CN101189040A - 用于分配设备的密封件 - Google Patents
用于分配设备的密封件 Download PDFInfo
- Publication number
- CN101189040A CN101189040A CNA2006800071034A CN200680007103A CN101189040A CN 101189040 A CN101189040 A CN 101189040A CN A2006800071034 A CNA2006800071034 A CN A2006800071034A CN 200680007103 A CN200680007103 A CN 200680007103A CN 101189040 A CN101189040 A CN 101189040A
- Authority
- CN
- China
- Prior art keywords
- sealing member
- valve
- encapsulant
- propylene
- described sealing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 24
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Abstract
一种用于药物分配装置的阀密封件,所述密封件由热塑性弹性体形成,该热塑性弹性体包括具有等规结晶度的丙烯组分。
Description
本发明涉及密封材料,特别涉及包含聚烯烃热塑性弹性体的密封材料。本发明密封件可以用于分配气雾剂形式的加压流体。该密封件特别适用于加压定剂量气雾剂吸入装置(pMDI)和适合分配药物的医疗检查装置。该密封件还可以用于泵和鼻递送装置。
例如,已知GB1201918提供分配设备,其中来自加压分配容器的加压流体以受控方式通过阀释放,该阀包括弹性体密封件,所述密封件是环形的并与滑阀杆合作以打开或关闭流体出入口。FR-A-2,549,568、WO95/02651和GB2,148,912以及PCT/GB96/01551分别公开了这类分配设备的其它例子。
对于药物应用,良好密封性能必须要求的材料性质包括:化学相容性(溶胀)、拉伸强度、永久压缩变形、应力松弛、弹性模量、法规依从性(regulatory compliance)、对液体和气体的低渗透性、低水平的可萃取物和可浸出物、以及萃取后的稳定性。
因此,不仅需要良好的工程性能,而且需要卫生性能,包括低水平的可萃取物和可浸出物,否则可能使药品的杂质增加到不可接受的程度,还可能与药品、载体或赋形剂反应。为此,通常以醇基体中的溶液或悬浮液形式提供由pMDI分配的产品,这在用于吸入治疗的药物化合物的分配方面尤其常见。
用于分配装置例如pMDI的计量阀通常由金属和/或热塑性部件和弹性橡胶部件的混合体制成。密封件本身通常包含弹性体如合成橡胶,例如丁腈橡胶。
由WO00/40479已知,将两相弹性体合金材料用于喷雾阀和流量调节器组合件中的调节构件。
使用“合金化”或“共混”材料的好处包括高弹性和低硬度。例如,当将较软弹性体组分分散到热塑性材料基材中时,可以获得有利的弹性和邵氏硬度(A)值。
制造含有弹性体材料的密封件通常包括硫化/交联天然和合成橡胶的步骤。促进剂是减少硫化/交联天然和合成橡胶所需时间的化合物。例子包括硫基化合物。促进剂还可以用于改善橡胶的抗渗透性和其它物理性质。
过氧化物例如过氧化二异丙苯也可用来硫化弹性体。但是,硫化反应可以是可变的并且这可能影响材料性质,在极端情况下,材料可能变脆。此外,反应产物不得不被移除,因为它们可能使弹性体的性能变差,例如老化。另一个问题是抗氧化剂使过氧化物失活。通常需要抗氧化剂以增强弹性体的老化性能。
将包含推进剂和药物混合物的pMDI装置在室温下加压,通常到至多5巴(500kPa)。在这些条件下,来自硫化/交联反应的残留副产物可能迁移出并干扰药物机理。
因此,在大多数药物应用中,还必需萃取或洗涤硫化弹性体,以除去由硫化反应和模塑过程产生的表面残留物和副产物。例子包括乙醇和超临界流体萃取。但是已经发现延长的萃取时间导致材料性能变差。此外,萃取步骤增加生产成本。
本发明的目的是提供一种用于分配装置的密封材料,其解决了现有技术相关的至少部分问题。
因此,在第一方面,本发明提供一种用于药物分配装置的阀密封件,所述密封件由包括具有等规结晶度的丙烯组分的热塑性弹性体制成。
根据本发明的密封件由包括具有等规丙烯结晶度的聚烯烃热塑性弹性体的材料制成。
本文所用术语“密封件”是指包括存在于药物分配装置中的任意密封构件或其一部分,包括但不限于静态的或动态的垫、座和密封。
应该理解,密封件可以提供为单独的组件或可以与阀整体形成,即共模制。
聚烯烃热塑性弹性体优选包含丙烯和一种或多种α-烯烃的二元共聚物或三元共聚物。所述α-烯烃优选选自乙烯、丁烯、己烯、辛烯和癸烯中的一种或多种。
聚烯烃热塑性弹性体优选包括具有2~25%等规结晶度的丙烯,优选5~15%的等规结晶度,还优选5~10%的等规结晶度。
聚烯烃热塑性弹性体优选包含至少80%的丙烯共聚单体,更优选至少85%的丙烯共聚单体。聚烯烃热塑性弹性体优选为半结晶的。
聚烯烃热塑性弹性体的分子量(Mw)为至少100,000,更优选为至少130,000。Mw/Mn优选为1.5~2.5,更优选约2。
优选的聚烯烃弹性体包含丙烯和其它α-烯烃的共聚物,其中之一优选为乙烯。丙烯的比例为至少80%。
等规丙烯优选为线性取代的烃聚合物,其中所有或基本上所有取代基位于碳链的同一侧。聚合物优选为高度立体规整的。
优选丙烯和其它α-烯烃的半结晶的二元或三元共聚物,优选含有至少80%的具有等规立体化学的丙烯。聚合物优选表现出基本均匀的分子间/分子内的组分和结晶度分布。
聚烯烃弹性体的优选例子为Vistamaxx(RTM),其由Exxon MobilChemical Company制造。聚烯烃弹性体还可从Dow获得,名称为Versify(RTM)。
本发明人已经发现丙烯和其它α-烯烃的二元共聚物或三元共聚物可以有效地与其它聚合物和/或填料合金化或共混使用,以制造在pMDI装置中作为有效密封材料的材料。因此,优选密封材料还包含附加的热塑性组分,例如选自苯乙烯-乙烯-乙烯-丙烯、苯乙烯-乙烯-丙烯、苯乙烯-丁二烯-苯乙烯、聚醚嵌段聚酰胺、聚醚-聚酯、乙烯-二烯、聚二甲基硅氧烷/脲共聚物和/或环烯烃共聚物的聚合物,包括其两种或更多种的组合。所述一种或多种附加热塑性组分在密封材料中的量为1~40wt.%,优选为1~10wt.%,还更优选为1~5wt.%。
所述一种或多种附加热塑性组分与聚烯烃热塑性弹性体的重量比优选为1∶99~40∶60。
密封材料优选还包含矿物和/或无机填料。相对于碳黑,优选矿物填料,以使多核芳香烃化合物的形成最小化。合适的例子包括硅酸镁、硅酸铝、二氧化硅、氧化钛、氧化锌、碳酸钙、氧化镁、碳酸镁、硅酸铝镁、氢氧化铝、滑石、高岭土和粘土中的任意一种,包括其两种或更多种的组合。优选地,所述填料是或包含硅酸镁、滑石、煅烧粘土、纳米颗粒粘土、高岭土和/或氨基硅烷涂覆的粘土、或涂有钛或锆酸盐偶联剂的粘土中的一种或多种。填料在密封材料中的量通常为1~40wt.%,优选为1~30wt.%,更优选为1~20wt.%,还更优选为1~10wt.%。
密封材料优选包含如本文所述的附加热塑性组分和如本文所述的矿物/无机填料。
可以通过常规方法例如使用双螺杆混炼挤出机或通过注射成型法制造聚合物合金、混合物或共混物。因此,可以通过包括如下步骤的方法制造密封件:提供包含具有丙烯结晶度的聚烯烃热塑性弹性体和任选如本文所述的一种或多种附加热塑性组分以及任选如本文所述的一种或多种填料的组合物;和使该组合物成型为密封件。在该方法中,使组合物成型为密封件的步骤可以包括一种或多种成型技术,例如压缩成型、注射成型和/或挤出。根据本发明的密封材料特别适合注射成型,并且这是有利的,因为其将生产周期从分钟(压缩/传递成型6~10分钟)降到秒(注射成型15~25秒)。注射成型与压缩/传递过程相比还导致加工废品减少。如果需要的话,密封件还可以与热塑性材料例如PBT、尼龙和/或聚缩醛共模制。
本发明人已经发现使半结晶的丙烯二元或三元共聚物与无机/矿物填料和/或热塑性组分合金化或共混,产生具有适于药物应用的密封应用的弹性体特性的组合物。惊奇地发现这可以不使用制造合金/共混物通常所需要的增塑剂或加工助剂或相容剂而实现。因此,如果需要的话,本发明可以制造基本上不含交联剂的密封材料。所述密封材料也可以基本上不含增塑剂。所述密封材料还可以基本上不含加工助剂。所述密封材料还可以基本上不含相容剂。
在优选实施方案中,本发明提供一种用于药物分配装置的阀密封件,所述密封件由由以下组分组成或基本由以下组分组成的材料制成:
聚烯烃热塑性弹性体,其包括具有半结晶性的丙烯组分,优选丙烯和α-烯烃的共聚物;
任选的一种或多种本文所述的附加热塑性组分;和
任选的一种或多种本文所述的矿物和/或无机填料;和
任何不可避免的杂质。
根据本发明的密封材料是非常洁净的,具有通常为8~500ppm(通过GC-MS)的可萃取物(extractible)水平。
与常规EPDM和腈类弹性体相比,根据本发明的密封材料还具有良好的密封性能。令人惊奇的是,密封材料的弹性体特性在提高的条件下得到保持,例如40℃/75%RH。
尽管不必要,但是如果需要的话,密封材料还可以包含增强剂、加工助剂、增塑剂、粘合剂、稳定剂、阻滞剂、偶联剂、抗氧化剂、润滑剂、颜料、蜡、树脂、抗臭氧剂、助促进剂或活化剂中的任意一种,包括其两种或更多种的组合。抗氧化剂的例子为2,2′-亚甲基-双(6-(1-甲基-环己基)-对甲酚)和辛基化的二苯胺。
如上所述,将根据本发明的密封件用于药物分配装置的好处是存在相对低水平的可浸出物和可萃取物。因此,虽然可以乙醇萃取(即,用回流乙醇洗涤)根据本发明制备的密封件,以降低可能迁移到药物混合物中的任意可浸出物,但是该步骤不是必要的并可以省去。这和需要乙醇萃取的常规热固性橡胶形成对比。如上所述,根据本发明的密封材料具有通常为8~500ppm(通过GC-MS)的可萃取物水平。应该理解,如果需要的话,还可以通过实施萃取步骤进一步降低可萃取物水平。
根据本发明的密封件可以用于分配装置例如鼻、肺或经皮递送装置所用的阀。优选密封件用于加压定剂量气雾剂吸入装置和适于分配药物的医疗检查装置。
本文所用术语“药物”是指包括可以递送或施用至人或动物的任意药物、化合物、组合物、药剂、试剂或产品,例如药、药品、生物学或医学产品。例子包括抗过敏药、镇痛药、支气管扩张药、抗组胺药、治疗用蛋白质和肽、镇咳药、心绞痛制剂、抗生素、消炎药制剂、激素或磺胺药物;例如引起血管收缩的胺、酶、生物碱或类固醇,包括其两种或更多种的组合。特别地,例子包括异丙去甲肾上腺素[α-(异丙基氨基甲基)原儿茶醇]、苯肾上腺素、苯丙醇胺、胰高血糖素、肾上腺素红、胰蛋白酶、肾上腺素、麻黄碱、那可丁、可待因、阿托品、肝素、吗啡、二氢吗啡酮、麦角胺、东莨菪碱、美沙吡林、氰钴胺素、特布他林、利米特罗、沙丁胺醇、氟尼缩松、秋水仙碱、吡布特罗、倍氯米松、奥西那林、芬太尼和二乙酰吗啡、链霉素、青霉素、普鲁卡因青霉素、四环素、氯四环素和羟四环素、促肾上腺皮质激素和肾上腺皮质激素例如可的松、氢化可的松、醋酸氢化可的松和泼尼松、胰岛素、色甘酸钠和莫米松,包括其两种或更多种的组合。
药物可以作为游离碱或本领域常规的一种或多种盐使用,例如乙酸盐、苯磺酸盐、苯甲酸盐、碳酸氢盐、酒石酸氢盐、溴化物、乙二胺四乙酸钙盐、樟脑磺酸盐、碳酸盐、氯化物、柠檬酸盐、二盐酸化物、乙二胺四乙酸盐、乙二磺酸盐、十二烷基硫酸盐(estolate)、乙磺酸盐、富马酸盐、fluceptate、葡萄糖酸盐、谷氨酸盐、乙醇酰基阿散酸盐(glycollylarsanilate)、己基间苯二酚盐(hexylresorcinate)、氢溴化物、氢氯化物、羟基萘甲酸盐、碘化物、羟乙磺酸盐、乳酸盐、乳糖酸盐、苹果酸盐、马来酸盐、扁桃酸盐、甲磺酸盐、甲基溴化物、甲基硝酸盐、甲基硫酸盐、半乳糖二酸盐(mucate)、萘磺酸盐、硝酸盐、双羟萘酸盐、(恩波酸盐(embonate))、泛酸盐、磷酸盐、二磷酸盐、聚半乳糖醛酸盐、水杨酸盐、硬脂酸盐、碱式乙酸盐、琥珀酸盐、硫酸盐、单宁酸盐、酒石酸盐和三乙碘化物(triethiodide),包括其两种或更多种的组合。也可以使用阳离子的盐,例如碱金属,例如Na和K,以及铵盐和本领域已知的药物可接受的胺盐,例如甘氨酸、乙二胺、胆碱、二乙醇胺、三乙醇胺、十八烷基胺、二乙胺、三乙胺、1-氨基-2-丙醇-氨基-2-(羟基甲基)丙烷-1,3-二醇和1-(3,4-二羟基苯基)-2异丙基氨基乙醇。
药物通常为适于吸入并为此目的可以以任何合适的方式提供的药物,例如作为粉末或作为在溶剂或载液例如乙醇中的溶液或悬浮液。
药物可以例如为适于治疗哮喘的药物。例子包括沙丁胺醇、倍氯米松、沙美特罗、氟替卡松、福莫特罗(formoterol)、特布他林、色甘酸钠(sodium chromoglycate)、布地奈德和氟尼缩松,以及生理学可接受的盐(例如,硫酸沙丁胺醇、羟萘甲酸沙美特罗、丙酸氟替卡松、二丙酸倍氯米松和硫酸特布他林)、溶剂化物和酯,包括其两种或更多种的组合。个别异构体例如R-沙丁胺醇也可以使用。应该理解,药物可以包含一种或多种活性成分例如氟莫特罗+氟替卡松(flutiform)并可以任选地与合适的载体例如载液一起提供。如果需要的话,可以包括一种或多种表面活性剂。
根据第二方面,本发明还提供一种具有本文所述的阀的药物分配装置。所述药物分配装置可以为例如鼻、肺或经皮递送装置。优选的装置为药物定剂量气雾剂吸入装置和医疗检查装置。
本发明还提供一种用于分配加压流体的分配设备,其包括限定腔室的阀体和阀构件,该阀构件可移动地延伸通过腔室和延伸通过至少一个环形密封件,所述密封件与阀构件和阀体合作以调节流体的排放,其中所述密封件或至少一个密封件如本文参照本发明第一方面所述。
该装置可以用于分配如本文所述的在溶液或悬浮液中的药品、药物、生物试剂、药和/或产品。
在一个优选实施方案中,分配设备包括具有阀体的加压分配容器,所述阀体具有两个环形的阀密封件,阀构件可轴向滑动通过所述阀密封件,所述密封件设置在阀腔室的入口和出口孔处,使得所述阀起到计量阀的作用。
如本文所述的分配设备可以包括可操作地连接到阀体并容纳待分配流体和氢氟烷推进剂的加压分配容器,所述氢氟烷推进剂包括134a或227型推进剂。本申请中所提及的推进剂的类型的名称由BritishStandard BS4580:1970的“Specification for number designations oforganic refrigerants″规定。因此,推进剂134a为1,1,1,2-四氟乙烷(CH2F-CF3),推进剂227为1,1,1,2,3,3,3-七氟丙烷(CF3-CHF-CF3)。
待分配流体通常包括作为载液中的溶液或悬浮液的液体或颗粒产品。载液优选包含醇,例如乙醇。可以存在一种或多种表面活性剂。
实施例和附图
现在将参照表1~3和图1~8中的下列非限制性实施例进一步描述本发明。
表1列出许多根据本发明的热塑性弹性体组合物。表2列出这些组合物的物理性质。表3给出根据本发明的热塑性弹性体组合物的GC-MS分析以及常规未乙醇萃取的EPDM橡胶和常规未乙醇萃取的丁腈橡胶的GC-MS分析的结果。
图1表示使用HFA 134a+10%乙醇在20℃/60%RH和40℃/75%RH下密封组合物的渗漏性能。作为比较,还提供常规EPDM橡胶密封件的数据。所述组合物满足USP26<601>对于气雾剂的渗漏测试要求。极限值基于USP26<601>对于气雾剂的渗漏测试要求。如果年平均渗漏率不大于净充入重量的3.5%并且没有一个容器的年渗漏大于净充入重量的5%,则满足要求。显而易见地,在高测试条件下,组合物(除EF187-2B1之外)均表现出比EPDM对照物更小的渗漏。
密封组合物的喷射重量性能如图2~7所示。引入常规EPDM橡胶密封件的性能用于比较。由各合金变体的3个样品确定喷射重量性能。包内填充有HFA 134a+10%乙醇,每包喷射5次。图2将合金EF185、EF186-2 B1和EF187-2 B2的喷射重量性能与EPDM对照物比较。图3将合金EF192-1 B1、EF193-2 B1和EF194 B1的喷射重量性能与EPDM对照物比较。图4将合金EF195 B1、EF196 B1和EF197的喷射重量性能与EPDM对照物比较。图5将合金EF198 B1、EF198 B2和EF199 B1的喷射重量性能与EPDM对照物比较。图6将合金EF199 B2、EF200B1、EF200 B2和EF201 B1的喷射重量性能与EPDM对照物比较。图7将合金EF201 B2、EF202 B1和EF202 B2的喷射重量性能与EPDM对照物比较。
密封组合物在HFA 134a+10%乙醇中常温下的溶胀特性如图8所示。常温下浸7天后计算密封件直径的变化。引入常规EPDM橡胶密封件的性能用于比较。结果表明浸在HFA 134a+10%推进剂中不影响密封件直径(除EF187~2B1之外)。组合物(除EF187/2之外)表现出相当于或优于EPDM对照物的耐HFA性。
表1
热塑性弹性体组合物
Vistamaxx1100:等规丙烯和α-烯烃的共聚物
Vistamaxx1120:等规丙烯和α-烯烃的共聚物
Vistamaxx 2100:等规丙烯和α-烯烃的共聚物
Topas 8007:环烯烃的共聚物
Pebax 2533:聚醚嵌段聚酰胺的共聚物
Septon 2063:苯乙烯、乙烯、丙烯、苯乙烯嵌段聚合物
Mistron Vapor R10C:片状滑石
Dokafill 600:粘土填料
表2
物理性质
样品 | 批号 | HFI*(g/10min) | 硬度邵氏A | 水分(%) | 密度(kg/m3) | TS(N/mm2) | E(100%)(N/mm2) | E(200%)(N/mm2) | E(300g)(N/mm2) | εb(%) |
EF185EF186~2EF187~2EF192~2EF193~2 | 11111 | 5,26,910,88,88,3 | 8082697072 | 0,150,170,220,120,17 | 0,90,890,890,970,99 | 8,86,110,99,58,3 | 5,84,93,33,13,3 | 7,25,53,83,64,0 | 8,25,54,34,14,8 | 450620940790680 |
EF194EF195EF196EF197EF198 | 11111 | 8,5756,84,77,9 | 6880748075 | 0,150,200,150,200,20 | 1,051,050,920,950,99 | 9,79,810,78,08,6 | 2,94,96,66,84,0 | 3,45,48,17,84,6 | 4,16,29,47,95,4 | 800710480360630 |
EF198EF199EF199EF200EF200 | 21212 | 8,11,71,95,55,6 | 7580808281 | 0,160,100,200,190,21 | 0,981,081,061,181,17 | 9,111,611,19,59,9 | 4,05,54,95,45,2 | 4,66,45,86,05,7 | 5,37,06,76,86,3 | 700600570640700 |
EF201EF201EF202EF202 | 1212 | 1,61,41,92,4 | 80807370 | 0,150,190,170,22 | 1,161,150,990,97 | 11,711,610,410,2 | 5,45,64,14,4 | 6,46,75,05,5 | 7,47,75,86,5 | 590570580510 |
表3
合金组合物和GC-MS分析
合金 | ||||||||||||||
EF185 | EF186~2 | EF187~2 | EFl92~2 | EFl93~2 | BF194 | EF195 | EF196 | EFP197 | EF198 | EF199 | EF200 | BF201 | EF202 | |
Vigtamaxx1100 | - | - | 100 | 100 | 100 | |||||||||
Vigtamaxx1120 | - | - | 100 | 100 | ||||||||||
Vigtamaxx2100 | 60 | 60 | 80 | 100 | 100 | 80 | 60 | 100 | 100 | |||||
Topas9007 | 20 | 20 | 20 | 20 | ||||||||||
Pebax2533 | - | - | 20 | |||||||||||
Septon2063 | - | 20 | - | 20 | ||||||||||
MistronVapoxR10C | - | - | 20 | 40 | lO | 10 | 20 | 40 | 60 | 60 | ||||
Dokafill600 | - | 20 | 10 | 20 | ||||||||||
EF185 | EF186~2 | EFl87~2 | EF192~2 | EF193~2 | EF194 | EF195 | EF196 | EFl97 | EPl98 | EF199 | EF200 | EF201 | EF202 | |
合金的GC-MS分析 | 571ppm | 389ppm | 1102ppm | 350ppm | 133ppm | 314ppm | 255ppm | 6ppm | 22ppm | 88ppm | ||||
通常用于PMDI的未乙醇萃取EPDM橡胶的GC-MS分析 | ||||||||||||||
EPDM橡胶的GC-MS分析 | l874ppm | |||||||||||||
通常用于PMDI的未乙醇萃取的丁腈橡胶GC-MS分析 | ||||||||||||||
丁腈橡胶的GC-MS分析 | 3146ppm |
Claims (24)
1.一种用于药物分配装置的阀的密封件,所述密封件由热塑性弹性体制成,所述热塑性弹性体包括具有等规结晶度的丙烯组分。
2.如权利要求1所述的密封件,其中所述聚烯烃热塑性弹性体包括丙烯和一种或多种α-烯烃的二元共聚物或三元共聚物。
3.如权利要求1或2所述的密封件,其中所述α-烯烃选自乙烯、丁烯、己烯、辛烯和癸烯中的一种或多种。
4.如前述权利要求中任一项所述的密封件,其中所述丙烯组分具有2~25%的等规结晶度,优选5~15%的等规结晶度。
5.如前述权利要求中任一项所述的密封件,其中所述聚烯烃热塑性弹性体包含至少80%的所述丙烯组分。
6.如前述权利要求中任一项所述的密封件,其中所述聚烯烃热塑性弹性体的分子量(Mw)为至少100,000。
7.如前述权利要求中任一项所述的密封件,其中所述密封材料包含附加的热塑性组分。
8.如权利要求7所述的密封件,其中所述附加的热塑性组分包括选自苯乙烯-乙烯-乙烯-丙烯、苯乙烯-乙烯-丙烯、苯乙烯-丁二烯-苯乙烯、聚醚嵌段聚酰胺、聚醚-聚酯、乙烯-二烯、聚二甲基硅氧烷/脲共聚物和环烯烃共聚物中的一种或多种聚合物。
9.如权利要求7或8所述的密封件,其中所述一种或多种附加的热塑性组分在所述密封材料中的量为1~40wt.%,优选为1~10wt.%。
10.如前述权利要求中任一项所述的密封件,其中所述密封材料还包含矿物和/或无机填料。
11.如权利要求10所述的密封件,其中所述填料选自粘土、煅烧粘土、纳米颗粒粘土、滑石和氨基硅烷涂覆的粘土中的一种或多种。
12.如权利要求10或11所述的密封件,其中所述填料在所述密封材料中的量为1~40wt.%,优选为1~30wt.%。
13.如前述权利要求中任一项所述的密封件,其中所述密封材料基本不含交联剂。
14.如前述权利要求中任一项所述的密封件,其中所述密封材料基本不含增塑剂。
15.如前述权利要求中任一项所述的密封件,其中所述密封材料基本不含加工助剂。
16.如前述权利要求中任一项所述的密封件,其中所述密封材料基本不含相容剂。
17.一种用于药物分配装置的阀,其具有如权利要求1~16中任一项所限定的密封件。
18.一种药物分配装置,其具有如权利要求17所述的阀。
19.如权利要求18所述的药物分配装置,其是药物定剂量气雾剂吸入装置。
20.一种用于分配加压流体的分配设备,所述分配设备包括限定腔室的阀体和阀构件,所述阀构件可移动地延伸通过所述腔室和延伸通过至少一个环形密封件,所述密封件与所述阀构件和所述阀体合作以调节流体的排放,其中所述密封件或至少一个所述密封件如权利要求1~16中任一项所限定。
21.一种分配设备,其包括具有阀体的加压分配容器,所述阀体具有两个环形的阀密封件,阀构件可轴向滑动通过所述阀密封件,所述密封件设置在阀腔室的入口和出口孔处,使得所述阀起到计量阀的作用,其中至少一个所述环形的阀密封件如权利要求1~16中任一项所限定。
22.如权利要求20或21所述的分配设备,其包括可操作地连接到所述阀体并容纳待分配流体和氢氟烷推进剂的加压分配容器,所述氢氟烷推进剂包括134a或227型推进剂。
23.如根据权利要求20~22中任一项所述的分配设备,其中所述待分配流体包括作为在包括醇的载液中的溶液或悬浮液的液体或颗粒产品。
24.根据权利要求23所述的分配设备,其中所述醇包括乙醇。
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-
2005
- 2005-03-04 GB GB0504565A patent/GB2423994B/en active Active
-
2006
- 2006-03-03 EP EP06709995.2A patent/EP1861143B1/en active Active
- 2006-03-03 WO PCT/GB2006/000772 patent/WO2006092618A1/en active Application Filing
- 2006-03-03 BR BRPI0609029A patent/BRPI0609029B8/pt active IP Right Grant
- 2006-03-03 CN CN2006800071034A patent/CN101189040B/zh active Active
- 2006-03-03 US US11/817,448 patent/US8129474B2/en active Active
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103370265A (zh) * | 2011-02-17 | 2013-10-23 | 阿普塔尔法国简易股份公司 | 流体产品分配装置 |
CN110740950A (zh) * | 2017-06-20 | 2020-01-31 | 阿普塔尔法国简易股份公司 | 流体产品分配装置 |
CN110740950B (zh) * | 2017-06-20 | 2022-04-12 | 阿普塔尔法国简易股份公司 | 流体产品分配装置 |
Also Published As
Publication number | Publication date |
---|---|
GB2423994A (en) | 2006-09-13 |
GB0504565D0 (en) | 2005-04-13 |
BRPI0609029B8 (pt) | 2021-06-22 |
US20080230567A1 (en) | 2008-09-25 |
WO2006092618A1 (en) | 2006-09-08 |
BRPI0609029B1 (pt) | 2018-02-14 |
BRPI0609029A2 (pt) | 2010-11-16 |
EP1861143A1 (en) | 2007-12-05 |
GB2423994B (en) | 2008-07-30 |
US8129474B2 (en) | 2012-03-06 |
CN101189040B (zh) | 2012-07-04 |
EP1861143B1 (en) | 2017-05-03 |
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