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

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

BackgroundThe study of myopia development is always the hotspot worldwide. Recently,scientist found that some growth factor secreted by retinal nerve epithelium cells and retinal pigment epithelium(RPE)cells are associated with the development of myopia. Whenever, the absorption of RPE cells to different wave-length lights is different. ObjectiveThis study was to investigate the effects of different wave-lengths lights on the proliferation of human RPE cells, and explore the influence of different wave-lengths lights on RPE cells secreting hepatocyte growth factor(HGF) ,basic fibroblast growth factor(bFGF) and transforming growth factor-β(TGF-β).Methods The fourth to fifth passages of human embryonic RPE cells were exposed to blue light( λ =480 nm),red light( λ =775 nm) and white light. The cells of control group were harvested in normal condition. The proliferation and growth of RPE cells were assayed by MTT,and the ultrastructure of cells was examined under the transmission electron microscopy at 48 hours after light exposure of RPE cells. Enzyme linked immunosorbent assay(ELISA) was adopted to determine the concentrations of HGF,bFGF and TGF-β in the culture medium in 12,24,48,72 hours. The expression of HGF mRNA in RPE cells was detected by RT-PCR. This study was approved by Ethic committee of Fudan University. ResultsThe A490 values of the cells exposed to blue light,red light,white light and white light were 0. 0218±0. 0014 ;0. 0353±0. 0025 ;0. 0371 ±0. 0024 and 0. 0445 +0. 0046 respectively with the significant difference among 4 groups ( F =12. 579, P＜0.05 ), and A490 value in blue light group, red light group were significantly lower than that of the control group ( t =2.043 ; t =2.024, P＜0.05 ). ELISA showed that the concentrations of HGF and TGF-β in culture medium were evidently elevated as the prolongation of light exposure in various light exposure groups in 72 hours(HGF) and 48 hours(TGF-β) compared with 12 hours with a predominating rise in the control group. The statistically significant differences were found in the concentrations of HGF and TGF-β between control group and blue light group or red light group in the( all P＜0. 05 ). The bFGF level was decreased with the time increase of various light exposure with the significant differences in 72 hours compared with 12 hours( P＜0.05 ). RT-PCR revealed the considerable difference about expression of HGF mRNA in RPE cells among these four groups( P＜0. 05 ), and the lest expression in HGF mRNA was in the blue light group compared with control group( t =3. 972,P＜0.05 ). Thinning of the chromatin, decreasing of organelle and loss of cellular membrane were seen in the blue light group, but no obvious change of ultrastructure of human embryo RPE cells was found in the ret and white light groups. ConclusionsThe irradiation of different wave-length light can effect the growth and proliferation and secretion of HGF,bFGF and TGFβ in human RPE cells in vitro,implying myopia formation is associated to exposure of different wave-length light.

Diabetic retinopathy is a series of typical pathological changes in retinal microvasculature caused by diabetes,which seriously affects the visual acuity and quality of life of patients.The development of spectral-domain optical coherence tomography provides a new approach to elucidate the pathogenesis of diabetic retinopathy,and this paper will give a brief review on the latest progress in the relationship between choroidal thickness measured by optical coherence tomography and diagnosis-treatment of diabetic retinopathy.

AIMTo examine the liver mechanism with which clenbuterol (CL) is explained how to affect growth metabolism.

METHODSThe technique of chronic poly catheter was used to study the effects of CL (0.8 mg/kg b w) on the hepatic flux of nitrogen, VFA and glucose in 4 sheep.

RESULTSThe urea-nitrogen flux in CL-treated period always was lower than that in control during 24 h. The average flux of urea-nitrogen in hepatic and portal vein were decreased by 16.86% (P < 0.01) and 15.51% (P < 0.05), respectively, compared with that of control. The peptide level in hepatic vein was decreased with the treatment of CL, average flux of peptide was decreased by 38.71% (P < 0.01). But the peptide level of portal vein in CL treatment period was similar to control. Moreover, VFA level in the portal vein was enhanced by CL, the average flux of acetate in portal vein was increased by 19.49% (P < 0.01). No difference of VFA level in hepatic vein was noted between CL-treated period and control. In addition, the glucose flux in hepatic vein was obviously increased with CL treatment, the average flux of glucose was increased by 25.96% (P < 0.01). And glucose flux in portal vein was also elevated during CL-treated period.

CONCLUSIONCL can affect growth metabolism of animal with increasing nitrogen deposition, improving absorption and utilization of VFA and enhancing glucose synthesis in sheep liver.

Animals ; Clenbuterol ; pharmacology ; Fatty Acids, Volatile ; metabolism ; Glucose ; metabolism ; Liver ; drug effects ; metabolism ; Sheep

OBJECTIVETo observe therapeutic effects of locking titanium plate for the treatment of comminuted proximal humeral fracture in elderly.

METHODSFrom June 2011 to May 2013, 72 elderly patients with comminuted proximal humeral- fractures were divided into locking titanium plate group and anatomical plate group, 36 cases in each group. In locking titanium plate group, there were 16 males and 20 females aged from 60 to 79 years old with an average of (69.55±5.62) years old; 10 cases were type Neer II, 18 were type Neer III and 8 cases were type Neer IV in accordance with Neer classification; treated with locking titanium plate. In anatomical plate group, there were 15 males and 21 females aged from 60 to 81 years old with an average of (69.76±5.70) years old; 9 cases were type Neer II, 20 were type Neer III and 7 cases were type Neer IV; and treated with anatomical plate. Clinical effects, preoperative and postoperative Neer scoring, operative time, bone healing time and incidence of complications between two groups were compared.

RESULTSAll patients were followed up from 1 to 3 years with an average of 15 months. The excellent and good rate of locking titanium plate group (91.7%) was significantly higher than anatomical plate group (75.0%). Postoperative Neer score of two groups were improved obviously, but locking titanium plate group (92.51±7.85) was higher than anatomical plate group (83.64±8.56); there was no significant differences between two groups in operative time (P>0.05); bone healing time in locking titanium plate was (18.6±3.4) weeks, and shorter than anatomical plate group (24.3±3.9) weeks; incidence of complications in locking titanium plate was (5.6%) shorter than anatomical plate group (22.2%), and had obviously differences between two groups.

CONCLUSIONLocking titanium plate for the treatment of comminuted proximal humeral fracture in elderly plays an important role in good rate, bone healing time and Neer score. It has advantages of early rehabilitation exercise, less shoulder pain, rapid recovery of shoulder joint, less complications, safe and effective, and be worthy of clinical application, especially for senile osteoporosis patients.

Aged ; Aged, 80 and over ; Bone Plates ; Case-Control Studies ; Female ; Fractures, Comminuted ; surgery ; Humans ; Male ; Middle Aged ; Shoulder Fractures ; surgery ; Titanium

Objective To report the preliminary results of registry and management for cerebral palsy in Minhang District of Shanghai. MethodsThe registry and management for cerebral palsy in Minhang District of Shanghai were reviewed. Results and ConclusionFrom February, 2009, the children with cerebral palsy (born from Jan.1, 2000 to Dec.31, 2008) and their families who resided in Minhang District participated in the registration adopting Scpchild Manual of Registry and Systematic Management for Cerebral Palsy. At the end of 2009, 41 children with cerebral palsy entered in the Registry System. Comparing with epidemiological investigation, registry and management for cerebral palsy can afford more information. The acceptance of the parents for registry need to be improved to extend the registry to more children.

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.
Drugs, Chinese Herbal ; pharmacology ; standards ; Humans ; Injections ; Medicine, Chinese Traditional ; Quality Control ; Risk ; Technology

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

Humans ; Leiomyoma ; pathology ; Microtomy ; methods ; Microwaves ; Paraffin Embedding ; methods ; Specimen Handling ; methods ; Thyroid Neoplasms ; pathology