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首页> 外文期刊>Journal of oncology pharmacy practice: official publication of the International Society of Oncology Pharmacy Practitioners >Loading profile of topotecan into polyvinyl alcohol microspheres (DC Bead?) over a 7-day period.
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Loading profile of topotecan into polyvinyl alcohol microspheres (DC Bead?) over a 7-day period.

机译：在7天的时间内将拓扑替康加载到聚乙烯醇微球（DC Bead？）中的过程。

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DC Bead? is successfully used for chemoembolization of various liver cancers. The purpose of this study was to determine the loading capacity of the semi-synthetic topoisomerase-1 inhibitor topotecan into the DC Bead? microspheres under static or agitated conditions and to assess the physicochemical stability over a period of 7 days.Commercially available topotecan hydrochloride powder (Hycamtin?) was reconstituted with water for injection to yield a nominal concentration of 1 mg/mL topotecan. Polyvinyl alcohol (PVA)-based microspheres (DC Bead?, 300-500 μm, 2 mL/vial) were mixed with 4 mL of the reconstituted topotecan solution. Vials were stored light protected at room temperature under static or agitated conditions for 7 days (n?=?3, for each loading condition). At different time intervals, samples were taken from the excess solution and assayed via a stability-indicating HPLC assay. Drug-loading profiles were determined by measuring the remaining topotecan concentration in the excess solution.Under agitated conditions, topotecan was loaded into the microspheres rapidly after mixing. After 5 min 86.4?±?0.1% of topotecan was loaded. Under static conditions, drug uptake was slower. Only 65.0?±?0% were loaded after 5 min; 86.6?±?0.1% drug uptake was achieved not until 1 h. Over a storage period of 7 days, topotecan remained loaded in the DC Bead? microspheres at a level of >90%.Drug uptake of 4 mg topotecan (1 mg/mL solution) into DC Beads? was faster under agitated loading conditions. Nevertheless, after 1 h, ～90% of topotecan was loaded into the DC Bead? microspheres independent from the type of loading condition. The loading rate remained >90% over the observation period of 7 days and light-protected storage at room temperature. Loading and stability of topotecan-loaded DC Beads? is suitable and convenient for preparation in a pharmacy-based cytotoxic preparation unit.
机译：DC珠？已成功用于各种肝癌的化学栓塞。这项研究的目的是确定半合成拓扑异构酶-1抑制剂拓扑替康在DC Bead？中的负载能力。微球在静态或搅拌条件下评估7天的理化稳定性。将市售的拓扑替康盐酸盐粉末（Hycamtin？）与注射用水冲配，制成名义浓度为1 mg / mL拓扑替康。将基于聚乙烯醇（PVA）的微球（DC Bead？，300-500μm，2 mL /瓶）与4 mL重构的拓扑替康溶液混合。将小瓶在室温下在静态或搅拌条件下避光保存7天（对于每种装载条件，n？=？3）。在不同的时间间隔，从过量的溶液中取出样品，并通过指示稳定性的HPLC测定法进行测定。通过测量过量溶液中剩余的拓扑替康浓度来确定载药曲线。在搅拌条件下，混合后将拓扑替康迅速加载到微球中。 5分钟后，装入86.4±0.1％的拓扑替康。在静态条件下，药物吸收较慢。 5分钟后仅加载65.0±±0％。直到1小时才达到86.6±0.1％的药物吸收。在7天的存储期内，托泊替康仍保留在DC Bead中吗？微球含量> 90％.DC磁珠中是否吸收了4 mg拓扑替康（1 mg / mL溶液）的药物？在搅拌加载条件下速度更快。然而，在1小时后，约90％的拓扑替康被装入DC微珠？微球与装载条件的类型无关。在7天的观察期内，装载率保持> 90％，并且在室温下避光保存。装载拓扑替康的DC微珠的负载和稳定性？适于在基于药物的细胞毒性制剂单元中制备且方便。

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