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CN104689377A - 用于积分或切割气囊导管的改进涂层制剂 - Google Patents

用于积分或切割气囊导管的改进涂层制剂 Download PDF

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CN104689377A
CN104689377A CN201510083319.XA CN201510083319A CN104689377A CN 104689377 A CN104689377 A CN 104689377A CN 201510083319 A CN201510083319 A CN 201510083319A CN 104689377 A CN104689377 A CN 104689377A
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antioxidant
oxidized
paclitaxel
balloon catheter
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U·施佩克
M·C·伯格
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Anchosger Co ltd
Spectronix Co ltd
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Abstract

本发明涉及积分或切割气囊导管，其至少部分表面载有至少一种氧化不敏感药物或不含聚合物的氧化不敏感药物制剂，和至少一种亲脂性抗氧化剂，至少一种亲脂性抗氧化剂的比例为相对于100重量％药物的3-100重量％，其中至少一种氧化不敏感药物选自紫杉烷类、沙利度胺、他汀类、皮质激素类和皮质激素类的亲脂性衍生物，并且至少一种亲脂性抗氧化剂选自去甲二氢愈创木酸、白藜芦醇和没食子酸丙酯。

Description

用于积分或切割气囊导管的改进涂层制剂
本分案申请是基于申请号为201080066293.3，申请日为2010年11月3日，发明名称为“用于积分或切割气囊导管的改进涂层制剂”的原始中国专利申请的分案申请。
发明领域
本发明涉及松散粘附在积分或切割气囊导管(scoring or cuttingballoon catheter)表面的药物向体内、通常在患病的血管内部位的传递。优选的申请是在经皮腔内血管成形术(PTA)或经皮腔内冠状动脉成形术(PTCA)的过程中的局部药物治疗。进行这种干预来恢复狭窄或闭塞血管中的血流、通常进入动脉的血流。在主动脉中引入导管。在远端处，导管载有直径非常小的折叠状圆柱形气囊以及挖出或切割被治疗血管或组织腔表面的额外工具或结构。在折叠状态下，气囊可进入或通过例如血管的狭窄或闭塞段。一旦定位于狭窄段，对气囊充气使血管的内腔扩大到其原始直径。同时，药物被传递到管壁上，以预防由于损伤管壁过度增生产生的早期和晚期再狭窄。
发明背景
医疗设备可以包含改善耐受性、有效性或设备体内使用期限的药物，或者设备用作药物载体。在任何情况下，剂量密度(例如mg药物/mg设备或mg药物/mm2设备表面)、化学稳定性、粘附性、释放速率和释放总量都很重要，并且往往是药物制剂的关键特征。这些性质越关键，对于设备的生产和应用的要求会变化得越多甚至相反。典型的例子是药物涂覆的血管成形术导管：药物涂层必须牢固粘附以经受生长过程(包括气囊的折叠、支架的卷曲、包装、运输至客户)和最终应用过程(包括通过狭窄止血阀、引入护套(sheath)或引导管的通道，以及通过可能的弯曲和狭窄血管的可变距离)中的机械应力。当气囊充气时，药物应在一分钟或更短的时间内尽可能快且充分地释放。该问题已被Cremers等(Cremers B,Biedermann M,Mahnkopf D,SchellerB.Comparison of two different paclitaxel-coated ballooncatheters in the porcine coronary restenosis model.Clin ResCardiol 2009；98:325-330)证实，其在猪冠状动脉内膨胀一分钟后的气囊中回收到高达50％的剂量，而其它涂覆有相同药物和剂量但是制剂不同的导管释放超过95％。使用刚性原型气囊得到了几近完美的结果(即仅损失剂量的10％，并且在动脉中膨胀后气囊上残留的药物为约10％)(Scheller B,Speck U,Abramjuk C,Bernhardt U,Nickenig G.Paclitaxel balloon coating-a novel method forprevention and therapy of restenosis.Circulation 2004；110:810-814)。将相同的涂层组合物涂覆于更有弹性的现代气囊导管会产生问题，即过早损失较多量的药物。由于设备的结构更加复杂和生产过程更加复杂，用足够有效的剂量的药物以可靠的方式对积分或切割气囊进行涂覆会产生其它的问题。
现有技术：保护药物不过早释放
药物从气囊中过早释放是各种方法涉及的主要问题。它们中有些是机械的，例如使用保护管、套管、包裹物(envelops)。例如USP5,370,614、USP 6,306,166和USP 6,616,650公开了在气囊充气前缩回的各种护套，或者USP 6,419,692提出了在气囊膨胀过程中爆裂的覆盖物。不同的方法是USP 5,893,840公开的具有微小腔的结构化的气囊膜，WO 94/23787公开的具有粗糙化的气囊膜来增强涂层的粘附性，或者最近的USP 7,108,684提出的保护气囊上含药层的袋，以及WO2009/066330公开的通过折叠气囊的折叠选择性放置药物的方法。尽管这些方法有效，但是其具有增加生产的复杂性和成本的缺点，或者使得设备的处理更加困难，或者增加设备的直径(必须保持尽可能的小，以便通过狭窄的病灶)。在一些实施方式中，保护膜或多孔(perforated)膜会干扰气囊的积分组件或阻碍药物向组织均匀传递，甚至会置病人处于风险。这些方法均未用于积分或切割气囊，并且不知道增加的复杂性和机械问题或者积分或切割结构对保护包裹物的干扰(反之亦然)会产生怎样的问题。
其它的方法使用物理或化学方法控制药物自气囊表面的释放，例如USP 5,304,121描述了仅在暴露于触发剂后才释放药物的水凝胶；USP5,199,951依赖于热活化；根据USP 7,445,792，描述了一种亲脂性“水化抑制剂”保护水溶性药物不过早释放；以及根据USP 5,370,614，描述了一种粘性基质保护药物不过早释放，但是该粘性基质在通过狭窄血管段的过程中必须通过护套来保护。这些方法都没有经过实践检验和被证明能满足快速、可靠和完全地将药物传递到靶组织的要求。这些方法都没有设计成使用积分或切割气囊。
持续药物释放的许多方法是已知的，并且成功用于实践中，但是它们不适用于与靶组织仅接触几秒钟或几分钟的医疗设备。持续药物释放往往是通过将药物嵌入到限制扩散到表面的速率并通过这种方式控制向临近组织传递的聚合物中实现。
因此，仍然需要一种能保护涂层在生产、处理和通向病灶过程中过早损失，并且还能允许在用户确定的位置和位点及时地立即完全释放活性成分的方法或制剂。在生产过程中，由于积分和切割气囊产品更加复杂的结构，该问题更加严重。积分和切割气囊具有治疗某些病变的优点，例如当常规的光滑气囊在充气过程中容易移位时，或者当受控且预定的血管壁损伤在气囊充气过程中更容易不受控制地分开时。但是，作为对膨胀过程中不可避免的损伤的反应，由于过度新生内膜增生引起的血管腔再狭窄问题与常规的气囊导管是一样的。
一种控制药物从医疗设备(例如血管成形术气囊)粘附和释放的有利方式是选择合适的制剂和涂层，其除了通常的设备操作(例如对折叠气囊充气诱导药物释放)外，不需要机械保护或者额外的与涂层之间的物理或化学相互作用。尽管这是理想的并且经常会去尝试，但是生产过程中和使用前的完美粘附性与在作用部位立即释放之间相互冲突的目标使得任务非常困难。种类繁多的专利申请模糊公开了对于常规气囊导管通过选择药物、选择特定的涂覆工艺或含不同添加剂的制剂来解决该问题的方法、组合物和设备。尽管从化学、药理学或药剂学教科书上抄写了大量的化合物，然而甚至是广泛的实验公开内容也不足以清楚地让熟悉该主题的人和本领域技术人员无需创造性地找到令人满意的解决办法。现有技术的例子有US 2008/0118544记载了过多数量的物质和物质种类，或者USP 7,445,795公开了“水化抑制剂”的应用，其不适合优选的例如WO 2004/028582公开的需要“水化促进剂”或“分散和溶出促进剂”的极亲脂性类药物。尽管亲水性添加剂(可看作“水化促进剂”)在某些常规气囊膜中运作良好(Scheller B,Speck U,AbramjukC,Bernhardt U,Nickenig G.Paclitaxel balloon coating-a novel method for prevention and therapy of restenosis.Circulat ion 2004；110:810-814)，但是其对各种现代常规或积分PTA或PTCA气囊的粘附性要么太弱要么太强，导致主要部分的药物过早损失或在靶位不充分释放。在积分或切割气囊导管上没有尝试任何已知的组合物。
现有技术：抗氧化剂
从理论上讲，抗氧化剂针对疾病组织几乎所有的特点，即“活性氧类”，并且应具有广泛的医疗应用。事实上，只有非常少的控制临床试验证明了抗氧化剂的有益效果(Suzuki K.Ant ioxidants fortherapeutic use:Why are only a few drugs in clinical use？Advanced Drug Delivery Reviews 2009；61:287-289)。在US2009/0136560中，抗氧化剂被提及作为治疗局灶血管疾病(例如狭窄、再狭窄、动脉粥样硬化斑块和易损斑块)的潜在有用药物，并且不含添加剂；在USP 5,571,523中，抗氧化剂作为血管平滑肌细胞的凋亡诱导剂；在WO 2004/022124中，抗氧化剂作为活性药物，或作为“水化抑制剂”。在US 2008/0241215中，普罗布考(probucol)是被批准用于治疗高脂血症(已知是动脉粥样硬化的危险因素)的药物，其在缓释制剂中被建议单独或与雷帕霉素或其它抗再狭窄剂联合作为支架涂层中的活性成分。US 6,211,247要求保护用于预防或治疗冠状动脉介入引起的各种血管病变的含有效剂量白藜芦醇的药物组合物。同样，US2007/0037739公开了包含各种生物活性剂的局部输送系统，包括单独或适合治疗或预防管腔细胞增殖异常的特定联合应用的白藜芦醇。上述提及的文献均未包含支持作为用于延迟药物释放的亲脂性药物的添加剂的数据，也没有公开能解决上述药物到达靶病灶前的粘附性和需要时立即释放的问题的特定药物组合物。
少量的抗氧化剂通常被用来保护药物或营养剂不被氧或氧化分解，已有申请提出用于涂覆在可移植医疗设备例如支架(US 2007/0020380、US 2009/0246253)或气囊导管(US 2005/0037048、US 2009/0246252，特别是第[105]段)上的药物。然而，抗氧化剂通常使用的比例小于相对于100重量％药物的1重量％。通常情况下，想要的是使用尽可能少的抗氧化剂，即小于相对于100重量％药物的1重量％(Voigt R.Lehrbuchder pharmazeutischen Technologie.5.Edition,Verlag Chemie,Weinheim-Deerfield Beach,Florida-Basel,1984)。US 2005/0037048公开了一个具体实施例，其涉及在聚合基质中的选定药物需要非常高比例的抗氧化剂。
同样，上述提及的文献没有提供任何暗示表明使用稳定(即抗氧化药物)和/或不提供治疗或预防作用剂量的抗氧化剂具有优点。
本发明
本发明的基础问题是提供一种积分或切割气囊导管，其具有改进的药物粘附性，并且对靶部位的药物释放没有不利影响。
该问题通过根据权利要求1所述的积分或切割气囊导管解决。换言之，所述问题通过至少部分表面载有至少一种氧化不敏感药物或氧化不敏感的不含聚合物的药物制剂以及至少一种亲脂性抗氧化剂的积分或切割气囊导管解决，至少一种亲脂性抗氧化剂的比例为相对于100重量％药物的3-100重量％，其中至少一种氧化不敏感的药物选自紫杉烷类、沙利度胺、他汀类、皮质激素类和皮质激素类的亲脂衍生物，并且至少一种亲脂性抗氧化剂选自去甲二氢愈创木酸、白藜芦醇和没食子酸丙酯。“不含聚合物”指没有额外的聚合物作为涂层的一部分。优选的实施方式在所附的权利要求书中公开。通常，抗氧化剂用来对抗氧的降解来稳定氧化敏感的药物。如果药物对氧化降解稳定，即如果药物是氧化不敏感的，它们在这方面被认为是无益的。下文中，术语“氧化不敏感的药物”、“活性药物”和“药物”能互换使用，如果涉及本发明，它们均指氧化不敏感的药物。
在测试大量的涂覆方法、添加剂和药物组合物时，令人惊奇地发现，以规定的质量比向氧化不敏感的更少或甚至更多的亲脂性和更多或更少的水溶性药物添加的某些亲脂性抗氧化剂，显著增加了处理和通向靶病灶的过程中药物对积分和切割气囊的粘附性，即使是靶病灶远离设备最初进入血液填充引入护套、引导管或含有快速流动血液的血管时的位置。这也用积分气囊进行了测试。尽管由于围绕折叠气囊的积分线运动使得涂层上施加了额外的机械应力(与常规气囊相比)，但是药物在进入狭窄止血阀和弯曲引导管过程中的损失非常低。因此，在将医疗设备引入到脉管系统的初始步骤过程中，量为3-100重量％的至少一种亲脂性抗氧化剂用作涂覆在积分或切割气囊导管上的药物的粘附促进剂。词语“至少一种亲脂性抗氧化剂”指单一的抗氧化剂，也包括不同抗氧化剂的混合物。还可进一步添加其它物质或药物化合物，进一步调节产品的性能以满足稳定性方面的需要或其它药物要求和耐受性等。
活性药物的例子有细胞增殖抑制剂，优选紫杉烷类，例如紫杉醇、多西紫杉醇和Protaxel。或者，氧化不敏感的药物的例子有特定的新血管形生抑制剂，例如沙利度胺，他汀类例如阿托伐他汀、西立伐他汀、氟伐他汀，或者抗炎药例如皮质激素类，或者更优选为皮质激素类的亲脂性衍生物，例如二丙酸倍他米松或地塞米松-21-棕榈酸酯(dexamethasone-21-palmi tate)。如果需要不同的药理作用，或者需要改进效果或耐受性，可应用各种药物或联合应用。因此，词语“至少一种药物或药物制剂”指单独的药物，还包括不同药物的混合物。优选的药物可以是亲脂性的(正丁醇和水之间的分配系数>10)，也可以是呈现极差水溶性的(<1mg/ml，20℃)。优选的是干燥状态下在长期贮存过程中无需添加抗氧化剂就化学稳定的那些药物，例如紫杉醇和其它紫杉烷类、他汀类、沙利度胺、皮质激素类和皮质激素类的亲脂性衍生物。其中，优选的药物是紫杉醇、protaxel和多西紫杉醇，最优选的药物是紫杉醇。药物的使用剂量必须提供所需的效果，并且不损害涂覆气囊(气囊导管)的技术特征，例如柔韧性。优选的剂量范围是1至10μg/mm2气囊表面，最优选高达6μg/mm2。
亲脂性抗氧化剂是在最高达40℃的温度下呈固体的抗氧化剂。优选的有去甲二氢愈创木酸、没食子酸丙酯和白藜芦醇，更优选的是去甲二氢愈创木酸和白藜芦醇，最优选的是仅白藜芦醇。普罗布考不是优选的添加剂。
将这些抗氧化剂与上述药物组合表现出改进的粘附性。不同的组合，特别是与其它的氧化不敏感药物的组合没有表现出显著的改进粘附性，或者需要极高量会损害气囊机械特征的抗氧化剂(远高于相对于100重量％药物的100重量％)。
亲脂性抗氧化剂指抗氧化剂在正丁醇和水之间的分配系数>1，更优选>10，甚至更优选>100。
优选地，药物的亲脂性大于抗氧化剂，即药物在正丁醇和水之间的分配系数高于抗氧化剂在正丁醇和水之间的分配系数。但是，如果辅药阻止药物从医疗设备中过早损失和/或促进快速和完全地向组织传递，那么它不应该因为其物理化学性质而被排除。
在所用的剂量密度中，所选择的抗氧化剂没有显示出与用涂覆医疗设备所治疗疾病有关的相关治疗或预防效果，所选择抗氧化剂的相对量也不是用于保护药物不受氧化分解。这意味着非生物活性剂量的抗氧化剂是优选的。剂量密度以及抗氧化剂与药物的质量关系仅根据药物对医疗设备表面的粘附性和从医疗设备表面的释放优化。抗氧化剂在医疗设备上的剂量太低以至于难以提供理想的药理作用，即其本身是无效的。医疗设备上不需要抗氧化剂来保护活性药物(例如抗增殖药物)不受生产、灭菌和贮存过程中的氧化分解；至少它不需要以根据本发明的剂量或浓度应用。“不需要”指活性药物足够稳定而不需要抗氧化剂或抗氧化剂的剂量或剂量密度或与活性药物的比例低于根据本发明的剂量。“足够稳定”指在涂覆设备和用于患者之间，生产后一年如果在环境温度下贮存由于氧化分解损失的活性药物小于5％(＝对氧化分解、不排除氧暴露的空气稳定的药物或药物制剂)。总之，本发明涉及抗氧化剂和无需保护不受氧化分解的药物的组合，或者至少一剂超过了通过其抗氧化作用保护药物不被氧化所需量的抗氧化剂。抗氧化剂作为添加剂或辅药，其在所选的剂量不被用作氧化敏感生物活性成分(药物)的稳定剂，自身也不显示治疗或预防作用。
抗氧化剂在医疗设备表面的剂量可根据治疗药物确定。优选的关系(重量/重量)是占药物重量的3-100量％的抗氧化剂。例如，如果药物的剂量密度是5μg/mm2医疗设备，那么抗氧化剂的量为0.15-5.0μg/mm2。如果药物以低于3μg/mm2设备表面积的剂量应用，或者药物对设备表面的粘附性被进一步改进，那么可选择较高比例的抗氧化剂。设备对于抗氧化剂的负荷量可达到10μg/mm2。更高的负荷量是可能的。抗氧化剂与药物关系的其它优选范围基于重量/重量是相对于100％药物的5-100％，更优选10-100％，甚至更优选20-100％，最优选50-100％。特别是50-100％重量/重量基础的范围显著增强了粘附性(见实施例3)。该关系还可以相对于摩尔定义：在一个优选的实施方式中，抗氧化剂以相对于药物10摩尔％至200摩尔％存在。较高量的抗氧化剂是有用的；它们仅在会呈现出与治疗疾病有关的自身显著的药理预防或治疗作用时被排除。
如果使用一种以上的药物，那么药物的总重量或者药物的总摩尔数用作计算抗氧化剂的量的基础。如果使用一种以上的抗氧化剂，那么抗氧化剂的总重量或抗氧化剂的总摩尔数用作计算抗氧化剂的量的基础。
可应用其它耐受良好并获得批准的添加剂和/或辅药，以进一步改善涂层的机械或药物性能。优选不含聚合物的涂层组合物。本发明组合物的一个特殊优势是它们不需要使用聚合物来阻止药物的过早释放。但是，可加入少量药物可接受的聚合物例如聚丙烯酸，例如以改善药物在气囊上的分配或在处理过程中干燥涂层的粘附性。少量是指相对于100重量％药物的约1-20重量％。如果使用聚合物，优选具有低至中等分子量的物质，即2000至50 000D。
一般情况下，药物以及药物与添加剂的混合物作为于挥发性溶剂中的液体制剂被涂覆在医疗设备上，根据本发明优选不添加聚合物，即不含聚合物。溶剂的选择对于药物在设备上的分配很重要，尤其是当设备在生产的后期阶段被涂覆时。积分或切割气囊的生产后期阶段可包括设备的积分或切割元件、将这些元件固定所需的结构和已经折叠的气囊。溶剂进一步决定涂层在干燥状态下的结构和粘附性以及药物从表面的释放。优选的有机溶剂有丙酮、四氢呋喃和各种醇，例如甲醇和乙醇。通常，添加1至30％(体积/体积)的水。一种药物或多种药物和抗氧化剂可同时溶解在相同的溶剂或溶剂混合物中应用。或者，它们可以分别溶解在相同或不同的溶剂中并依次应用。溶液在任一种情形中都是不含聚合物的。在一个优选的实施方式中，积分或切割气囊导管用至少一种氧化不敏感药物和至少一种抗氧化剂不含聚合物地涂覆，两者一起溶解于四氢呋喃或含有大于25％(v/v)四氢呋喃的溶剂混合物中，或者各自分别溶解于对于至少一种亲脂性抗氧化剂任选选择的不同溶剂中。另一个优选的实施方式是基于积分或切割气囊导管，其被至少一种氧化不敏感药物和至少一种抗氧化剂不含聚合物地涂覆，两者一起溶解于丙酮或含有大于25％(v/v)丙酮的溶剂混合物中，或者各自分别溶解于对于至少一种亲脂性抗氧化剂任选选择的不同溶剂中。用干颗粒例如微米或纳米颗粒、晶体、胶囊等或悬浮在液体制剂中的颗粒涂覆是可能的。粗糙或粘性的医疗设备表面有助于颗粒涂覆。
在医疗设备上提供差不多均匀的层的各种涂覆方法可由文献获知，并且在专利申请中已被公开。这些包括简单浸渍、喷雾，以及提供精确剂量和均匀分布的方法(例如WO 2009/018816)。涂层可以被逐步涂覆，可以是作为相同组成的多层，或可以是作为不同组成的层，例如药物是第一层，抗氧化剂是第二层，或者以相反的顺序。所有这些方法均可以应用于本发明的制剂。用例如(a)首先用药物和(b)其次用溶于药物难溶于其中的溶剂的抗氧化剂通过例如喷雾得到的顺序涂层得到基本上分离的层。这与抗氧化剂用来化学保护氧化敏感药物的应用完全不同，因为后者需要将抗氧化剂与药物混合均匀。
因此，本发明的一个优选的实施方式是一种积分或切割气囊导管，其用至少一种氧化不敏感药物和至少一种亲脂性抗氧化剂以氧化不敏感药物与抗氧化剂并非均匀混合的方式依次不含聚合物地涂覆。
此外，涂覆的积分或切割气囊导管可在生产过程的不同阶段于不同的条件下干燥，例如温度、气流、气体组成和压力。它们可以贮存在水蒸气密封的密封件内，并且在密封件内有分开包装的吸水剂。
本发明的主题是积分或切割气囊导管，例如用于血管成形术或冠状动脉血管成形术的导管。优选地是在图像引导介入治疗(interventional image guided therapy)过程中短时使用的积分或切割气囊导管。短时使用是指该设备不植入，而是在程序完成时被排出体外，通常是在小于10分钟内，但是绝不会迟于程序结束后几小时，优选5小时。导管可以含有由各种聚合物和共聚物、聚酰胺(尼龙12，pebax)、聚乙烯、聚氨酯、各种聚乙烯化合物等制成的气囊膜。对于独立的材料类型，药物的粘附性和释放性能可通过添加亲脂性抗氧化剂得到改善。此外，导管包含旨在积分或切割表面的元件，其与充气后的气囊直接接触，例如各种形状的线或气囊表面的突出物。
积分或切割气囊导管在其至少部分表面载有至少一种药物或药物制剂和至少一种亲脂性抗氧化剂，其至少部分表面旨在与被治疗的组织靠近接触，例如导管轴末端部分的气囊。这意味着表面至少有5％，优选大于50％，最优选大于90％被涂覆。积分或切割气囊导管的气囊有中心的圆柱形部分和两个相反的圆锥端。如果有小于100％的气囊导管表面被涂覆，那么优选圆柱形部分被涂覆，并且至少部分或全部的圆锥端保持未涂覆。
另一个实施方式是一种积分或切割气囊导管，其至少部分表面载有不含聚合物的至少一种莫司类(Limus)药物或莫司类药物制剂和至少一种亲脂性抗氧化剂，所述亲脂性抗氧化剂是去甲二氢愈创木酸或白藜芦醇，优选白藜芦醇，至少一种亲脂性抗氧化剂的比例为相对于100重量％药物的3-100重量％。
优选地，莫司类药物是mTOR抑制剂，更优选地选自西罗莫司、依维莫司、唑罗莫司、biolimus和坦罗莫司，最优选西罗莫司。关于实施该实施方式的优选方式，同样适用于如上述有关氧化不敏感药物/药物制剂和亲脂性抗氧化剂的组合。
下面，本发明通过实施例予以说明。
实施例1
用于A型经皮腔内冠状动脉成形术的气囊(AngioSculpt 3.5-20mm，AngioScore，Inc.，Fremont CA，USA)单独用紫杉醇或结合碘普罗胺(根据WO 02/076509的碘化造影剂)或用不同量的丁基化羟基甲苯(BHT)涂覆；溶剂：丙酮/乙醇/H2O。测试了涂覆气囊在通入止血阀、Medtronic Launcher JL 3.56F引导管的过程中以及在搅拌的血液(37℃)内一分钟时有关紫杉醇的损失。当以足够的浓度与涂层溶液混合时，BHT改进了紫杉醇的粘附性。
实施例2
用于A型经皮腔内冠状动脉成形术的气囊单独用紫杉醇或结合碘普罗胺(根据WO 02/076509的碘化造影剂)，见实施例2，或用丁基化羟基甲苯(BHT)或去甲二氢愈创木酸涂覆。测试了涂覆气囊在通入止血阀、Medtronic Launcher JL 3.56F引导管的过程中以及在搅拌的血液(37℃)内一分钟时有关紫杉醇的损失。当以足够的浓度与涂层溶液混合时，亲脂性抗氧化剂改进了紫杉醇的粘附性，而不会损害在冠状动脉中气囊充气过程中紫杉醇的释放(在不同的实验中测定)。
实施例3
用于A型经皮腔内冠状动脉成形术的气囊用没有白藜芦醇的紫杉醇或者与白藜芦醇组合的紫杉醇涂覆。如实施例1所述，测试了涂覆气囊有关紫杉醇的损失。当以足够的浓度与涂层溶液混合时，白藜芦醇改进了紫杉醇的粘附性。
实施例4
用于A型经皮腔内冠状动脉成形术的气囊在已经折叠的状态下用没有或有聚丙烯酸的紫杉醇涂覆。聚丙烯酸(分子量为约6000D，Polysciences Inc.，USA)和甘油改进了气囊上涂层的均匀性。

Claims (20)

1.用于血管成形术或冠状动脉成形术的气囊导管，其包括：
具有近端部分和远端部分的轴；
与轴的远端部分连接的可充气的气囊；
具有围绕气囊的形状的不可植入的线；
其中气囊导管在其至少部分表面上载有至少一种氧化不敏感药物和至少一种亲脂性抗氧化剂，至少一种亲脂性抗氧化剂的比例为相对于100重量％药物的3-100重量％，其中至少一种氧化不敏感药物选自紫杉烷类、沙利度胺、他汀类、皮质激素类和皮质激素类的亲脂性衍生物，并且至少一种亲脂性抗氧化剂选自去甲二氢愈创木酸、白藜芦醇和没食子酸丙酯。
2.根据权利要求1所述的气囊导管，其中所述线包括形状，一旦管内的气囊充气，所述形状对管的腔表面积分。
3.根据权利要求1所述的气囊导管，其中所述线包括形状，一旦管内的气囊充气，所述形状切割管的腔表面。
4.根据权利要求1所述的气囊导管，其中氧化不敏感药物为选自紫杉醇、protaxel和多西紫杉醇的紫杉烷类。
5.根据权利要求4所述的气囊导管，其中紫杉烷类为紫杉醇。
6.根据权利要求5所述的气囊导管，其中至少一种亲脂性抗氧化剂为去甲二氢愈创木酸。
7.根据权利要求1所述的气囊导管，其中至少一种亲脂性抗氧化剂为去甲二氢愈创木酸。
8.根据权利要求7所述的气囊导管，其中氧化不敏感药物为选自紫杉醇、protaxel和多西紫杉醇的紫杉烷类。
9.根据权利要求8所述的气囊导管，其中紫杉烷类为紫杉醇。
10.根据权利要求1所述的气囊导管，其中至少一种亲脂性抗氧化剂为白藜芦醇。
11.根据权利要求10所述的气囊导管，其中氧化不敏感药物为选自紫杉醇、protaxel和多西紫杉醇的紫杉烷类。
12.根据权利要求11所述的气囊导管，其中氧化不敏感药物为紫杉醇。
13.根据权利要求1所述的气囊导管，其中至少一种亲脂性抗氧化剂为没食子酸丙酯。
14.根据权利要求13所述的气囊导管，其中氧化不敏感药物为选自紫杉醇、protaxel和多西紫杉醇的紫杉烷类。
15.根据权利要求14所述的气囊导管，其中氧化不敏感药物为紫杉醇。
16.根据权利要求1所述的气囊导管，其中至少一种抗氧化剂在涂覆导管表面的负荷最高达10μg/mm2。
17.根据权利要求1所述的气囊导管，其中包含相对于至少一种氧化不敏感药物100重量％的比例为5-100重量％的至少一种亲脂性抗氧化剂。
18.根据权利要求1所述的气囊导管，其中包含相对于至少一种氧化不敏感药物100重量％的比例为10-100重量％的至少一种亲脂性抗氧化剂。
19.根据权利要求1所述的气囊导管，其中包含相对于至少一种氧化不敏感药物100重量％的比例为20-100重量％的至少一种亲脂性抗氧化剂。
20.根据权利要求1所述的气囊导管，其中包含相对于至少一种氧化不敏感药物100重量％的比例为50-100重量％的至少一种亲脂性抗氧化剂。
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