千喜片的定性定量方法研究

目的: 建立千喜片的定性定量方法,对制剂质量进行有效控制。 方法: 采用TLC方法,对方中主药穿心莲和千里光分别进行鉴别。采用HPLC法测定穿心莲中穿心莲内酯和脱水穿心莲内酯的含量,色谱柱为Agela C₁₈(5 μm,250 mm×4.6 mm)柱,以甲醇(A)-水(B)为流动相,进行梯度洗脱(0~15 min,45%A;15~35 min,45%A→60%A),流速1.0 mL·min^-1,检测波长为225 nm(穿心莲内酯)和254 nm(脱水穿心莲内酯)。 结果: 穿心莲和千里光的TLC鉴别专属性强;穿心莲内酯和脱水穿心莲内酯的线性范围分别为0.0646~0.968 μg(r=0.9998)和0.196~2.94 μg(r=0.9999),平均回收率(n=6)分别为99.5%(RSD=1.1%)和103.4%(RSD=1.1%)。 结论: 本方法简便、可靠、准确,可用于千喜片的质量控制。

Objective: To establish the qualitative and quantitative methods for Qianxi tablets. Methods: The Andrographis Herba and Senecionis Scandentis Hebra in Qianxi tablets were identified by TLC.The contents of andrographolide and dehydroandrographolide were determined simultaneously by HPLC.An Agela C₁₈ column(5 μm,250 mm×4.6 mm)was adopted,and the mobile phase was methanol(A)-water(B)with gradient elution(0-15min,45%A;15-35 min,45%A→60A)at the flow rate of 1.0 mL·min^-1. Results: The methods of identifying Andrographis Herba and Senecionis Scandentis Hebra by TLC had strong specificity.The calibration curves were linear in the rangs of 0.0646-0.968 μg(r=0.9998)for andrographolide and 0.196-2.94 μg(r=0.9999)for dehydroandrographolide;The mean recoveries(n=6)were 99.5%(RSD=1.1%)and 103.4%(RSD=1.1%),respectively. Conclusion: This method is simple,reliable accurate,and can be used to the control the quality of Qianxi tablets.