复合维生素B片评价性抽验结果分析及含量测定方法的改进  

Analysis of the Evaluation Test Results of Tabellae Vitamini B Compositae and Improvement the Quantitative Method

作　　者：许怀勇 祁娟 赵明 

机构地区：[1]雅安市产品质量检验检测中心,四川 雅安

出　　处：《药物资讯》2021年第5期245-251,共7页Pharmacy Information

摘　　要：目的:对四川省内2019年192批次评价抽验复合维生素B片检验结果进行统计分析,并对原有含量测定方法进行改进,增加了维生素B6的含量检测。方法:采用高效液相色谱法同时测定供试品中维生素B1、维生素B2、维生素B6和烟酰胺的含量,考察方法的可行性及线性范围。结果:维生素B1在7.488~73.162 μg∙mL−1浓度范围内,峰面积与浓度呈良好线性关系,线性方程:Y = 17.54886X − 13.71053,r = 0.9997;维生素B2在3.683~36.582 μg∙mL−1浓度范围内,峰面积与浓度呈良好线性关系,线性方程:Y = 59.51908X − 9.12808,r = 0.9999;维生素B6在0.522~5.127 μg∙mL−1浓度范围内,峰面积与浓度呈良好线性关系,线性方程:Y = 30.96344X − 0.61005,r = 0.9998;烟酰胺在24.651~249.208 μg∙mL−1浓度范围内,峰面积与浓度呈良好线性关系,线性方程:Y = 2.83243X + 3.49157,r = 0.9999;结论:采用该方法同时测定复合维生素B片中维生素B1、维生素B2、维生素B6和烟酰胺四种组分含量,具有样品处理简单、方便、快捷,定量结果准确、可靠等优点。Objective: To statistically analyze the test results of 192 batches of evaluation inspection Tabellae Vitaminin B Compositae samples in Sichuan Province in 2019, and to improve the original content determination method and increase the content determination of vitamin B6. Method: Simultaneous determination of vitamin B1, vitamin B2, vitamin B6, and nicotinamide in the test product by high performance liquid chromatography was performed to investigate the feasibility and linear range of the method. Results: The concentration of vitamin B1 in the range of 7.488~73.162 μg∙mL−1 showed a good linear relationship between the peak area and the concentration. The linear equation was: Y = 17.54886X − 13.71053, r = 0.9997;Vitamin B2 is in the range of 3.683~36.582 μg∙mL−1, the peak area and concentration have a good linear relationship, linear equation: Y = 59.51908X − 9.12808, r = 0.9999;Vitamin B6 in the concentration range of 0.522~5.127 μg∙mL−1, the peak area and concentration have a good linear relationship, linear equation: Y = 30.96344X − 0.61005, r = 0.9998;In the concentration range of nicotinamide from 24.651 μg∙mL−1 to 249.208 μg∙mL−1, the peak area has a good linear relationship with the concentration, a linear equation: Y = 2.83243X + 3.49157, r = 0.9999;Conclusion: The simultaneous determination of four components of vitamin B1, vitamin B2, vitamin B6, and nicotinamide in Tabellae Vitamini B Compositae by this method has the advantages of simple, convenient, fast, and accurate quantitative results.

关 键 词：复合维生素B片 评价性抽验结果分析 高效液相色谱法 含量测定 

分 类 号：R28[医药卫生—中药学]