Studies On Quality Control In The Manufacturing Process For Protopanaxatriol Saponin (PTS) And The Preparation With Near Infrared Spectroscopy

The manuacturing process of Traditional Chinese medicine(TCM) hans been mainly monitored with experience, experience. The absence of effective on-line monitoring techniques will affect the quality of TCM. This project is a research on near-infrared spectroscopy applied to quality control of the production process of protopanaxatriol saponin(PTS) and SanQiTongShu capsule.1.This article studied HPLC method validation for quantitative analysis of the PTS, it laid a good foundation for Near-infrared quantitative model. In this study,specificity, linearity, repeatability, recovery, precision, and stability all meet the requirements.2.Reference measurements of ginsenoside-Rg1,ginsenoside-Re and notoginsenoside-R1 were performed by HPLC,the study established the near infrared spectroscopy model for rapid determination in the extraction process of PTS by percolation. In the models,RMSECV for ginsenoside-Rg1 is 0.798, R2 is 0.9682, RMSEP for ginsenoside-Rg1 is 1.1097, R2 is 0.9831; RMSECV for ginsenoside-Re is 0.0945, R2 is 0.9681, RMSEP for ginsenoside-Re is 0.4916, R2is 0.9198; RMSECV for notoginsenoside-R1 is 0.259, R2is 0.9626, RMSEP for notoginsenoside-R1 is 0.3899, R2 is 0.9661; RMSEC for PTS is 1.1, R2is 0.9714, RMSEP for PTS is 0.9769, R2 is 1.8713. The results show that the present method can be applied for process analysis and quality control of protopanaxatriol saponin manufacturing process of extraction by percolation. 3.Reference measurements of ginsenoside-Rg1,ginsenoside-Re and notoginsenoside-R1 were performed by HPLC,and the ethanol content of Eluent,the study established the near infrared spectroscopy model for rapid determination in the purification process of PTS by macroporous resin. In the models,RMSECV for ginsenoside-Rg1 is 0.952, R2 is 0.9858, RMSEP for ginsenoside-Rg1 is 1.13, R2 is 0.9884; RMSECV for ginsenoside-Re is 0.106, R2 is 0.9787, RMSEP for ginsenoside-Re is 0.121, R2 is 0.9898; RMSECV for notoginsenoside-R1 is 0.214, R2 is 0.9793, RMSEP for notoginsenoside-R1 is 0.381, R2 is 0.9709; RMSECV for PTS is 0.921, R2 is 0.9874, RMSEP for PTS is 1.52, R2 is 0.9907. The results show that the present method can be applied for process analysis and quality control of protopanaxatriol saponin manufacturing process of purification by macroporous resin.4.The study established the method for controlling the uniformity of the Intermediates of SanQiTongShu capsule by near-infrared spectroscopy,which can effectively monitor the uniformity of the intermediate of the mixing process of SanQiTongShu capsule.The method can be applied for process analysis and quality control of SanQiTongShu capsule manufacturing process.