Study On The Value Of Chemical Control Products In Traditional Chinese Medicine Based On Multivariate Data Analysis

Traditional Chinese medicine (TCM) reference standards (RS) play an important role in the qualitative and quantitative analysis of TCM quality control as the specificity ingredients, characteristic composition, active ingredients and components。toxic ingredients and components. TCM chemical reference standards (CRS) as high purity of organic compounds, mainly used in TCM quality control standard with the identification and content determination of analysis detection, the value evaluation method follows the organic CRS of value evaluation. The candidate materials need to detect the organic principal components, organic impurity elements and inorganic components. So the factors influencing the accuracy of CRS fixed value study as well as the uncertainty of the value evaluation is CRS remain to be researched.In the process of the application and development of TCM CRS, because of the complexity of the Chinese herbal medicine and its preparation components, the quality control standards need to establish a multi-index evaluation model. However the preparation and the development of high purity CRS in TCM is difficult, especially on the extractions, separations and purifications. So constantly keep pace with of pharmaceutical standards is difficult, especially some poor stability, strong toxicity and high cost preparation of CRS, thus establishing the above special varieties of chemical substitutes, and ensure the accuracy and applicability is the best way for the development of TCM CRS.CRS mass balance research to the influential factors of the legal value is critical to ensure the accuracy of the assigned value. In the process of development and value evaluation, usually get a high purity raw materials (>99.5%) is more difficult, so the purity of raw materials, organic principal components and organic impurities of differences in ultraviolet response factor for determination of purity of HPLC value deviation needs assessment and quantitative analysis. This paper work in the CRS mass balance the legal value, based on the selection of high purity CRS puerarin as an organic principal component, at the same time, choose the structure analogue isoflavones and flavonoids CRS as the simulation of related impurities, explores the simulation evaluation of puerarin CRS in the process of the fixed value purity of raw materials and organic impurities in the influence factors and law of constant value. At the same time, through simulation of ciprofloxacin and nifedipine series, for puerarin simulation series of data and the results are verified. At the completion of organic CRS mass balance based on the research of the influence factors of legal values, further carry out the CRS of assigned value technology research, trying to quantitative nuclear magnetic resonance (NMR) as a complement and validation method, and establish the corresponding CRS valued technical requirements.Metronidazole was studied on the property value evaluation and uncertainty evaluation, to explore establishing the technical requirements of Certified Reference Material (CRM).In view of the poor stability, strong toxicity, limited source of TCM preparation of CRS to the problem of high cost, research on the substitution method, and establish the controlled alternative method of simultaneous determination of four saponins(escin la, escin Ib, isoescin la, isoescin Ib) in aescinate reference extracts. At the same time developed for marking value aescinate contrast extract accuracy is verified.Above is the first study to the CRS mass balance influence factors in the legal value of quantitative analysis; Based on the work of CRS value assignment, first developed the metronidazole as the CRM, for conducting CRS quantity traceability and provides a reference to the research on the uncertainty evaluation model; According to the technical requirements of reference substance replacement method, for the first time developed the four sapoins marked value of aescinate reference extracts, providing the technical support for quality control of aesculi semen and aescine preparations.