Purification of Polymeric Biomaterials
Purification of Polymeric Biomaterials
复制标题
聚合生物材料的纯化
DOI：
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发表时间：
2001
影响因子：
5.2
通讯作者：
D. S. Vidal
中科院分区：
文献类型：
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作者：
C. Wandrey;D. S. Vidal
摘要：采用过滤和沉淀相结合的方法，海藻酸钠（SA）和硫酸纤维素钠（SCS）中的内毒素浓度降低到200 EU/g聚合物的值。这是例如对于由大约420，000个包封的胰岛组成的适当的生物人工胰腺计算的调节阈值的十分之一。在6个月的储存期内，低内毒素（ET）水平保持在该阈值以下。聚合物的纯化过程不会对最终的微胶囊性质产生负面影响。来自纯化材料的微胶囊的机械稳定性甚至略高于来自原始聚合物的微胶囊。避免内毒素从装置释放的第二种方法是在珠或胶囊形成过程中其直接络合。可以证明二元、三元和四元复合物中内毒素结合的持久性可在培养基和盐水中储存。在培养基中3个月和在盐水中5个月后，检测到复合物中非常低的总内毒素释放。这种络合主要基于与参与的阳离子组分的静电相互作用，并为最终的生物人工器官或递送装置提供额外的安全性。
Abstract: Employing a combined filtration and precipitation method, the endotoxin concentration in sodium alginate (SA) and sodium cellulose sulfate (SCS) was reduced to a value of 200 EU/g polymer. This is one tenth of the regulatory threshold calculated, for example, for an appropriate bioartificial pancreas that consists of approximately 420,000 encapsulated islets of Langerhans. The low endotoxin (ET) levels were maintained below this threshold during a six‐month storage period. The purification procedure of the polymers did not negatively influence the final microcapsule properties. The mechanical stability of microcapsules from purified material is even slightly higher than that of microcapsules from the original polymers. A second approach to avoid endotoxin release from the device is its direct complexation during the bead or capsule formation process. The durability of endotoxin binding in binary, ternary, and quaternary complexes could be demonstrated for storage in culture medium and saline. Very low total endotoxin release from the complexes was detected after three months in culture medium and five months in saline. This complexation is primarily based on electrostatic interactions with the participating cationic components and provides additional security for the final bioartificial organ or delivery device.