中国药典附录Ⅰ(A-Z)中英文对照

A)

测定，按下式计算，应符合各品种项下的

有关规定。

Relative

density

Unless

specified

otherwise,

Weigh

accurately

a

sufficient

quantity

of

concentrated

decoction

being

examined,

dilute

with

double

quantities

of

water,

weigh

accurately

and

mix

well.

Carry

out

the

determination

of

relative

density

(Appendix

Ⅶ

A),calculate

by

the

following

formula.

Should

comply

with

the

requirements

under

individual monograph.

供试品相对密 度

=

W

1

?< /p>

W

1

?

f

W

2

?

1

?

f

Relative density of-W1-W1

×

f

concentrated decoction-W2-W1

×

f

式中

W

1

为比重瓶内供试品溶液的重量，

g

；< /p>

Where W

1

is the weight (g) of concentrated decoction in pycnometer;

W

2

为比重瓶内水的重量，

g

W

2

is the weight (g) of water in pycnometer. weight of water added in

f

?

加入供试品中的水重量

供试品重量< /p>

?

加入供试品中的水重量

f

?

weight

of

water

added

in

concentrat

ed

decoction

weight

of

concentrat

ed

decoction

?

weight

of

water

added

in

concentrat

ed

decoction

凡加药材细粉的煎膏剂，不检查相对密度。

It

is

not

necessary

to

examine

the

relative

density

when

the

concentrated

decoctions

contain fine powder of crude drugs.

【不溶物】

取供试品

5g,

加热水

200ml

，搅 拌使溶化，放臵

3

分钟后观察，不得有焦屑等

< br>异物（微量细小纤维、颗粒不在此限）

。

Insoluble materials

To 5g of the concentrated decoction add 200 ml of hot water, stir

to

dissolve,

allow

to

stand

for

3

minutes,

and

observe.

No

foreign

matters

such

as

scorched masses, etc. should be observed (a small amount of fine fibres and particles

are not defined in this limit).

加药材细粉的煎膏剂，应在未加人 药粉前检查，符合规定后方可加人药粉。加人药粉后不

再检查不溶物。

< br>

The concentrated decoction containing fine powder of crude drugs should be examined

before the powder is added. The powder is added if it complies with the requirements. It

is not necessary to examine the insoluble materials after the powder is added.

【装量】

照最低装量检查法（附录

Ⅻ

C)

检查，应符合规定。

Filling

Carry out the test for Minimum Fill (Appendix

Ⅻ

C),it should comply with the

specified requirement.

【微生物限度】

照微生物限度检查法（附录

XIII

C)

检查，应符合规定。

Microbial limit test

Comply with the requirements stated under Microbial Limit Tests

(Appendix XIII C).

（胶剂）

Ⅰ

G

Glues

胶剂系指动物皮、骨、甲 或角用水煎取胶质，浓缩成稠胶状，经干燥后制成的固体块状内

服制剂。

Glues

are

solid

lump

preparations

intended

for

internal

administration,

prepared

by

decocting animal skin, bone, shell or born with water, concentrating into thick gelatinous

mass and then drying.

胶剂在生产与贮藏期间应符合下列有关规定。

The production and storage of glues should comply with the following requirements.

一、胶剂所用原料应用水漂洗或浸漂，除去非药用部分，切成小块或锯成小段，再漂净。

and rinse the raw materials for the preparation of glues in water, remove foreign

matters or non medicinal parts, cut into small lumps or saw into small pieces, then wash

clean.

二、加水煎煮数次至煎煮 液清淡为度，合并煎煮液，静臵，滤过，浓缩。浓缩后的胶液在

常温下应能凝固。

with

water

for

several

times

until

the

decoction

becomes

light,

combine

the

decoctions, allow to stand, filter and concentrate the filtrate. The concentrated gelatinous

liquid should be able to coagulate under normal temperature.

三、胶凝前，可按各品种制法项下规定加入适量辅料（黄酒、冰糖、食用植物油等）

the glues begin to coagulate, add a suitable amount of excipients (yellow rice

wine,

crystal

sugar,

edible

vegetable

oil,

etc.),

according

to

the

requirements

for

processing specified in individual monograph.

四、胶凝后，按规定重量切成块状，阴干。

the glues coagulate, cut into lumps by weight as required and dry in the shade.

五、胶剂应为色泽均匀、无异常臭味的半透明固体。

should

be

translucent,

uniform

in

appearance

and

colour,

without

abnormal

odour.

六、一般应检查总灰分、重金属、砷盐等。

general, total ash, heavy metals, arsenic salts etc. should be determined

七、胶剂应密闭贮存、防止受潮。

should be preserved in well closed containers and protected from moisture.

胶剂应进行以下相应检查。

Following relevant tests should be carried out for glues.

【水分】

取供试品

lg

，臵扁形称量瓶中，精密 称定，加水

2ml,

臵水浴上加热使溶解后再

< br>干燥

,

使厚度不超过

2mm,< /p>

照水分测定法（附录Ⅸ

H

第一法）测定 ，不得过

15.0

％。

Determination of water

Put 1g of gules into the flat weighing bottle, weigh accurately,

add 2ml of water, then heat it in the water bath to dissolve it, and then dry it. Make sure

the thickness is not more than 2 mm. carry out the method for the determination of water

(Appendix

Ⅸ

H, method 1),the glues contain not more than 15.0 per cent of water.

【微生物限度】

照微生物限度检查法（附录

XIII

C)

检查，应符合规定。

Microbial

limit

test

Comply

with

the

requirements

stated

under

Microbial

Limit

Test

(Appendix XIII C).

（糖浆剂）

Ⅰ

H

Syrups

糖浆剂系指含有药材提取物的浓蔗糖水溶液。

Syrups

are

concentrated

aqueous

solutions

of

sucrose

containing

extracts

of

crude

drugs;

糖浆剂在生产与贮藏期间应符合下列有关规定。

The production and storage of syrups should comply with the following requirements.

一、含蔗糖量应不低于

45

％（

g/ml

）

。

should contain not less than 45per cent (g/ml)of sucrose

二、药材应按各品种项下规定的方法提 取、纯化、浓缩至一定体积，或将药物用新煮沸过

的水溶解。加入单糖浆；如直接加入蔗 糖配制，则需煮沸，必要时滤过，并自滤器上添加

适量新煮沸过的水至处方规定量。

crude

drugs

should

be extracted,

purified

and

concentrated

to

a

certain

volume

using the appropriate methods specified under the individual monograph, or drugs are

dissolved

with

freshly

boiled

water,

and

then

added

with

simple

syrups

are

prepared with solid sucrose, water is added and boiled and filtered, a suitable amount of

freshly boiled water may be added to the filtrate to comply with the labelled amount of

drugs described in individual monograph, then mixed well.

三、可加入适宜的附加剂 。如需加入防腐剂，山梨酸和苯甲酸的用量不得超过

0.3

％< /p>

(

其钾

盐、钠盐的用量分别按酸计）

，对羟基苯甲酸酯类的用最不得超过

0.05

％，如需加入其他

附加剂，其品种与用量应符合国家标准的有关规定，不影响成品的稳 定性，并应避免对检

验产生干扰。必要时可加入适量的乙醇、甘油或其他多元醇。

le additives may be added to syrups. If preservatives are needed, the amount of

sorbic acid and benzoic acid should not be more than 0.3% (its potassium or sodium salt

should be taken by the acid amount),or the amount of

p

-hydroxybenzoic acid esters, not

more than 0.05%.

If

other

additives

are

added,

the

varieties

and

amount

used

should

comply

with

the

requirements involved in national standards and do not interfere with stability and testing

of the preparation concerned. Suitable amount of ethanol, glycerin or other poly-alcohols

may be added if necessary.

四、除另有规定外，糖浆剂应澄清。在贮存期间不得有发霉、酸 败、产生气体或其他变质

现象，允许有少量摇之易散的沉淀。

should

be

clean,

unless

specified

otherwise.

No

mold

contamination,

rancid,

gas

or

other

deteriorations

are

allowed

during

storage.

A

small

amount

of

dispersible

precipitates are allowed.

五、一般应检查相对密度、

pH

general, relative density, pH value etc. should be determined.

六、除另有规定外，糖浆剂应密封，臵阴凉处贮存。

should be preserved in tightly closed containers. Stored in a cool place, unless

specified otherwise.

糖浆剂应进行以下相应检查。

Following relevant tests should be carried out for syrups.

【装量】

单剂量灌装的糖浆剂，照下述方法检查应符合规定。

Filling

Syrups packed in a single doe should comply with the following test.

检查法

取供试品

< br>5

支，将内容物分别倒人经校正的干燥量筒内，尽量倾净。在室温下检

1

的

95%

。

Procedure

Take

5

bottles

of

syrup,

pour

the

content

separately

to

the

calibrated

dry

graduated

cylinders,

remove

as

completely

as

possible examine at

room

temperature.

Compare the filling volume of each pack with the labeled amount. Not more than 1 bottle

in volume is less than the labelled amount, none is less than 95 per cent of the labeled

amount.

多剂量灌装的糖浆剂，照最低装量检查法（附录Ⅻ

C)

检查，应符合规定。

Syrups

packed

in

multiple

doses

comply

with

the

requirements

stated

in

Minimum

Fill(Appendix

Ⅻ

C)

【微生物限度】

照微生物限度检查法（附录

XIII

C

）检查，应符合规定。

Microb

i

al limit test

Comply with the requirements stated under Microbial Limit Tests

(Appendix XIII C).

（贴膏剂）

Ⅰ

I

Cataplasms

贴膏剂系指药 材提取物、药材或和化学药物与适宜的基质和基材制成的供皮肤贴敷，可产

生局部或全身 性作用的一类片状外用制剂。包括橡胶膏剂、巴布膏剂和贴剂等。

Cataplasms are sheet preparations made of extract of crude drugs, crude drugs or (and)

chemical

medicaments

and

appropriate

bases,

intended

for

application

to

skin,

may

produce local or general effects, including adhesive plasters, babu plasters and sticking

plasters etc..

橡胶膏剂 系指药材提取物或和化学药物与橡胶等基质混匀后，涂布于背衬材料上制成的贴

膏剂。橡 胶膏剂的制备方法常用的有溶剂法和热压法。常用溶剂为汽油、正已烷，常用基

质有橡胶 、热可塑性橡胶、松香、松香衍生物、凡土林、羊毛脂和氧化锌等。也可用其他

适宜溶剂 和基质。

Adhesive plasters are cataplasms prepared by mixing the extract of crude drugs or (and)

chemical medicaments with bases to the backing materials. The preparation methods of

this

agent

consist

of

solvents

method

and

hot-pressing

method.

The

commonly

used

solvents

consist

of

gasoline,

n-hexane,

and

commonly

used

bases

consist

of

rubber,

hot-plastic

rubber,

rosin,

rosin

derivatives,

vaselin,

lanoline

and

zine

oxide

etc..

Other

appropriate

solvents

and

bases

are

applicable.

Consist

of

ethylene/vinyl

acetate

copolymer, silicone rubber and polyethylene glycol etc.

巴布膏 剂系指药材提取物、药材或和化学药物与适宜的亲水性基质混匀后，涂布于背衬材

料上制 成的贴膏剂。常用基质有聚丙烯酸钠、羧甲基纤维素钠、明胶、甘油和微粉硅胶等。

Babu plasters are cataplasms prepared by well mixing the extract of crude drugs, crude

drugs or (and) chemical medicaments with appropriate hydrophilic bases, then spreading

to

the

backing

materials.

The

commonly

used

bases

consist

of

sodium

carboxymethylcellcdose, gelatin, glyce- rine, microniting silica gel and so on.

贴剂系指药材提取物或和化学药物与适宜的高分子材科制成的一种薄片状贴膏剂。主要由

背衬层、药物贮库层、粘胶层以及防粘层组成。常用基质有乙烯

-

醋酸乙烯共聚物、硅橡胶

和聚乙二醇等。

Sticking

plasters

are

lamellifom

cataplasms

made

of

extract

of

crude

drags

or

(and

)

chemical medicaments, and appropriate macromolecular materials mainly composed of

backing

liner,

drug-veserving

liner,

sticking

liner

and

anti- sticking

liner.

The

commonly

used

bases

consist

of

ethylene/vinyl

acetate

copolymer,

silicone

rubber,

and

polyethylene glycol etc..

贴膏 剂常用的背衬材料有棉布、无纺布、纸等；常用的盖衬材料有防粘纸、塑科薄膜、铝

箔< /p>

-

聚乙烯复合膜、硬质纱布等。

The

commonly

used

backing

materials

for

cataplasms

consist

of

calico,

non-weaving

cloth, paper and so on; commonly used covering materials consist of anti-sticking paper,

plastic film, aluminum foil, polyethylene compound film, hard gauze and so on.

贴膏剂在生产与贮藏期间应符合下列有关规定。

Production and storage of cataplasms should comply with the following requirements.

一、药材提取物应按各品种项下规定的方法进行提取。除另有规定外，固体药物应预先粉

碎成细粉或溶于适宜的溶剂中。

extracts of crude drugs are produced using the methods stated under individual

monographs. Unless specified otherwise, solid medicament should be finely powdered

previously or dissolved in a suitable solvent.

二、贴膏剂必要时可加入透皮促进剂、表面活性剂、保湿剂、防腐剂 或抗氧剂等。

erme

promoting

agents,

surfactants,

stabiliyers,

hygroscopic

agents,

preservatives, antioxidants may be added in cataplasms, if necessary.

三、贴膏 剂的膏料应涂布均匀，膏面应光洁，色泽一致，无脱膏、失黏现象；背衬面应平

整、洁净 、无漏膏现象。涂布中若使用有机溶剂的，必要时应检查残留溶剂。

plasters

of

cataplasms

should

be

spreaded

uniformly,

the

surface

should

be

smooth and clean, uniform in colour, not unglued and unviscous; Backing liner should be

smooth

and

clean,

no

plaster

leaked.

When

organic

solvents

are

used

in

spreading,

solvent residues should be examined if necessary.

四、贴膏剂每 片的长度和宽度，按中线部位测量，均不得小于标示尺寸。

length and width of each piece of a cataplasm, measured by the mid-line, are not

less than those labeled.

五、除另有规定外，贴膏剂应密封贮存。

specified

otherwise,

Cataplasms

should

be

preserved

in

tightly

closed

containers.

贴膏剂应进行以下相应检查。

Following relevant tests should be carried out for cataplasms.

【含膏量】

橡胶膏剂照第一法检查，巴布膏剂照第二法检查。

Extractives in plaster mass

Adhesive plasters are tested by Method 1, babu plasters

by method 2.

第一法

取供 试品

2

片（每片面积大于

35cm

的应切取

35cm

),

除去盖衬，精密称定，臵于

有盖玻璃容器中加适量有机溶剂（如三氯甲烷、乙醚等） 浸渍，并时时振摇，待背衬与膏

料分离后，将背衬取出，用上述溶剂洗涤至背衬无残附膏 料，挥去溶剂，在

105

℃干燥

30< /p>

分钟，移臵干燥器中，冷却

30

分钟。精 密称定，减失重量即为膏重，按标示面积换算成

100cm

2< /p>

的含膏量，应符合各品种项下的有关规定。

Method

1

Take

2

pieces

of

cataplasm

(take

35cm

2

for

the

cataplasms

larger

than

35cm

2

in area),remove the covering liner, weigh accurately and put into a terrarium with

cover macerate in suitable quantity of organic solvent (chloroform, aether etc.) and shake

over and again until cataplasm separates from the cloth. Take out the cloth and wash

with above solvents until no cataplasm remains on it. Remove the solvent and dry the

cloth

at

the

temperature

of

105

℃

for

30

minutes,

transfer

the

cloth

to

the

desiccator.

After

cooling

for

30

minutes,

weigh

accurately,

the

cloth.

The

difference

between

the

weightings is the weight of cataplasm. Calculate the weight per 100 cm

2

of the cataplasm

by the labelled area. The result should comply with the requirement specified in individual

monograph.

第二法

取供试品

< br>1

片，除去盖衬，精密称定，臵烧杯中加适量水，加热煮沸至背衬与膏