Development of a novel unified quality control strategy for proprietary Chinese medicines

Abstract

There is no effective method for unified quality evaluation for the same medicinal materials in similar prescriptions. In this study, we used Ginseng-Fuzi ( Aconitum carmichaelii ) proprietary Chinese medicines (GFPCMs), with different dosage forms, as examples to develop a new unified quality control strategy. Thus, using a high performance liquid chromatography-tandem mass spectrometry method, coupled with unified quality evaluation strategies to comprehensively characterize the contents of 12 aconitines and 25 ginsenosides containing eight groups of isomers in 10 GFPCMs. Quality control was carried out for the first time for aconitines and ginsenosides in Jianbuqiangshen Pill, Nanbao Capsule, Nvbao Capsule, Pingfengshengmai Capsule, Wumei Pill, and Xinbao Pill. Furthermore, 4 aconitines and 16 ginsenosides were firstly quantified in all 10 GFPCMs. Subsequently, there was a comprehensive comparison of the universality and accuracy of the quality control strategies based on absolute, normalized, and unit content. It was indicated the strategy-based unit content was more practical and effective. As for Fuzi, the total unit content of diester alkaloids should be less than 0.020%, while monoester alkaloids should be more than 0.010%. As for ginseng, the total unit content of Rb1, Rb2, Rc, Rg5, and Re should be higher than 2.0%, and the unit content of Rg5 was a good indicator for the classification of the dosage forms and processing methods. In summary, this strategy showed great potential for supervising the quality of Chinese medicine.