摘要
目的:测定胰岛素口腔喷雾剂(insulin buccal spray,IBS)中过氧化脂质(lipid peroxide,LPO)和丙二醛(MDA)的含量。方法:硫代巴比妥酸反应物法(thiobarbituric acid reactive substance assay,TBARS)测定MDA的生成量,氧化铁二甲酚橙法(ferrous oxidation xylenol orange assay,FOX)测定LPO的含量。结果:新配制的IBS中MDA值和LPO含量均与大豆磷脂原料中含量相近;同批卵磷脂原料配制的批号为20021104的IBS贮放半年后,其LPO含量和MDA值相对原料分别上升11.2％和10.6％;两方法所测结果呈一定的线性正相关。结论:IBS在配制及1年的保质期内,不会因LPO而引起安全用药问题;FOX法能用于脂质药物载体中LPO的测定。
Objective:To determine lipid peroxide (LPO) and malonyldialdehyde(MDA) in insulin buccal spray (IBS). Methods: TBARS (thiobarbituric acid reactive substance assay) and FOX (ferrous oxidation xylenol orange assay) were adopted to determine MDA and LPO respectively in IBS. Results:Both the content of LPO and MDA in newly prepared IBS were similar to those contained in raw soybean lecithin. In IBS prepared from raw material of the same batch number,the content of LPO and MDA in it after storage for 6 months was elevated by 11.2% and 10. 6% respectively in comparison with the raw material. Results of the 2 methods were comparable. Conclusion: No safety issues would be occurred within one year of quality-guarantee period for IBS. FOX can be used to determine LPO in carrier of lipid drugs.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2004年第3期248-250,共3页
Chinese Journal of New Drugs
