Institute for Health & Welfare Research, Robert Gordon University, Schoolhill, Aberdeen AB10 1FR, UK.
Int J Pharm. 2013 Sep 10;453(2):462-72. doi: 10.1016/j.ijpharm.2013.06.005. Epub 2013 Jun 17.
Lyophilised polysaccharide solutions and gels incorporating the broad spectrum antimicrobial compound, chlorhexidine digluconate (CHD), have potential application as self-adhering, topical delivery systems for the prophylaxis and treatment of wound infections. It is desirable to sterilise these dosage forms but they do not possess suitable thermal properties to be sterilised by autoclaving or dry heat procedures. Ionising radiation may offer a solution hence 'antimicrobial wafers' fabricated from guar (GG), xanthan (XG), karaya (KAG), sodium alginate (SA) and a 50:50 blend of SA:KAG, were gamma-irradiated (25 and 40 kGy). Wafer sterility was qualitatively determined and validated for bacterial and fungal species. The rheological properties of gels reconstituted from irradiated discs ('wafers') were measured and compared with control samples (non-irradiated) to assess changes to the flow properties. Diffusion of CHD from the resultant gels and viscous solutions, and efficacy against Pseudomonas aeruginosa, was determined using a disc diffusion test and release studies conducted in a diffusion cell apparatus. Although there was no change to cast shape, the rheological properties were drastically depleted for all irradiated samples except XG which showed no effective change in consistency, yield stress or efficacy, from the non-irradiated control. SA and SA-KAG samples displayed 'anomalous' release according to Korsmeyer-Peppas.
冻干多糖溶液和凝胶,其中包含广谱抗菌化合物洗必泰葡萄糖酸(CHD),具有作为自粘、局部给药系统的潜力,可用于预防和治疗伤口感染。这些剂型需要进行灭菌,但它们不具有适合通过高压灭菌或干热程序进行灭菌的热性能。因此,电离辐射可能是一种解决方案,因此由瓜尔胶(GG)、黄原胶(XG)、卡拉胶(KAG)、海藻酸钠(SA)和 SA:KAG 50:50 混合物制成的“抗菌片”进行了γ辐照(25 和 40 kGy)。定性确定和验证了片的无菌性,以检测细菌和真菌物种。从辐照的圆盘(“片”)重新形成的凝胶的流变性质进行了测量,并与对照样品(未辐照)进行了比较,以评估对流动性质的变化。使用圆盘扩散试验和在扩散池装置中进行的释放研究,测定了从所得凝胶和粘性溶液中扩散出的 CHD 的扩散情况以及对铜绿假单胞菌的功效。尽管浇铸形状没有变化,但除了 XG 之外,所有辐照样品的流变性质都明显耗尽,XG 的一致性、屈服应力或功效与非辐照对照样品没有明显变化。SA 和 SA-KAG 样品显示出根据 Korsmeyer-Peppas 方程的“异常”释放。