血液透析A浓缩液的制备与质量控制  

Preparation and quality control of type A concentrated solution of hemodialysis

作　　者：聂朝霞[1] 江爱[2] 何思润[3] 胡焰[3] 张铁忠[4] 李健和[4] 

机构地区：[1]衡阳市妇幼保健院药剂科,湖南衡阳421001 [2]湖南师范大学,长沙410012 [3]中南大学药学院,长沙410013 [4]中南大学湘雅二医院药学部,长沙410011

出　　处：《中南药学》2013年第9期657-660,共4页Central South Pharmacy

摘　　要：目的制备血液透析A浓缩液，并对其质量控制方法进行研究。方法采用火焰原子吸收分光光度法测定血液透析A浓缩液中K^＋、Na^＋、Ca^2＋、Mg^2＋的含量。结果K^＋、Na^＋、Ca^2＋、Mg^2＋的线性范围分别为1．0～5．0μg（r=0．9981）、0．4～1．2μg（r=0．9988）、1．0～5．0μg（r=0．9989）、0．2～0．6μg（r=0．9973）；加样回收率分别为100．7％、106.2％、97．6％、109．5％，RSD分别为1．2％、1.3％、1．1％、1．6％（n=6）。结论该制剂处方合理，制备工艺简便可行，质量可控，含量测定方法操作简单、结果准确、重复性和稳定性良好。Objective To prepare type A concentrated solution of hemodialysis and control its quality. Methods K^＋, Na^＋, Ca^2＋, and Mg^2＋ ion concentrations in type A concentrated solution of hemodialysis were determined by flame atom absorption spec- trometer. Results K^＋, Na^＋, Ca2 ＋, and Mg^2＋ ions had a good linearity at 1.0 - 5.0 μg （r = 0.998 1）, 0.4 - 1.2μg （r = 0.998 8）, 1.0 -- 5.0 μg （r = 0.998 9）, and 0.2 -- 0.6 gg （r = 0.997 3）, respectively. The average recoveries were 100.7%, 106.2%, 97.6%, and 109.5% with RSD of 1.2%, 1.3%, 1.1%, and 1.6% （n = 6）, respectively. Conclusion The formulation and preparation technique are simple, reasonable, and well controllable.

关 键 词：血液透析A浓缩液 处方工艺 质量控制 火焰原子吸收分光光度法 

分 类 号：R284.1[医药卫生—中药学]