《大学体验英语4》课后答案

Unit 1

Passage A

Ex.5 1. obligation 2. applauded 3. fulfilled 4. mirror 5. flexibility

6. devalue

7. striving

8. entailed

9. supposedly 10. Consequently

Ex6. 1. refer to as 2. at best 3. by the same token 4. at large 5. help up …as

Ex.8 Translate the following sentences into English.

1. With his promotion, he has taken on greater responsibilities.

2. He felt he did not have to make such a commitment to John any more.

3. Mary likes to go shopping in her spare time, as opposed to Lucy, who prefers to stay at home reading.

4. At best he’s ambitious, at worst a power-seeker without conscience or qualifications.

5. We have striven to the full to convince him, but we have made no headway.

Ex14. 1. equality 2. sustained 3. clue 4. expansiveness 5. was sacked

6. defined

7. sphere

8. sour

9. depressing 10. division

Ex15. 1. in the way 2. falling apart 3. have ruled out 4. at this rate 5. took up

Passage B Ex. 17 Translate the following sentences into English.

1. The popularity of Internet provides people with quick and convenient access to information.

2. Since he doesn’t agree to this plan, there is not much point in thinking about it any more.

3. I haven't seen it myself, but it is supposed to be a very good film.

4. If you don't work hard, you'll end up nowhere.

5. It's up to the United States to take the initiative in banning nuclear weapons.

Unit 2

Ex5. 1.awaited, 2.have overtaken, 3.pose, 4.cues, 5.has undermined,

6.soptted,

7.judged,

8.distracted,

9.offen d, 10.mask

Ex6. 1.brought out, 2.with the exception of, 3.thanks

to, 4.taken in, 5.capable of

Ex8. 1. He is no more fit to be a headmaster than any schoolboy would be.

2. As for her father, she is not sure whether he will accept her and her baby.

3. Staying up late will undermine one’s health while going to bed early and getting up early will benefit it.

4. The ambassador personally conveyed the president’s message to the premier.

5. The girl decided to open up and tell the police what she had seen. Ex14. 1.embarrassed, 2.tutor, 3.potential, 4.hence, 5.yield,

6.affection,

7.appropriate,

8.presentation,

9.roma ntic, 10.recommendation

Ex15. 1.in terms of, 2.participating in, 3.get down

to, 4.base...on, 5.acts on

Ex17. 1. Excessive exercises does more harm than good to one’s health. Therefore we must control the amount of exercise we do.

2. He made a few attempts to join in their conversation, but he gave up out of timidness.

3. Trains cannot compete with planes in terms of convenience and speed.

4. Making a comparison between Chinese and American cultures will help you to better understand and adapt to your study environment in the USA.

5. It is a traditional Chinese virtue for the young on buses to yield their seats to the old, the weak, the sick and the disabled.

Unit 3

Key to Exercises

5. 1. violated 2. derive 3. blocked 4. default 5. rationalized

6. quoted

7. exclusive

8. contacted

9. anonymous 10. charge 6 1. is up to 2.resulted in 3.was charged with 4.was unlikely 5. handing out

8. 1. It is simply unbelievable for him to change 500 dollars for a haircut.

2. People grant you the privilege, so you should serve the people wholeheartedly.

3. The weather forecast is very important so that we can decide when to go to sea.

4. The sound of guns violated the usual calmness of Sunday morning, and people had a strong feeling that the war was coming.

5. Even though you read three pages per minute, you will by no means finish the book by the end of this weekend.

Key to Exercises

14. 1.have witnessed 2. trample 3. abusing 4.manual 5. duplicated 6. knowingly 7. tactic 8. patrolling 9. budget 10. enforce

15. 1. end up 2. give...short shrift 3. step up ...to 4. infringed on

5. doesn’t fit into

16. 1 a fine 2. rights/law 3. to violate law/rights 4.

money 5.deadlines

6.a presentation

7. rehearsals

8. a copy/money

9.

permission 10.an interview

17. 1. He can beat his opponent easily without giving a second thought.

2. With little or no knowledge of driving, he drove the car onto the road.

3. It is illegal to make an unauthorized change in the construction of the bridge.

4. I could accept this fact calmly because I knew if I were not able to finish the mission, chances were that the team would be defeated.

5. Children in remote mountain areas are lacking in scientific and cultural knowledge.

Unit 4

Key to Ex.

5. 1. sensitive 2. classification 3. sufficiently 4. steer 5. familiarity

6. consequently

7. reward

8. qualifications

9. fundamentals 10. evaluate

6. 1. As for 2. focus…on 3. benefit…from 4. failed to 5. relevant to

8. 1. My grandfather’s interests rang from playing chess to climbing mountains although he is 70 years.

2. Surprisingly, Tom’s grandmother plays with dolls at the age of 80.

3. His selflessness and talent qualify him for the job most students dream to get.

4. What interpretation would you put on his odd/strange dream?

5. The brand-new car our boss has just bought id capable of making 200 kilometers an hour.

Key to EX.

14. 1. beyond 2. champions 3. ignored 4. obliged 5. sheer 6. lagged

7. prospects 8. proficiency 9. prejudice 10. claim

15. 1. in a way 2. drawing up 3. calls for 4. signed up for 5. set…back

17. 1. He suggested at the board meeting that the easy task should be left to Mary whose health is poor.

2. Mr Brown, who is in Hong Kong now, has a lot of teaching experience and will come to teach our students in the spring.

3. This is the best hotel in our city: the food is good and the

same is true of the service.

4. In order to attract more passengers, the caption assured all the passengers of the safety of traveling by ship.

5. His new car, for which he had paid ￥150 000, was seriously damaged in an accident and was beyond repair.

Unit 5

Key to Exercises

5. 1. morality 2. quest 3. downright 4. advocated 5. contemporaries

6. deceiving

7.exclusive

8. obstructing

9. captured 10. conscience 6. 1. took to 2. goes back 3. carry… out 4. pointed to 5. in opposition to

8. 1. The airplane they boarded soared out of sight right after it took off.

2. At the meeting, the two sides had a hot debate. The reformers put forward many reforming measures.

3. In the long run, we should learn more about science and technology. Besides our major subjects, knowledge of computers, English and driving is necessary for our work.

4. She does gymnastic exercises four times a week in the quest to achieve the perfect body.

5. Every morning in the park, some old people are doing physical exercises there, chatting with each other at the same time.

Key to Exercises

14. 1. compelled 2. compassion 3. disclosure 4. exploring

5. malnourished

6. plaguing

7. pledge

8. breach

9. span

10. transaction

15. 1. sitting idle 2. broke down 3. in all respects

4. gave… credit

5. by the conduct of

17. 1. Won’t it be better if we take measures to change the present situation?

2. I didn’t give him credit for such a skill. (I didn’t give credit to him for such a skill.)

3. They have been learning English up to now, though in their advanced age.

4. He has not been to school for seven days because of illness.

5. The children ran out of the classroom, jumping and singing.

Unit 6

Key to Exercises

5. 1. achievement 2. self-esteem 3. primitive 4. aroused 5. identified

6. confrontation

7. conflict

8. soaring

9. abandoned 10.

professional

6. 1. through thick and thin 2. root for 3. backed up 4. belonged to 5. stave off

8. 1. She portrayed her childhood as a time of wonder and discovery.

2. Experiments showed that nonsmokers committed fewer errors than smokers.

3. Football fans are often highly regarded not for their own achievement, but through their connection to a team that wins.

4. Despite the actors’ wonderful acting, the three-hour movie could not hold our attention.

5. Professor Wang is the only doctor I can rely on to save my son. Key to Exercises

14. 1. victim 2. depress 3. devote 4. concluded 5. beneficial 6. recreational 7. propelled 8. financial 9. nothing 10 regardless

15. 1. along with 2. agree with 3. in terms of 4. go back to 5. be responsible for

17. 1. We don’t think your proposal is quite in place, so you should give it up.

2. When he arrived home, he found nothing but some broken furniture there.

3. Given the condition of the engine, it is a wonder that it even starts.

4. In terms of employment, the hotel industry is the second largest industry in this country.

5. Everyone in this country had the right to live where he wants to, regardless of the color of his skin.

Unit 7

Key to exercises

5. 1. succession 2. prevalent 3 fragile 4. generated 5. accomplish

6. graceful

7. imposed

8. insecurity

9. indispensable 10. acclaim

6. 1. at stake 2. clings to 3. hang on 4. turned…over 5. referred to…as

8. 1. Although he said he had done a lot for the case, his success was at least in part due to luck.

2. The issue to be discussed is critical, because it will determine the future of many people.

3. I’ll try my best to avoid imposing my ideas on others.

4. Rarely can people face up to the defects in their own characters in such a situation.

5. College life is referred to as the most beautiful period of one’

s life.

Key to Exercises

14. 1. certify 2. consulted 3. monthly 4. maintained 5. benefits 6. survey 7. restless 8. aggressive 9. evaporated 10. maximum 15. 1. scrape together 2. sunk in 3. count on 4. account for 5. laid off

17. 1. Generally speaking he is quite learned, especially in the field of mathematics. However, when it comes to politics, he knows nothing.

2. According to the survey they made of the 1000 workers who missed out on the chance to go to university, their failure in the college entrance examinations had a profound effect on their later life.

3. Owing to cost rise, employers refuse to pay the retirement pension for their employees. On the flip side, employees are unwilling to stay in the same company for their whole lives.

4. Since you’ve told me who should take responsibility for the matter,

I will not pursue it any further.

5. I will try to set aside half an hour each day to do some exercise even in the busiest season.

(完整版)大学化学基础实验复习题

第一题选择题 1、一种钠盐可溶于水，该盐溶液加入HCl溶液后，有刺激性气体产生，同时有黄色沉淀生成，该盐是：（A）Na2S (B) Na2CO3(C) Na2SO3(D) Na2S2O3 （答：D） 2、将BaSO4与PbSO4分离开，宜采用： （A）NH3·H2O （B）HCl （C）H2S （D）NH4AC （答：D） 3、下列设备中，哪一种最适宜于测定原子量？ （A）威尔逊云室（B）电子显微镜（C）X－射线衍射仪（D）质谱仪 （答：D） 4、王水的成分是下列哪一种混合而成？（体积比） （A）HNO3+H2SO4 (1:3) (B) H2SO4+HCl (3:1) (C) HNO3+HCl (3:1) (D) HCl+HNO3 (3:1) （答：D） 5、微量成分是指被测组分的含量为： （A）>1% （B）<0.01% （C）0.01%～1% （D）0.01%～0.001% （答：C） 6、常量滴定管可估计到±0.01mL，若要求滴定的相对误差小于0.1％，在滴定时，耗用体积控制在：（A）10～20mL （B）20～30mL （C）30～40mL （D）40～50mL （答：B） 7、某溶液为无色，下列何种离子不能否定？ （A）Ni2+（B）Mn2+（C）Cr3+（D）Co2+ （答：B） 8、KMnO4能稳定存在于何处？

（A）空气中（B）HCl中（C）碱液中（D）稀H2SO4溶液中 （答：D） 9、用蒸馏操作分离混合物的基本依据是下列性质的哪种差异？ A密度（B）挥发度（C）溶解度（D）化学性质 （答：B） 10、在分光光度中，浓度测量的相对误差较小（<4％）的光度范围是： （A）0.1～0.2 （B）0.2～0.7 （C）0.8～1.0 （D）1.1～1.2 （答：B） 11、下列哪种氢氧化物既溶于NaOH，又溶于NH3·H2O （A）Al(OH)3（B）Zn(OH)2（C）Cd(OH)2（D）Ni(OH)2 （答：B） 12、1:1HCl的物质的量浓度为多少？ （A）2mol / L （B）4mol / L （C）6mol / L （D）8mol / L （答：C） 13、用紫外分光光度计可测定什么光谱： （A）原子吸收光谱（B）分子吸收光谱（C）电子吸收光谱（D）原子发射光谱（答：B） 14、以下说法不正确的有： （A）提纯多硝基化合物通常不采用蒸馏操作； （B）减压蒸馏能用来分离固体混合物； （C）液体有机物干燥完全与否可根据是否由浑浊变澄清来判断； （D）在测熔点时，通常在接近熔点时要求升温低于1℃/min。 （答：B）

微积分课后题答案第九章习题详解

第9章 习题9-1 1． 判定下列级数的收敛性： (1) 11 5n n a ∞ =?∑（a ＞0）； (2) ∑∞ =-+1 )1(n n n ; (3) ∑∞ =+13 1 n n ; (4) ∑∞ =-+12)1(2n n n ; (5) ∑∞ =+11ln n n n ; (6) ∑∞ =-12)1(n n ; (7) ∑∞ =+11 n n n ; (8) 0(1)21n n n n ∞ =-?+∑． 解：（1）该级数为等比级数，公比为 1a ,且0a >,故当1 ||1a <,即1a >时，级数收敛，当1 | |1a ≥即01a <≤时，级数发散. （2） Q n S =+++L 1= lim n n S →∞ =∞ ∴ 1 n ∞ =∑发散. （3）113 n n ∞ =+∑是调和级数11n n ∞=∑去掉前3项得到的级数，而调和级数11 n n ∞ =∑发散，故原 级数 11 3 n n ∞ =+∑发散. （4）Q 1112(1)1(1)22 2n n n n n n n ∞ ∞-==?? +--=+ ???∑∑ 而11 12n n ∞ -=∑,1(1)2m n n ∞ =-∑是公比分别为1 2的收敛的等比级数，所以由数项级数的基本性质

知111(1)2 2n n n n ∞ -=??-+ ???∑收敛，即原级数收敛. （5）Q ln ln ln(1)1 n n n n =-++ 于是(ln1ln 2)(ln 2ln 3)[ln ln(1)]n S n n =-+-+-+L ln1ln(1)ln(1)n n =-+=-+ 故lim n n S →∞ =-∞,所以级数 1 ln 1 n n n ∞ =+∑发散. （6）Q 2210,2n n S S +==- ∴ lim n n S →∞ 不存在，从而级数 1 (1) 2n n ∞ =-∑发散. （7）Q 1 lim lim 10n n n n U n →∞ →∞+==≠ ∴ 级数 1 1 n n n ∞ =+∑发散. （8）Q (1)(1)1 , lim 21212 n n n n n n U n n →∞--==++ ∴ lim 0n x U →∞≠，故级数1 (1)21n n n n ∞ =-+∑发散. 2． 判别下列级数的收敛性，若收敛则求其和： (1) ∑∞ =??? ??+13121n n n ； (2) ※ ∑∞ =++1)2)(1(1n n n n ; (3) ∑∞ =?1 2sin n n n π ; (4) 0πcos 2n n ∞ =∑． 解：Q （1）1111, 23n n n n ∞ ∞==∑∑都收敛，且其和分别为1和12，则1112 3n n n ∞ =?? + ???∑收敛，且其 和为1+ 12=3 2 . （2）Q 11121(1)(2)212n n n n n n ?? =-+ ?++++??

制药工程专业英语课文翻译

Unit 1 Production of Drugs About 5000 antibiotics have already been isolated from microorganisms，but of these only somewhat fewer than 100 are in therapeutic use. It must be remembered，however，that many derivatives have been modified by partial synthesis for therapeutic use;some 50，000 agents have been semisynthetically obtained from户lactams alone in the last decade. Fermentations are carried out in stainless steel fermentors with volumes up to 400 m3. To avoid contamination of the microorganisms with phages etc. the whole process has to be performed under sterile conditions. Since the more important fermentations occur exclusively under aerobic conditions a good supply of oxygen or air(sterile)is needed. Carbon dioxide sources include carbohydrates，e. g. molasses，saccharides，and glucose. Additionally the microorganisms must be supplied in the growth medium with nitrogen-containing compounds such as ammonium sulfate，ammonia，or urea，as well as with inorganic phosphates. Furthermore，constant optimal pH and temperature are required. In the case of penicillin G，the fermentation is finished after 200 hours，and the cell mass is separated by filtration. The desired active agents are isolated from the filtrate by absorption or extraction processes. The cell mass，if not the desired product，can be further used as an animal feedstuff owing to its high protein content. 关于5000抗生素已经分离出的微生物，但其中只有不到100有些治疗使用。必须记住，但是，许多衍生工具已被用于治疗使用部分合成修改;约50,000剂已被semisynthetically取得户内酰胺在过去十年孤独。发酵都是在不锈钢发酵罐出来的量高达400立方米。为了避免与噬菌体等微生物污染的全过程都必须在无菌条件下进行。由于更重要的发酵只发生在有氧条件下的氧气或空气好电源（无菌）是必要的。二氧化碳的来源包括碳水化合物，大肠杆菌克糖蜜，糖和葡萄糖。另外必须提供的微生物在与含氮如硫酸铵，氨水或尿素化合物生长介质，以及与无机磷酸盐。此外，不断最适pH和温度是必需的。在青霉素G的情况下，发酵完成200小时后，细胞的质量是由过滤分离。所需的活性剂是隔离的滤液吸收或提取工艺。大规模的细胞，如果不理想的产品，可进一步用作动物，由于其蛋白质含量高的饲料。 By modern recombinant techniques microorganisms have been obtained which also allow production of peptides which were not encoded in the original genes. Modified E. coli bacteria make it thus possible to produce A- and B- chains of human insulin or proinsulin analogs. The disulfide bridges are formed selectively after isolation，and the final purification is effected by chromatographic procedures. In this way human insulin is obtained totally independently from any pancreatic material taken from animals. Other important peptides，hormones，and enzymes，such as human growth hormone (HGH)，neuroactive peptides，somatostatin，interferons，tissue plasminogen activator (TPA)，lymphokines，calcium regulators like calmodulin，protein vaccines，as well as monoclonal antibodies used as diagnostics，are synthesized in this way. 利用现代微生物重组技术已获得这也让其中不是在原来的基因编码多肽的生产。改性大肠杆菌从而使可能产生A型和B -人胰岛素或胰岛素原类似物链。二硫键形成的选择性分离后，最终由色谱净化工序的影响。通过这种方式获得的人类胰岛素完全独立采取任何从动物胰腺材料。 其他重要肽，激素和酶，如人类生长激素（hGH），神经活性肽，生长抑素，干扰素，组织型纤溶酶原激活物（tPA），淋巴因子，如钙调节钙调蛋白，蛋白疫苗，以及作为诊断用单克隆抗体是合成了这种方式。 The enzymes or enzymatic systems which are present in a single microorganism can be used for directed stereospecific and regiospecific chemical reactions. This principle is especially useful in steroid chemistry. Here we may refer only to the microbiological 11-a- hydro xylation of progesterone to 11-a-hydroxyprogesterone，a key product used in the synthesis of cortisone. Isolated enzymes are important today not only because of the technical importance of the enzymatic saccharification of starch，and the isomerization of glucose to fructose，They are also significant in the countless test procedures used in diagnosing illness，and in enzymatic analysis which is used in the monitoring of therapy. A number of enzymes are themselves used as active ingredients. Thus preparations containing proteases (e. g. chymotrypsin，pepsin，and trypsin)，amylases and lipases，mostly in combination with synthetic antacids，promote digestion. Streptokinase and urokinase are important in thrombolytics，and asparaginase is used as a cytostatic agent in the treatment of leukemia. 这些酶或微生物在一个单一的酶系统，目前可用于立体定向和regiospecific化学反应。这个原则是有用的，尤其是在化学类固醇。在这里，我们只能引用的微生物十一水电黄体酮xylation至11人羟，一个关键的产品在可的松合成。隔离酶是重要的，不仅因为淀粉的酶法糖化技术重要性的今天，和葡萄糖异构果糖，他们也都在无数次试验在诊断疾病所用的程序显着，在酶的分析，在使用监测治疗。 数量的酶本身作为活性成分。因此，含有蛋白酶制剂（如糜蛋白酶，胃蛋白酶和胰蛋白酶），淀粉酶和脂肪酶的合成主要是在与抗酸药相结合，促进消化。链激酶和尿激酶溶栓是重要的，是天冬酰胺酶在治疗白血病细胞生长剂。 Finally mention must be made of the important use of enzymes as `biocatalysts’in chemical reactions where their

大学基础化学第三章习题答案

第三章 习题解答 1．（1）错误。原因：氨水为一元弱碱，其[OH -]=c k b θ (2)错误。原因：n HCl =n HAc 故所需NaOH 的摩尔数应相同，体积相同。 2．I=1/2∑CiZi 2 =1/2[0.050×(+3)2+3×0.050×(-1)2+2×0.020×(+1)2+0.020×(-2)2] =0.36 (mol ·L -1) 51 .3 101.3%31100.1][ % 31 1 , 500 / , 20 3.432 =?=??===-=???--+pH c H c k k c K c K a a a w a a ααα αθ θ θ按近似式计算 4. 应加入碱。原因：H 2S HS -+H + HS -S 2- + H + 要使[S 2-]增加，应减 小[H +]，使平衡右移，故应加碱。 5．稀氨水中加入少量晶体NH 4Ac ，会产生同离子效应，氨水解离度减小，颜色变浅（或消退）。 101.13.0)1097.2()1012.1(] [][][] [] [][ 10 97.23.01.01091.8][][][ ] [] [][ 6. 9 812222228 82121 2---+ -- -- +-+---+- -+- +?=???=?=∴?= +??=??=?=∴?=+?H HS K S HS S H K S H HS H S H K HS S H HS H K HS H S H a a a a θ θ θ θ 7．NH 4+-NH 3, Ac —-HAc, H 2O-H 3O +, H 2O-OH -, HSO 4—-SO 42-, HNO 3-NO 3-, H 2SO 4-HSO 4-, CO 32—-HCO 3-, HCO 3—-H 2CO 3 8. 质子酸：HCl 质子碱：NH 3, SO 42-, NO 3-, Ac -, OH - 两性物质：[Al(H 2O)4]3+, HSO 4-, HS -, HCO 3-, H 2PO 4-, H 2O 9. 否。原因：pH=-lg[H +] 10. pH=5.0 [H +]=1.0×10-5 =C HCl pH=11.0 [OH -]=1.0×10-3 =C NaOH 两者混合后， [OH -]≈1.0×10-3 故 pH ≈11.0 11．pH=1.4 [H +]=3.98×10-2 pH=5.0 [H +]=1.00×10-5 故成人胃液是 婴儿胃液[H +]的3980倍。

大学基础化学课后习题解答完整版

大学基础化学课后习题 解答 HUA system office room 【HUA16H-TTMS2A-HUAS8Q8-HUAH1688】

大学基础化学课后习题解答 第一章 溶液和胶体溶液 第二章 化学热力学基础 2-1 什么是状态函数它有什么重要特点 2-2 什么叫热力学能、焓、熵和自由能？符号H 、S 、G 、H 、S 、G 、θf m H ?、θ c m H ?、θf m G ?、θr m H ?、θm S 、θr m S ?、θr m G ?各代表什么意义 2-3 什么是自由能判据其应用条件是什么 2-4 判断下列说法是否正确，并说明理由。 （1）指定单质的θf m G ?、θf m H ?、θm S 皆为零。 （2）298.15K 时，反应 O 2(g) +S(g) = SO 2(g) 的θr m G ?、θr m H ?、θr m S ?分别等于SO 2(g)的 θf m G ?、θf m H ?、θm S 。 （3）θr m G ?＜0的反应必能自发进行。

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P61 Unit 5 药物研发 药物代谢作用和药代动力学 药物代谢和制药学研究需要建立一套关于化合物代谢和方式的知识，化合物水平及其代谢产物根据药物给予量和施用时间长度变化的方式（决定）。 在早期药物临床发展临床阶段,很少有代谢数据权威性的管理要求。然而，新陈代谢研究有助于解释毒理学结果和研究设计，以及有助于将动物安全性效率数据进行外插。 在生物学流体或组织中需要开发测定法测量药物和主要代谢产物水平。目的是快速开发可重现性方法。高效液相色谱通常用于分离，但其他技术如气相色谱在试用时也可以使用。例如检测法可以是紫外光，荧光测定法，电化学方法，质谱法。当化合物的活性很高时，体液和组织液中仅存痕量物质，检测可能出现问题。放射免疫测定法可以提供更高的灵敏度，以及在给定时间内有可能分析出更多的化合物。然而，放射免疫测定法有可能花很长时间来显影，并且缺少特异性将是一个问题。 需要关于化合物/代谢物血浆浓度的信息来支持毒理学研究，以及帮助选择剂量水平。有最初需要建立药代动力学的线性区域，即其中剂量对AUC可被认为是一个线性的范围。对非线性原因的确定例如代谢饱和的吸收/消除将有助于理解毒理学或药理学现象。 临床学 一旦已经完成并分析充分的动物试验，药物公司将决定是否将药物投入人体研究阶段。这一步通常包括公司专家，临床研究者和临床委员会的批准，并且在某些国家，例如在美国，还需要政府机构如FDA（美国食品和药品监督管理局）的审查。当出资公司向FDA提出一种新药的调查申请时，这种新药就首先被FDA 审查。FDA必须在30天内让出资者知道以他们的判断这个临床研究是否足够安全。如果足够安全，实际上IND可考虑在其中并且临床可以继续进行。如果不安全，FDA会将这个临床研究暂停直到他们的担忧成功解决。 规划这个临床方案时，很重要的是参考目标性质并且探究药物的潜在临床效益，尽可能早地参考这些，以便去除掉未能达到预期效果的候选药物。 新候选药物最初在人体内试用应遵循以下主要原则： 确定药物在人体内的安全性和耐受性。 确定一系列剂量的药代动力学和生物利用度。 确定药理学特性曲线。 在人体内精心设计和进行早期研究是很重要的，因为这些结果在稍后的研发中就剂量范围和给药频率而言能够进行更好的设计，并且更好的监视副作用和毒性。最初的临床试验设计应确保从研究中以最少的受试者数目获得最大的信息量，以便降低风险的传播。 首先，给少数受试者使用单一的，逐渐增加剂量的候选药物，并对这些受试者严密监督。以这种方法获得最大耐受剂量的指标。受试者通常是年轻的，健康的男性志愿者。使用健康的志愿者的一个好处是更容易定义任何不良反应的起因。不良反应包括毒性作用（存在于人体器官或组织的有害物质削弱他们的功能或者足以引起细胞死亡）和副作用（已知的或预期的药理作用在治疗剂量附近引起不期望的和不利的作用）。有生育能力的妇女志愿者不用于临床试验直到在动物中有足够的可重复性的母体试验。通常这些测试在临床Ⅰ期之前是不可用的，并且志愿者研究通常是在男性中实施。在美国和英国，临床试验可在男性中进行

制药工程专业英语 Unit 13 课文翻译

Unit 13 Sterile Products Sterile Products Sterile products are dosage forms of therapeutic agents that are free of viable microorganisms. Principally，these include parenteral，ophthalmic，irrigating preparations. Of these, and parenteral products are unique among dosage forms of drugs because they are injected through the skin or mucous membranes into internal body compartment. Thus，because they have circumvented the highly efficient first line of body defense，the skin and mucous membranes，they must be free from microbial contamination and from toxic components as well as possess an exceptionally high level of purity. All components and processes involved in the preparation of these products must be selected and designed to eliminate，as much as possible，contamination of all types，whether of physical，chemical，or microbiologic origin. Preparations for the eye, though not introduced into internal body cavities，are placed in contact with tissues that are very sensitive to contamination. Therefore，similar standards are required for ophthalmic preparations). Irrigating solutions are now also required to meet the same standards as parenteral solutions because during an irrigation procedure，substantial amounts of these solutions can enter the bloodstream directly through open blood vessels of wounds or abraded mucous membranes. Therefore，the characteristics and standards presented in this chapter for the production of large-volume parenteral solutions apply equally to irrigating solutions. Sterile products are most frequently solutions or suspensions，but may even be solid pellets for tissue implantation. The control of a process to minimize contamination for a small quantity of such a product can be achieved with relative ease. As the quantity of product increases，the problems of controlling the process to prevent contamination multiply. Therefore，the preparation of sterile products has become a highly specialized area in pharmaceutical processing. The standards established，the attitude of personnel，and the process control must be of a 第13 单元无菌产品 无菌产品 无菌产品是不含微生物活体的治疗剂剂型，其主要包括非肠道用的、眼用的和冲洗用的制剂。这之中，非肠道用产品在药物剂型当中是（较为）特别的因为它们是通过皮肤和黏膜被注射到人体内部的。这样，由于它们进入了高效率的人体第一道免疫防线——皮肤和黏膜，（所以）它们必须没有微生物感染和有毒成分，同时又（必须）具有特别高的纯度。这些产品的制备过程中涉及到的所有组分和（工艺）流程都必须经过选择和设计以尽可能地消除各种类型的污染，无论是来自物理的、化学的，还是微生物的。 眼用制剂尽管没有被引入到内部体腔，但它仍与对污染（物）敏感的组织有接触，因此，对眼用制剂也要求（与非肠道用制剂）类似的标准。 冲洗液现在也要求满足和非肠道用溶液一样的标准，因为在冲洗过程中，大量的冲洗液都可以通过敞开的血管伤口或者擦伤的黏膜组织直接进入到血液。因此，本章中描述的有关非肠道用溶液大批量生产的特点和标准，对于冲洗液同样适用。 无菌产品通常是溶液或者悬浮液，但甚至也可以是用于组织对端植入的固体药丸。对于少量的这种产品，使其污染降到最低的工艺控制可以相对容易地实现。（但）随着产品量的增加，控制工艺流程从而防止污染的困难也会增加。因而，无菌产品的制备已经成为药品加工里一个高度专业化的领域。制定的标准、人员的态度和工艺流程的控制都必须有着优秀的水平。