8种中药注射液中5-羟甲基糠醛及其转化物的含量测定

Determination of the contents of 5-hydroxymethylfurfural and its conversions in 8 kinds of traditional Chinese medicine injections

目的 建立同时测定中药注射液中5-羟甲基糠醛及其转化物含量的高效液相色谱(HPLC)方法。方法 用NP-HPLC法测定中药注射液中5-羟甲基糠醛及其转化物A、转化物B的含量。以Platisil silica (150 mm×4.6 mm, 5μm)为色谱柱,以正己烷-甲醇-二氯甲烷(80∶16∶4)为流动相等度洗脱,流速为1.0 mL·min^(-1),检测波长为284 nm,柱温为25℃,进样体积为10μL。结果 5-羟甲基糠醛及其转化物A、转化物B分别在1×10^(-8)~2×10^(-6)、2×10^(-8)~2×10^(-6)、1×10^(-7)~2×10^(-6)g·mL^(-1)范围内线性关系良好,R2均大于0.998 8;所测8种中药注射液中7种含有5-羟甲基糠醛,含量在4×10^(-8)~1.89×10^(-5)g·mL^(-1)之间,1种注射液检测到转化物B。结论 该方法简便准确,可用于含糖中药注射液中5-羟甲基糠醛及转化物A、转化物B的含量测定,为其质量控制提供参考。

Objective To establish a method for the simultaneous determination of the contents of 5-hydroxymethylfurfural and its conversions in traditional Chinese medicine injections by high performance liquid chromatography(HPLC).Methods Normal phase HPLC was used to determine the contents of 5-hydroxymethylfurfural and its conversion A and conversion B in traditional Chinese medicine injections. The separation was performed on a Platisil silica column(150 mm×4.6 mm, 5 μm), the mobile phase consisted of normal hexane-methanol-dichloromethane(80∶16∶4) by gradient elution at 25 ℃ column temperature and the flow rate was 1.0 mL·min^(-1). The injection volume was 10 μL and the detection wavelength was 284 nm.Results 5-hydroxymethylfurfural and its conversion A and conversion B showed good linearity with correlation coefficients higher than 0.998 8 in the ranges of 1×10^(-8)-2×10^(-6), 2×10^(-8)-2×10^(-6)and 1×10^(-7)-2×10^(-6)g·mL^(-1), respectively. Among the 8 kinds of traditional Chinese medicine injections, the content of 5-hydroxymethylfurfural in 7 kinds of injections were 4×10^(-8)-1.89×10^(-5)g·mL^(-1). Converted compound B was detected in one injection.Conclusion The method was simple and accurate for the determination of the contents of 5-hydroxymethylfurfural and its conversion A and conversion B in traditional Chinese medicine injections, and those results provide a reference for quality control.