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蒲公英 - 制药技术的传播者 GMP理论的实践者»蒲公英論壇 › 醫療器械 › 器械注冊 › 海綿類産品送檢生物學

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樓主

发表于 2024-3-26 09:33:56 | 只看該作者回帖奖励

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請问下大家，在送检海绵类产品的生物学试验的时候，检所有没有要求提供“产品是否为吸收剂”，以及“吸收量”这种参数？
有送過的大佬知道這個是怎麽測出來或者計算出來的嗎

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華微檢測賴工

沙發

发表于 2024-3-26 09:50:56 | 只看該作者

需要提供吸水量

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板凳

樓主| 发表于 2024-3-26 09:53:52 | 只看該作者

華微檢測賴工发表于 2024-3-26 09:50
需要提供吸水量

我們的産品會在水中溶解，非極性溶液中不反應，還需要考慮嗎

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華微檢測賴工

地板

发表于 2024-3-26 09:55:03 | 只看該作者

极性浸提液呢，可加微信沟通 189 2879 0749

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華微檢測賴工

5^#

发表于 2024-3-26 09:58:17 | 只看該作者

海州发表于 2024-3-26 09:53
我們的産品會在水中溶解，非極性溶液中不反應，還需要考慮嗎

涉及生物相容性需要用到雙極性

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王文喜（江蘇科

6^#

发表于 2024-3-26 12:45:21 | 只看該作者

當然要提供吸水量啊，做了很多海綿類的，計算也簡單的，就是把一定重量的海綿浸泡中水中，一定時間後取出，擠幹水分，稱重

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7^#

樓主| 发表于 2024-3-26 14:30:13 | 只看該作者

王文喜（江蘇科发表于 2024-3-26 12:45
当然要提供吸水量啊，做了很多海绵类的，计算也简单的，就是把一定重量的海绵浸泡中水中，一定时间后取出， ...

那非極性溶液呢，植物油這些？

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王文喜（江蘇科

8^#

发表于 2024-3-29 13:41:19 | 只看該作者

海州发表于 2024-3-26 14:30
那非極性溶液呢，植物油這些？

芝麻油也會浸潤海綿啊

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