| One of the biggest issues for traditional Chinese medicine (TCM) modernization is quality control, which is the bottleneck of bringing TCM to the global world. As a known fact that single TCM is a complex system itself, while bringing dozens of them together to create a new preparation, its complexity is even much bigger, this results in the huge difficulty in its quality control. With a commonly used complex preparation composed of19TCMs, Niuhuang Shangqing pill (NHSQP), as an example, the current research studied its quality regarding a variety of respects with multiple analytical methods along with chemometrics. The objective of this research is to develop scientific, reasonable, reliable and feasible methods to comprehensively ensure its quality. The following aspects and steps were taken to fulfill the mentioned objective:1.13TCMs in the formula were identified according to the Chinese pharmacopeia, and the other6were identified to be authentic as well.2. The principle of systematic fingerprints quantification was briefed and key parameters were elaborated.280-nm and five-wavelength RP-HPLC digitalized fingerprints of14batches of NHSQP samples were developed, and systematic fingerprints quantification method was employed to assess the results to reveal the feature of their fingerprints. A simultaneously quantitative method of6active components was developed via RP-HPLC, which is simple, precise and offered a feasible way to comprehensively ensure the quality of this preparation.3. The selection of HPCE background electrolytes was successfully optimized by tetrahedral optimization, which was simple, convenient and practical. The HPCE fingerprint of NHSQP was developed and assessed by macro-qualification similarity Sm and macro-quantification similarity Pm. HPCE quantification for two components, ferulic acid and baicalin, in the formula was also conducted by the current study. The two methods are simple, low-cost and low-pollutional, which was good at quality control of NHSQP without purchasing high-cost standards. 4. A rapid (20min of analysis time), sensitive (lower LOD and LOQ compared with conventional MRM method) and feasible (a regular LC-MS system was applied) MS method was successfully developed, which introduced DMRM method into complex TCM preparation for the first time. In the meantime, a standard operation procedure for developing a new DMRM method was recommended. After applying this method to the analysis of multiple samples, it was found that the quality of samples from the same company had relatively good consistency in quality among32batches of smples via PCA. Afterwards, OPLS-DA was employed to find the responsible reason. In addition, over accessing the Chinese pharmacopeia, the quality of12TCMs across the samples was analyzed.5. The UV fingerprint index and other theories and UV fingerprint quantification were put forward, which formed the digitalized and quantitative evaluation method for TCM UV fingerprint. The current paper tentatively conducted a study on combustion heat on32batches of NHSQP on the market and computed the combustion heat similarity, which reflected the integrate chemicals in a perspective of energy. It offered new reference for the quality assessment and new idea and method for TCM study on quality control and metabolism.Analyzing the quality of NHSQP in various angles with the methioned steps, the current study proved that the developed methods were scientific and effective. These methods were afterwards applied to the quality analysis of multiple batches of samples on sale, and successfully secured their quality. The developed methods were expected to be further applied to the quality control of other TCM preparations to ensure the safety of their usage. |
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