《化学药品注射剂与塑料包装材料相容性研究技术指导原则》公开征求意见

为了保证上市药品的质量，药品与包装系统的相容性问题一直是药品监管当局高度关注的问题，也是药品研制及生产企业亟待了解和研究的内容。为此，国家食品药品监督管理局药品审评中心成立了包材相容性研究指导原则课题组，经过前期的撰写和专家讨论，     

药品纸盒包装的绿色化设计

在生活中，药品是我们经常接触的产品，随着人们生活水平的提高，人们对自己所消费的产品的质量要求越来越高，同时对商品的外衣“包装”的要求也越来越高。多年来人们最多注重的是药品本身的效果，人们买药都必须去医院由医生开出药方才行，患者对药品几乎没有什么选择权，也就无所谓包装了。随着医疗体制的改革和药品分类管理的实施，现在大型的药品连锁超市开始出现在人们的日常生活当中，药品像其他商品一样摆在柜台上由人们根据自己的需要和喜爱自行挑选，患者自行选择药品的比例大大提高。随着非处方药（OTC药品）市场的不断扩大，包装就成为影响人们挑选的一个很重要的因素。而纸盒一直是药品外包装的主要形式，所以纸盒包装在药品包装领域则显得尤为重要。而药品包装又比其他产品特殊，就是大多数药品要直接人口的，它跟病人的生命健康有着直接关系。所以，在全球推行绿色化的今天，药品包装更应该先行一步。事实证明，现在的人们也是越来越关心药品包装的环保性和安全性。     

澳大利亚补充药品管理及对我国保健食品监管启示研究

澳大利亚将含有草药、维生素和矿物质、营养补充剂、顺势疗法和一些特定的芳香疗法制剂等治疗用途的产品称为补充药品，与我国保健食品的定位相似。澳大利亚补充药品分为备案制补充药品、评定备案制补充药品和注册制补充药品三类且健康声称与原料管理分开管理。本文总结归纳了澳大利亚补充药品的管理要求，同时结合我国保健食品的管理进行了分析，对我国保健食品的监管具有一定的借鉴意义     

安徽省食品药品监管督理局关于做好未通过新修订药品GMP认证无菌药品生产企业限期停产工作的通知

各市食品药品监督管理局，广德、宿松县食品药品监管局： 在各级食品药品监督管理部门和全省药品生产企业共同努力下，我省新版GMP实施工作推进顺利，已有27家企业93条生产线取得国家新版GMP证书或通过现场检查，有关工作进度快于全国平均水平。然而，全省还有个别企业或少数生产线没有通过国家认证。根据国家总局规定，现有药品生产企业血液制品、疫苗、注射剂等无菌药品的生产，应在2013年12月31日前达到《药品生产质量管理规范（2010年修订）》要求，逾期未通过新修订药品GMP认证的企业（车间）不得继续生产药品。现就无菌药品生产限期停产有关事宜通知如下：     

墨西哥药品包装市场在拉丁美洲处于领先地位

药品的创新和发展代表着拉丁美洲经济发展的一个重要方面，2005年拉丁美洲药品市场销售额达到240亿美元，比2004年增长了18．5％。其中，墨西哥、巴西和阿根廷是拉丁美洲三大主要市场，占到该地区药品行业总销售额的80％。     

严重违法药企将进“黑名单”

从10月1日起，药品生产企业将被戴上更强的“紧箍咒”。日前，国家食药监局公布药品安全“黑名单”管理规定（试行），严重违法的药品生产经营者、药品企业名称等信息都将被纳入“黑名单”。各地药监部门和国家食药监局将对“黑名单”进行公示。     

建构药品安全监管的合作治理网络

最近药品安全问题引人关注。而去年底，国务院常务会议讨论通过《国家药品安全规划（2011-2015年）》，会议明确指出：目前我国医药企业诚信体系不健全，药品安全仍处于风险高发期；在未来，应通过企业、协会、新闻媒体、政府监管部门的协力，建构药品安全监管的合作治理网络，通过多种监管工具的综合运用，才有可能降低药品安全风险。减少药品安全事件发生。     

复杂多折药品说明书告别手工时代——MBO药品说明书解决方案

众所周知，出于运输及仓储成本的考虑，一般的药品包装体积都不会很火，除了需要容纳药品本身外，还得装下内容全面的药品说明书。而内容全面的药品说明书无疑会扩大药。恼包装体积，     

国内外医药包装相关政策和我国未来医药包装发展

药品是特殊的商品，它的质量好坏直接关系到人民身体健康，为加强药品的监督管理，1985年我国颁布实施了《药品管理法》，但由于当时药事管理的局限性和对药包材的认识不足，药包材一直未被列入监督管理范畴。长期以来，我国对药包材监督管理一直沿用原国家医药管理局第10号令《药品包装用材料、容器生产管理办法》，由于实行行业管理，缺乏法律依据，     

药品包装印刷材料发展新趋势

目前由于药品包装材料的更新换代比较快，旧的包装材料己逐渐被淘汰，如玻璃瓶药品的包装、铁容器的药品包装、纸袋包装等。而新的药品包装已大量投入市场，如药品包装用泡罩包装、中成药软包装塑料膜(袋)以及铝塑复合膜等。     

Measuring in vitro biotransformation rates of super hydrophobic chemicals in rat liver s9 fractions using thin-film sorbent-phase dosing

Methods for rapid and cost-effective assessment of the biotransformation potential of very hydrophobic and potentially bioaccumulative chemicals in mammals are urgently needed for the ongoing global evaluation of the environmental behavior of commercial chemicals. We developed and tested a novel solvent-free, thin-film sorbent-phase in vitro dosing system to measure the in vitro biotransformation rates of very hydrophobic chemicals in male Sprague-Dawley rat liver S9 homogenates and compared the rates to those measured by conventional solvent-delivery dosing. The thin-film sorbent-phase dosing system using ethylene vinyl acetate coated vials was developed to eliminate the incomplete dissolution of very hydrophobic substances in largely aqueous liver homogenates, to determine biotransformation rates at low substrate concentrations, to measure the unbound fraction of substrate in solution, and to simplify chemical analysis by avoiding the difficult extraction of test chemicals from complex biological matrices. Biotransformation rates using sorbent-phase dosing were 2-fold greater than those measured using solvent-delivery dosing. Unbound concentrations of very hydrophobic test chemicals were found to decline with increasing S9 and protein concentrations, causing measured biotransformation rates to be independent of S9 or protein concentrations. The results emphasize the importance of specifying both protein content and unbound substrate fraction in the measurement and reporting of in vitro biotransformation rates of very hydrophobic substances, which can be achieved in a thin-film sorbent-phase dosing system.     

脱墨浆漂白过程自动加药系统应用实践

介绍西门子公司的纸浆漂白自动加药系统的功能及其在南纸300t/d废纸脱墨浆生产线上的应用实践。     

Conserving resources — cleaning chemicals

Conservation of cleaning chemicals requires a detailed survey of all departments, by a suitably qualified person, to establish the products and methods of application employed. This information can then be applied to rationalize and reduce the multiplicity of suppliers and products used. Suitability and selection of chemicals for specific cleaning operations and sources of waste are discussed, and three basic approaches to reduction and rationalization are suggested. The requirements, importance and benefits of correct control, monitoring and dosing of cleaning chemicals are examined, and attention is drawn to the need for properly controlled trials to establish which products are the most cost-effective. The reclamation and re-use of chemical solutions are also discussed.     

粘锦交织物留白染色

粘/锦交织物单染锦纶时,根据客户来样的颜色及要求采用除油工艺或全漂工艺进行前处理。文中给出了染色工艺参考处方和注意事项,即对助剂的用量、染料的配伍性、化料和加料顺序、设备调节、加料时间、温度调控等环节作了说明。     

影响浸染染色质量的因素

阐述了影响浸染染色质量的因素，包括原材料（坯布、染化料、助剂、水质）、前处理（烧毛、退煮漂、水洗、丝光、定形）、染色（染色设备、布重、浴比、pH值、小样工艺配方、配料等）和后整理（热迁移、柔软），并结合生产实践对生产工艺进行分析，提出了解决措施和注意事项。     

纯棉针织物的活性染料"一次准"染色工艺探讨

为实现活性染料对纯棉针织物“一次准”染色，在前处理、染色工艺方面进行改进。前处理采用非烧碱氧漂特效助剂＋双氧水；染色前采用脱氧酶去除织物上残留的双氧水，减少漂后水洗次数，缩短工艺流程；改进传统染色升温、加料方法。详细论述了生产中各个工序的技术管理要求，加强对染化料助剂库、化验室和染色等工序的严格管理，是实施染色“一次准”的基础。     

人造板调供胶应用技术研究

论述了调供胶技术在人造板生产中的重要意义,阐明了调供胶的概念,介绍了调供胶工段的组成。对如何提高调供胶技术水平,提出了新的看法。提高调供胶工段装备技术水平,可有效提高产品质量,降低生产成本。     

Solid phase dosing and sampling technique to determine partition coefficients of hydrophobic chemicals in complex matrixes

Determination of polymer-water and dissolved organic carbon (DOC)-water distribution coefficients of very hydrophobic chemicals (log K0w > 6) is not straightforward. Poor water solubility of the test compounds complicates the spiking and analysis of actual freely dissolved concentrations. By dosing a system via a PDMS-fiber and monitoring the depletion in the polymer, spiking and analysis of concentrations in the aqueous phase are avoided, and sorption to the polymer and other hydrophobic phases can be determined easily and accurate. In this publication we report the determination of poly(dimethyl-siloxane) (PDMS)-water, and Aldrich humic acid-water distribution coefficients for six PAHs with log K0w values varying from 4.56 to 6.85. The distribution coefficients to a PDMS fiber llog Kf) and the DOC (log KDOC) range from 3.86 to 5.39 and 4.78 to 7.43, respectively. Even for the most hydrophobic compounds, the distribution coefficients show small standard errors (< or = 0.05 log units). Therefore, this method might be applied to determine sorption coefficients of numerous, even more hydrophobic compounds, to humic acids as well as other dissolved hydrophobic matrixes.     

Screening for PBT chemicals among the "existing" and "new" chemicals of the EU

Under the European chemicals legislation, REACH, industrial chemicals that are imported or manufactured at more than 10 t/yr need to be evaluated with respect to their persistence (P), bioaccumulation potential (B), and toxicity (T). This assessment has to be conducted for several 10,000 of chemicals but, at the same time, empirical data on degradability, bioaccumulation potential and toxicity of industrial chemicals are still scarce. Therefore, the identification of PBT chemicals among all chemicals on the market remains a challenge. We present a PBT screening of approximately 95,000 chemicals based on a comparison of estimated P, B, and T properties of each chemical with the P, B, and T thresholds defined under REACH. We also apply this screening procedure to a set of 2576 high production volume chemicals and a set of 2781 chemicals from the EU's former list of "new chemicals" (ELINCS). In the set of 95,000 chemicals, the fraction of potential PBT chemicals is around 3%, but in the ELINCS chemicals it reaches 5%. We identify the most common structural elements among the potential PBT chemicals. Analysis of the P, B, and T data for all chemicals considered here shows that the uncertainty in persistence data contributes most to the uncertainty in the number of potential PBT chemicals.     

多法并用解决加碘均匀问题

我公司为解决加碘不均匀问题,从加碘设备、加碘工艺方法及加碘人员素质等方面进行全面改进和提高,使成品盐加碘一次合格率达到99.98%,效果理想。