复方苦参注射液糖类成分指纹图谱及含量研究

Study on Fingerprint and Content of Sugar Components in Compound Kushen Injection

关键词:  复方苦参注射液  高效液相色谱-蒸发光散射检测法  指纹图谱  含量测定

Key words:  Compound Kushen injection  HPLC-ELSD  fingerprint  content determination

摘要:

目的 采用HPLC-ELSD建立复方苦参注射液的糖指纹图谱，并同时测定其中果糖、松醇、葡萄糖、蔗糖的含量。方法 采用Prevail Carbohydrate ES(4.6mm×250mm，5μm)色谱柱，以乙腈-水为流动相梯度洗脱，流速为1mL·min^–1，柱温15℃，漂移管温度为60℃，雾化温度为60℃，以氮气为载气，流速为1.5L·min^–1。结果 建立了复方苦参注射液糖类成分指纹图谱，确立了6个共有峰，10批样品相似度均>0.95。4种成分在相应的浓度范围内与峰面积的线性关系良好，相关系数均>0.9996，平均加样回收率(n=9)分别为104.85%，103.40%，105.34%，104.71%，RSD值分别为2.55%，2.98%，1.65%，2.58%。结论 该研究建立的复方苦参注射液的糖指纹图谱及含量测定方法操作简单、重复性好，可为复方苦参注射液的质量标准研究提供更加全面的依据。

Abstract:

OBJECTIVE To establish the sugar fingerprint of Compound Kushen injection by HPLC-ELSD, and to determine the contents of fructose, terpinol, glucose and sucrose in Compound Kushen injection simultaneously.METHODS The chromatographic column was Prevail Carbohydrate ES(4.6 mm×250 mm, 5 μm). The mobile phase was acetonitrile-water with gradient elution. The flow rate was 1 mL·min^–1. The column temperature was 15 ℃. The ELSD drift tube temperature was 60 ℃. The atomization temperature was 60 ℃. The carrier gas(N₂) flow rate was 1.5 L·min^–1.RESULTS The sugar fingerprint of Compound Kushen injection was established, and 6 common peaks were distinguished. The similarity of 10 batches of samples were all >0.95. In the corresponding concentration range, 4 sugar components respectively showed the good linear relationships between the concentrations and the peak areas. The correlation coefficients were >0.999 6. The average recovery rates(n=9) were 104.85%, 103.40%, 105.34% and 104.71%, respectively. The RSDs were 2.55%, 2.98%, 1.65% and 2.58%, respectively.CONCLUSION The established method of fingerprint and multi-content determination method is simple with good repeatability, which can provide comprehensive reference for quality control of Compound Kushen injection.