[Data mining in traditional Chinese medicine product quality review].

The traditional Chinese medicine(TCM) enterprises have accumulated a large amount of product quality review(PQR) data. Mining these data can reveal the hidden knowledge in production and helps improve pharmaceutical manufacturing technology. However, there are few studies involving the mining of PQR data and thus enterprises lack the guidance to analyze the data. This study proposed a method to mine the PQR data, which consisted of 4 functional modules: data collection and preprocessing, risk classification of variables, risk evaluation by batches, and the regression analysis of quality. Further, we carried out a case study of the formulation process of a TCM product to illustrate the method. In the case study, the data of 398 batches of products during 2019-2021 were collected, which contained 65 process variables. The risks of variables were classified according to the process performance index. The risk of each batch was analyzed through short-term and long-term evaluation, and the critical variables with the strongest impact on the product quality were identified by partial least square regression. The results showed that 1 variable and 13 batches were of high risk, and the critical process variable was the quality of the intermediates. The proposed method enables enterprises to comprehensively mine the PQR data and helps to enhance the process understanding and improve the quality control.

Identification of bioactive ingredients with immuno-enhancement and anti-oxidative effects from Fufang-Ejiao-Syrup by LC-MS(n) combined with bioassays.

Fufang Ejiao Syrup (FES) is a widely used immune-boosting Traditional Chinese Medicine (TCM) in Eastern Asian countries. This study attempts to investigate the bioactive compounds in FES. First, FES extract was separated into fractions to facilitate the investigation and 72 compounds were identified using LC-MS(n). Subsequently, Immune-enhancement effects of FES and its components were investigated on bone marrow cells and neuroprotective effects against H2O2 induced oxidative damage were evaluated in SH-SY5Y neuroblastoma cells and bEnd.3. Our results indicated that fraction 3, 5, 6 and 8 showed significant improvements on immune function, while several fractions had cytoprotective effects against H2O2-induced oxidative injury. Jionoside A1 isolated from Radix Rehmanniae Praeparata displayed dose dependent immune-enhancement activity. 20(R)-ginsenoside Rg3 could protect bEnd.3 against oxidative damage. Furthermore, echinacoside, jionoside A1, vitexin-2-O-rhamnoside, acteoside and isoacteoside possessed moderate protective activities on H2O2-treated SH-SY5Y cells. In conclusion, our study provided both chemical and biological evidences to support clinical application of FES.