Study On The Material Foundation And Process Analysis Of Fufang Zhenzhu Tiaozhi Formula

Objective:To study the chemical foundation of Fufang Zhenzhu Tiaozhi formula by modern instrumental analysis techniques.To ensure the quality of the final product stability,uniform,laid a certain foundation and realize the rapid determination of the element of product process indicators by using near infrared spectroscopy combined with fingerprint technology.Methods:The chemical material basis of traditional Chinese medicine?FTZ?was systematically characterized by different types?organic small molecules,sugars,amino acids,elements and volatile oils?fingerprints.Then during three extraction process of FTZ,the index component content and NIRS data combined with the chemometrics analysis.The quantitative index components model set up,implement the rapid determination of the element of product of each index,and so as to realize the rapid evaluation of FTZ.Results:Using UPLC-TOF MS technique,93 of FTZ organic subclass compounds were identified.The free monosaccharide was derived from the manual and the HPLC was detected.3 kinds of free monosaccharides were found in FTZ.The free amino acids were automatically derived from HPLC and tested.9 free amino acids were found in FTZ.The FTZ samples after microwave digestion were detected by ipc-ms semi-quantitative detection,and 63 kinds of elements were obtained.All the five heavy metal elements of lead,cadmium,arsenic,mercury and copper are all quantitatively tested,and the results are in accordance with the requirements of pharmacopoeia.By GC-MS technique,FTZ extract volatile oil constituents identified 51common peak identified,including five terpenoids,oxygen terpenoids 19,8various aromatic compounds,aliphatic compounds 17,and 2 other compounds.In terms of PAT,to establish the calibration model,the THUNIR software was used to combine the data of NIR and HPLC with different pretreatment methods,band selection methods and partial least square method.The standard error of cross-validation,standard error of calibration,determination coefficient and latent variables were used to optimize the quantitative analysis models.The established models of 1^stt extractions and 2^nd extractions of notoginseng saponin R1,Ginseng saponin Rg1 and Ginseng saponin Rb1 in extraction A showed that the correlation coefficient were 99.66,99.66,99.54,98.49,97.74 and 97.71.The established models of 1^st extractions and 2^nd extractions of salvia acid and Buddleoside in extraction B showed that the correlation coefficient were97.84,99.33,95.77 and 97.82.The established models of 1^st extractions and2^nd extractions of Berberine and Palmatine hydrochloride in extraction C showed that the correlation coefficient were 99.46,99.16,98.30 and 97.86.Tests of the optimal models with prediction samples were made,which showed that the relative deviation of 1^st extractions and 2^nd extractions of these seven components were closed.The predicted values of the verification set are close to the real value,which can reflect the change of sample content in the extraction process.Conclusion:The fingerprints reveals the basis of FTZ chemical material comprehensively,and provides reference for its pharmacodynamic basis,quality standard enhancement and safety evaluation.Each index component of rapid quantitative model,realize the rapid determination of the element of product process indicators,and so as to realize the rapid evaluation of FTZ,for the stability of compound preparation of the final product quality controlled to provide important significance.