摘要
目的:建立乳没活络散(Rumohuoluo San)中三七皂苷R_1、人参皂苷Rg1和人参皂苷Rb1含量测定方法,以控制产品质量。方法:以高效液相色谱法,采用Inertsil ODS-3(4.6 mm×250 mm,5μm),Phenomonex C18(4.6 mm×250 mm,4μm),Hypersil C18(5.0 mm×200 mm,5μm),流动相乙腈(A)-水(B)梯度洗脱(0~12 min,19%A;12~32 min,19%~30%A;32~40 min,30%A;40~54 min,30%~38%A;54~60 min,38%A),检测波长203 nm,流速1.0 m L/min,柱温45℃,对本方君药三七中三七皂苷R_1、人参皂苷Rg1和人参皂苷Rb1特征性成分含量进行同时测定。结果:本方法可同时检测乳没活络散中三七皂苷R_1、人参皂苷Rg1和人参皂苷Rb1;上述3种成分进样浓度分别在0.04268~0.4268 mg/L、0.07564~0.7564 mg/L和0.08672~0.8672 mg/L时线性关系良好(r>0.9994),平均回收率分别为100.1%、99.78%和101.4%,RSD在1.3%~2.5%(n=9)。稳定性方面,3批乳没活络散经过6个月加速试验和24个月长期试验,各项指标均符合要求。结论:所建立的方法专属,准确度、精密度及耐用性良好,可用于乳没活络散的质量控制。乳没活络散质量可控稳定性好。
Objective To established a method for the determination of the contents of Notoginsenoside R1 , Ginsenoside Rg1 and Rb1 inRumohuoluo San and provide a reference for its quality control. Method High performance liquid chromatography （HPLC） method was employed to simultaneously determine the contents of Notoginsenoside R1 , Ginsenoside Rg1 and Rb1 inRumohuoluo San. The HPLC method was performed on Inertsil ODS -3 column （4. 6 mm X250 mm, 5 μm） , Phenomonex Cis column （4. 6 mm x250 mm, 4 μm） and Hypersil Cas column （5.0 mm X 200 mm, 5 μm） with acetonitrile （A） - water （B） as mobile phase for gradient e- lution （0-12 min, 19% -30%A; 32 -40 min, 30%A; 40 N54 min, 30% N38%A; 54 -60 min, 38%A）. The detection wave- length was 203 nm, the flow rate was 1.0 mL . min-1 and the column temperature was 45°C. Results The HPLC method can simulta- neously evaluate the contents of Notoginsenoside R1 , Ginsenoside Rg1 and Rb1 inRumohuoluo San. Notoginsenoside RI showed a good linear relationship from 0. 04268 - 0. 4268 mg/L, Ginsenoside Rg1 from 0. 07564 - 0. 7564 mg/L and Ginsenoside Rbl from 0. 08672 0. 8672 mg/L （ R 〉 0. 9994 ）. The average recovery of Notoginsenoside R1 , Ginsenoside Rg1 and Rb1 was 100. 1%, 99. 78% and 101. 4% respectively with RSD of 1.3 % -2. 5% （n = 9）. The stability test showed that the various indexes of 6 pilot test samples met the quality standard of Rumohuoluo San. Conclusion The established HPLC method is specific, accurate, reproducible and ro-bust, whcih is suitable for the quality control of Rumohuoluo San. Rumohuoluo San is stable and controllable in quality.
作者
孙佳
田勇
杨淑婷
陆定艳
陆苑
王永林
王爱民
李勇军
SUN Jia;TIAN Yong;YANG Shu ting;LU Yuan;WANG Yong lin;WANG Ai min;LI Yong jun(Guizhou Provincial Key Laboratory of Pharmaceutics / State Key Laboratory of Functions and Applications of Medicinal Plants,Guizhou Medical University,Guiyang 550004,China;Sinan Tianshi Traditional Orthopedies and Traumatology Hospital,Tongren 565100,China;College of Pharmacy,Guizhou Medical University,Guiyang 550025,China;Engineering Research Center for the Development and Application of Ethnic Medieine and TCM（Ministry of Education）,Guizhou Medieal University,Guiyang 550004,China)
出处
《中国民族民间医药》
2018年第16期22-25,共4页
Chinese Journal of Ethnomedicine and Ethnopharmacy
基金
贵州省优青项目(201511)
贵州省创新人才团队项目(20165613/5677)
