关于生物制品工艺验证的审评实践与思考

有效的工艺验证是药品质量的重要保证。由于生物制品来源于细胞基质、制备工艺复杂,具备结构表征不完全等特点,生物制品的工艺验证需进行特殊考虑。本文根据国内外相关指导原则并结合药品审评工作实践,总结了生物制品工艺验证中关于细胞基质、发酵与纯化过程、病毒安全性、层析介质寿命与一次性反应器耗材,以及中间体稳定性等的一般要求。同时,就目前国内生物制品注册管理中出现的工艺验证相关共性问题进行探讨。     

浅谈涂装车间的工艺管理

汽车涂装的质量取决于涂装工艺、涂装材料及涂装工艺管理,涂装工艺管理是一个衡量涂装工业水平最重要的因素,也是影响涂装质量的最重要因素,正所谓三分材料七分管理。以奇瑞涂装车间12线为例介绍日常涂装工艺管理的相关工作。     

国外硫酸工艺技术进展

介绍国外近期开发的几种硫酸生产工艺Cansolv SO2循环工艺、Regesox工艺、SAPNE工艺、Poseidon尾气循环工艺、Notrosyl工艺、Waterloo工艺，论述其特点及应用。建议国内积极开发拥有自主知识产权的新技术。     

复合材料产品设计和开发中的工艺设计和控制

工艺设计是采用先进的工艺设计方案、科学合理、经济可行地实现产品的设计意图。而工艺设计的控制是确保工艺设计可以达到规定目标的适宜性,充分性和有效性的的重要保障,从而使工艺设计能够完全、正确、统一、协调。本文结合复合材料气瓶阐述了复合材料产品设计和开发中的工艺设计程序及控制内容。     

新型—体化污水处理工艺对污染物去除效果的研究

对一种新型一体化污水处理工艺的基本原理进行了介绍,并通过对污水的试验研究,考察了CODCr、BOD5、TN、TP、SS的去除率,从中确定了最佳工艺参数。研究结果表明,该方法是一种高效、经济的工艺技术,可节省投资和运行费用,出水水质稳定,处理效果好,具有广泛的推广应用价值。     

树脂基复合材料成型工艺的发展

随着复合材料工业的迅速发展,传统的复合材料成型工艺日臻完善,新的成型方法不断涌现。本文通过梳理接触低压成型工艺、拉挤成型工艺、模压成型工艺、缠绕成型工艺、铺放成型工艺、RTM成型工艺这几种先进树脂基复合材料成型工艺的发展历程,分析发展过程中的关键技术,来研究先进复合材料成型工艺的演变,从而探讨未来树脂基复合材料成型工艺的发展方向。     

新型一体化污水处理工艺对污染物去除效果的研究

对一种新型一体化污水处理工艺的基本原理进行了介绍,并通过对污水的试验研究,考察了CODCr、BOD5、TN、TP、SS的去除率,从中确定了最佳工艺参数.研究结果表明,该方法是一种高效、经济的工艺技术,可节省投资和运行费用,出水水质稳定,处理效果好,具有广泛的推广应用价值.     

浅谈酸铜镀液中的Cu+产生的原因

1 前言 硫酸盐镀铜具有成本低、电流密度大、生产效率高,废水处理容易,并能得到有韧性的镜面光亮镀层,镀液整平性是其它镀铜液无法比拟的.但是,酸铜镀液易产生Cu ,以致于镀层出现局部粗糙或光亮度降低.     

山梨酸合成新工艺研究

着重介绍了山梨酸合成路线、工艺操作步骤,影响因素以及山梨酸防腐机理和应用概况。     

华亭FMTP项目废水处理工艺选择

为选定华亭FMTP项目配套污水处理工艺,实现投产后污水处理的达标排放,分析了污水预处理工艺、A2/O工艺、SBR工艺、MBBR工艺和BAF工艺的原理及各工艺的优缺点,结合华亭FMTP项目的实际情况和废水指标,预处理工艺选择混凝沉淀和气浮工艺,废水处理工艺选择了SBR和MBBR两级串联的处理工艺。     

樟树资源化学加工利用产业发展现状

油樟和樟树化学型中的芳樟、龙脑樟是中国特色樟科树种,总面积约8万公顷,主要分布在四川宜宾、四川广安、江西赣州、广西南宁、湖南新晃等地。樟树叶油中的1,8-桉叶素、芳樟醇和天然龙脑是重要的出口产品,也是医药、香精香料和日化行业的主要原料。本文综述了樟树资源特征、分布,介绍了油樟油、芳樟油、龙脑樟油的化学组成和生物活性,樟树油的主要产品及其提取、分离、纯化技术,以及质量控制、分析检测方法和存在的技术瓶颈;分析了樟树产业现状及其在医药、香料日化、食品等行业中的应用,阐述了樟树产业在应用基础研究、终端产品研发、国家、省级相关规划、标准化原料基地建设、樟树定向培育技术等方面存在的问题,并提出了相应的建议与对策,为樟树资源化学加工利用提供参考依据。     

Biosorption: critical review of scientific rationale,environmental importance and significance for pollution treatment

Biosorption may be simply defined as the removal of substances from solution by biological material. Such substances can be organic and inorganic, and in gaseous, soluble or insoluble forms. Biosorption is a physico‐chemical process and includes such mechanisms as absorption, adsorption, ion exchange, surface complexation and precipitation. Biosorption is a property of both living and dead organisms (and their components) and has been heralded as a promising biotechnology for pollutant removal from solution, and/or pollutant recovery, for a number of years, because of its efficiency, simplicity, analogous operation to conventional ion exchange technology, and availability of biomass. Most biosorption studies have carried out on microbial systems, chiefly bacteria, microalgae and fungi, and with toxic metals and radionuclides, including actinides like uranium and thorium. However, practically all biological material has an affinity for metal species and a considerable amount of other research exists with macroalgae (seaweeds) as well as plant and animal biomass, waste organic sludges, and many other wastes or derived bio‐products. While most biosorption research concerns metals and related substances, including radionuclides, the term is now applied to particulates and all manner of organic substances as well. However, despite continuing dramatic increases in published research on biosorption, there has been little or no exploitation in an industrial context. This article critically reviews aspects of biosorption research regarding the benefits, disadvantages, and future potential of biosorption as an industrial process, the rationale, scope and scientific value of biosorption research, and the significance of biosorption in other waste treatment processes and in the environment. Copyright © 2008 Society of Chemical Industry     

Graphene-Based Sensors for the Detection of Bioactive Compounds: A Review

Over the last years, different nanomaterials have been investigated to design highly selective and sensitive sensors, reaching nano/picomolar concentrations of biomolecules, which is crucial for medical sciences and the healthcare industry in order to assess physiological and metabolic parameters. The discovery of graphene (G) has unexpectedly impulsed research on developing cost-effective electrode materials owed to its unique physical and chemical properties, including high specific surface area, elevated carrier mobility, exceptional electrical and thermal conductivity, strong stiffness and strength combined with flexibility and optical transparency. G and its derivatives, including graphene oxide (GO) and reduced graphene oxide (rGO), are becoming an important class of nanomaterials in the area of optical and electrochemical sensors. The presence of oxygenated functional groups makes GO nanosheets amphiphilic, facilitating chemical functionalization. G-based nanomaterials can be easily combined with different types of inorganic nanoparticles, including metals and metal oxides, quantum dots, organic polymers, and biomolecules, to yield a wide range of nanocomposites with enhanced sensitivity for sensor applications. This review provides an overview of recent research on G-based nanocomposites for the detection of bioactive compounds, providing insights on the unique advantages offered by G and its derivatives. Their synthesis process, functionalization routes, and main properties are summarized, and the main challenges are also discussed. The antioxidants selected for this review are melatonin, gallic acid, tannic acid, resveratrol, oleuropein, hydroxytyrosol, tocopherol, ascorbic acid, and curcumin. They were chosen owed to their beneficial properties for human health, including antibiotic, antiviral, cardiovascular protector, anticancer, anti-inflammatory, cytoprotective, neuroprotective, antiageing, antidegenerative, and antiallergic capacity. The sensitivity and selectivity of G-based electrochemical and fluorescent sensors are also examined. Finally, the future outlook for the development of G-based sensors for this type of biocompounds is outlined.     

A review of liquid silicone rubber injection molding: Process variables and process modeling

Liquid silicone rubber (LSR) is an elastomer molded into critical performance components for applications in medical, power, consumer, automotive, and aerospace applications. This article reviews process behavior, material modeling, and simulation of the (LSR) injection molding process. Each phase of the LSR injection molding process is discussed, including resin handling, plastication, injection, pack and hold, and curing; and factors affecting the molding process are reviewed. Processing behavior of LSR is marked by transient interactions between curing, shear rate, temperature, pressure, and tooling. Therefore, current LSR models for curing, viscosity, pressure, and temperature are discussed. Process dynamics and material modeling are combined in LSR injection molding simulations with applications in mold design, troubleshooting process-induced defects, and management of shear stress and non-uniform temperatures between LSR and substrates during overmolding. Finally, case studies using commercial simulation software are presented, which have shown cavity pressure and flow front advancement within 3% of experimental values. Optimization of LSR materials, data collection, model fitting, venting, and bonding remain areas of continued interest.     

Potential of Polyvinylidene Fluoride/Carbon Nanotube Composite in Energy,Electronics, and Membrane Technology: An Overview

Polyvinylidene fluoride (PVDF) is a semicrystalline thermoplastic and electroactive polymer with piezoelectric and pyroelectric properties, thermal stability, elasticity, and chemical resistance. PVDF exits in five different phases (α, β, δ, γ, and ε-phase). Unique properties of this polymer enhances its use in chemical, biomedical, and electronic industries such as supercapacitors, transducers, actuators, and batteries. Carbon nanotube (CNT) is used as reinforcement to exploit full potential of PVDF in energy, electronics, and membrane technology. The nanofiller affects morphology, piezoelectric, pyroelectric, electrical, dielectric, thermal, and mechanical properties of PVDF-based nanocomposite. CNT content and chemical modification influence properties as well as application of PVDF.     

The Emerging Roles of Chromogranins and Derived Polypeptides in Atherosclerosis,Diabetes, and Coronary Heart Disease

Chromogranin A (CgA), B (CgB), and C (CgC), the family members of the granin glycoproteins, are associated with diabetes. These proteins are abundantly expressed in neurons, endocrine, and neuroendocrine cells. They are also present in other areas of the body. Patients with diabetic retinopathy have higher levels of CgA, CgB, and CgC in the vitreous humor. In addition, type 1 diabetic patients have high CgA and low CgB levels in the circulating blood. Plasma CgA levels are increased in patients with hypertension, coronary heart disease, and heart failure. CgA is the precursor to several functional peptides, including catestatin, vasostatin-1, vasostatin-2, pancreastatin, chromofungin, and many others. Catestatin, vasostain-1, and vasostatin-2 suppress the expression of vascular cell adhesion molecule-1 and intercellular adhesion molecule-1 in human vascular endothelial cells. Catestatin and vasostatin-1 suppress oxidized low-density lipoprotein-induced foam cell formation in human macrophages. Catestatin and vasostatin-2, but not vasostatin-1, suppress the proliferation and these three peptides suppress the migration in human vascular smooth muscles. Chronic infusion of catestatin, vasostatin-1, or vasostatin-2 suppresses the development of atherosclerosis of the aorta in apolipoprotein E-deficient mice. Catestatin, vasostatin-1, vasostatin-2, and chromofungin protect ischemia/reperfusion-induced myocardial dysfunction in rats. Since pancreastatin inhibits insulin secretion from pancreatic β-cells, and regulates glucose metabolism in liver and adipose tissues, pancreastatin inhibitor peptide-8 (PSTi8) improves insulin resistance and glucose homeostasis. Catestatin stimulates therapeutic angiogenesis in the mouse hind limb ischemia model. Gene therapy with secretoneurin, a CgC-derived peptide, stimulates postischemic neovascularization in apolipoprotein E-deficient mice and streptozotocin-induced diabetic mice, and improves diabetic neuropathy in db/db mice. Therefore, CgA is a biomarker for atherosclerosis, diabetes, hypertension, and coronary heart disease. CgA- and CgC--derived polypeptides provide the therapeutic target for atherosclerosis and ischemia-induced tissue damages. PSTi8 is useful in the treatment of diabetes.     

A review of ZrO2 nanoparticles applications and recent advancements

The many branches of nanoscience have made significant strides and advancements during the past ten years, as has the entire scientific community. Zirconia nanoparticles have several uses as adsorbents, nanosensors, nanocatalysts, and other types of nanomaterials. Their outstanding biomedical uses in dental care and drug delivery, as well as their intriguing biological characteristics, such as their anti-cancer, anti-microbial, and antioxidant activity, have further encouraged researchers to investigate their physicochemical properties using various synthetic pathways. Due to the popularity of zirconia-based nanomaterials, the current research comprehensively examines several synthesis techniques and their effects on the composition, dimensions, forms, and morphologies of these nanomaterials. In general, there are two methods for creating zirconia nanoparticles: chemical synthesis, which uses hydrothermal, solvothermal, sol-gel, microwave, solution combustion, and co-precipitation processes; and a greener method, which uses bacteria, fungi, and plant components. The aforementioned techniques have been evaluated in the present review for achieving particular phases and shapes. A thorough analysis of zirconia-based nanomaterial's uses is also included in the review. Furthermore, comparisons with their equivalent composites for various applications as well as the influence of particular phases and morphologies have been added. The final portion includes the summary, future outlook, and potential application.     

建筑陶瓷装饰技术的现状及发展趋势

简要介绍了建筑陶瓷领域、日用陶瓷和工艺美术陶瓷领域装饰技术的最新进展,着重介绍了引领陶瓷装饰技术发展和最新潮流的意大利、西班牙在这方面的水平和成果,他们为开放的中国从世界陶瓷大国尽快过渡到世界陶瓷强国提供了借鉴和方向。装饰技术的总体水平包括设计、装饰技法、装饰工艺、装饰材料和装饰机械装备等几大方面,其中设计是龙头,它应包括产品的图案设计、造型设计、色彩的搭配、产品的应用及展示设计等多个方面;装饰技法包括平面装饰和立体装饰、平铺和点缀、多种装饰材料的交替和组合应用等;装饰工艺包括布料(多管布料、多次布料、随机布料、微粉和干粒布料),丝网印刷(平面丝网印刷、辊筒印刷、胶辊印刷),各种施釉工艺,抛光,柔抛,釉抛和半釉抛工艺,磨边和水刀切割,拼花工艺等;装饰材料有各种色料、成釉、金属釉、干粒、印油、渗花液、喷墨印刷用耗材等;装饰机械装备包括各种装饰机械和工模具。     

套管损坏防治技术

针对油田套管损坏情况日益严重的现状,进行了套管损坏类型、特点及套损机理研究,形成了配套完善的套损防治技术体系。完善了从钻井、完井、固井及开发生产全过程的套损预防与保护系列技术,形成了以修胀套、爆炸整形、打通道、套管加固、取换套、侧钻为主的系列套管修复技术以及以工程测井为主的套管状况检测系列技术。并由实践认识到:只有坚持预防为主,研、防、治并举,建立适合不同油藏类型、不同开发阶段、不同开发方式的套损综合防治模式,才能解决油田套管损坏问题。     

油气集输过程中含油污泥减量化

集输过程中的含油污泥具有成分复杂、含液率高、乳化胶结稳定等特性，占油田危险废物新增量的约60%，是污染防治的重点。近年来，学者们开展了大量“调质-固液分离”减量化技术降低其环境风险和处置成本，但仍存在需要针对含油污泥不同来源优选相匹配的减量化调质方法和装置的难题。为此，本文回顾了氧化、破乳、絮凝、干化/半干、超声波、微波等化学与物理调质方法，离心机、叠螺机、压滤机3种固液分离装置研究进展，通过分别对各种调质方法及装置的对比分析，重点阐述了其作用机理、优缺点、适用对象。其中化学调质方法中破乳氧化、加酸更适用于高含聚油泥；表面活性剂破乳需加热，可与超声波相结合；有机和无机絮凝剂配合可提高罐底泥中油回收效果；干化/半干化法受经济效益制约。在文献基础上，认为未来应加强生物表面活性剂、生物电化学系统、椭圆叠螺机、基于固液分离装置数值模型基础上的设计与优化软件、多学科相结合的减量化耦合技术研究。