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生物材料降解这个过程采用的什么生产流程?

生物材料降解这个过程采用的什么生产流程?

来源网址:http://www.swjjkl.com 2020-05-28 15:57:10    

分析材料在正常使用情况下是否会降解对它的安全性评价来讲十分重要。对所有生物材料都进行降解研究既不可能也没有这个必要。因此,对哪些情况应考虑有必要进行降解研究、哪些情况可不必进行降解研究,ISO10993-9中作了原则规定。

It is very important to analyze whether the material will degrade in normal use for its safety evaluation. It is neither possible nor necessary to study the degradation of all biomaterials. Therefore, it is necessary to carry out degradation research on which conditions should be considered, and which conditions can be exempted from degradation research. Iso10993-9 has made principle provisions.
作为判别,主要根据如下:
As a judgment, the main basis is as follows:
(1)下列情况应考虑进行降解研究
(1) Degradation studies should be considered in the following cases
(a)材料是可被生物吸收的;
(a) The material is bioabsorbable;
(b)长期植入材料(大于30d),可能产生明显的生物降解;
(b) The long-term implanted materials (more than 30 days) may produce obvious biodegradation;
(c)通过对材料的广泛研究表明,在材料(尤指介入或植入材料)与人体长期接触期间,毒性物质可以或可能释放出来。
(c) Extensive research on materials has shown that toxic substances can or may be released during long-term contact between materials (especially interventional or implanted materials) and human body.
(2)下列情况不必进行降解研究
 
(2) Degradation studies are not necessary for
(a)可溶出的或以一定的量和速度从特定材料中释放出的物质已经过安全性评价及具有安全临床使用史;
(a) Soluble substances or substances released from specific materials at a certain amount and speed have been evaluated for safety and have a history of safe clinical use;
(b)在预计使用中已有充分的有关物质和降解产物的安全性评价研究数据。(b) There are enough safety evaluation data of related substances and degradation products in the expected use.
即使是有必要进行降解研究的材料,在设计降解系统评价前应首先熟悉文献中介绍的此种材料降解机理和生物降解的情况。根据文献中实验研究以及临床实验研究的结果进行判定。若能证明此材料已进行了降解的系统评价,它的结论是符合ISO10993-1中的规定要求或为生命体能接受此材料或能被证明已为临床长期安全应用,或有文献及实验研究中实验数据证明它与已知材料的降解研究一致,则无须进行雷同的试验。在设计降解评价方法时应考虑材料的化学特性与物理特性,所制成的器械和它的作用原理、使用时间、位置及其局部环境的化学特性等因素,对不同材质的部件要考虑不同的降解机理的区别。评价方法应与这些条件相符合。若能检索到相应的标准与文献中通用推荐的方法,应优先考虑采用规定的降解产物定性与定量标准。
Even if it is necessary to carry out degradation research on materials, before designing degradation system evaluation, we should first be familiar with the degradation mechanism and biodegradation situation of such materials introduced in the literature. According to the results of experimental research and clinical experimental research in the literature. If it can be proved that the material has been systematically evaluated for degradation, and its conclusion is that it meets the requirements of iso10993-1, or it can be accepted for life and physical ability, or it can be proved that it has been used for clinical long-term safety, or it is proved that it is consistent with the degradation Research of known materials by literature and experimental data, then no similar test is required. In the design of degradation evaluation method, the chemical and physical characteristics of the material, the device made and its principle of action, use time, location and chemical characteristics of local environment shall be taken into account, and the differences of different degradation mechanisms shall be taken into account for parts of different materials. The evaluation method should be consistent with these conditions. If the corresponding standards and the general recommended methods in the literature can be retrieved, the specified qualitative and quantitative standards of degradation products should be preferred.
由于研究降解问题比较复杂,设计实验方案尤为困难,目前大都采用体外的方法进行试验,在此基础上,根据体外研究结果考虑是否进行体内研究。体内研究时应考虑动物保护(见ISO10993-2)。用体外法评价材料和医疗器械的降解的方法有简单的,也有复杂的,简单的如材料浸泡在0.9%生理盐水中37±1℃72h、50℃±2℃ 72h、70℃±2℃ 24h、121℃±2℃ 1h,较复杂一些的如浸泡在含有酶、磷酯等的溶液中进行材料降解的情况观察。必要时材料或器械承受外加机械应力情况下进行降解试验,材料和器械体外降解试验的方法有两种,一种是加速试验,一种是实际时间试验。
Because of the complexity of degradation research, it is very difficult to design the experimental scheme. At present, most of the experiments are carried out in vitro. On this basis, whether to carry out in vivo research is considered according to the results of in vitro research. Animal protection should be considered in vivo studies (see iso10993-2). There are simple and complex methods to evaluate the degradation of materials and medical devices in vitro, such as soaking materials in 0.9% normal saline for 37 ± 1 ℃ 72h, 50 ± 2 ℃ 72h, 70 ± 2 ℃ 24h, 121 ± 2 ℃ 1H. Some of them are more complex, such as soaking materials in solutions containing enzymes, phosphates, etc. When necessary, materials or devices are subject to external mechanical stress for degradation test. There are two methods for in vitro degradation test of materials and devices, one is accelerated test, the other is actual time test.
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