RP-HPLC测定安乳消痛丸有效成分及药理分析

Pharmacological analysis and Active Ingredients of Anru Xiaotong Pills Determined by RP-HPLC

目的:建立反相高效液相色谱法(RP-HPLC)双波长切换技术同时测定安乳消痛丸中芍药苷、丹皮酚含量的方法,为全面评价安乳消痛丸质量提供科学依据,分析安乳消痛丸治疗乳腺增生的药理学作用。方法:色谱柱Waters XSELECT CSH-C18(4.6 mm×150 mm,5μm),流动相为乙腈(A)-0.1%磷酸溶液(B),梯度洗脱(0~15 min,A:10%~18%,B:90%~82%;15~30 min,A:18%~50%,B:82%~50%;30~35 min,A:50%~10%,B:50%~90%),柱温:28℃,流速为1.0 mL/min,波长230 nm(0~15 min,芍药苷)、274 nm(15~35 min,丹皮酚),进样量10μL。结果:芍药苷进样量在2.192~21.920μg范围内与色谱峰峰面积呈良好线性响应、丹皮酚进样量在0.0108~0.108μg范围内与色谱峰峰面积呈良好线性响应;平均回收率(n=3)分别为98.8%和98.2%,RSD值分别为1.08%和1.21%。结论:同时测定安乳消痛丸中芍药苷和丹皮酚含量,该方法简便快速、重复性好、专属性强,可用于安乳消痛丸的质量控制;白芍、柴胡二药配伍有增效减毒的协同作用,但芍药苷、丹皮酚在止痛效果上是否有协同作用尚未明确。

Objective:To provide scientific reference for comprehensive evaluation of the quality of Anru Xiaotong pills and analyze pharmacological effects of Anru Xiaotong pills in the treatment of hyperplasia of mammary glands through establishing dual wavelength switching technology of RP-HPLC and simultaneously detecting the contents of paeoniflorin and paeonol in the pills.Methods:Chromatographic column Waters XSELECT CSH-C18(4.6 mm×150 mm,5μm),mobile phase was acetonitrile(A)-0.1%phosphoric acid solution(B),gradient elution(0-15 min,A:10%-18%,B:90%-82%;15-30 min,A:18%-50%,B:82%-50%;30-35 min,A:50%-10%,B:50%-90%),column temperature:28℃,flow velocity was 1.0 mL/min,wavelength 230 nm(0-15 min,paeoniflorin),274 nm(15-35 min,paeonol),sample size 10μL.Results:Paeoniflorin presented good linear response when its sample size ranged from 2.192 to 21.920μg and chromatographic peak area,and paeonol showed good linear response when its sample size ranged from 0.0108 to 0.108μg and chromatographic peak area;average recovery rates(n=3)were 98.8%and 98.2%,RSD values were 1.08%and 1.21%.Conclusion:Simultaneous detection of paeoniflorin and paeonol in Anru Xiaotong pills could be used for quality control of the pills,the method is simple and fast,reproducible and specific;the compatibility of Baishao(paeoniae radix alba)and Chaihu(bupleuri radix)would bring the effects of synergism and attenuation,and whether the synergism exists in relieving the pain of paeoniflorin and paeonol needs to be verified.