EDI技术在医药用水制备中的应用研究

EDI是英文Electrodeionization的缩写,中文全称为"连续电去离子技术",是将电渗 析(ED)与离子交换(IE)有机结合的新型脱盐工艺.EDI通过在电渗析器的隔板中填充离子交换树脂,从而在直流电场作用下可同时实现连续去离子和树脂 连续电再生.但是EDI膜堆对进水的要求十分苛刻,为了保证长期稳定的出水水质,进水硬度要求低于1.0mg/L(以CaCO3计),甚至更低.在实际的 工程应用中,由于预处理不合格,水质波动或者操作失误等一些原因,EDI运行不稳定,膜堆结垢,成为困扰EDI技术应用的一大难点. 本文针对EDI运行过程中存在的问题,采用国产化材料组建EDI膜堆,对膜堆内部结构进行改造,并在其淡水室和浓水室均填充离子交换树脂,研究其产水水 质,稳定性及适宜的工作参数.实验研究表明,(1)操作电压与电流是影响EDI运行的重要因素.电压,电流过高或过低,产水电阻率均会降低.一级EDI膜 堆和二级EDI膜堆操作电流通常取2-3A.(2)二级EDI膜堆与一级EDI膜堆比较,适应性强,产水水质好且在较短的时间内就基本达到稳定.(3)二 级EDI膜堆的进水电导率控制在4.1-6.5μs/cm范围内波动时,膜堆运行40min时,产水电阻率达到最大.100min后产水电阻率基本稳定在 17MΩ·cm以上.产水pH值一直保持在6.0-6.5之间.(4)根据实际运行效果分析可知,晶源公司生产的一级EDI膜堆和二级EDI膜堆进水电导 率宜控制在10μs/cm以下,这样既可达到高纯水水质的要求,又可以延长膜堆的使用寿命;同时该膜堆淡水进水压力宜在0.35-0.4MPa,浓水流量 一般为进水流量的5-10%左右,极水流量控制在18-24L/min左右. 在以上研究的基础上,针对西安艾尔肤企业人造皮肤医药用水的特殊需要,并且达到节能降耗的目的,设计出"二级反渗透(RO)+二级EDI+超滤(UF)+ 混床(MB)"(以下简称"2RO+2EDI+UF+MB")组合式纯化水/高纯水/注射用水/超纯水生产系统来制出四种医药纯水,分别送至不同的生产车 间以供给不同工序使用;各管网水均为动态,以达到GMP要求.结果表明,(1)综合来说,"2RO+2EDI+UF+MB"系统污水产生较少,系统噪声较 低,自动化程度高,产水水质稳定,终端出水可以达到中国电子级超纯水GB/T11446.1-1997一级标准.将此组合工艺应用于实际生产中,起到很好 的指导意义.(2)"2RO+-2EDI+UF"非蒸馏法生产的水,产水电导率,细菌内毒素等各项指标均达到中国药典2010版对于纯化水和注射用水的标 准.(3)"2RO+2EDI+UF"非蒸馏法最大的优点是设备简单,投资少,占地小,污染少,节能节水且能实现自动化生产;所制的注射用水具有适宜的温 度,适用于配制不耐热的药品制剂;所制的水总是新鲜的,适于配制注射液.(4)采用"RO-EDI-UF"集成膜工艺代替多效蒸馏来生产注射用水,为国内 外药典关于注射用水的制备工艺提供实际参考价值及理论指导.

Retrospective comparison of abatacept (Aba) and half-dose posttransplant cyclophosphosphamide (PTCy) compared with standard dose PTCy GVHD prophylaxis.

e18555#Background: Aba and PTCy have improved outcomes for alternative donor transplants and have expanded the donor pool. However, Aba in the approved schedule has no impact on chronic GVHD and standard dose PTCy has been associated with increased infections and cardiovascular complications. As preclinical studies suggest that intermediate dose PTCy may be superior to full dose PTCy, we combined the approved dose and schedule of Aba with half-dose PTCy. Methods: A retrospective analysis at Montefiore Medical Center was conducted on adults (>18 years) with hematologic malignancies undergoing HSCT, comparing two GVHD prophylaxis regimens: standard dose PTCy versus Aba plus half-dose PTCy. The study included both matched and mismatched donor transplants. Endpoints included neutrophil and platelet engraftment, GRFS events and 100-day mortality. Results: Of the 110 patients, 66 received PTCy, and 44 Aba plus PTCy. The median age was 57 years, with no significant difference between the two groups. 43.9% of patients in the PTCy group and 50.% of patients in the Aba group had a diagnosis of acute myeloid leukemia (AML). Neutrophil engraftment was also faster in the Aba group (13.5 days [IQR 1]) versus the PTCy group (17.5 days [IQR 8], p < 0.001). Platelet engraftment occurred significantly faster in the Aba group (17 days [IQR 3]) compared to the standard PTCy group (28.5 days [IQR 20]). Hundred-day mortality was 18.2% after standard PTCy vs 0% in the Aba cohort. The time to significant adverse events (acute or chronic GVHD, relapse, or non-relapse mortality) was longer in the Aba plus half-dose PTCy group. Interestingly, while the rate of acute grade 3-4 GVHD was similar (4.5% in the Aba group vs 6.1% in the PTCy cohort), the rate of chronic GVHD was significantly higher in the Aba plus half-dose PTCy group (43.2% vs 4.5%) p < 0.001. Conclusions: Patients receiving Aba and half-dose PTCy achieved faster platelet and neutrophil engraftment and had lower 100-day mortality compared to those receiving standard PTCy. However, while the rates of acute GVHD were similar between the groups, the much higher incidence of chronic GVHD in the Aba cohort indicates that half-dose PTCy is inadequate to prevent cGVHD after PBSCT. Alternative GVHD strategies should be explored to better balance the benefits of faster engraftment with the risk of chronic GVHD.

A phase 2 study of bevacizumab in combination with carboplatin and paclitaxel in patients with non-squamous non-small-cell lung cancer harboring mutations of epidermal growth factor receptor (EGFR) after failing first-line EGFR-tyrosine kinase inhibitors (HANSHIN Oncology Group 0109)

We have conducted a phase 2 study to evaluate the efficacy and safety of carboplatin, paclitaxel, and bevacizumab in patients with non-squamous non-small-cell lung cancer (NSCLC) who are epidermal growth factor receptor (EGFR) mutation positive and for whom EGFR-tyrosine kinase inhibitor (TKI) 1st-line has failed. Patients with stage IIIB or IV non-squamous NSCLC harbored activating EGFR mutations that has failed 1st-line EGFR-TKI and an Eastern Cooperative Oncology Group performance status of 0 or 1 were included in this study. Patients received carboplatin at an area under the concentration–time curve 5 or 6, paclitaxel 200mg/m2, and bevacizumab 15mg/kg on D1. The combination therapy was repeated every 21 days for up to three to six cycles. Bevacizumab was continued until disease progression or unacceptable toxicity for patients without disease progression (PD). The primary endpoint was objective response rate (ORR). Thirty-one patients were enrolled between March 2010 and January 2013, with 30 patients being eligible. ORR was 37% (90% CI; 24–52%) and disease control rate, 83% (95% CI; 66–92%). The median progression free survival (PFS) was 6.6 months (95% CI; 4.8–12.0 months) and median overall survival, 18.2 months (95% CI; 12.0–23.4 months). The most common grade ≥3 hematologic toxicity was neutropenia (93%), and non-hematologic toxicity, febrile neutropenia (20%). There were no clinically relevant grade ≥3 bleeding events and no treatment-related deaths. The combination therapy of carboplatin, paclitaxel and bevacizumab did not achieve the initial treatment goal.

Optimizing Electrocoagulation-Adsorption Treatment System for Comprehensive Water Quality Improvement in Olive-Mill-Wastewater (OMW): Synergy of EC Utilizing Al Electrodes and Olive Stones Biochar as a Sustainable Adsorbent

This research employed "Response Surface Methodology (RSM)" to assess the effectiveness of electrocoagulation (EC) in treating olive mill wastewater (OMW) before applying adsorption with olive stone biochar (OS) as a sustainable adsorbent. Several parameters, including reaction time, current density (CD), inter-electrode distance, and the number of electrodes, were optimized. Analysis using Minitab 22.2 resulted in robust regression models with high coefficients of determination (R2). The optimal parameters were CD of 12.41 mA/cm2, a time of 45.61 min, an inter-electrode spacing of 1 cm, and a maximum of 6 electrodes, resulting in an energy consumption (ENC) of 9.85 kWh/m3. Significant pollutant percentage removals were achieved: 72.32% for total Kjeldahl nitrogen (TKN), 80.74% for turbidity, 57.44% for total phenol (TPh), 56.9% for soluble chemical oxygen demand (CODsoluble), and 56.6% for total chemical oxygen demand (CODtotal). After the EC, the adsorption of pollutants was conducted using OS biochar that was generated through the pyrolysis of OS at a temperature of 500 °C. FTIR analysis of the biochar revealed key absorption bands that indicated the presence of inorganic compounds, aromatic C=C, and phenolic groups O-H. The integrated EC and adsorption (ECA) process demonstrated markedly higher efficiencies, with TPh removal reaching 61.41%, turbidity reduction at 81.92%, TKN reduction at 77.78%, CODsoluble reduction at 70.31%, CODtotal reduction at 65.1%, and project cost of $2.88/m3. The ECA process presents a promising treatment approach for OMW.

Epidermal growth factor can be used in lieu of follicle-stimulating hormone for nuclear maturation of porcine oocytes in vitro

Epidermal growth factor (EGF) has been considered a potential regulator of meiotic and cytoplasmic maturation in mammalian oocytes, but inconsistencies exist between earlier studies, probably due to differences in the culture conditions used. Using a serum- and hormone-free in vitro maturation (IVM) medium, this study investigated the specific contribution of EGF on IVM of porcine (Sus scrofa) oocytes and its interactive effects with follicle-stimulating hormone (FSH), porcine follicular fluid (pFF), cumulus cells, and serum. It was noteworthy that EGF functionally mimicked the action of FSH and could completely replace FSH for nuclear maturation (83.2 ± 4.4% vs. 55.9 ± 5.2%; mean ± SEM), whereas EGF had a synergistic effect with FSH on cytoplasmic maturation of porcine oocytes (P < 0.05). Specific inhibition of EGF receptor (EGFR) by tyrphostin AG 1478 inhibited both EGF- and FSH-induced meiotic resumption (17.9 ± 5.2% and 18.2 ± 4.4%, respectively), thereby suggesting that EGFR signaling pathway was essential for oocyte reentry into the meiotic cell cycle. Furthermore, it is possible that FSH action occurs via the EGFR signaling pathway to induce meiotic maturation, although alternate pathways could not be excluded. There were also individual or combined effects of cumulus cells, FSH, serum, and pFF with EGF on IVM of porcine oocytes (P < 0.05). Although FSH had a synergistic effect with EGF on cytoplasmic maturation, pFF masked the effects of EGF on both nuclear and cytoplasmic maturation of porcine oocytes (P < 0.05). Moreover, the presence of cumulus cells was essential for EGF action. In conclusion, a defined system was used to better examine the effects of EGF. We inferred that EGF functionally mimics FSH for nuclear maturation of porcine oocytes, and its exogenous supplementation into IVM medium can optimize the beneficial effects of FSH on cytoplasmic maturation of oocytes to obtain enhanced embryo development in vitro.

The Optimal Design of 600 kJ SMES Magnet Based on Stress and Magnetic Field Analysis

In the development of large scale superconducting magnetic energy storage (SMES) systems, the problem of mechanical stresses induced in the windings by Lorentz force becomes more critical as dimensions of system and magnetic field increase. In this paper, an optimal design process of a 600 kJ SMES magnet combined with mechanical stress analysis is presented. A stress analysis method based on electromagnetic finite element analysis (FEA) is explained in detail. The results of the analysis led to the development of an optimum design, electro-magnetically and mechanically, of a single-pole double pancake coil (DPC) type 600 kJ SMES magnet. The stress in each DPC are described along with recommendations for winding tension in the manufacturing process to minimize radial and hoop stress in each DPC.

Development of a Simple Method to Concentrate the Radon222 Content of Water Samples for the Measurement of the Radon222 Concentration in Surface Water

Radon-222 (222Rn) is a useful indicator for analyzing the interaction between surface water and groundwater. To measure the 222Rn concentration in surface water, it is necessary to concentrate the 222Rn, because the concentration is normally too low for precise measurement. This operation is troublesome and requires a special apparatus. We described a convenient apparatus that uses forced-air circulation to concentrate the 222Rn content of water samples into toluene cooled in an ethanol-dry ice bath. This method takes advantage of the high solubility of radon concentration in cold toluene. We confirmed the practicality of the method for the precise measurement of low 222Rn concentrations in water experimentally. Application of the method to a field study in northeast Thailand revealed that the 222Rn concentration in the surface waters of an area at low elevation was higher than that in samples from an area of high elevation, which suggests that groundwater rises to the surface in the low-elevation area in the study region.