硅凝胶植入物辐照灭菌后组织相容性和致癌毒性研究

THE STUDY ON TISSUE COMPATIBILITY AND CARCINOGENIC TOXICITY OF THE RADIATION STERILIZED SILICA-GEL BREAST IMPLANTS

目的研究硅凝胶充填乳房植入物辐照灭菌后组织相容性和致癌毒性,以观察辐照灭菌植入物安全性。方法采用ISO11737标准规定方法对硅凝胶充填乳房植入物初始污染菌量进行检测和对辐射灭菌硅凝胶充填乳房植入物组织相容性和致癌性进行评价。结果3批次硅橡胶乳房植入物初始染菌量平均范围为需氧菌数164~208 cfu/件,真菌染菌数范围为24~41 cfu/件;经验证剂量辐照灭菌后,无菌检验100件产品结果均为阴性,验证剂量通过,得到灭菌剂量为23.1 kGy。辐照灭菌后的硅凝胶充填乳房植入物材质无细胞毒性、无植入后局部反应、无致癌性、不会致敏和引致皮内刺激。结论经设定剂量辐照灭菌后的硅凝胶充填乳房植入物未发生毒性作用,组织相容性良好、无致癌性,辐射灭菌作为医用高分子生物材料灭菌方法具有很好的生物安全性。

Objective To study tissue compatibility and carcinogenic toxicity of the radiation sterilized silica - gel breast implants in order to observe the safety of it. Methods According to the ISO11737 standard, the initial bacterial burden of the silica - gel breast implants was examined and the tissue compatibility and carcinogenic toxicity of the radiation sterilized silica - gel breast implants were evaluated. Results The mean range of initial bacterial burden of 3 batches of breast implants was 164 -208 cfu of aerobes per piece, and 24 -41 cfu of fungi per piece. After radiation sterilization with the verified dosage, the results of examination of 100 pieces of the products were microbial negative. The verified sterilizing dosage was 23.1 kGy. The radiation sterilized silica - gel breast implants had no cytotoxicity, no local reaction, no careinogenici- ty, no sensitization and no intracutaneous irritation. Conclusion After radiation sterilization with the specified dosage, the silica - gel breast implants have no toxic effect and carcinogenicity, and their tissue compatibility is good. Radiation sterilization is a biologically safe method for sterilization of medical high polymer biological material.