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1
、
Digitalis is one of
the most frequently used medications in the
treatment of heart
failure and
arrhythmia. It increases the contractility of the
heart muscle and modifies
vascular
resistance. It also slows conduction through the
atrioventricular node in the
heart,
making
it
useful
in
the
treatment
of
atrial
fibrillation
and
other
rapid
heart
rhythms
洋地黄是其中一个最常用的药物治疗心力衰竭
和心律失常。
它增加了的心肌收
缩血管阻力和修改。
它也减慢传导通过传导节点的心使它有用的治疗房颤和其他
快速心律
2
、
The
formulation of a parenteral product involves the
combination of one or more
ingredients
with a medicinal agent to
enhance the convenience
，
acce
ptability
，
or effectiveness
of
the product. Rarely is it preferable
to dispense a drug singly as a sterile dry powder
unless the formulation of a stable
liquid preparation is not possible
非肠道用
产品的配方涉及一个或者更多组成部分间的结合，
这些组成部分
（各自）
都含有一种用以提高产品方便性、可接受性或者疗效的有效成分。
（人们）很少
愿意把药物仅仅以一种无菌的、干燥的粉末（的形式）配售，除
非（把它做成）
稳定的液体制剂的配方是行不通的。
3
、
Production
生产
The
production
process
includes
all
of
the
steps
from
the
accumulation
and
combining
of
the
ingredients
of
the
formula
to
the
enclosing
of
the
product
in
the
individual
container
for
distribution.
Intimately
associated
with
these
processes
are
the personnel who carry
them out and the facilities in which they are
performed. The
most ideally planned
processes can be rendered ineffective by personnel
who do not
have the right attitude or
training
，
or by facilities
that do not provide an efficiently
controlled environment.
生产过程包括从配方的各个组成部分的积聚和结合到产品封装入用于分售
的单个包装内的所有步骤。
和这些过程有紧密联系的是搬运人员和执行这些步骤
的设备。
计划出来的最理想的过程也会因为没有正确态度或没有接受正
确培训的
人员或者不能提供一个有效的控制环境的设备而变得无效。
To
enhance
the
assurance
of
successful
manufacturing
operation
，
all
process
steps must be
carefully
reduced to
writing
after
being shown to
be
effective. These
written
process
steps
are
often
called
standard.
operating
procedures
(SOPs)
⑥
.No
extemporaneous
changes are
permitted to
be made in
these procedures;
any
change
must
go
through
the
same
approval
steps
as
the
original
written
SOP.
Further
，
extensive
records must be kept to give assurance at the end
of the production process
that all
steps have been performed as
prescribed
，
an aspect
emphasized in the FDA's
Good
Manufacturing
Practices.
Such
in-process
control
is
essential
to
assuring
the
quality of the
product
，
since these
assurances are
even more significant
than those
from
product
release
testing.
The
production
of .a
quality
product
is
a
result
of
the
continuous
,dedicated effort of the quality assurance
< br>，
production
，
an
d quality control
personnel within the
plant in developing
，
performi
ng
，
and confirming effective
sops
为了增加成功的生产操作的保证，
所有的过程步骤在
证明是有效的之后都要
仔细地归纳成书面材料，
这些书面的过程
步骤经常被称为标准操作规程
（
SOPs
）
。
这些规程是不允许进行临时改动的
,
任何改动都必须经过和原有的书面规程一样
的证明步骤的证
明。
而且，
还需要做大量的记录，
以便
在生产过程的最后用来保
证：
所有的步骤都是按照规定执行的。
这是美国食品及药物管理局药品生产质量
管理规范
,
这样的过程中的控制是必不可少的保证了产品的质量，因为这些保证
甚至比那些从产物释放测试更显著。
，高品
质的产品的生产厂在开发，执行，
并确认有效的
SOP
中的质量保证，生产和质量控制人员的连续，专用努力的结
果
4
、
Reactor
technology
comprises
the
underlying
principles
of
chemical
reaction
engineering(CRE)and
the
practices
used
in
their
application.
The
focuses
of
reactor
technology
are
reactor
confi
gurations
，
operating
< br>conditions
，
external
operating
environments
，
developmental
history
，
industrial
application
，
and evolutionary
change.
Reactor designs evolve from the
pursuit of new products and
uses
，
higher
conversion
，
more favorable
reaction selectivity
，
reduced
fixed and operating
costs
，
intrinsically
safe
operation
，
and
environmentally acceptable processing
反
应堆技术包括化学反应工程（
CRE
）
，并在其应用程序中使用的惯例的基本原
则。反应器技术的重点是反应器构型，经营状况
，外部经营环境，发展历史，工
业应用和进化改变。
反应堆设计
从追求新产品和用途的发展，
更高的转换，
更有
利的反应选择性，
减少了固定和运营成本，
本质安全的
操作，
并符合环保要求处
理
5
、
Drug
development aims to produce a novel therapeutic
agent which is superior in
efficacy
to
existing
remedies
and
which
causes
less
frequent
or
less
severe
adverse
effects.
药物研制旨在生
产出在疗效上优于现存药品，且副作用发生率减少、程度降低
的新型治疗药物。
6
、
Phase 1
involves small scale studies in normal volunteers.
These studies should
determine whether
the drug can be given to man without serious
symptoms or toxicity,
and whether it
has desired pharmacological effects .These studies
often begin with a
dose ranging study,
using 1/50 to 1/100 the effective dose in animals
and increasing
until
the
desired
effect,
or
adverse
effects,
are
seen.
These
studies
should
only
be
performed
on
volunteers
who
are
informed
about
the
implications
of
the
tests,
and
who
give
their
consent
freely
Studies
should
include
careful
assessment
of
clinical,
haematological
evidence
before
and
after
drug
administration
to
identify
pharmacological
actions
and
adverse
effects.
Phase
1
studies
should
only
be
performed
by
experienced
staff,
under
medical
supervision,
and
in
premises
with
appropriate resuscitative facilities
and support.
第一阶段，
新药小规模运用在正常志愿者身上的研究。
这个阶段的研究应确定
< br>药物是否能让正常人产生严重副反应和毒性反应，以及能否有明显的药理作用。
这
些研究往往从一个剂量范围开始，在
1/100
到
1/50
范围内的动物有效剂量开
始逐次增加使用剂量，
直到出现明显药
理作用或者副作用为止。
这些研究只能在
这样的志愿者身上进行
，
他们应该了解实验的影响并且自愿同意进行实验。
研究
还应包括仔细的评估临床，
根据实验前后的血药浓度来确定的药物的药
理作用及
不良影响。
这一阶段的研究只能在有经验的工作人员和
医生监督下进行，
并且有
抢救设备和复苏技术的支持。
Phase
2
studies
determine
whether
the
new
drug
has
the
desired
effect
on
patients
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