Quality Assessment of Kumu Injection, a Traditional Chinese Medicine Preparation, Using HPLC Combined with Chemometric Methods and Qualitative and Quantitative Analysis of Multiple Alkaloids by Single Marker

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. Copyright © 2011 Elsevier B.V. All rights reserved.

A new quantitative analysis of multi-component with single marker (QAMS) method for 11 saponins (ginsenosides Rg1, Rb1, Rg2, Rh1, Rf, Re and Rd; notoginsenosides R1, R4, Fa and K) in notoginseng was established, when 6 of these saponins were individually used as internal referring substances to investigate the influences of chemical structure, concentrations of quantitative components, and purities of the standard substances on the accuracy of the QAMS method. The results showed that the concentration of the analyte in sample solution was the major influencing parameter, whereas the other parameters had minimal influence on the accuracy of the QAMS method. A new method for calculating the relative correction factors by linear regression was established (linear regression method), which demonstrated to decrease standard method differences of the QAMS method from 1.20%±0.02% - 23.29%±3.23% to 0.10%±0.09% - 8.84%±2.85% in comparison with the previous method. And the differences between external standard method and the QAMS method using relative correction factors calculated by linear regression method were below 5% in the quantitative determination of Rg1, Re, R1, Rd and Fa in 24 notoginseng samples and Rb1 in 21 notoginseng samples. And the differences were mostly below 10% in the quantitative determination of Rf, Rg2, R4 and N-K (the differences of these 4 constituents bigger because their contents lower) in all the 24 notoginseng samples. The results indicated that the contents assayed by the new QAMS method could be considered as accurate as those assayed by external standard method. In addition, a method for determining applicable concentration ranges of the quantitative components assayed by QAMS method was established for the first time, which could ensure its high accuracy and could be applied to QAMS methods of other TCMs. The present study demonstrated the practicability of the application of the QAMS method for the quantitative analysis of multi-component and the quality control of TCMs and TCM prescriptions.

This review summarizes the isolation, structure determination, total syntheses and biological activities of simple indole alkaloids and those with a nonrearranged monoterpenoid unit, with literature coverage from 2012 to 2013. Covering: 2012 to 2013. Previous review: Nat. Prod. Rep. , 2013, 30 , 694–752 This review covers the literature on simple indole alkaloids and those with a nonrearranged monoterpenoid unit from the beginning of 2012 up to the end of 2013, which includes newly isolated alkaloids, structure determinations, total syntheses and biological activities.