TWI253929B - Drug solution filling plastic ampoule and production method therefore - Google Patents
Drug solution filling plastic ampoule and production method therefore Download PDFInfo
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- TWI253929B TWI253929B TW093111346A TW93111346A TWI253929B TW I253929 B TWI253929 B TW I253929B TW 093111346 A TW093111346 A TW 093111346A TW 93111346 A TW93111346 A TW 93111346A TW I253929 B TWI253929 B TW I253929B
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- layer
- plastic
- ampoule
- drug
- filled
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- 239000003708 ampul Substances 0.000 title claims abstract description 206
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- 229940079593 drug Drugs 0.000 title claims abstract description 84
- 238000011049 filling Methods 0.000 title claims abstract description 73
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- 239000003513 alkali Substances 0.000 description 1
- 229910001854 alkali hydroxide Inorganic materials 0.000 description 1
- 150000008044 alkali metal hydroxides Chemical class 0.000 description 1
- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 description 1
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- JZRWCGZRTZMZEH-UHFFFAOYSA-N thiamine Chemical compound CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N JZRWCGZRTZMZEH-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/02—Machines characterised by the incorporation of means for making the containers or receptacles
- B65B3/022—Making containers by moulding of a thermoplastic material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
- A61J1/067—Flexible ampoules, the contents of which are expelled by squeezing
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
- B29C49/04—Extrusion blow-moulding
- B29C49/04116—Extrusion blow-moulding characterised by the die
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/22—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor using multilayered preforms or parisons
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
- B65D1/09—Ampoules
- B65D1/095—Ampoules made of flexible material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
- B29C49/04—Extrusion blow-moulding
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/4273—Auxiliary operations after the blow-moulding operation not otherwise provided for
- B29C49/42808—Filling the article
Landscapes
- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Mechanical Engineering (AREA)
- Life Sciences & Earth Sciences (AREA)
- Hematology (AREA)
- Pharmacology & Pharmacy (AREA)
- Ceramic Engineering (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Manufacturing & Machinery (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Containers Having Bodies Formed In One Piece (AREA)
- Medicinal Preparation (AREA)
Description
1253929 玖、發明說明: 【發明所屬之技術領域】 本發明係關於事先將藥液填充而成的塑膠製安瓿。更詳 言之,係關於可防止水蒸氣、水蒸氣以外之氣體、光線或 藥物(藥劑、藥液、該等之溶劑等)往安瓿内部浸入或往安 咅瓦外部滲出,或可防止安訊内所收藏之藥劑、藥液、溶劑 等往安瓿内表面吸收·吸附的填充藥液之塑膠安瓿及其製 造方法。 【先前技術】 以往,收藏藥液之安瓿多使用玻璃製者。但是,玻璃安 訊所收藏的藥液pH若較高,則具有引起鹼片(alkali flake) 溶出的問題。又,亦具有安瓿開封時易於手指產生切傷之 問題、及安瓿破損之危險性、開封時所產生的碎片混入藥 液中之危險性等之問題。更且,關於玻璃安瓿中所含之鋁 於藥液中溶出的危險性,於美國食品藥物管理局(F D A )亦提 出勸告。於是,近年來,漸漸以無此些危險性的塑膠製安 咅瓦取而代之。 形成安瓿的塑膠,一般係使用具有柔軟性、且已確立安 全性之聚乙烯(PE)、聚丙烯(PP)等之聚烯烴。PE和PP雖 然對於酸性及鹼性藥物為極安定的材質,但由於對氧、空 氣、二氧化碳氣體等之吸收·穿透性極高,故不適合作為 收藏易氧化藥劑、藥液的安瓿之形成材料。尤其是,於小 容量安瓿之情況,隨著水分之穿透而令内容量減少,產生 藥液濃度顯著增大之問題。 5 312/發明說明書(補件)/93-07/93111346 1253929 於是,對於輸液袋等之薄膜成形品、輸液瓶等之吹 形品的成形材料,已進行各種於容器採用賦予防止氣 水蒸氣穿透能力(阻擂性)之多層體(層合體)的檢討。 塑膠層合體在製造薄膜和薄片時被廣泛使用,但於 之製造上,使用薄膜和薄片並不適合,故而必然地, 瓿的製造上係採用吹出成形。 關於以吹出成形所形成的安瓿,係記載於日本專 2 9 1 4 8 2 6號公報和日本專利特開昭6 0 - 2 4 8 4 4號公報中 者記載的安瓿(衛生品用容器)為使用聚環狀烯烴予以 成形者,後者記載的安瓿(注射藥劑封入用容器)則具 乙烯-醋酸乙烯酯共聚物(E V A )之鹼化物所構成的防氧 為中間層。 但是,於此等文獻中,僅記載以吹出成形形成安瓿 旨。又,此等文獻中,安瓿的密封為在注入藥液或投 劑後,將其開口部以不會產生接縫之方式,以熱封予 口而達成。此類情況中,在形成熱封部時,有伴隨著 使得多層構造被破壞之虞,其結果,恐損害採用聚環 烴或具有EVA多層構造所伴隨之防止氣體穿透能力等 用·效果。 另一方面,填充藥液之塑膠安瓿的其他製造方法可 所謂的吹出填充密封法(Blow-Fill-Seal method)(參 本專利特公昭3 3 - 8 0 7 8號公報、特公昭3 6 - 5 9 8 5號公 羅美拉葛(rommelag)公司的網頁(「 Welcome rommelag(R)」,「 BTS Process-The bottelpack 312/發明說明書(補件)/93-07/93111346 出成 體和 安瓿 於安 利第 。前 吹出 備由 層做 的要 入藥 以封 加熱 狀烯 之作 列舉 照日 報、 ! t 0 (R) 6 1253929
Pr〇cess」,「2003年 3月 19日檢索」,網際網路<URL; http://www.rornmelag.com/>) 〇 吹出填充密封法係將筒狀之熔融塑膠型坯以主金屬模具 夾住而形成安瓿本體,接著填充藥液後,以頭金屬模具連 續進行安瓿頭部的形成和密封,由於連續進行安瓿的成 形、藥液的填充、安瓿的密封,故不僅與單純的吹出成形 法為大為不同之方法,且可更加無菌地達成藥液的注入, 並具備可實現大量生產的優點。 但是,以吹出填充密封法所製造之安瓿的公知者係由PE 和PP等之聚烯烴所構成的單層體。因此,不僅以吹出填充 密封法製造層合構造之安瓿,且對形成此類層合構造之一 層賦予對於氣體、水蒸氣、光線及藥物之防止穿透能力(阻 擋性),和對於藥物之吸收附著(吸收、吸附)之防止能力在 目前之狀況均未進行任何檢討(參照日本專利特公昭 3 3 - 8 0 7 8號公報、特公昭3 6 - 5 9 8 5號公報、前述之羅美拉 葛公司之網頁、(股)姆促爾(M u t u a 1 )之網頁(參照「包裝設 備-容器成形無菌填充系統」,「2 0 0 3年3月1 9日檢索」, 網際網路 < ϋ R L·,h 11 p : / / w w w . mutual, c ο . j p > )、日新製藥(股) 之網頁(「聚乙烯瓶」,「2 0 0 3年3月1 9日檢索」,網際網 路 <URL ; http://www.yg-nissin.co.jp/BFS.htm>)0 賦予對於氣體、水蒸氣、光線及藥物之防止穿透能力(阻 擋性),和對於藥物之吸收附著的防止能力之對策,例如為 於具有耐氣體穿透性之袋中收納保存安瓿、以具有防止光 線穿透能力(光阻性)之素材覆蓋或外裝安瓿表面之方法。 7 312/發明說明書(補件)/93-07/93111346 1253929 但是,此些方法中由於需要另外的收納袋和覆蓋表面的材 料,故製造步驟變得複雜,具有製造成本上升等之問題。 【發明内容】 於是,本發明之目的在於提供可防止水蒸氣、水蒸氣以 外之氣體、光線或藥物往安瓿内部浸入或往安瓿外部滲 出,或可防止安瓿内所收藏之藥劑、藥液、溶劑等往安瓿 内表面之吸收·吸附的填充藥液之塑膠安瓿及其製造方法。 用以解決上述課題之本發明之填充藥液的塑膠安瓿,係 具備具有可撓性的容器本體部、密封該容器本體部之口部 的融黏部、和連接設置於該融黏部所構成之融黏部扭斷用 把手部,其特徵,為上述容器本體部、融黏部及把手部為 使用具備二個以上之層之筒狀型坯並且整體成形所構成 者,上述容器本體部為將上述型坯以開口模夾住而成形, 且於其内部填充藥液後將口部密封而成,且,上述型坯之 至少一層為具有由防止氣體穿透能力、防止水蒸氣穿透能 力、防止光線穿透能力、防止藥物穿透能力及防止藥物吸 收附著能力所組成群中選出之至少一種特性的機能性層。 若根據上述之填充藥液之塑膠安瓿,由於在安瓿製造上 採用吹出填充密封法,故可無菌地達成藥液的注入、密封。 並且,上述本發明之填充藥液之塑膠安瓿,係與於吹出成 形所成形之空安瓿中填充藥劑後,將開口部以不會產生接 縫之方式融黏者(參照日本專利第 2 9 1 4 8 2 6號公報和特開 昭6 0 - 2 4 8 4 4號公報記載之安瓿)不同,不必擔心口部融黏 部位之層構造受到破壞。因此,本發明之填充藥液之塑膠 8 312/發明說明書(補件)/93-07/93111346 1253929 安瓿於安瓿成形後,亦可充分發揮所期之特性(阻氣性等)。 本發明中對於機能性層所要求之特性,可列舉防止氣體 穿透能力(阻氣性)、防止水蒸氣穿透能力(水蒸氣阻擋 性)、防止光線穿透能力(光線阻擋性)、防止藥物穿透能力 (藥物阻擋性)及防止藥物吸收附著能力。此些特性係如後 述般,根據使用作為型坯中之機能性層部分中的塑膠材料 和其調配劑之種類即可決定。 另外,於日本專利特開2 0 0 1 - 7 0 3 9 9號公報中,記載可將 把手部扭斷予以開封之填充藥液的塑膠安瓿,更且對於此 類安瓿,記載可以吹出填充密封法進行製造之要旨,和可 視需要予以多層化或賦予遮光性之要旨(段落[0 0 0 7 ]、 [0012])。但是,於該公報中,對於令型坯本身多層化、或 於型坯中配置具備上述機能之素材所構成之層以令安瓿全 體賦予所欲之阻擋性,則無任何具體的記載或教示。 於本發明之填充藥液之塑膠安瓿中,其成形所用之型坯 的最内層由含有聚烯烴或聚環狀烯烴之樹脂所形成為佳。 經由令型坯之最内層為含有聚烯烴或聚環狀烯烴之樹 脂,則可使得填充藥液之塑膠安瓿的最内層,亦為使用含 有聚烯烴或聚環狀烯烴之樹脂所作成的層。聚烯烴和聚環 狀烯烴為安定的材質,且安全性已被確立,故將此材質配 置於最内層之填充藥液的塑膠安瓿,可安全地應用為醫療 用之容器。 於本發明之填充藥液之塑膠安瓿中,較佳情況為,其成 形所用之型坯為其最内層除外之至少一層係調配著色劑、 9 312/發明說明書(補件)/93-07/93111346 1253929 紫外線吸收劑及氧吸收劑所組成群中選出之至少一種之藥 劑所構成的層,且比該層更内側之層為具有防止藥物穿透 能力之層。 經由令型坯最内層除外之至少一層作成調配著色劑和/ 或紫外線吸收劑之層,則可對填充藥液之塑膠安瓿賦予防 止光線穿透能力(光線阻擋性,具體而言為對於光、紫外線 等之阻擋性)。又,令型坯最内層除外之至少一層作成調配 氧吸收劑之層,則可對填充藥液之塑膠安瓿賦予防止氧穿 透能力(阻氧性)。 調配著色劑、紫外線吸收劑或氧吸收劑所構成之層因為與藥液 等直接接觸,恐令其内部所含之著色劑等溶出。但是,若根據上 述之填充藥液的塑膠安瓿,由於在調配著色劑等而成之層之更内 側配置具有防止藥物穿透能力之層,故可防止發生著色劑等在安 瓿所收藏之藥液中溶出的問題。 配置於比上述調配著色劑等之層更内側之具有防止藥物 穿透能力之層,可列舉後述的多元醇層、聚酯層及聚環狀 婦烴層。 於本發明之填充藥液之塑膠安瓿中,其成形所用之型坯 的機能性層以 (i ) 含有聚醯胺層者; (i i ) 含有多元醇層者; (iii)含有聚酯層者;或 (i v ) 含有聚環狀烯烴層者 為佳。 10 312/發明說明書(補件)/93-07/93111346 1253929 具備如上述(i )之含有聚醯胺層之機能性層時,可對填充 藥液之塑膠安瓿賦予防止氣體穿透能力和防止水蒸氣穿透 能力。因此,此類安瓿亦可適用於收藏例如易氧化、且不 可於氧存在下保存之藥液、和可能因水分含量變化而令藥 效等產生顯著變化之藥液的用途。 具備如上述(i i )之含有多元醇層之機能性層時,可對填 充藥液之塑膠安瓿賦予防止氣體穿透能力、防止水蒸氣穿 透能力及防止藥物穿透能力及防止藥物吸收附著能力。因 此,此類安瓿亦可適用於收藏例如不可於氧存在下保存之 藥液、和可能因水分含量變化而令藥效等產生顯著變化之 藥液的用途。 例如,於安瓿具備含有著色劑、紫外線吸收劑、氧吸收 劑等藥劑之層之情況,經由於比該層更内側處配置多元 醇,可防止上述藥劑於安瓿内所填充之藥液中溶出。 具備如上述(i i i )之含聚酯層之機能性層時,可對填充藥 液之塑膠安瓿賦予防止氣體穿透能力、防止水蒸氣穿透能 力、防止藥物穿透能力及防止藥物吸收附著能力。因此, 此類安瓿亦可適用於收藏例如不可於氧存在下保存之藥 液、和可能因水分含量變化而令藥效等產生顯著變化之藥 液的用途。又,經由令聚酯層使用作為安瓶的最内層,可 防止安瓿的最内層吸收或吸附藥物。 聚環狀烯烴具有防止藥劑之吸附·收附能力、防止藥物 穿透能力(藥物阻擋性)、防止水蒸氣穿透能力,且具有透 明性優良之優點,故嘗試將其應用於醫療用容器的形成材 11 312/發明說明書(補件)/93-07/93111346 1253929 料(曰本專利特開平5 - 2 7 7 1 5 4號公報)。因此,具備如 (i v )之含有聚環狀烯烴層之機能性層時,可對填充藥 塑膠安瓿賦予防止藥物穿透能力(藥物阻擋性)、防止 吸收附著能力、防止水蒸氣穿透能力。 又,例如,於安瓿具備含有著色劑、紫外線吸收劑 吸收劑等藥劑之層時,經由於比該層更内側處配置聚 烯烴層,可防止上述藥劑於安瓿内所填充之藥液中溶 將聚環狀烯烴層使用作為安瓿之最内層時,可防止 之最内層吸收或吸附藥物。更且,於此情形中,形成 層之聚環狀烯烴以使用玻璃轉移溫度(T g )為 1 1 0 °C以 為佳。將玻璃轉移溫度為上述範圍之聚環狀烯烴使用 内層,則可藉此令吹出填充密封法所使用之成形金屬 的接縫(主金屬模具與頭金屬模具之接縫)部分,於内 填充、密閉後,防止發生漏液。聚環狀烯烴之玻璃轉 度於上述範圍中,特別以6 0〜1 0 5 °C為佳,且以6 0〜 為更佳。 另外,於曰本專利特開平5 - 2 9 3 1 5 9號公報中,雖記 用聚環狀烯烴所成形之安瓿例,但該文獻中,對於以 填充密封法製造安瓿則無任何記載,且並未提出關於 漏液問題之產生及其解決方法。 然而,聚環狀烯烴中,玻璃轉移溫度超過 1 1 0 °C者 般而言對於彎曲應力缺乏耐性,具有脆之特徵。因此 由具備使用玻璃轉移溫度為 1 1 0 °C以下之聚環狀烯烴 成之最内層、和含有玻璃轉移溫度超過 1 1 0 °C之聚環 312/發明說明書(補件)/93-07/93111346 上述 液之 藥物 、氧 環狀 出。 安瓿 最内 下者 於最 模具 容液 移溫 8 0°C 載使 吹出 上述 ,經 所構 狀烯 12 1253929 烴之層的層合體形成填充藥液之塑膠安瓿,可在内容液填 充、密閉後,防止發生漏液,並且經由折彎或扭彎安瓿之 融黏部(薄壁部),則可輕易進行安瓿的開封操作。 另外,非環狀之烯烴所構成的聚合體,相較於聚環狀烯 烴,一般而言其成形體的柔軟性高,且时衝擊性優良。因 此,形成塑膠安瓿的層合體不僅為含有環狀烯烴之層,且 具備含有非環狀聚烯烴之層時,可提高塑膠安瓿全體的耐 衝擊性。 本發明之填充藥液之塑膠安瓿亦可為以可切折之薄壁部 連結的複數之安瓿連結體。經由作成此類連結體,例如, 可輕易管理收藏同種藥液的複數個安瓿。 本發明之填充藥液之塑膠安瓿,於機能性層為具有防止 水蒸氣穿透能力或防止藥物吸收附著能力之層時,可作成 内容量為0.5〜20毫升的安瓿供使用。即,關於具備上述 (i)之聚醯胺層、上述(ii)之多元醇層、上述(iii)之聚醋 層、或上述(i v )之聚環狀烯烴層做為機能性層的塑膠安 瓿,適合應用於内容量為0.5〜20毫升的小容量安瓿。其 原因在於,内容量0.5〜20毫升的安瓿,由於收藏液的絕 對量少,收藏於安瓿中之期間的溶劑揮散,且隨著藥劑吸 收附著至安瓿,產生收藏液之性狀顯著變化之問題,經由 設置防止水蒸氣穿透能力和防止藥物吸收附著能力等優良 之聚醯胺層、多元醇層、聚酯層或聚環狀烤烴層,可防止 此類問題的發生。 本發明之填充藥液之塑膠安瓿的製造方法之特徵為: 13 312/發明說明書(補件)/93-07/93111346 1253929 將具備二個以上之層、且其至少一層為具有由防止氣體 穿透能力、防止水蒸氣穿透能力、防止光線穿透能力、防 止藥物穿透能力及防止藥物吸收附著能力所組成群中選出 之至少一種特性之機能性層的筒狀型坯,以容器本體部成 形用之下方開口模夾住,並於其内部形成空洞藉以成形出 容器本體部後, 於該容器本體部中填充藥液,其次, 成形出將該容器本體部之口部以上方開口模夾住,且密 封該口部的融黏部、和連接設置於該融黏部而成之融黏部 扭斷用把手部。 若根據上述製造方法,則可無菌地達成對填充藥液之塑 膠安瓿内注入、密封藥液。並且,於填充藥液後,令安瓿 之口部融黏密封時,可不破壞多層塑膠的層構造地形成融 黏部。 因此,上述之本發明的製造方法極適於作為可防止氣 體、水蒸氣、光線及藥劑往内部或外部穿透,或安瓿内之 藥劑、藥液、溶劑等被内表面吸收或吸附之填充藥液之塑 膠安瓿的製造方法。 於本發明之填充藥液之塑膠安瓿的製造方法中,型坯以 使用下列為佳: (a) 其最内層為含有由聚烯烴或聚環狀烯烴之樹脂所形 成者,或 (b ) 其最内層除外之至少一層為調配由著色劑、紫外線 吸收劑及氧吸收劑所組成群中選出之至少一種藥劑 14 312/發明說明書(補件)/93-07/93111346 1253929 所構成之層,且比該層更内側之層為具備防止藥物 穿透能力之層者。 上述(a )之情況,令上述方法所得之填充藥液的塑膠安 瓶,可更加安全地用作醫療用之容器。 上述(a )中,最内層為由含有聚環狀烯烴之樹脂所形成 時,根據前述同樣之理由,該聚環狀烯烴以使用玻璃轉移 溫度 1 1 0 °C以下者為佳,且以使用玻璃轉移溫度 6 0〜1 0 5 °C者為更佳。 又,於上述(a)之情形中,根據前述同樣之理由,型坯以 使用具備玻璃轉移溫度 1 1 0 °C以下之聚環狀烯烴所形成之 最内層、和玻璃轉移溫度超過 11 0 °C之聚環狀烯烴所形成 之層者為佳。 上述(b)之情況中,可對根據上述方法,所得之填充藥液 之塑膠安瓿賦予防止光線穿透能力(對於光、紫外線等之阻 擋性)。 【實施方式】 其次,一邊參照圖式一邊詳細說明本發明之填充藥液之 塑膠安瓿的製造方法。 〈填充藥液之塑膠安瓿〉 圖1及圖2為顯示本發明之填充藥液之塑膠安瓿的一實 施形態圖。 圖1所示之填充藥液之塑膠安瓿1 0具備:具有可撓性的 容器本體部1 1、將容器本體部之口部1 2密封的融黏部1 3、 和連接設置於融黏部1 3而成的把手部1 4。 15 312/發明說明書(補件)/93-07/93111346 1253929 圖2所示之填充藥液之塑膠安瓿1 8係與圖1所示之安瓿 1 0同樣地,具備:具有可撓性之容器本體部1 1、將容器本 體部之口部1 2密封的融黏部1 3、和連接設置於融黏部1 3 而成的把手部1 4。此安瓿1 8之情況,側緣部1 7彼此為透 過可扭斷之接續部1 9而連接設置。 填充藥液之塑膠安瓿的把手部 1 4 為經由折彎或扭彎而 自融黏部1 3被切離。經由扭斷把手部1 4,自融黏部1 3及 容器本體部1 1切離,則可令容器本體部1 1的口部1 2開 放,而將容器本體部1 1内所密封·填充的藥液1 5收集、 排出。 另外,形成安瓿1 0、1 8的層合體,於具備含有玻璃轉移 溫度超過 1 1 0 °C之聚環狀烯烴層之情形中,根據前述之理 由,可令融黏部1 3切離的操作簡易。 形成填充藥液之塑膠安瓿的塑膠16之特徵為,其至少一 層為具有由防止氣體穿透能力、防止水蒸氣穿透能力、防 止光線穿透能力、防止藥物穿透能力及防止藥物吸收附著 能力所組成群中選出之至少一種特性之機能性層。 填充藥液之塑膠安瓿的側緣部1 7,係在該安瓿以吹出填 充密封法予以成形時,經由將型坯以金屬模具予以夾入而 形成者。填充藥液之塑膠安瓿1 8可使用例如具備對應於連 接設置安瓿數的頭部和模頭之多頭式頭部而成形。 〈安瓿形成材料〉 於本發明之填充藥液之塑膠安瓿中,該安瓿中所含之機 能性層係如前述,具有防止氣體穿透能力、防止水蒸氣穿 16 312/發明說明書(補件)/93-07/93111346 1253929 透能力、防止光線穿透能力、防止藥物穿透能力及防止藥 物吸收附著能力所組成群中選出之至少一種特性為其特 徵。關於此類特性、及該機能性層所使用之塑膠材料種類 的對應為如前述。 本發明可使用之聚醯胺並無特別限定,可列舉例如尼龍 -6、尼龍-6,6、尼龍-6, 12、尼龍-12、伸二曱苯二胺聚醯 胺等。 本發明可使用之聚酯並無特別限定,可列舉例如聚對酞 酸乙二酯(P E T )、聚萘酸乙二酯、聚對酞酸丁二酯(P B T )等。 本發明可使用之多元醇並無特別限定,可列舉例如聚乙 烯醇(PVOH)、乙烯-乙烯醇共聚合體(EVOH)等。 本發明可使用之聚環狀烯烴並無特別限定,可列舉乙烯 與二環戊二烯類的共聚合體、乙烯與降冰片烯系化合物的 共聚合體、環戊二烯衍生物之開環聚合體、複數之環戊二 烯衍生物之開環共聚合體、及該等之氫化物等。 於本發明中,上述例示之聚環狀烯烴中特別以使用乙烯 與降冰片烯系化合物之共聚合體的氫化物、或一種以上之 環戊二烯衍生物之開環(共)聚合體之氫化物為佳。經由使 用此類聚環狀烯烴,可令安瓿的強度和防止水分穿透能力 更加良好,且,可對安瓿賦予防止氣體穿透能力。 上述聚環狀烯烴可列舉例如具有一般式(1 )所示之重複 單位與一般式(Γ )所示之重複單位的聚合物、或具有一般 式(2 )所示之重複單位的聚合物。 17 312/發明說明書(補件)/93-07/93111346 1253929
⑴
(式(1)及式(1,)中,R1、R1’、R2及V為相同或相異,表示 氫、烴殘基,或鹵素、醋、腈、σ比咬基等之極性基。R1、 R 1 ’、R2及R「亦可相互結合形成環。111及111’為1以上之整 數,η及η’為0或1以上之整數。)
(式(2)中,R3及R4為相同或相異,表示氫、烴殘基,或鹵 素、S旨、腈、吼σ定基等之極性基。R3及R4亦可相互結合形 成環。X及ζ為1以上之整數,y為0或1以上之整數。) 具有一般式(1 )及(1 ’)所示重複單位之聚合物係令一種 或二種以上之單體以公知之開環聚合方法聚合,或將所得 之開環聚合體依一般方法氫化。該聚合物之具體例可列舉 曰本 ΖΕΟΝ(股)製之商品名「ZEONOR(註冊商標)」、日本合 成橡膠(股)製之商品名「A R Τ 0 Ν (註冊商標)」等。 具有一般式(2)所示構造單位之聚合物,其單體為令一種 或二種以上之降冰片烯系單體、與乙烯依公知之方法加成 18 312/發明說明書(補件)/93-07/93111346 1253929 共聚者,和/或將其依一般方法氫化者。該聚合物之具體例 可列舉三井化學(股)製之商品名「A P E L (註冊商標)」、 TiconaGmbH製之商品名「T〇pas(註冊商標)」等。 具有上述一般式(1 )、( Γ )及(2 )所示重複單位之聚合物 中,其氫化物均為飽和聚合物,故除了氣體遮蔽性和水分 遮蔽性外,更具耐熱性和透明性,且安定性方面優良。 本發明所用之聚環狀烯烴的熔融流動速率(M F R )由安瓿 之成形性和成形品之力學特性等觀點而言,以 4〜3 0 g / 1 0 分鐘(1 9 0 °C )之範圍為佳。 本發明所用之聚環狀烯烴的分子量並無特別限定,但於 數平均分子量<Mn>方面以1萬〜10萬為佳,且以2萬〜5 萬為更佳。另夕卜,分子量可例如以環己烷做為溶劑之凝膠 滲透層析(G P C )分析而測定。 於本發明中,可使用於形成機能性層的樹脂除了上述例 示者以外,可列舉例如改質聚烯烴、聚偏氯乙烯(防止氣體 穿透能力、防止水蒸氣穿透能力)、聚丙烯腈(防止氣體穿 透能力、防止水蒸氣穿透能力、防止藥物穿透能力·防止 藥物吸收附著能力)等。 改質聚烯烴可列舉對屬無極性聚合物之聚乙烯和聚丙烯 等之聚烯烴加成羧基等之官能基者(例如,將順丁烯二酸等 不飽和羧酸予以接枝聚合而改質的聚烯烴等)等。具體例可 列舉例如三井化學(股)製之接黏性聚烯烴[商品名「A D Μ E R (R)LB540」、同公司「ADMER(R)NF510」、同公司「ADMER (R ) U F 3 0 0」等];三菱化學(股)製之高接黏性樹脂[商品名 19 312/發明說明書(補件)/93-07/93111346 1253929 「MODIC-AP (R) P512V」、同公司「MODIC-AP (R) L103」 等]等。此等改質聚烯烴根據接黏層之樹脂種類適當選擇使 用即可。 形成具有防止光線穿透能力(光線阻擋性)之層中,於塑 膠中調配下述之顏料或紫外線吸收劑即可。形成光線阻擋 性材料所用之顏料並非限定於此,但可列舉例如氧化欽、 氧化鋅、碳黑、紅色氧化鐵、二氧化矽等之無機顏料,和 献菁系、偶氮系、嗜吖酮(q u i n a c r i d ο η )系之有機顏料等。 另一方面,形成光線阻擋性材料所用之紫外線吸收劑並 非限定於此,但可列舉例如水楊酸苯酯、水楊酸對-辛基苯 酯等之水楊酸系紫外線吸收劑;2,4 -羥基二苯基酮、雙(2 -曱氧基-4-羥基-5 -苯甲醯苯基)曱烷等之二苯基酮系紫外 線吸收劑;2 -乙基己基-2 -氰基-3,3 -二苯基丙烯酸酯、和 乙基-2-氰基-3,3_二苯基丙稀酸_等之氰基丙稀酸S旨系紫 外線吸收劑;2-(5 -曱基-2-經苯基)苯并三哇、2-(3 -第三 丁基-5-曱基-2-羥苯基)-5 -氣基苯并三唑等之苯并三唑系 等。上述之顏料和紫外線吸收劑,於構成光線阻擋性層之 塑膠中添加0 . 0 1〜5重量%左右為佳。 具有防止氣體穿透能力(氣體阻擋性)之層中,尤其於形 成具有氧阻擋性之層方面,可於塑膠中調配鐵、亞硫酸氫 鈉、亞硫酸鈉、五倍子酚、抗壞血酸、生育酚等之氧吸收 劑。氧吸收劑於形成氧阻擋性層之塑膠中添加0 . 1 5〜5重 量%左右為佳。 於本發明之填充藥液之塑膠安瓿中,關於其機能性層以 20 312/發明說明書(補件)/93-07/93111346 1253929 外之層,一般以使用聚烯烴予以形成為佳。此類聚烯烴可 列舉聚乙烯、聚丙烯等之習知醫療用塑膠容器所用的各種 聚烯烴。又,亦可視需要於層間調配不飽和羧酸改質聚乙 烯、乙烯-丙烯酸共聚合體、乙烯-醋酸乙烯酯共聚合體等 之接黏性樹脂。關於形成其他層之塑膠,可調配層構成和 容器之形狀等,由廣範圍中適當選取密度、MFR等之性狀。 本發明可使用之聚烯烴並無特別限定,可採用先前公知 的各種聚烯烴。另外,各種聚烯烴中,尤其以使用聚乙烯 和聚丙稀為佳。 聚乙烯(P E )可使用所謂之高壓法(分支狀)低密度聚乙烯 (HP-LDPE)、直鏈狀低密度聚乙烯(LLDPE)、中密度聚乙烯 (MDPE)、高密度聚乙烯(HDPE)等之各種PE°PE之密度可由 0.900g/cm3至0.965g/cm3為止之PE塑膠的一般範圍中適 當選取。由與使用聚環狀烯烴所成層之成形性和安瓿之力 學特性等觀點而言,以較低密度之範圍,具體而言於0. 9 1 0 〜0.930g/cm3之範圍中選擇為佳。PE 之熔融流動速率 (M F R ),由與使用聚環狀稀烴所成層之成形性和安訊之力學 特性等觀點而言,以0 · 2〜2 0 g / 1 0分鐘(1 9 0 °C )為佳。 PE並不限定於同元聚合體,亦可為共聚物。此時之共聚 單體以丁烯-1、戊烯-1、己烯-1,4 -甲基戊烯-1、辛烯-1、 癸烯-1等之α _烯烴類為佳。共聚單體之含有比例為2 0莫 耳%以下為佳,且以3〜2 0莫耳%左右為更佳。 關於聚丙烯(Ρ Ρ )之種類、性狀並無特別限定,但以採用 一般之順聯(i s 〇 t a c t i c) Ρ Ρ 或間規(s y n d i 〇 t a c t i c ) Ρ Ρ (即,結 21 312/發明說明書(補件)/93-07/93111346 1253929 晶性之同元聚合體、或以此等做為主成分之結晶性共聚物 較為適當。該結晶性共聚合體中之共聚單體以乙烯、丁烯 -1等之α -烯烴類為佳。共聚單體之含有比例較佳為3 0莫 耳%以下,更佳為 2〜3 0莫耳%左右,再佳為 3〜2 5莫耳% 左右。Ρ Ρ之熔融流動速率(M F R )由與使用聚環狀烯烴所成 層之成形性和安瓿之力學特性等觀點而言,以 0 . 2〜 2 0 g / 1 0 分鐘(1 9 (ΓC )為佳。 對本發明之塑膠安瓿賦予防止氧穿透能力(氧阻擋性)方 面,於塑膠中調配鐵、亞硫酸氫鈉、亞硫酸鈉、五倍子酚、 抗壞血酸、生育酚等之氧吸收劑即可。氧吸收劑為於形成 氧阻擋性層之塑膠中添加0 . 1 5〜5重量%為佳。又,於形成 本發明之塑膠安瓿的塑膠中,可適當適量地混合丁基羥基 甲苯、十八烧基-3-(3,5-二-第三丁基-4 -經苯基)丙酸S旨等 之安定化劑;銀-沸石、檜木醇(h i η 〇 k i t i ο 1 )等之抗菌劑; 酞酸酯等之可塑劑等。使用調配此類添加劑之塑膠時,將 安瓿作成層合體、且將調配上述添加劑之塑膠層做為内壁 面側以外之層為佳。 〈安瓿之層構造〉 本發明之填充藥液之塑膠安瓿的最内層以使用聚乙烯和 聚丙烯所代表之聚烯烴、或聚環狀烯烴為佳。聚烯烴和聚 環狀烯烴係如前述,對於藥劑、藥液之安全性和安定性已 被確立,且融黏性亦優良。 具有防止藥物穿透能力(藥物阻擋性)之層若配置於比塑 膠安瓿之最内層更外側、且比其他機能性層更内側,於充 312/發明說明書(補件)/93-07/93111346 22 1253929 分發揮藥物阻擋性層之作用·效果上為佳。 〈配合劑等〉 形成本發明之填充藥液之塑膠安瓿的塑膠,亦可視需要 而混合。又,亦可視需要適當適量地混合丁基羥基曱苯、 十八烧基-3- (3,5 -二-第三丁基-4-經苯基)丙酸3旨等之安 定化劑;銀-沸石、檜木醇等之抗菌劑;酞酸酯等之可塑劑 等。關於調配此類添加劑所構成之層,以配置於比藥物阻 擋性層更外側為佳。 〈製造方法等〉 本發明之填充藥液之塑膠安瓿可使用具備多層擠壓機及 多層吹出用模頭之吹出填充密封機予以製造。 具體而言,首先,將具備二個以上層之筒狀型坯,以使 用多層吹出用模頭之擠壓成形予以形成。此型坏使用至少 一層為具有防止氣體穿透能力(氣體阻擋性)、防止水蒸氣 穿透能力(水分阻擋性)、防止光線穿透能力(光線阻擋 性)、防止藥物穿透能力(藥劑阻擋性)及防止藥物吸收附著 能力所組成群中選出之至少一種特性之機能性層。其次, 將此筒狀型坏以容器本體部成形用之下方開口模夾住,於 内部壓入空氣,或者,由金屬模具面穴吸引型坯而成形出 容器本體部,並對該容器本體部填充指定及指定量之藥 液。更且,將該容器本體部之口部以上方開口模夾住,成 形出將該口部密封的融黏部、和連接設置於該融黏部之融 黏部扭斷用把手部,即可製造本發明之填充藥液之塑膠安 瓿。型坯之層構造根據填充藥液之塑膠安瓿所要求之層構 312/發明說明書(補件)/93-07/93111346 23 1253929 造而適當設定即可。 關於以吹出填充密封法製造安瓿的條件,並無特別 定,根據通常的製造條件即可。關於型坯之熔融擠壓溫 和熔融擠壓速度,可根據所用樹脂和目的容器之形狀等 適當設定。 填充藥液之塑膠安瓿的總厚度以 3 0 0〜2 0 0 0 // m左右 佳。機能性層之厚度並無特別限定,可根據該層所具有 機能種類和使用目的等而適當選擇,通常為 1 0〜3 0 0 / 左右為佳。 〈可收藏之藥劑、藥液〉 本發明之塑膠安瓿中所收藏之藥液並無特別限定,可 據機能性層所具有之機能特性而適當選擇。 例如關於易氧化藥劑之溶液,收藏於本發明之塑膠安 中具備具有防止氣體穿透能力(氣體阻擋性)之層即可。 氧化藥劑可列舉例如維生素A等之維生素類;半胱胺酸 色胺酸等之胺基酸;還原型麩胱甘肽、脂肪乳劑、脂質 製劑等。 關於光劣化性藥劑之溶液,收藏於本發明安瓿中具備 有防止光線穿透能力(光線阻擋性)之層即可。光劣化性 劑可列舉例如維生素B 2、維生素B 1 2等之維生素類;鹽 溴克辛(B r 〇 in h e X i n e h y d r 〇 c h 1 〇 r i d e )、含糖氧化鐵劑、 酸阿托品、新斯的明(N e〇s t i g m i n e )、胺基丙炔_ ( A m i Propiolone)、氟旅 σ定醇(Haloperidol)、鹽酸麻黃 (Ephedrine hydrochloride)等 〇 31万發明說明書(補件)/93-07/93111346 限 度 而 為 之 t m 根 瓿 易 、 體 具 藥 酸 硫 η〇 驗 24 1253929 關於吸收吸附性藥劑之溶液,收藏於本發明安瓿中具備 具有防止藥物吸收附著能力之層即可。吸收附著性藥劑可 列舉例如維生素 D等之維生素類;硝基甘油;依降鈣素 (Elcatonin)等。 (實施例) 其次,列舉實施例,說明本發明之填充藥液的塑膠安瓿。 關於填充藥液之塑膠安瓿的形成材料,其簡寫、物性等 示於下。 (聚烯烴) • PE1:乙烯· 1-丁烯共聚合體(密度 〇.92g/cm3,熔融流 動速率(MFR)l. 0克/10分鐘(190°C ),商品名「ULTZEX 2 0 1 0 B」,三井化學(股)製) • PE2:於PE1中,將有機顏料(商品名「CR0M0PHTALYELL0W GR」和 r CROMOPHTAL YELLOW AGR」,均為 Ciba Geigy 公司 製)分別混合0 · 2重量%者。(具有防止紫外線穿透能力(紫 外線阻擋性)之塑膠) • P E 3 :於P E 1中,將做為氧吸收劑之亞硫酸鈉(平均粒徑約 8 // m )混合1 0重量%者。(具有防止氧穿透能力(氧阻擋性) 之塑膠) • PP1 :順聯聚丙烯(密度 0. 91g/cm3,MFR 1 . 6克/1 0分鐘 (2 3 ◦ °C ),物品編號「J 7 0 4」,三井化學(股)製) .PP2:於PP1中,將有機顏料(商品名「CR0M0PHTALYELL0W GR」和「CROMOPHTAL YELLOW AGR」)分別以0 . 2重量0/〇混合° (具有防止紫外線穿透能力之塑膠) 25 312/發明說明書(補件)/93-07/93111346 1253929 (改質聚烯烴) • A D 1 :順丁烯二酸改質聚乙烯(密度〇 · 9 2 g / c m3,M F R 0 · 9克 / 1 0分鐘(1 9 0 °C ),商品名「a D Μ E R Ν Β 5 5 Ο」,三井化學(股) 製) (多元醇) • EVOH1 :乙烯.乙烯醇共聚合體(融點175°C,MFR1· 6克/10分 鐘(190°C ),商品名「EVAL EP-H101」,KURARAY(股)製) (聚環狀烯烴) • COP 1 :降冰片烯系單體之開環聚合體氫化物(比重丨.〇 }, M F R 2 0克/ 1 0分鐘(2 8 0。(:),玻璃轉移溫度(T g ) 1 0 5 °C,商品 名「ZEONOR 1020R」,日本 ΖΕΟΝ(股)製) • C Ο Ρ 2 :降冰片烯系單體之開環聚合體氫化(比重丨.〇丨,μ f R 27克/分鐘(280 °0:),丁忌70。〇,商品名「2£(^01?7501?」,日 本ΖΕΟΝ(股)製) • C Ο Ρ 3 :降冰片烯系單體之開環聚合體氫化物(比重1 · 〇
1 ,MFR 20 克 / 分鐘(28(TC),Tgl36°C ,商品名「ZEONOR 1420R」日本ΖΕΟΝ(股)製) •COC1:乙烯與四環十二碳烯之共聚合體(比重1〇3,MFr25 克/10分鐘(260 °(:),了忌105。(:,商品名「人?£1^?160111'」, 三井化學(股)製) •C0C2:乙烯與四環十二碳烯之共聚合體(比重1〇2,MFR40 克 / 1 0 分鐘(1 9 0 °C ),T g 8 0 °C ,商品品「 APEL APL 6509」,三井化學(股)製) •C0C3:乙烯與四環十二碳烯之共聚合體(比重丨〇2,MFR40 26 312/發明說明書(補件)/93-07/93111346 1253929 克/ 1 0分鐘(1 9 (TC 三井化學(股)製) (聚酸胺) • N Y 1 ·.間二曱苯二 r MX NYLON 6001j (聚酯) • P E T 1 :聚對S大酸乙 製) 〈填充藥液之塑膠与 (實施例1 ) 使用具備二層吹 C 0 P 1 (聚環狀烯烴) 之外層,且於内部 成之二層構造的填 安瓿1 0為具有圖: // m、夕卜層 7 0 0 // in (實施例2 ) 使用具備二層吹 將C 0 P 1 (聚環狀烯 比例混合之塑膠所 外層,且於内部填 之二層構造的填充 瓿1 0為具有圖1户 外層 7 0 0 // m。 ),T g 7 0 °C ,商品名「APEL APL8008」, 胺-己二酸縮聚體(融點 2 4 3 °C ,商品名 ,三菱氣體化學(股)製) 二酯(商品名「三井P E T」,三井化學(股)
瓿的製造〉 出用模頭之吹出填充密封機,製造具備 所構成之内層、和 P E 1 (聚烯烴)所構成 填充0 . 0 0 5 %硝基甘油水溶液1 0毫升而 充藥液之塑膠安瓿(内容積1 0毫升)。此 所示之形狀,腔部之壁厚為内層1 0 0
出用模頭之吹出填充密封機,製造具備 煙)與P E 1 (聚稀烴)以5 0 : 5 0 (重量比)之 構成的内層、和 P P 1 (聚烤烴)所構成之 充0, 0 0 5 %項基甘油水溶液2 0毫升而成 藥液之塑膠安瓿(内容積20毫升)。此安 ί示之形狀,腔部之壁厚為内層1 0 0以in、 312/發明說明書(補件)/93-07/93111346 27 1253929 (實施例3 ) 使用具備三層吹出用模頭之吹出填充密封機,製造具備 P E 1 (聚烯烴)所構成之内層、C Ο P 1 (聚環狀烯烴)所構成之中 間層、及P E 1所構成之外層,且於内部填充0 . 0 0 5 %硝基甘 油水溶液 1 0毫升而成之三層構造的填充藥液之塑膠安瓿 (内容積10毫升)。此安訊10為具有圖1所示之形狀,腔 部之壁厚為内層50//m、中間層100//m、外層700//Π1。 (實施例4 ) 除了使用將COP1與PE1(聚烯烴)以50:50(重量比)之比 例混合者代替單獨之 C 0 P 1 (聚環狀烯烴)作為形成中間層 的塑膠、安瓿之内容積為5毫升、且安瓿内填充之0.005% 硝基甘油水溶液量為5毫升以外,以同實施例3之處理, 製造三層構造之填充藥液之塑膠安瓿。 (實施例5 ) 使用具備五層吹出用模頭之吹出填充密封機,製造具備 P E 1 (聚烯烴)所構成之内層、C Ο P 1 (聚環狀烯烴)和 P E 1以 5 0 : 5 0 (重量比)之比例混合之塑膠所構成的中間層(内層 側)、C 0 P 1 所構成之中間層(中間部)、C 0 P1 與 P E1 以 5 0 : 5 0 (重量比)之比例混合之塑膠所構成之中間層(外層 側)、及P E 1所構成之外層,且内部填充0 . 0 0 5 %硝基甘油 水溶液2 0毫升而成之五層構造的填充藥液之塑膠安瓿(内 容積2 0毫升)。此安瓿1 0為具有圖1所示之形狀,腔部之 壁厚為内層 5 0 // m、中間層(内層側、中間部及外層側)各 100// m、外層 700//Π1。 28 312/發明說明書(補件)/93-07/931113牝 1253929 (實施例6 ) 除了使用C〇P 1與P E 1 (聚烯烴)以8 Ο : 2 Ο (重量比)之比例 混合者代替單獨之 C 0 P 1 (聚環狀烯烴)作為形成中間層(中 間部)的塑膠、安瓿之内容積為1 0毫升、且安瓿内部填充 之0 . 0 0 5 %石肖基甘油水溶液量為1 0毫升以外,以同實施例5 之處理,製造五層構造之填充藥液之塑膠安瓿。 〈塑膠安瓿之性能評估〉 對於實施例1〜6之填充藥液之塑膠安瓿,分別施以1 0 6 °C、4 0分鐘之高壓蒸氣滅菌,其後,於6 0 °C下保存2週, 測定安瓿内所填充之硝基甘油水溶液中的硝基甘油含量。 測定結果與塑膠安瓿之層構造一起示於表 1。另外,硝基 甘油為吸收附著性高之藥劑。 測定結果為,任一種安瓿保存二週後之硝基甘油殘存量 均為9 5重量%以上,可知能充分抑制硝基甘油對於安瓿内 壁面的吸收、附著以及向安瓿外部的滲透·排出。換言之, 實施例 1〜6之安瓿防止藥物吸收附著能力和防止藥物穿 透能力均良好。其係因實施例1〜6之安瓿均具備聚環狀烯 烴層。 29 3 12/發明說明書(補件)/93-07/931 ]] 346 1253929 〈表1 > 上行:材質 中行··樹脂之混合比率(重量比) 下行:層之厚度 内層 中間層 外層 容積 内層側 中間部 外層側 (mL) 實施例 1 COP1 1 0 0 // m — — — PEI 700 // m 10 實施例 2 C0P1+PE1 (50:50) 1 00 // m — — — PP1 700 // m 20 實施例 3 PEI 50 /i m — COP1 1 0 0 // m — PEI 700 /z m 10 實施例 4 PEI 50 // m — COP1+PE1 (50:50) 1 0 0 // m — PEI 700 // m 5 實施例 5 PEI 50 // m COP1+PE1 (50:50) 1 0 0 // m COP1 1 0 0 // m C0P1+PE1 (50:50) 1 0 0 // m PEI 500 // m 20 實施例 6 PEI 50 μ m COP1+PE1 (50:50) 1 00 ^ m C0P1+PE1 (80:20) 1 0 0 // m C0P1+PE1 (50:50) 1 0 0 // m PEI 500 // m 10 〈填充藥液之塑膠安瓿的製造〉 (實施例7 ) 使用具備三層吹出用模頭之吹出填充密封機,製造具備 PE1(聚烯烴)所構成之内層、EV0H1(多元醇)所構成之中間 層、及P E 1所構成之外層,且於内部填充0 . 1 %色胺酸水溶 液10毫升而成之三層構造的填充藥液之塑膠安瓿(内容積 10毫升)。此安瓿10具有圖1所示之形狀,腔部之壁厚為 内層50#m、中間層100//m、外層700/zm。 (實施例8 ) 使用具備五層吹出用模頭之吹出填充密封機,製造具備 30 312/發明說明書(補件)/93-07/93111346 1253929 P E 1 (聚烯烴)所構成之内層、A D 1 (改質聚烯烴)所構成之中 間層(内層側)、E V Ο Η 1 (多元醇)所構成之中間層(中間部)、 A D1所構成之中間層(外層側)、及Ρ Ε1所構成之外層,且 内部填充0 . 1 %色胺酸水溶液5毫升而成之五層構造的填充 藥液之塑膠安瓿(内容積5毫升)。此安瓿10具有圖1所示 之形狀,腔部之壁厚為内層5 0 // m、中間層(内層側及外層 側)各1 0 // m、中間層(中間部)1 0 0 μ in、外層7 0 0 a m。 (實施例9 ) 使用具備四層吹出用模頭之吹出填充密封機,製造具備 Ρ Ε 1 (聚烯烴)所構成之内層、Ρ E 3 (阻氧性塑膠)所構成之中 間層(内層側)、Ε V Ο Η 1 (多元醇)所構成之中間層(外層側)、 及Ρ Ε 1所構成之外層,且内部填充 0 . 1 %色胺酸水溶液1 0 毫升而成之四層構造的填充藥液之塑膠安瓿(内容積10毫 升)。此安瓿1 0具有圖1所示之形狀,腔部之壁厚為内層 5 0 // m、中間層(内層側及外層側)各1 0 0 // m、外層6 0 0 // m。 〈塑膠安瓿之性能評估〉 對於實施例7〜9之填充藥液之塑膠安瓿,分別施以1 0 6 °C、4 0分鐘之高壓蒸氣滅菌,其後,於6 0 °C下保存二週, 測定安瓿内所填充之色胺酸水溶液中的色胺酸含量。測定 結果與塑膠安瓿之層構造等一起示於表 2。另外,色胺酸 為易氧化性的藥劑。 測定結果為,任一種安瓿於保存二週後之色胺酸殘存量 均為9 5重量%以上,可知能充分抑制色胺酸的氧化劣化。 換言之,實施例7〜9之安瓿防止氣體穿透能力(阻氣性, 31 312/發明說明書(補件)/93-07/93111346 1253929 特別係阻氧性)與防止藥物穿透能力均良好。其係因實施例 7〜9之安瓿均具備多元醇層。 〈填充藥液之塑膠安瓿的製造〉 (實施例1 0 ) 使用具備三層吹出用模頭之吹出填充密封機,製造具備 P E 1 (聚烯烴)所構成之内層、C Ο P 1 (聚環狀烯烴)所構成之中 間層、及 P E 2 (紫外線阻擋性塑膠)所構成之外層,且於内 部填充0 . 0 5 %維生素B 2水溶液1 0毫升而成之三層構造的 填充藥液之塑膠安瓿(内容積10毫升)。此安瓿10具有圖 1所示之形狀,腔部之壁厚為内層50#πι、中間層100//m、 外層 7 0 0 // m。 〈塑膠安瓿之性能評估〉 對於實施例1 0之填充藥液之塑膠安瓿,施以1 0 6 °C、4 0 分鐘之高壓蒸氣滅菌,其後,於6 0 °C下保存二週,測定安 咅瓦内所填充之維生素B 2水溶液中的維生素B 2含量。另外, 維生素B2為光劣化性之藥劑。 測定結果為,保存二週後之維生素B 2的殘存量為9 5重 量%以上,可知能充分抑制其光劣化。即,可知實施例 10 之安瓿之防止光線穿透能力(光線阻擋性)良好。其係因實 施例1 0之安訊具備調配著色劑(有機顏料)所構成之層。 又,可知亦能充分抑制外層所含之顏料溶出至維生素B 2 水溶液中。其係因在調配著色劑(有機顏料)所構成之層的 内側具備聚環狀烯烴層。 〈填充藥液之塑膠安瓿的製造〉 32 312/發明說明書(補件)/93-07/93111346 1253929 (實施例1 1 ) 使用具備五層吹出用模頭之吹出填充密封機,製造具備 P E 1 (聚烯烴)所構成之内層、A D 1(改質聚烯烴)所構成之中 間層(内層側)、Ν Υ 1 (聚醯胺;偏二曱苯二胺-己二酸聚縮合 體)所構成之中間層(中間部)、A D 1所構成之中間層(外層 側)、及P P 2 (紫外線阻擋性塑膠)所構成之外層,且於内部 填充4 Ο Ο I U / m L之棕摘酸松香油可溶化液2毫升而成之五層 構造的填充藥液之塑膠安瓿(内容積 2毫升)。此安瓿 10 具有圖1所示之形狀,腔部之壁厚為内層50//m、中間層(内 層側及外層側)各1 0 // m、中間層(中間部)1 0 0 // m、外層700 β m 〇 〈塑膠安瓿之性能評估〉 對於實施例1 1之填充藥液之塑膠安瓿,施以1 0 6 °C、4 0 分鐘之高壓蒸氣滅菌,其後,於6 0 °C、6 0 % R Η下保存二週, 測定安瓿内所填充之棕櫊酸松香油可溶化液中之棕櫚酸松 香油含量。另外,棕櫚酸松香油為易氧化性及光劣化性之 藥劑。 測定結果為,保存二週後之棕櫚酸松香油的殘存量為9 5 重量%以上,可知能充分抑制其氧化劣化及光劣化。即,可 知實施例1 1之安瓿之防止氣體穿透能力(阻氣性,特別係 阻氧性)和防止光線穿透能力(光線阻擋性)為良好。其係因 實施例1 1之安瓿具備調配著色劑(有機顏料)所構成之層。 又,可知亦能充分抑制外層中所含之顏料往棕櫚酸松香 油可溶化液中之溶出。其係因·於調配著色劑(有機顏料)所 33 312/發明說明書(補件)/93-07/93111346 1253929 構成層之内側具備聚醯胺酸。 另夕卜, 將關於 實施例 7〜1 1所 得之塑膠 安瓿的層 構造等 整理示於 表2。 〈表2 > 上行:材質 中行:樹脂之混合比率(重量比) 下行:層之厚度 内層 中間層 外層 容積 内層側 中間部 外層側 (mL) 實施例7 PE1 5 0 /i m — EVOH1 1 00 // m — PE1 70 0 // m 10 實施例8 PEI 5 0 # m AD1 1 0 // m EVOH1 1 00 // m ADI 1 0 // m PE1 70 0 // m 5 實施例9 PEI 50 /z m PE3 1 00 // m — EV0H1 1 00 // m PEI 600 // m 10 實施例10 PEI 5 0 // m — COP1 1 00 // m — PE2 700 // m 10 實施例11 PEI 5 0 // m ADI 1 0 // m NY1 1 00 // m ADI 1 0 /i m PP2 500 // m 2 〈填充藥液之塑膠安瓿的製造〉 (實施例1 2 ) 使用具備二層吹出用模頭之吹出填充密封機,製造具備 C Ο P 2 (聚環狀烯烴)所構成之内層、及 P E 1 (聚烯烴)所構成 之外層,且内部填充生理食鹽水10毫升而成之二層構造的 填充藥液之塑膠安瓿。此安瓿1 8為圖2所示之五連體,腔 部之壁厚為内層200//m、外層500//m。 (實施例1 3 ) 使用具備二層吹出用模頭之吹出填充密封機,製造具備 C Ο P 2 (聚環狀烯烴)所構成之内層、及C Ο P 3 (聚烯烴)所構成 之外層,且内部填充生理食鹽水10毫升而成之二層構造的 34 312/發明說明書(補件)/93-07/93111346 1253929 填充藥液之塑膠安瓿。此安瓿1 8為圖2所示之五 部之壁厚為内層200〆!!!、外層500//IT1。 (實施例1 4 ) 使用具備二層吹出用模頭之吹出填充密封機, C 0 C 1 (聚環狀烯烴)所構成之内層、及 P E 1 (聚烯妈 之外層,且内部填充生理食鹽水10毫升而成之二 填充藥液之塑膠安瓿。此安瓿18為圖2所示之五 部之壁厚為内層200//Π1、外層500//m。 (實施例1 5 ) 使用具備二層吹出用模頭之吹出填充密封機, C 0 C 2 (聚環狀烯烴)所構成之内層、及 P E 1 (聚烯妈 之外層,且内部填充生理食鹽水10毫升而成之二 填充藥液之塑膠安瓿。此安瓿18為圖2所示之五 部之壁厚為内層200/zm、外層500/zm。 (實施例1 6 ) 使用具備二層吹出用模頭之吹出填充密封機, C 0 C 3 (聚環狀烯烴)所構成之内層、及 P E 1 (聚婦妈 之外層,且内部填充生理食鹽水1 0毫升所構成之 的填充藥液之塑膠安瓿。此安瓿1 8為圖2所示之 腔部之壁厚為200//m、外層500//m。 (比較例1 ) 使用吹出填充密封機,製造COP3(聚環狀烯烴, 所構成,且内部填充生理食鹽水1 0毫升而成之單 塑膠安瓿。此安瓿1 8為圖2所示之五連體,腔部 312/發明說明書(補件)/93-〇7/93111346 連體,腔 製造具備 ί )所構成 層構造的 連體,腔 製造具備 i )所構成 層構造的 連體,腔 製造具備 i )所構成 二層構造 五連體, T g 1 3 6 °C ) 層構造的 之壁厚為 35 1253929 8 Ο Ο μ in。 (參考例1 ) 使用吹出填充密封機,製造C Ο Ρ 2 (聚環狀烯烴,Τ g 7 Ο °C ) 所構成,且内部填充生理食鹽水1 0毫升而成之單層構造的 塑膠安瓿1 8。此安瓿1 8為圖2所示之五連體,腔部之壁 厚為 8 0 0 // πι。 (參考例2 ) 使用吹出填充密封機,製造C 0 C 1 (聚環狀烯烴,T g 1 0 5 °C ) 所構成,且内部填充生理食鹽水1 0毫升而成之單層構造的 塑膠安瓿1 8。此安瓿1 8為圖2所示之五連體,腔部之壁 厚為 8 0 0 // m。 〈塑膠安瓿之性能評估〉 對於上述實施例1 2〜1 6、比較例1及參考例1〜2所得 之塑膠安瓿,以目視確認有無漏液。其結果,形成内層之 塑膠為聚環狀烯烴、且其玻璃轉移溫度(T g )為 1 1 0 °C以下 之實施例1 2〜1 6,於全部5 0個安瓿(五連體之安瓿1 0份) 中均未檢測出漏液。相對地,比較例1為於5 0個安瓶中有 八成之4 0個安瓿檢測出漏液。 另外,如參考例1及2所示般,塑膠安瓿亦可作為一種 聚環狀烯烴所構成的單層體而供實際使用。於此情況中, 形成安瓿全體的聚環狀烯烴以使用玻璃轉移溫度為 11 0 °C 以下者為佳。聚環狀烯烴之玻璃轉移溫度較佳為 6 0〜1 0 5 °C ,更佳為6 0〜8 (TC 。 將實施例1 2〜1 6、比較例1及參考例1〜2所得之塑膠 36 312/發明說明書(補件)/93-07/93111346 1253929 安瓿的層構造等,整理示於表3。 〈表3> 上行:材質(玻璃轉移溫. 度。c ) 下行:層 之厚度 内層 夕卜層 容積 (mL ) 實施 例 12 COP2(70〇C ) PEI 10 2 0 0 μ m 5 0 0 // m 實施 例 13 COP2(70〇C ) 2 0 0 // m COP3(70〇C ) 5 0 0 // m 10 實施 例 14 C 0 C 1 ( 1 0 5 °C ) PEI 10 2 0 0 // m 5 0 0 // m 實施 例 15 COC2(7(TC ) 2 0 0 // m PEI 5 0 0 // m 10 實施 例 16 COC3(7(TC ) 2 0 0 // m PEI 5 0 0 // m 10 比較 例 1 C 0 P 3 ( 1 3 6 °C ) 8 0 0 // m 10 參考 例 1 C0P2(70〇C ) 8 0 0 // m 10 參考 例 2 COC1 ( 1 05°C ) 8 0 0 // m 10 (產業上之可利用性) 如上所述,本發明可利用為能無菌且安定地保管、保存 易氧化藥劑、光劣化性藥劑、吸收附著製藥劑等的塑膠安 瓿,更且,可適用於此類塑膠安瓿的製造。 Φ 【圖式簡單說明】 圖1為示出本發明之填充藥液之塑膠安瓿之一實施形態 的部分剖視圖,(a )為其正面圖,(b )為其右側面圖。 圖2為示出本發明之填充藥液之塑膠安瓿之其他實施形 態的部分剖視正面圖。 (元件符號說明) 10 塑膠安瓿 11 容器本體部 37 312/發明說明書(補件)/93-07/93111346 1253929
12 口 部 13 融 黏 部 14 把 手 部 15 藥 液 16 塑 膠 17 側 緣 部 18 填 充 藥液之塑膠安瓿 19 接 續 部 312/發明說明書(補件)/93-07/93111346 38
Claims (1)
1253929 拾、申請專利範圍: 1 . 一種填充藥液之塑膠安 本體部、將該容器本體部之 置於該融黏部而成、融黏部 的塑膠安瓿,其特徵為, 上述容器本體部、融黏部 層之筒狀型坯予以一體地成 上述容器本體部為將上述 其内部填充藥液後將口部密 上述型场之至少一層為具 水蒸氣穿透能力、防止光線 及防止藥物吸收附著能力所 之機能性層。 2 .如申請專利範圍第1 中,上述型述之最内層係由 脂所形成。 3. 如申請專利範圍第 1 中,上述型坯之最内層除外 外線吸收劑及氧吸收劑所組 成之層,且較該層更内側之 層。 4. 如申請專利範圍第 1 中,上述機能性層為含有聚 5. 如申請專利範圍第 1 瓿,係具備具有可撓性之容器 口部密封的融黏部、及連接設 扭斷用把手部之填充藥液而成 及把手部係使用具備二個以上 形者, 型坯以開口模夾住成形,並於 封而成者,且 有由防止氣體穿透能力、防止 穿透能力、防止藥物穿透能力 組成群中選出之至少一種特性 項之填充藥液之塑膠安瓿,其 含有聚烯烴或聚環狀烯烴之樹 項之填充藥液之塑膠安瓿,其 之至少一層為調配著色劑、紫 成群中選出之至少一種藥劑而 層為具有防止藥物穿透能力之 項之填充藥液之塑膠安瓿,其 酸胺層者。 項之填充藥液之塑膠安瓿,其 39 312/發明說明書(補件)/93-07/93111346 1253929 中,上述機能性層為含有多元醇層者。 6 .如申請專利範圍第 1項之填充藥液之塑膠安瓿,其 中,上述機能性層為含有聚酯層者。 7. 如申請專利範圍第 1項之填充藥液之塑膠安瓿,其 中,上述機能性層為含有聚環狀烯烴層者。 8. 如申請專利範圍第 7項之填充藥液之塑膠安瓿,其 中,至少最内層為使用玻璃轉移溫度 1 1 0 °C以下的聚環狀 烯烴者。 9. 如申請專利範圍第 8項之填充藥液之塑膠安瓿,其 中,上述聚環狀烯烴的玻璃轉移溫度為6 0〜1 0 5 °C 。 1 0 .如申請專利範圍第 8項之填充藥液之塑膠安瓿,其 中,具備使用玻璃轉移溫度 1 1 0 °C以下之聚環狀烯烴所構 成的最内層、和含有玻璃轉移溫度超過 1 1 0 °C之聚環狀烯 烴之層。 1 1 .如申請專利範圍第 8項之填充藥液之塑膠安瓿,其 中,其為以可折斷之薄壁部所連結之複數安瓿的連結體。 1 2 .如申請專利範圍第1項之填充藥液之塑膠安瓿,其 中,上述機能性層為具有防止水蒸氣穿透能力和防止藥物 吸收附著能力之層,且内容量為0 . 5〜2 0毫升。 1 3 . —種填充藥液之塑膠安瓿之製造方法,其特徵為,將 具備二個以上之層、且至少一層為具有防止氣體穿透能 力、防止水蒸氣穿透能力、防止光線穿透能力、防止藥物 穿透能力及防止藥物吸收附著能力所組成群中選出之至少 一種特性之機能性層的筒狀型坏$以容器本體部成形用之 40 312/發明說明書(補件)/93-07/93111346 1253929 下方開口模夾住,並於其内部形成空洞藉以成形出容器本 體部後, 對該容器本體部填充藥液,其次, 將該容器本體部之口部以上方開口模夾住,成形出將該 口部密封之融黏部和連接設置於該融黏部而成的融黏部扭 斷用把手部。 1 4 .如申請專利範圍第1 3項之填充藥液之塑膠安瓿之製 造方法,其中,上述型坏係使用其最内層為由含有聚烯烴 或聚環狀烯烴之樹脂所形成者。 1 5 .如申請專利範圍第1 3項之填充藥液之塑膠安瓿之製 造方法,其中,上述型坯係使用其最内層除外之至少一層 為調配著色劑、紫外線吸收劑及氧吸收劑所組成群中選出 之至少一種藥劑所構成之層,且較該層更内側之層為具有 防止藥物穿透能力之層者。 1 6 .如申請專利範圍第1 4項之填充藥液之塑膠安瓿之製 造方法,其中,上述型坏為其最内層使用玻璃轉移溫度11 0 °C以下之聚環狀烯烴所形成者。 1 7 .如申請專利範圍第1 4項之填充藥液之塑膠安瓿之製 造方法,其中,上述型坯為其最内層使用玻璃轉移溫度6 0 〜1 0 5 °C之聚環狀稀烴所形成者。 1 8 ,如申請專利範圍第1 4項之填充藥液之塑膠安瓿之製 造方法,其中,上述型坯係使用具備玻璃轉移溫度 11 0 °C 以下之聚環狀烯烴所形成之最内層、和玻璃轉移溫度超過 1 1 0 °C之聚環狀烯烴所形成之層。 41 312/發明說明書(補件)/93-07/93111346
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-
2004
- 2004-04-19 US US10/554,094 patent/US8377029B2/en not_active Expired - Lifetime
- 2004-04-19 CA CA2526902A patent/CA2526902C/en not_active Expired - Fee Related
- 2004-04-19 PT PT04728250T patent/PT1616549E/pt unknown
- 2004-04-19 KR KR1020057020090A patent/KR100999705B1/ko active IP Right Grant
- 2004-04-19 JP JP2005505729A patent/JP4939054B2/ja not_active Expired - Lifetime
- 2004-04-19 AU AU2004231389A patent/AU2004231389B8/en not_active Ceased
- 2004-04-19 WO PCT/JP2004/005547 patent/WO2004093775A1/ja active Application Filing
- 2004-04-19 DK DK04728250.4T patent/DK1616549T3/da active
- 2004-04-19 EP EP04728250A patent/EP1616549B1/en not_active Revoked
- 2004-04-19 ES ES04728250T patent/ES2397136T3/es not_active Expired - Lifetime
- 2004-04-23 TW TW093111346A patent/TWI253929B/zh not_active IP Right Cessation
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2012
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Also Published As
Publication number | Publication date |
---|---|
JP4939054B2 (ja) | 2012-05-23 |
AU2004231389B2 (en) | 2009-09-17 |
JP2012135621A (ja) | 2012-07-19 |
KR100999705B1 (ko) | 2010-12-08 |
US8377029B2 (en) | 2013-02-19 |
EP1616549B1 (en) | 2012-10-10 |
WO2004093775A1 (ja) | 2004-11-04 |
JP5358694B2 (ja) | 2013-12-04 |
AU2004231389B8 (en) | 2009-10-01 |
TW200505405A (en) | 2005-02-16 |
PT1616549E (pt) | 2012-11-12 |
EP1616549A4 (en) | 2011-07-06 |
EP1616549A1 (en) | 2006-01-18 |
ES2397136T3 (es) | 2013-03-05 |
CA2526902C (en) | 2013-03-12 |
CA2526902A1 (en) | 2004-11-04 |
KR20060003896A (ko) | 2006-01-11 |
JPWO2004093775A1 (ja) | 2006-07-13 |
US20060229583A1 (en) | 2006-10-12 |
AU2004231389A1 (en) | 2004-11-04 |
DK1616549T3 (da) | 2012-11-05 |
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