醋酸氯己定消毒剂标准物质研制及均匀性不确定度评定  

Development on the reference material of the chlorhexidine acetate disinfectant and the uncertainty evaluation of its homogeneity

作　　者：董晓杰[1] 刘思然[1] 朱英[1] 

机构地区：[1]中国疾病预防控制中心环境与健康相关产品安全所,北京100021

出　　处：《中国消毒学杂志》2016年第11期1061-1062,1065,共3页Chinese Journal of Disinfection

摘　　要：目的研制均匀性良好的醋酸氯己定消毒剂基体标准物质。方法用高效液相色谱法和容量分析法分别对制备的醋酸氯己定消毒剂基本标准物质3个浓度水平进行检测,并通过统计学方法进行均匀性分析。结果所制备的标准样品含量(按醋酸氯己定质量分数计)分别为0.1%、0.5%和4.5%,性状均为无色透明状液体。用高效液相色谱法测定0.1%和0.5%样品含量,其测量结果的平均值为0.101%和0.501%,瓶间不均匀性导致的不确定度分量为0.0003%和0.0028%;用容量分析法测定4.5%样品含量,其测量结果的平均值为4.45%,瓶间不均匀性导致的不确定度分量为0.017%。结论本研究确定的方案制备出的醋酸氯己定消毒剂基本标准物质含量准确,均匀性良好。Objective To develop the homogeneous reference material of the chlorhexidine acetate disinfectant. Methods High performance liquid chromatography（HPLC） technology and volumetric analysis method were used to test the concentration of the prepared ehlorhexidine acetate disinfectant samples, the homogeneity of which was analyzed with variance analysis method. Results The obtained samples are colorless transparent liquid, the concentration of which is 0. 1%, 0.5% and 4.5% by mass fraction of chlorhexidine acetate, respectively. The samples of 0.1% and 0.5% are determined by HPLC, and the average measurement results are 0. 101% and 0. 501% , respectively, the corresponding uncertainty component of between - bottle homogeneity are 0. 0003% and 0. 0028%. The samples of 4.5% are determined by volumet- ric analysis method. The average measurement results is 4.45% , and the uncertainty component of between -bottle homo- geneity is 0. 017%. Conclusion The reference material of the ehlorhexidine acetate disinfectant prepared based on the scheme in this study has accurate concentration and good homogeneity.

关 键 词：醋酸氯己定 消毒剂 标准物质 均匀性 不确定度 

分 类 号：R187[医药卫生—流行病学]