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.
Drugs, Chinese Herbal ; administration & dosage ; chemistry ; standards ; Medicine, Chinese Traditional ; standards ; Quality Control ; Reproducibility of Results ; Risk Assessment

Objective To study the effects of environmental exposure to rare earth elements REEs on intelligence of children. Methods Intelligence quotient IQ were examined with Drawing a Man Test in 464 children aged 7-10 years living in RE ore containing area and the control area in Xunwu country Jiangxi province China. Fifteen kinds of REEs in 112 blood samples 69 samples from RE ore area and 43 samples from the control area  were detected by inductively coupled plasma source mass spectrometry ICP-MS. Results All 15 kinds of REEs were detected in each sample the content of blood REEs of the children in the rare earth area 2.18?1.08 ng/g was 1.73 times of that of the children in the control area 1.26?0.35 ng/g the difference was significant P

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.
Cluster Analysis ; Computer Graphics ; Data Mining ; methods ; Manufactured Materials ; Medicine, Chinese Traditional ; methods ; Quality Control

OBJECTIVETo analyze the relationship between symptoms and signs of temporomandibular disorders (TMD) and the patients' quality of life (QOL).

METHODSA total of 492 TMD patients were included in this study. The clinical examination results were recorded using Fricton index of temporomandibular joint function. "Visual analog scale (VAS) evaluation of QOL disturbance" was designed to quantitate patients' QOL, to evaluate the degree that the patients QOL was affected.

RESULTSChewing, daily life and emotion among all 8 items of QOL were frequently affected by TMD, and joint clicking had the least influence on QOL. Intermittent closed lock had more severe interference with QOL than joint clicking only. Severe and moderate pain or limited mouth opening affected the QOL more severely than mild pain or mild limited mouth opening. The simple linear relationship between Fricton index and patients' QOL was poor (r < 0.4).

CONCLUSIONSPain is the most frequently seen symptom in TMD. TMD could affect patients' QOL, including both physical and social-psychological functions. The results suggest that the patients' QOL as well as TMD symptoms and signs should be considered in the management of TMD.

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.
Bayes Theorem ; Chemical Precipitation ; Cold Temperature ; Cyclooctanes ; chemistry ; Ethanol ; chemistry ; Fructose ; analysis ; Fruit ; chemistry ; Glucose ; analysis ; Lignans ; chemistry ; Neural Networks (Computer) ; Polycyclic Compounds ; chemistry ; Reproducibility of Results ; Schisandra ; chemistry ; Time Factors

Objective To investigate whether fasting obestatin level is different in patients with impaired glucose tolerance or type 2 diabetes, and to explore the association between obestatin and lipid metabolism. Methods Eighty-four subjects without known diabetes were divided into three groups: normal glucose tolerance(NGT), impaired glucose tolerance (IGT) and type 2 diabetes (DM) Plasma obestatin levels were measured with a radioimmunoassay. The relationship between fasting obestatin levels and metabolic parameters was also analyzed. Results Fasting obestatin levels were lower in DM group [(2.82±0.78)ng/ml] and IGT group [(3.25±0.29)ng/ml] than in NGT group[(3.55±0.57) ng/ml, P＜0.01]. Triglycerides and low density lipoprotein cholesterol levels gradually increased among the three groups (P＜0.05). Multiple linear regression analysis revealed fasting obestatin level was independently associated with waist-to-hip ratio, triglyeride and low density lipoprotein cholesterol. The regression equation was obestatin=6.953-3.412×W/H-0.175×TG-0.123×LDL-C. Conclusions The decreased obestatin may be associated with IGR and T2DM, and obestatin level may be associated with lipid metabolism.

Objective To investigate the genotype distribution of extended-spectrum?-lactamases(ESBLs) and AmpC?-lacta- mases produced by Escherichia coli and Klebsiella pneumoniae in 10 teaching hospitals of China.Methods 90 clinical strains of E.coli and 61 strains of K.pneumoniae isolated in 2003 and confirmed to produce ESBLs were collected from 10 teaching hos- pitals in China.Analytical isoelectric focusing was used to measure the pI of the?-lactamases.Conjugation experiment was used to study the transfer of cefoxitin resistance.Plasmid-mediated AmpC enzyme genes were amplified and sequenced by multiplex polymerase chain reaction (MPCR).Results The prevalence of ESBL-producing E.coli and K.pneumoniae was about 50% in Wuhan,Nanjing and Jinan.The prevalence of ESBL-producing E.coli was lower than K.pneumoniae in Beijing.However,in other hospitals the prevalence of ESBL-producing E.coli was a little higher than K.pneumoniae.About 24.4% of ESBL-pro- ducing E.coli isolates and 19.4% of ESBL-producing K.pneumoniae isolates were resistant to cefoxitin.Cefoxitin-resistant i solate was identified in all hospitals except Shenyang.Major genotype of ESBL-producing isolates was CTX-M.The CTX-M-9 group was the most common group,followed by CTX-M-1.More K.pneumoniae isolates produced both ESBLs and AmpC en- zyme than E.coli.The genotype was CTX-M/DHA-1.The PCR results of 3 transconjugants producing both ESBLs and AmpC enzyme were the same as their donor isolates.Conclusions The genotype of ESBL-producing isolates is mainly CTX-M-9 group in these teaching hospitals.More K.pneumoniae isolates produced both ESBLs and AmpC enzyme than E.coli.Most of these isolates are due to geno type CTX-M/DHA-1,which can spread through plasmid.

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.
Chemistry, Pharmaceutical ; economics ; methods ; Cost Control ; Drugs, Chinese Herbal ; analysis ; economics ; isolation & purification ; Panax ; chemistry

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.
Chemical Fractionation ; methods ; Ginsenosides ; chemistry ; isolation & purification ; Models, Theoretical ; Panax ; chemistry ; Spectroscopy, Near-Infrared

Background:Dysregulation of microRNAs is associated with intestinal mucosal barrier injury,intestinal inflammation and intestinal dysfunction. Abnormal expression of microRNAs occurs in patients with inflammatory bowel disease(IBD). Aims:To investigate the expression and significance of microRNA-595( miR-595)in IBD. Methods:A total of 100 patients with IBD at Nanjing General Hospital of Nanjing Military Command of PLA from July 2012 to July 2014 were enrolled,in which 63 cases were ulcerative colitis(UC)and 37 cases were Crohn’s disease(CD). According to disease activity,patients were divided into active UC(aUC)group,remissive UC(rUC)group,active CD(aCD)group and remissive CD(rCD)group. A total of 42 healthy subjects were served as normal control(NC)group. Specimens of serum and intestinal tissue were collected. Expression of miR-595 in serum and intestinal tissue was determined by fluorescence quantitative PCR. Luciferase report gene plasmid containing the 3’UTR of neural cell adhesion molecule 1(NCAM1)or fibroblast growth factor receptor 2(FGFR2)and plasmid containing miR-595 were co-transfected into human colon cancer cell line HCT116 to detect the effect of miR-595 on transcriptional activities of NCAM1 and FGFR2. Results:Expression of miR-595 in serum and intestinal tissue in UC and CD groups was significantly higher than that in NC group(P < 0. 05), and that in aUC and aCD groups was significantly higher than that in rUC and rCD groups,respectively(P < 0. 05). MiR-595 could down-regulate the transcriptional activities of NCAM1 and FGFR2 through directly binding to the 3’UTR of NCAM1 and FGFR2. Conclusions:Expression of miR-595 in serum and intestinal tissue is increased in patients with IBD and correlates with disease activity. MiR-595 inhibits the expressions of tight junction protein NCAM1 and FGFR2,thereby inducing injury of intestinal mucosal barrier and promoting intestinal inflammation. MiR-595 can serve as a serum biomarker for diagnosis of IBD and disease activity evaluation.