日本PDA学術誌 GMPとバリデーション
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
解説
新規癒着防止材の開発事例
石原 弘之新美 大志千野 直孝甲斐 美穂相馬 祐輝渡邊 英二川西 徹朗
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2020 年 22 巻 1 号 p. 6-11

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We developed a novel spray-type dextrin hydrogel-based adhesion barrier designed to create a site-specific barrier on a target. Our novel hydrogel is composed of Powder A, which mainly contains N-hydroxysuccinimide-modified carboxymethyl dextrin and trehalose as a stabilizing agent, and Powder B, which is composed of sodium carbonate and sodium hydrogen carbonate. The spray device has several unique specifications that can be used under laparoscopic surgery. Furthermore, the shape and the appearance are characteristic so that this device can be appropriately used in a clinical situation. Here, we introduce the development process of a novel spray-type adhesion barrier as the case study of medical device.

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© 2020 日本PDA製薬学会
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