右旋糖酐铁注射液给药后注射部位未吸收铁含量检查方法改进研究  

improvement of iron absorption detection method for iron dextran injection

作　　者：石劲敏[1] 孙杰[1] 范俊沛[1] 唐黎明[1] 

机构地区：[1]上海市食品药品检验所药理毒理室/药物安全评价中心,上海201203

出　　处：《药物分析杂志》2014年第10期1883-1888,共6页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：采用微波消解法替代湿消解法对中国药典中右旋糖酐铁注射液品种的注射部位未吸收铁含量检查方法进行改进研究。方法：参照中国药典方法,分别采用非自身对照加湿消解法、自身对照加湿消解法和自身对照加微波消解法来考察未吸收铁含量。家兔右后腿注射0.2 mL·kg-1右旋糖酐铁注射液,7 d后处死,取出呈色肌肉,分别采用湿消解法或微波消解法对肌肉进行消化,消化完全的样品溶液采用紫外分光光度法测定其530 nm的吸收度,计算未吸收铁含量。结果：对微波消解法进行加样回收率测定,标准溶液和右旋糖酐铁注射液的平均加样回收率均在91.1%~113.1%之间,RSD在2.6%~14.4%之间。采用微波消解法检查右旋糖酐铁注射液给药后注射部位的未吸收铁含量,样品消化完全,空白对照OD值与湿消解法相比下降（OD值由0.2022下降为0.0413）并且稳定（SD值由0.1811下降为0.0253）,未吸收铁含量结果批内变异减小（含量由30.2%下降为20.8%,p〈0.001）,结果更加可靠和可重复（SD值由20.2%下降为11.5%）,并且提高实验效率约80%,节省硫酸、硝酸用量达95%。结论：采用微波消解法替代湿消解法检查右旋糖酐铁注射液给药后注射部位的未吸收铁含量简便易行,准确性和可重复性好,可提高实验效率,并保护实验人员安全和环境安全。Objective： To introduce microwave digestion to improve iron absorption detection method for iron dex- tran injection in Chinese Pharmacopoeia. Methods： Referring to Chinese Pharmacopoeia, iron absorption was de- tected using three methods, wet digestion, self- control plus wet digestion, and self- control plus microwave diges- tion. A dose of 0.2 mL of the injection per kg of the rabbits＇ weight was injected into each rabbit. After 7 days ,the rabbits were killed and the colored flesh was dissected from the bone. The pieces were then digested by wet diges- tion method or microwave digestion system, and the absorbance of the resulting solution was measured at 530 nm. The remaining injected iron was calculated. Results： The mean recoveries of microwave digestion in the samples spiked with standard solutions and iron dextran injection ranged from 91.1% to 113.1% （RSD 2.6% -14. 4% ）. Comparing the different study design and digestion methods, the results showed that the samples were completely di- gested using microwave digestion. The OD values of blank samples were lower （0. 0413 ）and more stable （standard deviation was 0. 0253 ） compared to those （0. 2022 _＋ 0. 1811 ） digested by wet digest method. The inter - batch vari- ance of iron absorption results was decreased from 30.2% to 20. 8% , and the iron absorption results were more reli- able and repeatable（ standard deviation was decreased from 20.2% to 11.5% ）. The detection efficiency was in- creased by 80% ,and the amounts of sulfate acid and nitric acid were decreased by 95%. Conclusion： Using micro- wave digestion to replace wet digestion in iron absorption detection for iron dextran injection is simple, repeatable,efficient, and eco -friendly,with improved accuracy. The method can also protect personnel from dangerous proce- dures.

关 键 词：右旋糖酐铁注射液 注射部位未吸收铁含量 微波消解法 湿消解法 

分 类 号：R917[医药卫生—药物分析学]