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Preparation for sustained release of a physiologically active polypeptide and its preparation

机译:持续释放生理活性多肽的制剂及其制备

摘要

A method for producing a sustained-release preparation, which comprises dispersing a physiologically active polypeptide into an organic solvent solution of a biodegradable polymer and removing the organic solvent, wherein the polypeptide is a powder obtained by lyophilizing an aqueous solution of the polypeptide which solution has a water-miscible organic solvent and/or a volatile sa which improves the ease of handling of the physiologically active polypeptide powder in the process for producing the preparation; which makes it possible to industrially produce the sustained-release preparation in large scale; which provides a sustained-release preparation showing high and stable concentration of the active component in blood in long term, low initial release ratio of the physiologically active polypeptide, and high entrapment ratio of the polypeptide into the sustained-release preparation.
机译:一种制备持续释放制剂的方法,该方法包括将生理活性多肽分散到可生物降解的聚合物的有机溶剂溶液中并除去有机溶剂,其中所述多肽是通过将所述多肽具有的水溶液冷冻干燥而得到的粉末。与水混溶的有机溶剂和/或挥发性盐;在制备制剂的过程中提高了生理活性多肽粉末的易处理性;这使得有可能大规模生产该缓释制剂。它提供了一种缓释制剂,该制剂长期显示出高且稳定的血液中活性成分浓度,生理活性多肽的初始释放率低,并且该多肽在该缓释制剂中的包封率高。

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