摘要
选用对数去除率(log-reduction,LR)坐标研究非医疗保健产品菌落总数的辐照灭菌剂量设定问题。以具有标准抗性分布(Standard distribution of resistances,SDR)的菌落总数为研究对象,选择剂量范围从0-1至0-20k Gy,剂量间隔从1至10 k Gy的共56种实验剂量点选取方案,按照传统方法拟合出每个实验方案下的菌落总数"D10值",并计算出LR坐标下相应的灭菌剂量曲线。计算结果表明,传统线性拟合"D10值"法设定菌落总数灭菌剂量的有效范围为LR≤LRmax,其中LRmax为增量剂量实验中最大剂量点Dmax对应的LR值。在此有效范围内,采用最大剂量斜率Dmax/LRmax设定的菌落总数灭菌剂量比传统线性拟合"D10值"法设定的灭菌剂量更接近理论值。最大剂量斜率法与传统方法相比可以大大减少实验次数,并且所设定的菌落总数灭菌剂量更加准确,可以减少不必要的过量辐照,是对传统方法的一大改进。
In this paper, coordinate of log-reduction（LR） is selected to solve the problem of radiation sterilization dose setting of bioburden for non health care products. Bioburden having standard distribution resistances（SDR） is used to perform the calculations. ＂D10 values＂ of bioburden are fitted according to traditional method from data of total 56 experimental dose selection plans with dose range from 0-1 to 0-20 kGy and dose interval from 1 to 10 kGy. Afterwards, the corresponding sterilization dose curves under the coordinate of log-reduction are calculated. The calculations show that the effective range of sterilization dose set by traditional method is LR≤LRmax, and LRmax is LR value corresponding to maximum dose（Dmax） in the incremental dose experiment. Within this effective range, the sterilization dose of bioburden set by the slope of maximum dose（Dmax / LRmax） is much closer to the theoretical value than that by ＂D10 value＂ of bioburden. Usage of maximum dose slope method could reduce the number of experiments significantly and the sterilization dose of bioburden is more accurate that can reduce the unnecessary radiation dose compared with traditional method. The maximum dose slope method is a great improvement on traditional method.
出处
《辐射研究与辐射工艺学报》
CAS
CSCD
2015年第2期41-48,共8页
Journal of Radiation Research and Radiation Processing
基金
中央高校基本科研业务费青年科技创新基金(No.NS2014060)资助
关键词
最大剂量斜率法
菌落总数
辐照灭菌
灭菌剂量设定
对数去除率坐标
Maximum dose slope method
Bioburden
Radiation sterilization
Sterilization dose setting
Coordinate of log-reduction
作者简介
第一作者：龚频，男，1980年7月出生，2002年毕业于南京大学，核物理与核技术专业，助教，从事辐照灭菌研究，E—mail：Gongpin@nuaa．edu．cn
通讯作者：陈达，教授，博士生导师，院士，E-mail：dachen@nuaa．edu．cn
