中药生产过程质量控制关键技术研究进展

中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。     

凉血通瘀方干预高血压大鼠急性脑出血模型对脑组织中差异miRNA表达的影响＊

目的 研究凉血通瘀方对高血压大鼠急性脑出血模型脑组织miRNA表达的影响，对差异表达的miRNA靶基因进行分析，探索凉血通瘀方可能的药效机制。方法 将自发性高血压大鼠随机分成对照组（B）和实验组（C）。适应性饲养一周后，C组灌胃凉血通瘀方，B组灌胃等体积生理盐水，连续5天，每天1次。构建脑出血模型后收集脑组织，借助全转录组测序技术获得miRNA表达量，与miRBase数据库比对获取已知miRNA，使用miRDeep2预测新miRNA。差异分析软件为DESeq2，筛选阈值为|log₂FC| ≥1 并且P <0.05。对显著差异表达的miRNA进行靶基因预测，对靶基因进行GO功能、KEGG通路富集和PPI网络分析。结果 实验组和对照组对比，共发现21个显著差异表达的miRNA，上调有9个，下调有12个，共预测得到1243个有统计学意义的靶基因。GO富集分析发现，生物过程中突触囊泡分泌的调节、神经递质分泌的调节和神经递质运输的调节占前三位，神经元投射终点、全膜、质膜区域和细胞投射则是主要的细胞成分。分子功能分别为小GTPase绑定、底物特异性跨膜转运蛋白活性和离子跨膜转运体活性。通路分析结果显示，靶基因在癌证通路、pI3K-Akt信号通路、人类乳头瘤病毒感染、神经活性配体-受体相互作用和MAPK通路等分布广泛。采用STRING网站和Cytoscape软件，根据MCC算法筛选出ADRA2C、CASR、CCL28、CCR1、DRD2、GNAT3、GRM2、DYNC1LI1、GABBR1、GNAI1等核心靶基因。结论 凉血通瘀方对脑出血急性期鼠脑组织内miRNA的表达有重要影响；显著差异表达miRNAs可能通过靶向核心基因调控凉血通瘀方干预急性脑出血的病理过程及预后。     

The technological imperative in tuberculosis care and prevention in Vietnam

ABSTRACT

A monocausal bacteriological understanding of infectious disease orients tuberculosis control efforts towards antimicrobial interventions. A bias towards technological solutions can leave multistranded public health and social interventions largely neglected. In the context of globalising biomedical approaches to infectious disease control, this ethnography-inspired review article reflects upon the implementation of rapid diagnostic technology in low- and middle-income countries. Fieldwork observations in Vietnam provided a stimulus for a critical review of the global rollout of tuberculosis diagnostic technology. To address local needs in tuberculosis control, health managers in resource-poor settings are readily cooperating with international donors to deploy novel diagnostic technologies throughout national tuberculosis programme facilities. Increasing investment in new diagnostic technologies is predicated on the supposition that these interventions will ameliorate disease outcomes. However, suboptimal treatment control persists even when accurate diagnostic technologies are available, suggesting that promotion of singular technological solutions can distract from addressing systemic change, without which disease susceptibility, propagation of infection, detection gaps, diagnostic delays, and treatment shortfalls persist.     

An electronic travel guide for visually impaired – vehicle board recognition system through computer vision techniques

Abstract

Purpose: In the context of assistive technology, mobility takes the meaning of “moving safely, gracefully, and comfortably”.The aim of this article is to provide a system which will be a convenient means of navigation for the Visually Impaired people, in the public transport system.

Method: A blind regular commuter who travels by public transport facility finds difficulty in identifying the vehicle that is nearing the stop. Hence, a real-time system that dynamically identifies the nearing vehicle and informs the commuters is necessary. This paper proposes such a system namely the “Vehicle Board Recognition System” (VBRS). Computer Vision techniques such as segmentation, object recognition, text detection and optical character recognition are utilized to build the system, which will detect, analyze, derive and communicate the information to the passengers.

Results: Thanks to the rapid development in technology, there are several navigation systems both hand held and wearable, available to help visually impaired (VI) people move comfortably both indoor and outdoor. Many blind people are not comfortable in using these devices or they are not affordable for them. Thus the proposed system gives them the comfort of navigation.

Conclusion: This system can be installed in the bus stop to assist the Visually Impaired, from externally rather than their hand held or wearable assistive devices.

• Implications for rehabilitation

• This proposed system will help the visually impaired to

• ensure secure navigation

• be independent of the others

• develop self confidence.

• overcome the training, affordability of wearable/ handheld devices.

     

山药粗多糖的提取工艺

对鲜山药中水溶性粗多糖的提取工艺进行了研究,通过单因素试验和L9（34）正交试验,研究了料液比、提取温度、时间和乙醇体积分数对粗多糖得率的影响,极差分析及方差分析结果表明提取温度和料液比是影响山药粗多糖提取的主要因素,较优的工艺为料液比1 g：9 mL,温度50 ℃,时间2.5 h,乙醇体积分数75%,在此工艺条件下,鲜山药粗多糖得率为0.2449%（以鲜山药质量计）.     

Development of a new sensor based on micro-electro-mechanical systems for objective in vivo measurement of the cutaneous temperature: application to foundations

BACKGROUND/AIMS: The purpose of this work was to develop a new sensor for objective in vivo measurement of the cutaneous temperature based on micro-electro-mechanical systems (MEMS), and to compare these performances with those of a classical thermocouple. Research on this new sensor was carried out to allow the quantification of the thermal properties of the made-up skin. METHODS: Sixteen female subjects divided into two different age groups (18-35 and >50 years old) were recruited for this study. Several zones of the face and forearms were made up at random with foundations containing or not a thermoregulator raw material. The quantity of foundation applied on the skin was standardized and measurements were carried out first before make-up, and then 10 s and 5 min after make-up. The new sensor and the thermocouple were used successively on each zone. The cutaneous temperature was expressed in degrees celsius. RESULTS/CONCLUSION: The two systems are similar in terms of repeatability and reproducibility, with some differences in sensibility. The data measured by the MEMS sensor appear lower than those measured by the thermocouple. After make-up, the MEMS sensor detects a progressive increase of the temperature in time whereas the thermocouple detects a decrease. We found the same evolution on the face but in a more attenuated way. These results tend to show that the devices do not measure the same phenomenon. The thermocouple appears more sensitive to the thermal response of the made-up surface whereas the MEMS sensor appears more sensitive to the heat transfers in the interface between the skin and make-up.     

A new bioabsorbable sleeve for lung staple-line reinforcement (FOREseal™): report of a three-center phase II clinical trial

Objective: To investigate on the feasibility, safety, and effectiveness of a new bioabsorbable material for lung staple-line reinforcement. Methods: This prospective open trial included 66 patients (mean age of 56 ± 17 years) who underwent various types of lung resection using staplers with knitted calcium alginate sleeves for buttressing (FOREseal™, Laboratoires Brothier, Nanterre, France) at three academic centers: 29 lobectomies, 22 emphysema surgeries, 15 wedge resections or lung biopsies. Intraoperative air leakage was assessed at a mean respiratory peak pressure of 30 cmH₂O, and rated as grade 1, 2, or 3. Persistent air leakage in the postoperative course, as well as any relevant event, was assessed daily. The follow-up period was of 6 months. Results: No technical problem linked to the device occurred. Hemostasis of the cutting edges was completed in all patients. Fifty-six percent of the patients had no intraoperative air leak and 27.3% had grade 1 leaks. Mean postoperative air leaks and thoracic drainage times were 1.9 ± 2.3 days and 6 ± 5.3 days, respectively. In-hospital mortality was nil. There was no empyema. Mean hospital stay was 9.1 ± 6.6 days. At follow-up, one patient underwent lung transplantation, and pathology of the explanted specimen showed the absence of device-related foreign-body inflammation. One patient complained from metalloptysis, and another one, with a metastatic invasive aspergillosis, developed an infectious recurrence that required reoperation. Conclusions: FOREseal is an ergonomic, safe, and promising new material instead of nonabsorbable materials and xenomaterials for staple-line reinforcement. A randomized comparative study is now in progress.     

Effects of acute administration of d-amphetamine and haloperidol on procedural learning in man

The effects of an indirect dopamine-agonist, d-amphetamine, and a non-selective dopamine receptor antagonist, haloperidol, were investigated in normal male volunteers using a between-subjects double-blind design in a procedural learning task, thought mainly to involve unconscious/automatic learning. The results showed: (1) d-amphetamine facilitated response speed, whereas haloperidol inhibited it, in comparison to placebo; (2) the linear increase in procedural learning corresponded with pharmacological manipulation of degree of dopaminergic activity, i.e. subjects given haloperidol showed the least, and subjects given d-amphetamine the greatest, procedural learning. The implications of these findings are discussed in relation to investigation of abnormalities of procedural learning processes in schizophrenia. Received: 28 June 1996/Final version: 2 October 1996     

Attentional demands of continuously monitoring orientation using vestibular information.

The aim of this series of experiments was to determine whether attention is normally required for continuously processing vestibular information concerning orientation, or is required only when orientation is disrupted (eg by vestibular dysfunction or by conflicting visual and vestibular orientation cues). In the first two studies, healthy subjects were passively oscillated, and indicated when they perceived they were passing through their starting position. There was only weak evidence for interference between performance on this 'continuous orientation monitoring task' and on concurrent mental tasks. However, a third study showed that when patients with vestibular imbalance carried out the continuous orientation monitoring task their performance on a concurrent mental arithmetic task was substantially impaired. This dual task interference was correlated with inaccuracy in judging orientation on the continuous orientation monitoring task, which in turn correlated with severity of recent vestibular symptomatology (assessed by questionnaire). In a fourth experiment, disorientation was induced in healthy subjects by rotating the visual field about the line of sight. Bidirectional interference was observed between monitoring orientation (assessed by accuracy in setting a rod to the perceived vertical) and performance of an arithmetic task. Dual task interference was correlated with baseline levels of disorientation induced by the visual field, as indicated by inaccuracy in judging the visual vertical. These findings suggest that monitoring orientation makes significant demands upon cortical processing resources when disorientation is induced, whether the disorientation results from deficient sensory functioning or from ambiguous perceptual information.     

Phase-constrained data extrapolation method for reduction of truncation artifacts

The authors present an improvement to a sigma-filter extrapolation method for the reconstruction of magnetic resonance (MR) images from symmetric discrete Fourier data. By making use of the phase information in the image data, the proposed method can overcome the data inconsistency problem of the original method for handling MR image data with large phase variations, such as those obtained in gradient-echo pulse sequences. Reconstruction results show that its performance is comparable with that of the modified complex sigma-filter method proposed previously to handle the inconsistency problem. However, the new approach has the advantage of reducing computation time by a factor of two with use of a sigma filter applied to real instead of complex images. It is expected that this method will be more practical for use in clinical MR imaging systems.