运用气相色谱法评价体外循环一次性血管路中2-氯乙醇残留量的安全性

Safety Evaluation of 2-Chloroethanol Remnant in Disposable Blood Pipeline in Vitro Circulation by GC Chromatography

目的建立评价体外循环一次性血管路中2-氯乙醇残留量安全性的方法。方法采用气相色谱法对体外循环一次性血管路中2-氯乙醇残留量进行测定,优化各种检测条件。结果该法的分离度在3.0以上,理论塔板数在10000以上,线性关系较好,相关系数r=0.9996,精密度试验的RSD为3.68%,重复性试验的RSD为3.11%,平均加样回收率为100.5%(RSD=4.12%)。结论本方法灵敏度高,重复性好,简便可行,可有效地评价该类产品2-氯乙醇残留量的安全性。

Objective A method was established for the safety evaluation of 2-Chloroethanol remnant in disposable blood pipeline in vitro circulation. Methods HS-GC-ECD was used to quantitate 2-Chloroethanol remnant in disposable blood pipeline in vitro circulation. Every test condition was optimized. Results The resolutions between the adjacent peaks were more than 3.0 and the number of theoretical plates were more than 10 000. A good linearity was obtained（r=0.9996）. The R.SD of accuracy test was 3.68%. The RSD of repeatability test was 3.11%. The average recovery rate is 100.5%, and the RSD of recovery test is 4.12%. Conclusion The method is sensitive, simple and good stability, which can be used for the safety evaluation of 2-Chloroethanol remnant of this type of products.