Basic fibroblast growth factor (FGF)-2 has been shown to regulate many cellular functions including cell proliferation, migration, and differentiation, as well as angiogenesis in a variety of tissues, including skin, blood vessel, muscle, adipose, tendon/ligament, cartilage, bone, tooth, and nerve. These multiple functions make FGF-2 an attractive component for wound healing and tissue engineering constructs; however, the stability of FGF-2 is widely accepted to be a major concern for the development of useful medicinal products. Many approaches have been reported in the literature for preserving the biological activity of FGF-2 in aqueous solutions. Most of these efforts were directed at sustaining FGF-2 activity for cell culture research, with a smaller number of studies seeking to develop sustained release formulations of FGF-2 for tissue engineering applications. The stabilisation approaches may be classified into the broad classes of ionic interaction modification with excipients, chemical modification, and physical adsorption and encapsulation with carrier materials. This review discusses the underlying causes of FGF-2 instability and provides an overview of the approaches reported in the literature for stabilising FGF-2 that may be relevant for clinical applications. Although efforts have been made to stabilise FGF-2 for both in vitro and in vivo applications with varying degrees of success, the lack of comprehensive published stability data for the final FGF-2 products represents a substantial gap in the current knowledge, which has to be addressed before viable products for wider tissue engineering applications can be developed to meet regulatory authorisation.

中文翻译：

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成纤维细胞生长因子2-A稳定方法的临床应用综述。

碱性成纤维细胞生长因子（FGF）-2已被证明可调节许多细胞功能，包括细胞增殖，迁移和分化，以及各种组织（包括皮肤，血管，肌肉，脂肪，肌腱/韧带）的血管生成，软骨，骨骼，牙齿和神经。这些多种功能使FGF-2成为伤口愈合和组织工程构造的诱人成分。然而，FGF-2的稳定性被广泛认为是开发有用药物的主要关注点。在文献中已经报道了许多方法来保持水溶液中FGF-2的生物活性。这些努力大部分是为了维持FGF-2活性进行细胞培养研究，少数研究寻求开发用于组织工程应用的FGF-2缓释制剂。稳定化方法可分为利用赋形剂进行离子相互作用改性，化学改性以及利用载体材料进行物理吸附和包封的大类。这篇综述讨论了FGF-2不稳定性的根本原因，并概述了文献中报道的稳定FGF-2的方法，这些方法可能与临床应用有关。尽管已努力在体外和体内应用中稳定FGF-2并取得了不同程度的成功，但是缺乏针对最终FGF-2产品的全面公开的稳定性数据，这代表了当前知识的重大缺陷，