[Formulation of technical guidelines in line with characteristics and principles of traditional Chinese medicine changes to improve quality of such preparations--interpretation of Technical guidelines for the study of pharmaceutical changes in traditional Chinese medicines].

In leading the high-quality development of Chinese medicine preparations, it is an important link to formulate the scientific, reasonable, and feasible guidelines for the change of Chinese medicines in accordance with the change characteristics and principles of the Chinese medicines is an important work to promote the Technical guidelines for the study of pharmaceutical changes in traditional Chinese medicines was formed by a broad consensus based on the characteristics and research results of the pharmaceutical changes in Traditional Chinese Medicines(TCM)with the principles of science and risk management. This guideline has clarified the basic principles and requirements for the evaluation of changes in TCM, specified the research and verification work of common change scenarios, defined the boundaries of changes in TCM, and proposed to encourage the use of new technologies, new methods, and new excipients that meet product characteristics. It will definitely promote the quality improvement and the secondary development of TCM. In this article, the revision background and main content of the guideline were introduced, and the main features of the Guideline were analyzed, in order to provide references for the industry.

Comparative microRNAome analysis of the testis and ovary of the Chinese giant salamander.

MicroRNAs (miRNAs) are 18-24 nucleotides non-coding RNAs that regulate gene expression by post-transcriptional suppression of mRNA. The Chinese giant salamander (CGS, Andrias davidianus), which is an endangered species, has become one of the important models of animal evolution; however, no miRNA studies on this species have been conducted. In this study, two small RNA libraries of CGS ovary and testis were constructed using deep sequencing technology. A bioinformatics pipeline was developed to distinguish miRNA sequences from other classes of small RNAs represented in the sequencing data. We found that many miRNAs and other small RNAs such as piRNA and tsRNA were abundant in CGS tissue. A total of 757 and 756 unique miRNAs were annotated as miRNA candidates in the ovary and testis respectively. We identified 145 miRNAs in CGS ovary and 155 miRNAs in CGS testis that were homologous to those in Xenopus laevis ovary and testis respectively. Forty-five miRNAs were more highly expressed in ovary than in testis and 21 miRNAs were more highly expressed in testis than in ovary. The expression profiles of the selected miRNAs (miR-451, miR-10c, miR-101, miR-202, miR-7a and miR-499) had their own different roles in other eight tissues and different development stages of testis and ovary, suggesting that these miRNAs play vital regulatory roles in sexual differentiation, gametogenesis and development in CGS. To our knowledge, this is the first study to reveal miRNA profiles that are related to male and female CGS gonads and provide insights into sex differences in miRNA expression in CGS.

[Common questions and suggestions of evaluation for NDA of TCM].

According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.

Therapeutic effect of Jinzhen oral liquid for hand foot and mouth disease: a randomized, multi-center, double-blind, placebo-controlled trial.

BACKGROUND: No specific antiviral agent against hand foot and mouth disease (HFMD) is available for clinical practice today. OBJECTIVE: To evaluate the efficacy and safety of Jinzhen oral solution in treating uncomplicated HFMD. METHODS: In this randomized, double-blind, placebo-controlled trial, 399 children aged 1 to 7 years with laboratory confirmed HFMD were randomized to receive Jinzhen oral liquid or placebo 3 times daily for 7 days with a 3-day follow-up. The primary outcomes were time to the first disappearance of oral ulcers and vesicles on hand or foot and time to the first normalization of temperature (fever clearance). RESULTS: There were 199 children enrolling into the Jinzhen group including 79 with fever and 200 into the placebo group including 93 with fever. Jinzhen reduced the time to the first disappearance of oral ulcers and vesicles on hand or foot to 4.9 days (95% CI, 4.6 to 5.2 days), compared with 5.7 days (95% CI, 5.4 to 6.0 days) in the placebo group (P = 0.0036). The median time of fever clearance was shorter in the 79 children who received Jinzhen (43.41 hrs, 95% CI, 37.05 to 49.76) than that in the 93 children who received placebo (54.92 hrs, 95% CI, 48.16 to 61.68) (P = 0.0161). Moreover, Jinzhen reduced the risk of symptoms by 28.5% compared with placebo (HR, 0.7150, 95% CI, 0.5719 to 0.8940, P = 0.0032). More importantly, treatment failure rate was significantly lower in the Jinzhen group (8.04%) compared with that in the placebo group (15.00%) (P = 0.0434). The incidence of serious adverse events did not differ significantly between the two groups (9 in Jinzhen group vs. 18 in placebo, P = 0.075). CONCLUSIONS: Children with HFMD may benefit from Jinzhen oral liquid treatment as compared with placebo. TRIAL REGISTRATION: Chinese Clinical Trial Registry (http://www.chictr.org/en/) ChiCTR-TRC-10000937.

[Pollution characteristics and ecological risk assessment of heavy metals in surface sediments of Qingshan Reservoir in Lin' an City, Zhejiang Province of East China].

A total of 8 representative surface sediment sampling sites were collected from the Qingshan Reservoir in Lin'an City of Zhejiang Province to investigate the differences in the total concentrations of As, Cr, Cu, Ni, Mn, Pb, and Zn among the sampling sites. The different forms of the heavy metals, i. e., acid soluble, easily reducible, easily oxidizable, and residual, were determined by BCR sequential extraction method, and the pollution degrees and potential ecological risk, of the heavy metals in the surface sediments at different sampling sites of the Reservoir were assessed by using geo-accumulation index (I(geo)) and Hakanson potential ecological risk index. There existed obvious spatial differences in the total concentrations of the heavy metals in the surface sediments of the Reservoir. The sampling sites nearby the estuaries of the tributaries flowing through downtowns and heavy industrial parks to the Reservoir had obviously higher heavy metals concentrations in surface sediments, as compared to the other sampling sites. In the sediments, Mn was mainly in acid extractable form, Cu and Pb were mainly in reducible form, and As was mainly in residual form. The surface sediments at the sampling sites nearby the estuaries of the tributaries flowing through downtowns to the Reservoir had higher proportions of acid extractable and reducibles forms of the heavy metals, which would have definite potential toxic risk to aquatic organisms. Among the 7 heavy metals in the surface sediments, As showed the highest pollution degree, followed by Cu, Ni, Mn, Pb, and Zn, which were at moderate pollution degree, while Cr was at non-pollution degree, with relatively low potential ecological risk. Through the comparison of the sampling sites, it was observed that the surface sediments at the sites nearby the estuaries of Jinxi River and Hengxi River flowing through downtowns and heavy industrial parks to the Reservoir showed obviously higher heavy metals pollution degree and potential ecological risk.

[Characteristics of soil denitrifying enzyme activity in riparian zones with different land use types in Chongming Island, Shanghai of China].

By using acetylene inhibition method, this paper studied the soil denitrifying enzyme activity (DEA) and its affecting factors in the riparian zone with different land use types (cropland riparian, forested riparian, and grassy riparian zones) in Chongming Island, Shanghai of China. The riparian soil DEA was (0.69 +/- 0.11)--(134.93 +/- 33.72) microg N x kg(-1) x h(-1), which differed obviously among different land types, with a decreasing trend of forested riparian zone > cropland riparian zone > grassy riparian zone. The soil DEA was significantly (P < 0.05) higher in 0-10 cm in 10-30, 30-50, and 50-70 cm layers. There were significant positive relationships between soil DEA and soil TOC, TN, and NO(3-)-N (P < 0.01). Land use change mainly altered the soil natural structure and soil physical and chemical properties, decreased the accumulation of soil organic carbon, and affected the soil nitrogen transformation, and thus, inhibited the occurrence of riparian soil denitrification.

[Effects of saltwater incursion on the microbiological characteristics and denitrification in a riparian rhizosphere soil in Chongming Island of Shanghai, East China].

A simulation test was conducted to study the effects of saltwater incursion on the microbiological characteristics and denitrification in the riparian rhizosphere soils vegetated with different plants in Chongming Island of Shanghai. Saltwater incursion changed the microflora in the rhizospheric soils. Except for actinomycete whose quantity had slight increase, the quantities of bacteria, fungi, nitrifiers, and denitrifiers all decreased to some extent by saltwater incursion, with the denitrifiers decreased by 51.8%, suggesting that the riparian soil microflora responded differentially to saltwater incursion. The activities of soil nitrogen-transforming enzymes were significantly inhibited by saltwater incursion, and the inhibitory effects differed with the enzymes. Nitrite reductase activity was most sensitive to saltwater incursion, with an inhibition rate of 43.5%, followed by urease activity, with 37.4% inhibition, and by dehydrogenase (29.5% inhibition). Saltwater incursion inhibited the denitrification, with the average denitrification rate decreased by 34.9%. There existed significant differences in the eco-physiological responses of the microbes in the rhizosphere soils vegetated with different plants to the saltwater incursion. The microbial quantities and enzyme activities showed the highest inhibition percentages in the rhizosphere soil of Zizania aquatica, followed by in the rhizosphere soils of Acorus calamus and Phragmites australis. Under saltwater incursion, the inhibition percentages of microbial quantities, enzyme activities, and denitrification rate in the rhizosphere soil of A. calamus-P. australis were significantly lower, as compared with those in the rhizosphere soils vegetated with Z. aquatica, A. calamus, and P. australis, respectively, suggesting that mixed vegetation showed a better buffer effect on the responses of riparian rhizosphere soil microbiological processes and denitrification to saltwater incursion.

[Excitation-emission matrix fluorescence spectra characteristics of DOM in a subsurface constructed wetland for advanced treatment of municipal sewage plant effluent].

Composition and dynamics of dissolved organic matter (DOM) were analyzed in a horizontal subsurface constructed wetland for advanced treatment of municipal sewage plant effluent using three-dimensional excitation emission matrix fluores cence spectroscopy (3D-EEM). The results indicate that the two subsurface constructed wetlands performed excellent purification of organic substances, and the removal rates of COD(cr), and DOC were 61.6% and 70.1%, respectively. The constructed wetland system filled with ceramsite showed slightly greater removal efficiency of organic substance than that with zeolite substrate. Four different types of peaks such as aromatic protein-like compounds (S), soluble microbial byproducts (T), fulvic acid-like compounds, visible fulvic-like (M) and UV fulvic-like compounds (A) were found in DOM from inflow and outflow of the subsurface wetlands based on the three-dimensional fluorescence spectroscopy analysis. The fluorescence intensity of the four peaks was significantly decreased in the effluent after purification by the subsurface constructed wetlands. Especially, the visible fulvic-like compounds and soluble microbial byproducts were effectively removed from the sewage plant effluent by the subsurface constructed wetland with fluorescence intensity reduction percentages of 16.4% and 11.7%. Aromatic structures of humic-like compounds were weakened and organic compounds with benzene rings were decreased in the outflow of the subsurface constructed wetland. This indicates that the subsurface constructed wetlands can decompose the chemically stable and biorefractory humic-like compounds. The fluorescence intensity of M and T peaks decreased along distance, while the fluorescence intensity of S peaks firstly increased, then decreased along the distance of the subsurface constructed wetlands. As compared to zeolite substrate constructed wetland system, the constructed wetland system filled with ceramsite was more effective to reduce the fluorescence intensity of characterized peaks of DOM from the sewage plant effluent.

Hypoxia-inducible factor 1 regulated ARC expression mediated hypoxia induced inactivation of the intrinsic death pathway in p53 deficient human colon cancer cells.

Apoptosis repressor with caspase recruitment domain (ARC), an anti-apoptotic protein, plays an important role in the regulation of apoptosis by blocking both the extrinsic and intrinsic death pathways. However, its regulatory mechanism remains largely undefined. Here, we reported that hypoxia up-regulated the expression of ARC in p53 deficient human colon cancer cells. Moreover, ARC is a direct target of the hypoxia-inducible factor 1 (HIF-1), a key transcriptional factor for the cellular response to hypoxia. Silencing the expression of HIF-1α in SW480 colon cancer cells by RNA interference abolished hypoxia induced ARC expression. Using luciferase reporter and ChIP assay, we showed that HIF-1α directly bound to hypoxia-responsive element located at -419 to -414 of ARC gene, which is essential for HIF-1-induced expression. As a result of the increased ARC expression, TRAIL-induced apoptosis was reduced by hypoxia. These discoveries would shed novel insights on the mechanisms for ARC expression regulation and hypoxia induced inactivation of the intrinsic death pathway.

A novel dynamic sensing of wearable digital textile sensor with body motion analysis.

This work proposes an innovative textile sensor system to monitor dynamic body movement and human posture by attaching wearable digital sensors to analyze body motion. The proposed system can display and analyze signals when individuals are walking, running, veering around, walking up and down stairs, as well as falling down with a wearable monitoring system, which reacts to the coordination between the body and feet. Several digital sensor designs are embedded in clothing and wear apparel. Any pressure point can determine which activity is underway. Importantly, wearable digital sensors and a wearable monitoring system allow adaptive, real-time postures, real time velocity, acceleration, non-invasive, transmission healthcare, and point of care (POC) for home and non-clinical environments.

Sleeping ECG and body position monitoring system.

A textile-based ECG system for sleeper is presented. The electrode in the system is supported by a foam pad to ensure good contact as well as comfort to the wearer, and a flexible rubber to ensure that the electrode will electrically connect to the wearer only when pressed. Eight electrodes are multiplexed such that exactly two electrodes are pressed to connect the wearer no matter how the wearer lies. When the wearer lies in different positions, he/she will press different two electrodes, and then the morphology of the output ECG signal will be different accordingly. By this feature, the system can not only detect ECG but also determine the position of the sleeper.

A wireless gait analysis system by digital textile sensors.

This paper studies the feasibility of spatio-temporal gait analysis based upon digital textile sensors. Digitized legs and feet patterns of healthy subjects and their relations with spatio-temporal gait parameters were analyzed. In the first experiment, spatio-temporal gait parameters were determined during over ground walking. In the second experiment, predicted running, backward walking, walking up stairs and walking down stairs parameters were determined. From the results of the experiments, it is concluded that, for healthy subjects, the duration of subsequent stride cycles and left/right steps, the estimations of step length, cadence, walking speed, central of pressure and central of mass trajectory, can be obtained by analyzing the digital signals from the textile sensors on pants and socks. These parameters are easily displayed in several different graphs allowing the user to view the parameters during gait. Finally, the digital data are easily to analyze the feature of activity recognition.

[Residence time distributions and spatial variation of N, P in the subsurface-flow constructed wetlands for purification of eutrophic aquaculture water].

Hydraulic residence time distributions (RTD) and spatial variations of N, P were studied in a small-scale horizontal subsurface-flow constructed wetlands (HSFCWs) planted with Cyperous alternifolius and Typha angustifolia respectively for purification of eutrophic aquaculture water. The results show that the residence time distribution curves of the investigated HSFCWs lie between plug-flow and completely mixed model with characteristic values (sigma2) of 0.3246 and 0.4108, respectively. Compared with Typha angustifolia, Cyperous alternifolius wetland shows fine flow pattern with characteristics of smoother RTD curve and weaker vertical mixed flow. Total nitrogen (TN) and ammonia nitrogen (NH4+-N) show stratified distributions in the two HSFCWs, especially in the front end of the wetland beds. TN in the lower layer is higher than that in the upper, while NH4+-N in the middle layer is the lowest in all the sampling layers. Total phosphorus (TP) and phosphate (PO4(3-)-P) increases with sampling depth. Differences in TP and PO4(3-)-P between the layers decrease gradually along distance. Cyperous alternifolius wetland shows better stratification distributions of N, P, as compared with Typha angustifolia, which is mainly contributed to the difference in flow patterns between the two HSFCWs. On average, concentrations of TN and TP in the rear end of the Cyperous alternifolius wetland are 19.3% and 12.5% lower, respectively, as compared to the Typha angustifolia wetland, suggesting that removal efficiencies of the Cyperous alternifolius wetland for purification of eutrophic aquaculture water is higher than those of the Typha angustifolia.

A real-time maximum-likelihood heart-rate estimator for wearable textile sensors.

This paper presents a real-time maximum-likelihood heart-rate estimator for ECG data measured via wearable textile sensors. The ECG signals measured from wearable dry electrodes are notorious for its susceptibility to interference from the respiration or the motion of wearing person such that the signal quality may degrade dramatically. To overcome these obstacles, in the proposed heart-rate estimator we first employ the subspace approach to remove the wandering baseline, then use a simple nonlinear absolute operation to reduce the high-frequency noise contamination, and finally apply the maximum likelihood estimation technique for estimating the interval of R-R peaks. A parameter derived from the byproduct of maximum likelihood estimation is also proposed as an indicator for signal quality. To achieve the goal of real-time, we develop a simple adaptive algorithm from the numerical power method to realize the subspace filter and apply the fast-Fourier transform (FFT) technique for realization of the correlation technique such that the whole estimator can be implemented in an FPGA system. Experiments are performed to demonstrate the viability of the proposed system.

Exquisite textiles sensors and wireless sensor network device for home health care.

In this study, we propose a wearing system with four sensors, ECG (electrocardiogram), three-axis accelerometer, temperature, and tight-switch, applied for remote monitoring system in home-care. The sensors ECG, measured with wearable electrodes made of the steel textile to generate the real-time heart-rate estimator, tight-switch, made of the steel textile to check whether wearing person dresses properly, accelerometer, and temperature parameters are received via the ZigBee receiver within an exquisite belt. Since the movable textile electrodes will cause of unfixed contacts when the wearing person is in motion, making the heart-rate estimation much a sophisticated work, the tight-switch sensor and FIR (Filter Impulse Response) filter technology are applied here to get the more satisfiable heart-rate. The other two bio-sensors can detect the whether fall-down or not and normal body-temperature of this wearing person. Moreover, the ZigBee device with small size, low-power consumption, and high-reliability characteristics is designed to transmit the detected bio-information from these four sensors. Therefore, the vital system embedded with the capability of real-time heart-rate estimation and transmission makes it highly suitable for applications of remote healthcare and wellness.

A novel design and evaluation of wearable digital sensor for monitoring posture.

In this study, we propose a novel design of the wearable digital sensor, embedded within a monitoring suit for posture monitoring. Our studies are going to solve wearable monitoring systems' drawbacks, include non-washable, uncomfortable, and high power -consumption due to complex signal processing. There are two digital sensor designs, dome shape type and clip shape type, knitted on clothes. The characteristics of these two digital sensor designs are easy implementation, small size, low power-consumption, and comfort. Our proposed system can catch up and monitor postures of the real-time information from the wearing person. Therefore, the monitoring system embedded with the capability of detecting real-time postures and transmission makes it highly suitable for applications of remote healthcare and wellness.