TWI586383B - 一種用於治療關節炎之吸入式醫藥組成物及其備製方法 - Google Patents

一種用於治療關節炎之吸入式醫藥組成物及其備製方法 Download PDF

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TWI586383B
TWI586383B TW103114135A TW103114135A TWI586383B TW I586383 B TWI586383 B TW I586383B TW 103114135 A TW103114135 A TW 103114135A TW 103114135 A TW103114135 A TW 103114135A TW I586383 B TWI586383 B TW I586383B
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gas
pharmaceutical composition
inhaled pharmaceutical
hydrogen
treating arthritis
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TW103114135A
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TW201540328A (zh
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林信湧
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林信湧
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Priority to TW103114135A priority Critical patent/TWI586383B/zh
Priority to CN201410337830.3A priority patent/CN105012337A/zh
Priority to US14/664,508 priority patent/US9339456B2/en
Priority to DE102015104361.0A priority patent/DE102015104361B4/de
Priority to JP2015060838A priority patent/JP2015205863A/ja
Priority to KR1020150041758A priority patent/KR20150120851A/ko
Publication of TW201540328A publication Critical patent/TW201540328A/zh
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Description

一種用於治療關節炎之吸入式醫藥組成物及其備製方法
本發明係有關於一種吸入式醫藥組成物及其備製方法，特別是有關於一種用於治療關節炎之吸入式醫藥組成物及其備製方法。
關節炎(Arthritis)包括退化性關節炎(Degenerative Joint Disease,DJD)、類風濕性關節炎(Rheumatoid Arthritis,RA)及其他關節病症。習知關節炎病症之特徵為發炎和疼痛，且大多數關節炎病症為持續性地惡化。
臨床上在治療關節炎病患時通常使用的藥物包括非類固醇消炎止痛藥(Nonsteroidal Anti-Inflammatory Drugs,NSAIDs)，以減輕關節炎病患的疼痛。由於當人體受到傷害時，環氧化酶-2(Cyclo-Oxygenase-2,COX-2)便會表現而引發發炎反應，因此藉由非類固醇消炎止痛藥可以用來抑制環氧化酶-2(COX-2)的活性，藉以減輕炎性反應。非類固醇消炎止痛藥通常可分為非選擇性藥物，如吲哚美辛(Indomethacin)、氟聯苯丙酸(Flurbiprofen)；及環氧化酶-2(COX-2)之選擇性藥物，如塞拉庫西比(Celecoxib)。
然而，由於非類固醇消炎止痛藥在結構上都屬於弱酸對於消 化道刺激較強，同時由於非類固醇消炎止痛藥在抑制環氧酶的作用下進而會降低前列腺素對消化道粘膜的保護作用，因此，非類固醇消炎止痛藥主要存在的副作用為胃腸道障礙(如對胃腸道刺激，誘發胃潰瘍等)。
如上所述，因此目前缺乏一種能兼具治療效果且降低對患者產生副作用之關節炎之藥劑。
有鑒於此，本發明提供一種用於治療關節炎之吸入式醫藥組成物，其包含一第一氣體及一霧化藥液。第一氣體包含一氫氣，氫氣佔吸入式醫藥組成物之氣體體積濃度介於2%~96%之間。霧化藥液包含選自於吲哚美辛(Indomethacin)、氟聯苯丙酸(Flurbiprofen)以及塞拉庫西比(Celecoxib)所組成族群中之一或其組合。
根據本發明之一實施例提供一種用於治療關節炎之吸入式醫藥組成物，第一氣體係藉由電解水所產生之一氫氧混合氣體，其氫氣與氧氣之體積比約為2：1。於一實施例中，氫氣佔吸入式醫藥組成物之氣體體積濃度介於2%~66.66%之間。此外，本發明吸入式醫藥組成物另包含一第二氣體，用以降低吸入式醫藥組成物中氫氣之氣體體積濃度，其中第二氣體係為選自於由空氣、水蒸汽、鈍氣、氧氣及其組合所組成族群中的一種氣體。於另一實施例中，氫氣佔吸入式醫藥組成物之氣體體積濃度介於4.7%~66.66%之間。
根據本發明之另一實施例提供一種用於治療關節炎之吸入式醫藥組成物，氫氣佔吸入式醫藥組成物之氣體體積濃度介於60%~66.66%之間。此外，於另一實施例提供一種用於治療關節炎之吸入式醫藥組成物， 氫氣佔吸入式醫藥組成物之氣體體積濃度大於66.66%。
此外，本發明另提供一種用於治療關節炎之吸入式醫藥組成物之製備方法，包含下列步驟：(S1)備製一第一氣體，第一氣體包含一氫氣；(S2)霧化一藥液以產生一霧化藥液，藥液包含選自於吲哚美辛(Indomethacin)、氟聯苯丙酸(Flurbiprofen)以及塞拉庫西比(Celecoxib)所組成族群中之一或其組合；以及(S3)混合第一氣體以及霧化藥液以產生該吸入式醫藥組成物，其中氫氣佔吸入式醫藥組成物之氣體體積濃度介於2%~96%之間。
根據本發明之一實施例提供一種用於治療關節炎之吸入式醫藥組成物之製備方法，本發明方法之步驟(S1)係為電解水以產生第一氣體，第一氣體含一氫氧混合氣體，其氫氣與氧氣之體積比約為2：1。
根據本發明之另一實施例提供一種用於治療關節炎之吸入式醫藥組成物之製備方法，本發明方法之步驟包含：(S21)備製一第一氣體，第一氣體包含一氫氣；(S22)霧化一藥液以產生一霧化藥液，藥液包含選自於吲哚美辛(Indomethacin)、氟聯苯丙酸(Flurbiprofen)以及塞拉庫西比(Celecoxib)所組成族群中之一或其組合；(S23)準備一第二氣體；以及(S24)混合第一氣體、第二氣體以及霧化藥液以產生吸入式醫藥組成物，其中第二氣體用以降低吸入式醫藥組成物中該氫氣之氣體體積濃度。於此實施例中，本發明用於治療關節炎之吸入式醫藥組成物中氫氣佔吸入 式醫藥組成物之氣體體積濃度，可因第二氣體加入而降低吸入式醫藥組成物中該氫氣之氣體體積濃度。
此外，根據本發明之另一實施例提供一種用於治療關節炎之吸入式醫藥組成物之製備方法，其中氫氣佔吸入式醫藥組成物之氣體體積濃度介於60%~66.66%之間。於另一實施例提供一種用於治療關節炎之吸入式醫藥組成物之製備方法，其中氫氣佔吸入式醫藥組成物之氣體體積濃度大於66.66%。
相較於習知技術，本發明提供一種用於治療關節炎之吸入式醫藥組成物及其製備方法，本發明吸入式醫藥組成物除了可以提供患者直接吸入之服用便利性外，並可以藉由氫氣以去除患者體內之惡性自由基，並藉由霧化藥液以增加患者之藥物吸收療效。
S1~S3、S21~S24‧‧‧流程步驟
100‧‧‧電解裝置
102‧‧‧電解槽
104‧‧‧電解水
106A、106B‧‧‧電極
108‧‧‧第一氣體
110‧‧‧第一氣體管路
200‧‧‧氣體混合系統
210‧‧‧霧化/揮發氣體混合槽
212‧‧‧霧化藥液
214‧‧‧吸入式醫藥組成物
216‧‧‧震盪器
220‧‧‧藥液
第一圖係繪示本發明之用於治療關節炎之吸入式醫藥組成物之製備方法於一具體實施例之方法流程圖。
第二圖係繪示本發明之用於治療關節炎之吸入式醫藥組成物之製備方法於另一具體實施例之方法流程圖。
第三圖係繪示本發明之用於治療關節炎之吸入式醫藥組成物之製備方法中步驟(S1)於一具體實施例之電解裝置示意圖。
第四圖係繪示本發明之用於治療關節炎之吸入式醫藥組成物之製備方法中步驟(S2)及(S3)於一具體實施例之氣體混合系統之示意圖。
為了讓本發明的優點，精神與特徵可以更容易且明確地了 解，後續將以實施例並參照所附圖式進行詳述與討論。值得注意的是，這些實施例僅為本發明代表性的實施例，其中所舉例的特定方法、裝置、條件、材質等並非用以限定本發明或對應的實施例。
本發明提出一種用於治療關節炎之吸入式醫藥組成物，其包含一第一氣體及一霧化藥液。第一氣體包含一氫氣，氫氣佔吸入式醫藥組成物之氣體體積濃度介於2%~96%之間。霧化藥液包含選自於吲哚美辛(Indomethacin)、氟聯苯丙酸(Flurbiprofen)以及塞拉庫西比(Celecoxib)所組成族群中之一或其組合。
於本發明之實施例中，第一氣體更包含一氧氣，而第一氣體係藉由電解水所產生之一氫氧混合氣體，其氫氣與氧氣之體積比約為2：1。於實際應用時，氫氣與氧氣之體積比原則是2：1，但是有時在蒐集電極之氫氣或氧氣會有些許誤差，但仍約為2：1。而霧化藥液則係藉由針對一藥液進行霧化或揮發所產生，其中藥液包含選自於吲哚美辛(Indomethacin)、氟聯苯丙酸(Flurbiprofen)以及塞拉庫西比(Celecoxib)所組成族群中之一或其組合，且上述藥物應用於關節炎治療上已為本領域的技術人員所熟知，故在此不多加贅述。於本實施例中，氫氣佔吸入式醫藥組成物之氣體體積濃度介於2%~66.66%之間。
本發明吸入式醫藥組成物另包含一第二氣體，第二氣體用以降低吸入式醫藥組成物中氫氣之氣體體積濃度，其中第二氣體係為選自於由空氣、水蒸汽、鈍氣、氧氣及其組合所組成族群中的一種氣體。於本實施例中，氫氣佔吸入式醫藥組成物之氣體體積濃度可介於4.7%~66.66%之間，惟不以此範圍為限。
於另一具體實施例中，本發明吸入式醫藥組成物可以藉由混合第一氣體以及霧化一體積為40c.c.之藥液所產生之霧化藥液所製備，而氫氣佔吸入式醫藥組成物之氣體體積濃度介於60%~66.66%之間。於另一實施例中，也可以用氫氣瓶提供所需氫氣，並與霧化藥液進行混合，此時氫氣佔吸入式醫藥組成物之氣體體積濃度將可能會高於66.66%，例如67%~96%之間。於另一實施例中，也可直接蒐集電解水中所產生之氫氣(而非氫氧混合氣)直接與霧化藥液進行混合，此時氫氣佔吸入式醫藥組成物之氣體體積濃度將也會高於66.66%。
請參閱第一圖，係繪示本發明之用於治療關節炎之吸入式醫藥組成物之製備方法於一具體實施例之方法流程圖。如圖所示，本發明吸入式醫藥組成物之製備方法包含下列步驟：(S1)備製一第一氣體，第一氣體包含有一氫氣；(S2)霧化一藥液以產生一霧化藥液，藥液包含有選自於吲哚美辛(Indomethacin)、氟聯苯丙酸(Flurbiprofen)以及塞拉庫西比(Celecoxib)所組成族群中之一或其組合；以及(S3)混合第一氣體以及霧化藥液以產生吸入式醫藥組成物，其中氫氣佔吸入式醫藥組成物之氣體體積濃度介於2%~96%之間。
根據本發明之一實施例提供一種用於治療關節炎之吸入式醫藥組成物之製備方法，本發明方法之步驟(S1)係為電解水以產生第一氣體，第一氣體含一氫氧混合氣體，其氫氣與氧氣之體積比約為2：1。於實際應用時，氫氣與氧氣之體積比原則是2：1，但是有時在蒐集電極之氫氣或氧氣會有些許誤差，但仍約為2：1。於一實施例中，氫氣佔吸入式醫藥 組成物之氣體體積濃度介於2%~66.66%之間，惟不以此範圍為限。
請參閱第二圖，係繪示本發明之用於治療關節炎之吸入式醫藥組成物之製備方法於另一具體實施例之方法流程圖。如圖所示，本發明吸入式醫藥組成物之另一製備方法，包含下列步驟：(S21)備製一第一氣體，第一氣體包含有一氫氣；(S22)霧化一藥液以產生一霧化藥液，藥液包含有選自於吲哚美辛(Indomethacin)、氟聯苯丙酸(Flurbiprofen)以及塞拉庫西比(Celecoxib)所組成族群中之一或其組合；以及(S23)準備一第二氣體；以及(S24)混合第一氣體、第二氣體以及霧化藥液以產生吸入式醫藥組成物。
根據本發明之一實施例提供一種用於治療關節炎之吸入式醫藥組成物之製備方法，本發明方法之步驟(S21)係為電解水以產生第一氣體，第一氣體含一氫氧混合氣體，其氫氣與氧氣之體積比約為2：1。於實際應用時，氫氣與氧氣之體積比原則是2：1，但是有時在蒐集電極之氫氣或氧氣會有些許誤差，但仍約為2：1。此外，本發明用於治療關節炎之吸入式醫藥組成物中氫氣佔吸入式醫藥組成物之氣體體積濃度，可因第二氣體加入而降低吸入式醫藥組成物中該氫氣之氣體體積濃度，於本實施例中，氫氣佔吸入式醫藥組成物之氣體體積濃度可介於4.7%~66.66%之間，惟不以此範圍為限。
當然，於另一實施例中，也可以用氫氣瓶提供所需氫氣，並與霧化藥液進行混合，此時氫氣佔吸入式醫藥組成物之氣體體積濃度將可 能會高於66.66%，例如67%~96%之間。但因吸入氣體中氫氣體積濃度太高(如高於96%)可能使氧氣體積濃度太低而對人體產生缺氧之不良影響，因此此時需注意控制氫氣體積濃度不要高於96%，如介於67%~90%之間。於另一實施例中，也可直接蒐集電解水中所產生之氫氣(而非氫氧混合氣)直接與霧化藥液進行混合，此時氫氣佔吸入式醫藥組成物之氣體體積濃度將也會高於66.66%。
請參閱第三圖，係繪示本發明之用於治療關節炎之吸入式醫藥組成物之製備方法中步驟(S1)於一具體實施例之電解裝置示意圖。於本實施例中，本發明能夠藉由電解水以產生含有氫氧混合氣體之第一氣體，其中電解裝置100包含一電解槽102、一電解水104、電極106A、106B以及一電源。
首先，電解槽102用以容納電解水104，其中電解水104主要成份為純水，惟不以此為限，於實際應用時，電解水能夠視需要以添加少量的電解質，如氫氧化鈉、碳酸鈣、氯化鈉等。再者，電解槽102中包含電極106A、106B，電極106A、106B分別為一陰極電極及一陽極電極，並耦接至一電源(未繪示於圖中)，藉以提供電解水所需之電能。於一具體實施例中，電極106A、106B能夠是固定的極性，如電極106A為陰極，電極106B為陽極，惟電極的極性不以固定為限。於另一具體實施例中，電極106A、106B能夠是交替變換的極性，如在某一時間點，電極106A為陰極，電極106B為陽極；經過一預定時間後，在另一時間點，電極106A切換為陽極，電極106B切換為陰極，其後依此類推。
接著，電解槽102中的電解水104經過電極106A、106B通電 後會開始電解，而在陰極(負極)產生氫氣，陽極(正極)產生氧氣，且釋出於電解槽102的上部，以形成一第一氣體108，其中第一氣體108由電解槽102的第一氣體管路110輸出，以作為後續的使用，惟不以此為限。於另一個實施例中，本發明亦能夠將陰極產生之氫氣與陽極產生之氧氣，個別以一氣體導管導引出電解槽102，之後再進行混合而產生第一氣體108。
由於電解水104經過電解後所產生的氫氣及氧氣之體積比約為2：1。於一具體實施例中，本發明能夠再添加第二氣體112，藉以降低吸入式醫藥組成物中該氫氣之氣體體積濃度，例如氫氣佔吸入式醫藥組成物之氣體體積濃度可以控制介於4.7%~66.66%之間，其中第二氣體係為選自於由空氣、水蒸汽、鈍氣、氧氣及其組合所組成族群中的一種氣體。
請參閱第四圖，係繪示本發明之用於治療關節炎之吸入式醫藥組成物之製備方法中步驟(S2)及(S3)於一具體實施例之氣體混合系統之示意圖。本發明吸入式醫藥組成物之製備方法中步驟(S2)及(S3)可以藉由氣體混合系統200，藉以霧化藥液220並混合第一氣體108進而產生吸入式醫藥組成物214。
氣體混合系統200包含一霧化/揮發氣體混合槽210，霧化/揮發氣體混合槽210藉由第一氣體管路110與電解裝置100(如第三圖所示)耦接，以接收第一氣體108，並與霧化藥液212混合，以形成吸入式醫藥組成物214。霧化/揮發氣體混合槽210更包括一震盪器216(例如超音波震盪器)，適於對霧化/揮發氣體混合槽210中藥液220進行霧化，以產生霧化藥液212。藥液220可以為吲哚美辛(Indomethacin)、氟聯苯丙酸(Flurbiprofen)以及塞拉庫西比(Celecoxib)所組成族群中之一或其組合，且上述藥物應用於關節炎治 療上已為本領域的技術人員所熟知，故在此不多加贅述。
於另一具體實施例中，霧化/揮發氣體混合槽210中可容納之藥液約40~100c.c之範圍，預估以60分鐘內霧化完畢，故霧化藥液本身產氣量約0.67cc/min~1.67cc/min之間，而電解槽102控制每分鐘產氣量約2,000cc/min~3,000cc/min之間，其中如電解槽產氣之結果僅僅是氫氧混合氣(氫氣及氧氣之體積比約為2：1)，則氫氣佔吸入式醫藥組成物之氣體體積濃度介於66.61%~66.65%之間。但有時因電解槽電解之熱能，會蒸發電解水而使電解槽產氣之結果除氫氧混合氣外，還可能含有少量些許之水蒸氣，因此氫氣佔吸入式醫藥組成物之氣體體積濃度會低於66.61%，例如介於60%~66.61%之間，當然上述之少量些許水蒸氣可以藉由降溫而減少。本發明吸入式醫藥組成物之備製方法可以藉由混合氫氧混合氣以及霧化藥液所製備，一般而言氫氣佔吸入式醫藥組成物之氣體體積濃度介於60%~66.66%之間。
由上述實施例可知，本發明吸入式醫藥組成物包含氫氣與霧化藥液，以提供患者(未繪示)吸入。人體因各種原因，(比如疾病、飲食、所處環境或生活習慣)引生的惡性自由基，亦稱有害自由基，可以與吸入的氫氣還原成部份的水，而排出體外。間接減少人體自由基的數量，達到酸性體質還原至健康的鹼性體質，可以抗氧化進而也達到消除慢性疾病效果。另外，液態藥液於一實施例中經過霧化後形成1~5微米的藥水粒子，經由吸入的方式，而透過鼻黏膜或肺泡直接吸收，可以更有利於人體吸收，也就是說較少霧化藥液劑量即可達成原先一般口服或注射所需要藥劑量之治療效果，也因為使用少量霧化藥液劑量，也間接降低藥劑對人體產生之副作用。當然藥液也可以是口服藥溶於水後之混合液。因此，本發明藉由 具有氫氧與霧化藥液之吸入式醫藥組成物，供人體吸入後可以達成更好之治療或醫療效果。
相較於習知技術，本發明提供一種用於治療關節炎之吸入式醫藥組成物及其製備方法，本發明吸入式醫藥組成物除了可以藉由氫氣以去除患者體內之惡性自由基，並藉由霧化藥液以增加患者之藥物吸收療效，透過較少霧化藥液劑量即可達成原先一般口服或注射所需要藥劑量之治療效果，因而能使用少量霧化藥液劑量，間接地降低藥劑對人體產生之副作用。
藉由以上較佳具體實施例之詳述，係希望能更加清楚描述本發明之特徵與精神，而並非以上述所揭露的較佳具體實施例來對本發明之範疇加以限制。相反地，其目的是希望能涵蓋各種改變及具相等性的安排於本發明所欲申請之專利範圍的範疇內。因此，本發明所申請之專利範圍的範疇應根據上述的說明作最寬廣的解釋，以致使其涵蓋所有可能的改變以及具相等性的安排。
S1~S3‧‧‧流程步驟

Claims (15)

  1. 一種用於治療關節炎之吸入式醫藥組成物，其包含一第一氣體及一霧化藥液，其中該第一氣體包含一氫氣及一氧氣，該氫氣佔該吸入式醫藥組成物之氣體體積濃度介於4.7%~96%之間，該霧化藥液包含選自於吲哚美辛(Indomethacin)、氟聯苯丙酸(Flurbiprofen)以及塞拉庫西比(Celecoxib)所組成族群中之一或其組合。
  2. 如申請專利範圍第1項所述之用於治療關節炎之吸入式醫藥組成物，其中該第一氣體係藉由電解水所產生之一氫氧混合氣體，其氫氣與氧氣之體積比約為2：1。
  3. 如申請專利範圍第1項所述之用於治療關節炎之吸入式醫藥組成物，另包含一第二氣體，用以降低該吸入式醫藥組成物中該氫氣之氣體體積濃度，其中該第二氣體係為選自於由空氣、水蒸汽、鈍氣及其組合所組成族群中的一種氣體。
  4. 如申請專利範圍第1項所述之用於治療關節炎之吸入式醫藥組成物，其中該氫氣佔該吸入式醫藥組成物之氣體體積濃度介於4.7%~66.66%之間。
  5. 如申請專利範圍第1項所述之用於治療關節炎之吸入式醫藥組成物，其中該氫氣佔該吸入式醫藥組成物之氣體體積濃度介於60%~66.66%之間。
  6. 如申請專利範圍第1項所述之用於治療關節炎之吸入式醫藥組成物，該氫氣佔該吸入式醫藥組成物之氣體體積濃度大於66.66%。
  7. 如申請專利範圍第1項所述之用於治療關節炎之吸入式醫藥組成物，其中該霧化藥液係藉由針對一藥液進行霧化或揮發所產生。
  8. 一種用於治療關節炎之吸入式醫藥組成物之製備方法，包含下列步驟：(S1)備製一第一氣體，該第一氣體包含一氫氣及一氧氣；(S2)霧化一藥液以產生一霧化藥液，該藥液包含選自於吲哚美辛 (Indomethacin)、氟聯苯丙酸(Flurbiprofen)以及塞拉庫西比(Celecoxib)所組成族群中之一或其組合；以及(S3)混合該第一氣體以及該霧化藥液以產生該吸入式醫藥組成物，其中該氫氣佔該吸入式醫藥組成物之氣體體積濃度介於4.7%~96%之間。
  9. 如申請專利範圍第8項所述之用於治療關節炎之吸入式醫藥組成物之製備方法，於步驟(S3)中更混合一第二氣體。
  10. 如申請專利範圍第9項所述之用於治療關節炎之吸入式醫藥組成物之製備方法，其中該第二氣體用以降低該吸入式醫藥組成物中該氫氣之氣體體積濃度。
  11. 如申請專利範圍第9項所述之用於治療關節炎之吸入式醫藥組成物之製備方法，其中該第二氣體係為選自於由空氣、水蒸汽、鈍氣及其組合所組成族群中的一種氣體。
  12. 如申請專利範圍第8項所述之用於治療關節炎之吸入式醫藥組成物之製備方法，其中步驟(S1)係為電解水以產生該第一氣體，該第一氣體含一氫氧混合氣體，其氫氣與氧氣之體積比約為2：1。
  13. 如申請專利範圍第8所述之用於治療關節炎之吸入式醫藥組成物之製備方法，其中該氫氣佔該吸入式醫藥組成物之氣體體積濃度介於4.7%~66.66%之間。
  14. 如申請專利範圍第8項所述之用於治療關節炎之吸入式醫藥組成物之製備方法，其中該氫氣佔該吸入式醫藥組成物之氣體體積濃度介於60%~66.66%之間。
  15. 如申請專利範圍第8項所述之用於治療關節炎之吸入式醫藥組成物之製備方法，其中該氫氣佔該吸入式醫藥組成物之氣體體積濃度大於66.66%。
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