ABSTRACT
For the quality management system of herbal medicines, intermediate and finished products it exists the " short board" effect of methodologies. Based on the concept of process control, new strategies and new methods of the production process quality control had been established with the consideration of the actual production of traditional Chinese medicine an the characteristics of Chinese medicine. Taking Banlangen granule as a practice example, which was effective and widespread application, character identification, determination of index components, chemical fingerprint and biometrics technology were sequentially used respectively to assess the quality of Banlangen herbal medicines, intermediate (water extraction and alcohol precipitation) and finished product. With the transfer rate of chemical information and biological potency as indicators, the effectiveness and transmission of the above different assessments and control methods had been researched. And ultimately, the process quality control methods of Banlangen granule, which were based on chemical composition analysis-biometric analysis, had been set up. It can not only validly solute the current status that there were many manufacturers varying quality of Banlangen granule, but also ensure and enhance its clinical efficacy. Furthermore it provided a foundation for the construction of the quality control of traditional Chinese medicine production process.
Subject(s)
Drugs, Chinese Herbal , Reference Standards , Medicine, Chinese Traditional , Reference Standards , Quality ControlABSTRACT
ObjectiveTo establish a new,rapid,and reliable reversed-phase ultra performance liquid chromatography (RP-UPLC) method for the simultaneous determination of six quaternary ammonium alkaloids (QAAs) in Coptidis Rhizoma.MethodsThe effect of different experimental parameters on the analysis of QAAs by RP-UPLC was evaluatcd.ResultsOptimal resolution was achieved with an Acquity UPLC BEH C18 column using a gradient elution profile and a mobile phase consisting of water spiked with 10 mmol/L ammonium bicarbonate (A,pH adjusted to 10.0 by ammonia water) and acetonitrile (B),at a flow rate of 0.30 rnL/min and wavelength of 345 nm.The column temperature was set at 30 ℃.The proposed method was found to be reproducible,precise,and rapid according to the method validation.Conclusion The proposed method,which is compatible with MS analysis and the preparation of QAA,provides some helpful insights into the quality control of Coptidis Rhizoma.