TWI422491B - 複室容器 - Google Patents
複室容器 Download PDFInfo
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- TWI422491B TWI422491B TW95133476A TW95133476A TWI422491B TW I422491 B TWI422491 B TW I422491B TW 95133476 A TW95133476 A TW 95133476A TW 95133476 A TW95133476 A TW 95133476A TW I422491 B TWI422491 B TW I422491B
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- layer
- container
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- 229920000098 polyolefin Polymers 0.000 claims abstract description 44
- 125000004122 cyclic group Chemical group 0.000 claims abstract description 37
- 229920001684 low density polyethylene Polymers 0.000 claims abstract description 25
- 239000004702 low-density polyethylene Substances 0.000 claims abstract description 25
- 229920000089 Cyclic olefin copolymer Polymers 0.000 claims abstract description 19
- 239000010410 layer Substances 0.000 claims description 126
- 238000007789 sealing Methods 0.000 claims description 36
- 239000004711 α-olefin Substances 0.000 claims description 21
- 239000003814 drug Substances 0.000 claims description 13
- 239000011888 foil Substances 0.000 claims description 9
- 239000000203 mixture Substances 0.000 claims description 8
- 239000007788 liquid Substances 0.000 claims description 6
- 230000004888 barrier function Effects 0.000 claims description 5
- 229920000728 polyester Polymers 0.000 claims description 5
- 229910052751 metal Inorganic materials 0.000 claims description 3
- 239000002184 metal Substances 0.000 claims description 3
- 238000001465 metallisation Methods 0.000 claims description 3
- 238000007740 vapor deposition Methods 0.000 claims description 3
- 239000002356 single layer Substances 0.000 claims description 2
- 238000005192 partition Methods 0.000 abstract description 5
- QQONPFPTGQHPMA-UHFFFAOYSA-N propylene Natural products CC=C QQONPFPTGQHPMA-UHFFFAOYSA-N 0.000 abstract 1
- 125000004805 propylene group Chemical group [H]C([H])([H])C([H])([*:1])C([H])([H])[*:2] 0.000 abstract 1
- 239000010408 film Substances 0.000 description 94
- -1 polypropylene Polymers 0.000 description 32
- 238000000034 method Methods 0.000 description 21
- 239000004698 Polyethylene Substances 0.000 description 19
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- 229920000573 polyethylene Polymers 0.000 description 17
- 229920005989 resin Polymers 0.000 description 17
- 239000011347 resin Substances 0.000 description 17
- 229920001155 polypropylene Polymers 0.000 description 15
- 229920000642 polymer Polymers 0.000 description 11
- 229940079593 drug Drugs 0.000 description 10
- 230000004927 fusion Effects 0.000 description 10
- 238000002156 mixing Methods 0.000 description 9
- 150000001336 alkenes Chemical class 0.000 description 8
- 239000000126 substance Substances 0.000 description 8
- 229920010126 Linear Low Density Polyethylene (LLDPE) Polymers 0.000 description 6
- 229910052782 aluminium Inorganic materials 0.000 description 6
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical group [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 6
- 229920001179 medium density polyethylene Polymers 0.000 description 6
- 239000004701 medium-density polyethylene Substances 0.000 description 6
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 description 5
- 238000004519 manufacturing process Methods 0.000 description 5
- 239000000463 material Substances 0.000 description 5
- 238000003860 storage Methods 0.000 description 5
- 238000012360 testing method Methods 0.000 description 5
- 238000003466 welding Methods 0.000 description 5
- 239000003795 chemical substances by application Substances 0.000 description 4
- 229920000092 linear low density polyethylene Polymers 0.000 description 4
- 239000004707 linear low-density polyethylene Substances 0.000 description 4
- 239000000178 monomer Substances 0.000 description 4
- 229920000139 polyethylene terephthalate Polymers 0.000 description 4
- 239000005020 polyethylene terephthalate Substances 0.000 description 4
- WOCIAKWEIIZHES-UHFFFAOYSA-N ruthenium(iv) oxide Chemical compound O=[Ru]=O WOCIAKWEIIZHES-UHFFFAOYSA-N 0.000 description 4
- 125000004432 carbon atom Chemical group C* 0.000 description 3
- 229920001577 copolymer Polymers 0.000 description 3
- 239000007789 gas Substances 0.000 description 3
- 239000002985 plastic film Substances 0.000 description 3
- 239000005977 Ethylene Substances 0.000 description 2
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 2
- 229920003355 Novatec® Polymers 0.000 description 2
- 229910004298 SiO 2 Inorganic materials 0.000 description 2
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- 229920006223 adhesive resin Polymers 0.000 description 2
- 125000000217 alkyl group Chemical group 0.000 description 2
- 229910000420 cerium oxide Inorganic materials 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- ZSWFCLXCOIISFI-UHFFFAOYSA-N cyclopentadiene Chemical compound C1C=CC=C1 ZSWFCLXCOIISFI-UHFFFAOYSA-N 0.000 description 2
- 150000002430 hydrocarbons Chemical group 0.000 description 2
- 229910052739 hydrogen Inorganic materials 0.000 description 2
- 239000001257 hydrogen Substances 0.000 description 2
- 238000010030 laminating Methods 0.000 description 2
- RLAWWYSOJDYHDC-BZSNNMDCSA-N lisinopril Chemical compound C([C@H](N[C@@H](CCCCN)C(=O)N1[C@@H](CCC1)C(O)=O)C(O)=O)CC1=CC=CC=C1 RLAWWYSOJDYHDC-BZSNNMDCSA-N 0.000 description 2
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- 230000001954 sterilising effect Effects 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 229920001169 thermoplastic Polymers 0.000 description 2
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- 239000004416 thermosoftening plastic Substances 0.000 description 2
- LIKMAJRDDDTEIG-UHFFFAOYSA-N 1-hexene Chemical compound CCCCC=C LIKMAJRDDDTEIG-UHFFFAOYSA-N 0.000 description 1
- KWKAKUADMBZCLK-UHFFFAOYSA-N 1-octene Chemical compound CCCCCCC=C KWKAKUADMBZCLK-UHFFFAOYSA-N 0.000 description 1
- HECLRDQVFMWTQS-RGOKHQFPSA-N 1755-01-7 Chemical compound C1[C@H]2[C@@H]3CC=C[C@@H]3[C@@H]1C=C2 HECLRDQVFMWTQS-RGOKHQFPSA-N 0.000 description 1
- JOYRKODLDBILNP-UHFFFAOYSA-N Ethyl urethane Chemical compound CCOC(N)=O JOYRKODLDBILNP-UHFFFAOYSA-N 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- PNEYBMLMFCGWSK-UHFFFAOYSA-N aluminium oxide Inorganic materials [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 1
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- 238000007796 conventional method Methods 0.000 description 1
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- 238000009820 dry lamination Methods 0.000 description 1
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- 238000010828 elution Methods 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
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- 229920002457 flexible plastic Polymers 0.000 description 1
- 230000005251 gamma ray Effects 0.000 description 1
- 238000005984 hydrogenation reaction Methods 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 239000003999 initiator Substances 0.000 description 1
- 239000005001 laminate film Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
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- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 239000011859 microparticle Substances 0.000 description 1
- 229920006284 nylon film Polymers 0.000 description 1
- JRZJOMJEPLMPRA-UHFFFAOYSA-N olefin Natural products CCCCCCCC=C JRZJOMJEPLMPRA-UHFFFAOYSA-N 0.000 description 1
- 239000003505 polymerization initiator Substances 0.000 description 1
- 238000006116 polymerization reaction Methods 0.000 description 1
- 230000000379 polymerizing effect Effects 0.000 description 1
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 238000010526 radical polymerization reaction Methods 0.000 description 1
- 238000007151 ring opening polymerisation reaction Methods 0.000 description 1
- 239000002344 surface layer Substances 0.000 description 1
- 229920001897 terpolymer Polymers 0.000 description 1
- 239000010409 thin film Substances 0.000 description 1
Classifications
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- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
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Landscapes
- Health & Medical Sciences (AREA)
- Mechanical Engineering (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Package Specialized In Special Use (AREA)
- Packages (AREA)
- Wrappers (AREA)
- Laminated Bodies (AREA)
- Vacuum Packaging (AREA)
Description
本發明係有關於一種複室容器、特別是醫療用多層複室容器,複室容器具有藉由連接片隔離之複數小容器,該連接片具有能夠剝離的密封層(稱為易剝離性密封層),更詳言之,係有關於一種複室容器,藉由剝離具有易剝離性密封層之連接片,能夠將複數小容器連通,混合收容在兩小容器中的內容物。
以往,為了分開收容液劑、粉末劑或固體劑之具有複數小容器的複室容器,通常係由可撓曲性塑膠薄膜形成。複數小容器之一方的小容器與鄰接之另一方的小容器係藉由能夠連通之隔開構件加以隔開。該隔開部係將形成小容器之薄膜的內面之間直接熔接、或是使嵌入薄膜介於中間而被挾持在該內面之間,進行熔接而成。該隔開部藉由對已收容內容物之小容器施加外壓,能夠容易地剝離,複數小容器之中產生連通而能夠混合所收容的內容物。
形成小容器之塑膠薄膜(包含薄片),係使用含有由直鏈狀低密度聚乙烯(LLDPE)及聚丙烯(PP)的混合樹脂所構成的內層與直鏈狀低密度聚乙烯(LLDPE)所構成的外層之2層薄膜,或是含有由直鏈狀低密度聚乙烯(LLDPE)及聚丙烯(PP)的混合樹脂所構成的內層及由直鏈狀低密度聚乙烯(LLDPE)與乙烯-α烯烴係彈性體之混合樹脂所構成的中間層及由直鏈狀低密度聚乙烯(LLDPE)所構成的外層之3層薄膜(專利文獻1、專利文獻2等)。此等多層薄膜係由直鏈狀低密度聚乙烯(LLDPE)及聚丙烯(PP)的混合樹脂所構成的內層互相以熔接溫度約110~130℃密封形成易剝離性密封層,且以熔接溫度約170~200℃密封形成強熔接層。
又,形成小容器之塑膠薄膜係使用鋁箔積層體(聚酯/鋁箔/聚乙烯之3層薄膜)、含有二氧化矽蒸鍍層之積層體薄膜(PE/SiO2
/PET/SiO2
/PE)、聚乙烯製的筒狀薄膜(專利文獻3、專利文獻4)。複室容器係由重疊含有前述鋁箔積層體及二氧化矽蒸鍍層之積層體而成的小容器、及由聚乙烯筒狀薄膜所構成的小容器所形成。此種複數小容器係在聚乙烯之內面之間,挾持介於其間之聚乙烯及聚丙烯的聚合物摻合體所構成之弱熔接部形成薄膜,進行熔接而成。
以往,形成弱熔接部之薄膜,係採用與聚乙烯(最內層的形成材料)之熔接強度小(弱熔接)的樹脂,例如將聚乙烯及與其未有具相溶性的樹脂之摻合物。
另一方面,在上述複室容器中,由於從線形聚烯烴溶出低分子量成分及由黏著層溶出成分等雜質與有效成分之藥劑相互作用,會發生藥劑含量下降、藥劑類似物質增加、藥液的濁度增加、或不溶性微粒子增加等問題。
在此種狀況下,本發明者等提案揭示一種醫療用多層複室容器,能夠γ射線滅菌,且能夠減少由此等多層容器溶出之低分子量成分及黏著層成分、能夠消除因此等成分與藥物的相互作用所造成的藥劑含量下降、藥劑類似物質增加、藥液的濁度增加、或不溶性微粒子增加等問題,而且具有藥劑安定性之醫療用多層複室容器,該醫療用多層複室容器係由含有第1層及第2層之多層薄膜所構成,該第1層係位於小容器的最內層、由環狀聚烯烴或含有環狀聚烯烴之聚合物摻合物所構成,而該第2層係由與第1層鄰接之線狀聚烯烴所構成。
[專利文獻1]特3060132號公報[專利文獻2]特3079403號公報[專利文獻3]特3016348號公報[專利文獻4]特開2003-104391號公報
本發明之課題,係至少1個小容器(複室容器)將其最內層之由環狀聚烯烴所構成的層作為主要使用容器時,提供一種密封層(易剝離性密封層),其與最內層之由環狀聚烯烴所構成的層強熔接,使用時能夠與由環狀聚烯烴所構成的層剝離而能夠將複室容器內的內容物混合。
亦即,係提供一種複室容器,具有至少最內層係由環狀聚烯烴之薄膜形成的小容器,其特徵在於一方的小容器與另一方的小容器係藉由連接片區隔,該連接片部具有易剝離性密封層,該易剝離性密封層含有低密度聚乙烯及丙烯-α烯烴共聚物。
在本發明,因為最內層的環狀聚烯烴層為非晶性,所以互相不容易弱熔接。又,以往賦與易剝離性之通常進行的方法,係藉由摻合對容器本體的材質係相同材質的樹脂與相異材料的樹脂,來使其具有易剝離性。但是使用環狀聚烯烴作為容器本體時,摻合與該材質不同的材質而成的容器本體,例如薄片會有未具易剝離性、或長期保存時易剝離性消失的情形。在本發明係與環狀聚烯烴不同材質的樹脂,其中藉由使用摻合低密度聚乙烯及丙烯-α烯烴共聚物而成的薄片,在使用時容器內的內容物能夠混合,能夠實現易剝離性、且長期間維持其強度。
在本發明,複室容器係指具有複數小容器之容器,一方的小容器與另一方的小容器係藉由連接片區隔之容器。具體的例子係收容有液劑之液劑小容器及收容藥劑之藥劑小容器,藉由具有易剝離性密封層之連接片以液體密封的方式區隔之容器。其中一個例子係在2個小容器的一方的端部,具備相向的一對連接片,該等連接片之間被另外一方的小容器的端部插入並熔接,兩小容器藉由該連接片被區隔成之容器。
在本發明,小容器係指構成複室容器之容器,其中,至少1個小容器之至少最內層係由環狀聚烯烴之薄膜所形成的容器。通常係分開收容液劑、粉末劑或固體劑之小容器。其形狀及大小係因所收容的內容物而異。構成複室容器之其他小容器,可包含最內層並非由環狀聚烯烴樹脂所形成的小容器。
在本發明,構成至少1個小容器之薄膜,係指至少最內層係含有環狀聚烯烴之單層薄膜或多層薄膜。較佳是多層薄膜,其含有第1層及第2層之多層薄膜,該第1層之最內層係環狀聚烯烴;而該第2層係鄰接該第1層、且由線狀聚烯烴所構成。
環狀聚烯烴係熱塑性飽和降烯系聚合物,係已眾所周知(特開平4-276253號公報、特開平5-317411號公報、特開平8-155007號公報等)。其具體例可舉出的有具有化學式1及/或化學式2所示結構單位之聚合物。
(式中,R1
及R2
係氫或碳數1~10的烴殘基,各自可相同或不同,又,R1
及R2
亦可互相形成環。n係正的整數)
(式中,R3
及R4
係氫或碳數1~5的烴殘基,各自可相同或不同,又,R3
及R4
亦可互相形成環。1及m係正的整數,p係0或正的整數)
具有化學式1所示結構單位之聚合物係單體,係使用例如2-降烯、及其烷基及/或亞烷基取代體,例如5-甲基-2-降烯、5,5-二甲基-2-降烯、5-乙基-2-降烯、5-丁基-2-降烯、5-亞乙基-2-降烯等;二環戊二烯、2,3-二氫二戊二烯、及該等之甲基、乙基、丙基、丁基等烷基取代體;二亞甲基八氫萘、及其烷基及/或亞烷基取代體,例如6-甲基-1,4:5,8-二亞甲基-1,4,4a,5,6,7,8,8a-八氫萘、6-乙基-1,4:5,8-二亞甲基-1,4,4a,5,6,7,8,8a-八氫萘、6-亞乙基-1,4:5,8-二亞甲基-1,4,4a,5,6,7,8,8a-八氫萘等;環戊二烯之三或四聚物,例如4,9:5,8-二亞甲基-3a,4,4a,5,8,8a,9,9a-八氫-1H-芴、5,8-亞甲基-1,4,4a,4b,5,8,8a,9b-八氫-1H-茀、4,11:5,10:6,9-三亞甲基-3a,4,4a,5,5a,6,9,9a,10,10a,11,11a-十二氫-1H-環五蒽等,將藉由眾所周知之開環聚合法聚合所得到的開環聚合物,使用通常的加氫方法進行加氫所製得之飽和聚合物。
又,具有化學式2所示結構單位之聚合物,係藉由眾所周知之聚合法將如前述之降烯系單體與乙烯共聚合而得到的聚合物及/或其加氫物,都是飽和聚合物。
在本發明所使用環狀聚烯烴,熱塑性飽和降烯系聚合物可以是極性單體之開環聚合物的加氫物、該降烯系單體與乙烯的共聚物、以及該共聚物的加氫物。
由環狀聚烯烴所形成的層,其厚度通常為3~5000微米,以5~2000微米為佳,作為醫療用複室容器使用時,其厚度通常為10~500微米,以20~300微米為佳。
鄰接由環狀聚烯烴所構成的第1層之由線狀聚烯烴所構成的第2層,可舉出的有低密度聚乙烯、直鏈狀低密度聚乙烯、中密度聚乙烯、高密度聚乙烯、聚丙烯、丙烯-α烯烴共聚物。由上述線狀聚烯烴所形成的層,其厚度通常為3~5000微米,以5~2000微米為佳,作為醫療用複室容器使用時,其厚度通常為10~500微米,以20~300微米為佳。
構成前述小容器之薄膜,在前述由線狀聚烯烴所構成的第2層上,必要時可更具有氣體阻障層及/或可印刷層。可印刷層係意指能夠將印刷墨水等介質印刷之層,用以在容器表面表示文字或圖案。在本發明,可印刷的層有例如聚對酞酸乙二酯等聚酯層、或是蒸鍍有二氧化矽等無機物之聚酯層。又,氣體阻障層具體上有金屬箔、金屬蒸鍍層或無機物蒸鍍層,金屬箔包含例如鋁箔等。金屬蒸鍍層可舉出的有氧化鋁蒸鍍聚酯薄膜或耐綸薄膜等。無機物蒸鍍層可舉出的有二氧化矽蒸鍍聚酯薄膜等。
在本發明,易剝離性密封層係意指形成小容器之薄膜互相弱熔接後,在藥劑調配時能夠容易地剝離之層。通常,易剝離性密封層係藉由對收容有內容的小容器施加外壓,能夠容易地剝離,使複數小容器中產生連通,將容器中的內容物混合。
在本發明,使小容器區隔之連接片係由前述易剝離性密封層所構成的弱熔接密封部及強熔接密封部所構成。
在本發明,弱熔接密封部其特徵係具有易剝離性密封層,該易剝離性密封層係含有低密度聚乙烯、及丙烯-α烯烴共聚物之組成物。
在本發明,低密度聚乙烯可使用例如將乙烯單體使用有機過氧化物等自由基引發劑作為聚合引發劑,藉由高壓自由基聚合法聚合而成之高壓法低密度聚乙烯。而且,在本發明,上述低密度聚乙烯係熔融流動速度(MFR)係0.5~8.0克/10分鐘的範圍內者,又,密度可使用0.900~0.930之低密度聚乙烯樹脂。可舉出的有TOSSO製「PTOROSEN」、Japan Polyethylene製「NOVATEC」、住友化學製「EKSEREN」、UBE-MARUZEN POLYETHYLENE製「UBE Polyethylene」、PRIMEPOLYMER製「MIRASON」等。又,本發明之丙烯-α烯烴共聚物之α烯烴係碳數2或4~8的α烯烴,具體上可使用乙烯、丙烯、戊烯、己烯、庚烯、辛烯或此等2種以上。亦即,本發明之丙烯-α烯烴共聚物的具體例,除了可以是丙烯-乙烯共聚物、丙烯-丁烯共聚物等二元共聚物以外,亦可以是丙烯、乙烯、丁烯共聚物等三元共聚物。
又,本發明之丙烯-α烯烴共聚物的熔點例如在100℃~150℃的範圍。市面已銷售之丙烯-α烯烴共聚物可舉出的有例如Japan Polyethylene製「NOVATEC PP」、「WINTEC」、住友化學製「EKUSEREN」、SANLLOMER製及RIMEPOLYMER製聚丙烯等。
低密度聚乙烯及丙烯-α烯烴共聚物的重量混合比例以80:20~20:80為佳,以75:25~25:75為更佳,以70:30~30:70為最佳。低密度聚乙烯大於80重量%時,使用所製得薄膜來形成易剝離性密封層時,為了剝離該易剝離性密封層之弱熔接密封強度增加,小於20重量%時,為剝離該易剝離性密封層之弱熔接密封強度變為不穩定。
本發明之連接片(亦稱為易剝離性薄片),係從前述低密度聚乙烯及丙烯-α烯烴共聚物的混合物依照常法製得。該混合物的混合方法沒有特別限定,以使用預先將樹脂顆粒乾摻合的方法、或使用雙軸擠壓機進行熔融摻合方法為佳。
本發明之易剝離性薄片,為了提升氣體阻障性、易剝離性、及力學性質等,亦可以是使易剝離性密封層之至少一方作為表面層,層壓其他樹脂的層而成之易剝離性積層薄膜。前述其他樹脂及其他樹脂的層,可按照用途選擇使用。具體上,其他樹脂可舉出的有直鏈狀低密度聚乙烯樹脂、環狀聚烯烴系樹脂等熱塑性樹脂、或此等樹脂之混合物等。
本發明之易剝離性薄片可使用T模頭成形、吹塑成形等通常熱塑性樹脂所使用的成形方法之相同方法製成薄片狀。又,易剝離性積層薄片可使用共擠壓成形、乾式層壓、擠壓塗布等方法製造。
使用上述方法所得到之本發明的易剝離性薄膜,其厚度以5~500微米左右為佳,以20~400微米為更佳。小於5微米時,會有薄膜的強度不充分、難以形成具有優良剝離性的密封層。又,大於500微米時,薄膜的柔軟性降低、薄膜的熔接亦變為困難。
又,本發明之易剝離性積層薄片,其厚度為10~500微米,以20~400微米為佳。該薄片中,具有易剝離性之薄片係佔有薄片整體厚度的5%以上,以10%以上為佳。小於5%時,由該薄片所形成的易剝離性片層的剝離強度降低。
在本發明,強熔接係指將形成小容器之薄膜熱熔接,以液體密封的方式收容內容物,同時以不會因來自外部的壓力等而產生剝離的程度進行熔接。使形成本發明的最內層之由環狀聚烯烴構成的層互相強熔接,係藉由例如在150~200℃、以壓力0.2~0.5MPa、1~3秒,進行熔接來達成。為了保持品質,例如保證3年的製品時,以在60℃、保存7星期後之T字剝離強度20N/15mm以上的強度為佳。
又,在60℃、保存7星期係指通常施行放射線滅菌過的製品,會有必須保證3年期間的品質之情形,為了在短期確認,參考規格(IAEA:TEC DOC-539(1990)),實施60℃×7天時,係相當於180天。
在本發明,弱熔接係指使上述連接片互相之間、或是使連接片與形成小容器的薄膜之最內層互相熔接後,在藥劑調配時能夠容易剝離之狀態。本發明使由低密度聚乙烯與丙烯-α烯烴共聚物之摻合物所構成的連接片互相之間、或是使該連接片與由環狀聚烯烴所構成的層為弱熔接,可藉由例如在130~170℃、以壓力0.1~0.3MPa、0.5~2秒,進行熔接來達成。為了維持弱熔接密封的品質時,例如以在60℃、保存7星期後之T字剝離強度0.5~3N/15mm範圍的強度為佳。
形成本發明之易剝離性密封層之方法沒有特別限定,可採用以往眾所周知之易剝離性密封層的製造方法。此種方法有例如以下的方法。
(1)在最內層之具有環狀聚烯烴之一側的薄膜上,使構成易剝離性密封層之小片薄膜強熔接,而使在最內層之具有環狀聚烯烴之另外一側的薄膜弱熔接於該小片薄膜上。
(2)在最內層之具有環狀聚烯烴之二片薄膜之間,插入構成易剝離性密封層之小片薄膜,設定2個模具之溫度差,一者的薄膜側為強熔接、另一者的薄膜側為弱熔接。
(3)在最內層之具有環狀聚烯烴之一側的薄膜上,使構成易剝離性密封層之小片薄膜弱熔接,而使在該小片上之具有其他層之薄膜強熔接。
本發明之小容器的製造方法沒有特別限定,可採用以往眾所周知之小容器的製造方法。此種方法有例如以下的方法。
(1)使2片薄膜前後互相重疊,同時在比兩薄膜的最下端部少許上方側的部分之間,夾住構成易剝離性密封層之薄膜,在兩薄膜的左右兩側部,在除了下端部以外的部分,以無法剝離的方式進行強熔接。接著對易剝離性密封層進行弱熔接。藉此,2片薄膜的上部側係成為往上方開口之袋狀,下端部成為前後相向之一對連接片部。此等連接片部之間係往左右兩側及下方開放。或是對構成易剝離性密封層之薄膜的下端部,使兩薄膜弱熔接,形成區隔部(弱熔接密封部),同時在其左右兩側使兩薄膜以無法剝離的方式進行強熔接。
藉此,兩薄膜的上部側成為往上方開口之袋狀,下端部成為前後相向之一對連接片部,在此等連接片部之間,係往左右兩側及下方開放。在此填充藥劑,同時使兩薄膜的上部以無法剝離的方式進行強熔接,形成第1小容器(參照專利文獻4、第3圖)。
(2)在上下開口狀之管的上端部,插入構成易剝離性密封層之薄膜,使管與構成易剝離性密封層之薄膜進行弱熔接,形成區隔部(弱熔接密封部),同時在其左右兩側使管的前後壁部以無法剝離的方式進行強熔接。接著,在管的下端部插入連接埠,將此等以無法剝離的方式進行強熔接,同時使管的下端部之剩餘的開口部以無法剝離的方式進行強熔接,接著,從連接埠往小容器填充液狀內容物,藉由開關將連接埠關閉,形成第2小容器(參照專利文獻4、第5圖)。
本發明之連接小容器的方法,沒有特別限定,可採用以往眾所周知之小容器的製造方法。此種方法有例如以下的方法。
將第1小容器之兩連接片部之間往下方大幅度開放,在兩連接片部之間,將第2小容器的上端部自下方插入,將此等熱熔接來使兩小容器連接而整體化。
以下,使用實施例來具體地說明本發明。
在實施例中T字剝離強度係使用萬能試驗機,將2片薄膜的兩端張開為180度,藉由所設置之夾頭夾住各端。在此狀態下,將一端往上方拉伸,來測定已熔接的部分之所需要應力。依照容器的大小或使用形態,弱密封強度可以有各式各樣的設定,例如使用100毫升的輸液容器時,溶解操作時之弱密封強度若為0.5~3N/15毫米時,可說係適當的狀態。
在250℃時擠出環狀聚烯烴(ZEON Japan製、商品名ZEONOA),來製造薄膜(60微米)。在該薄膜A(100毫米×155毫米)上,載置摻合低密度聚乙烯(密度0.922克/立方公分、TOSSO製、商品名PETOROSEN)及丙烯-α烯烴共聚物(Tm135℃、Japan Polypropylene製、商品名NOBATEC PP)而成的小片薄膜(混合重量比、70/30、50/50、30/70、60毫米×30毫米),使用模具溫度180℃的模具強熔接2秒。接著,在前述小片薄膜上,載置另外的環狀聚烯烴薄膜B(100毫米×155毫米),使用模具溫度150℃的模具強熔接1.5秒,進行弱熔接,來調製熔接小片薄膜而成之2片的環狀聚烯烴(A及B)。
將試料進行放射滅菌後,切割成試片(15毫米×50毫米)大小,使用萬能試驗機(INSTRON),測定剝離薄膜B與小片薄膜之T字剝離強度。又,亦測定將試料保存在60℃ 1星期、3星期或7星期時之T字剝離強度。結果如表1所示。
又,薄膜A與小片薄膜之T字剝離強度(剛製造後)為15N/15mm。
在250℃時擠出環狀聚烯烴(ZEON Japan製、商品名ZEONOA),來製造薄膜(60微米)。在該薄膜A(100毫米×155毫米)上,載置摻合低密度聚乙烯(密度0.926克/立方公分、UBE-MARUZEN POLYETHYLENE製、商品名UBE Polyethylene)及丙烯-α烯烴共聚物(Tm135℃、Japan Polypropylene製、商品名NOBATEC PP)而成的小片薄膜(混合重量比、70/30、50/50、30/70、60毫米×30毫米),使用模具溫度180℃的模具強熔接2秒。接著,在前述小片薄膜上,載置另外的環狀聚烯烴薄膜B(100毫米×155毫米),使用模具溫度155℃的模具強熔接1.5秒,進行弱熔接,來調製熔接小片薄膜而成之2片的環狀聚烯烴(A及B)。
將試料進行放射滅菌後,切割成試片(15毫米×50毫米)大小,使用萬能試驗機(INSTRON),測定剝離薄膜B與小片薄膜之T字剝離強度。又,亦測定將試料保存在60℃ 1星期、3星期或7星期時之T字剝離強度。結果如表2所示。
使用表3所示小片薄膜代替在實施例1之小片薄膜,與實施例1同樣地熔接2片環狀聚烯烴,作為試料。薄膜B與小片薄膜之間的T字剝離強度如表3所示。表3中之略號如下。
LDPE(a):密度0.922克/立方公分之低密度聚乙烯、TOSSO製、商品名PETROSEN LDPE(b):密度0.926克/立方公分之低密度聚乙烯、UBE-MARUZEN POLYETHYLENE製、商品名UBE Polyethylene LLDPE:直鏈狀低密度聚乙烯r-PP:丙烯-α烯烴共聚物h-PP:聚丙烯單獨聚合物
使用表4所示小片薄膜代替在實施例1之小片薄膜,與實施例1同樣地熔接2片環狀聚烯烴,作為試料。薄膜B與小片薄膜之間的T字剝離強度如表4所示。表4中之略號如下。
LDPE(a):密度0.922克/立方公分之低密度聚乙烯、TOSSO製、商品名PETROSEN COP:環狀聚烯烴
從表1~表4可清楚明白,使用低密度聚乙烯及丙烯-α烯烴共聚物的摻合物之小片,即使在60℃、保存7星期後,亦能夠維持易剝離性薄片。
將環狀聚烯烴(ZEON Japan製、商品名ZEONOA)與中密度聚乙烯(密度0.938)一同使用共擠壓機,在250℃時擠出來製造2層薄膜(前者30微米、後者20微米)。在該2層薄膜的中密度聚乙烯層上,使聚烯烴系黏著性樹脂介於中間,依順序層壓聚對酞酸乙二酯薄膜(三菱化學製、厚度12微米)及中密度聚乙烯薄膜(密度0.938、厚度40微米),成為4層薄膜(前薄膜)。
接著,將環狀聚烯烴(ZEON Japan製、商品名ZEONOA)與中密度聚乙烯(密度0.938)一同使用共擠壓機,在250℃時擠出來製造2層薄膜(前者30微米、後者20微米)。另外,使用聚胺基甲酸酯系黏著劑(武田藥品工業製)層壓鋁箔(SANALUMI製、厚度20微米)及聚對酞酸乙二酯薄膜(東洋紡製、厚度16微米),得到2層積層體。在前述2層薄膜之中密度聚乙烯層上,使胺基甲酸酯系黏著性樹脂介於中層來層壓2層積層體之鋁箔,製造4層薄膜(後薄膜)。
重疊四方形之前述4層膜(前薄膜)與前述4層薄膜(後薄膜),在其基端之間,夾住摻合低密度聚乙烯與丙烯-α烯烴共聚物而成的小片薄膜(混合重量比、70/30),使用上部模具溫度80℃、下部模具溫度140℃、壓力0.3MPa對一面進行強熔接,對外一面進行弱熔接。而後,對該基端側的兩端,使用170℃、壓力0.3MPa進行強熔接,形成藥劑區隔室(縱140毫米×115毫米的藥劑側袋狀容器)。在兩薄膜的基端側,剩餘有未夾住前述薄膜之未熔接部分。
該藥劑區隔室係在袋狀物的狀態下施行γ線滅菌,從前端無菌地填充10克粉末狀抗生物質,將該前端強熔接而形成袋狀容器。
Claims (9)
- 一種複室容器,其係具有至少最內層係由環狀聚烯烴之薄膜形成的小容器,其特徵在於一方的小容器與另一方的小容器係藉由連接片而區隔,該連接片係具有含低密度聚乙烯及丙烯-α烯烴共聚物之易剝離性密封層,且低密度聚乙烯及丙烯-α烯烴共聚物之組成,係以重量比為80:20~20:80。
- 如申請專利範圍第1項之複室容器,其中該易剝離性密封層,係易剝離性單層薄膜或在表面具有易剝離性層之多層薄膜。
- 如申請專利範圍第1項之複室容器,其中該連接片係由該易剝離性密封層所成之弱熔接密封部、及強熔接密封部所構成。
- 如申請專利範圍第1項之複室容器,其中構成該小容器之薄膜,係含有第1層及第2層之多層薄膜,該第1層之最內層係環狀聚烯烴;而該第2層係鄰接該第1層、且由線狀聚烯烴所構成。
- 如申請專利範圍第4項之複室容器,其中構成該小容器之薄膜,係在該由線狀聚烯烴所構成的第2層上,更具有氣體阻障層及/或可印刷層。
- 如申請專利範圍第5項之複室容器,其中該氣體阻障層係金屬箔、金屬蒸鍍層或無機物蒸鍍層。
- 如申請專利範圍第5項之複室容器,其中該可印刷層係聚酯層或具有無機物蒸鍍薄膜之聚酯層。
- 如申請專利範圍第1項之複室容器,其中該小容器係收 容液劑之小容器及收容藥劑之小容器。
- 如申請專利範圍第1項之複室容器,其中該複室容器係於2個小容器的一者之端部具備相向的一對連接片,在該等連接片之間插入另一者之小容器的端部並熔接,兩小容器係藉由該連接片而被區隔之容器。
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- 2006-09-07 AT AT06018777T patent/ATE454982T1/de not_active IP Right Cessation
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2013
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Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2005168811A (ja) * | 2003-12-11 | 2005-06-30 | Fujimori Kogyo Co Ltd | ヒートシール構造及び複室容器 |
JP2005170455A (ja) * | 2003-12-11 | 2005-06-30 | Fujimori Kogyo Co Ltd | 複室包装体及び医療用複室容器 |
Also Published As
Publication number | Publication date |
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JP4888646B2 (ja) | 2012-02-29 |
JP2007098122A (ja) | 2007-04-19 |
CN1931118A (zh) | 2007-03-21 |
DE602006011689D1 (de) | 2010-03-04 |
KR20130069701A (ko) | 2013-06-26 |
US20070062825A1 (en) | 2007-03-22 |
EP1762379A3 (en) | 2007-09-12 |
EP1762379A2 (en) | 2007-03-14 |
EP1762379B1 (en) | 2010-01-13 |
TW200720088A (en) | 2007-06-01 |
CN1931118B (zh) | 2012-01-11 |
KR101310177B1 (ko) | 2013-09-23 |
KR20070030121A (ko) | 2007-03-15 |
ATE454982T1 (de) | 2010-01-15 |
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