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皮质类固醇释放型人工耳蜗:生物材料和药物输送系统的新型混合体。

Corticosteroid-releasing cochlear implant: a novel hybrid of biomaterial and drug delivery system.

机构信息

Department of Novel Drug Delivery Systems, Iran Polymer and Petrochemical Institute, 14965/115 Tehran, Iran.

Department of Biomaterials, Iran Polymer and Petrochemical Institute, 14965/115 Tehran, Iran.

出版信息

J Biomed Mater Res B Appl Biomater. 2010 Aug;94(2):388-398. doi: 10.1002/jbm.b.31666.

Abstract

In this study, drug-eluting cochlear implant (CI) electrodes were prepared, and the amount of drug released was determined. Dexamethasone (DEX) (0.25-2% w/w, the weight percent of the final cured polymer) was used as a bioactive agent to suppress postsurgical inflammations upon mixing with a two-part nonrestricted pourable medical-grade silicone elastomer. Batch reproducibility analysis was performed on three consecutive batches. Drug release experiments were accomplished in normal saline medium, where DEX was analyzed via a validated HPLC method. The drug loading percentage and the device surface area were the most dominant parameters explored to monitor the drug release behavior from CI coatings. Total cumulative amount of DEX released from various loaded samples was in the order of 2 > 1 > 0.5 > 0.35 > 0.25% w/w, but the cumulative percentage of drug released showed a reverse order. The DEX dosages between 0.1 and 1 microg were released from samples of smallest to highest loadings during the initial 24 h, and dosages <1-5 microg were released from similar samples of various loadings at the first patency 2 weeks. The extent of crosslinking was only effective on release profile at lower drug loadings of 0.25% w/w relative to 0.5%. It was also found that release profile was not affected by postcuring. (c) 2010 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2010.

摘要

在这项研究中,制备了载药耳蜗植入(CI)电极,并测定了药物释放量。地塞米松(DEX)(0.25-2%w/w,最终固化聚合物的重量百分比)被用作生物活性物质,与非限制型可浇注医用级硅橡胶弹性体的两部分混合,以抑制术后炎症。对三个连续批次进行了批重复性分析。在生理盐水介质中进行药物释放实验,通过验证的 HPLC 方法分析 DEX。药物负载百分比和器件表面积是监测 CI 涂层中药物释放行为的最主要参数。从各种负载样品中释放的 DEX 总量按 2 > 1 > 0.5 > 0.35 > 0.25%w/w 的顺序排列,但药物释放的累积百分比呈相反顺序。在最初的 24 小时内,从小到高载药量的样品中释放出 0.1 到 1 微克的 DEX 剂量,而在最初的 2 周通畅时,从各种载药量的类似样品中释放出 1 到 5 微克的 DEX 剂量。交联度仅对 0.25%w/w 的较低药物载药量的释放曲线有影响,而对 0.5%w/w 的药物载药量没有影响。还发现,释放曲线不受后固化的影响。(c)2010 Wiley 期刊,生物医学材料研究部分 B:应用生物材料,2010 年。

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