文章摘要

文章信息/Info

Title:: Research on the preparation method for leaching liquid of the dura sealant material

作者:: 董芳芳1; 2△; 苑康见1; 2; 邓凤娟1; 2; 赵艳1; 2; 张尚1; 2; 李正强1; 2; 孔凡照1; 2; 赵成如1; 2; 1.赛克赛斯生物科技股份有限公司，济南 250101；2.山东体内植入材料工程技术研究中心，济南 250101

Author(s):: DONG Fangfang1; 2; YUAN Kangjian1; 2; DENG Fengjuan1; 2; ZHAO Yan1; 2; ZHANG Shang1; 2; LI Zhengqiang1; 2; KONG Fanzhao1; 2; ZHAO Chengru1; 2; 1. Success Bio-Tech CO., Ltd.，Jinan 250101,China；2.Shandong Institute of Implantable Materials Engineering and Technology Research Center，Jinan 250101

Keywords:: Dural sealant material; Hydrogel; Biological test; Leaching liquid; Sample preparation

摘要:: 医疗器械产品浸提液作为医疗器械生物学评价试验的样品，其制备条件是保证生物学评价试验结果具有可靠性和可比性的关键。为进一步明确不同浸提条件对浸提液溶出物的影响，本研究在制备硬脑膜封合医用胶产品的生物学评价试验样品时，选用GB T 14233.1推荐的两种浸提比例，以及ISO10993-12（即GB T 16886.12）中推荐的5种浸提条件，进行浸提液的制备。采用红外光谱（FTIR）、差示扫描量热（DSC）、〖JP2〗pH值、渗透压、紫外光谱（UV）、液相色谱（HPLC）、电感耦合等离子体质谱(ICP-MS)进行分析。结果表明，不同浸提条件不具有一致性，适合硬脑膜封合医用胶浸提液的浸提条件为0.1 g/mL，(37±1)℃，(72±2) h。

Abstract:: As the sample for biological evaluation test of medical devices, the preparation conditions of medical device extract are the key to ensure the reliability and comparability of biological evaluation test results. In order to clarify the effects of different extraction conditions on the extractables of the extraction solution, we selected two extraction ratios recommended in GB T 14233.1 and five extraction conditions recommended in ISO 10993-12 (i.e. GB T 16886.12) to prepare the biological test samples of dura mater seal medical adhesive products. Infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), pH value, osmotic pressure, ultraviolet spectrum（UV）, liquid chromatography (HPLC), and inductively coupled plasma mass spectrometry (ICP-MS) were used for analysis. The results show that different extraction conditions are not equivalent, and the suitable extraction conditions for the material are 0.1 g/mL, (37±1)℃，(72±2) h.