HPLC法测定参芪扶正注射液中5-羟甲基糠醛的含量及其来源的初步探讨

目的: 建立己糖降解产物5-羟甲基糠醛的含量测定方法,对参芪扶正注射液中的5-羟甲基糠醛进行测定,并对其来源进行初步探讨。 方法: 采用Diamonsil C₁₈(250 mm×4.6 mm,5 μm,)色谱柱,以乙腈-0.5%醋酸溶液(3∶97)为流动相,检测波长284 nm,流速1.0 mL·min^-1,柱温30 ℃。 结果: 5-羟甲基糠醛在浓度为 0.94~18.8 μg·mL^-1 范围内与峰面积具有良好的线性关系(r=0.9999),精密度和重复性的RSD分别为0.7%和 2.2%。在模拟高温灭菌的过程中发现仅有果糖受热后转化生成5-羟甲基糠醛及其相关物质。 结论: 该方法操作简便,结果准确可靠,可用于参芪扶正注射液中5-羟甲基糠醛的含量测定,为进一步评价中药注射液的安全性提供参考。

Objective: To establish a method for the determinantion of 5-hydroxymethylfurfural in Shengqifuzheng injection. Methods: The HPLC separation was performed on a Diamonsil C₁₈ reversed-phase column with the mobile phase of acetonitrile-0.5% acetic acid(3∶97),and the determination wavelength was 284 nm.The column temperature was kept at 30 ℃,and the mobile phase flow rate was 1.0 mL·min^-1. Results: The calibration curves showed good linear regression (r=0.9999) within 0.94 and 18.8 μg·mL^-1.Precisions and repeatabilities of the methods were 0.7% and 2.2%,respectively.Otherwise,only fructose generated 5-hydroxymethylfurfural after high-temperature sterilization. Conclusion: The method was simple,reliable and suitable for the quality control of the products,supplying helpful information to the further study on the safety evaluation of traditional Chinese medicine injection.

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