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cai7net 2020-2-24 22:48
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个人分类: 学习心得|2117 次阅读|1 个评论
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ffang 2013-5-2 10:39
吴楠,王坤余 ** ,徐晓颖, 但年华,王康建 (四川大学制革清洁技术国家工程实验室,四川 成都610065) 摘要 :本文研究了复鞣剂和抗氧化剂对皮革中六价铬形成的影响。研究结果表明: 复鞣剂对皮革中六价铬形成的抑制作用因其化学组成和结构不同而异,含有多酚羟基的复鞣剂表现出较好的抑制作用 。 使用栲胶和/或抗氧化剂容易取得令人满意的效果 。 关键词: 皮革;六价铬;复鞣剂;抗氧化剂;栲胶 Effect of Retanning Agents and Antioxidant on the Formation of Hexavalent Chromium in Chrome Tanned Leather WU Nan, WANG Kun-yu**, XU Xiao-ying, DAN Nian-hua, WANG Kang-jian (National Engineering Laboratory for Clean Technology of Leather Manufacture, Sichuan University, Chengdu 610065, China) Abstract: The effect s of the retanning agents and antioxidant on the content of Cr( Ⅵ ) in the leather were analyzed. The inhibitory effects of the retanning agents on the formation of Cr(Ⅵ) in the leather were different, because of their chemical composition and structure. The retanning agents containing polyphenol hydroxyl groups showed a higher inhibitory ability. The use of tanning extracts and/or antioxidant can easily provide the satisfactory inhibition. Key words: leather; hexavalent-chromium; retanning agents; antioxidant; vegetable extracts 前言 六价铬具有致癌性和致突变性,它的毒性是三价铬的 100 多倍,多产生于印染、皮革加工、有机合成等行业 。在生产过程中,如何防止六价铬的产生是当今亟待解决的一个重要问题。在制革领域,因铬鞣革具有收缩温度高,耐水洗能力强,耐贮存,柔软、丰满、弹性和延伸性好等优点,铬盐鞣革在皮革加工中占有绝对的主导地位。虽 鞣革使用的是三价铬盐,但是成品革中却能检测出六价铬,有的 六价铬含量 甚至高达100 mg/kg 。鉴于六价铬的毒性, 世界各国对皮革中的六价铬含量做了严格规定: 一般要求残留在成革中的六价铬含量低于 5mg/kg ,欧盟则要求低于 3mg/kg ,皮革手套的限量为 2mg/kg 。 随着人们对生态环境和健康的要求不断提高 ,为消费者提供合格的皮革及其制品是皮革行业的必然选择。 据文献报道,皮革含有六价铬的主要原因有 : (1) 使用了含六价铬或六价铬含量超标的化工材料; (2) 坯革在湿态染整过程中浴液 pH 偏高; (3) 使用的部分加脂剂或复鞣剂有助于六价铬的形成; (4) 皮革受强热和光照等作用或储运过程中因环境温度、湿度等作用等。这些因素都有可能使皮革六价铬含量超标,特别是后两种情况。面对日益严峻的形势,制革工作者多试图用植物鞣剂和抗氧化剂解决皮革六价铬含量超标的问题 。 本文就常用的复鞣剂及 CR63 抗氧化剂对皮革中六价铬含量的影响做了进一步考察,希望对皮革加工中 六价铬含量的控制有一定的参考和指导作用。 1 实验 部分 1.1 主要材料和仪器 1.1.1 主要实验材料 二苯碳酰二肼(上海试剂三厂),丙酮、磷酸、磷酸氢二钾(成都长联化工试剂有限公司),冰乙酸、重铬酸钾(成都科龙化工试剂厂)均为分析纯; Tergotan RAC pdr 复鞣剂、 Syncotan MRL 复鞣剂 ( Clariant 化料公司) , SILVATEAM LEDORESIN FF 复鞣剂( 广州市施华化工技术有限公司) ,荆树皮栲胶(阿根廷),栲胶 BA ( 广西百色林化总厂), DESOTAN CL 复鞣剂(德赛尔化工实业有限公司), BA 加脂剂(德国司马化学公司), JM 加脂剂(达威股份), FATMATE WHI 加脂剂( 福建巴特斯化工实业有限公司) 均为工业品 ,皮革系工艺实验室提供 。 1.1.2 主要仪器 实验转鼓,上海华泰机床电器厂; DHG-9053A 型电热恒温鼓风干燥箱,上海精宏实验设备有限公司; HZS-H 水浴振荡器,哈尔滨东联电子技术开发; BS110S 电子天平,北京赛多利斯天平有限公司; UV-9100 紫外可见分光光度计,北京瑞利分析仪器公司。 1.2 实验方 法 1.2.1复鞣加脂基本工艺 原料:铬鞣山羊蓝湿革,厚度 0.9-1.1 mm (单层) ( 1 )水洗回软:水 200% , 温度 25℃ ,转 15min ( 2 )中和:水 150% ,温度 32℃-35℃ 甲酸钠 1% ,小苏打 0.6%~0.8% , 60 min (要求: pH 值 5.0-5.5 ) 水洗:水 250%-300% , 32℃-35℃ ,闷洗 10 min ( 3 )复鞣:水 150% ,温度 32℃-35℃ 复鞣剂 适量,转 60 min ;排液水洗 ( 4 )加脂:水 150% ,温度 50℃-55℃ 加脂剂 10% ,转 60 min ;甲酸 1%-1.2% , 20 min×2 (要求: pH 值 3.5~3.6 ) ( 5 )抗氧化剂处理:在加脂液中进行, CR63 抗氧化剂 1.5% , 转 60 min 甲酸 0.3%~0.4% , 30min (要求: pH 值 3.5~3.6 ) 水洗出鼓,静置过夜,干燥备用。 1.2.2 复鞣及干燥 将山羊蓝湿革沿背脊线对称分为八块,取其中七块称重,编号。 1 号坯革中和后直接用 FATMATE WHI 加脂剂加脂; 2~7 号坯革中和后分别用不同的复鞣剂复鞣,其后用 FATMATE WHI 加脂剂加脂。 所得的每一份革样一分为二,分别经室温 48h 和 60 ℃ 6 h 干至全透。所用复鞣剂的性能见表 1 。 表1 实验所用复鞣剂的性能及指标 Tab.1 Information of the retanning agents used in experiment 名称 Tergotan RAC pdr DESOTAN CL 栲胶 BA Syncotan MRL 荆树皮 栲胶 SILVATEAM LEDORESIN FF 成分 氨基树脂 聚氨酯 改性栲胶 酚醛合成鞣剂 栲胶 马来酸酐 性能 浅棕色粉末;阴离子/两性 淡黄色液体;两性 浅棕色 粉末 透明琥珀色液体;阴离子型 浅棕色粉末 浅棕色液体 阴离子型 1.2.3 抗氧化剂处理皮革 将山羊蓝湿革沿背脊线对称分为六块,分别称重,编号。 1~3 号中和后用氨基树脂复鞣剂( Tergotan RAC pdr ) 复鞣, 1 号和 2 号分别用 FATMATE WHI 加脂剂和 BA 加脂剂加脂, 3 号用 FATMATE WHI 加脂后再用抗氧化剂 CR63 处理; 4~6 号中和后先用 SILVATEAM LEDORESIN FF 复鞣剂复鞣, 4 号和 5 号分别使用 FATMATE WHI 加脂剂和 BA 加脂剂加脂, 6 号用 FATMATE WHI 加脂后再用抗氧化剂 CR63 处理。所得革样经 60 ℃ 6 h 干燥后,检测坯革中六价铬的含量。 1.2.4 六价铬含量的测定 按国际通用的 IUC-18 方法,用 pH=8.0 ± 0.1 的磷酸盐缓冲溶液持续振荡 3h 萃取革样中的六价铬,过滤,滤液中的六价铬在酸性条件下和二苯碳酰二肼发生显色反应,用分光光度法测定,标准曲线法定量。 2 结果与讨论 2.1 复鞣剂种类对皮革中六价铬含量的影响 铬鞣坯革经不同的复鞣剂复鞣,在相同的加脂、干燥条件下,其中六价铬的含量如表 2 所示。在室温自然干燥条件下,所用复鞣剂对坯革中六价铬的形成都具有一定的抑制作用,尤其是含有酚羟基的复鞣剂其作用更强。如经聚氨酯 DESOTAN CL 和改性栲胶 BA 复鞣后,革样中的六价铬含量都降低了 40% 以上。因为这些复鞣剂能与革内的 Cr 3+ 形成较稳定的结构,使 Cr 3+ 难以被氧化成 Cr 6+ 。表 2 结果还显示,复鞣剂抑制革内 Cr 6+ 形成的能力与其分子组成和结构密切相关,尤其是在较高温度下。像氨基树脂、马来酸酐这类复鞣剂在室温下对 Cr 6+ 形成有一定的抑制作用,但在 60℃ 以上的干燥条件下,几乎不具有任何抑制 作用。而 聚氨酯复鞣剂 DESOTAN CL 、酚醛树脂 Syncotan MRL 、荆树皮栲胶 和改性栲胶 BA 仍然具有较好的抑制作用,尤其改性栲胶 BA 的抑制效果最好。 表2不同 复鞣剂复鞣的皮革中六价铬含量 Tab.2 Cr( Ⅵ ) content found in the leather treated with different retanning agents 复鞣剂 空白样 Tergotan RAC pdr DESOTAN CL 栲胶 BA Syncotan MRL 荆树皮 栲胶 LEDORESIN FF 坯革状态 较柔软,丰满性一般 较柔软,较丰满 较柔软,丰满性一般 浅棕色,柔软,丰满 颜色最浅,较柔软丰满 浅黄色,柔软,丰满 较柔软,丰满性一般 Cr 6+ 含量 A 2.78 1.86 1.59 1.56 1.94 2.86 1.60 (mg/kg) B 7.28 7.90 2.33 1.38 2.80 3.21 6.85 说明:A室温48h干燥,B 60 ℃ 6 h干燥 2.2 栲胶对皮革六价铬含量的影响 蓝湿革用荆树皮栲胶和改性栲胶 BA 复鞣后,用 JM 加脂剂加脂,所得革样经 60℃6 h 干燥或 80℃10 h 干燥后,坯革中六价铬的含量如图 1 所示。与空白样相比(只用 JM 加脂剂处理的革样),使用栲胶复鞣剂能抑制革中六价铬的形成,既或是在 80℃ 高温下干燥,栲胶仍有非常好的抑制效果。使用荆树皮栲胶复鞣,革中六价铬的含量降低了 80.9% ,使用改性栲胶 BA 复鞣降低了 92.5% 。这是因为栲胶中存在多酚羟基,革中的酚羟基可以通过捕获氧化物自由基,抑制不饱和双键的氧化作用,从而阻止脂类自由基的链式反应,抑制过氧化物自由基的进一步形成,防止了成革中六价铬的形成,与俞从正等人的研究结果一致 。使用改性栲胶 BA 复鞣的革其六价铬含量比使用荆树皮栲胶复鞣革的更低。 这可能是由于栲胶 BA 经过改性,分子更小,渗透性能及与铬的结合性能更好。 尽管栲胶对皮革中六价铬的形成有很好的抑制作用,但由于栲胶的颜色较深、分子较大,在生产实践中,其应用受到成革风格和颜色等限制。 2.3 抗氧化剂对皮革中六价铬形成的预防作用 考虑到栲胶运用的局限性,作者就生产实践中应用较多的氨基树脂( Tergotan RAC pdr )和 SILVATEAM LEDORESIN FF 复鞣剂,与抗氧化剂或与分子中不含不饱和双键的加脂剂搭配使用,探索抑制皮革中六价铬形成的另一途径。如图 2 所示,经 Tergotan RAC pdr 和 SILVATEAM LEDORESIN FF 复鞣的革样,经 WHI 加脂剂及 CR63 抗氧化剂处理后,革样中六价铬含量明显降低,其含量几乎都在 3mg/kg 以下,表明 CR63 抗氧化剂对皮革中六价铬的产生具有较好的抑制作用。 作者曾考察了加脂剂对皮革中六价铬含量的影响 。结果发现, BA 加脂剂不但有良好的加脂效果,而且对坯革中六价铬的形成也有很好的抑制作用。如图 2 所见,经 Tergotan RAC pdr 和 SILVATEAM LEDORESIN FF 复鞣的革样,经 BA 加脂剂加脂后,革样中六价铬含量显著降低,其六价铬含量也都在 3mg/kg 以下,表明 BA 加脂剂对皮革中六价铬的形成亦有良好的抑制效果。 实验结果表明,虽然使用 Tergotan RAC 、 LEDORESIN FF 和 WHI 进行复鞣、加脂,有利于成革中六价铬的形成,使其六价铬的含量仍高于规定标准,如若配合使用 CR63 抗氧化剂或使用 BA 加脂剂进行加脂,便可使成革六价铬含量降低到规定指标。当然,从两组数据可见, CR63 有较好的抑制皮革中六价铬生成的作用,但其抑制作用因使用不同的复鞣剂而异。如果不使用抗氧化剂,选择合适的加脂剂也能有效的控制皮革中六价铬的含量。 3 结论 ( 1 )栲胶和 CR63 抗氧化剂对皮革中六价铬的产生具有较好的抑制作用 。 ( 2 ) CR63 抗氧化剂在不同的复鞣加脂条件下, 对皮革中六价铬产生的 抑制效果不同,使用时应综合考虑所用的复鞣剂和加脂剂类型。 ( 3 )在不使用植物鞣剂和抗氧化剂的情况下,注意复鞣剂和加脂剂的搭配,也能较好的 控制皮革中六价铬的产生 。 参考文献 易宗俊 , 马兴元 , 俞从正 , 等 . 皮革中六价铬的综合防治 . 皮革与化工 , 2009, 26(2) : 25-29 孙根行 , 俞从正 . 皮革中六价铬的研究进展 . 中国皮革 , 2002, 31(7) : 35-39 许春树 . 皮革中六价铬的研究进展评述 . 西部皮革 , 2005, 27(6) : 15-20 俞从正 , 刘鹏杰 , 段力民 , 等 . 储存条件对皮革中六价铬含量的影响 . 中国皮革 , 2004, 33(19) : 36-40 Graf D, Boehme D. The influence of the relative humidity of air during storage on the formation lowering of Cr( Ⅵ ) in chrome tanned leather. World Leather, 2000, 13(5):38 俞从正 , 孙根行 , 彭晓凌 , 等 . 皮革中的 Cr( Ⅵ ) 产生原因及预防研究 . 陕西科技大学学报 , 2003, 21(2) : 1-5 苏静 , 俞从正 , 王瑞 , 等 . 橡腕栲胶的改性及其对 Cr ( Ⅵ ) 防治作用研究 . 皮革科学与工程 , 2010, 20(3) : 28-33 胡强 , 俞从正 , 王瑞 . 鞣花酸防治皮革中 Cr ( Ⅵ ) 的应用研究 . 皮革科学与工程 , 2011, 21(2) : 28-30 高鸿超 , 丁志文 , 汤克勇 . 抗氧化剂预防皮革中六价铬的作用研究 . 中国皮革 , 2007, 36(11) : 12-14 龚英 , 陈武勇. 第八届 AICLST 会议论文综述 . 皮革科学与工程 , 2011, 21(1) : 28-33 吴楠 , 徐晓颖,陶小平,等 . 复鞣加脂对皮革中六价铬含量的影响 . 皮革科学与工程 , 2012, 22(4): 29-33. 本文引用地址: http://blog.sciencenet.cn/blog-63259-685966.html 分享到: 收藏 分享 修改 | 删除 | IP: 125.71.200.11 | 热度 | 生成文章 | 模块推送 | 举报 全部 作者的其他最新博文 • 功能皮革系列之阻燃皮革(3) • 没食子酸/硫酸铝改性脱细胞猪真皮基质的工艺优化及评价 • 功能皮革系列之阻燃皮革(2)* • 若干金属配合物与胶原的反应性能 • 基于DMT- Ⅱ配合鞣剂的少铬鞣研究 热门博文导读 • 地震空区地震可能性是大是小? • 喷®笑了 • 收到一封很意外的来自印度的邮件,不知道该怎么办 • 萧丑还是很不错的同志! • 博士们、留学生们千万别进中国的学术圈——由施一公当选美国院士 • 香溪唱和之满庭芳 当前推荐数: 0 推荐到博客首页 发表评论 评论 ( 0 个评论) 1/ 0 | 总计:0 | 首页 | 上一页 | 跳转 评论 王康建 加为好友 给我留言 打个招呼 发送消息
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cai7net 2013-5-1 19:51
Probability and Stochastic Process Tutorial (1) Probability is often characterized as “ a precise way to deal with our ignorance or uncertainty ”. Everyone has an intuitive understanding of the question “what are the chance of (something happening)?”. Stochastic process is then dealing with probabilities over time (or over some independent and indexed variable such as distance). There exist a number of excellent or classic textbooks on probability and stochastic processes. It is one of my favorite oral examine question which I always tell student beforehand to prepare as well as in my opinion the most useful tools of an applied mathematician and/or engineer. http://blog.sciencenet.cn/home.php?mod=spaceuid=1565do=blogid=13708 and http://blog.sciencenet.cn/home.php?mod=spaceuid=1565do=blogid=656455 Yet in my experience it is also one of the most confusing subjects for many students to learn. Why? In this series of blog articles (of which this is the first) I shall try to explain the subject in my own way and my experience in learning the subject. It is NOT my intention to replace the excellent textbooks . The main purpose of these articles, I hope, is that by reading the articles will make the subject matter more approachable and less imposing. They are NOT meant toreplace the many excellent textbook on the subject . I write this article not in the rigorous style required for a scholastic textbook but more in the spirit of a teacher who is engaged in a face-to-face session with a student. It will be highly informal but will make the big picture come across easier. Hopefully, it will even make it possible to read and gain insight to textbooks and articles written in measure-theoretic language. My approach will be strictly from a user point of view requiring nothing beyond freshman calculus and ability to visualize n-dimensional space as a natural generalization of our familiar 3-D space. So here goes . . . Let us start by making one simplifying assumption which for people interested in practical application is not at all important or restrictive. This is the Finiteness Assumption (FA) – We assume there is no INFINITLY large number, i.e., no infinity but there can be very large numbers, e.g. 10^100 (a number estimated to be larger than the total number of atoms in the universe.) If one deals only with real computation on digital computers, this assumption is automatically satisfied. By making this assumption we assume away all the measure-theoretic terminologies that populate theoretical probability literature and confuse the uninitiated. With the FA assumption we now define what is a random variable. Random Variable (r.v.) – a random variable is a variable that may take on any number of finite values when sampled (i.e. looked at). We characterize ar.v. by specifying its histogram. A histogram spells out which sampled values in a range of values the r.v. may take on what percentage of the time. Fig. 1 it a typical histogram. It is actually a histogram of a random variable which is the readership (or hits) of my blog articles for the pastfour years. 23 % 6% 5% 2% 300 1500 2700 3600 4800 6000 7200 8400 9600 Fig. 1 histogram of readership of my blog articles (2009-2013): x-axis is #of hits, y-axis is #of article in this hit range Note each bar of the histogram is expressed as a percentage so that the total sum of bars adds up to one or 100%, i.e., with probability one (for sure) the r.v. takes on values somewhere in the total range. While the range of values this r.v. may take on is finite by virtue of assumption FA , to completely specify a r.v. still can take a great deal of data. (In fact, it took me about 3 hours to collect data and make this graph which is why I did not compile the data for all 5+ year of my blog life) This is inconvenient in computation. To simplify the description (specification) we develop two common rough characterizations. The Mean of a r.v. – Intuitively, if you imagine a cardboard cutout of the shape of the histogram, then the value along the x-axis at which a knife edge placed perpendicular to the x-axis that will balance this cardboard shape is the mean of this r.v..Mathematically, it is simply the average of the value of hits for each article, the ScienceNet in fact compute this value for all bloggers and displays the top-100 bloggers. My own current average happens to be 4130 per article and ranks 26th on the list. Variance of ar.v. - This is a measure of the spread of the histogram. A small variance roughly mean the histogram is mostly spread over a small range of numbers around its mean and vice versa for a large variance. It is a measure of the variability of the values of the r.v.. In stock marketterminology, the b of a stock is simply the variance of the daily value of the stock and a measure of its volatility. Mathematically variance is called the second central moments of the histogram Now we can develop further rough characterization of the histogram by defining what are called its higher central moments, such as skewness of the histogram, which is the third central moment . But in practice such higher moment are rarely needed nor data on these moments often available. So much for a single r.v.. But we often have to deals with more than one random variable. Let us consider two r.v.s, x and y. Now the histogram of the random variables x-y becomes a 3D object. Graphically it looks like a multi-peak terrain map (think of Quilin in the Kwangxi province of south China or the skyscrapers of the Manhattan island of NY). But here a new concept intrudes. It is called “ joint probability ” or “ correlation/covariance (in case of an approximate specification)” between the r.v.s x and y. It captures relationship, if any, between the r.v.s. We are all familiar with notion that smart parents tends to produce smart children. If we represent the intelligence of parents as r.v. x and that of the child is .r.v y, then mathematically we say y is positively correlated with x. If we look down on the 3D histogram of x and y, then we shall see the peaks scatter along a northeast to southwest direction as illustrated in Fig.2 y x Fig.2 bird’s eye view of 3D histogram with correlation In other words, knowing the value of y will give a different idea about the probable value of x. More generally we say x and y are NOT independent but correlated . Mathematically we denote the joint probability p(x,y) (i.e., the histogram) as a general 3D function. We also define conditional probability of x given the value of y as p(x/y) p(x,y)/p(y) or p(y/x) p(x,y)/p(x) Where p(y) and p(x) , called marginally probability of y and x respectively are simply the resultant 2D histograms when we collapse the 3D histogram onto the y or x axis respectively. Graphically, the conditional probability p(x/y) is simply the 2D histogram one sees if we take a cross sectional view of the 3D histogram at the particular value of y. Mathematically we need to divide p(x,y) by p(y) to normalize the values so that p(x/y) will still have area equal to one (100%) satisfying the definition of a histogram. Now it is possible that the bird’s eye view of the 3D histogram is a rectangle (vs. the view of Fig. 2). In other word p(x/y)=p(x) no matter which value of y we choose. In this case, by definition of p(x/y), we have p(x,y)=p(y)p(x). We say the r.v.s x and y are independent . Intuitively this satisfies the notion that knowing y does not tell us anything new about the probable values of x and vice versa about y when knowing x. Computationally, this simplifies a function of 2 variables into product of single variable functions, a great computational simplification when n random variables are involved. To roughly characterize the two generalr.v.s we have a mean vector and a 2x2 covariance matrix with diagonal element the variance of x and y and the symmetrical covariance in the off-diagonal position s x 2 s xy s yx s y 2 To summarize. We have so far introduced concepts 1. Random variable characterized by histograms 2. Rough characterization of histograms by mean and variance 3. Joint probability (3D histogram) of two r.v.s 4. Independence and conditional probability 5. Covariance matrix Now suppose we have n r.v.s instead of two, everything I said about the two r.v.s apply. We merely have to change 2D and 3D to n and n+1 dimensions. The mean of n r.v.s becomes a n-vector and the covariance matrix is a nxn matrix. In your mind’s eye you can visualize everything in n dimension the same way as Fig.1 and 2. The joint probability (histogram) p(x 1 , x 2 , . . . , x) is a n variable function. And if the n variables are independent from each other, we write p(x 1 , x 2 , . . . , x n )=p(x 1 )p(x 2 ). . . p(x n ). No new concepts are involved. Concept-wise, believe it or not, these in my opinion are all you need to know about probability and stochastic processes to function in the engineering world even if your interest is academic and theoretical . In my 46 years of active research and engineering consulting in stochastic control and optimization, I never had to go beyond the knowledge described above. The following articles will simply illustrate and explain how to apply these ideas to more practical uses. Computationally, because of exponential growth, to deal with arbitrary n-variable function is impossible. http://blog.sciencenet.cn/blog-1565-26889.html . Data-wise, it also involve astronomically large amount of data. To simplify notations at least theoretically, we make a continuous approximation of these discrete data and introduce continuous variables and functions. To emphasize, for our purpose, this is only a convenient approximation and simplification. No new ideas are involved. This will be the content of next article. Beyond introducing continuous variables, we also need to develop carious special cases of joint probability structures to simplify description and calculations, subsequent articles will address these issues. Once again, let me emphasize that from my view point these simplifications and special cases are need for computational feasibility and practicality. Nothing conceptually new is involved.
个人分类: 生活点滴|2 次阅读|1 个评论
test music
nqed 2013-5-1 00:53
We'll let them come true
3 次阅读|0 个评论
test
cai7net 2013-4-11 17:12
并不孤独的孤儿药 首先要说明的是,孤儿药并非是针对孤儿的药,孤儿最需要的不是“药”,而是“爱”。我不清楚,中文孤儿药最初的来源,,也从一个侧面显示我国在这方面和欧美的巨大差距。本文力图就孤儿药这个话题,但我估计很可能不是中文原创,而是英文Orphan Drug的直译, 取自孤儿孤苦无依且乏人重视的概念。 我国目前尚没有一种自主研发成功的孤儿药,本文的主要内容不得不主要谈美国和欧盟对孤儿药的研发情况。对于孤儿药的话题,经检索,科学网此前没有一篇博文是专门针对这个话题的,整个互联网上的相关中文信息和资料也不多,相对深入介绍的,更是没有看到做一个相对全面的综述介绍,本文为第一部分,希望能够抛砖引玉,引起科学网博友的进一步深入讨论。 说 孤儿药,首先还要先谈孤儿病或者说罕见病,目前,我国并并没有一个官方的明确的罕见病定义。也没有一个明确的数字(发病率)来划分罕见病和普通病,因为在世界上某个地方或者某个特定群体被视为罕见病的疾病,在别的地方却可能很常见。 世界卫生组织( WHO )将罕见病定义为患病人数占总人口 0.65%-1% 的疾病,常见的有白血病、地中海贫血、血友病、苯丙酮尿症、白化病、法布瑞病、成骨不全症、戈谢病等 ( 1 ),绝大多数(有报道说是80%) 罕见病是遗传病,因此,即使病人在出生后不出现症状,也会伴随病人一生。很多罕见病在病人婴幼儿时期就出现症状,大约30%罕见病儿童在5岁前病逝 (5)。 在美国, 罕见病是指受影响病人在20万人(限于美国)之下的疾病,而欧盟的定义则是发病率在万分之五的病,据估计,美国47%的罕见病的病人人数少于2万5千人 (2), 最罕见的罕见病到底有多罕见呢?!有一种基因缺乏症, 目前确诊病人,全球只有一个病人,这个病(即 ribose-5-phosphate isomerasedeficiency )被视为最罕见的 罕见病(不能更罕见了!)。研究表明,大约十分之一的美国人患有罕见病 (5)。据估计,在美国和欧洲,共有超过5千5百万人患用罕见病,而我国总人口远超过美国和欧洲的人口总和,据估计,我国共有超过1千万罕见病患者。美国FDA认可6000种罕见病,欧盟版FDA,即EMA(European Medicines Agency)认可8000种罕见病 (4)。自从1983年美国国会通过孤儿药法案以来,美国FDA已经批准约350种孤儿药(包括生物药)用于治疗大约200种罕见病。所以即使是在美国,绝大多数罕见病迄今仍然是无药可治,但这也显示孤儿药还有很大的市场空间。
个人分类: 学习心得|3 次阅读|0 个评论
test blog
热度 1 cai7net 2013-4-11 16:09
并不孤独的孤儿药 首先要说明的是,孤儿药并非是针对孤儿的药,孤儿最需要的不是“药”,而是“爱”。我不清楚,中文孤儿药最初的来源,,也从一个侧面显示我国在这方面和欧美的巨大差距。本文力图就孤儿药这个话题,但我估计很可能不是中文原创,而是英文Orphan Drug的直译, 取自孤儿孤苦无依且乏人重视的概念。 我国目前尚没有一种自主研发成功的孤儿药,本文的主要内容不得不主要谈美国和欧盟对孤儿药的研发情况。对于孤儿药的话题,经检索,科学网此前没有一篇博文是专门针对这个话题的,整个互联网上的相关中文信息和资料也不多,相对深入介绍的,更是没有看到做一个相对全面的综述介绍,本文为第一部分,希望能够抛砖引玉,引起科学网博友的进一步深入讨论。 说 孤儿药,首先还要先谈孤儿病或者说罕见病,目前,我国并并没有一个官方的明确的罕见病定义。也没有一个明确的数字(发病率)来划分罕见病和普通病,因为在世界上某个地方或者某个特定群体被视为罕见病的疾病,在别的地方却可能很常见。 世界卫生组织( WHO )将罕见病定义为患病人数占总人口 0.65%-1% 的疾病,常见的有白血病、地中海贫血、血友病、苯丙酮尿症、白化病、法布瑞病、成骨不全症、戈谢病等 ( 1 ),绝大多数(有报道说是80%) 罕见病是遗传病,因此,即使病人在出生后不出现症状,也会伴随病人一生。很多罕见病在病人婴幼儿时期就出现症状,大约30%罕见病儿童在5岁前病逝 (5)。 在美国, 罕见病是指受影响病人在20万人(限于美国)之下的疾病,而欧盟的定义则是发病率在万分之五的病,据估计,美国47%的罕见病的病人人数少于2万5千人 (2), 最罕见的罕见病到底有多罕见呢?!有一种基因缺乏症, 目前确诊病人,全球只有一个病人,这个病(即 ribose-5-phosphate isomerase deficiency )被视为最罕见的 罕见病(不能更罕见了!)。研究表明,大约十分之一的美国人患有罕见病 (5)。据估计,在美国和欧洲,共有超过5千5百万人患用罕见病,而我国总人口远超过美国和欧洲的人口总和,据估计,我国共有超过1千万罕见病患者。美国FDA认可6000种罕见病,欧盟版FDA,即EMA(European Medicines Agency)认可8000种罕见病 (4)。自从1983年美国国会通过孤儿药法案以来,美国FDA已经批准约350种孤儿药(包括生物药)用于治疗大约200种罕见病。所以即使是在美国,绝大多数罕见病迄今仍然是无药可治,但这也显示孤儿药还有很大的市场空间。
1612 次阅读|13 个评论

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