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EP
7.5
SUBSTANCES FOR PHARMACEUTICAL USE
药用物质
DEFINITION
定义
Substances for pharmaceutical use are any organic or inorganic substances that are used
as active substances or excipients for the production of medicinal products for human or
veterinary
use.
They
may
be
obtained
from
natural
sources
or
produced
by
extraction
from raw materials, fermentation or synthesis.
药用物质是指人用或兽用医疗产品生产中所使用的活性物质或辅料，
其可能是有机的或无机
的物质。这些物质可能是从自然途径获取，或从原料中萃取、发酵或合成得到。
This general monograph does not apply to herbal drugs, herbal drugs for homoeopathic
preparations,
herbal
drug
preparations,
extracts,
or
mother
tinctures
for
homoeopathic
preparations, which are the subject of separate general monographs (Herbal drugs (1433),
Herbal drugs for homoegopathic
preparations
(2045),
Herbal drug
preparations
(1434),
Extracts (0765), Mother tinctures for homoeopathic preparations (2029)). It does not apply
to
raw
materials
for
homoeopathic
preparations,
except
where
there
is
an
individual
monograph for the substance in the non-homoeopathic part of the Pharmacopoeia.
本通论不适用于草药制品、顺势疗法制剂用草药、
草药制剂、
提取物、
或顺势闻法制剂的药
酒母体，这些品种应参照各自的各论（草药制品（
1433
）、顺势疗法制剂用草药（
2045
）、
草药制剂（
1434
）、提取物（
0765
）、或顺势闻法制剂的药酒母体（
2029
））。也不适用
于顺势疗法制剂用的原料，除非在药典的非顺势疗法部分另有各论。
Where a substance for pharmaceutical use not described in an individual monograph of
the
Pharmacopoeia
is
used
in
a
medicinal
product
prepared
for
the
special
needs
of
individual
patients,
the
need
for
compliance
with
the
present
general
monograph
is
decided in the light of a risk assessment that takes account of the available quality of the
substance and its intended use.
如果某种药用物质在药典里没有各论，
这种物质用于满足个别病人的特殊需求的医疗产品制
备，
则应该考虑可以获得的该物质的质量及其用途，
基于风险评估来决定该药用物质需符合
的相关总论要求，且该物质应满足这些要求。
Where medicinal products are manufactured using substances for pharmaceutical use of
human or animal origin, the requirements of chapter 5.1.7. Viral safety apply.
如果药品生产中使用的药用物质是人类或动物来源，则需要满足
5.1.7
病毒安全性
的要求