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

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。

Abstract: 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.