TWI749723B - 藥物包裝用複合膜材 - Google Patents
藥物包裝用複合膜材 Download PDFInfo
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- C08G63/00—Macromolecular compounds obtained by reactions forming a carboxylic ester link in the main chain of the macromolecule
- C08G63/02—Polyesters derived from hydroxycarboxylic acids or from polycarboxylic acids and polyhydroxy compounds
- C08G63/12—Polyesters derived from hydroxycarboxylic acids or from polycarboxylic acids and polyhydroxy compounds derived from polycarboxylic acids and polyhydroxy compounds
- C08G63/16—Dicarboxylic acids and dihydroxy compounds
- C08G63/18—Dicarboxylic acids and dihydroxy compounds the acids or hydroxy compounds containing carbocyclic rings
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Abstract
本發明公開一種藥物包裝用複合膜材,其包括一熱封層、一鋁箔層以及一抗衝擊層。熱封層含有1,4-丁二醇、間苯二甲酸、異戊二醇以及異丙醇中的至少一種衍生的殘基,以使熱封層具有130
oC至180
oC之間的熔點,鋁箔層設置於熱封層上,且抗衝擊層設置於鋁箔層上。本發明的藥物包裝用複合膜材無毒性,且具有優越的抗衝擊性能和熱封性能。
Description
本發明涉及一種藥物包裝材料,特別是涉及一種藥物包裝用複合膜材。
藥物是一種用於預防、治療疾病的特殊商品,其與消費者的健康和生命安全息息相關。包裝材料由於會直接接觸到藥物,包裝材料中一旦含有有害物質,在使用過程中就可能被排出而造成藥物汙染,影響用藥安全;此外,若包裝材料的阻隔性能不佳,就有可能讓水氣、氧氣和光線透過,導致藥物發生化學變化而降低保存期限。因此,有必要對藥物包裝材料的使用性能加以關注。
現有的藥物包裝材料大部分是由鋁箔、內側具熱封性的聚氯乙烯(PVC)層與外側塑料層複合而成,惟PVC含有有毒物質塑化劑,會危害人體健康,存在安全上的隱患。另外,市面上雖然有包裝材料將PVC替換成環狀烯烴共聚物(cyclic olefin copolymer, COC)或非PVC塑料,但環狀烯烴共聚物的成本較高,而非PVC塑料也並非完全無毒。
本發明所要解決的技術問題在於,針對現有技術的不足提供一種安全無毒的藥物包裝用複合膜材。
為了解決上述的技術問題,本發明所採用的其中一技術方案是提供一種藥物包裝用複合膜材,其包括一熱封層、一鋁箔層以及一抗衝擊層。所述熱封層含有1,4-丁二醇、間苯二甲酸、異戊二醇以及異丙醇中的至少一種衍生的殘基,而具有130
oC至180
oC之間的熔點,所述鋁箔層設置於所述熱封層上,所述抗衝擊層設置於所述鋁箔層上。
在本發明的一實施例中,所述熱封層含有1至50莫耳百分比的1,4-丁二醇衍生的殘基、1至50莫耳百分比的間苯二甲酸衍生的殘基、1至50莫耳百分比的異戊二醇衍生的殘基及/或1至50莫耳百分比的異丙醇衍生的殘基。
在本發明的一實施例中,所述熱封層含有10莫耳百分比的異戊二醇衍生的殘基以及4莫耳百分比的異丙醇衍生的殘基。
在本發明的一實施例中,所述抗衝擊層的組成包括一抗衝擊性高分子,其選自於熱塑性聚酯彈性體、尼龍、聚對苯二甲酸丁二醇酯以及聚對苯二甲酸乙二醇酯-1,4-環己烷二甲醇酯所組成的群組。
在本發明的一實施例中,所述抗衝擊層是由一聚酯組成物所形成,所述聚酯組成物包含所述抗衝擊性高分子,且基於100重量百分比的所述聚酯組成物,所述抗衝擊性高分子的含量為1至70重量百分比。
在本發明的一實施例中,所述聚酯組成物還包含一般聚酯,且基於100重量百分比的所述聚酯組成物,所述一般聚酯的含量為30至90重量百分比。
在本發明的一實施例中,所述一般聚酯為聚對苯二甲酸乙二酯(PET)。
在本發明的一實施例中,所述熱封層的厚度為10微米至200微米,所述鋁箔層的厚度為5微米至20微米,且所述抗衝擊層的厚度為10微米至100微米。
在本發明的一實施例中,所述藥物包裝用複合膜材還包括一第一貼合層以及一第二貼合層,所述熱封層通過所述第一貼合層結合於所述鋁箔層的一表面上,且所述抗衝擊層通過所述第二貼合層結合於所述鋁箔層的相對另一表面上。
在本發明的一實施例中,所述第一貼合層與所述第二貼合層各為一聚烯烴熱熔膠所形成,且所述第一貼合層與所述第二貼合層的厚度各為2微米至5微米。
本發明的其中一有益效果在於,本發明所提供的藥物包裝用複合膜材,其能通過“熱封層為一改性聚酯層,其含有1,4-丁二醇、間苯二甲酸、異戊二醇以及異丙醇中的至少一種衍生的殘基”以及“鋁箔層設置於熱封層上,且抗衝擊層設置於鋁箔層上”的技術特徵,以確保藥物的品質和安全性,且所形成的藥物包裝可以在儲存及運輸過程中維持完整性。
為使能更進一步瞭解本發明的特徵及技術內容,請參閱以下有關本發明的詳細說明與圖式,然而所提供的圖式僅用於提供參考與說明,並非用來對本發明加以限制。
以下是通過特定的具體實施例來說明本發明所公開有關“藥物包裝用複合膜材”的實施方式,本領域技術人員可由本說明書所公開的內容瞭解本發明的優點與效果。本發明可通過其他不同的具體實施例加以施行或應用,本說明書中的各項細節也可基於不同觀點與應用,在不背離本發明的構思下進行各種修改與變更。另外,本發明的附圖僅為簡單示意說明,並非依實際尺寸的描繪,事先聲明。以下的實施方式將進一步詳細說明本發明的相關技術內容,但所公開的內容並非用以限制本發明的保護範圍。另外,本文中所使用的術語“或”,應視實際情況可能包括相關聯的列出項目中的任一個或者多個的組合。
除非另外定義,否則本文中使用的所有技術及科學術語,都具有與本領域技術人員通常所理解含義相同的含義。當術語以單數形式出現時,涵蓋此術語的複數形式。
除非另有指示,否則本文中提到的所有百分比都為重量百分比。當提供一系列上、下限範圍時,涵蓋所提到的範圍的所有組合,如同明確列出各組合。
參閱圖1所示,本發明一實施例提供一種藥物包裝用複合膜材Z,其主要包括一熱封層1、一鋁箔層2及一抗衝擊層3,鋁箔層2設置於熱封層1上,且抗衝擊層3設置於鋁箔層2上。使用時,熱封層1可以在熱環境下(如加壓的熱環境下)發生熔融,鋁箔層2具有優越的阻隔性能,能避免藥物與水分、氣體(氧氣)或光線接觸發生變質,抗衝擊層3能抵抗外力衝擊,使藥物包裝保持完整。
熱封層1為一改性聚酯層,其含有1,4-丁二醇、間苯二甲酸、異戊二醇及異丙醇中的至少一種衍生的殘基。值得說明的是,1,4-丁二醇、間苯二甲酸、異戊二醇及異丙醇皆可以在聚合過程中形成低聚物混合物,使得基於聚酯的熱封層1具有較低的熔點,其為130
oC至180
oC,從而本發明的複合膜材Z可以在此溫度範圍下進行熱封。此外,熱封層1的厚度會影複合膜材Z的熱封強度,熱封層1的厚度越厚,則複合膜材Z的熱封強度越強;基於實用性和成本的考量,熱封層1的厚度可為10微米至200微米。
參閱圖2所示,實際應用時,可以將一個或多個藥物置於兩片複合膜材Z之間,兩片複合膜材Z以熱封層1朝內的方式重疊在一起,然後進行熱壓使熔點較低的熱封層1發生熔融並結合成一體,如此即完成藥物的包裝。
在本實施例中,熱封層1可含有1至50莫耳百分比的1,4-丁二醇衍生的殘基、1至50莫耳百分比的間苯二甲酸衍生的殘基、1至50莫耳百分比的異戊二醇衍生的殘基及/或1至50莫耳百分比的異丙醇衍生的殘基,優選為同時含有10莫耳百分比的異戊二醇衍生的殘基及4莫耳百分比的異丙醇衍生的殘基。本文所用的術語“殘基”,是指化學反應產物中衍生自特定化合物的一基團或單元,例如通過酯化(esterification)或聚縮合(polycondensation)反應所合成的聚酯或共聚酯中,衍生自二酸或二醇成分的基團。
進一步而言,熱封層1可由第一聚酯組成物所形成,第一聚酯組成物主要包含一般聚酯及改性劑;例如,可將第一聚酯組成物熔融並押出形成一熔融層,熔融層經過冷卻定型即形成熱封層1。在第一聚酯組成物中,一般聚酯為聚對苯二甲酸乙二醇酯(PET),改性劑選自於1,4-丁二醇、間苯二甲酸、異戊二醇及異丙醇中的至少一種;基於100重量百分比的第一聚酯組成物,一般聚酯的含量可為30至99重量百分比,且改性劑的含量可為1至50重量百分比。然而,以上所述只是可行的實施方式,而並非用以限制本發明。在一些實施例中,一般聚酯可為聚對苯二甲酸丙二醇酯(PPT)、聚對苯二甲酸丁二醇酯(PBT)、聚萘二甲酸乙二醇酯(PEN)或聚萘二甲酸丁二醇酯(PBN)。
鋁箔層2可由一高純度鋁箔(含有99%以上的鋁)或摻雜有金屬和非金屬元素的改性鋁箔所形成,鋁箔層2的厚度可為5微米至20微米,且優選為10微米;若鋁箔層2太厚(即鋁箔層的厚度大於20微米),則會增加生產成本,若鋁箔層2太薄(即鋁箔層的厚度小於5微米),則達不到所需的阻隔效果。值得說明的是,在鋁箔層2的存在下,水分、氧氣、光線等無法與藥物直接接觸並產生不利影響,因此可以確保藥物的品質和安全性,並延長藥物的保質期限。在一些實施例中,為了提高鋁箔層2的耐針孔性和延展性,鋁箔層2摻雜有鐵和矽,其中鐵含量可為0.1至5重量百分比,且優選為0.3至1重量百分比,矽含量可為0.1至5重量百分比,且優選為0.3至1重量百分比。
抗衝擊層3為一聚酯層,其組成包括一抗衝擊性高分子。值得說明的是,在抗衝擊層3的存在下,本發明的複合膜材Z的抗衝擊強度提高了近一倍,從而所形成的藥物包裝可以在儲存及運輸過程中維持完整性。為了達到所需的抗衝擊效果,抗衝擊層3的厚度可為50微米至100微米。在一些實施例中,抗衝擊層3的厚度為55微米、60微米、65微米、70微米、75微米、80微米、85微米、90微米或95微米。
進一步而言,抗衝擊層3可由第二聚酯組成物所形成,第二聚酯組成物主要包含一般聚酯及抗衝擊性高分子;例如,可將第二聚酯組成物熔融並押出形成一熔融層,熔融層經過冷卻定型即形成抗衝擊層3。在第二聚酯組成物中,一般聚酯為PET、PPT、PBT、PEN或PBN,且優選為PET,抗衝擊性高分子選自於熱塑性聚酯彈性體(TPEE)、尼龍(如尼龍6、尼龍11、尼龍66或尼龍12)、聚對苯二甲酸丁二醇酯以及聚對苯二甲酸乙二醇酯-1,4-環己烷二甲醇酯(Polyethylene Terephthalate-Glycol,PETG)所組成的群組;基於100重量百分比的第二聚酯組成物,一般聚酯的含量可為30至99重量百分比,且抗衝擊性高分子的存在量可為1至70重量百分比。然而,以上所述只是可行的實施方式,而並非用以限制本發明。
根據實際應用,第二聚酯組成物可包含至少一種功能性添加劑,例如色料、無機類聚酯改質劑、加工流動助劑、成核劑及/或抗氧化劑。進一步而言,添加色料可以改變複合膜材Z的外觀顏色,其可舉出碳黑、二氧化鈦、硫酸鋇及碳酸鈣。
無機類聚酯改質劑可以提高抗衝擊層3的耐熱性,且在無機類聚酯改質劑的存在下,抗衝擊層3可具有特定的表面粗糙度和霧度。無機類聚酯改質劑的具體例包括:二氧化矽(SiO
2)、二氧化鈦(TiO
2)、氫氧化鋁(Al(OH)
3)、氧化鋁(Al
2O
3)、氫氧化鎂(Mg(OH)
2)、氧化鎂(MgO)、碳酸鈣(CaCO
3)、氧化硼(B
2O
3)、氧化鈣(CaO)、鈦酸鍶(SrTiO
3)、鈦酸鋇(BaTiO3)、鈦酸鈣(CaTiO
3)、鈦酸鎂(2MgO•TiO
2)、二氧化鈰(CeO
2)、燻矽石(fume silica)、滑石、碳酸鋇、硫酸鈣、硫酸鋇、磷酸鋰、磷酸鈣、磷酸鎂、氮化硼(BN)、氮化鋁(AlN)、碳黑及高嶺土;無機類聚酯改質劑可以顆粒形式存在,且基於100重量百分比的第二聚酯組成物,無機類聚酯改質劑的含量可為0.01至2重量百分比。
加工流動助劑可以降低熔融押出聚酯原料時的機械扭力,減少聚合物分子鏈斷鏈。加工流動助劑可為季戊四醇硬脂酸酯(PETS)或其類似物,其在高温下具有良好的熱穩定性、低揮發性、較高的流動性和脫模性能,且對部分結晶的聚酯有很好的成核效果;且基於100重量百分比的第二聚酯組成物,加工流動助劑的含量可為0.01至2重量百分比。
成核劑可以提高總結晶度,從而抗衝擊層3的耐熱性可以得到改善;成核劑也可以促進結晶成長,使得結晶大小微細化,減少大球晶產生,以及可以避免膜面脆化。成核劑可為礦物材料、金屬氧化物、矽化合物、有機酸或無機酸的金屬鹽、磷酸酯金屬鹽、多元醇衍生物、磺醯亞胺化合物、玻璃粉末、金屬粉末或其任意組合;且基於100重量百分比的第二聚酯組成物,成核劑的含量可為0.0003至2重量百分比。
礦物材料作為成核劑,可舉出:石墨、滑石及高嶺土;金屬氧化物作為成核劑,可舉出:氧化鋅、氧化鋁及氧化鎂;矽化合物作為成核劑,可舉出:氧化矽、矽酸鈣及矽酸鎂;有機酸或無機酸的金屬鹽作為成核劑,可舉出:碳酸鎂、碳酸鈣、碳酸鈉、碳酸鉀等碳酸金屬鹽、硫酸鋇、硫酸鈣、苯甲酸鈉及對叔丁基苯甲酸鋁;磷酸酯金屬鹽作為成核劑,可舉出芳香族磷酸酯金屬鹽;多元醇衍生物作為成核劑,可舉出二亞苄基山梨醇。
作為形成抗衝擊層3的第二聚酯組成物的抗氧化劑,可單獨或同時使用一級抗氧化劑與二級抗氧化劑;一級抗氧化劑可以快速地與過氧化自由基(peroxy radical, ROO•)發生反應,以終止自由基連鎖反應,而二級抗氧化劑可以與氫過氧化物(ROOH)反應,並將其轉化為無自由基且無反應活性的產物;值得說明的是,一級抗氧化劑與二級抗氧化劑可以發揮良好的協同作用,以提供更好的抗氧化效果。
一級抗氧化劑可選自於酚類化合物或胺類化合物,具體可舉出商標名為Irganox 1010、Irganox 1425、Irganox 245、Anox 1315、Anox PP18、Anox 20、Lowinox 1790、Lowinox TBM-68及Naugard 445的市售品;且基於100重量百分比的第二聚酯組成物,一級抗氧化劑的含量可為0.01至1重量百分比。二級抗氧化劑可選自於亞磷類化合物或硫酯類化合物,具體可舉出商標名為Sandostab P-EPQ、Irgafos 168及Naugard 412S的市售品;且基於100重量百分比的第二聚酯組成物,二級抗氧化劑的含量可為0.01至1重量百分比。
此外,可以對未延伸的抗衝擊層3實施延伸加工,使其具有更優越的機械性能。在一些實施例中,所實施的延伸加工方式可為逐次雙軸延伸加工,即未延伸的抗衝擊層3先在特定的溫度及延伸倍率下進行縱向(或稱“長度方向”,MD)延伸加工,然後在特定的溫度及延伸倍率下進行橫向(或稱“寬度方向”,TD)延伸加工;根據實際需要,可將縱向延伸加工與橫向延伸加工的順序反過來。在一些實施例中,所實施的延伸加工方式可為同步雙軸延伸加工,即未延伸的抗衝擊層3在特定的溫度及延伸倍率下同時進行縱向延伸加工與橫向延伸加工。
複參閱圖1所示,在本實施例中,熱封層1可通過一第一貼合層4結合於鋁箔層2的一表面(如內表面)上,且抗衝擊層3可通過一第二貼合層5結合於鋁箔層2的相對另一表面(如外表面)上。第一貼合層4與第二貼合層5各可為一聚烯烴膠層,其組成包括聚烯烴(polyolefin, PO)及熱熔膠;第一貼合層4與第二貼合層5的厚度可為2微米至5微米。
表1中列出本發明的藥物包裝用複合膜材Z的幾個代表性實施例,然而,本發明不以上述所舉的例子為限。
表1
◎代表品質優(very good)
○代表品質良(good)
△代表品質差(poor)
╳代表品質極差(very poor)
項目 | 實施例 | 比較例 | |||
1 | 2 | 3 | 1 | ||
熱封層 | 1,4-丁二醇 (mol%) | 0 | 0 | 0 | 0 |
間苯二甲酸 (mol%) | 0 | 0 | 0 | 0 | |
異戊二醇(mol%) | 10 | 0 | 11 | 0 | |
異丙醇(mol%) | 4 | 12.5 | 10 | 21 | |
鋁箔層 | 鋁 (%) | 99.2 | 99.2 | 99.2 | 99.2 |
鐵 (%) | 0.4 | 0.4 | 0.4 | 0.4 | |
矽(%) | 0.2 | 0.2 | 0.2 | 0.2 | |
抗衝擊層 | PET (wt%) | 80 | 90 | 90 | 100 |
熱塑性聚酯彈性體 (wt%) | 20 | 10 | 0 | 0 | |
尼龍 (wt%) | 0 | 10 | 0 | 0 | |
PETG(wt%) | 0 | 0 | 10 | 0 | |
複合膜材物性 | 熱封層厚度 (使用厚度計測得) | 20 | 20 | 20 | 20 |
熱封強度 (根據ASTM F2029標準測得) | ◎ | ◎ | △ | ╳ | |
抗衝擊強度 (根據ASTM D256標準測得) | ◎ | ○ | ○ | △ | |
封包性 (從產品外觀來做評估) | ◎ | ◎ | △ | ╳ | |
綜合評比 | ◎ | ◎ | ◎ | ╳ |
[實施例的有益效果]
本發明的其中一有益效果在於,本發明所提供的藥物包裝用複合膜材,其能通過“熱封層含有1,4-丁二醇、間苯二甲酸、異戊二醇以及異丙醇中的至少一種衍生的殘基”以及“鋁箔層設置於熱封層上,且抗衝擊層設置於鋁箔層上”的技術特徵,以確保藥物的品質和安全性,且所形成的藥物包裝可以在儲存及運輸過程中維持完整性。
更進一步來說,熱封層為一改性聚酯層,本身安全無毒性,不會造成環境汙染,可以取代業界普遍使用的聚氯乙烯(PVC)熱封層。再者,由於1,4-丁二醇、間苯二甲酸、異戊二醇及異丙醇皆可以在聚合過程中形成低聚物混合物,基於聚酯熱封層可具有較低的熔點(熔點為130
oC至180
oC),從而本發明的複合膜材可以使用較低的溫度進行熱封,可降低生產成本;且在實際應用時,可通過調整熱封層的厚度來控制熱封強度。
更進一步來說,抗衝擊層的組成包括一抗衝擊性高分子,且抗衝擊性高分子選自於熱塑性聚酯彈性體(TPEE)、尼龍(如尼龍6、尼龍11、尼龍66或尼龍12)、聚對苯二甲酸丁二醇酯以及聚對苯二甲酸乙二醇酯-1,4-環己烷二甲醇酯(Polyethylene Terephthalate-Glycol,PETG)所組成的群組;因此,本發明的複合膜材Z的抗衝擊強度可提高近一倍。
以上所公開的內容僅為本發明的優選可行實施例,並非因此侷限本發明的申請專利範圍,所以凡是運用本發明說明書及圖式內容所做的等效技術變化,均包含於本發明的申請專利範圍內。
Z:複合膜材
1:熱封層
2:鋁箔層
3:抗衝擊層
4:第一貼合層
5:第二貼合層
D:藥物
圖1為本發明的藥物包裝用複合膜材的結構示意圖。
圖2為本發明的藥物包裝用複合膜材的實施方式示意圖。
Z:複合膜材
1:熱封層
2:鋁箔層
3:抗衝擊層
4:第一貼合層
5:第二貼合層
Claims (10)
- 一種藥物包裝用複合膜材,其包括:一聚酯熱封層,所述聚酯熱封層含有1,4-丁二醇、間苯二甲酸、異戊二醇以及異丙醇中的至少一種衍生的殘基,而具有130℃至180℃之間的熔點;一鋁箔層,所述鋁箔層設置於所述聚酯熱封層上;以及一抗衝擊層,所述抗衝擊層設置於所述鋁箔層上。
- 如請求項1所述的藥物包裝用複合膜材,其中,所述聚酯熱封層含有1至50莫耳百分比的1,4-丁二醇衍生的殘基、1至50莫耳百分比的間苯二甲酸衍生的殘基、1至50莫耳百分比的異戊二醇衍生的殘基及/或1至50莫耳百分比的異丙醇衍生的殘基。
- 如請求項2所述的藥物包裝用複合膜材,其中,所述聚酯熱封層含有10莫耳百分比的異戊二醇衍生的殘基以及4莫耳百分比的異丙醇衍生的殘基。
- 如請求項1所述的藥物包裝用複合膜材,其中,所述抗衝擊層的組成包括一抗衝擊性高分子,其選自於熱塑性聚酯彈性體、尼龍、聚對苯二甲酸丁二醇酯以及聚對苯二甲酸乙二醇酯-1,4-環己烷二甲醇酯所組成的群組。
- 如請求項4所述的藥物包裝用複合膜材,其中,所述抗衝擊層的組成是一聚酯組成物,所述聚酯組成物包含所述抗衝擊性高分子,且基於100重量百分比的所述聚酯組成物,所述抗衝擊性高分子的含量為1至70重量百分比。
- 如請求項5所述的藥物包裝用複合膜材,其中,所述聚酯組成物還包含一般聚酯,且基於100重量百分比的所述聚酯組成物,所述一般聚酯的含量為30至99重量百分比。
- 如請求項6所述的藥物包裝用複合膜材,其中,所述一般聚酯為聚對苯二甲酸乙二酯。
- 如請求項1所述的藥物包裝用複合膜材,其中,所述聚酯熱封層的厚度為10微米至200微米,所述鋁箔層的厚度為5微米至20微米,且所述抗衝擊層的厚度為10微米至100微米。
- 如請求項1所述的藥物包裝用複合膜材,其中,所述藥物包裝用複合膜材還包括一第一貼合層以及一第二貼合層,所述聚酯熱封層通過所述第一貼合層結合於所述鋁箔層的一表面上,且所述抗衝擊層通過所述第二貼合層結合於所述鋁箔層的相對另一表面上。
- 如請求項9所述的藥物包裝用複合膜材,其中,所述第一貼合層與所述第二貼合層各為一聚烯烴熱熔膠所形成,且所述第一貼合層與所述第二貼合層的厚度各為2微米至5微米。
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TW109128486A TWI749723B (zh) | 2020-08-20 | 2020-08-20 | 藥物包裝用複合膜材 |
CN202011447913.XA CN114074468A (zh) | 2020-08-20 | 2020-12-09 | 药物包装用复合膜材 |
JP2021078362A JP2022035974A (ja) | 2020-08-20 | 2021-05-06 | 薬品包装用複合フィルム |
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