[Novel method for the evaluation of the synchronicity of the chemomic release/dissolution of multi-component traditional Chinese medicines].

Due to the diversity of components within the traditional Chinese medicines (TCMs), the release profiles of the components in the TCM dosage forms vary dramatically and no quantification method is available to determine the variance yet. Based upon the principles of Kalman filter method, the authors defined a new parameter, relative chemomic error (epsilon), to evaluate the asynchronous nature of the components in TCMs, and a derivative parameter as synchronization factor (SF) to quantify the synchronicity of the chemome of the TCMs. The average synchronization factor (SF(av)) was accordingly derived to simultaneously quantify the release/dissolution profiles of the multi-components in TCMs. Randomly generated simulation data were processed to demonstrate the chemomic data processing and the methodology. The results indicated that the novel parameter epsilon was well correlated (r = 0.996 8) with the coefficient of variation from the conventional release profiles of all the components. As the asynchronicity was the intrinsic characteristics of the multi-component TCMs, the synchronicity might be a new target of quality control of TCMs. The methods established by this report can be used a quantitative tool for the evaluation of the chemomic release synchronization of TCMs.