Shanghai Research Center for Modernization of Traditional Chinese Medicine, National Engineering Laboratory for TCM Standardization Technology, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.
J Chromatogr A. 2011 Aug 19;1218(33):5618-27. doi: 10.1016/j.chroma.2011.06.058. Epub 2011 Jun 22.
Single standard to determine multi-components (SSDMC) is a novel and rational method for quality control of botanical products and traditional Chinese medicines (TCMs). However, it is restricted to wide application due to unknown fluctuation in conversion factors when it is performed in different laboratories. To evaluate the fluctuations of conversion factors, we selected Salvia miltiorrhiza as an example to determine three components of tanshinones by SSDMC method. Then ruggedness and robustness test were adopted to comprehensively investigate three kinds of factors that may influence stability of conversion factors, which were related with environmental parametric variables, operational parametric variables and peak measurement parametric variables. Nested-factorial-design was used to perform ruggedness tests. One-variable-at-a-time (OVAT) procedure and Plackett-Burman (PB) design were both used in robustness test. The results showed that stability of conversion factors was principally related with accuracy of wavelength of UV detector, peak measurement parameters and concentration of standard solution. The acceptable range of conversion factors was obtained from robustness test. Our results showed that conversion factors were inevitable to change, but when key parameters were well controlled, the range of its fluctuation was acceptable and the SSDMC method could be used widely in different laboratories.
单标准测定多成分（SSDMC）是一种新颖而合理的植物产品和中药（TCM）质量控制方法。然而，由于在不同实验室进行时转换因素的未知波动，该方法的应用受到限制。为了评估转换因素的波动，我们选择丹参作为示例，采用 SSDMC 方法测定丹参酮的三种成分。然后采用稳健性和鲁棒性试验综合考察了可能影响转换因素稳定性的三种因素，这些因素与环境参数变量、操作参数变量和峰测量参数变量有关。嵌套因子设计用于进行稳健性试验。单变量法（OVAT）程序和 Plackett-Burman（PB）设计都用于鲁棒性试验。结果表明，转换因素的稳定性主要与紫外检测器波长的准确性、峰测量参数和标准溶液浓度有关。从稳健性试验中获得了可接受的转换因素范围。我们的结果表明，转换因素不可避免地会发生变化，但只要控制好关键参数，其波动范围是可以接受的，SSDMC 方法可以在不同的实验室广泛应用。
