Anitua Eduardo, Pino Ander, Troya María
J Drugs Dermatol. 2018 Oct 1;17(10):1115-1121.
In this study, the stability of a novel autologous topical serum (ATS) derived from plasma rich in growth factors technology (PRGF) has been evaluated. As skin ages, mechanical, protective and restorative properties decrease leading to multiple clinical conditions. In recent years, topical administration of growth factors has emerged as a promising therapeutic alternative to promote wound healing and skin regeneration. Determination of stability is a crucial step in the formulation process in order to develop an effective product. Blood from 8 healthy donors was harvested and the autologous topical serum was obtained. Resulting ATS samples were either kept fresh or stored for 1, 2, and 3 months at 4ºC. Physical properties and growth factor content were determined in ATS samples at each time of storage. The effect on human dermal fibroblast proliferation and the sterility of the samples was also studied. All the analyzed parameters remained stable along the storage time while pH values increased slightly with respect to fresh samples. No microbial contamination was detected in any of the samples. Preservation of the autologous topical serum up to 3 months under refrigeration does not affect either its physical or mechanical properties or neither alters the growth factors´ composition, thus preserving its biological potential. This achievement enables patients with chronic disorders to maintain their treatment with a lower frequency of blood extractions without affecting the efficacy of PRGF therapy. J Drugs Dermatol. 2018;17(10):1115-1121.
在本研究中,对一种源自富含生长因子血浆技术(PRGF)的新型自体局部血清(ATS)的稳定性进行了评估。随着皮肤老化,其机械、保护和修复特性会下降,从而导致多种临床病症。近年来,局部应用生长因子已成为促进伤口愈合和皮肤再生的一种有前景的治疗选择。稳定性的测定是制剂研发过程中的关键步骤,以开发出有效的产品。采集了8名健康供体的血液并获得了自体局部血清。所得的ATS样本要么保持新鲜,要么在4℃下储存1、2和3个月。在每个储存时间点测定ATS样本的物理性质和生长因子含量。还研究了其对人真皮成纤维细胞增殖的影响以及样本的无菌性。在整个储存期间,所有分析参数均保持稳定,而pH值相对于新鲜样本略有升高。在任何样本中均未检测到微生物污染。在冷藏条件下将自体局部血清保存长达3个月既不影响其物理或机械性能,也不会改变生长因子的组成,从而保留其生物学潜力。这一成果使患有慢性疾病的患者能够以较低的采血频率维持治疗,而不影响PRGF疗法的疗效。《药物皮肤病学杂志》。2018年;17(10):1115 - 1121。