Strategies and key technologies for risk control and management in quality of Chinese medicine injections based on integrated pharmacology / 中国中药杂志

This paper focuses on the quality risk control and management of Chinese medicine (CM) injections. The most important technological requirements are analyzed, and a strategy for integrated pharmacology to study CM mechanism is proposed. A key technology system for quality risk control and management was further constructed. The strategy and technology system was finally applied to Shengmai injection for quality risk control and management.

Dynamic predictive modeling of extraction process for red ginseng using near-infrared spectroscopy / 中国中药杂志

It is the objective of this study to develop dynamic predictive model for the extraction process of red Ginseng using NIR spectroscopy. NIR spectroscopy was collected online and PLSR models were developed for total quantity of ginsenosides. The performance of NIR prediction model achieved R, RMSEC, RMSEP of 0.996 09, 0.018 9, 0.016 8, respectively. A first order dynamic mass transfer model was combined with NIR prediction of the quality indicator to predict the trajectory of the extraction process based upon the initial 3 or 4 data points. The results showed good agreement with actual measurements indicating reasonable accuracy of the predictive model. It could potentially be used for advanced predictive control of the extraction process.

Data integration, data mining and visualization analysis of traditional Chinese medicine manufacturing process / 中国中药杂志

Huge amount of data becomes available from the pharmaceutical manufacturing process with wide application of in- dustrial automatic control technology in traditional Chinese medicine (TCM) industry. The industrial big data thus provides golden op- portunities to better understand the manufacturing process and improve the process performance. Therefore it is important to implement data integration and management systems in TCM plants to easily collect, integrate, store, analyze, communicate and visulize the data with high efficiency. It could break the data island and discover useful information and knowledge to improve the manufacturing process performance. The key supporting technologies for TCM manufacturing and industrial big data management were introduced in this paper, with a specific focus on data mining and visualization technologies. Using historic data collected from a manufacturing plant of Shengmai injection of SZYY group, we illustrated the usefulness and discussed future prospects of data mining and visualization technologies.

Multi-objective optimization of extraction process for red ginseng based upon extraction efficiency and cost control / 中国中药杂志

It is the objective of this study to optimize the extraction process of red ginseng to minimize the unit cost of extracting effective ingredients. The relation between the target variables of total quantity of ginsenosides and first extraction time, first extraction solution amount, second extraction time, second extract solution amount were studied with Box-Behnken experimental design method. At the same we also considered the cost of extraction solution and energy usage. The objective function was set as unit cost of target (total quantity of ginsenosides or its purity) for the multi-objective optimization of extraction process. As a result, the optimal process parameters were found as first extraction time (108.7 min), first extraction solution amount folds (12), second extraction time (30 min), second extraction solution amount folds (8) to minimize the unit cost. It indicated that this approach could potentially be used to optimize industrial extraction process for manufacturing Chinese medicine.

Reliability theory based on quality risk network analysis for Chinese medicine injection / 中国中药杂志

A new risk analysis method based upon reliability theory was introduced in this paper for the quality risk management of Chinese medicine injection manufacturing plants. The risk events including both cause and effect ones were derived in the framework as nodes with a Bayesian network analysis approach. It thus transforms the risk analysis results from failure mode and effect analysis (FMEA) into a Bayesian network platform. With its structure and parameters determined, the network can be used to evaluate the system reliability quantitatively with probabilistic analytical appraoches. Using network analysis tools such as GeNie and AgenaRisk, we are able to find the nodes that are most critical to influence the system reliability. The importance of each node to the system can be quantitatively evaluated by calculating the effect of the node on the overall risk, and minimization plan can be determined accordingly to reduce their influences and improve the system reliability. Using the Shengmai injection manufacturing plant of SZYY Ltd as a user case, we analyzed the quality risk with both static FMEA analysis and dynamic Bayesian Network analysis. The potential risk factors for the quality of Shengmai injection manufacturing were identified with the network analysis platform. Quality assurance actions were further defined to reduce the risk and improve the product quality.

Network analysis of ethanol precipitation process for Schisandrae chinensis fructus / 中国中药杂志

A set of central composite design experiments were designed by using four factors which were ethanol amount, ethanol concentration, refrigeration temperature and refrigeration time. The relation between these factors with the target variables of the retention rate of schizandrol A, the soluble solids content, the removal rate of fructose and the removal rate of glucose were analyzed with Bayesian networks, and ethanol amount and ethanol concentration were found as the critical process parameters. Then a network model was built with 2 inputs and 4 outputs using back propagation artificial neural networks which was optimized by genetic algorithms. The R2 and MSE from the training set were 0.983 8 and 0.001 1. The R2 and MSE from the test set were 0.975 9 and 0.001 8. The results showed that network analysis method could be used for modeling of Schisandrae Chinensis Fructus ethanol precipitation process and identify critical operating parameters.

Progress on chemical components and anti-cerebral injury effects of storax / 中国中药杂志

The Chinese medicine storax is one of the resuscitation-inducing aromatic herbs used to treat stoke, epilepsy, convulsion, etc. In this review, authors summarized the progress on chemical compositions and anti-cerebral injury effects of storax. Gas chromatography-mass spectrometry (GC-MS) were used to determine the main chemical compositions of storax . And the anti-cerebral ischemia, anti-convulsion, and anti-memory defect effects of storax and its compound preparation were discussed. At last, authors have tried to propose a number of recommendations for the future research.

Caffeic acid ester fraction from Erigeron breviscapus inhibits microglial activation and provides neuroprotection / 中国结合医学杂志

<p><b>OBJECTIVE</b>To investigate the effects of caffeic acid ester fraction (Caf) from Erigeron breviscapus, mainly composed of dicaffeoylquinic acids (diCQAs), on microglial activation in vitro and focal cerebral ischemia in vivo.</p><p><b>METHODS</b>The production of nitric oxide (NO), tumor necrosis factor α (TNF-α), and interleukin-1β (IL-1β) induced by lipopolysaccharide (LPS) treatment in rat primary cultured microglia were measured by Griess reaction or enzyme-linked immunosorbent assay. Cell viability of cortical neurons was measured using AlamarBlue reagent. The behavioral tests and the infarct area of brain were used to evaluate the damage to central nervous system in rat middle cerebral artery occlusion (MCAO) model of cerebral ischemia. Real time polymerase chain reaction was used to determine the expression of inducible nitric oxide synthase (iNOS), TNF-α and IL-1β mRNA in ischemic cerebral tissues.</p><p><b>RESULTS</b>Caf inhibited the production of NO, TNF-α and IL-1β induced by LPS treatment in primary microglia in a dose-dependent manner. Exposure of cortical neurons to conditioned medium from Caf-treated microglia increased neuronal cell viability (P<0.01) compared with conditioned medium from LPS-treated alone. In MCAO rat model of cerebral ischemia, Caf could significantly improve neurobehavioural performance and reduce percentage infarct volume compared with the vehicle group (P<0.05). Caf could also significantly inhibit the up-regulation of iNOS, TNF-α, and IL-1β gene expressions in ischemic cerebral tissues.</p><p><b>CONCLUSION</b>Caf could suppress microglial activation, which may be one mechanism of its neuroprotective effect against ischemia.</p>

Effect of dan-shen, san-qi of different proportion on platelet aggregation and adhesion in normal rabbits / 中国中药杂志

<p><b>OBJECTIVE</b>To observe the effect of the crude extracts of Dan-shen root and San-qi of different proportion on platelet aggregation and adhesion in normal rabbits.</p><p><b>METHOD</b>With rabbits, ig. (4d, exsanguinated via carotid artery, percentage of platelet aggregation and adhesion was measured.</p><p><b>RESULT AND CONCLUSION</b>Aspirin (4.4 mg/Kg) could markedly inhibit platelet aggregation and adhesion in normal rabbit. The proportions of Dan-shen root/San-qi (10:0, 10:1, 10:3, 10:6, 1:10) could markedly inhibit platelet aggregation, among which 10:3 was the best. San-qi alone had little effect on aggregation. The proportions of Dan-shen root/San-qi (10:3, 10:6, 0:10) could markedly inhibit platelet adhesion, among which 0:10 was the best, and the proportions(10:0, 10:1, 1:10) had little effect.</p>