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采用质量源于设计(QbD)原则的创新型原位凝胶益生菌微粒制剂促进烧伤创面愈合。

Advancing burn wound healing with an innovative in situ gelling probiotic microparticle formulation employing quality by design (QbD) principles.

作者信息

Moraffah Fatemeh, Samadi Nasrin, Abdollahi Mohammad, Ostad Seyed Naser, Dolatabadi Roshanak, Pirouzzadeh Maryam, Vatanara Alireza

机构信息

Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, 1414614411, Iran.

Department of Drug and Food Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, 1414614411, Iran; Pharmaceutical Quality Assurance Research Center, The Institute of Pharmaceutical Sciences (TIPS), Tehran University of Medical Sciences, Tehran, 1414614411, Iran.

出版信息

J Tissue Viability. 2025 May;34(2):100860. doi: 10.1016/j.jtv.2025.100860. Epub 2025 Jan 21.

Abstract

Scientists investigated probiotic-containing dressings to address the challenges associated with burn injuries, namely infection and antimicrobial resistance. The present investigation sought to evaluate the impact of innovative probiotic-loaded microparticles with in situ gelling characteristics on infected burns. The strain, Lactiplantibacillus plantarum, was selected due to its demonstrated wound-healing potential. Subsequently, a formulation was designed to sustain the growth capacity of probiotics. Polymers with a high moisture absorption capacity were exclusively used to avoid powder dispersion from wounds. The formulation was stabilized through the reduction of water content using the spray-drying process. The ideal composition was identified by analyzing the influence of the spray-drying inlet temperature, polymer type, and concentrations on probiotic viability, process efficiency, swelling ratio, and flow properties of powders. Morphological analysis showed the presence of microparticles with significant exchangeable surface areas. The rheological properties of the formulation demonstrated its ability to withstand high temperatures and mechanical stress. Moreover, FTIR and DCS spectra provided evidence of interconnection between the polymers. Examination of the growth profiles of both formulated and free probiotics revealed a consistent growth rate and an extended lag time. Animal studies have shown that the optimal microparticles exhibited superior efficacy compared to the control groups across all parameters and displayed enhanced effectiveness against Pseudomonas aeruginosa. The proposed delivery method, with its simple application and prevention of normal flora transmission, may have the potential to improve burn wound infection treatments.

摘要

科学家们研究了含益生菌的敷料,以应对与烧伤相关的挑战,即感染和抗菌耐药性。本研究旨在评估具有原位凝胶特性的新型载益生菌微粒对感染烧伤的影响。选择植物乳杆菌菌株是因为其已证明具有伤口愈合潜力。随后,设计了一种配方以维持益生菌的生长能力。专门使用具有高吸湿能力的聚合物以避免粉末从伤口处散落。通过喷雾干燥过程降低含水量来稳定配方。通过分析喷雾干燥入口温度、聚合物类型和浓度对益生菌活力、工艺效率、溶胀率和粉末流动性的影响,确定了理想的组成。形态分析表明存在具有显著可交换表面积的微粒。该配方的流变学特性表明其能够承受高温和机械应力。此外,傅里叶变换红外光谱(FTIR)和差示扫描量热法(DCS)光谱提供了聚合物之间相互连接的证据。对配方化益生菌和游离益生菌的生长曲线进行检查发现,两者生长速率一致且滞后时间延长。动物研究表明,与对照组相比,最佳微粒在所有参数上均表现出更高的疗效,并且对铜绿假单胞菌显示出更强的有效性。所提出的给药方法应用简单且可防止正常菌群传播,可能具有改善烧伤创面感染治疗的潜力。

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