复方维生素E口腔药膜含量测定方法研究  

Determination Method for Compound Vitamin E Oral Pellicle

作　　者：曲婷[1] 陈岩[1,2] 乔宏艳 刘亮[1] 李小红[1] QU Ting;CHEN Yan;QIAO Hongyan;LIU Liang;LI Xiaohong(Department of Pharmacy,The First Affiliated Hospital of Harbin Medical University,Harbin,Heilongjiang,China 150001;Department of Pharmacy,Xiang′an Hospital of Xiamen University,Xiamen,Fujian,China 361101)

机构地区：[1]哈尔滨医科大学附属第一医院药学部,黑龙江哈尔滨150001 [2]厦门大学附属翔安医院药学部,福建厦门361101

出　　处：《中国药业》2020年第3期50-53,共4页China Pharmaceuticals

基　　金：黑龙江省卫生计生委科研课题[2017-027]

摘　　要：目的改进复方维生素E口腔药膜现有质量标准。方法将药膜放入少量纯化水中,水浴加热,溶解后,滴加适量无水乙醇,上清液加甲醇稀释。色谱柱为Sinochrom ODS-BP柱(200 mm×4. 6 mm,5μm),流动相为甲醇-异丙醇(88∶12,V/V),流速为1. 0 m L/min,检测波长为284 nm,柱温为40℃,进样量为10μL。结果维生素E质量浓度在50~800μg/m L范围内与峰面积线性关系良好(r=0. 999 9);精密度和稳定性均良好,RSD分别为1. 13%和0. 71%;平均加样回收率为95. 55%和100. 56%,RSD为2. 66%和1. 46%(n=3);6批药膜中维生素E的含量分别为标示量的98. 10%~101. 70%。结论热溶法将膜剂中有效物质的提取回收率大于95. 00%,显著高于超声波的提取率。该方法操作简便、结果准确、专属性强、重复性好,可用于复方维生素E口腔药膜中维生素E含量的快速测定。Objective To improve the current method for determining the content of compound vitamin E oral pellicle. Methods The pellicle was placed in a small amount of purified water heated in a water bath and dissolved,an appropriate amount of absolute ethanol was dropped into the pellicle solution,and the supernatant was diluted with methanol. The chromatographic column was Sinochrom ODS-BP column( 200 mm × 4. 6 mm,5 μm). The mobile phase was methanol-isopropanol( 88 ∶ 12,V/V) at the flow rate of1. 0 m L/min,the detection wavelength was 284 nm,and the column temperature was 40℃ . Results The concentration of vitamin E showed a good liner relationship in the range of 50-800 μg/m L( r = 0. 999 9). The precision and stability were satisfactory with RSDs of 1. 13% and 0. 71% respectively. The average recoveries were 95. 55% and 100. 56%,RSDs were 2. 66% and 1. 46%( n = 3).The contents of vitamin E in the 6 batches of compound vitamin E oral pellicle were in the range of 98. 10%-101. 70% of the labeled amount. Conclusion The heat dissolving method can improve the recovery rate of the effective substances in the pellicle to more than 95. 00%,which is significantly higher than the ultrasonic extraction rate. This method is simple in operation,accurate in results,strong in specificity,and good in reproducibility,and can be used for rapid determination of vitamin E content in the compound vitamin E oral pellicle.

关 键 词：维生素E 口腔药膜 前处理 高效液相色谱法 含量测定 

分 类 号：R977.2[医药卫生—药品] R927.2[医药卫生—药学]