RESUMO
As intelligent production of traditional Chinese medicine （TCM） has been inevitable， informatization and automation of the production process have become the precondition for realizing intelligent manufacturing of TCM， of which the accumulation of critical material attribute and the critical quality attribute are the basis. The study of material properties is of great significance to achieve the quality control of the final product in the process， but there is a lack of systematic induction and summary of the research on the attribute of TCM pills. Therefore， the authors analyzed and summarized the attributes of raw materials， excipients and intermediates in the pill unit process according to the classification of powder properties， rheological properties and texture properties. What’s more， the impact of material attributes on the quality of the final product was summarized. Besides， this review summarized the attribute characterization techniques involved in the pill process and provided some suggestions for the characterization of product quality attributes. Finally， based on the concept of quality by design （QbD）， the authors proposed that the study of material attribute should be combined with process analytical technology （PAT）， and the focus of drug quality control should be moved forward to guide equipment upgrading， so as to realize intelligent continuous manufacturing of TCM pills.
RESUMO
OBJECTIVE: We conducted a study to understand the genetic effect of ERCC1 and RRM1 on the chemotherapy response and clinical outcome of Non-Small Cell Lung Cancer (NSCLC). METHODS: The relative cDNA quantification for ERCC1 and RRM1 was conducted using a fluorescence-based real-time detection method among 294 NSCLC patients. RESULTS: Compared with the internal reference gene ß-action, the median levels of ERCC1 and RRM1 expression were 2.43×10(-2) and 0.11×10(-2), respectively. Our study showed response to platinum-containing regimen chemotherapy was high in those with high ERCC1 expression, and the OR (95% CI) were 1.73(1.06-2.81). An apparently high response to chemotherapy was decreased when patients were carrying both high expression of ERCC1 and RRM1, with OR (95% CI) of 2.57(1.21-4.90). Patients with high expression of ERCC1 were associated with a longer OS by multivariate Cox proportional hazards model. Moreover, those carrying both high levels of ERCC1 and RRM1 were seem to have a longer OS when compared with those with low expression (HR=0.31, 95% CI=0.13-0.62 for OS). CONCLUSION: This observation could be used in personalized chemotherapy, increase the response rate and prolonged survival time, and could encourage to explore the predictive value of other genes.
