摘要
目的:建立可用于中药三七质量控制的人参皂苷Rg1,Rb1,Rd,Re及三七皂苷R1的"一测多评"定量检测方法。方法:采用HPLC-DAD测定5种活性皂苷成分之间的相对校正因子,并分别以这5种成分中的任1种作为参照成分,建立可对另外4种成分定量检测的"一测多评"方法。分别采用5台不同的HPLC仪器,5种不同C18色谱柱及4个检测波长验证所建立方法的耐用性。进而采用建立的"一测多评"方法测定并计算43批三七药材样品中5种皂苷类成分含量,并与外标法比较,以评价"一测多评"法的准确性。结果:5种皂苷成分分别为参照成分时,43批药材中Rg1,Rb1,Rd,Re,R1的"一测多评"法含量计算结果(Wf)均与外标法的含量测定结果(Ws)无显著性差异,2种方法的含量测定结果的比值(Ws/Wf)为(94.02±2.11)%～(99.75±0.79)%,说明方法准确度高、重复性好。相对校正因子耐用性良好,在不同色谱柱、不同仪器及不同检测波长下RSD分别为0.42%～3.7%,0.52%～3.5%,0.79%～4.9%。采用相对保留值方法可以对5种成分色谱峰准确定位,其数值的RSD为0.18%～13%。结论:本研究建立了准确、快速且耐用性良好的5种活性皂苷类成分同时定位定量的三七"一测多评"方法,为"一测多评"法应用于中药质量控制提供了可靠依据。
Objective： To establish a quantitative method of multi-components by single marker（QAMS） for determining gin- senoside Rg1 , Rb1 , Rd, Re and notoginsenoside R, for the purpose of the quality control of Panax notoginseng. Method： The relative correction factors（RCFs）between the five active saponins were determined by HPLC-DAD. With any of the five eonsituents as refer- enee, a QAMS method was established for detect the quantitation of the other four consituents. The durability of the method was evaluated with five different HPLC instruments, five different C18chromatographic columns and four detective wavelengths. Subsequently, the new QAMS method was used to determine the contents of five saponins contained in 43 batches of notoginseng samples, and compare with external standard methods, in order to evaluate the accuracy of the QAMS method. Result： When the five saponins were taken for reference, there was no significant difference between the contents of Rg1 , Rb1 , Rd, Re and R1 contained in the 43 batches of medi- cines calculated by the QAMS method （ Wt. ） and the content determination result of the external standard method （ Ws ）. The ratio of their results was （ Ws/ Wt ） （94.02 ± 2. 11 ） % - （99. 75 ±0. 79 ） % , suggesting that the method was highly accurate. Their relative correction factors showed good durability, ranging between 0.42% -3.7% , 0. 52% -3.5% and 0.79% -4. 9% , respectively, with different chromatographic columns, different instruments and difterent detective wavelengths. The relative retention value method could be adopt- ed for accurately position the chromatographic peak of the five eonsituents, with their values ranging between O. 18%-13%. Conclu- sion ： An accurate, rapid and highly durable QAMS method is established for simultaneous determination and location of five saponins, so as to provide reliable basis for the application of the QAMS method in quality control of traditional Chinese medicines.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2012年第22期3438-3445,共8页
China Journal of Chinese Materia Medica
基金
国家"重大新药创制"科技重大专项(2009ZX09502-023)
中医药行业科研专项(200707009)
国家药典委员会标准研究项目(Y2-305)
关键词
一测多评
HPLC
三七
人参皂苷
三七皂苷
相对校正因子
中药质量控制
耐用性
QAMS method
HPLC
Panax notoginseng
ginsenoside
notoginsenoside
relative correction factor
quality con- trol of traditional Chinese medicine
robustness
