纤维素类可吸收止血产品体外降解终点判断的研究

梅昕; 马凤森; 喻炎; 陈海波; 江滔

doi:10.3969/j.issn.1671-7104.2016.02.015

纤维素类可吸收止血产品体外降解终点判断的研究

梅昕¹,
马凤森^1, ,,
喻炎¹,
陈海波²,
江滔¹

1 浙江工业大学药学院, 杭州市, 310014;
2 浙江省医疗器械检验院, 杭州市, 310018

详细信息

作者简介:
梅昕,E-mail:messi_power@126.com

通讯作者:
马凤森,教授,E-mail:merrigen@126.com

中图分类号: R318.08
计量
- 文章访问数: 23
- HTML全文浏览量: 0
- PDF下载量: 2
出版历程
- 收稿日期: 2015-12-07
- 网络出版日期: 2024-02-19
- 刊出日期: 2016-03-29

Research of Determining Complete Degradation Time in Vitro Based on Cellulose Absorbable Hemostatic Products

1 College of Pharmaceutical Science, Zhejiang University of Technology, Hangzhou, 310014;
2 Zhejiang Institute for the Control of Medical Device, Hangzhou, 310000

摘要

摘要: 为了准确、快速、有效地判断可溶性止血产品的体外完全降解时间，对GB/T 16886标准中现行的失重法进行了优化，采用透析袋结合还原糖测试法，于3%过氧化氢溶液、37℃、150 rpm条件下进行降解，第3 d、6 d、8 d、10 d、14 d取出透析袋，真空干燥测失重百分率，并测定了降解过程中透析袋外的还原糖累积含量，利用SPSS 22.0软件以Pearson Correlation Coefficient法对二者进行相关性分析。结果表明失重百分率与还原糖累积含量之间的相关系数为0.957，说明二者高度相关，验证了透析袋结合还原糖测试法评价体外降解终点的可行性。该方法也为其他类可溶性材料体外降解终点的判断提供思路。
- 可吸收止血产品 /
- 相关性 /
- 完全降解时间 /
- 体外降解
Abstract: To develop a method for determining complete degradation time of soluble hemostatic products in vitro with accuracy, high speed and effectiveness, the current weight loss method originated from GB/T 16886 serial standards was optimized by using dialysis bag combined with assay of reducing sugar. The degradation was carried out with 3% hydrogen peroxide solution, at 37℃, 150 rpm. The dialysis bags were taken out in the 3rd, 6th, 8th, 10th and 14th day, vacuum drying followed by percentage of weight loss testing. Cumulative content of reducing sugar in degradation solution out of dialysis bag was determined simultaneously. The correlation analysis was performed by SPSS 22.0 equipped with Pearson Correlation Coefficient. The correlation coefficient between percentage of weight loss and cumulative content of reducing sugar was 0.957, which illustrated high correlation with each other. Hence dialysis bag combined with assay of reducing sugar is capable of evaluating the degradation endpoint of soluble hemostatic products in vitro. The method also provides a way for the evaluation of degradation of other degradable biomaterials in vitro.
- absorbable hemostatic products /
- correlation /
- complete degradation time /
- degradation in vitro

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参考文献(16)

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