CN113975593A - 一种可达龙药物球囊及其制备方法 - Google Patents
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Abstract
本发明涉及一种可达龙药物球囊及其制备方法，通过将可达龙、聚乙交酯、聚己内酯的混合溶液涂覆于球囊表面而得。相比于药物治疗，本发明具有减少药物使用量，不存在停药率，副作用大量减少的优点；相比于非药物治疗，本发明运用技术成熟，无需损伤正常心肌，临床并发症较少；相比于心包内用药，本发明不需要特殊导管，技术操作难度低，可操作性强；相比于其他治疗方法，本发明所需的治疗费用最低。
Description
技术领域
本发明属于房颤治疗领域，特别涉及一种可达龙药物球囊及其制备方法。
背景技术
房颤是临床最常见的持续性心律失常，常见心悸、眩晕等症状，其最主要的危害是形成血栓从而导致脑卒中。现阶段针对房颤的治疗包括维持窦性心律及预防血栓形成。恢复窦性心律是治疗房颤的根本，对于不能恢复窦性心律的患者，应维持其心室率在较慢水平。恢复窦性心律包括药物治疗及非药物治疗两种方式。常用药物包括β受体阻滞剂、洋地黄类、钙通道拮抗剂、胺碘酮等。非药物治疗主要是指通过射频消融术控制房颤，降低其发生率。近年来文献报道了一种新的治疗方式，采用介入与药物治疗相结合的方法，利用一种特殊导管，将胺碘酮等药物注入心包。(Garcia,Jose R et al.“Minimally InvasiveDelivery of Hydrogel-Encapsulated Amiodarone to the Epicardium Reduces AtrialFibrillation.”Circulation.Arrhythmia and electrophysiology vol.11,5(2018):)从而实现心包内给药，以维持心室率。但是，心包内用药这一方法目前仅进行了动物实验，尚未有临床研究，需要特殊导管，操作难度较大。
发明内容
本发明所要解决的技术问题是提供一种可达龙药物球囊及其制备方法，解决了可达龙药物与球囊的结合及定位释放上的困难。
本发明提供了一种可达龙药物球囊，通过将可达龙、聚乙交酯、聚己内酯的混合溶液涂覆于球囊表面而得。
本发明提供了一种可达龙药物球囊的制备方法，包括：
将质量比为1-2:1-2:1-2的可达龙、聚乙交酯、聚己内酯的混合溶液涂覆于球囊表面，多次烘干、浸泡，得到可达龙药物球囊。
所述烘干温度为30℃。
所述浸泡时间为30s-60s。
有益效果
由于可达龙属于水溶性药物，因此本发明通过PGA和PCL的结合，解决了可达龙药物与球囊的结合及定位释放上的困难；相比于药物治疗，本发明具有减少药物使用量，不存在停药率，副作用大量减少的优点；相比于非药物治疗，本发明运用技术成熟，无需损伤正常心肌，临床并发症较少；相比于心包内用药，本发明不需要特殊导管，技术操作难度低，可操作性强；相比于其他治疗方法，本发明所需的治疗费用最低。
附图说明
图1为可达龙药物球囊组织残余率。
具体实施方式
下面结合具体实施例，进一步阐述本发明。应理解，这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解，在阅读了本发明讲授的内容之后，本领域技术人员可以对本发明作各种改动或修改，这些等价形式同样落于本申请所附权利要求书所限定的范围。
实施例1
将质量比为2:1:1的可达龙、聚乙交酯、聚己内酯的混合溶液涂覆于球囊表面，多次烘干、浸泡，得到可达龙药物球囊。通过称重法精确药物含量，低温烘干保存。
①可达龙药物球囊组织释放率
以喷涂法将可达龙覆盖在球囊表面，测出并计算每个球囊实际载药量，通过介入方法，采用狗动物模型，将可达龙药物球囊置入肺静脉进行球囊扩张60秒。即刻取相应肺静脉段，通过高效液相测药物浓度(表1)。
表1：可达龙药物球囊药物组织释放率(n＝5)
| 球囊实际药物含量 | 组织实际药物含量 | 释放百分比 |
| 1.024±0.042 | 0.28±0.039 | 27.34％ |
由表1可知，可达龙药物球囊释放效果好。
②可达龙药物球囊组织残余量率(n＝5)
可达龙药物球囊释放药物后，按照时间点0天，1天，3天，7天，14天，28天，180天，360天测组织药物残余量(图1)。
由图1可知，可达龙药物球囊有良好的缓释效果。
比较例1
将质量比为3:1的可达龙、聚乙交酯的混合溶液涂覆于球囊表面，多次烘干、浸泡，得到可达龙药物球囊。通过称重法精确药物含量，低温烘干保存。
表2可达龙药物球囊药物组织释放率(n＝5)
| 球囊实际药物含量 | 组织实际药物含量 | 释放百分比 |
| 1.018±0.027 | 0.13±0.026 | 12.77％ |
比较例2
将质量比为3:1的可达龙、聚己内酯的混合溶液涂覆于球囊表面，多次烘干、浸泡，得到可达龙药物球囊。通过称重法精确药物含量，低温烘干保存。
表3可达龙药物球囊药物组织释放率(n＝5)
| 球囊实际药物含量 | 组织实际药物含量 | 释放百分比 |
| 1.009±0.016 | 0.17±0.027 | 16.85％ |
比较例3
将质量比为3:1的可达龙、聚乳酸的混合溶液涂覆于球囊表面，多次烘干、浸泡，得到可达龙药物球囊。通过称重法精确药物含量，低温烘干保存。
表4可达龙药物球囊药物组织释放率(n＝5)
| 球囊实际药物含量 | 组织实际药物含量 | 释放百分比 |
| 1.065±0.078 | 0.11±0.028 | 10.33％ |
Claims (4)
1.一种可达龙药物球囊，其特征在于：通过将可达龙、聚乙交酯、聚己内酯的混合溶液涂覆于球囊表面而得。
2.一种可达龙药物球囊的制备方法，包括：
将质量比为1-2:1-2:1-2的可达龙、聚乙交酯、聚己内酯的混合溶液涂覆于球囊表面，多次烘干、浸泡，得到可达龙药物球囊。
3.根据权利要求1所述的制备方法，其特征在于：所述烘干温度为30℃。
4.根据权利要求1所述的制备方法，其特征在于：所述浸泡时间为30s-60s。
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| CN1799650A (zh) * | 2005-12-30 | 2006-07-12 | 李文涛 | 生物可降解载药物高分子材料支架的制备方法 |
| CN102458497A (zh) * | 2009-04-24 | 2012-05-16 | 优洛可股份有限公司 | 涂有虫胶和太平洋紫杉醇的导管球囊 |
| CN104857573A (zh) * | 2010-03-25 | 2015-08-26 | 路通医疗股份有限公司 | 用于医疗设备的释药涂层 |
| KR20120138180A (ko) * | 2011-06-14 | 2012-12-24 | 가천대학교 산학협력단 | 약물 전달을 위한 리포좀-마이크로 구조체 및 이의 제조방법 |
| US20170281914A1 (en) * | 2016-03-31 | 2017-10-05 | Surmodics, Inc. | Localized treatment of tissues through transcatheter delivery of active agents |
| CN110691567A (zh) * | 2017-04-20 | 2020-01-14 | 480生物医药股份有限公司 | 用于治疗窦炎的可植入支架 |
| CN110141760A (zh) * | 2019-06-05 | 2019-08-20 | 山东百多安医疗器械有限公司 | 一种表面载药的椎体成形扩张球囊及其制备方法 |
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