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响应面法和田口方法用于评估配方因素对米诺环素从胶原海绵中释放的联合效应。

Response surface methodology and Taguchi approach to assess the combined effect of formulation factors on minocycline delivery from collagen sponges.

作者信息

Ghica M V, Albu M G, Popa L, Moisescu St

机构信息

Physical and Colloidal Chemistry Department, Faculty of Pharmacy, Carol Davila University of Medicine and Pharmacy Bucharest, Romania.

出版信息

Pharmazie. 2013 May;68(5):340-8.

Abstract

An important aspect to be considered in the healing of acute or chronic cutaneous wounds is the associated potential infection management. Collagen, the most abundant protein of the extracellular matrix, with proven properties in wounds healing and tissues regeneration, is one of the most widely used biopolymers as carrier matrix for controlled drug delivery systems. For this reason, the purpose of the current paper is the development of some minocycline-loaded collagen topical sponges uncross-linked and cross-linked with glutaraldehyde, obtained by lyophilization of appropriate hydrogels prepared according to the 3-factor, 3-level face-centered central composite design. The determination of drug delivery from the sponges was performed by assessment of some physicochemical parameters involved in this complex process: sponges surface wettability, swelling ratio and the percentage of minocycline released from the sponges. The application of the response surface methodology allowed the setting of the formulation parameters optimum ranges, which ensure an adequate minocycline release to the application site. The design robustness was checked using the signal-to-noise ratio performance indicator. The optimum collagen-minocycline sponges determined based on the statistical screening technique could be suitable for topical drug delivery in infected wounds healing with moderate to high exudate.

摘要

在急性或慢性皮肤伤口愈合过程中需要考虑的一个重要方面是相关潜在感染的管理。胶原蛋白是细胞外基质中最丰富的蛋白质,在伤口愈合和组织再生方面具有已被证实的特性,是作为可控药物递送系统载体基质应用最广泛的生物聚合物之一。因此,本文的目的是开发一些负载米诺环素的胶原蛋白局部用海绵,这些海绵未交联以及用戊二醛交联,通过根据三因素、三水平的面心中央复合设计制备的适当水凝胶冻干得到。通过评估该复杂过程中涉及的一些物理化学参数来测定海绵的药物递送情况:海绵表面润湿性、溶胀率以及从海绵中释放的米诺环素的百分比。响应面方法的应用使得能够设定制剂参数的最佳范围,从而确保向应用部位充分释放米诺环素。使用信噪比性能指标检查设计稳健性。基于统计筛选技术确定的最佳胶原蛋白 - 米诺环素海绵可能适用于中度至高度渗出性感染伤口愈合的局部药物递送。

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