-
//
本篇包括人卫第四版
Unit 3B
，
Unit4A
，
5A
，
8A
，
10A
，
12AB
，
< br>13A
等七篇课文
Unit
3 Text B The Other Side of Antibiotics
抗生素的另一面
Antibiotics have eliminated or
controlled so many infectious diseases that
virtually everyone
has
benefited
from
their
use
at
one
time
or
another.
Even
without
such
personal
experience,
however, one would have to be isolated
indeed to be unaware of the virtues, real and
speculative,
of
these
“miracle”
drugs
1
.
The
American
press,
radio,
and
television
have
done
a
good
job
of
reporting
the truly remarkable story of successes in the
chemical war on germs.
What
′
s more,
any
shortcomings on their part have been more than
made up for by the aggressive public relations
activity of the pharmaceutical
companies which manufacture and sell antibiotics.
抗生素可以消除或控制很多种感染疾病，以致几乎每人生病时都习惯于使用它而受益，<
/p>
但是如果一个人没有这样的亲身经历，
他必定是离群索居才会不知
道这些
“特效药物”
或真
实或推测的优
点。
美国的出版物、
电台或电视台用大量的篇幅报道了有关对细
菌的化学战中
获得的这些显著功绩。而它的缺点却被生产和销售抗生素的制药公司通过公
关活动掩藏了。
In comparison, the
inadequacies and potential dangers of these
remarkable drugs are much
less widely
known. And the lack of such knowledge can be bad,
especially if it leads patients to
pressure
their
doctors
into
prescribing
antibiotics
when
such
medication
isn
’
t
really
needed,
or
leads them to switch doctors until they
find one who is, so to speak, antibiotics-
minded
2
.
相比而言，
使用这些药物的危险性并不广为人知。
对这种知识的缺乏将更糟糕，<
/p>
特别是
当患者要求医生开处方用抗生素而事实并不需要，
或患者频繁地更换医生直至找到一个同意
开抗生素处方的医生。
Because the good side of the
antibiotics story is so very well-known, there
seems more point
here to a review of
some of the immediate and long-range problems that
can come from today
’
s
casual
use
of
these
drugs.
It
should
be
made
clear
in
advance
that
calamities
from
the
use
of
antibiotics
are
rare
in
relation
to
the
enormous
amounts
of
the
drugs
administered.
But
the
potential hazards, so
little touched on generally, do need a clear
statement.
因为抗生素的好的一面已广为人知，
今
天抗生素的滥用导致短期或长期问题。
我们预先
应该知道与抗生
素的巨大的使用量相比
,
它产生危害的例子是少见的。
但是，
尽管十分少见，
需要对这种潜在的危险作
一个清楚的说明。
The antibiotics are
not, strictly speaking, exclusively prescription
drugs. A number of them
are
permitted
in
such
over-the-counter
products
as
nasal
sprays,
lozenges,
troches,
creams,
and
ointments. Even if these products do no
harm there is no point whatsoever in using them.
If you
have an infection serious enough
to warrant the launching of chemical warfare, you
need much
bigger doses of the
antibiotics than any of the non-prescription
products are allowed to contain.
严格来讲，抗
生素并不全是处方药。许多抗生素被允许作为非处方药
(
如鼻喷
雾剂、键
剂、片剂、软膏和乳膏
),
尽
管它们没有危害，也不能随意地使用。如果你患了严重的感染，
你就得需要比非处方药所
允许最大剂量更大剂量的抗生素了。
Over-the-
counter products, however, account for only a
small percentage of total antibiotics
production. It is the prescription
dosages that give people trouble.
然而，
非处方药品只是整个抗生素类产品的一小部分，
正是处方药物给人类
带来了麻烦。
//
These
drugs
—
even allowing for the
diverse abilities of the many narrow-spectrum ones
and
the
versatility
of
the
broad-
spectrum
ones
—
are
not
the
cure-alls
they
often
are
billed
as
being.
There are wide gaps in their ability
to master contagious diseases. Such
important infections as
mumps, measles,
common colds, influenza, and infectious hepatitis
still await conquest. All are
virus
infections
and
despite
intense
efforts,
very
little
progress
has
been
made
in
chemotherapy
against viruses. Only small progress
has been achieved against fungi. Many strains of
bacteria and
fungi are naturally
resistant to all currently available antibiotics
and other chemotherapeutic drugs.
这些药物一
即使允许最大能力
,
很多窄谱抗生素和广谱抗生素也并不是如宣
传的那样治
疗百病。它们的能力与治疗传染性疾病间还存在很大的差距。如腮腺炎、麻疹
、普通感冒、
流行性感冒和传染性肝炎等严重感染性疾病仍有待解决。
< br>这些都是病毒感染，
尽管做出了很
大的努力，
但是在抗病毒的化疗药物的研究上几乎没有什么进展。
抗真菌药物的研究上
只取
得一点小成就。很多细菌和真菌对现有的抗生素和其他化疗药物具有耐药性。
Some
microorganisms
originally
sensitive
to
the
action
of
antibiotics,
especially
staphylococcus,
have developed resistant strains. This acquired
resistance imposes on the long
range
value of the drugs a very important limitation,
which is not adequately met by the frequent
introduction of new antimicrobial
agents to combat the problem.
一些原来对抗生素敏
感的细菌，
特别是葡萄球菌现在也产生了耐药性，
这些获得的耐
药
性对药物的长期使用产生重要的限制，频繁引人新的抗菌药物也不能完全解决这个问题
。
It
has
been
pretty
well
established
that
the
increase
in
strains
of
bacteria
resistant
to
an
antibiotic
correlates
directly
with
the
duration
and
extent
of
use
of
that
antibiotic
in
a
given
location. In one
hospital a survey showed that, before erythromycin
had been widely used there,
all strains
of staphylococci taken from patients and personnel
were sensitive to its action. When
the
hospital started extensive use of erythromycin,
however, resistant staphylococcus strains began
to appear.
现已经确定，
在一些地区，
抗生素广泛和长期的使用与细菌耐药性增加有直接的相互关
系。
某医院调查显示，
在红霉素广泛使用以前，
所有从病人身上取出的葡萄球菌都对红霉素
敏感
.
然而，自从医院开始广泛应用红霉素以来，耐药葡萄球菌菌株开始出现。
The development of bacterial
resistance can be minimized by a more
discriminating use of
antibiotics, and
the person taking the drug can help here. When an
antibiotic must be used, the best
way
to prevent the development of resistance is to
wipe out the infection as rapidly and thoroughly
as possible. Ideally, this requires a
bactericidal drug, which destroys, rather than a
bacteriostatic
drug, which inhibits.
And the drug must be taken in adequate dosage for
as long as is necessary to
eradicate
the infection completely. The doctor, of course,
must choose the drug, but patients can
help by being sure to take the full
course of treatment recommended by the doctor,
even though
symptoms
seem
to
disappear
before
all
the
pills
are
gone.
In
rare
instances
the
emergence
of
resistance
can
be
delayed
or
reduced
by
combinations
of
antibiotics.
Treatment
of
tuberculosis
with streptomycin alone results in a
high degree of resistance, but if para-
aminosalicylic acid or
isoniazid
is
used
with
streptomycin
the
possibility
that
this
complication
will
arise
is
greatly
reduced.
更有区别的应用抗生素可以最大限度地抑制细菌耐药性的发展，
使用药物的病人可对此<
/p>
有所帮助。
当必须使用一种抗生素时，
最
好的避免耐药性方法就是尽快彻底地去除感染。
这
就需要用能杀
死细菌的杀菌药，
而不是抑制细菌的抑菌药。
这种药物必须使用
一定剂量，
并
且一定的时间以完全根除这种感染。
医生当然得选这种药，
但患者须遵医嘱、
使用足够的
治
疗量，
即使在药物吃完以前症状似乎已经消失。
少数情况下联合用药可以推迟或降低耐药性
//
的
产生。
用链霉素单独治疗结核病会导致高度的耐药，
但如果链霉
素联用对氨基水杨酸或异
烟肼将大大降低耐药性。
In
hospital
treatment
of
severe
infections,
the
sensitivity
of
the
infecting
organism
to
appropriate antibiotics is determined
in the laboratory before treatment is started.
This enables the
doctor
to
select
the
most
effective
drug
or
drugs;
it
determines
whether
the
antibiotic
is
bactericidal or bacteriostatic for the
germs at hand; and it suggests the amount needed
to destroy
the
growth
of
the
bacteria
completely.
In
either
hospital
or
home,
aseptic
measures
can
help
to
reduce the prevalence of
resistant strains of germs by preventing cross
infection and the resultant
spreading
of organisms.
在医院治疗严重感染时，
感染菌
对抗生素的敏感性在治疗前已在实验室确定，
这样可以
使医生选
择最有效的药物，
可以决定使用抑菌还是杀菌的抗生素，
并可对
能完全破坏细菌生
长所需的用量给出建议。
无论在医院或是在家
里，
无菌措施由于避免了交叉感染以及由此造
成的生物体传播，
从而可以降低细菌耐药菌株的广泛流行。
Every
one
of
the
antibiotics
is
potentially
dangerous
for
some
people.
Several
serious
reactions
may
result
from
their
use.
One
is
a
severe,
sometimes
fatal,
shock-like
anaphylactic
action, which may strike people who
have become sensitized to penicillin. Anaphylactic
reaction
happens less frequently and is
less severe when the antibiotic is given by mouth.
It is most apt to
occur
in
people
with
a
history
of
allergy,
or
a
record
of
sensitivity
to
penicillin.
Very
small
amounts of penicillin,
even the traces which get into the milk of cows
for a few days after they are
treated
with the antibiotic for mastitis, may be
sufficient to sensitize; hence, the strong
campaign
by food and drug officials to
keep such milk off the market.
对有些人来说任何
一种抗生素都可能有潜在的危险。
一些严重的反应可能是由于它们的
应用产生的，
其中之一就是严重的有时甚至是致死性的过敏性休克，
对青霉素过敏的人使用
青霉素将很危险。
口服抗生素将
使过敏频率降低或降低严重性。
青霉素过敏或有过敏史者更
容易
发生。
奶牛使用抗生素治疗乳腺炎几天后，
其牛奶中带入的极其
少量甚至痕量的青霉素
也可能足以引起过敏。所以食品药品监督官员采取强有力的措施防
止这种牛奶进人市场。
To minimize the
risk of anaphylactic shock in illnesses where
injections of penicillin are the
preferred
treatment,
a
careful
doctor
will
question
the
patient
carefully
about
allergies
and
previous
reactions.
In
case
of
doubt
another
antibiotic
will
be
substituted,
if
feasible,
or
other
precautionary measures
will be taken before the injection is given.
当注射青霉素是首选治疗方案时，
为降低这种过敏性休克，
谨慎的医生会仔细询问病人
的过敏史及其反应。
如过敏
史不清楚，
医生会用其他抗生素代替或注射前用其他方法检查其
是否过敏。
Other
untoward
reactions
to
antibiotics
are
gastrointestinal
disorders
—
such
as
sore
mouth,
cramps, diarrhea, or anal
itch
—
which occur most
frequently after use of the tetracycline group but
have also been encountered after use of
penicillin and streptomycin. These reactions may
result
from
suppression
by
the
antibiotic
of
bacteria
normally
found
in
the
gastrointestinal
tract.
With
their
competition
removed,
antibiotic-resistant
staphylococci
or
fungi,
which
also
are
normally
present,
are
free
to
flourish
and
cause
what
is
called
a
super-
infection.
Such
infections
can
be
extremely
difficult to cure.
其他抗生素不良反应包括胃肠道不适，如口腔
疼痛、痉挛、腹泻、肛门瘙痒，这种情况
在使用四环素类抗生素后经常发生，
在使用青霉素和链霉素后也会遇到。
这些反应可能是由
于使用的抗生素抑制了正常的胃肠道菌群引起的。
随着这种竞争的消除，
正常存在的葡萄球
菌或真菌耐药菌株自由繁殖并引起所谓的超感染，这种感
染将更难治疗。
//
A few
antibiotics have such toxic effects that their
usefulness is strictly limited. They include
streptomycin and dihydro-streptomycin,
which sometimes cause deafness, and
chloramphenicol,
which may injure the
bone marrow. Drugs with such serious potential
dangers as these should be
used only if
life is threatened and nothing else will work
有些抗生素有毒性作用，
使其应用受到了严格的限制。
< br>这类抗生素包括会导致耳聋的链
霉素和双氢链霉素，
以及
会产生骨髓损伤的氯霉素。
这些有严重危险的药物只有在生命受到
威胁或其他药物无效时才使用。
All
the
possible
troubles
that
can
result
from
antibiotic
treatment
should
not
keep
anyone
from
using
one
of
these
drugs
when
it
is
clearly
indicated.
Nor
should
they
discourage
certain
preventive uses of antibiotics which
have proved extremely valuable.
由于有些抗生素
疗效确切，
因此使用抗生素所带来的所有可能的麻烦也不能阻止任何人
< br>用任何一种抗生素，对于被证明是有效的抗生素，人们不会不鼓励它们的使用。
翻译
1.
另一种发现新的抗生素的高难度方法是合理药物设计，
即利用有关分子结构的知识
来进行全新的药品设计或改进。
Rational drug design is another more
difficult method of new antibiotics discovery,
that is to
say, design or improve a
brand new drug by using the knowledge of molecular
structure.
2.
制药工业在探索和开发新药的同
时还要对抗现有抗生素不断増长的微生物耐药性，
这将是一条漫长的道路。
When
pharmaceutical
industry
explores
and
develops
a
new
drug,
it
fights
against
the
microbial resistances to
available antibiotics all the time. It is a very
long way.
3.
应该大力鼓励医生、
制药业以及公众态度的转变。
必须将抗生素视为一种应被谨慎
使用并且仅在真正必需时才使用的宝贵资源。
The
change
of
doctors,
pharmaceutical
industry
and
the
public
attitudes
should
be
encouraged greatly. The antibiotics
must be viewed as a precious resource only used
cautiously in
real needs.
4.
全世界都必须在医学教育的初期就进行关于抗生素的审慎使用及其耐药危险的灌
输，并且，这种教育还应贯穿于医学工作者的整个医疗生涯。
The
cautious
use
of
antibiotics
and
their
hazardous
resistances
should
be
pumped
into
the
medical
students
during
their
early
medical
education
throughout
the
world.
What's
more,
this
education should penetrate through the
medical worker's whole career.
5.
制药工业必须停止推进非临床使用抗生素的生产，
并且，
< br>它应该认识到，
它将从抗
生素的合理使用中获利，因此，
应该对为此所作的各种尝试提供财务援助。
Pharmaceutical industry must stop
producing the non-clinical antibiotics, and it may
realize
that it will benefit a lot from
rational use of antibiotics. Hence, it should
offer financial aids to all
these
attempts.
Unit 4 Text A The
Scope of Pharmacology
药理学范畴
In
its
entirety,
pharmacology
embraces
the
knowledge
of
the
history,
source,
physical
and
chemical properties,
compounding, biochemical and physiological
effects, mechanisms of action,
absorption, distribution,
biotransformation and excretion, and therapeutic
and other uses of drugs.
Since a drug
is broadly defined as any chemical agent that
affects living processes, the subject of
//
pharmacology is obviously
quite extensive.
总体来说，药理学包括药物的以下诸方面内容
:
历史背景、来源、理化特性、合成、生
化
生理作用、作用机制、吸收、分布、生物转化和排泄以及治疗作用和其他作用。由于药物
被一般性定义为影响生命过程的化学物质，因而药理学范畴显然是极其广泛的。
For
the
physician
and
the
medical
student,
however,
the
scope
of
pharmacology
is
less
expansive than
indicated by the above definitions. The clinician
is interested primarily in drugs
that
are useful in the prevention, diagnosis, and
treatment of human disease, or in the prevention
of pregnancy. His study of
the pharmacology of
these
drugs can be reasonably limited to
those
aspects
that
provide
the
basis
for
their
rational
clinical
use.
Secondarily,
the
physician
is
also
concerned
with
chemical
agents
that
are
not
used
in
therapy
but
are
commonly
responsible
for
household
and
industrial
poisoning
as
well
as
environmental
pollution.
His
study
of
these
substances
is
justifiably
restricted
to
the
general
principles
of
prevention,
recognition,
and
treatment of such toxicity or
pollution. Finally, all physicians share in the
responsibility
to help
resolve the continuing sociological
problem of the abuse of drugs.
然而，
就医生和医学生生而言，
药理学范畴并没有上述定义那么广泛。
临床医生的主要
兴趣在于药物对人类疾病的预防、诊断及治疗
.
或是在避孕方而所起的作用。因而他对这些
药物的
药理学研究不仅仅周限于某些方面，只要能为其合理的临床用药提供理论根据就行。
其次
，
医生也关注某些化学物质，这些物质虽然不用于治疗，
但通常
与家庭中毒；
工业中毒
以及环境污染有关。
医生对这些物质的研究当然仅限于一般性了解。
对这类中毒或汚污染的
防范、
诊断和治疗。
最后，
所有医生都应责无旁贷地为解决药品滥用所引起的社会问题而做
出自己的努力。
A
brief
consideration
of
its
major
subject
areas
will
further
clarify
how
the
study
of
pharmacology is best
approached from the standpoint of the specific
requirements and interests of
the
medical student and practitioner. At one time, it
was essential for the physician to have a broad
botanical knowledge, since he had to
select the proper plants from which to prepare his
own crude
medicinal preparations.
However, fewer drugs are now obtained from natural
sources, and, more
importantly,
most
of
these
are
highly
purified
or
standardized
and
differ
little
from
synthetic
chemicals.
Hence,
the
interests
of
the
clinician
in
pharmacognosy
are
correspondingly
limited.
Nevertheless, scientific curiosity
should stimulate the physician to learn something
of the sources
of drugs, and this
knowledge often proves practically useful as well
as interesting. He will find the
history of drugs of similar value.
从医学生和从业医师的特別耑求和一般兴趣的角度来看，
什么才是药理学
学习的最佳途
径呢？只要对其主要学科领域稍加研究便可知晓。
以前，
医师必须拥有广泛的植物方而的知
识，因为他得挑选适当
的植物，
且将其制备成简单的药物制剂。然而，
现在的药物已很
少取
自于天然植物，
而且更为重要的是大多数天然药物已被高度
提纯，
且与合成的化学药物无甚
区别，
所以，临床医生对生药学的兴趣也相应减弱。尽管如此，应该激励临床医生了解药物
的来
源的科学好奇心，
这方面知识往往被证明不但有趣，
而且有用。
他将会发现了解药物的
历史同样具有价值。
The
preparing,
compounding,
and
dispensing
of
medicines
at
one
time
lay
within
the
province of the
physician, but this work is now delegated almost
completely to the
pharmacist
1
.
However, to write intelligent
prescription orders, the physician must have some
knowledge of the
physical and chemical
properties of drugs and their available dosage
forms, and he must have a
basic
familiarity with the practice of pharmacy. When
the physician shirks his responsibility in this
regard,
he
invariably
fails
to
translate
his
knowledge
of
pharmacology
and
medicine
into
//
prescription orders and medication best
suited for the individual patient.
药物的制
备、
合成与销售一度都是医生的职责，
但这项工作现在几乎全归
药师了。
不过
临床医师要想开出合理的处方，必须对药物的理化
性质及其现有剂型有所了解
,
必须基本了
解药房业务。
若临床医师逃避这方面责任，
他肯定用不好药理
学及药物知识，
从而难以开出
适合每位患者的最佳医疗处方。<
/p>
I
Pharmacokinetics deals with the
absorption, distribution, biotransformation, and
excretion of
drugs.
These
factors,
coupled
with
dosage,
determine
the
concentration
of
a
drug
at
its
sites
of
action
and,
hence,
the
intensity
of
its
effects
as
a
function
of
time.
Many
basic
principles
of
biochemistry and enzymology and the
physical and chemical principles that govern the
active and
passive transfer and the
distribution of substances across biological
membranes are readily applied
to the
understanding of this important aspect of
pharmacology
2
.
药物
动力学涉及药物的吸收、
分布、
生物转化以及排泄等方面。
这些因素再加上剂量便
决定了药物在其作用点的浓度，
进而决定了其与时间成函数关系的药效强度。
在对药理学这
< br>一重要方面的理解过程中，
常常运用到许多有关生物化学和酶学方面的基本原理和
物理化学
方面的一些基本法则，
而这些原理和法则决定着物质在
生物膜之间的主动和被动转移及分布。
The
study
of
the
biochemical
and
physiological
effects
of
drugs
and
their
mechanisms
of
action is termed as
pharmacodynamics. It is an experimental medical
science that dates back only
to the
later half of the nineteenth century. As a border
science, pharmacodynamics borrows freely
from
both
the
subject
matter
and
the
experimental
techniques
of
physiology,
biochemistry,
microbiology,
immunology,
genetics,
and
pathology.
It
is
unique
mainly
in
that
attention
is
focused on the
characteristics of drugs. As the name implies, the
subject is a dynamic one. The
student
who attempts merely to memorize the
pharmacodynamic properties of drugs is foregoing
one of the best opportunities for
correlating the entire field of preclinical
medicine. For example,
the actions and
effects of the saluretic agents can be fully
understood only in terms of the basic
principles of renal physiology and of
the pathogenesis of edema. Conversely, no greater
insight
into
normal
and
abnormal
renal
physiology
can
be
gained
than
by
the
study
of
the
pharmacodynamics of the saluretic
agents.
对药物的生化生理作用及其作用机制的研究称为药效学。
这是一门实验医学，
其历史仅
可追溯到
19
世纪后半叶。作为边缘学科，药效学从生理学、生化学、微生物学、免疫
学、
遗传学和病理学等诸多学科的主要理论和实验技术中吸取了大量内容。
该学科的独到之处主
要在于其关注的要点是药物的特征。
顾名思义，
该科目属于动态学科。
学生如果仅仅打算死
记硬背药物的药效学特性的话，
那他将会丧失把整个临床前期医学连
为—体的这一最佳机会。
例如
:
利盐排
泄剂的活性和效用只有在肾脏生理学和水肿发病机制的基本原理的基础上才能
完全理解。
换句话说，
只有通过对利盐排泄剂的药效学研究，
才能最深人地了解肾脏生理学
正常和异常两方面情况。
Another
ramification
of
pharmacodynamics
is
the
correlation
of
the
actions
and
effects
of
drugs
with their chemical structures. Such structure-
activity relationships are an integral link in the
analysis
of
drug
action,
and
exploitation
of
these
relationships
among
established
therapeutic
agents
has
often
led
to
the
development
of
better
drugs.
However,
the
correlation
of
biological
activity with
chemical structure is usually of interest to the
physician only when it provides the
basis for summarizing other
pharmacological information.
药效学的另一分支是研
究药物活性和效用与其化学结构的相互关系。
这种构效关系是分
析药物作用不可或缺的部分，
将这种关系应用于现有的治疗药物中往往会促使药品的更新
换
代。
然而，
只有当生物活性与化学结
构的关联能够为总结其他药物学信息提供基础时，
临床
//
医师才会对此产生兴趣。
The
physician
is
understandably
interested
mainly
in
the
effects
of
drugs
in
man.
This
emphasis on clinical pharmacology is
justified, since the effects of drugs are often
characterized
by
significant
interspecies
variation,
and
since
they
may
be
further
modified
by
disease.
In
addition, some drug effects, such as
those on mood and behavior, can be adequately
studied only
in man. However, the
pharmacological evaluation of drugs in man may be
limited for technical,
legal, and
ethical reasons, and the choice of drugs must be
based in part on their pharmacological
evaluation in animals. Consequently,
some knowledge of animal pharmacology and
comparative
pharmacology is helpful in
deciding the extent to which claims for a drug
based upon studies in
animals can be
reasonably extrapolated to
man
3
.
临床医师的兴趣主要集中
于药物对人体的疗效。
临床药理重视这一点是合理的，
因为药<
/p>
物的作用往往因种属的明显差异而大相径庭，
并可能由于疾病的作
用而发生进一步改而且有
些药物作用——诸如对情绪和行为的作用—只有通过人体才能得
以充分研究，
不过药物对人
体的药理学评价可能因技术、
法律及伦理道德方面的原因而受到限制，
对药物的选择在一定
程度上也只得以它们在动物身上所进行的药理学评价为基础。
因此，
动物药理学和比较药理
学方面的知识有助于确定以动物实验为基础的
某种新药研制何时才可用于人体。
Pharmacotherapeutics deals with the use
of drugs in the prevention and treatment of
disease.
Many drugs stimulate or
depress biochemical or physiological function in
man in a sufficiently
reproducible
manner
to
provide
relief
of
symptoms
or,
ideally,
to
alter
favorably
the
course
of
disease.
Conversely,
chemicotherapeutic
agents
are
useful
in
therapy
because
they
have
only
minimal
effects
on
man
but
can
destroy
or
eliminate
parasites.
Whether
a
drug
is
useful
for
therapy
is
crucially
dependent
upon
its
ability
to
produce
its
desired
effects
with
only
tolerable
undesired effects.
Thus, from the standpoint of the physician
interested in the therapeutic uses of a
drug,
the
selectivity
of
its
effects
is
one
of
its
most
important
characteristics.
Drug
therapy
is
rationally
based
upon
the
correlation
of
the
actions
and
effects
of
drugs
with
the physiological,
biochemical,
microbiological,
immunological,
and
behavioral
aspects
of
disease.
Pharmacodynamics provides one of the
best opportunities for this correlation during the
study of
both the preclinical and the
clinical medical sciences.
药物治疗学涉及如何在疾病
防治中使用药物。
许多药物以强有力的可重现方式促进或抑
制着
人体的生理生化功能，
进而使症状得以缓解或促使病程朝着令人满意的方向转变。
相反，
化疗药物的治病功能是因为其对人体作用很小但却能杀死或清除
寄生生物。
—种药物是否可
以用于治疗，
关键取决于其能否产生预期的治疗效果，
同时其副作用在可容忍的范围内。
这
样，
从关注药物疗效的临床医师的观点来看，<
/p>
药物作用的选择性便是其最重要特点之一。
药
物的活性和疗效与疾病诸方面——生理、
生化、
微生物、<
/p>
免疫和行为——的联系理所当然地
成为药物治疗的基础。
药效学便为临床前期和临床期医学研究这种联系提供了一个绝好的机
会。
Toxicology is that aspect
of pharmacology that deals with the adverse
effects of drugs. It is
concerned not
only with drugs used in therapy but also with the
many other chemicals that may be
responsible
for
household,
environmental,
or
industrial
intoxication.
The
adverse
effects
of
the
pharmacological agents employed in
therapy are properly considered an integral part
of their total
pharmacology.
The
toxic
effects
of
other
chemicals
are
such
an
extensive
subject
that
the
physician must usually confine his
attention to the general principles applicable to
the prevention,
recognition, and
treatment of drug poisonings of any cause.
毒理学是研究药物副作用的药理学分支。
它不仅涉及治疗药物，
还涉及引起家庭、
环境
//
或工业中毒的许多其他化学物质。
治疗性药物的副作用应被视为整个药理学的一个组成部
分。
其他化学物质的毒副作用范围太广，
临床医师通常只能将注
意力放在预防、
确认和处理各种
药物中毒的基本原则上。
翻译
1)
药物作用于人体的科学叫药理学
，
研究这门学问的科学家便是药理学家。
药理学不是一
门能够独立研究的科学，
而是与其它学科紧密相关的。
< br>药理学家不仅要了解人体内进行
的正常反应过程，还应懂得机体功能是怎样受疾病
影响的。
The science of the
effects of drugs on the body is called
pharmacology, and the scientists who
study it are pharmacologists.
Pharmacology is not a science that can be studied
on its own,
but that closely related to
other branches of science. Pharmacologists should
not only
understand the normal
processes that take place in the body, but know
how the functions of
the body are
affected by disease.
2)
医生和医学生对药理学的理解和要求没有其定义范畴那么广泛。
临床医生
主要关心药品
药理学所提供的合理临床用药的理论基础，
他们的
主要兴趣在于药物对人类疾病的预防、
这段及治疗，或者在避孕方面所起的作用。
For physicians and medical
students, the scope of pharmacology is not so
expansive as its
common definition. The
clinician is interested primarily in drags that
are useful in the
prevention,
diagnosis, and treatment of human disease, or in
the prevention of pregnancy.
3)
所有医生都应该负起责任解决药
品滥用所引起的各种社会问题。
药物用得恰当，
将是人
类的一大福音，用得不当，则可能毁了人类。病人（特别是老年病人）经常性使用一种
以上治疗药物的话，往往会发生产生毒性的药物相互作用。
All physicians should share the
responsibility to resolve kinds of sociological
problems
caused by the abuse of drugs.
Properly used, drugs are great blessing to
mankind; improperly
used, they could
destroy human race. When a patient, particularly
the elderly is prescribed
frequently to
take more than one therapeutic agent, drug
interactions resulting in toxicity will
occur.
4)
以前，
医师必须具备很广泛的植物学知识，
因为他要懂
得挑选适当的植物的能力和技巧，
并将它们制备成简单的草药。
现在，
由于大多数天然药物被高度提纯，
且与合成的化学
药物无甚区别，所以临床医生对生药学的兴趣也相应减弱。
At one time, it was essential for the
physician to have broad botanical knowledge,
because
they had to possess the ability
and skill to select proper plants from which to
prepare his own
crude medicinal
preparations.
5)
对药物的生化生理作用及其活性机制的研究叫做药效学，
该学科的独到之处主要在于其<
/p>
关注的要点是药物的特征。药效学作为一门边缘学科，大量借鉴了生理学、生物化学、
免疫学、病理学等学科的理论和实验技术。
The study of biochemical and
physiological effects of drags and their
mechanisms of action
is termed as
pharmacodynamics, whose uniqueness lies mainly in
that its attention is focused
on the
characteristics of the drug. As a broader
science
，
it borrows freely
from both the
theories and experimental
techniques of physiology, biochemistry,
immunology, and
pathology.
Unit 8 Text A
What Analytical Chemists Do?
分析化学家做什么？
//
Analytical
chemistry
is
concerned
with
the
chemical
characterization
of
matter
and
the
answer
to
two
important
questions:
what
is
it
(qualitative)
and
how
much
is
it
(quantitative).
Chemicals make up everything we use or
consume, and knowledge of the chemical composition
of many substances is important in our
daily lives. Analytical chemistry plays an
important role in
nearly
all
aspects
of
chemistry,
for
example,
agricultural,
clinical,
environmental,
forensic,
manufacturing,
metallurgical,
and
pharmaceutical
chemistry.
The
nitrogen
content
of
a
fertilizer
determines its
value. Foods must be analyzed for contaminants
(e.g., pesticide residues) and for
essential nutrients (e.g. vitamin
content). The air in cities must be analyzed for
carbon monoxide.
Blood
glucose
must
be
monitored
in
diabetics
(and,
in
fact,
most
diseases;
are
diagnosed
by
chemical analysis). The presence of
trace elements from gun powder on a murder
defendant's hand
will
prove
a
gun
was
fired.
The
quality
of
manufactured
products
often
depends
on
proper
chemical proportions,
and measurement of the constituents is a necessary
part of quality control.
The
carbon
content
of
steel
will
determine
its
quality.
The
purity
of
drugs
will
determine
their
efficacy.
分
析化学是研究物质的化学特征并能回答两个重要问题
:
是什么<
/p>
(
定性
)
以及有
多少
(
定
量
)
。我们所使用和消耗的一切都是由化学物质组成的，所以日常生活中了解物质的化学成<
/p>
分是非常重要的。
分析化学几乎在化学的各个领域都起着至关重要
的作用，
比如农业、
临床、
环境、
法医、
制造业、
冶金以及药物化学。
化学肥料中氮的含量决定了其价值。
对食物而言，
必须分析其中的污染物
(
比如杀虫剂残留）
和必要的营养成分
(
如维生素含量
)
。
对城市空气而
言，必须分析其
中的一氧化碳含量。糖尿病患者需检测血糖
(
事实上，大多数疾
病都是通过
化学分析来诊断的
)
。谋杀
嫌疑犯手上火药中痕量元素的存在可以证明手枪是开过火的。出
厂产品的质量取决于合适
的化学成分比例，
因此对组分的测定是质量控制中必不可少的一个
环节。钢铁中碳的含量决定其质量，药物的纯度决定其疗效。
What is Analytical Science?
什么是分析科学？
The
above
description
of
analytical
chemistry
provides
an
overview
of
the
discipline
of
analytical chemistry. There have been
various attempts to more specifically define the
discipline.
The
late
Charles
N.
Reilley
said:
chemistry
is
what
analytical
chemists
do
The
discipline has expanded beyond the
bounds of just chemistry, and many have advocated
using the
name
analytical
science
to describe the
field. This term is used in a National Science
Foundation
report from
workshops on “Curricular Developments
in the Analytical Sciences
.
”
Even this term
falls
short
of
recognition
of
the
role
of
instrumentation
development
and
application.
One
suggestion is that we
use the term
analytical science and
technology.
通过以上描述可以对分析化学这门学科有大致的了解，
为更加明确地定义这门学科，
人
们也有过多种
尝试。
已故的
y
曾说过
“分析化学家从事的工作就是分析化学”
:
。
这门学科的发展已跨越了纯化学的界限，
许多人已提倡使用“分析科学”
来描述该领域。在
名为
“分析科学的课程发展”
的工作组所做的国家科学基金报告中已使用这一名词。
但是该
< br>名词忽视了仪器发展和应用的作用，有人建议使用“分析科学和技术”这一名词。
The Federation of European Chemical
Societies held a contest to define analytical
chemistry,
and the following suggestion
by K. Cammann was selected.
Analytical
Chemistry
provides
the
methods
and
tools
needed
for
insight
into
our
material world
…
for answering four basic questions
about a material sample:
●
What?
●
Where?
//
●
How much?
●
What
arrangement, structure or form?
欧洲化学会联盟
曾举行了一次会议来定义分析化学，
n
所提出的如下建议被采纳
：
分析化学提供了洞察物质世界所需要的方法和工具，
它回答了关于某一物质样品的四个基本
问题：
?是什么？
?在哪里？
?有多少？
?是何种排列、结构或形态？
The
Division
of
Analytical
Chemistry
of
the
American
Chemical
Society
provides
a
comprehensive
definition
of
analytical
chemistry,
which
may
be
found
on
their
website.
It
is
reproduced
in most part here:
Analytical
Chemistry
seeks
ever
improved
means
of
measuring
the
chemical
composition of
natural and artificial materials. The techniques
of this science are used to
identify
the
substances
which
may
be
present
in
a
material
and
to
determine
the
exact
amounts of the
identified substance.
美国化学会的“分析化学分类”为分析
化学提供了一个全面的定义，可以在其网
站査到，此处摘录部分内容：
< br>
分析化学探索不断改进的方法，
用以检测天然和人造材
料的化学组成。
此种科学
的技术手段用来鉴别可能存在于一种材
料中的物质以及测定给定物质的准确含量。
Analytical chemists work to improve the
reliability of existing techniques to meet the
demands
for
better
chemical
measurements
which
arise
constantly
in
our
society.
They
adopt proven
methodologies to new kinds of materials or to
answer new questions about
their
composition
and
their
reactivity
mechanisms.
They
carry
out
research
to
discover
completely
new
principles
of
measurement
and
are
at
the
forefront
of
the
utilization
of
major
discoveries,
such
as
lasers
and
microchip
devices
for
practical
purposes.
Their
efforts serve the
needs of many fields:
分析化学家致力于提高已有技术的可靠
性以更好地满足社会中频繁出现的化学
检测的需求。
他们将已证
实的方法学应用于新型材料，
或回答关于其组成及反应机制
的新
问题。他们开展研究，探索全新的检测原理，站在了将激光和微芯片等重大发现
应用于实
际用途的最前沿。他们的努力满足了许多领域的需求：
-
In
medicine
,
analytical
chemistry
is
the
basis
for
clinical
laboratory
tests
which
help
physicians diagnose disease and chart
progress in recovery.
-
In
industry
,
analytical
chemistry
provides
the
means
of
testing
raw
materials
and
for
assuring the quality of
finished products whose chemical composition is
critical. Many
household products,
fuels, paints, pharmaceuticals, etc. are analyzed
by the procedures
developed by
analytical chemists before being sold to the
consumer.
-
Environmental quality
is often evaluated by testing for
suspected contaminants using the
techniques of analytical
chemistry.
-
The nutritional value of
food
is
determined by chemical analysis for major
components
such as protein and
carbohydrates and trace components such as
vitamins and minerals.
Indeed, even the
calories in a food are often calculated from its
chemical analysis.
Analytical chemists also make important
contributions to fields as diverse as forensics,
//
archaeology, and space
science.
?医药领域中
,
分
析化学是临床实验室检测的基础，此类检测可以帮助医生诊断疾
病，绘制康复过程图。<
/p>
?工业领域中，分析化学提供原料的检测手段，保证对化学成分
要求严格的最终
产品的质量。许多家庭用品、燃料、涂料、药品等在出售给消费者前就已
经被由分析
化学家建立的方法分析检测。
?环境质量经常通过采用分析化学技术检测疑似污染物的方法得到评价。
食品的营养价值是通过对其中蛋白质、
碳水化合物等主要成分以及维生素
、
矿物
质等微量成分的化学分析而得以确定。
< br>实际上，
甚至食物的热量也经常通过化学分析
的方法来计
箅的。
分析化学在法医学、考古学和太空科学等多个领域也作
出了重要贡献。
Qualitative and
Quantitative Analyses: What Does Each Tell Us?
定性分析和定量分析
:
它们各自告诉我们什么
？
The
discipline
of
analytical
chemistry
consists
of
qualitative
analysis
and
quantitative
analysis.
The
former
deals
with
the
identification
of
elements,
ions,
or
compounds
present
in
a
sample (we may be interested in whether
only a given substance is present), while the
latter deals
with the determination of
how much of one or more constituents is present.
The sample may be
solid, liquid, gas,
or a mixture. The presence of gunpowder residue on
a hand generally requires
only
qualitative knowledge, not of how much is there,
but the price of coal will be determined by
the percent of sulfur impurity present.
分析化学学科包括定性分析和定量分析。
前者解决样品中所存在
元素、
离子和化合物的
鉴别问题
(
我们感兴趣的仅是一种给定的物质是否存在
)
，而后者要解决测定已存在的一种或
多种组分含量是多少的问题。检测样品可能是固体
、液体、气体，也可能是混合物。手上的
火药残留通常只需要定性的了解即可
,
并不需要知道残留量是多少，但煤炭的价格则由其中
硫杂质的百分含量所决定。
Qualitative
tests
may
be
performed
by
selective
chemical
reactions
or
with
the
use
of
instrumentation. The formation of a
white precipitate when adding a solution of silver
nitrate to a
dissolved
sample
indicates
the
presence
of
chloride.
Certain
chemical
reactions
will
produce
colors
to
indicate
the
presence
of
classes
of
organic
compounds,
for
example,
ketones.
Infrared
spectra will give “fingerprints”
of
organic
compounds or their functional groups.
定
性鉴别可能通过选择性的化学反应或者使用仪器完成。
当把硝酸银溶液滴加到一份溶
解样品中，
生成白色沉淀就说明了氯离子的存在。
< br>特定的化学反应会产生颜色，
指示某一类
有机化合物的存
在，
如酮类化合物。
红外光谱可以给出有机化合物或官能团的<
/p>
“指纹图谱”
。
A clear distinction should be made
between the terms selective and specific:
●
A
selective
reaction or test
is one that can occur with other substances but
exhibits a
degree of preference for the
substance of interest.
●
A
specific
reaction
or test is one that occurs only with the substance
of interest.
对选择性和专属性这两个术语应该做以明确的区分：
?选择性反应或鉴别是指可以和其他物质发生反应但对敏感物质显示一定程度的偏好。
?专属性反应或鉴别是指仅与敏感物质发生反应。
Unfortunately,
few
reactions
are
specific
but
many
exhibit
selectivity.
Selectivity
may
be
achieved by a number of
strategies. Some examples are:
●
Sample preparation (e.g.,
extractions, precipitation)
●
Instrumentation (selective
detectors)
//
●
Target
analyte
derivatization
(e.g.,
derivatize
specific
functional
groups
with
detecting
reagents)
●
Chromatography, which
provides powerful separation
可惜虽然许多反应呈现
出选择性，但极少数反应具有专属性。通过许多途径可以实现选
择性，例如：
?样品处理
(
如萃取和
沉淀）
?使用仪器
(
选择性检测器）
?目标分析物衍生化
(
如用检测试剂衍生化特定的官能团）
?色谱法，可达到充分分离。
For
quantitative
analysis,
a
history
of
the
sample
composition
will
often
be
known
(it
is
known that
blood contains glucose), or else the analyst will
have performed a qualitative test prior
to
performing
the
more
difficult
quantitative
analysis.
Modern
chemical
measurement
systems
often exhibit sufficient selectivity
that a quantitative measurement can also serve as
a qualitative
measurement.
However,
simple
qualitative
tests
are
usually
more
rapid
than
quantitative
procedures.
Qualitative analysis is composed of two fields:
inorganic and organic.
The former is
usually covered in introductory
chemistry courses, whereas the latter is best left
until after the
student has had a
course in organic chemistry.
对于定量分析，我们通
常要知道样品组成的来历
(
就像我们知道血液中含有葡萄糖
)
，否
则在更具难度的定量分析前，
分析工作者先需要进行定性实验。
现代化学检测系统往往具有
较好的选择性，
定量检测方法同样适合于定性检测。
然而，
简单的定性鉴别常常比定量的过
程更为快捷。定型分
析由无机和有机两个领域组成，前者通常包含于入门式的化学课程中，
而后者最好在学生
学完一门有机化学课程后再去涉猎。
In
comparing qualitative versus quantitative
analysis, consider, for example, the sequence of
analytical procedures followed in
testing for banned substances at the Olympic
Games. The list of
prohibited
substances
includes
about
500
different
active
constituents:
stimulants,
steroids,
beta-blockers,
diuretics, narcotics, analgesics, local
anesthetics, and sedatives. Some are detectable
only as their metabolites. Many
athletes must be tested rapidly, and it is not
practical to perform a
derailed
quantitative analysis on each. There are three
phases in the analysis: the fast-screening
phase,
the
identification
phase,
and
possible
quantification.
In
the
fast-screening
phase,
urine
samples are rapidly tested for the
presence of classes of compounds that will
differentiate them
from
“normal”
samples.
Various
techniques
incl
ude
immunoassays,
gas
chromatography,
and
liquid
chromatography.
About
5%
of
the
samples
may
indicate
the
presence
of
unknown
compounds
that
mayor
may
not
be
prohibited
but
need
to
be
identified.
Samples
showing
a
suspicious
profile
during
the
screening
undergo
a
new
preparation
cycle
(possible
hydrolysis,
extraction,
derivatization), depending on the nature of the
compounds that have been detected. The
compounds
are
then
identified
using
the
highly
selective
combination
of
gas
chromatography/mass spectrometry
(GC/MS). In this technique, complex mixtures are
separated
by
gas
chromatography,
and
they
are
then
detected
by
mass
spectrometry,
which
provides
molecular
structural data on the compounds. The MS data,
combined with the time of elution from
the gas chromatograph, provide a high
probability of the presence of a given detected
compound.
GC/MS is expensive and time
consuming, and so it is used only when necessary.
Following the
identification phase,
some compounds must be precisely quantified since
they may normally be
present at low
levels, for example, from food, pharmaceutical
preparations, or endogenous steroids,
and
elevated
levels
must
be
confirmed.
This
is
done
using
quantitative
techniques
such
as
//
spectrophotometry or gas
chromatography.
比较定性分析和定量分析，
我们不妨以奥林匹克运动会对违禁药物的检验为例了解分析过程
的步骤。
禁止药物目录中包含了大约
500
种不同的活性成分<
/p>
:
兴奋剂类、
类固醇，
< br>β阻断剂、
利尿剂、麻醉剂、止痛剂、局部麻醉剂和镇静剂。有些只有以代谢物的
形式才能被检测。许
多运动员必须快速被检测，
对每个人做细致
的定量分析是不可行的。
分析过程中有三个阶段
:
快速筛选期、鉴别期以及可能需要的定量期。
在快速筛选期，
对尿样进行快速检测，找出其
中区别于正常样品的各类组分
,
所使用的技术包括免疫分析、
气相色谱及液相色谱。
大约
5%
的样品会检测出未知化合物，
不论这些物质被禁止与否，
都需要做进一步鉴别。
< br>在筛选过程
中显示出可疑情况的样品，
需要根据已检出化
合物的性质进行新一轮的处理过程
(
可能水解、
萃取或衍生化
)
，然后使用高选择性的气相色谱一质谱
联用技术
(GC/MS)
对该化合物进行鉴
定。
在该技术中，
复杂混合物通过气相色谱得到分离，
然后再通过可提供化合物的分子结构
信息的质谱进行检测。
结合质谱数据和气相色谱的洗脱时间，
我们对确认给定的待测化合物
的存在就有更大的把握。
GC/MS
昂贵、
费时，
因此在必要时才会使用。
经过鉴
定阶段以后，
一些化合物需要准确定量。这些可能
源于如食物、药品或内源性类固醇的化合物，在正常
情况下即以很低的浓度
存在
的水平也需要确定。这可以通过分光光度法或气相色谱等
定量
技术来解决。
翻译
1)
分析化学的核心任务在于解决两个问题
:
一个是有什么
;
另一个是有多少。也就是定性
分析和定量分析。定性分析是指鉴别所含的物质而定量分析是测定物质的准确含量。
< br>
Analytical chemistry aims to
resolve two questions: what it is and how much it
is, that is
qualitative analysis and
quantitative analysis. Qualitative analysis is to
identify the elements,
ions and
compounds contained in a sample while quantitative
analysis is to determine the
exact
quantity.
2)
分析化学
的发展已经超出了化学的边界，
因此有人提议用分析科学来描述这个领域。
但
是，
该名词忽视了仪器发展和应用的作用，
有人建议使用
“分析科学和技术”
这一名词。
Analytical chemistry has
expanded beyond the bounds of just chemistry, and
many have
advocated using the name
analytical science to describe the field. Even
this term falls short of
recognition of
the role of instrumentation development and
application. One suggestion is
that we
use the term analytical science and technology.
3)
分析化学家致力于提高已有技术
的可靠性以更好的满足社会中频繁出现的化学检测的
需求。
他们
将已证实的方法学应用于新型材料，
或回答关于其组成及反应机理的新问题。
Analytical chemists work to
improve the reliability of existing techniques to
meet the
demands for better chemical
measurements which arise constantly in our
society. They adopt
proven
methodologies to new kinds of materials or to
answer new questions about their
composition and their reactivity
mechanisms.
4)
定性
鉴别可能通过选择性的化学反应或者仪器分析来完成。
例如当把硝酸银溶液滴加到
一份溶解样品中，
生成白色沉淀就说明了样品中氯离子的存在。
而红外光谱可以给出有
机化合物或官能团的“指纹”
< br>。
Qualitative tests may
be performed by selective chemical reactions or
with the use of
instrumentation. For
example
，
the formation of a
white precipitate when adding a solution
of silver nitrate to a dissolved sample
indicates the presence of chloride. Infrared
spectra will
give “fingerprints” of
organic compounds or their functional
groups.
5)
违禁药物检查的第一阶段称作快速筛选阶段，
通常采用气相色谱或液相色谱等
定量分析
//
的方法检查出可疑样本；
第二阶段使用气质联用对可疑样本进一步检测；
最后，
应用分
光光度法或气相色谱进行准确定量。
The first phase in the testing of
banned substances is called fast-screening phase,
in
which qualitative analysis such as
GC or LC is adopted to test suspicious samples. In
the
second phase, GC-MS is employed for
further testing of those suspicious samples.
Finally,
spectrophotometry or GC is
applied for accurate quantification.
Unit 10 Text A The United States
Pharmacopoeia
（
1
）
美国药典
(1)
The
United States Pharmacopoeia
(USP)
—
the National Formulary
(NF) is published in
continuing pursuit
of the mission of United States Pharmacopoeia
Convention (USPC): To
improve the
health of people around the world through public
standards and related programs that
help ensure the quality and safety of
medicines and foods.
《美国药典<
/p>
/
国家处方集》的出版是美国药典委员会不断追寻的使命
:
通过有助于保
证<
/p>
食品和药品质量和安全的公共标准和相关计划，提高全世界人民身体健康。
This text from USP-NF, provides
background information on the United States
Pharmacopoeia Convention (USPC), as
well as general information about the 32nd
revision of the
United States
Pharmacopeia (USP 32) and the 27th edition of the
National Formulary (NF 27).
本课文内容节选自《美国药典
/
国家处方集》，介绍了美国药
典委员会的一些情况以
及
《美国药典
》第
32
版和《国家处方集》第
27<
/p>
版的基本情况。
1. THE
HISTORY OF USP-NF
《美国药典
/
国家处方集》的历史
On January
1, 1820, 11 physicians met in the
Senate
Chamber
of the U.S.
Capitol
building
to establish a pharmacopoeia for the
United States. These practitioners sought to
create a
compendium
of the
best
therapeutic
products,
give them useful names, and provide
recipes
for
their
preparation. Nearly a year later, on December 15,
1820, the first edition of The
Pharmacopoeia of the United States was
published. Over time, the nature of the United
States
Pharmacopeia (USP) changed from
being a compendium of recipes to a compendium of
documentary
standards that
increasingly are
allied
with
reference materials, which together
establish the identity of an article
through tests for strength, quality, and purity.
The publishing
schedule of the USP also
changed over time. From 1820 to 1942, the USP was
published at
10-year intervals; from
1942 to 2000, at 5-year intervals; and beginning
in 2002, annually.
1820
年
1
月
1
日，
11
位医生在美国国会大厦参议院会议厅召开会
议制定美国药典。这
些医师们试图制定一部最好治疗产品的手册，
给出它们有效名称，
提供制剂处方。
大概
—
年
以后，
1820
年
12
月
15
日，《美国药典》第一版出版了。经过一段时间，《美国药典》的
性质从一部
处方手册转变成了不断增加参照材料的文献标准手册，
通过检査手段共同建立品
种规格、
质量和纯度等标准。
后来，
《美国药典》
出版周期也发生了改变。
从
1820
年到
1942
年，《美国药典》每隔十年出版一版
;
从
1942
年到
2000
年，每五年出
版一版
;
从
2002
< br>年开
始，每年出版一版。
In
1888, the American Pharmaceutical Association
published the first national formulary
under the title The National Formulary
of Unofficial Preparations (NF). Both the USP and
the NF
were recognized in the Federal
Food and Drugs Act of 1906 and again in the
Federal Food, Drug,
and Cosmetic Act
1938. In 1975, USP acquired the National Formulary
(NF), which now contains
excipients
standards with
references to allied reference materials. Today,
USP continues to
develop USP and NF
through the work of the Council of Experts into
compendia that provide
//
standards for articles based on
advances in analytical and
metrological
science. As
these and
allied sciences evolve, so do
USP and NF.
1
188
8
年，
美国药学会出版了第一部国家处方集，
< br>名称为
《非正式制剂的国家处方集》
。
< br>《美国药典》
（
USP
)
和
《国家处方集》
（
NF
)
都得到
1906
年
《联邦食品药品法案》
的认可。
1975
年
USP
合并了
NF
，现在
NF
通过引
用相关参考材料收录了辅料的标准。如今
，
UPS
不断通过专家委员会的工作，把
USP
和
NF
观发展成为提供以分析和计量科学进步为基础
的品种标准手册。有了这些工作和科学的进展
,USP
和
NF
确实得到发展。
2. USP
GOVERNANCE
STANDARDS-SETTING, AND ADVISORY BODIES
USP's governing, standards-setting, and
advisory bodies include the USP Convention, the
Board of
Trustees
the Council of Experts and its Expert Committees,
Advisory Panels, and staff.
Additional
volunteer bodies include
Stakeholder
Forums, Project
Teams, and Advisory Groups,
which act
in an advisory capacity to provide input to USP's
governing, standards-setting, and
management bodies.
2
美国药典的管理、标准制定和顾问机构
美国药典的管理、标准制定和顾问机构包括
:
美国药典大会、
理事委员会、专家委员会
和专家小组委员会、顾问小组以及员工。
?
其他志愿机构包括
:
股东论坛、项
目团队、和顾问
小组，他们以顾问身份给美药典的管理、标准制定和经营机构提供信息或
资金。
USP
Convention
—
USP's direction and priorities are determined by
more than 400
Convention members
divided into nine categories.
Eligible
organizations
within each membership
category are
invited to appoint a representative. Convention
composition is determined to ensure
suitable representation of those
sections of the health care system that are
influenced by, and in
turn influence,
USP's activities. Convention members elect USP's
President,
Treasurer
and
other
members of the Board of Trustees
as well as the Council of Experts. They also vote
on resolutions
to guide USP's
scientific policy and public health initiatives
and update, as needed, USP's
Constitution
and
By-Laws
.
美国药典大会美国药典的方针和重点由超过
400
位的
药典大会成员来决定，
他们分为
9
个类
别。
下属类别中符合条件的组织被邀请派一个代表。
药典大会的
组成坚决保证卫生保健
体系中的这些部门适当的代表性，
这些部
门受到药典大会的影响，
反过来也影
响药
典大会的
活动。药典大会成员选举
USP
总裁、财务主管、其他理事会和专家委员会的成员。他们也
投票决定指导药典的科学
决策、公共卫生措施，如果必要，也更新药典的章程
和内部
规章
。
Board of
Trustees
—
USP's
Board of Trustees is
entrusted
with management of
the
business affairs, finances, and
property of USP. During its five-year term, the
Board defines USP's
strategic direction
through its key policy and operational decisions.
理事委员会药典的理事委员会负责管理药典的业务、
金融和财产。
在五年任期内，
管理
委员会通过关键决策和可操作性明确美国药典的策略方向。
Council
of
Experts
—
The
Council
of
Experts
is
the
standards-setting
body
of
USP.
It
is
composed
of
57
Expert
Committee
Chairs
elected
to
five-
year
terms
by
USP's
Convention
members.
A
Nominating
Committee,
consisting
of
the
Chair
of
the
Council
of
Experts,
the
Convention
President,
and
the
Vice
Chair
of
the
Nominating
Committee
for
the
Council
of
Experts, nominates
individuals who are subsequently elected by the
members of the Council of
Experts to serve as Expert Committee
members. Collectively, the Expert Committee Chairs
and
members comprise more than 500
volunteers drawn from 50 countries. The 41
Standards Expert
Committees are
responsible for the content of
USP
–
NF, the Food Chemicals
Codex
and associated
publications and organized in
Collaborative Groups for topics of common
interest.
专家委员会
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