SA · 涨知识|3D打印药片安全吗?

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  Fred外刊笔记

  全国大学生英语竞赛特等奖

  CATTI笔译口译认证

  写在前面

  不知道大家有没有遇到这个问题:单词背也背了(有时背得还很辛苦),但就是用不出来(口语&写作中)

  其实解决方式也不难:

  1. 结合原文和大量例句看别人是怎么用的(这个过程叫“输入”)

  p.s. 例句不要只看1个,否则自己还是学不到在【不同的语境中】该词的用法,这也是我会一个单词配好几个例句的原因

  2. 自己造句(这个过程叫“输出”),通过造句,你就“逼”自己不得不思考“我可以把这个词用在哪呢?”“用的时候要注意什么?”等等问题,你在【主动学习】,那以后在口语或写作中,你当然就可以自然而然地用出来了,不需要在“用词”上烦恼了,只需要focus在你口语/写作的“内容”上,这才是核心,所以,记得完成页面底部的“趁热打铁”部分,要学就学透了,要学就追求高质量!

  原 文 泛 读

  据外媒报道,一款由Aprecia Pharmaceuticals制药公司生产的名为Spritam的癫痫药片已经在美国上市。

  据悉该药品不同于传统药片之处在于采用了美国麻省理工学院提供的3D打印技术完成整个制药流程,相比于传统药片质地更加疏松。

  虽然和传统药片相比在药物成份和药效方面并无变化,但是在水中溶解速度更快,更容易被人体所吸收,同时因为这个特性十分适宜于儿童药片生产,能较好的适应孩童脾胃,且安全性更高,能够减小儿童因为意外吸入气管造成的危险。

  目前该公司已经决定将3D打印药物技术应用于更多的药物生产中去。

  随着医学的不断发展,确保其质量的人也必须与时俱进!

  读外刊 · 看世界

  As Medicine Evolves, So Too Must Those Who Assure Its Quality

  From tree bark to digital therapies — USP has been safeguarding therapeutics for 200 years and is anticipating the next big medical breakthroughs.

  The past few years have illustrated the startling speed with which medicine can evolve. Since 2022, the US Food & Drug Administration (FDA) has approved first-of-their-kind drugs based on RNA, gene therapy, and cancer-killing chimeric antigen receptor (CAR) T-cells and signed off on human trials to explore the clinical use of CRISPR-mediated genome editing. And throughout this process, the US Pharmacopeia (USP) has been working in the background to ensure that quality standards are in place for new medical products reaching the market. “200 years ago, our first monographs were basically recipes: ‘take bark from this tree and boil it for this long and you should get a brown liquid’,” says Michael Levy, Head of Research & Innovation (R&I) at USP. “Obviously weve evolved tremously since then, but it’s just a continuation of what we’ve always done—we’re just doubling down on it.”

  Regular revisions to quality standards to accommodate advances in knowledge and changes in medical practice were built into the USP process by its founders. Today, to ensure its standards stay current, USP also works to stay ahead of the rapidly changing technology curve. Well before a cutting-edge medicine reaches the market, the underlying tools and techniques are already percolating up into the scientific literature and presentations at international conferences. USP combs through this early-stage work and projects which prospects seem most likely to impact the quality of therapeutics within the next decade or so. “We ask what’s on the horizon, what are the quality issues potentially associated with that tr or technology, and how does USP need to respond,” says Levy. USP then explores some of these technologies, working through a typical research approach with preliminary proof-of-concept work potentially followed by longer-term “incubation projects” conducted by subject-matter experts.

  One example of a technology that USP R&I is exploring is the use of 3D printers in medicine production. The first 3D-printed pill has been approved by FDA and is already on the market – an anticonvulsant drug for people with epilepsy. Each pill is 3D printed with a carefully designed, highly porous structure that allows it to rapidly dissolve in liquid for easy administration. USP R&I is also exploring applications of this technology in other contexts, perhaps including multiple components or redesigning pill shapes to facilitate ease of swallowing. Safeguarding quality in this context will require a deep understanding of the printer technology to ensure consistency in production and minimize risk of cross-contamination, as well as careful profiling of the various ‘resins’ used to incorporate active ingredients into the printed pill. “This is still very early research,” says Levy.

  QUALITY IN THE VIRTUAL WORLD

  Most of USP’s history has revolved around chemical and biological entities that directly interact with a patient’s body, but the last few years have seen the advent of ‘digital therapeutics’. These are software tools designed to help patients and their physicians or caregivers to manage medical conditions. “These are software with no associated medicine, but which has been shown to have a positive therapeutic effect,” says Levy. For example, FDA has cleared mobile medical applications designed to help track and manage recovery from substance abuse issues. In 2022, USP established a collaboration with the Digital Therapeutics Alliance (DTA) aimed at helping guide companies entering this space to achieve the highest standards for their products. “We’re looking at how to ensure that these products work well and offer reproducible performance over time in a reliable way,” says Megan Coder, executive director of the DTA. She adds, “there’s scientific rigor and methodology that goes into each digital therapeutic.”

  At first glance, it seems difficult to assess a digital therapeutic in the same manner as one would assess quality for an antibiotic or cancer drug. But the general principles used by USP to set standards for conventional drugs—identity, strength, purity, and performance—may be broad enough to be translated to the digital world. “For identity, for example, you can ask ‘how do I know that a piece of software is what I think it is?’” says Levy. “If there’s a trivial bug in the software and you patch it, is it still the same as the unpatched version?” Coder notes that the notion of active and inactive ingredients also holds true for digital therapeutics, just like with their chemical counterparts, and that one of DTA’s priorities in collaboration with USP is to explore formalizing quality standards for some of the commonly used ‘digital excipients’ in these products. “These are components that many digital products will have, like libraries and data stacks,” says Coder. “Then we can move on to explore the ‘active ingredients’, like algorithms that are unique to each product.”

  This is only the beginning of a deeper push into the digital realm. Big data has become a fact of life in biomedical research and drug discovery, and many groups are turning to tools such as artificial intelligence (AI) and machine learning to efficiently extract meaning from many terabytes of information. USP recently launched an internal program to investigate some of the quality challenges surrounding AI technologies, and how to shore up confidence in these tools as they become more ubiquitous. For example, Levy notes that many algorithms currently used in research are essentially ‘black boxes’ in terms of how they process data, making it a challenge to assess quality. There may also be opportunities for standardization in terms of the datasets used to train these programs, just as validated reference materials are an essential tool for biochemical assays. “USP could help set standards to ensure that bias isn’t built into algorithms through their training datasets,” says Levy.

  Levy foresees a future in which the now-disparate threads of pharmaceutical technology, medical devices, and digital systems are routinely integrated—and potentially even networked together. Accordingly, his goal is to expand on USP’s expertise in chemical and biological medicines by building a team of digital experts who can help prepare the organization for the challenges to come. “As that ecosystem becomes increasingly complicated, we will need to have the right capabilities to be able to look at quality standards in that area,” he says.

  词 汇 卡 片

  1. sign off on...

  to officially agree to something

  正式同意......

  - Judge Kemp just signed off on that warrant.

  坎普法官刚签署了那份拘捕令。

  - She signed off on the budget cuts.

  她赞成削减预算。

  2. monograph [ˈmɒnəɡrɑːf] CN

  a long article or a short book on a particular subject

  专论,专题文章;专著

  - a monograph on Beethovens symphonies

  关于贝多芬交响乐的专著

  - The subject was grateful, and the industrious Weitbrecht-Rotholz has been able to give a remarkable list of authorities in his imposing monograph.

  这个题目大受读者欢迎,魏特布瑞希特-罗特霍尔兹下了不少工夫,在他写的一篇洋洋洒洒的专题论文里开列了一张篇目,列举出富有权威性的一些文章。

  3. percolate [ˈpɜːkəleɪt] vi.

  if an idea, feeling, or piece of information percolates through a group, it gradually spreads

  (观念、感觉或信息)逐渐传开

  - The message has begun to percolate through the organization.

  那消息开始在整个机构中传了开来。

  - It had percolated through to us that something interesting was about to happen.

  我们听说将要发生一件有趣的事。

  4. literature [ˈlɪtrətʃə(r)] UN

  all the information relating to a subject, especially information written by specialists

  文献,文献资料

  - Its important to keep up-to-date with the literature in your field.

  跟踪阅读最新的专业文献非常重要。

  - There is very little literature on the disease.

  关于这种疾病的文献资料很少。

  - Ive read all the available literature on keeping rabbits.

  我阅读了我能找到的养兔的全部资料。

  5. comb through...

  to search carefully among things

  仔细搜寻......

  - Ill comb through some of the evidence here.

  我在这里梳理一下这些证据。

  - Whats the first thing you guys do when you wake up? Check your phone? Your laptop? Read email, comb through your social networks?

  你们醒来时做的第一件事是什么?查看手机?笔记本电脑?读电子邮件,梳理你的社交网络?

  6.on the horizon

  coming in the near future

  即将发生/到来地

  - Scientists believe that a major breakthrough is on the horizon.

  科学家们相信重大突破就要来了。

  - She saw no options on the horizon.

  她找不到方法。

  7. anticonvulsant [ˌæntikənˈvʌlsənt] adj.

  抗痉挛的

  8. epilepsy [ˈepɪlepsi]

  癫痫

  9. proliferate [prəˈlɪfəreɪt] vi./vt.

  to increase in number or amount quickly

  激增,扩散

  - Small businesses have proliferated in the last ten years.

  在过去的十年里,小型企业大量涌现。

  - Computer courses continue to proliferate.

  计算机课程层出不穷。

  10. porous [ˈpɔːrəs] adj

  describes something that has many small holes, so liquid or air can pass through, especially slowly

  多孔的;能渗漏的

  - porous soil with good drainage

  有良好排水系统的渗漏性土壤

  - porous brick walls

  多孔砖墙

  - a porous polymer membrane

  多孔聚合物膜

  11. administration UN

  the act of giving a drug to sb

  (药物的)施用

  - the administration of antibiotics

  施用抗生素

  - There are strict controls on the administration of drugs.

  药品的施用受严格管制。

  12. clear vt.

  to give or get official permission for something to be done

  批准;使得到......的许可

  - He was cleared by doctors to resume skating in August.

  他得到医生的许可在八月份重新开始滑冰。

  - His appointment had been cleared by the board.

  他的任命已由董事会批准。

  - Ill have to clear it with the manager.

  这事我需要获得经理的准许。

  14. substance abuse

  药物滥用

  - Investigators have been stymied by uncooperative witnesses.

  调查人员因为目击者不合作而工作受阻。

  - Alexandra Fleischmann is a scientist in the WHOs department of mental health and substance abuse.

  亚历山德拉是世界卫生组织心理健康和药物滥用部门的一名研究人员。

  - Were detecting more depression and substance abuse in younger populations.

  我们发现越来越多的年轻人患抑郁症,而且会滥用药物。

  15.hold true

  to be true, or to remain true

  对......适用/有效

  - However, this idea does not seem to hold true for the majority of mass strandings because examination of the animals stomach contents reveal that most had not been feeding as they stranded.

  然而,这种想法并不适用于大多数大规模的搁浅,因为当检查搁浅的动物时,发现多数动物的胃里没有食物。

  注:

  - This principle holds true in every case.

  这条原则在任何情况下都适用。

  16. excipient [iksipiənt] CN

  赋形剂

  背景知识补充:

   赋形剂(英语:excipient)为药物中附著于有效成分的天然或合成物质,主要在于提升药物中有效成分的作用(所以又称为增量剂、稀释剂等),或在药物最终剂型中促进溶解、吸收以增强有效成分的发挥。

   赋形剂在药物制作过程中,使用粉末或非黏性物质来处理有效成分,并能维持药物于有效期限内不会在体外产生变性。赋形剂的选择,取决于给药途径、剂型、有效成分等因素。

  17. shore up confidence in...

  增强在......方面的自信

  - The steady development of the Chinese economy will provide more business and job opportunities for other countries and help shore up confidence in the world economy.

  中国经济的稳定发展将给其他国家提供更多发展机遇和就业机会,有助于提振世界经济信心。

  - Europes Central Bank has already issued guarantees designed to shore up confidence in troubled economies like Italy, Portugal and Greece.

  欧洲中央银行已作出担保,旨在提振人们对意大利、葡萄牙和希腊等陷入困境的经济体的信心。

  18. ubiquitous [ju:bikwitəs] adj.

  seeming to be seen everywhere

  普遍存在的,似乎无处不在的

  - Leather is very much in fashion this season, as of course is the ubiquitous denim.

  皮装在这个季节非常流行,当然牛仔服也似乎无处不在。

  - The Swedes are not alone in finding their language under pressure from the ubiquitous spread of English.

  不仅仅是瑞典人感觉到了自己的语言正承受着英语无处不在所带来的压力。

  - The radio, that most ubiquitous of consumer-electronic appliances, is about to enter a new age.

  作为使用最普遍的消费电器,收音机将进入一个新时代。

  19. assay [əˈseɪ] CN/UN

  the testing of metals and chemicals for quality, often to see how pure they are

  (金属、化学物质的)鉴定,试验,测定

  语 法 / 长 难 句 分 析

  ❶ USP then explores some of these technologies, working through a typical research approach with preliminary proof-of-concept work potentially followed by longer-term “incubation projects” conducted by subject-matter experts.

  上面这句话比较长,

  不看下面的解析,自己先尝试一下:

  1. 主干是什么?

  2. 其他成分是什么?

  主干:

  USP then explores some of these technologies

  其他成分:

  1. working through ... subject-matter experts是现在分词作方式状语

  2. 在该方式状语中存在两个过去分词作后置定语的情况:

  其一,followed by...修饰前面的a typical research approach

  其二,conducted by...修饰前面的incubation projects

  ❷ In 2022, USP established a collaboration with the Digital Therapeutics Alliance (DTA) aimed at helping guide companies entering this space to achieve the highest standards for their products.

  这句话也比较长,不过不难,

  不看下面的解析,自己先尝试一下:

  1. 主干是什么?

  2. 其他成分是什么?

  主干:

  In 2022, USP established a collaboration with the Digital Therapeutics Alliance (DTA)

  其他成分:

  1. aimed at... 修饰前面的the Digital Therapeutics Alliance (DTA),相当于一个定语从句that is aimed at...

  2. entering this space是现在分词作后置定语修饰前面的companies

  注:

  1. help后面可以直接加一个动词原形,所以我们看到原句中helping后面直接跟了动词guide

  2. to achieve中的"to"是动词不定式:guide sb to do sth(指导某人做某事)

  [你分析对了吗?]

  趁 热 打 铁

  任选上面19个词中的1个造句,评论告诉我哦,会一一回复哒~

   Fred英语笔记

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