TWI825037B - 組成物 - Google Patents
組成物 Download PDFInfo
- Publication number
- TWI825037B TWI825037B TW107138206A TW107138206A TWI825037B TW I825037 B TWI825037 B TW I825037B TW 107138206 A TW107138206 A TW 107138206A TW 107138206 A TW107138206 A TW 107138206A TW I825037 B TWI825037 B TW I825037B
- Authority
- TW
- Taiwan
- Prior art keywords
- composition
- oil
- indomethacin
- arnica
- mass
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims description 88
- CGIGDMFJXJATDK-UHFFFAOYSA-N indomethacin Chemical compound CC1=C(CC(O)=O)C2=CC(OC)=CC=C2N1C(=O)C1=CC=C(Cl)C=C1 CGIGDMFJXJATDK-UHFFFAOYSA-N 0.000 claims abstract description 169
- 229960000905 indomethacin Drugs 0.000 claims abstract description 83
- 239000007788 liquid Substances 0.000 claims abstract description 61
- 239000000284 extract Substances 0.000 claims abstract description 53
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- 241000283973 Oryctolagus cuniculus Species 0.000 claims abstract description 35
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- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 claims 1
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Classifications
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Botany (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
本發明提供一種改善液狀或半固體狀之組成物中之吲哚美辛之穩定性之新穎手段。
一種液狀或半固體狀之組成物,其含有以下成分(A)及(B):(A)吲哚美辛或其鹽;(B)兔菊屬之植物或其萃取物。
Description
本發明係關於一種含有吲哚美辛之組成物等。
吲哚美辛係非類固醇性消炎鎮痛劑(NSAID)之一種(非專利文獻1),發揮優異之消炎鎮痛效果。
因此,被廣泛用作外用消炎鎮痛劑之有效成分,迄今為止開發、市售有將變形性關節病、肌肉痛、外傷後之腫脹、疼痛等疾病及症狀之消炎、鎮痛等作為功效之使用吲哚美辛之外用劑。
於將吲哚美辛用作外用消炎鎮痛劑之有效成分之情況下,由可視患部之形狀柔軟地塗敷、貼附組成物並藉由組成物與患部間之確實之接觸而實現持續之藥物吸收之觀點而言,較佳為如洗劑、凝膠劑或乳霜劑等塗敷劑或者敷劑、貼劑等貼附劑般以液狀或者半固體狀之組成物之形式進行利用。
然而,已知有於將吲哚美辛調配於液狀或半固體狀之組成物中之情況下,經時地產生含量降低等而導致穩定性成為問題。迄今為止,作為改善該穩定性之手段,提出有各種手段(例如專利文獻1~11等)。
目前認為山金車等菊科兔菊屬之植物或其萃取物具有消炎作用。然而,關於與吲哚美辛組合而製成液狀或半固體狀之組成物、或吲哚美辛之穩定性因製成液狀或半固體狀之組成物而情 況如何,迄今為止尚未有任何報告等。
[專利文獻1]日本專利特開平05-255083號公報
[專利文獻2]日本專利特開平05-271077號公報
[專利文獻3]日本專利特開平05-286856號公報
[專利文獻4]日本專利特開平05-286857號公報
[專利文獻5]日本專利特開平08-113537號公報
[專利文獻6]日本專利特開平10-158165號公報
[專利文獻7]日本專利特開2000-72672號公報
[專利文獻8]日本專利特開2001-302502號公報
[專利文獻9]日本專利特開2002-29970號公報
[專利文獻10]日本專利特開2002-29971號公報
[專利文獻11]日本專利特開2002-145775號公報
[非專利文獻1]日本藥典第十七修訂版解說書,廣川書店股份有限公司 第C-740~745頁
因此,本發明之課題在於提供一種改善液狀或半固體狀之組成物中之吲哚美辛之穩定性之新穎手段。
因此,本案發明人為了解決上述課題而進行了努力研究,結果發現,藉由使含有吲哚美辛或其鹽(於本說明書中有時稱為「成分(A)」)之液狀或半固體狀之組成物中進而含有以山金車酊為代表之兔菊屬之植物或其萃取物(於本說明書中有時稱為「成分(B)」),可抑制吲哚美辛之經時性之含量降低,從而完成本發明。
即,本發明提供一種液狀或半固體狀之組成物,其含有以下成分(A)及(B):(A)吲哚美辛或其鹽;及(B)兔菊屬之植物或其萃取物。
又,本發明提供一種組成物中之吲哚美辛或其鹽之穩定方法,其包括如下步驟:使含有以下成分(A):(A)吲哚美辛或其鹽;之液狀或半固體狀之組成物中含有以下成分(B):(B)兔菊屬之植物或其萃取物。
根據本發明,可抑制液狀或半固體狀之組成物中之吲哚美辛之經時性之含量降低。因此,可提供穩定性優異之含有吲哚美辛或其鹽之醫藥。
首先,以下對「組成物」之態樣之發明進行說明。
於本發明中,「吲哚美辛或其鹽」中除吲哚美辛本身以外,亦 包含吲哚美辛之藥學上所允許之鹽、進而吲哚美辛或其藥學上所允許之鹽與水或醇等之溶劑合物。其等為公知之化合物,可藉由公知之方法進行製造,此外亦可使用市售者。於本發明中,作為吲哚美辛或其鹽,較佳為吲哚美辛(化學名:[1-(4-氯苯甲醯基)-5-甲氧基-2-甲基-1H-吲哚-3-基]乙酸,[1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetic acid)。
於本發明中,液狀或半固體狀之組成物中之吲哚美辛或其鹽之含量並無特別限定,只要視所需之消炎鎮痛效果進行適當研究後決定即可。於本發明中,相對於組成物總質量(再者,於本說明書中,所謂「組成物總質量」,尤其是於敷劑或貼劑等貼附劑之情況下,意指膏體總質量,於霧劑之情況下,意指除氣溶膠以外之藥液總質量),較佳為含有以吲哚美辛之游離體換算計為0.1~10質量%之吲哚美辛或其鹽,更佳為含有0.5~5質量%,特佳為含有1~3質量%。
於本發明中,所謂「兔菊屬之植物」,意指屬於菊科兔菊屬(山金車屬)之植物體,只要屬於該屬,則具體種類並無特別限定,可舉例如以下學名之植物:Arnica montana(山金車)、Arnica chamissonis(卡密松山金車)、Arnica fulgens(光亮山金車)、Arnica cordifolia(圓葉山金車)、Arnica latifolia(寬葉山金車)、Arnica longifolia(長葉山金車)、Arnica sachalinensis(薩哈林山金車)等。於本發明中,作為山金車,可使用單一種類之植物,亦可將數種不同種類之植物組合使用。於本發明中,由吲哚美辛之穩定化之觀點而 言,較佳為使用Arnica montana(山金車)。又,於本發明中,兔菊屬之植物之使用部位並無特別限定,可使用其整株植物或一部分(花、蕾、葉、枝、根等)或將其等之2種以上組合使用。其中,作為使用部位,較佳為花。
兔菊屬之植物可視需要調節其形態,可切斷或粉碎成小片、小塊或者粉碎成粉末。又,考慮到製造組成物時之操作方便性等,亦可使用對兔菊屬之植物實施某種萃取處理所得者(於本說明書中稱為「兔菊屬之植物之萃取物」)。
再者,「兔菊屬之植物之萃取物」係除了萃取處理以外,亦包括實施加熱、乾燥、粉碎等加工處理所得者。具體而言,本發明之「兔菊屬之植物之萃取物」亦包括:將兔菊屬之植物視需要製成適當大小後,添加適當之滲出液(萃取溶劑)而滲出之液體、或將該滲出液進行濃縮所得之液體(軟浸膏(soft extract)、酊等)、進而使其等乾燥所得者(乾燥萃取物等)等。
兔菊屬之植物之萃取物之製造方法並無特別限定,例如可依日本藥典第十七修訂版 製劑總則之「浸膏劑」、「浸劑/煎劑」、「酊劑」、「流浸膏劑」之項之記載等公知之植物萃取物之製造方法為參考進行製造。具體而言,例如可藉由視需要將兔菊屬之植物切斷、加熱、乾燥、粉碎等後添加適當之萃取溶劑進行萃取而製造。所獲得之萃取物亦可視需要進而進行濃縮、乾燥等。
作為上述萃取溶劑,可舉例如:甲醇、乙醇、異丙醇、正丁醇、乙二醇、丙二醇、1,3-丁二醇、甘油等醇類;二乙醚等醚類;丙酮、乙基甲基酮等酮類;乙酸乙酯等酯類;乙腈等腈類;戊烷、己烷、環戊烷、環己烷等烷烴類;二氯甲烷、氯仿等鹵代烷烴 類;苯、甲苯等芳香族烴;二甲基甲醯胺;二甲基亞碸;水(包含熱水)等。其等可分別單獨使用,亦可將2種以上組合使用。作為醇類,較佳為低級一元醇(較佳為碳數1~6之一元醇)、低級多元醇(較佳為碳數2~6之多元醇)。
作為萃取溶劑,較佳為水、乙醇等低級一元醇、丙二醇、1,3-丁二醇等低級多元醇或其等之2種以上之混合液,更佳為水、低級一元醇或其等之混合液,尤佳為水、乙醇或其等之混合液。
萃取操作並無特別限定,可適當採用自植物進行萃取之操作所應用之公知方法,具體而言,可舉例如:於萃取溶劑中之浸漬(冷浸、溫浸、滲濾等)、使用超臨界流體或亞臨界流體之萃取等。再者,為了提高萃取效率,亦可進行攪拌或於萃取溶劑中進行均質化。
萃取溫度並無特別限定,根據所使用之萃取溶劑、萃取操作等而有所不同,較佳係設為5℃左右至萃取溶劑之沸點以下之溫度。
萃取時間並無特別限定,根據所使用之萃取溶劑、萃取操作等而有所不同,較佳為設為1小時~14天左右。
於本發明中,作為「兔菊屬之植物或其萃取物」,較佳為山金車(Arnica montana)或其萃取物。作為山金車之萃取物,可列舉山金車酊、山金車萃取物。作為兔菊屬之植物或其萃取物,更佳為選自山金車酊及山金車萃取物(軟浸膏、乾燥萃取物)中之1種以上之山金車之萃取物,再更佳為山金車酊、準藥品原料標準2006中所收錄之山金車萃取物,特佳為山金車酊。
於本發明中,作為兔菊屬之植物或其萃取物,可使用市售品,作為具體之市售品,可舉例如山金車酊(ALPS藥品工業(股))、山金車萃取物(丸善製藥(股))、Pharcolex arnica(ICHIMARU PHARCOS(股))、山金車萃取物、山金車酊(以上為日本粉末藥品(股))等。
於本發明中,液狀或半固體狀之組成物中之兔菊屬之植物或其萃取物之含量並無特別限定,由吲哚美辛之穩定化之觀點而言,相對於組成物總質量,較佳為含有0.001~6質量%之兔菊屬之植物或其萃取物,更佳為含有0.003~4質量%,特佳為含有0.005~2質量%。又,於將兔菊屬之植物之萃取物之含量換算成原生藥量之情況下,相對於組成物總質量,以原生藥換算量計較佳為含有0.003~1.5質量%,更佳為含有0.007~0.6質量%,特佳為含有0.03~0.3質量%。
尤其是於使用山金車作為兔菊屬之植物之情況下,由吲哚美辛之穩定化之觀點而言,相對於組成物總質量,較佳為含有0.01~5質量%之山金車或其萃取物,更佳為含有0.1~3質量%,特佳為含有0.2~1質量%。進而,於將山金車之萃取物之含量換算成原生藥量之情況下,相對於組成物總質量,以原生藥換算量計,較佳為含有0.01~1質量%,更佳為含有0.02~0.5質量%,特佳為含有0.04~0.2質量%。
又,於本發明中,液狀或半固體狀之組成物中之吲哚美辛或其鹽與兔菊屬之植物或其萃取物之含有比並無特別限定,由吲哚美辛之穩定化之觀點而言,相對於吲哚美辛或其鹽以其游離體換算計1質量份,較佳為含有0.001~6質量份之兔菊屬之植物或其萃取物,更佳為含有0.003~4質量份,特佳為含有0.005~2質量份。又,於將兔菊屬之植物之萃取物之含量換算成原生藥量之情況下,由吲哚美辛之穩定化之觀點而言,相對於吲哚美辛或其鹽以其 游離體換算計1質量份,較佳為含有以原天然藥換算量計為0.003~1.5質量份之兔菊屬之植物之萃取物,更佳為含有0.007~0.6質量份,特佳為含有0.01~0.2質量份。
尤其是於使用作為兔菊屬之植物之山金車之情況下,由吲哚美辛之穩定化之觀點而言,相對於吲哚美辛或其鹽以其游離體換算計1質量份,較佳為含有0.01~5質量份之山金車或其萃取物,更佳為含有0.05~3質量份,特佳為含有0.1~1質量份。進而,於將山金車之萃取物之含量換算成原生藥量之情況下,由吲哚美辛之穩定化之觀點而言,相對於吲哚美辛或其鹽以其游離體換算計1質量份,較佳為含有0.01~1質量份之山金車之萃取物,更佳為含有0.02~0.5質量份,尤佳為含有0.04~0.2質量份。
於本發明中,由進一步改善吲哚美辛之穩定性之觀點而言,較佳為使液狀或半固體狀之組成物進而含有薄荷腦等萜烯類(於本說明書中有時稱為「成分(C)」)。如後述試驗例所示,闡明了若單獨使用則反而使吲哚美辛之穩定性變差之萜烯類,係在與兔菊屬之植物或其萃取物組合之情況下,將進一步改善吲哚美辛之穩定性。再者,亦有如下優勢:適用外用消炎鎮痛劑之患部大多因炎症而發熱,若使具有冷卻感或清涼感之萜烯類含於組成物中,則可獲得良好之使用感。
於本發明中,所謂可任意地調配於液狀或半固體狀之組成物中之「萜烯類」,意指除萜烯烴以外,亦包括萜烯醇、萜烯醛、萜烯酮、萜烯氧化物、萜烯內酯等在內之總稱(類萜),其結構 並無特別限定,可列舉單萜烯、倍半萜烯或其等之衍生物等。又,可為環式亦可為鏈式。
作為此種萜烯類,具體而言,可舉例如:異龍腦、鳶尾酮、蘿勒萜、香芹醇、香芹艾菊酮(carvotanacetone)、香旱芹孟酮(carvomenthone)、香旱芹酮、蒈烯(carene)、蒈酮、莰烯、樟腦、香葉草醇(geraniol)、香檜烯(sabinene)、番紅花醛(safranal)、環檸檬油醛(cyclocitral)、檸檬醛、香茅醛、香茅酸、香茅醇、桉樹腦(cineole)、異丙基甲苯(cymene)、洋樅萜(sylvestrene)、瑞香草酚(thymol)、異崖柏醇、苦艾腦、萜品醇(terpineol)、萜品烯、萜品油烯、三環烯、橙花醇、蒎烯、松蒎醇、松醇、辣薄荷烯酮、水芹醛、水芹烯(phellandrene)、葑烯(fenchene)、小茴香醇、紫蘇醇、紫蘇醛、龍腦、月桂油烯、薄荷腦、薄荷酮、紫羅蘭醇、紫羅蘭酮、沈香醇、檸檬烯(limonene)等;可將其等單獨使用或將2種以上組合使用。再者,於該等萜烯類中存在光學異構物之情況下,只要未特別指定,則包含任一種異構物。即,於本說明書中,作為萜烯類之成分名,只要未指定特定之光學異構物,則該成分表述包含各種光學異構物單體及其等之任意比例之混合物之全部,可為單一之光學異構物,亦可為各種光學異構物之任意比例之混合物(例如「薄荷腦」之記載包含dl-薄荷腦、d-薄荷腦、l-薄荷腦之任一種)。
上述萜烯類之中,由吲哚美辛之穩定化之觀點而言,較佳為環式之類萜,更佳為環式之單類萜,再更佳為單環式或二環式之單類萜,又更佳為具有對薄荷烷骨架之單類萜(例如異丙基甲苯、瑞香草酚(thymol)、萜品烯、萜品油烯、水芹烯、檸檬烯等對薄荷烷之不飽和衍生物;香芹醇、萜品醇、薄荷腦等具有對薄荷烷 骨架之單萜烯醇;香旱芹酮、薄荷酮等具有對薄荷烷骨架之單萜烯酮;紫蘇醛等具有對薄荷烷骨架之單萜烯醛;桉樹腦等具有對薄荷烷骨架之單萜烯醚等)或具有烷骨架之單類萜(例如龍腦等具有烷骨架之單萜烯醇;樟腦等具有烷骨架之單萜烯酮等),進而更佳為自由桉樹腦、瑞香草酚、萜品醇、薄荷腦、檸檬烯、樟腦及龍腦所構成之群組選擇之1種以上,再更佳為自由桉樹腦、樟腦、瑞香草酚、龍腦及薄荷腦所構成之群組選擇之1種以上,又更佳為薄荷腦,特佳為自由l-薄荷腦及dl-薄荷腦所構成之群組選擇之1種以上。
再者,於使液狀或半固體狀之組成物含有萜烯類之情況下,除直接使用萜烯類以外,亦可使用包含萜烯類之精油。
作為此種精油,可舉例如:大茴香油、香水油(ylang-ylang oil)、鳶尾油、茴香油、甜橙油、香水樹油、洋甘菊油、白千層油(cajeput oil)、葛縷子油(caraway oil)、華澄茄油(cubeb oil)、葡萄柚油、桂皮油、芫荽籽油、番紅花油、山椒油、紫蘇油、檸檬桉油、香茅油、生薑油、小豆寇油、樟腦油、薑草油、綠薄荷油、胡椒薄荷油、香葉油、大茴香油、丁香油、松節油、苦橙油、橙花油、羅勒油、薄荷油、玫瑰草油、甘椒油、卑檸油、香葉油(bay oil)、歐亞薄荷油、荊芥油、香柑油、玫瑰木油、芳樟油、牛至油、紅橘油、蜜蜂花油、桉葉油、萊姆油、熏衣草油、沈香油、檸檬油、檸檬草油、玫瑰油、迷迭香油、羅馬洋甘菊油等;可將其等單獨使用或將2種以上組合使用。
其等之中,較佳為香水油、茴香油、甜橙油、洋甘菊油、桂皮油、紫蘇油、香茅油、生薑油、樟腦油、胡椒薄荷油、香葉油、丁 香油、松節油、苦橙油、橙花油、薄荷油、玫瑰草油、香柑油、桉葉油、熏衣草油、沈香油、檸檬油、玫瑰油、迷迭香油、羅馬洋甘菊油等,更佳為樟腦油、胡椒薄荷油、松節油、薄荷油、桉葉油,尤佳為薄荷油。
於本發明中,液狀或半固體狀之組成物中之萜烯類之含量並無特別限定,只要適當研究後決定即可,由吲哚美辛之穩定化之觀點而言,相對於組成物總質量,較佳為含有0.01~15質量%之萜烯類,更佳為含有0.1~10質量%,特佳為含有0.5~8質量%。
尤其是於使用薄荷腦作為萜烯類之情況下,由吲哚美辛之穩定化之觀點而言,相對於組成物總質量,較佳為含有0.1~10質量%之薄荷腦,更佳為含有0.3~8質量%,特佳為含有0.5~6質量%。
又,於本發明中,液狀或半固體狀之組成物中所包含之吲哚美辛或其鹽與萜烯類之含有比並無特別限定,只要適當研究後決定即可,由吲哚美辛之穩定化之觀點而言,相對於吲哚美辛或其鹽以其游離體換算計1質量份,較佳為含有0.01~14質量份之萜烯類,更佳為含有0.05~11質量份,特佳為含有0.3~8質量份。
尤其是於使用薄荷腦作為萜烯類之情況下,由吲哚美辛之穩定化之觀點而言,相對於吲哚美辛或其鹽以其游離體換算計1質量份,較佳為含有0.1~12質量份之薄荷腦,更佳為含有0.2~9質量份,特佳為含有0.4~7質量份。
進而,於本發明中,液狀或半固體狀之組成物中所包含之兔菊屬之植物或其萃取物與萜烯類之含有比並無特別限定,只要適當研究後決定即可,由吲哚美辛之穩定化之觀點而言,相對於兔菊屬之植物或其萃取物1質量份,較佳為含有0.01~80質量份之 萜烯類,更佳為含有0.3~60質量份,特佳為含有0.5~40質量份。又,於將兔菊屬之植物之萃取物之含量換算成原生藥量之情況下,相對於兔菊屬之植物之萃取物以原生藥換算量計1質量份,較佳為含有0.1~300質量份之萜烯類,更佳為含有0.5~225質量份,特佳為含有2~175質量份。
尤其是於使用薄荷腦作為萜烯類之情況下,由吲哚美辛之穩定化之觀點而言,相對於兔菊屬之植物或其萃取物1質量份,較佳為含有0.1~70質量份之薄荷腦,更佳為含有0.2~50質量份,特佳為含有0.4~30質量份。又,於將兔菊屬之植物之萃取物之含量換算成原生藥量之情況下,相對於兔菊屬之植物之萃取物以原生藥換算量計1質量份,較佳為含有1~250質量份之薄荷腦,更佳為含有5~200質量份,特佳為含有10~150質量份。
於本發明中,「液狀或半固體狀之組成物」之性狀並無特別限定,可為溶液、膠體溶液(溶膠(懸浮液或乳濁液))、凝膠等之任一者。又,溶劑或者基劑之種類、性質等並無特別限定,可為親水性,亦可為油性等疏水性,進而亦可將種類不同之數種溶劑、基劑適當混合、乳化等後使用。作為此種溶劑、基劑,具體而言,可舉例如作為後述添加物所例示之成分等。
於本發明中,由組成物之使用感之觀點而言,液狀或半固體狀之組成物較佳為含有水(再者,於本說明書中,將含有水之組成物稱為「含水組成物」)。適用外用消炎鎮痛劑之患部大多因炎症而發熱,若於組成物中含有水,則可藉由冷卻效果獲得良好 之使用感。然而,於在組成物中含有水之情況下,吲哚美辛容易因水解而分解,因此其穩定性尤其成為問題。然而,如後述試驗例所示,於本發明中,即使於液狀或半固體狀之組成物為含水組成物之情況下,亦具有吲哚美辛之穩定性得到顯著改善之優異效果。
此處,組成物中之水之含量並無特別限定,由組成物之使用感、吲哚美辛之穩定化之觀點而言,相對於組成物總質量,較佳為1質量%以上,更佳為5質量%以上,再更佳為10~90質量%,又更佳為20~70質量%,特佳為30~50質量%。
又,於本發明中,由組成物之使用感之觀點而言,亦可使液狀或半固體狀之組成物含有醇。作為醇,較佳為低級醇。此處,所謂該「低級醇」,意指碳數1~6之直鏈狀或支鏈狀之一元醇,具體而言,可舉例如乙醇、異丙醇、正丙醇等,可將其等單獨使用或將2種以上組合使用。作為低級醇,較佳為乙醇、異丙醇及其等之混合物。
組成物中之醇之含量並無特別限定,由組成物之使用感之觀點而言,相對於組成物總質量,較佳為5質量%以上,更佳為10~90質量%,再更佳為15~70質量%,特佳為20~60質量%。
又,於本發明之組成物為含水組成物之情況下,作為組成物之pH值(25℃),較佳為3~7,更佳為4~6。
於本發明中,於液狀或半固體狀之組成物中,亦可包含上述以外之藥物、例如自由鎮痛成分、抗炎症成分、抗組織胺成分、殺菌成分、收斂/保護成分、血流促進成分、溫感成分、局部麻醉成分、止咳劑、那可汀類、支氣管擴張劑、祛痰劑、催眠鎮靜劑、維生素類、胃黏膜保護劑、制酸劑、抗膽鹼劑、天然藥類、中藥配 方等所構成之群組選擇之1種或2種以上作為醫藥成分。
作為鎮痛成分,可舉例如:阿司匹林、阿司匹林鋁、乙醯胺酚、異丙基安替比林、布洛芬、乙水楊胺、水楊醯水楊酸、水楊醯胺、水楊酸、水楊酸乙二醇、水楊酸乙二醇酯、水楊酸鈉、水楊酸甲酯、噻拉米特鹽酸鹽、乳醯乙氧基苯胺、氯索洛芬等。
作為抗炎症成分,可舉例如:愈創薁磺酸鈉、甘草酸及其衍生物以及其等之鹽類(例如甘草酸二鉀、甘草酸單銨等)、甘草次酸、蜂蜜麯黴蛋白酶、半鹼蛋白酶、沙雷肽酶、麯黴酸性蛋白酶、黴蛋白酶、鳳梨酶等。
作為抗組織胺成分,可舉例如:鹽酸氮卓斯汀、酒石酸阿利馬嗪、鹽酸氮異丙嗪、鹽酸異丙海汀、依巴斯汀、鹽酸依匹斯汀、反丁烯二酸依美斯汀、奧沙米特、二苯二磺酸卡比沙明、順丁烯二酸卡比沙明、反丁烯二酸氯馬斯汀、順丁烯二酸d-氯芬尼拉明、順丁烯二酸dl-氯芬尼拉明、反丁烯二酸可多替芬、鹽酸二苯特羅、磷酸二苯特羅、鹽酸二苯拉林、茶氯酸二苯拉林、鹽酸苯海拉明、水楊酸苯海拉明、單寧酸苯海拉明、鹽酸西替利嗪、鹽酸曲普利啶、鹽酸曲吡那敏、鹽酸桑西胺、非索那定、鹽酸芬乙嗪、鹽酸普敏太定、亞甲基二水楊酸普敏太定、苯磺酸貝他斯汀、鹽酸高氯環嗪、過敏美奎錠、鹽酸甲地嗪、美海屈林等。
作為殺菌成分,可舉例如氯化苄烷銨等。作為收斂/保護成分,可舉例如氧化鋅等。作為血流促進成分,可列舉:維生素E、維生素E乙酸酯、菸鹼酸苄酯、肝素類似物質、聚乙烯磺酸鈉等。作為溫感成分,可舉例如:壬酸香草基醯胺、辣椒素、辣椒、辣椒軟浸膏、辣椒乾燥萃取物等。作為局部麻醉成分,可舉例如利 多卡因、顛茄萃取物等。
作為止咳劑,可舉例如:鹽酸阿洛拉胺、鹽酸依普拉酮、枸緣酸維靜寧、鹽酸氯哌斯汀、聯苯醯苯酸氯哌斯汀、地布酸鈉、磷酸二甲啡烷、檸檬酸替培啶、海苯酸替培啶等。
作為那可汀類,可舉例如鹽酸那可汀、那可汀等。
作為支氣管擴張劑,可舉例如:鹽酸特美奎諾、去氧腎上腺素鹽酸鹽、鹽酸甲氧那明等。作為祛痰劑,可舉例如氨-茴香精、氯化銨等。
作為催眠鎮靜劑,可舉例如烯丙基異丙基乙醯基脲或溴異戊醯脲脲等。
作為維生素類,可舉例如:維生素B1、維生素B2、維生素B5、維生素B6、維生素B12、維生素C、橙皮苷及其衍生物以及其等之鹽類等(例如硫胺素、硫胺素氯化物鹽酸鹽、硫胺素硝化物、鹽酸基世甲命、鹽酸西托硫胺、呋喃硫胺、鹽酸呋喃硫胺、奧托硫胺、賽可硫胺、二硫硫胺、雙異丁硫胺、雙苯醯硫胺、丙舒硫胺、苯磷硫胺、核黃素、核黃素磷酸酯、核黃素丁酸酯、核黃素磷酸鈉、泛醇、泛硫乙胺、泛酸鈉、鹽酸吡哆醇、吡哆醛磷酸酯、氰鈷胺、甲鈷胺、抗壞血酸、抗壞血酸鈉、抗壞血酸鈣、橙皮苷等)。
作為胃黏膜保護劑,可舉例如:吉胃適、鹽酸西曲酸酯、索法酮、替普瑞酮、氯化S-甲基蛋胺酸等。
作為制酸劑,可舉例如:胺基乙酸、鋁矽酸鎂、矽酸鎂、合成矽酸鋁、合成鋁碳酸鎂、氧化鎂、二羥基鋁胺基乙酸鹽、氫氧化鋁鎂、氫氧化鋁凝膠、乾燥氫氧化鋁凝膠、氫氧化鋁-碳酸鎂混合乾燥凝膠、氫氧化鋁-碳酸氫鈉之共沈澱產物、氫氧化鋁-碳酸鈣-碳酸 鎂之共沈澱產物、氫氧化鎂、氫氧化鎂-硫酸鋁鉀之共沈澱產物、碳酸鎂、碳酸氫鈉、沈澱碳酸鈣、矽酸鋁鎂、無水磷酸氫鈣、磷酸氫鈣、烏賊骨、石決明、牡蠣等。
抗膽鹼劑,可舉例如:鹽酸羥苄利明、鹽酸雙環維林、鹽酸美噻噸、噻哌溴銨、溴甲貝那替秦、鹽酸哌侖西平、異丙碘銨、二苯基哌啶基甲基二氧戊環碘化物等。
作為天然藥類,可舉例如:野梧桐(mallotus japonicus)、阿仙藥(gambir)、淫羊霍(epimedium herb)、茴香(fennel)、薑黃(curcuma)、延胡索(corydalis tuber)、黃芩(scutellaria eoot)、黃精(polygonatum Rhizome)、黃柏(phellodendron Bark)、櫻皮(cherry bark)、黃連(coptis root)、遠志(polygala root)、莪術(curcuma phaeocaulis valeton)、纈草(valeriana fauriei briq)、洋甘菊、栝蔞仁(trichosanthis semen)、桔梗(platycodon grandiflorus)、杏仁(apricot Kernel)、枸杞子(lycium fruit)、枸杞葉(lycium chinense)、荊芥(schizonepeta tenuifolia)、桂皮(cinnamomi cortex)、決明子(cassia obtusifolia)、龍膽、童氏老鸛草(geranium thunbergii)、紅花(safflower)、香附子(cyperus rhizome)、牛黃(oriental bezoar)、五味子(schisandra fruit)、細辛(asiasarum root)、山梔子(gardenia fruit)、山椒(zanthoxylum piperitum)、紫苑(aster tataricus)、地骨皮(lycium Bark)、紫草根(lithospermi radix)、芍藥(paeonia lactiflora)、麝香(musk)、沙參(adenophora stricta)、車前子(plantago seed)、車前草(plantago asiatica)、獸膽(包含熊膽)、生薑(ginger)、地龍(geosaurus)、辛夷(magnolia kobus)、馬栗、石蒜(lycoris)、美遠志、川芎(cnidium rhizome)、前胡(peucedanum praeruptorum)、當藥 (swertia japonica)、蒼術(atractylodes lancea rhizome)、桑白皮(mulberry bark)、紫蘇(perilla herb)、大蒜(garlic)、竹節人參(panax japonicus)、陳皮(citrus unshiu peel)、當歸(angelica acutiloba)、吐根(carapichea ipecacuanha)、南天果實(nandinae fructus)、胡蘿蔔(ginseng)、浙貝母(fritillaria bulb)、麥門冬(ophiopogon root)、半夏(pinellia tuber)、番紅花(crocus sativus)、反鼻(agkistrodon halys pallas)、白芷(angelica dahurica root)、白術(atractylodes rhizome)、茯苓(poria sclerotium)、丹皮(moutan bark)、楊梅皮(myricae cortex)、鹿茸(pilose antler)等天然藥及其等之萃取物(膏、酊、乾燥萃取物等)等。
作為中藥配方,可舉例如:桂枝湯(keishi-to)、香蘇散(koso-san)、柴胡桂枝湯(saikokeishi-to)、小柴胡湯(Shosaiko-to)、麥門東湯(bakumondo-to)、半夏厚朴湯(Hangekoboku-to)等。
又,於本發明中,亦可於液狀或半固體狀之組成物中視其劑型、投予方法等調配醫藥品領域、化妝品領域等中所使用之添加物。作為此種添加物,可舉例如:膠化劑、多元醇、油脂類、乳化劑、助溶劑、pH值調整劑、抗氧化劑、軟化劑、增黏劑、保濕劑、防腐劑、穩定劑、經皮吸收促進劑、矯味劑/甜味劑、黏著劑、黏著賦予樹脂、填充劑、交聯劑、基劑等。
作為膠化劑,可舉例如:羧基乙烯基聚合物等丙烯酸系高分子;羥乙基纖維素、羥丙基纖維素、羥丙甲纖維素、甲基纖維素、乙基纖維素等水溶性或者水膨潤性之纖維素系高分子;聚乙烯醇;聚乙烯基吡咯啶酮等。
作為多元醇,可舉例如:甘油、濃甘油、乙二醇、丙二醇、1,3- 丁二醇、聚乙二醇、聚丙二醇等。
作為油脂類,可舉例如:角鯊烷、石蠟、液態石蠟、輕質液態石蠟、凡士林、凝膠化烴等烴類;肉豆蔻酸異丙酯、肉豆蔻酸辛基十二烷基酯等脂肪酸酯類;山萮醇、月桂醇、肉豆蔻醇、鯨蠟醇、硬脂醇、異硬脂醇、油醇等高級醇類;山萮酸、月桂酸、肉豆蔻酸、硬脂酸、異硬脂酸、油酸等高級脂肪酸;巴西棕櫚蠟、鯨蠟、蟲膠、荷荷芭油、蜂蠟、白蜂蠟、褐煤蠟、羊毛脂、精製羊毛脂、還原羊毛脂等臘類;聚矽氧油等。
作為乳化劑,可舉例如:丙二醇單脂肪酸酯、乙二醇單脂肪酸酯、甘油單脂肪酸酯、聚甘油脂肪酸酯、山梨糖醇酐脂肪酸酯、蔗糖脂肪酸酯、甲基葡萄糖苷脂肪酸酯、烷基聚葡萄糖苷、聚乙二醇脂肪酸酯等多元醇脂肪酸酯或多元醇烷基醚;聚氧乙烯烷基醚、聚氧乙烯烷基苯基醚、聚氧乙烯植固醇、聚氧乙烯植物固烷醇、聚氧乙烯聚氧丙烯烷基醚等聚氧乙烯醚;聚氧乙烯單脂肪酸酯、聚乙二醇二脂肪酸酯、聚氧乙烯甘油脂肪酸酯、聚氧乙烯山梨糖醇酐脂肪酸酯、聚氧乙烯山梨醇脂肪酸酯、聚氧乙烯甲基葡萄糖苷脂肪酸酯、聚氧乙烯氫化蓖麻油、聚氧乙烯蓖麻油、聚氧乙烯植物油、聚氧乙烯烷基醚脂肪酸酯、聚氧乙烯聚氧丙烯二醇等醚酯等非離子性界面活性劑;月桂基硫酸鈉、鯨蠟基硫酸鈉等離子性界面活性劑;辛基十二烷醇等高級醇等。
作為助溶劑,例如除了作為上述乳化劑所例示之非離子性界面活性劑或離子性界面活性劑以外,亦可列舉甘油、液態石蠟、克羅米通、聚乙二醇等。
作為pH值調整劑,可舉例如:檸檬酸、檸檬酸鈉、 檸檬酸酐、蘋果酸、順丁烯二酸、琥珀酸、反丁烯二酸、酒石酸、酒石酸鈉、乳酸、乳酸鈣、乳酸鈉、乙酸、乙酸鈉、冰乙酸等有機酸或其鹽;鹽酸、硫酸、磷酸、磷酸氫鈉、磷酸二氫鉀、磷酸二氫鈉、碳酸鈉、碳酸氫鈉等無機酸或其鹽;氫氧化鈉、氫氧化鉀、氫氧化鈣、氫氧化鎂等氫氧化鹼;三乙醇胺、二乙醇胺、二異丙醇胺等胺類等。
作為抗氧化劑,可舉例如亞硫酸鈉、抗壞血酸、亞硫酸氫鈉、亞硫酸鈉、依地酸鈉、異抗壞血酸、鹽酸半胱胺酸、檸檬酸、維生素E、維生素E乙酸酯、大豆卵磷脂、沒食子酸丙酯等。
作為軟化劑,可舉例如:尿囊素、杏仁油、橄欖油、甘油、液態石蠟、角鯊烷、角鯊烯、精製羊毛脂、中鏈脂肪酸三酸甘油酯、菜籽油、蓖麻油、丙二醇、聚丁烯等。
作為增黏劑,可舉例如:聚乙烯基吡咯啶酮、羧甲基纖維素、膠體性矽酸鋁、三仙膠、刺槐豆膠、黃耆膠、瓜爾膠、明膠、阿拉伯膠、海藻酸、白蛋白等。
作為保濕劑,可列舉:玻尿酸鈉、甘油、1,3-丁二醇、丙二醇、脲、蔗糖、赤藻糖醇、山梨糖醇、純化水等。
作為防腐劑,可舉例如:對羥基苯甲酸甲酯、對羥基苯甲酸乙酯、對羥基苯甲酸丙酯、對羥基苯甲酸異丙酯、對羥基苯甲酸丁酯、對羥基苯甲酸異丁酯、對羥基苯甲酸苄酯、苯甲酸鈉、苯甲酸、苯甲酸苄酯、氯化苄烷銨、氯化鯨蠟基吡啶鎓、苄索氯銨、胺乙基磺酸等。
作為穩定劑,可舉例如:己二酸、抗壞血酸、亞硫酸鈉、亞硫酸氫鈉、氯化鈉、氫化油、半胱胺酸、苄醇、二丁基羥基甲苯、輕 質矽酸酐、對羥苯甲酸甲酯、對羥苯甲酸乙酯、對羥苯甲酸丙酯等。
作為經皮吸收促進劑,可舉例如己二酸二異丙酯等脂肪酸酯類。
作為矯味劑/甜味劑,可舉例如:乙醯磺胺酸鉀、甜菊、索馬甜、蔗糖素、潘糖、海藻糖、赤藻糖醇、乳糖醇、異麥芽酮糖醇、偶合糖、低聚果醣、半乳寡醣、乳果寡糖、異麥芽寡醣、巴拉金寡糖、棉子糖、阿斯巴甜、果糖、木糖醇、黑砂糖、糖精或其鹽、山梨糖醇、乳糖、白糖、蜂蜜、葡萄糖、麥芽糖醇、麥芽糖、甘露糖醇、飴糖等。
作為黏著劑,可舉例如:丙烯酸-丙烯酸辛酯共聚合體、丙烯酸酯-乙酸乙烯酯共聚合體、丙烯酸2-乙基己酯-乙烯基吡咯啶酮共聚合體溶液、丙烯酸2-乙基己酯-甲基丙烯酸2-乙基己酯-甲基丙烯酸十二烷基酯共聚合體溶液、丙烯酸乙酯-甲基丙烯酸甲酯共聚物分散液、丙烯酸甲酯-丙烯酸2-乙基己酯共聚合體樹脂乳膠、丙烯酸系樹脂烷醇胺溶液、甲基丙烯酸-丙烯酸正丁酯共聚物、丙烯酸蠶絲蛋白共聚樹脂、丙烯酸澱粉300、丙烯酸澱粉1000、丙烯酸丁酯-甲基丙烯酸2-乙基己酯-二丙酮丙烯醯胺共聚合體、丙烯酸丁酯-甲基丙烯酸2-羥基乙酯-二丙酮丙烯醯胺共聚合體、丙烯酸丁酯-丙烯酸乙酯-甲基丙烯酸2-羥基乙酯-二丙酮丙烯醯胺共聚合體、丙烯酸丁酯-丙烯酸2-乙基己酯-甲基丙烯酸2-羥基乙酯-二丙酮丙烯醯胺共聚合體、丙烯酸異壬酯-甲基丙烯酸2-羥基乙酯-二丙酮丙烯醯胺共聚合體、丙烯酸2-乙基己酯-甲基丙烯酸2-羥基乙酯-二丙酮丙烯醯胺共聚合體、丙烯酸丁酯-丙烯酸乙酯-甲基丙烯酸3-羥基丙酯-甲基丙烯酸2-羥基乙酯-二丙酮丙烯醯胺共聚合體、丙烯酸丁酯-丙 烯酸乙酯-甲基丙烯酸3-羥基丙酯-二丙酮丙烯醯胺共聚合體等丙烯酸系黏著劑;順式異戊二烯橡膠、苯乙烯異戊二烯橡膠、順式聚異戊二烯橡膠、高順聚異戊二烯橡膠、苯乙烯丁二烯橡膠、苯乙烯-異戊二烯-苯乙烯嵌段共聚合體、苯乙烯-丁二烯-苯乙烯嵌段共聚合體、聚異戊二烯、聚異丁烯、氯丁二烯橡膠、聚丁烯、天然橡膠乳膠、SBR合成乳膠等合成橡膠系黏著劑、及聚丙烯酸、聚丙烯酸鈉、聚丙烯酸部分中合物、N-乙烯基乙醯胺-丙烯酸鈉共聚合體、聚乙烯醇、聚乙烯基吡咯啶酮、羥甲基纖維素、羧甲基纖維素鈉、海藻酸、海藻酸鈉、明膠、阿拉伯膠等;以及利用鋁、鋅、鎂、鈣等之金屬鹽使其等進行交聯而成者等敷劑基劑。
作為黏著賦予樹脂,可舉例如:松香、氫化松香甘油酯、酯膠、順丁烯二醯化松香甘油酯、萜烯樹脂、石油樹脂、脂環式飽和烴樹脂、脂肪族烴樹脂等。
作為填充劑,可舉例如:高嶺土、氧化鋅、氧化鋁、氧化鈦、氧化鎂、氧化鐵、硬脂酸鋅、滑石、碳酸鈣、二氧化矽等。
作為交聯劑,可舉例如:乾燥氫氧化鋁凝膠、氫氧化鋁鎂、鋁矽酸鎂、偏鋁矽酸鎂、合成鋁碳酸鎂、二羥基鋁胺基乙酸鹽等。
作為基劑,可舉例如:乙基纖維素、鹿角菜膠、羧甲基纖維素鈉、瓊脂、三仙膠、膨潤土、蒙脫石、羥丙基纖維素、羥基丙基甲基纖維素、棕櫚酸糊精、肉豆蔻酸糊精等。
於本發明中,適用液狀或半固體狀之組成物之劑型並無特別限定,可視其利用目的等,自例如日本藥典第十七修訂版 製劑總則等所記載之劑型中適當選擇。作為此種劑型,具體而言,可舉例如:適用於皮膚等之製劑(外用液劑、噴霧劑、軟膏劑、乳霜 劑、凝膠劑、貼附劑等)、供進行經口投予之製劑(經口液劑、糖漿劑、經口凍膠劑等)等日本藥典第十七修訂版 製劑總則所記載之劑型。再者,作為外用液劑,可舉例如擦劑、洗劑等,作為噴霧劑,可舉例如外用氣溶膠劑、泵壓噴霧劑等,作為貼附劑,可舉例如貼劑、敷劑等。再者,於將液狀或半固體狀之組成物以具體之劑型進行製劑化之情況下,只要視劑型,適當對各劑型應用公知之手段即可,即,將液狀或半固體狀之組成物收容至容器(例如瓶狀容器、管狀容器、片狀容器、噴霧劑用容器等);將液狀或半固體狀之組成物於支持體上擴展並成形;與噴射劑混合後收容至氣溶膠罐中等。
於本發明中,作為液狀或半固體狀之組成物之劑型,較佳為自由外用液劑、噴霧劑、軟膏劑、乳霜劑、凝膠劑及貼附劑所構成之群組選擇之劑型,更佳為自由擦劑、洗劑、外用氣溶膠劑、泵壓噴霧劑、軟膏劑、乳霜劑、凝膠劑、貼劑及敷劑所構成之群組選擇之劑型,特佳為自由洗劑、軟膏劑、乳霜劑、凝膠劑及敷劑所組成之群組選擇之劑型。
於本發明中,液狀或半固體狀之組成物之製造方法並無特別限定,可視供調配之成分之種類或量、組成物之性狀、劑型、投予路徑或用途等並藉由例如日本藥典第十七修訂版 製劑總則等所記載之公知方法進行製造。
於本發明中,液狀或半固體狀之組成物之投予方法、適用方法並無特別限定,可列舉經口及經皮、經陰道等非經口。於本發明中,由液狀或半固體狀之組成物之特性(可視患部之形狀柔軟地塗敷、貼附組成物並藉由組成物與患部間之確實之接觸而實現持續之藥 物吸收之觀點)而言,較佳為非經口,特佳為經皮投予。
於本發明中,液狀或半固體狀之組成物由於含有屬於非甾體抗炎藥(NSAID,Nonsteroidal Antiinflammatory Drugs)之一種之吲哚美辛或其鹽,因此可用作醫療用藥品或非處方藥(OTC,Over The Counter)藥品,具體而言,例如可用於作為外用消炎鎮痛劑;解熱鎮痛藥等內服藥等。
繼而,以下對「方法」之態樣之發明進行說明。
本發明亦關於一種組成物中之吲哚美辛或其鹽之穩定方法(較佳為組成物中之吲哚美辛或其鹽之含量降低之抑制方法),其包括如下步驟:使含有以下成分(A):(A)吲哚美辛或其鹽;之液狀或半固體狀之組成物中含有以下成分(B):(B)兔菊屬之植物或其萃取物。
於該態樣之發明中,調配成分(A)之步驟、調配成分(B)之步驟之順序並無特別限定,只要直接或間接地製作出含有成分(A)及(B)之液狀或半固體狀之組成物即可。
再者,於該態樣之發明中,各種語句之意義、各成分之調配量等全部與針對上述本發明之「組成物」所說明者相同。
本說明書係與以上之實施形態關聯地揭示例如以下所例示之發明,但並不受其等任何限定。
[1]一種液狀或半固體狀之組成物,其含有以下成分(A)及(B):(A)吲哚美辛或其鹽;及(B)兔菊屬之植物或其萃取物。
[2]如[1]記載之組成物,其中,成分(A)為吲哚美辛。
[3]如[1]或[2]記載之組成物,其中,成分(B)係自由Arnica montana、Arnica chamissonis、Arnica fulgens、Arnica cordifolia、Arnica latifolia、Arnica longifolia及Arnica sachalinensis以及其等之萃取物所構成之群組選擇之1種以上。
[4]如[1]或[2]記載之組成物,其中,成分(B)係山金車或其萃取物。
[5]如[1]或[2]記載之組成物,其中,成分(B)係自由山金車、山金車酊及山金車萃取物所構成之群組選擇之1種以上。
[6]如[1]~[5]中任一項記載之組成物,其係含水組成物。
[7]如[1]~[6]中任一項記載之組成物,其進而含有低級醇。
[8]如[7]記載之組成物,其中,低級醇係自由乙醇及異丙醇所構成之群組選擇之1種以上。
[9]如[1]~[8]中任一項記載之組成物,其進而含有以下成分(C):(C)萜烯類。
[10]如[9]記載之組成物,其中,成分(C)係自由異龍腦、鳶尾酮、蘿勒萜、香芹醇、香芹艾菊酮、香旱芹孟酮、香旱芹酮、蒈烯、蒈酮、莰烯、樟腦、香葉草醇、香檜烯、番紅花醛、環檸檬油醛、檸檬醛、香茅醛、香茅酸、香茅醇、桉樹腦、異丙基甲苯、洋樅萜、瑞香草酚、異崖柏醇、苦艾腦、萜品醇、萜品烯、萜品油烯、三環烯、橙花醇、蒎烯、松蒎醇、松醇、辣薄荷烯酮、水芹醛、水芹烯、葑烯、小茴香醇、紫蘇醇、紫蘇醛、龍腦、月桂油烯、薄荷腦、薄荷酮、紫羅蘭醇、紫羅蘭酮、沈香醇及薴所構成之群組選擇之1種以上。
[11]如[9]記載之組成物,其中,成分(C)為薄荷腦。
[12]如[1]~[11]中任一項記載之組成物,其係自由外用液劑、噴霧劑、軟膏劑、乳霜劑、凝膠劑、貼附劑、經口液劑、糖漿劑及經口凍膠劑所構成之群組選擇之劑型。
[13]如[1]~[11]中任一項記載之組成物,其係自由外用液劑、噴霧劑、軟膏劑、乳霜劑、凝膠劑及貼附劑所構成之群組選擇之劑型。
[14]如[1]~[11]中任一項記載之組成物,其係自由擦劑、洗劑、外用氣溶膠、泵壓噴霧劑、軟膏劑、乳霜劑、凝膠劑、貼劑及敷劑所構成之群組選擇之劑型。
[15]如[1]~[11]中任一項記載之組成物,其係自由洗劑、軟膏劑、乳霜劑、凝膠劑及敷劑所構成之群組選擇之劑型。
[16]一種組成物中之吲哚美辛或其鹽之穩定方法(較佳為組成物中之吲哚美辛或其鹽之含量降低之抑制方法),其包括如下步驟:使含有以下成分(A):(A)吲哚美辛或其鹽;之液狀或半固體狀之組成物中含有以下成分(B):(B)兔菊屬之植物或其萃取物。
[17]如[16]記載之方法,其中,成分(A)為吲哚美辛。
[18]如[16]或[17]記載之方法,其中,成分(B)係自由Arnica montana、Arnica chamissonis、Arnica fulgens、Arnica cordifolia、Arnica latifolia、Arnica longifolia及Arnica sachalinensis以及其等之萃取物所構成之群組選擇之1種以上。
[19]如[16]或[17]記載之方法,其中,成分(B)係山金車或其萃 取物。
[20]如[16]或[17]記載之方法,其中,成分(B)係自由山金車、山金車酊及山金車萃取物所構成之群組選擇之1種以上。
[21]如[16]~[20]中任一項記載之方法,其中,組成物為含水組成物。
[22]如[16]~[21]中任一項之方法,其中,組成物進而含有低級醇。
[23]如[22]記載之方法,其中,低級醇係自由乙醇及異丙醇所構成之群組選擇之1種以上。
[24]如[16]~[23]中任一項記載之方法,其包括使組成物進而含有以下成分(C)之步驟:(C)萜烯類(於該態樣之發明中,調配成分(A)之步驟、調配成分(B)之步驟、調配成分(C)之步驟之順序並無特別限定,只要直接或間接地製作出含有成分(A)、成分(B)及成分(C)之液狀或半固體狀之組成物即可)。
[25]如[24]記載之方法,其中,成分(C)係自由異龍腦、鳶尾酮、蘿勒萜、香芹醇、香芹艾菊酮、香旱芹孟酮、香旱芹酮、蒈烯、蒈酮、莰烯、樟腦、香葉草醇、香檜烯、番紅花醛、環檸檬油醛、檸檬醛、香茅醛、香茅酸、香茅醇、桉樹腦、異丙基甲苯、洋樅萜、瑞香草酚、異崖柏醇、苦艾腦、萜品醇、萜品烯、萜品油烯、三環烯、橙花醇、蒎烯、松蒎醇、松醇、辣薄荷烯酮、水芹醛、水芹烯、葑烯、小茴香醇、紫蘇醇、紫蘇醛、龍腦、月桂油烯、薄荷腦、薄荷酮、紫羅蘭醇、紫羅蘭酮、沈香醇及檸檬烯所構成之群組選擇之1種以上。
[26]如[24]記載之方法,其中,成分(C)係薄荷腦。
以下,列舉實施例對本發明詳細地進行說明,但本發明並不受該等實施例任何限定。
製備總量每100g中含有表1所示之成分及分量之液狀之組成物。
將所獲得之各種組成物分別添加至玻璃瓶中,於以下之4個條件(條件1:50℃下2週,條件2:50℃下1個月,條件3:60℃下2週,條件4:60℃下1個月)下在暗處進行保存。使用高效液相層析(HPLC,high performance liquid chromatography)裝置並藉由內標準法對保存前後之組成物中之吲哚美辛之含量進行測定。根據所獲得之測定值,將各種組成物之於各保存條件下保存後之吲哚美辛之含量作為將試驗開始時之含量設為100%時之相對值(殘存率:%)並進行評價。並且,根據所獲得之各保存條件下之吲哚美辛之殘存率,藉由熱力學解析算出於25℃下保存36個月之情況下之吲哚美辛之殘存率。將結果示於表1。
如表1所記載之結果表示,於未調配山金車酊之比較例1之組成物中,於25℃下保存36個月後之吲哚美辛之殘存率為75.5%,而吲哚美辛之含量大幅降低,相對於此,於調配有山金車酊之實施例1之組成物中殘存率為94.2%,吲哚美辛之含量降低得到抑制。
根據以上之試驗結果可闡明,藉由使含有吲哚美辛或其鹽之液狀或半固體狀之組成物進而含有以山金車酊為代表之兔菊屬之植物或其萃取物,吲哚美辛之經時性之含量降低得到抑制。
又,闡明了於未調配山金車酊而僅調配有l-薄荷腦之比較例2之組成物中,於25℃下保存36個月後之吲哚美辛之殘存率為60.1%,與均未調配山金車酊、l-薄荷腦之比較例1之組成物(75.5%)相比,吲哚美辛之含量亦進而大幅降低,若僅調配l-薄荷腦,則吲哚美辛之含量更加降低。
另一方面,闡明了於組合調配有山金車酊與l-薄荷腦之實施例2之組成物中,於25℃下保存36個月後之吲哚美辛之殘存率為 95.7%,與僅調配有山金車酊之實施例1之組成物(94.2%)相比,吲哚美辛之經時性之含量降低亦更加得到抑制。
根據以上之試驗結果可得知,以l-薄荷腦為代表之萜烯類儘管單獨使用會降低吲哚美辛之含量,但在與兔菊屬之植物或其萃取物組合並含於含有吲哚美辛或其鹽之液狀或半固體狀之組成物中之情況下,將進一步抑制吲哚美辛之經時性之含量降低。
以下表示醫藥製劑之製造例。
藉由常規方法製造總量100mL中含有下述表2~3所記載之成分及分量(g)之液狀組成物(配方例1~8),將該組成物收容至在聚丙烯製之容器本體之口部安裝有海綿狀之聚胺基甲酸乙酯製塗敷構件之瓶容器中,分別設為製造例1-1~1-8之醫藥製劑(洗劑)。
藉由常規方法製造總量100mL中含有下述表4~5所記載之成分及分量(g)之半固體狀之組成物(配方例9~16)。準備將低密度聚乙烯製之薄膜作為最內層並於其外側(中間層)積層了鋁箔、進而於其外側積層了低密度聚乙烯製之薄膜而成的層壓薄膜製之管容器(層壓管),將上述半固體狀之組成物收容至該容器中,分別設為製造例2-1~2-8之醫藥製劑(凝膠劑)。
藉由常規方法製造總量100g中含有下述表6~7所記載之成分及分量(g)之半固體狀之組成物(配方例17~24)。準備將高密度聚乙烯製之薄膜作為最內層並於其外側(中間層)積層了聚對苯二甲酸乙二酯製之薄膜、進而於其外側積層了高密度聚乙烯製之薄膜而成的層壓薄膜製之管容器(層壓管),將上述半固體狀之組成物收容於該容器中,分別設為製造例3-1~3-8之醫藥製劑(軟膏劑)。
藉由常規方法製造總量100mL中含有下述表8~9所記載之成分及分量(g)之半固體狀之組成物(配方例25~32)。準備將低密度聚乙烯製之薄膜作為最內層並於其外側(中間層)積層了尼龍製之薄膜、進而於其外側積層了低密度聚乙烯製之薄膜而成的層壓薄膜製之管容器(層壓管),將上述半固體狀之組成物收容至該容器中,分別設為製造例4-1~4-8之醫藥製劑(乳霜劑)。
藉由常規方法製造總量100g中含有下述表10~11所記載之成分及分量(g)之半固體狀之組成物(配方例33~40),將其均勻地塗佈於聚對苯二甲酸乙二酯(PET,Polyethylene terephthalate)薄膜上,與聚酯製之不織布貼合而製作黏著片。將該黏著片裁剪成70 mm×100mm並利用鋁包材進行收容,分別設為製造例5-1~5-8之醫藥製劑(敷劑)。
藉由常規方法製造總量100g中含有下述表12~13所記載之成分及分量(g)之半固體狀之組成物(配方例41~48),將其均勻地塗佈於PET薄膜上,與聚酯製之不織布貼合而製作黏著片。將該黏著片裁剪成70mm×100mm並利用鋁包材進行收容,分別設為製造例6-1~6-8之醫藥製劑(貼劑)。
於製造例1之各種洗劑、製造例2之各種凝膠劑、製造例3之各種軟膏劑、製造例4之各種乳霜劑、製造例5之各種敷劑、製造例6之各種貼劑中,使用等量之原生藥換算量之山金車萃取物(山金車之70%甲醇製萃取物)代替山金車酊,除此以外,藉由相同之方法製造製造例7之各種洗劑、製造例8之各種凝膠劑、製造例9之各種軟膏劑、製造例10之各種乳霜劑、製造例11之各種敷劑、製造例12之各種貼劑。
根據本發明,可抑制液狀或半固體狀之組成物中之吲 哚美辛之經時性之含量降低。因此,可提供一種穩定性優異之含有吲哚美辛或其鹽之醫藥,且可於醫藥品產業等中較佳地利用。
Claims (6)
- 一種液狀或半固體狀之含水組成物,其含有以下成分(A)及(B):(A)吲哚美辛或其鹽;(B)兔菊屬之植物或其萃取物。
- 如請求項1之組成物,其中,成分(B)係山金車或其萃取物。
- 如請求項1之組成物,其中,成分(B)係山金車、山金車酊或山金車萃取物。
- 如請求項1之組成物,其進而含有以下成分(C):(C)萜烯類。
- 如請求項4之組成物,其中,成分(C)係薄荷腦。
- 如請求項1至5中任一項之組成物,其係自由擦劑、洗劑、外用氣溶膠劑、泵壓噴霧劑、軟膏劑、乳霜劑、凝膠劑、貼劑、敷劑、經口液劑、糖漿劑及經口凍膠劑所構成之群組選擇之劑型。
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