七连栓质量控制研究

Study on Quality Control of Qilian Suppository

目的 :建立七连栓的质量控制方法。方法 :采用薄层色谱法对主药黄连、三七进行定性鉴别 ;采用反相高效液相色谱法梯度洗脱 ,蒸发光散射器检测三七中人参皂苷Rg1 、Rb1 的含量。结果 :本品薄层色谱特征明显 ,专属性强 ;人参皂苷Rg1 在进样量为1 56μg～3. 74μg 范围内线性关系良好 (r=0. 9993 ,RSD=1. 6 % ) ,回收率为99 .10 % ;人参皂苷Rb1 在进样量为1 .44μg～3 46μg范围内线性关系良好 (r=0. 9981 ,RSD=1 .2 % ) ,回收率为102. 13 %。结论 :本方法简便、灵敏、准确、重现性好 ,可用于七连栓的质量控制。

OBJECTIVE:To establish the method to control the quality of Qilian suppository.METHODS:TLC was perˉformed to identify Rhizoma coptidis and Radix Notoginseng.A reverse phase HPLC-ELSD method was adopted to determine the content of ginsenoside Rg 1 and ginsenoside Rb 1 in Radix Notoginseng.RESULTS:The study on the quality control showed that the characteristic of identification by TLC was distinct and highly specific.In this quantification method,the linear ranges of ginsenoside Rg 1 and Rb 1 were1.56μg～3.74μg(r=0.9993,RSD=1.6%)and1.44μg～3.46μg(r=0.9981,RSD=1.2%)respectively.The average recovery rate of ginsenoside Rg 1 was99.10%,and RSD=1.6%(n=3);the average recovery rate of ginsenoside Rb 1 was102.13%,and RSD=1.2%(n=3).CONCLUSION:The method is simple,sensitive,accurate and reˉpeatable.It can be used for the quality control of Qilian suppository.