KR20070060950A - 경피·경점막 흡수 제제 - Google Patents
경피·경점막 흡수 제제 Download PDFInfo
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- KR20070060950A KR20070060950A KR1020057017497A KR20057017497A KR20070060950A KR 20070060950 A KR20070060950 A KR 20070060950A KR 1020057017497 A KR1020057017497 A KR 1020057017497A KR 20057017497 A KR20057017497 A KR 20057017497A KR 20070060950 A KR20070060950 A KR 20070060950A
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- South Korea
- Prior art keywords
- hydrochloride
- agents
- transmucosal
- agent
- acid
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- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
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Abstract
경피, 경점막 흡수제제는 충분한 흡수량을 얻을 수 없는 경우가 많고, 각종 약제의 경피, 경점막 흡수를 증진하는 첨가제의 개발이 요구되고 있다. 소요 성분과 히드록시 아파타이트를 배합함으로써 경피, 경점막 흡수를 촉진하는 조성물을 제공한다, 히드록시 아파타이트의 최대 입경이 1㎛ 이하, 바람직하게는 0.1㎛ 이하이며, 히드록시 아파타이트의 배합량이, 배합하는 약물에 대해 0.1~1000중량%이다.
Description
본 발명은 피부나 점막에 적용하여 소요 성분의 경피, 경점막 흡수성이 증진된 경피, 경점막 흡수 제제에 관한 것이다.
약물을 체내 순환계로 투여하는 제형으로, 경구제, 주사제 등의 형태의 투여가 주로 이용되어 왔지만, 최근 경피, 경점막 흡수에 의한 피부나, 구강, 콧구멍, 직장, 질, 눈 등의 점막에 적용하는 경피, 경점막 흡수 제제가 소화관 환경의 영향이나 간장에서의 대사의 영향에 의한 약효의 감퇴가 일어나기 어렵고, 주사와 같은 아픔이 없으며, 약물의 혈중농도를 장시간 일정 레벨 이상으로 유지하기 쉽고, 필요에 따라 약물의 투여를 간단히 중단할 수 있는 등 이점 및 간편성 때문에 많은 약제에 이용되고 있다.
그러나, 일반적으로 약물을 경피적, 경점막적으로 투여하는 경우, 이물질의 체내에의 침입을 막는 배리어(barrier) 기능을 가진 피부의 각질층이나 점막에서의 약물의 흡수 효율이 나쁘고, 약효를 얻기 위해 충분한 분량의 약물을 투여하는 것은 반드시 쉽지 않다.
그 때문에, 제라닐 아세테이트를 배합하여 표피 세포층의 배리어 기능을 저감시킴으로써 약물의 흡수량을 향상시키는 것 (특개평 5-178762호 공보), 덱스트란 을 사용한 점막 흡수성의 약물담체 (특개평 5-238956호 공보), 점착제, 점착 부여 수지, 약물, 경피흡수 촉진제 및 경피흡수 촉진제 방출 촉진제로 이루어지는 점착제층을 적층한 경피흡수 첨부제 (특개평 7-101864호 공보), 모노올레인산 글리세린을 10∼20중량%, 에탄올을 30∼60중량%, 물을 30∼60중량% 함유한 약리 활성 물질의 경피흡수를 촉진한 외용제(특허 제3471840호 명세서), 경피/경점막 흡수를 개선하는 것을 목적으로 하는 마이크로 에멀젼 제제(특개평 7-2689호 공보), 글리세릴 변성 실리콘을 배합한 경피흡수 촉진제(특허 제3417744호 명세서), 난흡수성 물질에알기닌, 그 중합체 또는 그 중합체의 염을 첨가한 경점막 흡수제제용 조성물(특개평 10-95738호 공보), 스크랩을 배합함으로써 약물의 경피, 경점막 흡수성을 증진한 외용제(특개평 11-80031호 공보), 4∼l5μm의 세라믹스를 외용첨부제에 배합함으로써 약제의 경피흡수가 촉진된다(임상약리 23(1) Mar 1992). 그 밖에 용해도 파리미터가 특정 범위 내에 있는 유제를 유효성분으로 한 경피흡수 촉진제, 차조기과 식물 (labiate plant)의 추출물로 이루어지는 경피흡수 촉진제, 다가 알코올 지방산 에스테르류 및 알킬황산 에스테르류를 유효성분으로 한 경피흡수 촉진제, 중쇄 지방산염류와 글리시레틴산염류를 배합한 경점막용 흡수 촉진제, 알기닌, 알기닌의 중합체, 알기닌의 염 등을 사용한 경점막 흡수 조제, 프로필렌 글리콜, 폴리올 지방산 에스테르, 라우로마크로골을 함유한 경피흡수 촉진 조성물, 약제 농도를 높게 하는 등, 여러 가지 경피, 경점막 흡수 촉진 방법, 조성물이 개시되어 있다. 또한 히드록시 아파타이트를 사용한 혈관 투여제로 인산칼슘 미결정체에 약제를 첨가하고, 혈관 내에 투여함으로써 약제의 효과를 촉진 또는 지연시키거나, 암 세포 등의 각종 세포, 에이즈, ATL, 간염 바이러스 등의 바이러스 등에 선택적으로 흡착시키고, 분화, 증식을 콘트롤 하며, 동시에 약제를 작용시키는 방법 (특개평 5-255095호 공보)이 개시되어 있다.
그러나, 경피나, 경점막 흡수제에 있어서는, 충분한 흡수량을 얻을 수 없는 경우가 많고, 다양한 약제의 경피, 경점막 흡수를 증진하는 첨가제의 개발이 요구되고 있다.
특허문헌 1 : 특개평 5-178762호 공보
특허문헌 2 : 특개평 5-238956호 공보
특허문헌 3 : 특개평 7-101864호 공보
특허문헌 4 : 특허 제3471840호 명세서
특허문헌 5 : 특개평 7-2689호 공보
특허문헌 6 : 특허 제3417744호 명세서
특허문헌 7 : 특개평 10-95738호 공보
특허문헌 8 : 특개평l1-80031호 공보
특허문헌 9 : 특개평5-255095호 공보
비특허문헌 1 : 「임상 약리」23(1), Mar 1992
본 발명은 피부나 점막에 적용하여, 소요 성분이 우수한 경피, 경점막 흡수 증진효과를 가진 경피, 경점막 흡수 제제의 제공을 목적으로 한 것이다.
본 발명은 상기 목적을 달성하기 위하여 검토를 거듭한 결과, 소요 성분과 히드록시 아파타이트를 함유시키고, 경피, 경점막 흡수 조성물을 피부나 점막에 적용함으로써 소요 성분의 경피, 경점막 흡수성을 촉진시킬 수 있는 것을 찾아내고, 본 발명을 완성하기에 이르렀다.
본원에 이용하는 히드록시 아파타이트는, 통상, Ca10(PO4)6(OH)2 인 화학양론 조성으로 표시되는데, Ca/P 몰비가 1.67이 되지 않는 비화학양론 대상인 경우라도, 히드록시 아파타이트의 성질을 나타내고, 아파타이트 구조를 취할 수 있다는 특징이 있다.
본 발명에 있어서는, 화학양론 조성 및 비화학양론 조성의 히드록시 아파타이트는 어느 것이든 사용할 수 있고, Ca/P 몰비 1.4∼1.8의 것을 사용할 수 있다. 히드록시 아파타이트의 Ca/P 몰비의 제어는, 원료의 염의 조합비 및 합성 조건의 제어로 수행한다. 예를 들어, 히드록시 아파타이트의 습식합성법에 있어서, 합성시에 암모니아수 등으로 수용액을 염기성으로 조정하면, Ca/P 몰비가 높아지고, 수용액을 희석된 산으로 중성 또는 약산성으로 조정하면 Ca/P 몰비를 낮게 할 수 있다.
본 발명에서 사용하는 상기 히드록시 아파타이트로는, 결정성 및 저결정성은 어느 것이든 사용할 수 있지만, 저결정성 또는 비정질인 것이 바람직하다.
본 발명에 말하는 「저결정성」이란, X선 회절 피크가 고결정성의 분체에 비해 넓은 (broad)한 결정질 분체임을 말한다.
「비정질」이란, X선 회절 패턴이 폭넓은 할로우를 나타내고, 결정 특징을 나타내는 회절 패턴을 얻을 수 없는 아주 작은 입자로 이루어지는 분체를 말한다.이하, 저결정성의 히드록시 아파타이트, 비정질의 히드록시 아파타이트를 각각 「저결정성 아파타이트」 및 「비정질 아파타이트」라고 한다.
본 발명에서 사용하는 저결정성 아파타이트 또는 비정질 아파타이트로는, 예를 들어, 상기한 것처럼 습식법에 의해 합성한 아파타이트를 동결 건조 혹은 100℃ 이하의 온도로 건조한 것, 또는 300℃ 정도 이하의 온도로 소성한 것을 사용한다.저결정성 아파타이트 또는 비정질 아파타이트는 결정성이 높은 히드록시 아파타이트 (이하,「결정질 아파타이트」라고 함)와 비교하여 입경이 작은 입자로 이루어진다.
본 발명에서 사용하는 히드록시 아파타이트 입자로는, 최대 입경이 1.0μm이하의 것이 바람직하고, 최대 입경 0.1μm 이하인 것이 더욱 바람직하며, 최대 입경 0.05μm 이하인 것이 더더욱 바람직하다.
평균 입경으로는, 바람직하게는 0.6μm 이하, 더욱 바람직하게는 0.07μm 이하, 더더욱 바람직하게는 0.04μm 이하이다.
평균 입경이 작을수록 비표면적이 커져서 약제를 흡착하는 성질이 높아지므로, 입자의 평균 입경의 하한은 특별히 한정되지 않지만, 예를 들어, 평균 입경의 하한값은 O.Olμm 정도인 것이 바람직하다.
히드록시 아파타이트 입자를, 바람직하게는 최대 입경 1.Oμm 이하, 더욱 바람직하게는 최대 입경 0.1μm 이하, 더더욱 바람직하게는 0.05μm 이하로 조정하는 방법은, 분쇄에 의해 수행하는 것이 가능하다. 이 때, 히드록시 아파타이트를 최대 입경 1.Oμm 이하, 바람직하게는 최대 입경 0.1μm 이하, 더욱 바람직하게는 0.05μm 이하로 분쇄한 후에, 소요 성분 및 경피, 경점막 흡수제에 사용하는 기타 성분, 기제와 혼합하여 사용하는 것이 가능하지만, 분쇄한 히드록시 아파타이트에 미리 소요 성분을 담지시킨 후, 경피, 경점막 흡수제에 사용하는 기타 성분, 기제와의 혼합을 수행하는 것이, 경피, 경점막 흡수 효과 면에서 더 바람직하다.
경피, 경점막 흡수제에 사용하는 히드록시 아파타이트의 배합량은, 소요 성분에 따라 다르기 때문에, 일률적으로 결정하는 것은 어렵지만, 소요 성분에 대해 O.1∼1000중량%가 바람직하고, 더 충분한 경피, 경점막 흡수 효과를 얻기 위해, 1∼500중량%가, 나아가 10%∼200중량%가 적당하다.
본 발명의 히드록시 아파타이트를 포함하는 제제를 사용하면, 각종 경피, 경점막 흡수시키는 성분을 가지는 경피, 경점막 흡수 제제에 대해, 이들 성분의 경피 혹은 경점막에의 투과성을 현격하게 향상시킬 수 있다.
이와 같은 본 발명에 사용되는 경피, 경점막 흡수시키는 성분으로는, 각종 약제, 미용 성분 중 경피, 경점막 흡수에 이용하는 것이면 어느 것이든 적용 가능하며, 특별히 한정은 없다.
구체적으로는, 예를 들어 해열 소염 진통제, 통풍, 고요산혈증 치료제, 비스테로이드계 항염증제, 스테로이드계 항염증제, 창상 치유제, 제암제, 최면·진통제, 항불안제, 항정신병제, 항울제, 항조제, 항비스타민제, 항간질제, 국소 마취제, 말초순환장해 치료약, 항파킨슨병제, 근이완제, 자율신경 작용제·진증제, 항발한제, 뇌순환·대사 개선제, 강심제, 항협심증제, β차단약, Ca 길항약, 항부정맥제, 강압제, 혈관 확장제, 충혈제거제, 혈관 보강제, 고지혈증 치료제, 승압제, 호흡 촉진제, 기관지 확장제·천식 치료제, 진해제, 거담제, 소화성궤양 치료제, 연하제, 제토제, 지리·정장제, 위건·소화약, 하제, 치질 치료약, 신경인성 방광치료약, 전립선 비대·빈뇨 치료약, 신장결석·요로결석 치료약, 이뇨약, 이담제, 당뇨병용제, 하수체 호르몬제, 부신피질 호르몬제, 성호르몬제, 프로스타글란딘류, 갑상선 기능이상 치료제, 골다공증·골대사 개선제, 아미노산류, 비타민제, 지혈제, 항혈전제, 항생물질, 설파제, 항진균제, 항바이러스제, 항HIV제, 기생충·원충용제, 항류마티스제, 면역 억제제, 썬스크린제, 항알레르기제, 안과용제, 건선치료제, 피부 연화제·피부 완화제, 보습 성분, 양모·발모제, 펩티드 호르몬제, 금연 보조제, 다이어트 성분, 미백 성분, 노화 방지 성분, 다당류, 식물 추출물·정유류, 효소류, 백신 등을 들 수 있는데, 이들에 한정되는 것이 아니라, 이들은 단독으로 또는 2종 이상 혼합하여 사용할 수 있다.
본 발명의 다른 태양은 경피·경점막 흡수 제제의 제조를 위한 경피·경점막 흡수시키는 성분 및 히드록시 아파타이트의 사용이다. 상기 히드록시 아파타이트로서 바람직하게는 상기 입경의 히드록시 아파타이트를 사용할 수 있다.
또한 본 발명에 관계되는 질환의 예방 또는 치료 방법은, 상기 경피·경점막 흡수시키는 성분 및 히드록시 아파타이트를 함유하는 경피·경점막 흡수 제제를 유효량 투여하는 것을 특징으로 한다. 또한 본 발명에 관한 미용, 건강 증진 방법은 상기 경피·경점막 흡수 제제를 유효량 투여하는 것을 특징으로 한다.
이하, 본 발명에 사용할 수 있는 「경피·경점막 흡수시키는 성분」을 더 상세히 설명하는데, 이들에 한정되는 것은 아니다. 본 발명의 예방 방법, 치료 방법, 혹은, 미용 또는 건강 증진 방법에 있어서 대상이 되는 질환은, 이러한 성분에 대응하는 질환이다.
[해열소염 진통제]
아스피린, 아세트아미노펜, 이부프로펜, 인도메타신, 케토프로펜, 디클로페낙 나트륨, 디플루니살, 피록시캄, 페나세틴, 페노프로펜 칼슘, 펠비낙, 플루루비프로펜, 말레인산 클로로페닐아민, 살리실산, 살리실산 메틸 등.
[통풍·고요산혈증 치료제]
콜히친, 벤즈브로마론, 프로베네시드, 설핀피라존, 알로프리놀 등.
[비스테로이드계 항염증제]
아스피린, 아세트아미노펜, 이부프로펜, 인도메타신, 에토돌락, 살리실산, 살리실산 글리콜, 디클로페낙 나트륨, 디플루니살, 수프로펜, 술린닥, 케토프로펜, 톨메틴 나트륨, 플루르비프로펜, 페노프로펜, 페노프로펜 칼슘, 잘토프로펜, 피록시캄, 아미노피린, 안티피린, 술피린, 옥시펜부타존, 나프록센, 에토페나메이트, 살리실아미드, 술린닥, 트리에탄올아민 살리실산, 메페남산, 플루페남산, 메클로페남산, 콜히친, 부펙사막, 펠비낙, 록소프로펜, 펜부펜, 디플루니살, 알클로페낙, 페닐부타존, 벤다작, 등.
[스테로이드계 항염증제]
암시노니드, 길초산 프레드니솔론, 길초산 디플루코톨론, 길초산 베타메타손, 초산 베타메타손, 초산 덱사메타손, 디프로피온산 베타메타손, 덱사메타손, 피발산 플루메타손, 프로피온산 베클로메타손, 베타메타손, 트리암시놀론 아세토니드, 할시노니드, 플루오시노니드, 플루오시롤론 아세토니드, 플루오로메톨론, 플루드록시코티드, 프레드니솔론, 메틸프레드니솔론, 메틸프레드니솔론 아세테이트, 히드로코티손, 히드로코티손 부틸레이트, 프로피온산 클로베타졸 등.
[창상 치유제]
알란토인 및 그 유도체, 글리시리진산 및 그 유도체, 글리시레틴산 및 그 유도체, ε-아미노카프론산, 감초 (Glycyrrhiza Radix), 자근 (Lithospermum Radix), 아줄렌, 아줄렌술폰산 나트륨, 염화 베르베린, 황산 베르베린, 염화 리소자임, 히노키티올, 알로에 등.
[제암제]
시클로포스파미드, 5-플루오르우라실, 염산 이다루비신, 염산 에피루비신, 염산 블레오마이신, 염산 다우노루비신, 염산 독소루비신, 염산 피라루비신, 엑티노마이신 C, 아드리아마이신, 마이토마이신 C, 게피티니브, 인터페론 β, 피시바닐, 6-메루캅토푸린, 에토포시드, 시스플라틴, 카르보플라틴, 네다플라틴, 옥잘리플라틴, 카르보콘, 지노스타틴·스티말라머, 독소루비신, 님스틴 하이드로클로라이드, 네오칼치노스타틴, 파클리탁셀, 밀파란, 트레티노인, 인산 에스트라무스틴 나트륨, 다우노루비신, 히드록시카르바미드, 테가푸르, 메르캅토푸린, L―아스파라기나아제, 메토트렉세이트, 소부족산, 부술판, 구연산타목시펜, 플루타미드, UFT, 황산 페플로마이신, 황산 빈블라스틴, 빈크리스틴, 황산 빈크리스틴, 시타라빈 옥포스페이트, 옥시플루리딘, 크로모마이신 A, 아세글라톤, 아나스트로졸, 우베니멕스, 염산 파드로졸 수화물, 염산 프로카르바진, 구연산 토레미펜, 비칼루타미드, 메실산 이마티닙 등.
[최면·진통제]
브롬바레릴 요소, 알릴 이소프로필아세틸 요소, 에스타조람, 트리아조람, 미다조람, 플루니트라제팜, 니메타제팜, 니트라제팜, 플루라제팜, 하록사조람, 쿠아제팜, 조피클론, 졸피뎀, 헥소바르비탈, 펜토바르비탈, 아모바르비탈, 바르비탈, 세미숙신산 부톡타미드, 클로랄 수화물, 브롬바레릴 요소, 트리클로로에틸 나트륨, 펠라핀, 몰핀, 황상 몰핀, 히드로몰핀, 옥시몰핀, 코데인, 디히드로코데인, 날록손, 나롤핀, 펜타조신, 메타돈, 메타돈 염산염, 브로티조람, 하록사조람, 페노바르비탈, 염산 릴마자폰 등.
[항불안제]
브롬바레릴 요소, 아모바르비탈, 디아제팜, 니트라제팜, 플루라제팜, 클로티아제팜, 플루토프라제팜, 로라제팜, 프라제팜, 메다제팜, 브로마제팜, 옥사제팜, 토피소팜, 클로라제프산 디칼륨, 플루디아제팜, 알프라조람, 에티조람, 옥사조람, 클록사조람, 멕사조람, 플루타조람, 히드록시진, 염산 히드록시진, 염산 티오리다진, 염산 클로르디아제폭시드, 파모산 피란텔, 염산 클로로마진, 말레인산 레보메프로마진, 로프라제프산 에틸 등.
[항정신병제]
아목사핀, 염산 아미트립티린, 염산 노르트립티린, 염산 마프로티린, 염산 이미프라민, 클로카프라민, 클로르프로마진, 술피리드, 티오리다진, 티미페론, 트리플루오페라진, 네모나프리드, 할로페리돌, 에난트산 플루페나진, 데칸산 플루페나진, 데칸산 할루페리돌, 조테핀, 리스페리돈, 푸말산 쿠에티아핀, 올란자핀, 말레인산 트리미프라민, 말레인산 레보메프로마진 등.
[항울제]
아목사핀, 염산 아미트립티린, 염산 이미프라민, 염산 클로미프라민, 염산 사프라진, 염산 로페프라민, 염산 도술레핀, 염산 트라조돈, 염산 노르트립티린, 염산 마프로티린, 염산 미안세린, 염산 밀나시프란, 말레인산 트라미프라민, 말레인산 세팁티린, 말레인산 플루복사민 등.
[항조제]
탄산 리튬 등.
[항히스타민제]
디펜히드라민, 염산 디펜히드라민, 탄닌산 디펜히드라민, 라우릴황산 디펜히드라민, 말레인산 크롤페닐아민, 주석산 아리메마진, 염산 트리프로리딘, 염산 메클리진, 프로메타진, 염산 프로메타진, 염산 호모클로르시클리진, 메키타진, 푸말산 클레마스틴, 염산 이프로헵틴, 염산 시프로헵타딘, 테오클산 디페닐피라린, 나파디실산 메브히드롤린, 염산 디페닐피라린, 디멘히드리나트, 염산 이소티펜딜, 말레인산 디메틴덴 등.
[항간질제]
페노바르비탈, 페노바르비탈 나트륨, 메타르비탈, 프리미돈, 히단톨 D, E, F, 카르바마제핀, 발프로산 나트륨, 에소토인, 페니토인, 프리메타디온, 아세틸페네투라이드, 술티암, 클로나제팜, 디아제팜, 니트라제팜, 에톡스시미드, 조니사미드, 아세타졸라미드, ACTH, 비타민 B6 등.
[국소 마취제]
코카인, 아미노안식향산 에틸, 염산 테트라카인, 프로카인, 염산 프로카인, 디부카인, 염산 디부카인, 리도카인, 염산 리도카인, 염산 옥시부프로카인, 염산 부피바카인, T-CAIN, 염산 메피바카인, 염산 프로피토카인, 옥세사제인 등.
[말초순환장해 치료약]
이노시톨 헥사니코티네이트, 헤프로니케이트, 염산 톨라졸린, 염산 이속스푸린 등.
[항파킨슨병제]
레보도파, 드록시도파, 메실산 페르골리드, 메실산 브로모크립틴, 염산 트리헥시페니딜, 염산 타리펙솔, 염산 아만타딘, 염산 비페리덴, 염산 피로헵틴, 염산 프로페나민, 염산 마자티콜, 염산 메틱센, 비페리덴 등.
[근이완제]
디아제팜, 염화 투보쿠라린, 염화 숙사메토늄, 판쿠로늄 브로마이드, 베쿠로늄 브로마이드, 단트로렌 나트륨, 아플로쿠알론, 염산 에페리손, 염산 톨페리손, 카바민산 클로르페네신, 바클로펜, 염산 티자니딘, 메실산 프리디놀, 펜프로바메이트, 메토카바몰 등.
[자율신경 작용제·진경제]
염화 베타네콜, 염화 카프로늄, 염화 아세틸콜린, 네오스티그민, 피리도스티그민 브로마이드, 디스티그민 브로마이드, 염화 암베노늄, 염화 에드로포늄, 취화 프리피늄, 브롬화 글리코피로늄, 황산 아트로핀, 아니소트로핀 메틸브로마이드, 스코폴아민 히드로브로메이트, 부틸 스코폴아민 브로마이드, 메틸황산 N-메틸 스코폴아민, 염산 파파베린, 요오드화 옥사븀, 발레타메이트 브로마이드, 염산 피페리돌레이트, 스코폴리아 추출물, 부트로퓸 브로마이드, 트레피부톤, 에토미돌린, 티메피듐 브로마이드, 티키지움 브로마이드, 에틸피페타네이트 브로마이드, 요오드화 티에모늄, 메틸베낙티지움 브로마이드, 프로판테린 브로마이드, 염산 디시클로민, 프로프로피온, 말레인산 에르고메트린, 토피소팜 등.
[항발한제]
스코폴아민, 프로판테린 브로마이드, 제4급 알록시 메틸 암모늄염 등.
[뇌순환·대사개선제]
시티콜린, 아데노신 3인산 2나트륨, γ―아미노락산, γ―아미노 β―히드록시락산, γ―올리자놀, 호판텐산 칼슘, 이데베논, 염산 메클로페녹세이트, 염산 비페메란, 염산 인데록사진, 말레인산 리수리드, 아니라세탐, 염산 티아프리드, 주석산 이펜프로딜, 염산 파수딜, 니세르고린, 이부딜라스트, 푸말산 부로빈카민, 펜톡시피린, 염산 플루나리진, 염산 목시실레이트, 메실산 디히드로에르고톡신, 오자그렐 나트륨, 푸말산 니조페논 등.
[강심제]
디곡신, 디기톡신, 메틸디곡신, 라나토시드 C, 데스라노시드, 프로스실라리딘, 염산 도파민, 염산 도부타민, 도카르파민, 에피네페린, 노르에피네페린, 염산 이소프레나린, 암리논, 염산 올프리논, 밀리논, 카페리티드, 아미노피린, 디프로피린, 베스나리논, 피모벤단, 크라테구스 추출물, 트랜스 파이 옥소캄파, 우비데카레논, 아미노산 에틸술폰, 카페리티드산 등.
[항협심증제]
니트로글리세린, 아질산 아밀, 질산 이소소르비드, 1질산 이소소르비드, 2질산 이소소르비드, 니페디핀, 염산 니카르디핀, 닐바디핀, 니솔디핀, 니트렌디핀, 염산 마니디핀, 염산 베니디핀, 염산 바르니디핀, 베실산 암로디핀, 염산 에포니디디핀, 페로디핀, 실니디핀, 염산 베라파밀, 염산 딜타아젬, 염산 에타페논, 디피리다몰, 트라피딜, 니코란딜, 염산 트리메타지딘, 염산 디라제프 등.
[β 차단약]
염산 프로프라노롤, 염산 부페터롤, 염산 부프라토롤, 염산 알프레노롤, 염산 인데노롤, 염산 옥스프레노롤, 염산 부니트로롤, 황산 펜부토롤, 말론산 보핀도롤, 핀도롤, 염산 카르테오롤, 주석산 메토푸로롤, 아테노롤, 푸말산 비소부로롤,염산 베탁소롤, 염산 아세부토롤, 염산 세리푸로롤, 염산 라베타롤, 카르베디롤, 염산 베반토롤, 염산 아모수라롤, 염산 아로티노롤, 니프라디롤, 염산 티리소롤 등.
[Ca 길항약]
니페디핀, 염산 니카르디핀, 닐바디핀, 니솔디핀, 니트렌디핀, 염산 마니디핀, 염산 베니디핀, 염산 바르니디핀, 염산 에포니디핀, 페로디핀, 실니디핀, 아라니디핀, 베실산 암로디핀, 염산 베라파밀, 염산 딜티아젬 등.
[항부정맥제]
염산 옥스프레노롤, 황산 키니딘, 염산 프로카인아미드, 디소피라미드, 인산 디소피라미드, 아지마린, 숙신산 디벤조린, 염산 베프리딜, 염산 피르메놀, 염산 프로프라놀롤, 염산 리도카인, 염산 니페카란트, 염산 소타롤, 염산 멕실레틴, 염산 아프린딘, 초산 프레카이니드, 염산 필지카이니드, 염산 프로파페논, 염산 아미오다론, 브레틸륨, 염산 브페토롤, 염산 부프라노롤, 염산 부쿠모롤, 말레인산 티모롤, 나도롤, 핀도롤, 말론산 보핀도롤, 염산 알프레노롤, 염산 인데노롤, 염산 카르테오롤, 황산 펜부토롤, 염산 부니트로롤, 주석산 메토푸로롤, 아세부토롤, 아테노롤, 푸말산 비소프로롤, 염산 베탁소롤, 염산 세리푸로롤, 염산 라베타롤, 염산 아로티노롤, 염산 아모수라롤, 카베디롤, 니프라디롤, 염산 티리소롤, 염산 베반토롤 등.
[강압제]
메틸도파, 초산 구아나벤즈, 레세르핀, 레시나민, 염산 구안파신, 황산 구안파신, 염산 프라조신, 염산 부나조신, 염산 테라조신, 우라피딜, 메실산 독사조신,메실산 디히드로에르고톡신, 프라조신, 아라세프릴, 캅토프릴, 말레인산 에나라프릴, 염산 데라프릴, 시라자프릴, 리시노프릴, 염산 베나제프릴, 염산 이미다프릴,염산 키나프릴, 염산 테모카프릴, 트란도라프릴, 클로니딘, 염산 클로니딘, 구아네티딘, 베타니딘, 황산 구아네티딘, 염산 히드랄라진, 부드랄라진, 염산 토드랄라진, 카드랄라진, 니트로프루시드 나트륨, 브롬화 헥사메토늄, 캄실산 트리메타판, 메티크란, 메틸도파 등.
[혈관 확장제]
에프록세이트, 에타페논, 옥시페드린, 카보크로멘, 이염산 딜라제프, 염산 딜티아젬, 염산 베니디핀, 염산 베라파밀, 니솔디핀, 니트렌디핀, 베실산 암로디핀, 4질산 펜타에리트리톨, 니코란딜, 디피리다몰, 질산 이소소르비드, 트라피딜, 니트로글리세린, 니페디핀, 프레닐아민, 몰시도민, 인산 트롤니트레이트, 이노시톨 헥사니코티네이트, 이속수프린, 나이리드린, 구연산 니카메테이트, 니코틱 알코올, 시크란델레이트, 헤프로니케이트, 염산 트리메타지딘, 신나리진, 부드랄라진, 염산 히드랄라진, 염산 토드랄라진, 카드랄라진, 니트로프루시드 나트륨, 염산 이속수프린, 황산 바메탄 등.
[충혈 제거제]
에피네프린, 염산 에피네프린, 염산 에페드린, 염산 테트라히드로졸린, 염산나파졸린 등.
[혈관 보강제]
루틴 등.
[고지혈증 치료제]
클로피브레이트, 클리노피브레이트, 심피브레이트, 베자피브레이트, 페노피브레이트, 니코몰, 니세리트롤, 니코틴산 토코페롤, 코레스티라민, 프로부콜, 프라바스타틴 나트륨, 심바스타틴, 플루바스타틴 나트륨, 아토바스타틴 칼슘 수화물, 클로피브레이트 알루미늄, 대두유 불감화물 (unsaponifiables), 정제 대두 레시틴, γ―올리자놀, 옥시메토론, 리놀산 에틸, 덱스트란 황산나트륨, 폴리엔포스파티딜코린, 에스타라제, 이코사펜트산 에틸, 코레스티미드, 멜리나미드 등.
[승압제]
염산 도파민, 염산 도부타민, 도카르파민, 데노파민, 염산 페닐에프린, 에피네프린, 노르에피네프린, 염산 노르에피네프린, 염산 에틸레프린, 염산 이소프레나린, 염산 미도드린, 부클라데신 나트륨, 주석산 수소 메타라미놀, 염산 메톡사민, 메틸 황산 아메지늄 등.
[호흡 촉진제]
염산 독자프람, 메드록시프로게스테론, 레바롤판, 염산 날록손, 티오피린, 디프로피린, 염산 디메피린, 염산 이소프레날린, 황산 오르시프레날린, 염산 클로프레날린, 황산 터부탈린, 황산 헥소프레날린, 염산 에페드린, 염산 메틸에페드린, dl-메틸에페드린삭카리네이트, 염산 메톡시페나민, 디몰포아민, 염산 트리메톡시놀, 황산 살부타몰, 푸말산 포르모테롤, 염산 툴로부테롤, 툴로부테롤, 브롬화수소산 페노테롤, 염산 프로카테롤, 염산 클렌부테롤, 염산 마부테롤, 황산 이소프로테롤, 디곡신, 디기톡신, 메틸디곡신, 라나토시드 C, 데슬라노시드, 프로스실라리딘 등.
[기관지 확장제·천식 치료제]
테오피린, 아미노피린, 콜린 테오피린, 디프로피린, 염산 에페드린, 염산 메틸에페드린, dl-메틸에페드린 삭카리네이트, 염산 메톡시페나민, 황산 오르시프레나린, 염산 클로르프레나린, 염산 트리메톡시놀, 황산 살부타몰, 황산 터부타린, 황산 헥소프레나린, 염산 이소프레나린, 푸말산 포르모테롤, 툴로부테롤, 염산 툴로부테롤, 브롬화수소산 페노테롤, 염산 프로카테롤, 염산 클렌부테롤, 염산 마부테롤, 살부타몰, 터부타린, 툴로부테롤, 페노테롤, 프로카테롤, 클렌부테롤, 황산 이소프로테롤, 크로모글리케이트산 나트륨, 트라닐라스트, 페밀로라스트, 푸말산 케토티펜, 아젤라스틴, 프로피온산 베클로메타손, 브롬화 이프라트로퓸, 브롬화 플루트로퓸, 브롬화 옥시트로퓸, 니페디핀, 니트렌디핀, 염산 마니디핀, 염산 베니디핀, 염산 바르니디핀, 베실산 암로디핀, 염산 에포니디핀, 펠로디핀, 실니디핀, 염산 베라파밀, 염산 딜티아젬 등.
[진해제]
노스카핀, 인산 디메모르판, 히벤즈산 티페피딘, 구연산 옥세라딘, 구아이페네신, 브롬화수소산 엑스트로메토르판, 구연산 펜톡시베린, 염산 에프라지논, 염산 포미노벤, 클로페라스틴, 염산 클로페다놀, 인산 벤프로페린, 노스카핀, 앵두나무 껍질 추출물, 차전초 (plantago herb), 행인 (apricot kernel) 등.
[거담제]
염산 L-메틸시스테인, 아세틸시스테인, 염산 브롬헥신, 카르복시스테인, 푸도스테인, 염산 암브록솔, 암모니아·회향주정, 세네가 등.
[소화성 궤양 치료제]
시메티딘, 염산 라니티딘, 파모티딘, 오메프라졸, 오메프라졸 나트륨, 란소프라졸, 라베프라졸 나트륨, 염산 록사티딘 아세테이트, 니자티딘, 라푸티딘, 염산 피렌제핀, 프로글루미드, 세크레틴, 우로가스트론, 산화마그네슘, 침강 탄산칼슘, 건조수산화 알루미늄겔, 메타규산 알루민산 마그네슘, 합성규산 알루미늄, 히드로탈사이트, 수크랄페이트, 아줄렌, 에구알렌 나트륨, 알디옥사, 게파르네이트, 테프레논, 오르노프로스틸, 염산 세트락세이트, 술피리드, 말레인산 이르소글라딘 등.
[연하제]
황산 마그네슘, 유산 나트륨, 구연산 마그네슘, 인공 카루루스염, 카르멜로즈 나트륨, 카스터오일, 비자코딜, 피코술페이트 나트륨, 페노발린, 세나 추출물 (sena extract), 센노시드 등.
[제토제]
클로르프로마진 등.
[지리·정장제]
염산 로페라미드, 차질산 비스무스, 탄닌산 알부민, 염화 베르베린, 황산 베르베린, 탄닌산 베르베린, 천연규산 알루미늄, 티락타아제, β―칼락토시다아제, 브롬화 메펜졸레이트, 폴리카르보필 칼슘, 예덕 나무 (Mallotus japonicus), 살라조술파피리딘, 메살라진, 비피더스균 (Lactobacillus bifidus), 카제이균 (Lactobacillus casei), 낙산균 (Clostridium butyricum), 락토민, 항생제 내성 유산균, 건조 효모, 디메티콘 등.
[위건·소화약]
메토클로프라미드, 돔페리돈, 시사프리드, 염산 이토프리드, 구연산 모사프리드, 말레인산 트리메부틴, 디아스타제, 판크레아틴 등.
[하제]
카르메로즈 나트륨, 카스터 오일, 비자코딜, 피코술페이트 나트륨, 페노발린, 세나 추출물, 센노시드 등.
[치질 치료약]
트리베노시드, 헤모린구알, 메릴롯 추출물, 서카네텐, 페놀 등.
[신경인성 방광 치료약]
염산 옥시부티닌, 염산 프로피베린, 염산 플라복세이트 등.
[전립선 비대·빈뇨 치료약]
옥센돌론, 카프론산 게스토노론, 초산 클로르마디논, 파라프로스트, 에비프로스타트, 알릴에스트레놀, 염산 탐술로신, 나프토피딜, 세르니틴 폴렌 추출물 등.
[신결석·요로결석 치료약]
참가시나무 (Quercus salicina) 추출물 등.
[이뇨약]
트리클로르메티아지드, 히드로클로로티아지드, 벤질히드로클로로티아지드, 인다파미드, 트리파미드, 클로르탈리돈, 메티크란, 메프루시드, 프로세미드, 부메타니드, 에타크린산, 피레타니드, 아조세미드, 토라세미드, 스피로노락톤, 트리암테렌, 칸레노산 칼륨, 아세타졸아미드, 이소소르비드 등.
[이담제]
히메크로몬, 아네톨트리티온, 오살미드 등.
[당뇨병용제]
인슐린, 톨부타미드, 클로르프로파미드, 아세토헥사이미드, 글리클로피라미드, 톨라자미드, 글리벤클라미드, 글리클라지드, 글리메피리드, 글리부졸, 염산 부포르민, 염산 메트포르민, 염산 피오글리타존, 나테글리니드, 아카르보스, 보글리보스, 에팔레스타트 등.
[하수체 호르몬제]
소마트로핀, 메카세르민, 초산 테트라코삭티드, 하수체성 고나도트로핀, 혈청성 고나도트로핀, 태반성 고나도토로핀, 바소프레신, 초산 데스모프레신, 옥시토신 등.
[부신피질 호르몬제]
초산 코르티손, 히드로코르티손, 초산 히드로코르티손, 인산 히드로코르티손 나트륨, 숙신산 히드로코르티손 나트륨, 초산 플루드로코르티손, 프레드니솔론, 초산 프레드니솔론, 부틸초산 프레드니솔론, 숙신산 프레드니솔론 나트륨, 인산 프레드니솔론 나트륨, 초산 할로프레돈, 메틸프레드니솔론, 초산 메틸프레드니솔론, 숙신산 메틸프레드니솔론 나트륨, 트리암시놀론, 트리암시놀론 아세테이트, 트리암시놀노론 아세토니드, 덱사메타손, 초산 덱사메타손, 인산 덱사메타손 나트륨, 팔미틴산 덱사메타손, 베타메타손과 인산 베타메타손의 합제, 베타메타손, 인산 베타메타손 나트륨, 초산 파라메타손, 프로피온산 베클로메타손 등.
[성 호르몬제]
에스트라디올, 17β―에스트라디올, 안식향산 에스트라디올, 프로피온산 에스트라디올, 길초산 에스트라디올, 에티닐 에스트라디올, 에스트리올, 프로피온산 에스트리올, 안식향산 초산 에스트리올, 결합형 에스트로겐, 포스페스트롤, 프로게스테론, 노르테스토스테론, 카프론산 게스토노론, 노르에티스테론, 초산 노르에티스테론, 프레그난디올, 프로피온산 테스트스테론, 에난트산 테스트스테론, 카리디노게나아제, 프라스테론 황산 나트륨, 알프로스타딜, 베라프로스트 나트륨, 에포프로스테놀 나트륨, 게메프로스트, 디노프로스트, 디노프로스트 트로메타민, 디노프로스톤 베타덱스, 초산 시프로테론, 메틸테스토스테론, 플루옥시메스테론, 프로피온산 드로모스타놀론, 구연산 클로미펜, 시클로페닐, 다나졸, 초산 고세렐린, 초산부세렐린, 초산 나파렐린, 메실산 부로모크립틴, 테르구리드 등.
[프로스타글란딘제]
프로스타글란딘 F2α, 프로스타사이클린, 프로스타글란딘 E1, 프로스타글란딘 E2, 알프로스타딜, 베라프로스트 나트륨, 게메프로스트, 디노프로스톤, 디노프로스트, 디노프로스트 트로메타민, 5-플루오로프로스타사이클린, 7-플루오로프로스타사이클린 등.
[갑상선 기능이상 치료제]
레보티록신 나트륨, 리오티로닌 나트륨, 건조 갑상선, 티아마졸, 프로필티오우라실 등.
[골다공증·골대사 개선제]
알파칼시돌, 칼시트리올, 메나테트레논, 엘카토닌, 연어 칼시토닌, 알렌드로산 나트륨 수화물, 에티드론산 2나트륨, 파미드론산 2나트륨, 인카드론산 2나트륨, 이프리플라본 등.
[아미노산류]
L-아스파라긴산 및 그의 염, 아미노에틸 술폰산 등.
[비타민제]
팔미틴산 레티놀, 알파칼시돌, 염산 티아민, 리보플라빈, 판테놀, 시아노코발라민, 염산 피리독신, 니코틴산, 엽산, 판토텐산 칼슘, 아스코르빈산, 초산 토코페롤, 니코틴산 토코페롤, 비오틴, 파이토나디온, 기타 복합 비타민제 등.
[지혈제]
카르바조크롬 술폰산 나트륨, 메실산 안드레노크롬 구아닐히드라존, ε-아미노카프론산, 트라넥삼산, 폴리도카놀, 올레인산 모노에탄올아민, 헤모코아굴라제, 트롬빈 등.
[항혈전제]
복합형 에스트로겐, 우로키나아제, 티소키나아제, 알테플라아제, 나사루플라아제, 나테플라아제, 몬테플라아제, 파미테플라아제, 바트록소빈, 염산 티클로피딘, 실로스타졸, 리마프로스트 알파덱스, 오자그렐 나트륨, 아르가트로반, 이코사펜트산 에틸, 염산 사르포그렐레이트, 헤파린 칼슘, 헤파린 나트륨, 황산 프로타민, 달테파린 나트륨, 와파린, 와파린 칼슘, 구연산 나트륨, 안티트롬빈 III(유전자 재조합), 에포에틴 알파(유전자 재조합), 에포에틴 베타 (유전자 재조합), 레노그라스팀, 필그라스팀, 나르토그라스팀 등.
[항생물질]
페니실린 G, 페니실린 V, 벤질페니실린 칼슘, 벤질페니실린 벤자틴, 페네티실린 칼륨, 크록사실린 나트륨, 플루클록사실린 나트륨, 암피실린, 암옥시실린, 헤타실린, 시클라실린, 카르베니실린, 염산 타람피실린, 티카르실린 나트륨, 술베니실린, 술베니실린 나트륨, 카린다실린 나트륨, 피페라실린 나트륨, 염산 피브메실리남, 토실산 술타미실린, 클라부란산 칼륨, 페녹시메틸 페니실린 칼륨, 페녹시메틸 페니실린, 디클록사실린 나트륨, 옥사실린, 클록사실린, 클라부란산 칼륨 또는 티카르실린 나트륨, 술박탐 나트륨, 암피실린, 암피실린 나트륨, 세팔로리딘, 세파졸린, 세파로글리신, 벤자틴, 세파로틴 나트륨, 세파렉신, 세파만돌 나트륨, 세푸록심 나트륨, 세파탁심 나트륨, 세프티족심 나트륨, 세프타지딤, 세프부페라존 나트륨, 라타목세프 나트륨, 프로목세프 나트륨, 아즈트레오남, 카루모남 나트륨, 메로페넴, 이미페넴, 실라스타틴 나트륨, 파니페넴, 베타미프론, 황산 겐타마이신, 황산 카나마이신, 토브라마이신, 스트렙토마이신, 디베카신, 프라디오마이신, 포스포마이신, 염산 반코마이신, 염산 테트라사이클린, 옥시테트라사이클린, 디메틸 클로로테트라사이클린, 독시사이클린, 미노사이클린, 에리트로마이신, 로이코마이신, 죠사마이신, 키타사마이신, 록시트로마이신, 염산 린코마이신, 클린다마이신, 아미카신, 그라미시딘, 그라미시딘 S, 카프레오마이신, 사이클로세린, 엔비오마이신, 리팜피신, 나이스타틴, 트리코마이신, 포스포노마이신, 암포테리신 B, 클로람페니콜, 티암페니콜, 그리세로풀빈, 발리오틴, 피롤니트린, 식카닌, 니트로푸란토인, 세파메진 등.
[술파제]
초산 마페니드, 술파디아진, 술파디아진 은, 술파메톡사졸 나트륨, 술파디메톡신, 술파메톡사졸, 술파모노메톡신, 술피소미딘, 술피소미딘 나트륨 등.
[항진균제]
나프티오메이트, 클로트리마졸, 염산 클로코나졸, 질산 이소코나졸, 질산 술코나졸, 플루코나졸, 이트라코나졸, 미코나졸, 케토코나졸, 티오코나졸, 비포나졸,글리세오풀빈, 식카닌, 트리코마이신, 피마리신, 암포테리신 B, 니스타틴, 피롤니트린, 엑살아미드, 톨시클레이트, 바리오틴, 할로프로긴, 페닐요오드 우데시아노에이트, 플루시토신, 염산 터비나핀, 나프티핀, 옥티프록스, 시클로피록스, 올라민, 아시클로비르, 이독수리딘 등.
[항바이러스제]
아시클로비르, 염산 발라시클로비르, 비다라빈, 간시클로비르, 아만타딘, 비다라빈, 이노신 프라노벡스, 염산 아만타딘, 인산 오셀타미비르, 리바비린 등.
[항HIV제]
지도부딘, 아지도티미딘, 사닐부딘, 잘시타빈, 디다노신, 라미부딘, 황산 아마카비르, 에파비렌쯔, 네비라핀, 메실산 데라비르딘, 사키나비르, 메실산 사키나비르, 메실산 넬피나비르, 리토나비르, 황산 인디나비르, 암프레나비르 등.
[기생충·원충용제]
키니네, 메트로니다졸, 티니다졸, 술파독신, 피리메타민, 염산 메플로킨, 파모산 피란텔, 메벤다졸, 티아벤다졸, 구연산 디에틸카르바마진, 프라지칸텔, 이세티온산 펜타미딘 등.
[항류마티즘제]
부실라민, 살라조술파피리딘, 페니실아민, 액타리트, 로벤자리트, 아우로티오말레이트 나트륨, 아우라노핀, D-페니실아민, 파네실산 프레드니솔론 등.
[면역 억제제]
시클로스포린, 아자티오프린, 미조리빈, 무로모나브-CD3, 타크로리무스 수화제, 염산 구스페리무스, 미코페놀산 모페틸, 메소트렉세이트, 시클로포스파미드 등.
[썬스크린제]
p-아미노안식향산, p-디메틸 아미노안식향산 등.
[항알레르기제]
시프로헵타딘 하이드로클로라이드, 트라닐라스트, 크로모글리크산 나트륨, 암렉사녹스, 레피리나스트, 타자노라스트, 페미로라스트 칼륨, 푸말산 케토티펜, 옥사토미드, 메키타진, 염산 펙소페나딘, 에바스틴, 염산 세티리딘, 자피르루카스트, 몬텔루카스트 나트륨, 푸말산 에메다스틴 등.
[안과용제]
콘드로이틴 황산 나트륨, 메틸 황산 네오스티그민, 글루타티온, 브롬화 디스티그민, 크로모글리크산 나트륨 등.
[건선 치료제]
메톡살렌 등.
[피부 연화제·피부완화제]
히드로퀴논, 헤파린, 요소, 콘드로이틴 황산 등.
[보습 성분]
세라미드, 히알루론산, 코엔자임 Q10, 이소플라본, 리피듀어(LIPIDURETM), 세리신 등.
[양모·발모제]
염산 카프로늄, 미녹시딜, 세파란틴, 당약추출물 (swertia herb extract), 비타민E 유도체, 당근 추출물, 니코틴산 아미드, 니코틴산 벤질, 고삼 (Sophora root) 추출물, 죽절 인삼 (Panacis japonici rhizoma), 비오틴, 펜타데칸산 글리세리드, 아세틸메티오닌, 이노시톨, L-세린, 염산 피리독신, 판토텐산 칼슘, 안식향산 에스트라디올, 에티닐 에스트라디올, 디에틸스틸베스트롤, 테스토스테론, 메틸 테스토스테론, 히드로코르티손, 디펜히드라민, 하수오(polygoni radix), 다카날 등.
[펩티드 호르몬제]
인슐린, 안지오텐신, 바소프레신, 펠리프레신, 프로티렐린, 고나도트로핀 방출호르몬, 코티코트로핀, 프로락틴, 소마트로핀, 티로트로핀, 황체형성 호르몬, 칼시토닌, 칼리크레인, 파라티린 (parathyrin), 클루카곤, 옥시토신, 가스트린, 세크레틴, 혈청성 고나도트로핀 등.
[금연 보조제]
니코틴, 염산 부프로피온 등.
[다이어트 성분]
가르시니아(garcinia), 캅사이신, 시트러스, 김네마 (Gymnema), 구아바, 멜릴로트, 청파파야 추출물, 나이아신, 실리움 (psyllium) 등.
[미백 성분]
하이드로퀴논, 알파 아르부틴, 비타민C, 코지산, 갈로겐 (gallogen), 카모마일 추출물, 루시놀 등.
[노화 방지 성분]
코엔자임 Ql0, 멜라토닌, DHEA, 트레티노인, 아조엔 등.
[다당류]
헤파린, 콘드로이틴 황산 나트륨 등.
[식물 추출물·정유류]
갈퀴꼭두서니 뿌리, 포도, 아가리쿠스, 으름 덩굴 , 엉겅퀴, 신선초, 아선약 (gambir), 아보카도, 알테아 (althea), 아르니카, 알로에베라, 삼지구엽초 , 둥글레, 은행나무잎, 일랑일랑, 회향풀, 심황, 해표초, 오매(烏梅), 오약(烏藥), 갈철석, 가시오갈피, 현호색, 황기, 황금, 황백, 황련, 바나나, 올리브, 오렌지, 고추나물, 해인초, 에리트리나 (Erythrina indica), 하고초, 백참나무, 하수오, 베토니, 갈근, 활석, 카모릴리 (camolile), 비자나무, 괄루인, 감초, 한련초, 길경, 국화, 오렌지 피스 (orange pease), 기나수, 캐트닙, 살구씨, 오이, 둥글레, 체로키 로즈 (Cherokee Rose), 과로황 (過路黃), 고삼, 자몽, 형개 (schizonepeta herb), 카시아 눈 (cassia buds), 계피, 가시연꽃의 씨, 결명자, 용담, 현초, 향부자, 후박, 우황, 가시오갈피나무, 코코넛, 후추, 우방자, 호박, 밀 배아, 컴프리, 세신(細辛), 사이프레스, 샤프란, 산사나무, 산초, 지황, 수세미오이, 자근 (Lithosermi Radix), 차조기, 들깨, 시트로넬라, 라임, 시나몬, 단풍터리풀, 적석지(赤石脂), 작약, 자작나무 (Betula alba), 쇠뜨기, 셀비어 (Salvia officinalis), 만다린, 적작약, 참깨, 오분자기, 말로우, 제라늄, 짚신나무, 천궁, 세인트존스워트, 상백피, 심황, 대황, 대두 추출물, 대두 발효 추출물, 대추, 타임, 차 추출물, 정향나무, 진피, 차 나무, 인도사사 클라시플로라 (Indosasa crassiflora McClure), 스위트티 (첨차), 삼칠, 동과, 두릅 뿌리, 금잔화, 동충하초, 도인 유, 감귤껍질, 약모밀, 토사자 씨, 두충, 양지꽃속 (Potentilla anseina), 당근, 마늘, 광나무, 네롤리, 맥아(몰트), 백선, 세할미꽃, 맥문동, 바질, 파슬리, 율무, 바닐라, 해방풍, 하마멜리스, 장미, 히스, 피크노제놀, 마름, 히노키티올, 백단향, 비파나무, 빈랑나무의 열매, 복령, 부자, 블루베리, 베타인, 홍화, 페파민트, 헨나, 봉숭아 추출물, 방풍, 작약, 홉, 호호바, 감귤, 마황, 송엽, 마로니에, 만다린, 민트, 상황버섯, 레몬 밤, 속새, 목향, 복숭아 잎, 센토리, 수레국화, 유칼립투스, 바위취 (Saxifraga), 유자나무, 율무, 쑥, 나한과, 라벤더, 루이보스, 레몬, 레몬그라스, 레몬 버어베나, 개나리, 로즈우드, 로즈 힙, 로즈마리 등.
[효소류]
트립신, 파파인, 프로테아제, 세라펩타아제, 리소자임, 브로멜라인, 스트렙토키나아제, 플라스민, 우로키나아제, α―키모트립신, 세라티오 펩티다아제, 세미 알칼리 펩티다아제, 염화 리소자임 등.
[백신]
황달, 홍역, 풍진, 수두, 결핵, 척수성 소아마비, 콜레라, 장티푸스, 광견병, 일본뇌염, 간염, 디프테리아, 백일해, 파상풍, 인플루엔자, 페스트, 진드기 매개뇌염, 수막염 등.
또한 본 발명에 사용되는 제형은 특별히 제한은 없으며, 종래 피부, 점막에 접촉하는 형태로 사용되고 있는 제형, 예를 들어, 크림제, 연고제, 액제, 리니멘트제, 로션제, 유제, 분제, 포제, 테이프제, 패치제, 파프제, 플라스터제, 좌제, 점비제, 점안제, 질제, 치마제, 츄잉껌 등 임의의 제형으로 할 수 있다.
이하에 본 발명의 실시예에 대해 설명하는데, 본 발명의 범위가 이에 의해 한정되는 것은 아니다.
이하, 본 발명을 실시예에 의해 상세히 설명한다.
실시예
[실시예 1 : 입경이 다른 히드록시 아파타이트 (이하, HAP)의 피부투과성 비교시험]
입경이 다른 HAP의 피부투과성에 관한 실험은, 후지이의 방법(2)을 개량하여 수행했다.
실험에는 사이타마 실험동물공급소로부터 구입한 8주 정도 된 암컷 헤어리스랫트를 이용했다. 랫트의 복부피부를 떼어, 조심스럽게 지방을 제거한 후, 실험까지 ―80℃에 보존했다. 투과성 시험에는, 동결한 피부를 실온에 약 30분간 방치하고, 자연 해동한 Ful1-thickness skin을 이용했다.
피부투과시험에는, 후지이가 개발한 개량 Franz형 셀을 사용했다. 셀은 피부를 사이에 두고 시료를 삽입하는 상부나 챔버:도너 상 (각질층 쪽)과, 하부 챔버:리셉터 상 (진피 쪽)이 되도록 이루어지도록 장착하고, 리셉터 상 쪽에는 등장 인산 완충액 (pH 7.1) 16m1을 37℃로 유지하고, 교반기로 교반했다. 도너 상에는, 0.5ml의 시료를 첨가하고, 실험중에는 상부를 실험실 필름으로 봉했다.
도너 상에 첨가하는 시료는 무처치 대조군으로서, 아무것도 더하지 않은 등장 인산 완충액를 비교 (비교 시험예 1)로 하고, 최대 입경이 0.05μm이하 (평균 입경 약 0.03μm)의 HAP를 등장 인산 완충액에 1% 현탁한 것 (시험예 1-1), 최대 입경이 0.1μm이하 (평균 입경 약 0.06μm)의 HAP를 등장 인산 완충액에 1중량% 현탁한 것 (시험예 1-2), 최대 입경이 1μm이하 (평균 입경 약 0.5μm)의 HAP를 등장 인산 완충액에 l중량% 현탁한 것 (시험예 l-3), 및 최대 입경 20μm (평균 입경 약 8μm)의 HAP를 등장 인산 완충액에 1중량% 현탁한 것 (시험예 1- 4)를 사용하여 시험했다.
이번 실험에서는, 각 시료에 있어서, 24시간 후의 리셉터 상의 칼슘량을 측정하고, 계산에 의해 피부를 투과한 HAP량으로 하며, 그 결과를 표 1에 나타냈다. 각 이온의 측정은, ICP를 사용했다.
[표 1]
HAP 피부투과량 | |
시험예 1-1 | 98% |
시험예 1-2 | 94% |
시험예 1-3 | 75% |
시험예 1-4 | 32% |
비교시험예 1 | 0.7% |
표 1에서 입경이 큰 HAP에 비해, 최대 입경 1μm이하의 HAP, 나아가 최대 입경 0.1μm이하의 HAP의 피부투과율이 현격하게 좋은 것이 인정된다. HAP를 포함하지 않는 비교예 1에 있어서도 약간 칼슘이 측정되었기 때문에 HAP 량으로서 기록했지만, 이것은 피부 내에 존재하는 칼슘을 측정한 것이다.
[실시예 2 : 입경이 다른 HAP의 점막 투과성 비교 시험]
실험에는, 8주 정도 된 암컷 골든 햄스터를 사용했다. 마취의 영향을 피하기 위해 동물을 머리를 잘라 도살한 즉시 구강 점막을 채취했다. 채취 후, 건조되지 않도록 충분히 주의하면서 점막에서 기저막까지 채취했다.
점막 투과성 시험에는, 개량 Franz형 셀을 사용했다. 셀은 시료를 삽입하는 상부 챔버 (도너 상)과 구강 점막을 사이에 끼고, 하부 챔버 (리셉터 상)로 이루어지며, 리셉터 상은 카나마이신을 첨가한 등장 인산 완충액 (pH 7.1) 16ml을 37℃로 유지하고, 교반기로 교반했다. 도너 상에는, 0.5m1의 시료를 첨가하고, 실험중에는 상부를 래보래터리 필름으로 봉했다.
도너 상에 첨가하는 시료는, 무처치 대조군으로서, 아무것도 더하지 않은 등장 인산 완충액를 비교 (비교시험예 2)로 하고, 최대 입경이 0.05μm이하 (평균 입경 약 0.03μm)의 HAP를 등장 인산 완충액에 1중량% 현탁한 것 (시험예 2-1), 최대 입경이 O.1μm이하 (평균 입경 약 0.06μm)의 HAP를 등장 인산 완충액에 1중량% 현탁한 것 (시험예 2-2), 최대 입경이 1μm이하 (평균 입경 약 0.5μm)의 HAP를 등장 인산 완충액에 1중량% 현탁한 것 (시험예 2-3), 및 최대 입경 20μm (평균 입경 약 8μm)의 HAP를 등장 인산 완충액에 1중량% 현탁한 것 (시험예 2-4)를 사용하여 시험했다.
이번 실험에서는, 각 시료에 있어서, 24시간 후의 리셉터 상의 칼슘량을 측정하고, 계산에 의해 점막을 투과한 HAP량으로 하며, 그 결과를 표 2에 나타냈다. 각 이온의 측정은 ICP를 사용했다.
[표 2]
HAP 점막투과율 | |
시험예 2-1 | 95% |
시험예 2-2 | 89% |
시험예 2-3 | 68% |
시험예 2-4 | 22% |
비교시험예 2 | 0.9% |
표 2에서 입경이 큰 HAP에 비해, 최대 입경 1μm이하의 HAP, 나아가 최대 입경 0.1μm이하보다도 작은 입경의 HAP의 점막 투과율이 두드러지게 좋은 것이 인정된다.
[약제투과성 시험용 조성물의 조정]
HAP 입경에 의한 약제 투과성 비교 시험용의 조성물을 표 3에 나타낸다. 인도메타신은 물에 불용이기 때문에, 에탄올을 이용하여 시험용 조성물의 조정을 수행했다. 또한 비교로서 HAP를 포함하지 않는 조성물을 작성했다 (비교예 1).
[표 3]
실시예 3 | 실시예 4 | 실시예 5 | 비교예 1 | |
인도메타신 | 1% | 1% | 1% | 1% |
에탄올 | 40% | 40% | 40% | 40% |
히드록시 아파타이트 (최대 입경 0.1μm이하) | 1% | - | - | - |
히드록시 아파타이트 (최대 입경 1μm이하) | - | 1% | - | - |
히드록시 아파타이트 (최대 입경 20μm이하) | - | - | 1% | - |
정제수 | 잔량 | 잔량 | 잔량 | 잔량 |
합계 | 100% | 100% | 100% | 100% |
HAP 배합량에 의한 약제 투과성 비교 시험용 조성물 (연고)을 표 4, 표 5에 나타낸다. 실시예 9는, 인도메타신과 HAP를 사전에 교반기로 혼합한 후에, 다른 제제와의 혼합을 하였다. 실시예 10은 모든 제제를 같이 혼합하여 이용했다. 비교로서 HAP를 약제의 l500중량% 배합한 조성물 (비교예 2), 및 HAP를 포함하지 않은 조성물 (비교예 3)을 작성했다.
[표 4]
실시예 6 | 실시예 7 | 실시예 8 | 실시예 9 | 실시예 10 | |
인도메타신 | 1% | 1% | 1% | 1% | 1% |
백색바세린 | 25% | 25% | 25% | 25% | 25% |
스테아릴알콜 | 22% | 22% | 22% | 22% | 22% |
프로필렌글리콜 | 12% | 12% | 12% | 12% | 12% |
라우릴황산나트륨 | 1% | 1% | 1% | 1% | 1% |
히드록시 아파타이트 (최대 입경 0.1μm이하) | 0.001% | 0.01% | 0.1% | 1% | 1% |
정제수 | 잔량 | 잔량 | 잔량 | 잔량 | 잔량 |
합계 | 100% | 100% | 100% | 100% | 100% |
[표 5]
실시예 11 | 실시예 12 | 실시예 13 | 비교예 2 | 비교예 3 | |
인도메타신 | 1% | 1% | 1% | 1% | 1% |
백색바세린 | 25% | 25% | 25% | 25% | 25% |
스테아릴알콜 | 22% | 22% | 22% | 22% | 22% |
프로필렌글리콜 | 12% | 12% | 12% | 12% | 12% |
라우릴황산나트륨 | 1% | 1% | 1% | 1% | 1% |
히드록시 아파타이트 (최대 입경 0.1μm이하) | 2% | 5% | 10% | 15% | - |
정제수 | 잔량 | 잔량 | 잔량 | 잔량 | 잔량 |
합계 | 100% | 100% | 100% | 100% | 100% |
[시험예 3 : HAP 입경에 의한 인도메타신의 피부 투과성 비교 시험]
실험은 헤어리스 랫트의 복부 피부를 사용하여 수행했다. 리셉터 (진피 쪽) 상쪽의 용액은, 등장 인산 완충액 (pH 7.1) 16ml을 37℃로 유지하고, 교반기로 교반했다. 도너 (각질층 쪽) 상쪽에, 실시예 3∼5, 및 비교예 1의 시료를 각각 1g 첨가 (적용면적 3.14cm2)하고, 상부를 래보래터리 필름으로 봉했다 (시험예 3-1∼3-3, 및 비교 시험예 3).
시험개시 후, 1, 3, 6, 12, 24시간 후에 채취한 리셉터 용액 중 약물 농도를고속액체 크로마토그라피에 의해 정량하여 피부를 투과한 약물량을 측정했다. 그 결과를 표 6에 나타낸다. 표 안의 수치는 피부 투과량(μg/cm2)을 나타낸다.
[표 6]
시간 | 시험예3-1 (실시예 3) | 시험예3-2 (실시예 4) | 시험예3-3 (실시예 5) | 비교시험예3 (비교예 1) |
1 | 44.7 | 7.9 | 4.6 | 2.3 |
3 | 140.0 | 23.8 | 8.2 | 6.4 |
6 | 250.6 | 56.1 | 19.5 | 10.0 |
12 | 391.2 | 139.4 | 47.2 | 16.1 |
24 | 545.8 | 370.1 | 153.3 | 62.5 |
[시험예 4 : HAP 입경에 의한 인도메타신의 점막 투과성 비교 시험]
실험은 골든 햄스터의 구강 점막을 사용하여 수행했다. 리셉터 (기저쪽) 상측 용액은, 등장 인산 완충액 (pH 7.1) 16ml를 37℃로 유지하고, 교반기에서 교반했다. 도너 (점막쪽) 상측에, 실시예 3∼5, 및 비교예 l의 시료를 각각 1g 첨가 (적용면적 3.14cm2)하고, 상부를 래보래터리 필름으로 봉했다 (시험예 4-1∼4-3, 및 비교 시험예 4).
시험개시 후, l, 3, 6, 12, 24시간 후에 채취한 리셉터 용액 중 약물 농도를 고속액체 크로마토그래피에 의해 정량하여 피부를 투과한 약물량을 측정했다. 그 결과를 표 7에 나타낸다. 표 안의 수치는 점막 투과량(μg/cm2)을 나타낸다.
[표 7]
시간 | 시험예4-1 (실시예 3) | 시험예4-2 (실시예 4) | 시험예4-3 (실시예 5) | 비교시험예4 (비교예 1) |
1 | 30.6 | 5.4 | 2.8 | 1.2 |
3 | 95.5 | 19.9 | 4.3 | 2.5 |
6 | 186.3 | 48.7 | 11.9 | 6.3 |
12 | 332.8 | 127.2 | 33.0 | 11.1 |
24 | 512.7 | 311.6 | 98.1 | 37.4 |
[시험예 5 : HAP 배합량에 의한 인도메타신의 피부 투과성 비교 시험]
실험은 헤어리스 랫트의 복부 피부를 사용하여 수행했다. 리셉터 (진피쪽) 상측 용액은 등장 인산 완충액 (pH 7.1) 16m1를 37℃로 유지하고, 교반기로 교반했다. 도너 (각질층 쪽) 상측에, 실시예 6∼13, 및 비교예 2, 3의 시료를 각각 lg 첨가 (적용면적 3.14cm2)하고, 상부를 래보래터리 필름에서 봉했다 (시험예 5-1∼5-8, 및 비교 시험예 5-1∼5-2).
시험개시 후, 24시간 후에 채취한 리셉터 용액 중 약물 농도를 고속 액체 크로마토그래피에 의해 정량하여 피부를 투과한 약물량을 측정했다. 그 결과를 표 8에 나타낸다. 표 안의 수치는 피부 투과량(μg/cm2)을 나타낸다.
[표 8]
피부 투과량(μg/cm2) | |
시험예 5-1 | 189.2 |
시험예 5-2 | 237.4 |
시험예 5-3 | 285.7 |
시험예 5-4 | 315.8 |
시험예 5-5 | 280.1 |
시험예 5-6 | 284.3 |
시험예 5-7 | 279.0 |
시험예 5-8 | 270.5 |
비교시험예 5-1 | 251.4 |
비교시험예 5-2 | 21.9 |
HAP 무배합 비교 시험예 5-2의 약제의 피부 투과량에 비해, 약제에 대한 HAP의 배합량이 0.1중량%인 시험예 5-1의 약제의 피부 투과량이 크게 촉진되어 있고, 나아가 약제에 대한 HAP의 배합량이 10중량%인 시험예 5-3~약제에 대한 HAP의 배합량이 200중량%인 시험예 5-6 (표 4 및 표 5 참조)에서는 약제의 피부 투과량이 효과적으로 촉진되고 있다. 또한 약제와 HAP를 미리 교반기에서 혼합한 후에 다른 제제와 혼합한 조성물에서의 시험예 5-4에서는, 특히 큰 약제의 피부 투과량을 나타냈다.
[실시예 14 : 각종 약제의 피부 투과성 시험]
각종 약제 투과성 시험용 조성물 (실시예 14-1∼14-16)을 표 9에 나타낸다. 비교로서 각 조성물의 HAP를 포함하지 않는 조성물 (비교예 4-1∼4-16)을 작성했다.
[표 9]
성분 | 배합량(%) | |
실시예 14-1 | 염산 날록손 | 1.0 |
HAP | 0.1 | |
글리세린 | 10.0 | |
정제수 | 나머지 | |
실시예 14-2 | 인슐린 | 1.0 |
HAP | 0.01 | |
덱스트린 | 5.0 | |
정제수 | 나머지 | |
실시예 14-3 | 아지도티미딘 | 1.0 |
HAP | 1.0 | |
에탄올 | 10.0 | |
정제수 | 나머지 | |
실시예 14-4 | 염산 에페리손 | 1.0 |
HAP | 0.1 | |
정제수 | 나머지 | |
실시예 14-5 | 염산 에페드린 | 1.0 |
HAP | 0.01 | |
정제수 | 나머지 | |
실시예 14-6 | 데칸산 플루페나진 | 1.0 |
HAP | 2.0 | |
에탄올 | 5.0 | |
정제수 | 나머지 |
실시예 14-7 | 콜히친 | 1.0 |
HAP | 0.1 | |
에탄올 | 2.0 | |
정제수 | 나머지 | |
실시예 14-8 | 발프로산 나트륨 | 1.0 |
HAP | 3.0 | |
정제수 | 나머지 | |
실시예 14-9 | 황산 아트로핀 | 1.0 |
HAP | 1.0 | |
정제수 | 나머지 | |
실시예 14-10 | 염산 메클로페녹세이트 | 1.0 |
HAP | 0.01 | |
정제수 | 나머지 | |
실시예 14-11 | 염산 트리메타지딘 | 1.0 |
HAP | 0.1 | |
정제수 | 나머지 | |
실시예 14-12 | 염산 토드랄라진 | 1.0 |
HAP | 1.0 | |
정제수 | 나머지 | |
실시예 14-13 | 클로피브레이트 | 1.0 |
HAP | 5.0 | |
에탄올 | 1.0 | |
정제수 | 나머지 | |
실시예 14-14 | 디노프로스트 | 1.0 |
HAP | 0.5 | |
에탄올 | 2.0 | |
정제수 | 나머지 | |
실시예 14-15 | 니코틴 | 1.0 |
HAP | 3.0 | |
정제수 | 나머지 | |
실시예 14-16 | 나이아신 | 1.0 |
HAP | 0.1 | |
정제수 | 나머지 |
[시험예 6 : 각종 약제의 피부 투과성 비교 시험]
피부 투과성 시험은 헤어리스 랫트의 복부 피부를 사용하여 수행했다. 리셉터 (진피쪽) 상측 용액은 등장 인산 완충액 (pH 7.1) 16ml를 37℃로 유지하고, 교반기로 교반했다. 도너 (각질층쪽) 상측에, 실시예 14-1∼14-16, 및 비교예 4-1∼4-16의 시료를 각각 1g 첨가 (적용면적 3.14cm2)하고, 상부를 래보래터리 필름으로 봉했다 (시험예 6-1∼6-16, 및 비교 시험예 6-1∼6-16).
시험개시 후, 24시간 후에 채취한 리셉터 용액 중 약물 농도를 고속 액체 크타낸다. 표 안의 수치는 피부 투과량(μg/cm2)를 나타낸다.
[표 10]
피부 투과량(μg/cm2) | 피부 투과량(μg/cm2) | ||
시험예 6-1 | 373.9 | 비교시험예 6-1 | 35.1 |
시험예 6-2 | 43.7 | 비교시험예 6-2 | 7.3 |
시험예 6-3 | 614.1 | 비교시험예 6-3 | 41.8 |
시험예 6-4 | 405.6 | 비교시험예 6-4 | 32.0 |
시험예 6-5 | 541.0 | 비교시험예 6-5 | 47.2 |
시험예 6-6 | 136.5 | 비교시험예 6-6 | 14.6 |
시험예 6-7 | 250.7 | 비교시험예 6-7 | 20.2 |
시험예 6-8 | 898.3 | 비교시험예 6-8 | 64.7 |
시험예 6-9 | 82.4 | 비교시험예 6-9 | 11.4 |
시험예 6-10 | 359.2 | 비교시험예 6-10 | 30.5 |
시험예 6-11 | 309.0 | 비교시험예 6-11 | 25.6 |
시험예 6-12 | 671.8 | 비교시험예 6-12 | 43.4 |
시험예 6-13 | 634.9 | 비교시험예 6-13 | 45.9 |
시험예 6-14 | 310.6 | 비교시험예 6-14 | 24.8 |
시험예 6-15 | 1057.3 | 비교시험예 6-15 | 66.0 |
시험예 6-16 | 1296.1 | 비교시험예 6-16 | 69.3 |
실시예 14-1에서 사용한 마약 길항약인 염산 날록손은 마약성 진통약인 몰핀 이나 코데인과 유사한 구조를 가지는 점에서, 이들 마약성 진통약에 있어서도 시험예 6-1, 비교 시험예 6-1과 동등한 시험 결과를 얻을 수 있는 것으로 생각된다.
[실시예 15-1 : 크림제]
톨부타미드 10.0
HAP (최대 입경 0.1μm이하) 1.0
세탄올 5.0
폴리에틸렌 글리콜 3.0
글리세린 5.0
유동 파라핀 10.0
HAP (최대 입경 0.1μm이하) 1.0
정제수 나머지
합계 100.0
[실시예 15-2 : 액제]
미녹시딜 0.5
글리시리지네이트디칼륨 O.1
판토테닐알콜 0.2
기나수 (Cinchona bark) 추출물 1.0
HAP (최대 입경 0.1μm이하) 1.0
폴리옥시에틸렌경화 카스터 오일 0.3
프로필렌 글리콜 5.0
HAP (최대 입경 0.1μm이하) 1.0
에탄올 60.0
정제수 나머지
합계 100.0
[실시예 15-3 : 테이프제]
니코틴 15.0
HAP (최대 입경 0.1μm이하) 15.0
에스테르 껌 12.0
실리콘 점착제 58.0
합계 100.0
[실시예 l5-4 : 패치제]
니트로글리세린 14.0
HAP (최대 입경 0.1μm이하) 5.0
에스테르 껌 13.0
실리콘 점착제 68.0
합계 100.0
[실시예 15-5 : 파프제]
소마트로핀 0.5
HAP (최대 입경 0.1μm이하) 5.0
L-히스티딘 0.1
폴리아크릴산 나트륨 2.0
젤라틴 5.0
폴리비닐 알코올 1.0
글리세린 l5.0
솔비톨 15.0
폴리옥시에틸렌 글리콜 l.0
카올린 2.0
모노라우린산 폴리에틸렌 글리콜 1.5
카스터 오일 1.0
1,3―부틸렌 글리콜 3.0
살리실산 글리콜 1.0
정제수 나머지
합계 100.0
[실시예 15-6 : 좌제, 질제]
디아제팜 1.0
HAP (최대 입경 0.1μm이하) 0.01
폴리옥시에틸렌 폴리옥시프로필렌 글리콜 나머지
합계 100.O
[실시예 15-7 : 점비제]
글리시리지네이트 디칼륨 0.2
말레인산클로르페니라민 O.l
HAP (최대 입경 0.1μm이하) 0.05
인산 수소 칼륨 0.01
염화 벤잘코늄 0.01
프로필렌 글리콜 0.5
정제수 나머지
합계 100.0
[실시예 l5-8 : 점안제]
메틸 황산 네오스티그민 0.005
초산 d-α―토코페롤 0.02
콘드로이틴 황산 나트륨 0.1
메틸 황산 네오스티그민 0.005
HAP (최대 입경 0.1μm이하) 0.0002
에데트산 나트륨 O.1
프로필렌 글리콜 0.5
소르빈산 칼륨 O.1
염화 나트륨 0.3
정제수 나머지
합계 100.0
[실시예 15-9 : 치마제]
가르시니아 (garcinia) 추출물 20.0
HAP (최대 입경 0.1μm이하) 0.02
글리세린 20.0
폴리에틸렌 글리콜 3.0
라우릴황산 나트륨 1.0
잔탄 껌 0.5
히드록시에틸 셀룰로오스 0.5
멘톨 0.5
정제수 나머지
합계 100.0
[실시예 l5-10 : 츄잉껌]
독시플루리딘 5.0
HAP(최대 입경 0.1μm이하) 0.5
껌 베이스 28.0
자일리톨 30.0
파라티나이트 21.0
말티톨 3.8
연화제 0.8
향료 l.0
말티톨 시럽 나머지
합계 100.0
[시험예 7 : 각종 제형에서의 경피·경점막 조성물 준비와, 경피·경점막 투과성 시험]
각종 제형으로 조성물을 준비하고, 실시예 15-1∼15-5에 대해서는, 실시예 14와 같은 방법으로 피부 투과성 시험을 수행했다 (시험예 7-1∼7-5). 또한 실시예 15-6∼15-10에 대해서는, 시험예 4와 같은 방법으로, 점막 투과성 시험을 수행했다. 실시예 15-10의 츄잉껌에 관해서는, 껌 베이스를 제외한 조성물에 시험을 했다(시험예 7-6∼7-10). 실시예 15-1∼15-10에 대해 비교로서 HAP를 배합하지 않는 조성물을 준비하고, 시험을 했다 (비교 시험예 7-1∼7-10).
이러한 결과를 표 11에 나타낸다.
[표 11]
피부 투과량(μg/cm2) | 피부 투과량(μg/cm2) | ||
시험예 7-1 | 1596.1 | 비교시험예 7-1 | 127.4 |
시험예 7-2 | 285.2 | 비교시험예 7-2 | 20.6 |
시험예 7-3 | 91.5 | 비교시험예 7-3 | 15.9 |
시험예 7-4 | 84.7 | 비교시험예 7-4 | 17.3 |
시험예 7-5 | 7.4 | 비교시험예 7-5 | 2.1 |
피부 투과량(μg/cm2) | 피부 투과량(μg/cm2) | ||
시험예 7-6 | 152.9 | 비교시험예 7-6 | 17.5 |
시험예 7-7 | 38.3 | 비교시험예 7-7 | 9.2 |
시험예 7-8 | 4.6 | 비교시험예 7-8 | 0.8 |
시험예 7-9 | 23.8 | 비교시험예 7-9 | 7.0 |
시험예 7-10 | 421.4 | 비교시험예 7-10 | 43.7 |
이상의 결과로부터, 각종 성분에 히드록시 아파타이트를 배합한 경우의 경피·경점막 흡수성이 증가하는 것을 알 수 있다.
본 발명에 의하면, 피부나 점막에 적용하여, 소요 성분의 경피, 경점막 흡수성이 증진된 경피, 경점막 흡수 제제가 제공된다.
Claims (12)
- 경피흡수시키는 성분 및 히드록시 아파타이트를 함유한 것을 특징으로 하는 경피 흡수 제제.
- 제 1 항에 있어서, 상기 히드록시 아파타이트의 최대 입경이 1μm 이하임을 특징으로 하는 경피 흡수 제제.
- 제 1 항에 있어서, 상기 히드록시 아파타이트의 최대 입경이 0.1μm이하 임을 특징으로 하는 경피 흡수 제제.
- 제 1 항 내지 제 3 항 중 어느 한 항에 있어서, 상기 히드록시 아파타이트의 배합량이, 배합하는 약물에 대해 0.1∼1000%임을 특징으로 하는 경피 흡수 제제.
- 제 1 항 내지 제 4 항 중 어는 한 항에 있어서, 상기 경피 흡수시키는 성분이, 해열 소염 진통제, 통풍·고요산혈증 치료제, 비스테로이드계 항염증제, 스테로이드계 항염증제, 제암제, 최면·진통제, 항불안제, 항정신병제, 항울제, 항조제, 항히스타민제, 항간질제, 국소 마취제, 항파킨슨병제, 근이완제, 자율신경 작용제·진경제, 항발한제, 뇌순환·대사 개선제, 강심제, 항협심증제, 항부정맥제, 강압제, 혈관 확장제, 충혈제거제, 혈관 보강제, 고지혈증 치료제, 승압제, 호흡 촉진제, 기관지 확장제·천식 치료제, 진해제, 거담제, 소화성궤양 치료제, 연하제, 제토제, 지리·정장제, 이담제, 당뇨병용제, 하수체 호르몬제, 부신피질 호르몬제, 성호르몬제, 프로스타글란딘류, 갑상선 기능이상 치료제, 골다공증·골대사 개선제, 아미노산류, 비타민제, 항혈전제, 항생물질, 설파제, 항진균제, 항바이러스제, 항HIV제, 기생충·원충용제, 항류마티스제, 면역 억제제, 항알레르기제, 펩티드 호르몬제, 금연 보조제, 다이어트 성분, 다당류, 식물 추출물·정유류, 효소류 및 백신으로부터 선택되는 1종 및/또는 1종 이상을 포함하는 성분임을 특징으로 하는 경피 흡수 제제.
- 제 1 항 내지 제 5 항 중 어느 한 항에 있어서, 상기 경피 흡수 제제의 제형이 크림제, 연고제, 액제, 테이프제, 패치제, 또는 파프제임을 특징으로 하는 경피 흡수 제제.
- 경점막 흡수시키는 성분 및 히드록시 아파타이트를 함유한 것을 특징으로 하는 경점막 흡수 제제.
- 제 7 항에 있어서, 상기 히드록시 아파타이트의 최대 입경이 1μm이하임을 특징으로 하는 경점막 흡수 제제.
- 제 7 항에 있어서, 상기 히드록시 아파타이트의 최대 입경이 0.1μm이하임을 특징으로 하는 경점막 흡수 제제.
- 제 7 항 내지 제 9 항 주 어느 한 항에 있어서, 상기 히드록시 아파타이트의 배합량이, 배합하는 약물에 대해 0.1∼1000%임을 특징으로 하는 경점막 흡수 제제.
- 제 7 항 내지 제 10 항 중 어느 한 항에 있어서, 상기 경점막 흡수시키는 성분이, 해열 소염 진통제, 통풍, 고요산혈증 치료제, 비스테로이드계 항염증제, 스테로이드계 항염증제, 창상치유제, 제암제, 최면·진통제, 항불안제, 항정신병제, 항울제, 항조제, 항비스타민제, 항간질제, 국소 마취제, 항파킨슨병제, 근이완제, 자율신경 작용제·진경제, 항발한제, 뇌순환·대사 개선제, 강심제, 항협심증제, 항부정맥제, 강압제, 혈관 확장제, 충혈제거제, 혈관 보강제, 고지혈증 치료제, 승압제, 호흡 촉진제, 기관지 확장제·천식 치료제, 진해제, 거담제, 소화성궤양 치료제, 연하제, 제토제, 지리·정장제, 이담제, 당뇨병용제, 하수체 호르몬제, 부신피질 호르몬제, 성호르몬제, 프로스타글란딘류, 갑상선 기능이상 치료제, 골다공증·골대사 개선제, 아미노산류, 비타민제, 지혈제, 항혈전제, 항생물질, 설파제, 항진균제, 항바이러스제, 항HIV제, 기생충·원충용제, 항류마티스제, 면역 억제제, 썬스크린제, 항알레르기제, 안과용제, 건선치료제, 피부 연화제·피부 완화제, 양모·발모제, 펩티드 호르몬제, 금연 보조제, 다이어트 성분, 다당류, 식물 추출물·정유류, 효소류 및 백신으로부터 선택되는 1종 및/또는 1종 이상을 포함하는 성분임을 특징으로 하는 경점막 흡수 제제.
- 제 7 항 내지 제 11 항 중 어느 한 항에 있어서, 상기 경점막 제제의 제형이 크림제, 연고제, 액제, 테이프제, 패치제, 파프제, 좌제, 점비제, 점안제, 질제, 치마제, 또는 츄잉껌임을 특징으로 하는 경점막 흡수 제제.
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KR101006455B1 (ko) * | 2008-10-22 | 2011-01-06 | 양정우 | 구아바 성분으로 포함하는 경피흡수용 패치제 및 그 제조방법 |
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2005
- 2005-02-22 JP JP2006539145A patent/JPWO2006038315A1/ja active Pending
- 2005-02-22 US US10/552,541 patent/US20070166362A1/en not_active Abandoned
- 2005-02-22 CN CNA2005800001253A patent/CN1838969A/zh active Pending
- 2005-02-22 CA CA002522152A patent/CA2522152A1/en not_active Abandoned
- 2005-02-22 KR KR1020057017497A patent/KR20070060950A/ko not_active Application Discontinuation
- 2005-02-22 EP EP05710502A patent/EP1797900A1/en not_active Withdrawn
- 2005-02-22 WO PCT/JP2005/002771 patent/WO2006038315A1/ja active Application Filing
- 2005-02-22 RU RU2005129267/15A patent/RU2357758C2/ru active
- 2005-02-22 AU AU2005209706A patent/AU2005209706A1/en not_active Abandoned
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR100847222B1 (ko) * | 2007-01-04 | 2008-07-17 | 주식회사 엘지생활건강 | 흡수율이 증가된 상변이 피부 미용 패치 |
KR101006455B1 (ko) * | 2008-10-22 | 2011-01-06 | 양정우 | 구아바 성분으로 포함하는 경피흡수용 패치제 및 그 제조방법 |
Also Published As
Publication number | Publication date |
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RU2357758C2 (ru) | 2009-06-10 |
US20070166362A1 (en) | 2007-07-19 |
JPWO2006038315A1 (ja) | 2008-07-31 |
AU2005209706A1 (en) | 2006-04-27 |
RU2005129267A (ru) | 2007-03-27 |
CN1838969A (zh) | 2006-09-27 |
EP1797900A1 (en) | 2007-06-20 |
WO2006038315A1 (ja) | 2006-04-13 |
CA2522152A1 (en) | 2006-04-07 |
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