CN1635853A - 给药方法 - Google Patents
给药方法 Download PDFInfo
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- CN1635853A CN1635853A CN03804368.8A CN03804368A CN1635853A CN 1635853 A CN1635853 A CN 1635853A CN 03804368 A CN03804368 A CN 03804368A CN 1635853 A CN1635853 A CN 1635853A
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- Materials For Medical Uses (AREA)
Abstract
一种给药方法，通过流化和使用微管用气体喷射，使细小的粉末药物精确的施用到靶位(特别是体腔内的靶位)。关于给药模式，特别地，在上述方法中所施用的是单独的药物或生物聚合物，或用作载体的生物聚合物。更具体地说，一种细小药物粉末的给药方法，该粉末中含有磨细的一种或多种类型的药物和/或生物聚合物的细小颗粒，将它们相互混合，用气体流化，然后通过气流在微管中传递流化的物质，并从微管末端向靶位喷射细小的药物粉末。此外，给药方法包括微管中同轴放置的毛细管，将药物和/或生物聚合物的水溶液从毛细管补充到气流中，然后将其与气体传递的其它药物和/或生物聚合物的细小颗粒混合。
Description
现有技术的描述
发明领域
本发明涉及一种给药方法，其中通过利用微管内气体的流化方法和/或喷射方法，使细小的粉末药物精确的施用到靶位，特别是体腔内的靶位。具体地说，本发明涉及一种药物和一种施用生物聚合物的方法，从而使单个药物或生物聚合物，或以生物聚合物为载体的药物能够喷射，或者使细小的颗粒、多种药物的溶液或其混合物能够被喷射。
发明背景
生物聚合物典型地包括具有生物相容性的多糖或蛋白质，例如氧化纤维素、羧甲基纤维素、透明质酸、胶原等常规用于各种类型应用的生物聚合物。例如，JP-A-H09-328,432(1997)公开了含有壳多糖作为止血剂的喷雾药物，其中装有喷雾剂；JP-A-2000-186,048公开了含有聚阳离子化合物粉末和聚阴离子化合物粉末的止血剂；以及JP-A-H07-155,377(1995)公开了喷射细小粉末状颗粒的粉末喷射器，可将诸如止血剂等细小粉末状颗粒喷射到体腔内部，和喷射粉末的喷口。此外，例如，US4,657,548，US5,582,591，US6,365,187，US6,372,718，US6,403,570，授权前公布的美国专利No.20010000142A1和No.20010006957A1公开了各种类型的具有生物粘合性或用作止血剂的生物聚合物。由于这些生物聚合物具有止血或防止粘合的功能，因此现已用于外科手术部位或伤口部位止血，防止粘合，防止瘢痕、伤口修复、伤口愈合，和封口等。
另一方面，这些生物聚合物不同类型的应用形式依据它们各自的使用目的而定，因此，现已研发出诸如无纺布型、薄膜型、细粒型或凝胶型的各种应用形式。因此，其应用局限于它们各自的使用目的，并且在止血和/或防止粘合时，生物聚合物不能被一般地和广泛地应用。
特别地，应用这些生物聚合物体的靶位由于大小、形状、应用位置等而多种多样，因此，存在一个宽范围的变化。从而使生物聚合物很难精确地附着和/或保持在靶位。具体地，要强调的是，几乎不可能在体腔内或内窥镜手术后的部位应用生物聚合物进行止血或防止粘合。
本发明的发明者积极地研发，取得了技术进步，从而使生物聚合物能够精确地附着或保持在任何大小、形状或位置的应用部位，并且发明者终于发现通过设计具有能够被气体喷射力流化的超细颗粒的生物聚合物，并利用气体喷射将细小的颗粒喷射到体腔内或内窥镜手术后的手术部位，生物聚合物能以非常容易的方式应用到靶位。基于这些研究，发明者提出一种细小颗粒的生物聚合物，它能够以更容易的方式止血、防止粘合，防止瘢痕、伤口修复、伤口愈合，和封口等(JP-A-2001-259212)。
同时，现在没有任何有效方法来施用用于修复腐烂的表面或外科手术切除后的粘膜表面的药物。特别地，由于全身给药例如口服给药或注射给药的靶向疾病部位的药物浓度较低，因此需要非常大的剂量才能达到较高的药效，由此导致的问题是使发生副作用的机会增加了。
因此，近些年发现了有效地将药物只传递到靶向疾病部位的技术，作为改善药效的途径。但是，现在还没有研究出一种精确和直接的在腐烂表面或外科手术切除后的薄膜表面给药的方式。
因此，本发明的发明者进一步发展了前人所提出的流化和气体喷射生物聚合物细小颗粒的技术，并发现除了生物聚合物，药物也能够精确的结合和固定到给药部位，例如伤口表面等，甚至到达体腔，由此完成了本发明。
因此，考虑上述的情况，本发明的目的在于提供一种通过利用气体流化和注射，以及细小管(微管)注射，将细小粉末状药物精确的施用在靶位，特别是体腔内的靶位的方法，并且还提供施用生物聚合物本身作为药物或以生物聚合物为载体的药物的方法。更具体地，本发明的另一目的是提供一种施用药物或生物聚合物的方法，该方法能够将药物或生物聚合物使用在任何大小、形状和位置的应用部位，该方法能够以更容易的方式提供靶向的结果，例如止血、防止粘合、防止瘢痕、修复伤口、愈合伤口，和封口等。
发明简述
为了解决本申请中公开的问题，根据权利要求1的本发明的一个方面是一种细小粉末状药物的给药方法，其特征在于将药物粉碎成平均颗粒直径等于或小于100μm从而达到气体流动性的颗粒，制备细小粉末和气体的均匀流体，通过气流用微管传递，从微管的末端将细小的粉末状药物喷射在靶位上，喷射的量是可以调节的。
根据权利要求2的本发明的另一方面是一种施用生物聚合物的方法，包括用气体流化一种或多种类型的生物聚合物的细小颗粒，从而制备均匀的生物聚合物和气体的混合相流体；通过气流经微管传递混合相流体；并将细小颗粒的生物聚合物从微管的末端喷射到靶位，从而在伤口部位止血，封口，防止器官粘合并修复伤口。
具体地，根据本发明的给药方法包括粉碎药物和生物聚合物来减少粉碎粉末的单位重量，用载气将其流化，通过微管传递，从微管末端喷射细小的粉末状药物和生物聚合物，药物和生物聚合物可精确的通过狭窄的空间，从身体表面到达身体较深部分的靶位，而常规给药不可能实现。各种类型的生物聚合物可用于止血、封口，防止器官粘合，伤口修复等。所用的大多数生物聚合物的类型和剂型根据药物治疗目的不同而不同，其剂量也有所不同。但是，本发明的方法能够提供这些生物聚合物精确给药的有利效果。
根据本发明的给药方法，细小的粉末药物可与作为药物载体的生物聚合物的细小颗粒混合，利用气体的流体动力学将其施用到靶位。因此，为了改善药物和靶位的粘合性，根据权利要求3的本发明的另一方面是一种施用生物聚合物的方法，包括将生物可吸收的生物聚合物载体的细小颗粒与细小的药物粉末混合；通过流动气体，经过微管传递气体流化的粉末；将生物聚合物粉末和细小的粉末状药物的混合粉末从微管的末端喷射到靶位，从而在伤口部位止血，封口，防止器官的粘合，修复伤口。
根据本发明的给药方法中，发现振动用于混合细小颗粒粉末和气体的容器能更有效的使流化的细小颗粒以高的可再现浓度到达被施用部位，并改善其与气体的流动性。因此，根据权利要求4的本发明的另一方面是一种根据权利要求1至3任意一项的方法，其中细小粉末状药物和气体的均匀流体或生物聚合物和气体的均匀流体，或细小粉末药物和气体与生物聚合物载体的均匀流体通过振动用于混合细小药物粉末或生物聚合物和气体的混合容器来制备。振动可以通过例如摇摆振动、转动振动、超声振动等进行。
此外，根据本发明的给药方法中，在靶位上喷射的确定的量可通过控制流化粉末的浓度和将细小的颗粒粉末从微管末端喷射出来的气体流速实现。因此，根据权利要求5的本发明的另一方面是一种根据权利要求1至3任意一项的方法，其中从微管末端喷射出来的细小粉末状药物或生物聚合物的量通过调节流化粉末的粉末浓度和气流来调节。
根据本发明的给药方法中，当施用的药物或生物聚合物是溶液形式时，溶液可经过具有更小直径且置于微管内的毛细管注射到微管，通过气流反复粘附和分离微管内壁上的溶液，减小溶液的液滴大小，从微管末端喷射液滴，从而实现在靶位精确给药。因此，根据权利要求6的本发明的另一方面是一种根据权利要求1至5任意一项的方法，其中比微管直径更小的更小直径的管在微管中与微管同轴，将生理盐水、注入溶液或药物和/或生物聚合物的水溶液从更小直径的管中注射到更小直径管的气流中，从而喷射其与流化气体中的药物和/或微管中的生物聚合物细小颗粒的混合物。
另一方面，与上述研究形成对照，具有更小直径的管在微管中与微管同轴，用气流流化的细小粉末经过更小直径的管传递，药物、生物聚合物等的水溶液经过外管(微管)和内管(更小直径的管)之间的空隙传递，各水溶液在邻近微管的出口处混合并被喷射，从而能够在靶位精确给药。因此，根据权利要求7的本发明的另一方面是一种根据权利要求1至5任意一项的方法，其中比微管直径更小的更小直径的管在微管中与微管同轴，通过气流将细小的粉末状药物经过更小直径的管传递，生理盐水、注入溶液或药物和/或生物聚合物等的水溶液经过内外管间的空隙传递，细小的粉末状药物和要被喷射的水溶液在微管的末端混合。
此外，根据权利要求8的本发明的另一方面是一种根据权利要求1至7的任意一项方法，其中气体流化的药物持续释放，从而推迟药物性质的释放。根据权利要求9的本发明的另一方面是一种根据权利要求8的方法，其中通过将药物微胶囊化、喷雾干燥或冷冻干燥来延长药物性质的释放。
此外，根据权利要求10的本发明的进一步方面是一种给药的方法，包括流化生物聚合物的细小粉末，流化不同容器内的细小粉末状药物，用气流经过微管传递各细小粉末，通过先喷射细小的粉末状药物，从微管的末端将细小粉末喷射到靶位，再喷射生物聚合物粉末，覆盖靶位上的药物组分层，从而防止药物扩散和泄漏到靶位以外的其它部位。
具体地，根据本发明，药物的细小粉末通过利用气体的流体动力学喷射并应用在靶位上，然后进一步用生物聚合物的细小颗粒覆盖药物粘合表面，从而确保防止药物的细小粉末泄露和扩散到靶位以外的其它部位。
此外，根据权利要求11的本发明的另一方面是一种给药方法，包括连接含有两种不同类型的组分且与微管相连的容器，将药物从微管末端喷射到靶位，其中在喷射的前半部分，与微管末端更近的容器与其它容器相比，其所含组分被喷出的量更大，且其中在喷射的后半部分，与气体入口一侧相连的容器与其它容器相比，其所含组分被喷出的量更大，从而逐渐变化各喷射组分的浓度。
具体地，根据本发明的方法，通过喷射覆盖给药部位的外包层能形成从给药部位内侧到外侧的自动形成梯度的组分浓度分布。例如，在受伤表面附近的内层可用含有更高浓度促进伤口修复的组分的组合物覆盖，并且外层可用具有更好封口性质的生物聚合物覆盖。这样喷射覆盖，例如，能通过两个含有细小粉末气体的管或两个含有水溶液的管串连的方法实现，组分从管中再从喷射口传递到邻近的管，逐渐混合两种组分到一个浓度梯度。
可供选择地，在本发明中，可施用多种生物聚合物，特别是两种类型的水溶性的、表现出粘性或被凝结的生物聚合物，在这种情况下，其一组细小颗粒粉末或溶液，或一组溶液可被施用到靶位。因此，根据权利要求12的本发明的另一方面是一种施用生物聚合物的方法，其中可应用能溶于水并显示粘性和凝结的两种类型的生物聚合物，其中一组细小颗粒粉末和溶液，或其一组溶液分别经过各自的微管通过气流传递，并在微管末端混合，从而将其喷射到靶位。
在这种情况，如果两种类型的生物聚合物是阴离子生物聚合物和阳离子生物聚合物，其在溶液状态可结合显示出完全不同于任何单个组分的物理性质和生物可结合性，特别是显著增加的粘度。虽然由于两种生物聚合物结合物的高粘度使得其很难经过微管传递，但是可通过气流传递其中一种与气流形成的细小颗粒粉末的生物聚合物或传递均与气流形成溶液的两种生物聚合物，并在喷射时将其混合，来将具有更大的粘合性的高粘度凝胶物喷射到靶位。
因此，根据权利要求13的本发明的另一方面是一种根据权利要求12的施用生物聚合物的方法，其中一组两种类型的生物聚合物是阴离子生物聚合物和阳离子生物聚合物，根据权利要求14的本发明的另一方面是一种根据权利要求12或13的施用生物聚合物的方法，其中生物聚合物选自合成聚合物、多糖、肽和蛋白质。
根据权利要求15的本发明的更具体的方面是一种施用用于伤口表面止血或封口的药物的方法，其特征在于将两个毛细管同轴放置在微管内，血纤维蛋白原单独或与其它凝血因子的结合液体，和凝血酶单独或其与氯化钙的结合溶液从一个毛细管和另一个毛细管分别注射到微管内的气流中，从而在两种溶液混合时，将混合物从微管末端喷射到靶位。
在这种情况，根据权利要求16的本发明的更具体的方面是一种给药方法，所述药物用于伤口表面的止血或封口，其特征在于所用粉末含有单独的作为主要成分的血纤维蛋白原或其与生物聚合物的细小混合粉末和含有凝血酶作为主要成分的水溶液，并将其混合物喷射到靶位。
含有血纤维蛋白原作为主要成分的粉末可含有，例如纤维蛋白、凝血因子XIII、纤连蛋白、抑肽酶等，并且含有凝血酶作为主要成分的粉末可以是凝血酶和氯化钙的结合粉末。
此外，根据权利要求17的本发明的另一方面是一种在根据权利要求1至16任意一项的给药方法中，用作持续释放药物的流化基质细小颗粒粉末，其中药物通过库仑力、氢键和疏水键组成的分子间相互作用在溶液中结合到生物聚合物上，干燥后，在较低的温度下粉碎。在这种情况，可利用基质的性质来确保药物的持续释放。
这里，当混合不同离子电荷的生物聚合物时，由于其中含有离子键，所以混合物具有新的物理性质，并且粘度显著增加或溶解性显著地降低。因此，将通过混合、配制过程或一种带电聚合物与具有相反电荷的药物进行化学结合制备的粉末用气体流化，与带有相反电荷的生物聚合物溶液注射，形成少量的可溶物和少量的可降解凝胶或半固体物质，从而能够持续的释放施用在靶位的药物，以及将其覆盖。此外，其物理性质包括作为止血、防止粘合、伤口修复和组织封口的药物的功能特性。
因此，根据权利要求18的本发明的另一方面是施用伤口表面止血或封口的药物的方法，其中将根据权利要求17的药物和具有与权利要求17的生物聚合物细小颗粒粉末基质相反离子电荷的生物聚合物从微管末端，以细小颗粒粉末状态或溶液状态喷射到靶位。
此外，根据本发明的给药方法能够喷射给予用于整形手术中骨治疗中所用的粘合剂和填充剂。由于整形手术中骨治疗中所用的粘合剂和填充剂通常用刮刀混合陶瓷粉末和液体粘合剂，在靶位上研磨混合物，放置在内部，很少形成均匀的表面。但是，根据本发明的给药方法流化和喷射施用陶瓷粉末，由于陶瓷粉末能够精确的施用在需要细致处理的由癌症的外科切除手术引起的较大的头颅缺损部分和骨缺损部分，因此，骨替代物的形成能够容易的进行，即使在手术面狭窄的情况下。
因此，根据权利要求19的本发明的另一方面是根据权利要求2至7任意一项的方法，其中生物聚合物是磷酸钙型粉末、羟基磷灰石型粉末或玻璃型材料的粉末，是骨粘固粉或人造骨填料，其中将磷酸钙型粉末或羟磷灰石粉末和液体粘合剂的混合溶液，或玻璃型材料和含水酸的混合溶液从微管的末端喷射，以在靶位上形成骨替代物。
附图说明
图1是表示本发明给药方法的基本结构简图。
图2是表示微管结构的简图，它表示了微管内同轴放置的毛细管。
图3是表示微管结构的简图，它表示了微管内同轴放置的两个毛细管。
图4是实施例1中所用的粉末气体喷射器的简图。
图5是实施例2中所用的粉末气体喷射器的简图。
图6是实施例3中所用的粉末气体喷射器的简图。
图7是实施例4中所用的利用两种气雾剂的气体喷射器的透视简图。
实施本发明的最佳方式
以下更详细的描述本发明。
本发明所用的生物聚合物在某种意义上是具有所谓的生物相容性的聚合物，作为典型的生物聚合物，对其没有特殊的限制，只要聚合物具有止血、防止粘合、防止疤痕、修复伤口、愈合伤口、封口等作用。更具体地，可应用羧甲基纤维素、羧乙基纤维素、氧化纤维素、琼脂糖、壳多糖、壳聚糖、透明质酸、淀粉、糖原、藻酸盐、果胶、葡聚糖、软骨素硫酸盐、明胶、胶原等，或一种或多种类型的上述生物聚合物。
此外，具有生物可吸收性的化合物也可用作生物聚合物，这样的生物可吸收材料可以是聚乳酸、乳酸-乙二醇共聚物、胶原、琼脂糖、聚乙烯醇、纤维蛋白凝胶、明胶、壳多糖、壳聚糖、氧化纤维素、羧甲基纤维素、果胶、淀粉、葡聚糖、琼脂糖、海藻酸、软骨素、软骨素硫酸盐、岩藻糖、角叉菜胶、乙烯-乙酸乙烯酯共聚物、聚乙醇酸、乳酸-己内酰酮共聚物、磷酸钙、碳酸钙、羟磷灰石等。
此外，能够用本发明的给药方法给药的药物可以包括各种类型的药物，其中典型的药物可以是低分子量的药物，例如杀菌剂、抗生素、止血剂、抗肿瘤剂和抗炎剂，肽例如细胞生长因子、细胞抑制因子、神经营养因子等，蛋白质药物或各种类型抗体药物，含有基因治疗的基因的载体(腺病毒、逆转录病毒、脂质体、水凝胶等)或裸DNA等。
这些药物可以以细小粉末或水溶液的形式，通过根据本发明的方法给药。其中，对于药物以细小粉末形式与生物聚合物一起给药的情况，当和生物聚合物的等电点分离时，通过其中所含的离子键等，药物的粘度会提高，其从生物聚合物中的释放能力降低，从而更好的持续释放。因此，本发明的方法还具有能够根据所给药物的类型适当选择生物聚合物的类型的优点。
为了确保所用的药物持续释放，粉末通过以下方法制备：在水溶液中将带有电荷的药物预先键合到带有不同电荷的生物聚合物上，然后冷冻干燥，随后粉碎成能够通过本发明的给药方法给药的形式。
作为可供选择的提供持续释放的方法，可将所给的药物装入微胶囊形成细小颗粒，这些细小的颗粒可单独或与生物聚合物一起，通过本发明的给药方法给药。
在本发明的给药方法中，药物和/或生物聚合物主要通过以下方法精确的施用在靶位上：在载气流中流化药物和/或生物聚合物，将其经过微管传递，从微管的末端注射药物和/或生物聚合物的细小颗粒。因此，优选应用能够通过药物和/或载气流化的细小颗粒。这样的细小颗粒优选具有大约80％的颗粒直径小于100μm，且平均颗粒直径等于或小于50μm的粒径分布。
这里，在本发明的给药方法中，所施用的药物和/或生物聚合物不特定的限制于细小的粉末，当然溶液形式的也可通过本发明的给药方法给药。
虽然各种类型的气体可用于作为本发明的载气，但是考虑安全和方便，优选应用二氧化碳和氮气。优选医院注射气体使用的气体管道设备。
本发明的给药方法中的药物或生物聚合物优选在混合室内用气体流化，并粉碎成粉末。此外，为了混合用气体流化的液体和细小粉末，可将液体通过毛细管注入微管，液体与粉末接触并混合。经过微管的气流流速在促进流化从微管末端喷射的药物混合物的足够量气体的水平，在气体固定在这样的流速之后，例如，细菌等可通过管道经过细菌过滤器除去，粉末在粉末混合室内流化，药物和/或生物聚合物的细小粉末通过微管传递，从微管的末端喷射药物等，从而喷射到靶向的给药部位，特别是活体的给药部位。
以下将参考附图1表示的简图，更详细的描述本发明的给药方法。
图1显示了本发明的给药方法的基本结构。具体地，例如二氧化碳或氮气的流化气体从外侧设备(101)的气体供应源(A)流出，通过压力调节阀(B)调节气体压力后，通过设备部分(102)气体流速控制阀(D)和流量计(C)控制流速，然后用细菌过滤器(F)除去气体中所含的细菌，之后将气流最终输入到粉末气体混合室(E)中，药物和/或生物聚合物在其中流化。
在混合室中药物和/或生物聚合物的流化优选在混合室内进行，定量混合器包括滚动振荡器、旋转振荡器或超声波振荡器，药物和/或生物聚合物的粉末均匀混合，并通过定量混合器(混合室)内的气体流化。然后将气体流化的混合粉末由气体经过微管(103)传递到微管(103)末端喷射。在这种情况，设备部分(102)的细菌过滤器-混合室-微管可以是任意部分(104)，可容易的根据适合给药靶位的药物和/或生物聚合物的类型替换。
当通过上述方法给药的药物和/或生物聚合物是溶液时，毛细管(104)被同轴放置在微管(103)内，当液体类型的药物和/或生物聚合物从毛细管末端朝着微管中的气流方向注射时(如图中箭头所示)，液体被气流分散成雾，然后从微管末端将雾喷出，从而能够将其喷射到靶位上。可用于这种情况的微管的图示结构在图2中给出。
或者，可混合两种或多种液体类型的药物和/或生物聚合物，通过本发明的给药方法给药。在这种情况，需要两个或多个毛细管(105，106)同轴放置在微管(103)内，将独立的药物和/或生物聚合物的溶液注入微管内的气流中(如图中箭头所示)，在毛细管的末端形成雾，雾可从微管的末端喷出。微管的图示结构在图3中给出。
或者，本发明的给药方法可应用小型贮气钢瓶作为流体气体的供应源。此外，如果微管与气雾剂偶合，并且毛细管与微管结合，就可以实现微型化或任意应用。在这种情况，两种类型的气雾剂结合并通过喷口偶合，两种类型的药物和/或生物聚合物从各自的气雾剂同时注射，并在偶合部位混合，然后将药物和/或生物聚合物从整个微管末端喷出。
实施例
通过以下的实施例进一步详细的描述本发明。
实施例1
实施例1中所用的粉末气体喷射器的简图在图4中给出。
在该设备中，例如，使用压力调节阀(2)调节气体供应源(1)的二氧化碳气体的压力，气体供应源例如二氧化碳贮气钢瓶或医院等地的二氧化碳气体供应管道网，之后通过流速控制阀(3)和流量计(4)控制设备(110)中的气体流动，然后用细菌过滤器(5)除去气体中所含的细菌。在包括振荡器(6)的定量混合器(7)内流化气体和粉末状药物和/或生物聚合物，然后用气体经微管(8)传递，最后从微管末端喷射。
氯化溶菌酶是一种作为药物制备的抗炎酶，将其细小粉末与具有止血和防止粘和有益作用的羧甲基纤维素生物聚合物以1∶20的混合重量比混合，之后进行流化，然后喷射并从微管末端将其施用在外科手术后的组织分离表面上。
实施例2
实施例2中所用的粉末气体喷射器的简图在图5中给出。这里，图中出现的符号与图4中的符号含义相同。
该设备的功能与实施例1相似，其中使用压力调节阀(2)调节气体供应源(1)的二氧化碳气体的压力，气体供应源例如二氧化碳贮气钢瓶或医院等地的二氧化碳气体供应管道网，之后通过流速控制阀(3)和流量计(4)控制设备(110)中的气体流动，然后用细菌过滤器(5)除去气体中所含的细菌。在包括振荡器(6)的定量混合器(7)内流化气体和粉末状药物和/或生物聚合物，然后用气体经微管(8)传递，最后从微管末端喷射，另外，毛细管(未显示)放置在微管(8)内，例如图2中所示，通过泵(10)从液体储存器(9)中注射药物和/或生物聚合物的溶液。
将10g羧甲基纤维素作为生物聚合物加入粉末-气体混合室内。在与泵(10)相连的液体管道(9)中加入7ml 10％的阳离子纤维素水溶液，在其它地方将粉末流化，然后从毛细管中将阳离子纤维素溶液注入微管(8)并混合，最后喷射混合物并从微管末端将其应用在手术后的组织分离表面上。当这两种组分混合时，它们开始相互偶合，并具有粘性，然后将混合物牢固的粘附在组织分离表面，粘附的混合物不会熔化，从而显示出更好的封口效果，不需要通过体液将其分散来促进止血、防止粘合和伤口修复。
实施例3
实施例3中所用的粉末气体喷射器的简图在图6中给出。这里，图中出现的符号与图4和图5中出现的符号含义相同。
该设备的功能与实施例1和实施例2相似，其中使用压力调节阀(2)调节气体供应源(1)的二氧化碳气体的压力，气体供应源例如二氧化碳贮气钢瓶或医院等地的二氧化碳气体供应管道网，之后通过流速控制阀(3)和流量计(4)控制设备中的气体流动，然后用细菌过滤器(5)除去气体中所含的细菌。然后，设计设备，以便其能够经过微管(8)传递液体，并从微管末端喷射这样的液体，此外，将两个毛细管(未显示)放置在微管内，如图3所示，例如，药物和/或生物聚合物的溶液分别通过泵(10a、10b)从液体管道(9a、9b)中注射。
作为手术所用的封口剂，将5ml 10％血纤维蛋白原水溶液和5ml2500单位的凝血酶水溶液分别储存在不同的管道内(9a、9b)，通过泵(10a、10b)经过毛细管从这些管道中注入微管内，将它们与气体混合形成雾，然后从微管末端将血纤维蛋白原和凝血酶的混合物喷射到靶位。可利用在创伤表面产生的血纤维蛋白作为止血和封口剂。
实施例4
本实施例所用的应用两种气雾剂的粉末气体喷射器的正面透视简图在图7中给出。在本实施例中，将装有多种(在本实施例中是两种)气雾剂的小型贮气钢瓶(20a、20b)用作流化气体供应源，两个气雾剂管道与微管(21a、21b)相连，将药物和/或生物聚合物通过并为一体的两个微管，从微管(22)末端喷出。优选地，微管与气雾剂的偶合可通过安装双偶合驱动器进行，通过成为一体的两个与热收缩管具有下推阀的气雾剂管道形成。
将10g 10％的血纤维蛋白原水溶液和5ml 2500单位的凝血酶水溶液分别装入10ml气雾剂管道内作为储备溶液，再在4kg/cm2的压力下装入作为注射剂的氮气。通过按下下推按钮，将含有血纤维蛋白原的水溶液和含有溶血酶的水溶液从各自的气雾剂管道中注射，通过驱动器混合，以雾的形式经过微管传递，最后从微管末端喷射到靶位，进行止血。
工业实用性
如上所述，本发明提供一种利用流化和气体注射以及用细小的管(微管)注射，将细小的粉末状药物精确施用在靶位上的方法，特别是体腔内的靶位，还提供一种施用本身作为药物的生物聚合物的方法，或施用以生物聚合物为载体的药物的方法。具体地，本发明的给药方法优点在于不管药物或生物聚合物的施用部位的大小、形状和位置，都能够以更容易的方式得到例如止血、防止粘合、防止疤痕、修复伤口、愈合伤口、封口等靶向结果。
具体地，本发明的给药方法包括：将药物和生物聚合物粉碎来减少粉碎粉末的单位重量，用载气将其流化，通过微管传递，从微管末端注射细小的粉末状药物和生物聚合物，被这样构造的药物和生物聚合物可精确的通过狭窄的空间，从身体表面到达身体较深部分的靶位，而常规给药不可能实现。
此外，本发明的给药方法的特征在于该方法包括：将作为药物载体的生物聚合物的细小颗粒与细小的粉末状药物混合；使用气体将其经微管传递；将混合的细小粉末状生物聚合物和药物从微管末端喷射到靶位，使得粘合性高于单独使用药物的粘合性，因此，该方法的有利效果在于可将细小的粉末状药物与作为药物载体的生物聚合物的细小颗粒混合，通过流体力和气体的喷射力将其施用到靶位。
此外，本发明的给药方法包括：处理在不同的管道中的流化的生物聚合物的细小粉末和流化的药物细小粉末；经过微管用气流传递各细小粉末；将细小的药物粉末从微管末端喷射到靶位；之后，喷射生物聚合物的细小颗粒来覆盖靶位上的药物组分层，从而能获得防止药物扩散到靶位以外其它部位的有利效果。
或者，在本发明中，可以施用大多数生物聚合物，特别是能溶于水并显示粘性或可凝结的两种类型生物聚合物，在这种情况，将这样的一组细小颗粒粉末和溶液或一组溶液施用到靶位，可获得有利的效果。
Claims (19)
1、一种细小粉末状药物的给药方法，其特征在于将药物粉碎成平均颗粒直径等于或小于100μm的颗粒从而提供随气体的流动性，制备细小粉末和气体的均匀流体，通过气流将其传递过微管，并从微管的末端将细小的粉末状药物喷射到靶位上，喷射的量是能调节的。
2、一种施用生物聚合物的方法，包括：
用气体流化一种或多种类型的生物聚合物的细小颗粒，从而制备均匀的生物聚合物和气体的混合相流体；
通过气流将所述混合相流体传递过微管；和
将细小颗粒的生物聚合物从微管的末端喷射到靶位，从而在伤口部位止血，封口，防止器官粘合并修复伤口。
3、一种施用生物聚合物的方法，包括：
将生物可吸收的生物聚合物载体的细小颗粒与细小的药物粉末混合；
通过流动气体，将用气体流化的粉末传递过微管；和
将生物聚合物粉末和细小的粉末状药物的混合粉末从所述微管的末端喷射到靶位，从而在伤口部位止血，封口，防止器官粘合，和修复伤口。
4、根据权利要求1至3任意一项的方法，其中通过振动用于混合细小药物粉末或生物聚合物与气体的混合容器，制备细小粉末状药物和气体的均匀流体或生物聚合物和气体的均匀流体，或细小粉末药物和气体与生物聚合物载体的均匀流体。
5、根据权利要求1至3任意一项的方法，其中通过调节流化粉末的粉末浓度和气流来调节从微管末端喷射出来的细小粉末状药物或生物聚合物的量。
6、根据权利要求1至5任意一项的方法，其中在微管中进一步提供了直径比微管更小的小直径管，且其与微管同轴，其中将盐水、注入溶液或药物和/或生物聚合物的水溶液从更小直径的管注射到更小直径管的气流中，从而喷射其与微管中流化气体中的药物和/或生物聚合物细小颗粒的混合物。
7、根据权利要求1至5任意一项的方法，其中在微管中进一步提供了比微管直径更小的更小直径的管，且其与微管同轴，通过气流将细小的粉末状药物经过较小直径的管传递，并且生理盐水、注入溶液或药物和/或生物聚合物经过内外管间的空隙传递，细小的粉末状药物和要被喷射的水溶液在微管的末端混合。
8、根据权利要求1至7任意一项的方法，其中被气体流化的药物持续释放，从而推迟药物性质的释放。
9、根据权利要求8的方法，其中通过将药物微胶囊化、喷雾干燥或冷冻干燥来保持药物性质的释放。
10、一种给药的方法，包括：
在不同容器内流化生物聚合物的细小粉末和流化细小粉末状药物；
用气流经过微管传递各细小粉末；和
从微管的末端将细小粉末喷射到靶位，通过：
首先喷射细小粉末状药物，和其次喷射生物聚合物粉末，来覆盖靶位上的药物组分层，从而防止药物扩散和泄漏到靶位以外的其它部位。
11、一种给药方法，包括：
连接含有两种不同类型的组分且与微管相连的容器；和
将药物从微管末端喷射到靶位，
其中在喷射的前半部分，与微管末端更近的容器与其它容器相比，其所含组分被喷出的量更大，且
其中在喷射的后半部分，与气体入口一侧相连的容器与其它容器相比，其所含组分被喷出的量更大，从而逐渐变化各喷射组分的浓度。
12、一种施用生物聚合物的方法，其中应用了能溶于水并显示粘性或凝结的两种类型的生物聚合物，其中它们的一组细小颗粒粉末和其溶液，或其一组溶液分别经过各自的微管通过气流传递，并在微管末端混合，从而将其喷射到靶位。
13、根据权利要求12的方法，其中所述两种类型的生物聚合物是阴离子生物聚合物和阳离子生物聚合物的组合。
14、根据权利要求12或13的方法，其中生物聚合物选自合成聚合物、多糖、肽和蛋白质。
15、一种施用用于伤口表面止血或封口的药物的方法，其特征在于将两个毛细管同轴放置在微管内，将血纤维蛋白原单独或其与其它凝血因子的结合液体，和凝血酶单独或其与氯化钙的结合溶液分别从一个毛细管和另一个毛细管注射到微管内的气流中，从而在两种溶液混合时，将混合物从微管末端喷射到靶位。
16、一种施用用于伤口表面的止血或封口的药物的方法，其特征在于使用了含有单独的作为主要成分的血纤维蛋白原粉末或其与生物聚合物的细小混合粉末，和含有凝血酶作为主要成分的水溶液，并将其混合物通过权利要求15的方法喷射到靶位。
17、根据权利要求1至16任意一项的给药方法中用作持续释放的药物的流化基质细小颗粒粉末，其中药物通过库仑力、氢键和疏水键组成的分子间相互作用在溶液中结合到生物聚合物上，干燥后，在较低的温度下粉碎。
18、一种施用用于伤口表面止血或封口的药物的方法，其中将根据权利要求17的药物和具有与权利要求17的生物聚合物细小颗粒粉末基质相反的离子电荷的生物聚合物从微管末端，以细小颗粒粉末状态或溶液状态喷射到靶位。
19、根据权利要求2至7任意一项的方法，其中生物聚合物是磷酸钙型粉末、羟基磷灰石型粉末或玻璃型材料的粉末，其为骨粘固粉或人造骨填料，其中将磷酸钙型粉末或羟磷灰石粉末和液体剂的混合溶液，或玻璃型材料和含水酸的混合溶液从微管的末端喷射，以在靶位上形成骨替代物。
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| JP42480/2002 | 2002-02-20 | ||
| JP2002042480 | 2002-02-20 | ||
| PCT/JP2003/001693 WO2003070110A1 (fr) | 2002-02-20 | 2003-02-18 | Procede d'administration de medicament |
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| CN201010129296.9A Division CN101898004A (zh) | 2002-02-20 | 2003-02-18 | 施用药物的装置 |
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| CN03804368.8A Expired - Fee Related CN1635853B (zh) | 2002-02-20 | 2003-02-18 | 施用细小粉末状药物的装置 |
| CN201010129296.9A Pending CN101898004A (zh) | 2002-02-20 | 2003-02-18 | 施用药物的装置 |
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| US (1) | US7427607B2 (zh) |
| EP (1) | EP1477119A4 (zh) |
| JP (2) | JP4474165B2 (zh) |
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| CN107106152B (zh) * | 2014-09-11 | 2020-06-05 | 奥姆里克斯生物药品有限公司 | 至医疗施用装置的添加件 |
| CN108261604A (zh) * | 2017-12-07 | 2018-07-10 | 上海昊海生物科技股份有限公司 | 用于伤口护理、创面封闭的无菌粉末喷涂装置 |
| CN113474445A (zh) * | 2019-01-08 | 2021-10-01 | 赛多利斯斯泰帝生物科技有限责任公司 | 生物处理技术设备 |
Also Published As
| Publication number | Publication date |
|---|---|
| US7427607B2 (en) | 2008-09-23 |
| JP4461200B2 (ja) | 2010-05-12 |
| JP2010057938A (ja) | 2010-03-18 |
| JP4474165B2 (ja) | 2010-06-02 |
| WO2003070110A1 (fr) | 2003-08-28 |
| US20050123485A1 (en) | 2005-06-09 |
| EP1477119A4 (en) | 2009-06-10 |
| CN1635853B (zh) | 2010-05-12 |
| CN101898004A (zh) | 2010-12-01 |
| EP1477119A1 (en) | 2004-11-17 |
| JPWO2003070110A1 (ja) | 2005-06-09 |
| AU2003211376A1 (en) | 2003-09-09 |
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