喷雾干燥法生产无菌原料药的质量风险与控制

喷雾干燥在药品生产中应用较多,喷雾干燥塔分为离心式、气流式、压力式,传统的喷雾干燥法生产无菌原料药过程中在不溶性微粒、无菌、均一性、有效成分降解等方面存在质量风险,应该针对性地在设备设计、清洁、灭菌、无菌粉冷却、混粉、环境控制等方面对各种风险加以严格控制,才能有效地生产出高品质的无菌原料药。     

SARM1 Ablation Is Protective and Preserves Spatial Vision in an In Vivo Mouse Model of Retinal Ganglion Cell Degeneration

The challenge of developing gene therapies for genetic forms of blindness is heightened by the heterogeneity of these conditions. However, mechanistic commonalities indicate key pathways that may be targeted in a gene-independent approach. Mitochondrial dysfunction and axon degeneration are common features of many neurodegenerative conditions including retinal degenerations. Here we explore the neuroprotective effect afforded by the absence of sterile alpha and Toll/interleukin-1 receptor motif-containing 1 (SARM1), a prodegenerative NADase, in a rotenone-induced mouse model of retinal ganglion cell loss and visual dysfunction. Sarm1 knockout mice retain visual function after rotenone insult, displaying preservation of photopic negative response following rotenone treatment in addition to significantly higher optokinetic response measurements than wild type mice following rotenone. Protection of spatial vision is sustained over time in both sexes and is accompanied by increased RGC survival and additionally preservation of axonal density in optic nerves of Sarm1^−/− mice insulted with rotenone. Primary fibroblasts extracted from Sarm1^−/− mice demonstrate an increased oxygen consumption rate relative to those from wild type mice, with significantly higher basal, maximal and spare respiratory capacity. Collectively, our data indicate that Sarm1 ablation increases mitochondrial bioenergetics and confers histological and functional protection in vivo in the mouse retina against mitochondrial dysfunction, a hallmark of many neurodegenerative conditions including a variety of ocular disorders.     

甜菜雄性不育系选育技术研究

本文以内蒙古甜菜育种工作为基础,较为系统地介绍了选育甜菜雄性不育系的各项技术,从理论和实践两个方面总结了从事此项研究的经验。全文分为5个部分:1.基础雄性不育材料的获得和利用;2.O型系的筛选;3.隔离繁殖技术;4.采用加代措施缩短选育年限;5.雄性不育与环境的关系。     

中国核农学的发展历程与成就

文章概述了我国核农学的创建与发展历程以及核技术农业应用研究所取得的主要成果。我国核农学始于1956年,经过50多年的发展,现已形成科研协作网络、学术交流网络、国际交流网络。这三大网络全面推动了中国农业核技术应用的核农学的形成与发展,在辐射育种、航天育种、同位素示踪技术在农业中的应用、农产品辐照贮藏和保鲜加工、辐射害虫防治、低剂量辐射刺激增产等方面取得了显著成绩。此外,文章还就中国核农学今后的发展构想以及核农学优先发展的主要领域提出了构思和建议。     

Decolorization of textile dyes by Bjerkandera sp. BOL 13 using waste biomass as carbon source

BACKGROUND: Phanerochaete chrysosporium, Trametes versicolor and Bjerkandera sp BOL13 were compared for decolorization of azo dyes supplied individually or as a mixture. The dye decolorization was also evaluated during continuous treatment under non‐sterile conditions using a lignocellulosic growth substrate. RESULTS: Bjerkandera sp BOL13 showed the highest dye decolorization potential. This fungus was also found to support high decolorization of Remazol Red RR at an initial pH of 4‐6 and when using straw as co‐substrate. The fungus was evaluated for Remazol Red RR decolorization in a continuously fed packed‐bed bioreactor operated under non‐sterile conditions with 3 days of hydraulic retention time. When glucose was supplied as growth‐substrate, decolorization efficiencies of 65‐90% were maintained for 12 days in a bioreactor packed with wooden material. The decolorization efficiency was lower when glucose was not fed to the fungus or when a plastic material was used as packing. Higher manganese peroxidase and laccase activities were also recorded when the wood packing was used. Contamination caused a drop in decolorization efficiency after 17‐19 days operation. CONCLUSIONS: The potential of Bjerkandera sp BOL13 for decolorization of azo dyes under non‐sterile conditions using lignocellulosic growth substrates was demonstrated. Research is needed to reduce contamination under non‐sterile conditions. © 2012 Society of Chemical Industry     

Sterility (ste) genes of Schizosaccharomyces pombe

In previous experiments of Girgsdies (1982), eight sterile (ste) mutants of Schizosaccharomyces pombe did not sporulate when fused with h⁺ or h^? protoplasts. We succeeded in achieving sporulation with these mutants. Two hitherto unknown ste genes, ste7 and ste8, were found.     

单粒型甜菜新品种“中甜─吉甜单一”的选育

利用引入的国外杂种选育二环系，成功地育成生产力稳定，经济效益较高，抗病性较好的“中甜—吉甜单一”单粒型甜菜新品种，实现了吉林省甜菜单粒种零的突破。本文报导了选育“中甜—吉甜单一”的历史背景和从初级到高级各选育阶段的一系列研究数据；讨论了从国外引进杂种中选育单粒二环系的途径来创新和丰富我国甜菜单粒种资源库的必要性、可行性和有效性，以及在充分利用单粒雄性不育系培育高强优势杂种的同时，注意利用单粒二环系育成普通遗传单粒种的可能性与现实性。论述了“中甜—吉甜单一”品种的特点和生产效应。     

The Effect of Coating Process and Additives on EVA Coated Tyvek® for Gas Sterilizable Medical Packaging Applications

Tyvek^®, as an ethylene oxide (EtO) gas sterile medical packaging material with a high‐gas permeation and serving as an excellent microbial barrier, must be coated with heat‐sealable adhesives to thermally seal various plastic packaging trays or films. Tyvek^® sheet coated with heat‐sealable adhesives must have both porous structure and good sealing strength to various substrates. In this study, an acid pre‐coating method was distinctively introduced to minimize reactions between the blowing agent and acid during mixing, to resultantly generate ethyl vinyl acetate (EVA) layers with porous structure on Tyvek^® sheets. To determine the feasibility of applying the as‐prepared coated Tyvek^® as a sterile medical packaging material, we investigated the properties of the coating solution and coated Tyvek^® as a function of process and additive composition. Finally, EtO gas sterilization tests were performed, and property changes in the coated Tyvek^® were investigated. Properties of the coated Tyvek^® were strongly dependent on the pre‐coating process and the composition of various additives. Pre‐coating with citric acid led to less of a reaction between citric acid and ammonium carbonate as a blowing agent during mixing and resulted in both good seal strength and air permeation for the coated Tyvek^® sheets. The coated Tyvek^® sheets, composed of a water‐based EVA emulsion solution with various additives, were not affected by the EtO sterilization process and yielded good resistance to humidity, EtO gas and vacuum cycles. The coated Tyvek^® sheets prepared by applying an acid pre‐coating may be a promising candidate for gas sterilizable medical device packaging materials. Copyright © 2017 John Wiley & Sons, Ltd.     

鱼类腐败菌腐败能力测定方法

通过分析比较接种腐败菌的大黄鱼无菌鱼块和灭菌鱼汁,在贮藏中感官、挥发性盐基氮(total volatile base nitrogen,TVBN)、三甲胺(trimethylamine,TMA)和腐败菌的变化,以及腐败菌生长动力学参数和腐败代谢产物的产量因子(YTVBN/CFU 和YTMA/CFU),探讨无菌鱼块和灭菌鱼汁两种腐败能力的测定方法。结果表明：接种腐败希瓦氏菌的无菌鱼块和灭菌鱼汁的货架期分别为162h 和132h,此时的TVBN 含量分别为32.16mg/100g 和29.64mg/100mL,TMA含量为9.31mg/100g 和0.99mg/100mL,腐败希瓦氏菌菌数为8.67 lg(CFU/g)和8.56 lg(CFU/mL),产量因子YTVBN/CFU为2.58 × 10-10mg TVBN/CFU 和1.98 × 10-10mL TVBN/CFU,产量因子YTMA/CFU 为2.12 × 10-10mg TMA/CFU 和1.27× 10-11mL TMA/CFU。TMA 作为接种鱼汁的理化指标是不可靠的,而TVBN 可以作为接种鱼汁的理化指标。接种腐败希瓦氏菌的无菌鱼块和灭菌鱼汁产量因子YTVBN/CFU 的相对误差为23.64%,因此灭菌鱼汁作为腐败菌腐败能力测定方法具有一定的可靠性。     

无菌熔接片加热升温过程的数值模拟分析

本文针对无菌熔接片的加热升温过程进行数值模拟分析,具体考察了熔接片基片材质、所施加电压以及电阻线电导率等三个参数对其加热升温过程的影响结果表明,在所考察的镍、铜和不锈钢三种基片中铜为综合性能较好的材料:此外,所施加电压与电阻线的电导率对熔接片的升温加热过程也有明显影响。本文的研究结果能为无菌熔接片的优化设计提供一定的指导作用,进而促进开放式医用导管无菌熔接技术与装备的发展。