硅凝胶辐照灭菌后遗传毒性及适应性试验

RESEARCH ON THE HEREDITARY TOXICITY AND ADAPTABILITY OF SILICONEGEL BREAST FILLING STERILIZED BY IRRADIATION

目的研究硅凝胶充填乳房植入物辐照灭菌后遗传毒性和适应性，探索辐照灭菌在高分子生物材料灭菌中的应用。方法按照ISO11737和ISO10993标准规定，采用活菌计数方法和遗传毒性试验，对硅凝胶充填乳房植入物初始污染菌量、辐照后产品遗传毒性等进行测定。结果不同批次细菌数平均范围为165～215efu／件，真菌数平均范围为24～41efu／件；3个批次不同次检出初始染菌数，细菌数平均范围13～512 cfu／件，真菌数平均范围为3～76 cfu／件。硅凝胶产品经辐照灭菌处理，不引起细胞及其内部结构改变，无致突变和致畸变作用，无遗传毒性。经辐照灭菌处理后的硅凝胶包装不能穿透细菌和真菌，亦不能穿透人工污染的粘质沙雷菌，辐照灭菌包装材料可以阻菌。经验证剂量辐照后，抽检100件产品均达到无菌，经过计算查表得出硅凝胶产品灭菌剂量为23．1 kGy。结论硅凝胶充填乳房植入物经辐照灭菌处理不会产生遗传毒性，对其包装材料性质无影响，通过灭菌剂量验证。

Objective To study the hereditary toxicity and adaptability of siliconegel breast filling （SBF） after its sterilization by means of irradiation and to approach the application of irradiation in the field of polymeric biomaterials sterilization. Method Based on ISO11137 and ISO10993 standards,the bioburden counts and genotoxicity of SBF were determined using vital cell counting method and hereditary toxicity test before and after its irradiation. Results The mean numbers of bacteria and fungi of different groups of SBF were 165 -215 cfu/piece and 24 -41 cfu/piece respectively, three different groups of which had scales of 13 - 512 cfu/piece bacteria and 3 -76 cfu/piece fungi. After being irradiated, the packing of SBF can not be penetrate by bacteria, fungi and artificially contaminated Serratia marcescens , the SBF had no mutant and hereditary toxicity and still maintained an unchanged cellular structure. 100 samples of SBF products irradiated with verification dose had no growth of microorganisms. According to the certain formula method, the calculated siliconegel products sterilization dose is 23.1 kGy. Conclusion The irradiated packing material is capable of preventing the microbial penetration. SBF has no genotoxicity and character changing after irradiation sterilization.