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目的:建立消癌平注射液HPLC指纹图谱,并准确测定消癌平注射液中tenacissoside H(TSH)等7种甾体有效成分的含量。方法:采用Agilent Eclipse XDB-C18色谱柱,流动相乙腈-水,梯度洗脱,柱温30℃,流速0.8 m L·min-1,平衡时间10min,进样20μL,蒸发光散射检测器漂移管温度60℃,载气压力0.4 MPa,检测17β-tenacigenin B(17β-TB),tenacigenin B(TB),tenacigenin A(TA),tenacigenoside A(TSA),marsdenoside I(MSI)和tenacissoside F(TSF)的含量;并运用《中药色谱指纹图谱相似度评价系统》软件建立消癌平注射液的对照指纹图谱,计算其相似度。结果:11批消癌平注射液的HPLC指纹图谱有13个共有峰,相似度均在0.94以上。TSH等7种甾体在标准曲线范围内均呈现良好的线性(r>0.999),精密度、重复性和准确度均符合要求。结论:所建立的HPLC-ELSD方法操作简便、结果可靠,具有良好的精密度、稳定性和重复性,结合指纹图谱研究为消癌平注射液中多成分含量测定和质量控制提供了依据。
OBJECTIVE: To establish HPLC fingerprint of Xiaojianping injection and determine the content of seven kinds of steroid active ingredients such as tenacissoside H (TSH) in Xiaojianping injection accurately. Methods: Agilent Eclipse XDB-C18 column was used. The mobile phase of acetonitrile-water was eluted with gradient elution. The column temperature was 30 ℃, the flow rate was 0.8 m L · min-1 and the equilibrium time was 10 min. Ten beta-tenacigenin B (tenβ-tenacigenin B), tenacigenin A (TA), tenacigenoside A (TSA), marsdenoside I (MSI) and tenacissoside F (TSF) were detected at a temperature of 60 ℃ and a carrier gas pressure of 0.4 MPa. ; And the use of “Chinese medicine chromatographic fingerprint similarity evaluation system” software to establish the control fingerprints of Xiao-Jin-Ping injection, calculate the similarity. Results: The HPLC fingerprints of 11 batches of Xiao-Jin-Ping injection had 13 common peaks with similarities of more than 0.94. Seven kinds of steroids, such as TSH, showed a good linearity (r> 0.999) within the standard curve range, and the precision, repeatability and accuracy of these steroids met the requirements. Conclusion: The established HPLC-ELSD method has the advantages of simple operation, reliable results, good precision, stability and repeatability. Combined with the fingerprint analysis, the HPLC-ELSD method provides a basis for the determination of multi-component content and quality control in Xiao-Jinping injection.