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目的:建立采用一测多评法测定止痢宁片中4个萜类内酯含量的分析方法,验证该方法的可行性。方法:采用Kromasil C18色谱柱(250 mm×4.6 mm,5μm),以甲醇(A)-水(B)为流动相,梯度洗脱(0~60 min,45%A→80%A),流速1.0 m L·min~(-1),检测波长225 nm(0~24 min,检测穿心莲内酯;33~60 min,测木香烃内酯和去氢木香内酯)、250 nm(24~33 min,检测脱水穿心莲内酯);以脱水穿心莲内酯为内标,建立穿心莲内酯、木香烃内酯和去氢木香内酯间的相对校正因子,分别采用一测多评法和外标法测定止痢宁片中4个萜类内酯的含量,比较一测多评法计算值与外标法实测值的差异。结果:在一定的线性范围内,穿心莲内酯、木香烃内酯和去氢木香内酯与脱水穿心莲内酯间的相对校正因子分别为0.872、1.424和1.337,一测多评法计算值与外标法实测值之间没有显著性差异,所得的相对校正因子可信。结论:一测多评法质量评价模式可用于止痢宁片中4个萜类内酯的含量测定。
OBJECTIVE: To establish a method for the determination of four terpene lactones in Zhilining tablets by a multi-evaluation method, and to verify the feasibility of the method. Methods: Kromasil C18 column (250 mm × 4.6 mm, 5 μm) was used with gradient elution (0-60 min, 45% A → 80% A) with methanol (A) 1.0 m L · min -1, detection wavelength at 225 nm (0-24 min, detection of andrographolide; 33-60 min, measurement of carnitol and dehydrocostus), 250 nm (24 ~ 33 min, the detection of dehydroandrographolide); Dehydroandrographolide as an internal standard, and the establishment of andrographolide, wood ketone lactone and dehydrocostus between the relative correction factor, respectively, And the external standard method to determine the content of four terpene lactones in Zhilianning tablets. The difference between the calculated value of one test and that of the external standard method was compared. Results: In a certain linear range, the relative correction factors of andrographolide, wood ketone lactone and dehydrocostus and dehydroandrographolide were 0.872, 1.424 and 1.337 respectively. There is no significant difference between the measured value and external standard method, and the relative correction factor obtained is credible. Conclusion: A multi-evaluation method for quality evaluation can be used for determining the content of 4 terpene lactones in Zhilining tablets.