글루타르알데히드 디알레히드녹말의 알데하이드류, 에폭시화합물, 이소시아네이트화합물로 이루어진 가교제 또는 중합제 그룹으로부터 선택되거나; 또는 폴리부텐, 천연라텍스, 아세트산비닐 에멀젼 및 폴리아크릴산 에스테르 에멀젼으로 이루어진 점착부여제 그룹으로부터 선택되거나, 상기 그룹들로부터 2종 이상 혼합되는 것을 특징으로 하는 록소프로펜염 함유 습포제(카타플라스마).
- 제 3항에 있어서,pH 조정제는 습포제의 pH가 4 내지 8로 유지되도록 하며, 시트르산(citric acid)·주석산·아세트산(acetic acid)·말산(malic acid)·숙신산(succinic acid)·타르타르산(tartaric acid)의 유기산, 트리에탄올아민(triethanol amine)·디이소프로판올아민(diisopropanol amine) 또는 디에탄올아민(diethanol amine)의 수용성 유기아민류가 단독 또는 2종 이상 혼합된 것을 특징으로 하는 록소프로펜염 함유 습포제(카타플라스마).
- 제 3항에 있어서,흡수촉진제는 디이소프로필아디페이트(diisopropyladipate), 폴리에틸렌글리콜(polyethlene glycol), 레시틴(recitin), 디메틸술폭시드(dimethylsulfoxide), 미리스트산이소프로필, 스쿠왈렌, 말기름, 크로타미톤, n-옥틸-β-D-글루코시드(OG), n-옥틸-β-D-티오글루코시드(OTG), 에이존, 1-[2-(데실티오)에틸] 아자시클로펜탄-2-온(HPE-|0|로 약칭함), 1-멘톤, 1-멘톨(mentol), 박하유, 유칼리유, 1-리모넨, d-리모넨, d1-리모넨 또는 기타의 정유, 혹은 계면활성제, 예를 들면, 글리세린지방산에스테르, 소르비탄지방산에스테르, 프로필렌글리콜지방산에스테르,프로필렌글리콜 모노라우릴에테르. 모노올레산폴리옥시에틸렌 (20EO)소르비탄(상품명 : 폴리소르베이트 80), 폴리옥시에틸렌(POE로 약칭함), 경화피마자유, POE소르비탄모노라우레이트, POE노닐페닐에테르, POE라우릴에테르, POE(40)스테아레이트, POE(20)모노스테아레이트, 라우르산 디에탄올아미드, 라우릴황산나트륨, 라우로마크로골 또는 모노스테아르산폴리에틸렌글리콜,글리세릴 모노올리에이트. 글리세릴 모노라우릴에테르' 소비탄 모노올리에이트, 글리세릴 트리올리에이트, 아이소프로필미리스테이트, 이 단독 또는 2종 이상 혼합된 것을 특징으로 하는 록소프로펜염 함유 습포제(카타플라스마).
- 제 11항에 있어서,흡수촉진제는 습포제(카타플라스마)의 총량에 대해서0.01 내지 10 중량%, 바람직하게는 0.1 내지 7 중량%, 더욱 바람직하게는 0.3 내지 5 중량% 인 것을 특징으로 하는 록소프로펜염 함유 습포제(카타플라스마).
- 제 3항에 있어서,자극완화제는 염산디펜히드라민, 타닌산디펜히드라민, d1-말레산클로로페닐아민, d-말레산클로로페닐아민, 말레산클로로페닐아민 등의 항히스타민제; 안렉사녹스, 이브시라스트, 아젤라스틴, 옥사토미드, 크로모글리크산나트륨, 타자노라스트, 테르페나딘, 토라니라스트, 푸마르산케토티펜, 레피리나스토 등의 항알레르기제, 또는 스테로이드제; 기타 글리틸리틴산, 글리틸레틴산, α, β, γ의 시클로덱스트린 또는 시클로덱스트린으로부터 유도되는 화합물이 단독 또는 2종 이상 혼합된 것을 특징으로 하는 록소프로펜염 함유 습포제(카타플라스마).
- 제 3항에 있어서,약효보조제(NSAID ; Non-steroidal Anti-inflammatory Drug)는 1-멘톨 (mentol), 캄파(camphor), 유칼리유, 고추엑스, 캅사이신, 비타민 E, 플라토닌, 로트엑스, 황백나무분말, 서양칠엽수엑스, 베라돈나엑스, 노닐산와닐아미드, 테레빈유 또는 니코틴산벤질이 단독 또는 2종 이상 혼합된 것을 특징으로 하는 록소프로펜염 함유 습포제(카타플라스마).
- ⅰ) 록소프로펜과 록소프로펜 나트륨염을 각각 필요에 따라서 흡수촉진제,계면활성제 및 물(정제수)에 혼합하여 균일하게 제조하는 단계 ;ⅱ) 수용성 고분자를 물(정제수)과 보습제로 용해 및 혼합분산한 후 필요에 따라 부형제 및 기타의 첨가제를 첨가하여 균일한 연합물로 제조하는 단계 ;ⅲ) 단계 ⅰ)의 혼합물에 단계 ⅱ)의 혼합물을 첨가하여 균일한 연합물을 제조하는 단계 ; 및ⅳ) 상기 연합물을 통상의 방법으로 기재층 위에 얇게 바른 후 그 위에 박리피복물을 붙이는 단계로 구성되는 것을 특징으로 하는 록소프로펜염 함유 습포제(카타플라스마)의 제조방법.
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