妇科千金分散片质量标准研究

Study of quality standard for Fukeqianjin dispersible tablets

目的妇科千金分散片的质量标准研究。方法采用薄层色谱法鉴别当归、穿心莲、党参,用高效液相色谱法测定穿心莲内酯和脱水穿心莲内酯的含量。SHIMADZU VP-ODS(150×4.6mm,5μm)柱,以甲醇∶水=52∶48为流动相,穿心莲内酯检测波长为225nm,脱水穿心莲内酯检测波长为254nm。结果能准确对当归、穿心莲、党参进行定性鉴别;穿心莲内酯与脱水穿心莲内酯分别在0.2004～2.0400μg与0.1172～0.7024μg呈良好线性关系。结论本法简便、快速、准确,灵敏,可作为该制剂质量控制的有效方法。

OBJECTIVE To study the quality standard for Fukeqianjin Dispersible Tablets. METHODS TLC was used to qualitatively differentiate among Radix Angelicae, Herba Andrographis and Radix Codonopsis. HPLC was used to measure the content of andrographolide and 14- deoxy- 11,12-didehydroandrographolide in Fukeqianjin dispersible tablets. A neuocedur Ct8 Column was used, with the mobile phase of methanol-water（52：48）. The detective wavelength were 225nm and 254nm.RESULTS Radix Angelicae, Herba Andrographis and Radix Codonopsis could be differentiated qualitatively by TLC. The linear ranges of andrographolide and 14-deoxy-11, 12-didehydroandrographolide were 0. 2004 - 2.0400μg and 0. 1172 -- 0.7024μg, respectively;CONCLUTION The methods is simple, rapid and accurate. It can be used for the quantitative determination of Fukeqianjin dispersible tablets.