Muselík Jan, Wojnarová Lenka, Masteiková Ruta, Sopuch Tomáš
Veterinární a Farmaceutická Brno, Farmaceutická Fakulta Ustav Technologie léků.
Ceska Slov Farm. 2013 Apr;62(2):95-8.
Carboxymethyl cellulose, especially its sodium salt, is a versatile pharmaceutical excipient. From a therapeutic point of view, sodium salt of carboxymethyl cellulose is used in the production of modern wound dressings to allow moist wound healing. Wound dressings must be sterile and stable throughout their shelf life and have to be able to withstand different temperature conditions. At the present time, a number of sterilization methods are available. In the case of polymeric materials, the selected sterilization process must not induce any changes in the polymer structure, such as polymer chains cleavage, changes in cross-linking, etc. This paper evaluates the influence of different sterilization methods (γ-radiation, β-radiation, ethylene oxide) on the stability of carboxymethyl cellulose and the results of long-term and accelerated stability testing. Evaluation of samples was performed using size-exclusion chromatography. The obtained results showed that ethylene oxide sterilization was the least aggressive variant of the sterilization methods tested. When the γ-radiation sterilization was used, the changes in the size of the carboxymethyl cellulose molecule occurred. In the course of accelerated and long term stability studies, no further degradation changes were observed, and thus sterilized samples are suitable for long term storage.
羧甲基纤维素，尤其是其钠盐，是一种用途广泛的药用辅料。从治疗角度来看，羧甲基纤维素钠用于生产现代伤口敷料，以实现伤口的湿性愈合。伤口敷料在其整个保质期内必须无菌且稳定，并且必须能够承受不同的温度条件。目前，有多种灭菌方法可供选择。对于聚合材料，所选的灭菌过程不得引起聚合物结构的任何变化，例如聚合物链断裂、交联变化等。本文评估了不同灭菌方法（γ射线辐射、β射线辐射、环氧乙烷）对羧甲基纤维素稳定性的影响以及长期和加速稳定性测试的结果。使用尺寸排阻色谱法对样品进行评估。所得结果表明，环氧乙烷灭菌是所测试的灭菌方法中最温和的变体。当使用γ射线辐射灭菌时，羧甲基纤维素分子的尺寸发生了变化。在加速和长期稳定性研究过程中，未观察到进一步的降解变化，因此灭菌后的样品适合长期储存。
