血塞通咀嚼片质量标准研究

Research on Quality Standard of Xuesaitong Chewable Tablets

目的:对血塞通咀嚼片的质量标准进行增修提高。方法:采用比色法测定血塞通咀嚼片中三七总皂苷的含量;建立超高效液相色谱法测定血塞通咀嚼片中人参皂苷Rg1、Re、Rb1、Rd及三七皂苷R1的含量。结果:三七总皂苷的线性范围为0.0941~0.2197 mg/mL(r=0.9997),回收率在95.0%~103.0%之间,RSD%=2.14(n=6)。人参皂苷Rg1、Re、Rb1、Rd及三七皂苷R1的线性范围分别为1132.7624~1194.8616μg/mL(r=0.9999)、18.6776~168.0984μg/mL(r=0.9997)、139.8296~1258.4664μg/mL(r=0.9999)、38.3648~345.2832μg/mL(r=0.9999)和37.3552~336.1968μg/mL(r=0.9999),平均回收率分别为98.0%、98.4%、97.2%、98.2%以及97.5%。结论:建立的方法操作简便、结果准确、重复性好,可用于控制血塞通咀嚼片的质量。

Objective To revise and improve the specification of Xuesaitong Chewable Tablets.Methods The content of total notoginsenoside was determined by UV.The contents of ginsenoside Rg1,Re, Rb1,Rd and notoginsenoside R1 were determined by by UHPLC.Result The linear range of total notoginsenoside was 0.0941~0.2197 mg/mL(r=0.9997),The average recovery was 95.0%~103.0%,RSD%=2.14(n=6).The linear range of ginsenoside Rg1,Re, Rb1,Rd and notoginsenoside R1 was 1132.7624~1194.8616 μg/mL(r=0.9999),18.6776~168.0984 μg/mL(r=0.9997),139.8296~1258.4664 μg/mL(r=0.9999),38.3648~345.2832 μg/mL(r=0.9999),37.3552~336.1968 μg/mL(r=0.9999).The average recovery was 98.0%、98.4%、97.2%、98.2% and 97.5%.Conclusion The method is simple, the reproducibility is good and it can be used as the quality control of Xuesaitong Chewable Tablets.