元胡止痛系列制剂指纹图谱研究

Study on fingerprint of Yuanhuzhitong series preparations

目的建立元胡止痛系列制剂统一的指纹图谱。方法采用Thermo Acclsim 120 C18(4.6 mm×250 mm,5μm)色谱柱,乙腈-甲醇(4∶1)为流动相A,25 mmol·L-1乙酸钠溶液(含庚烷磺酸钠15 mmol·L-1,用冰醋酸调pH=6.4)为流动相B,检测波长:280 nm;柱温:35℃,流速:1 mL·min-1进行梯度洗脱。结果指纹图谱共标定9个共有峰,利用对照品比对归属了5个峰,另采用Waters xevo G2 Q-Tof LC/MS对另外4个色谱峰进行了指认。结论该方法分析时间短、耐用性好,可用于元胡止痛系列制剂的质量控制。

Objective To establish the unified fingerprint of Yuanhuzhitong series preparations by HPLC. Methods The chromatographic separation was performed on a Thermo Aeelsim 120 C18 （4.6 mm× 250mm,5 μm） column by gradi- ent elution with aeetonitrile - methanol （4：1） as mobile phase A and 25 mmol . L-1 sodium acetate solution（ contained so- dium heptane sulfonate 15 mmol . L-1 ,adjusted pH to 6.4 with glacial acetic acid） as mobile phase B. The flow rate was 1 mL . min-l. The detection wavelength was 280 nm, and the column temperature was 35 ℃. Results 9 common peaks on the fingerprint of Yuanhuzhitong preparations were indicated, among which 5 peaks were confirmed by contrast with refer- ence substance, and the other 4 peaks were identified by Waters xevo G2 Q - Tof LC/MS. Conclusion The method was less analysis time and reliable,it can be used for the quality control of Yuanhuzhitong series preparations.