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(芳香水劑)
References:
Remington: The Science and Practice of
Pharmacy,2013, Chap. 39.
Pharmaceutical Dosage Forms and Drug
Delivery Systems, 8th edition, Chap. 13
1
Definition
The USP defines Aromatic Waters as clear,
saturated aqueous solutions (unless otherwise
specified) of volatile oils or other aromatic or
volatile substances.
They are free from empyreumatic and other
foreign odors.
They are used principally as flavored or perfumed
vehicles.
2
Preparation Methods
I. Official Processes
a) Distillation
It is the most satisfactory but the slowest and
expensive method.
drug / distillate ratio
fresh drugs 1/2~2/1
dried drugs (e.g., cinnamon, 1 / 10
dill, anise, caraway, fennel)
dried leaf (e.g., peppermint) 3 / 10
»Use Purified Water as distillation vehicle.
»After distillation, any excess oil in the distillate is
removed and, if necessary, the clear-water portion
3 is filtered.
»If the volatile principles in water are delicate and
present in small quantities (e.g., as in orange
flower and rose water), the distillate is returned
several times to the still with fresh portions of
flowers. So-called double distilled, triply distilled,
or quadruple distilled.
Such process is called cohobation*.
»Cohobation is applied to preparation such as
Strong Rose Water.
5
II. Alternative Methods
1) By dissolving well-defined substances
in purified water.
E.g., Camphor water
2) By incorporating the volatile oil with 15
g talc or with a sufficient quantity of
purified siliceous earth or pulped filter
paper. Purified water (1000 mL) is added
and the mixture is agitated for 10 min.
6
Why using talc, purified siliceous earth or
pulped filter paper?
Greatly increases the surface of the
volatile substances, insuring more rapid
saturation of water.
These dispersing substances form an
efficient filter bed, which produces a
clear solution.
They are unreactive.
7
3) Use of soluble concentrates.
Examples of preparing concentrated
waters such as peppermint, dill,
cinnamon, caraway and anise:
Dissolve 20 mL of the volatile oil in 600
mL of 90% ethanol add purified
water in successive small portions to
1000 mL (shake vigorously after each
addition) add 50 g of sterilized talc
shake occasionally for hours and filter
8
4) Incorporation of solubilization agents
such as polysorbate 20 (Tween 20).
To be susceptible to mold growth
In concentration higher than 2%,
impart an objectionable oily taste.
12
Distilled and boiled water should be used
in the preparation of medicated waters.
(∵Distilled water may be contaminated
with mold-producing organisms.)
No preservative should be added to
medicated waters.
If deterioration occurred, the aromatic
water should be discarded.
13
芳香水劑 (中華藥典第七版)
芳香水劑為揮發油或其他芳香性或揮發性物
質之澄明飽和水溶液,除另有規定外,其臭與
味均與原使用之揮發性物質之臭與味相同,且
不得有焦臭或其他異臭。除另有規定外,可依
下列任何一法製得之:
一、蒸餾法-取供用之芳香植物或藥品100 g,
置適當蒸餾器中,加水2,000 mL蒸餾之。注
意蒸餾之溫度不可過高,以免燒焦而致產品
留有焦臭。將最初所得之餾出液1,000 mL,
傾回蒸餾器內再行蒸餾,收集餾出液達1,000
mL。並自餾出液中分離析出之油液,取用澄
明水溶液部分。必要時,用潤濕之濾紙過濾,
14 即得。
二、振搖法(1)-本法製造時所用之原料及其用量如下:
揮發油或其他揮發物質 2 mL或2 g
蒸餾水 適量
共製 1,000 mL
取揮發性物質(如為固體應先研成細粉),置適當容器中,
加蒸餾水1,000 mL反復振搖約十五分鐘,然後靜置十二小
時以上,用潤濕之濾紙,反復過濾至濾液澄明為止,再經
濾紙加適量之蒸餾水,使全量達1,000 mL,即得。
三、振搖法(2)-取揮發性物質(如為固體應先行研成細粉)
2 mL或2 g,加精製滑石粉15g或適量之精製矽土或濾紙
漿,研和均勻,加蒸餾水1,000 mL,用力振搖十分鐘,
使之完全混合。然後將混合物用潤濕之濾紙反覆過濾,
直至濾液澄明為止,再經濾紙加適量蒸餾水,使全量達
1,000 mL,即得。
15 貯藏法-芳香水劑應置緊密阻光容器內,於低溫處貯之。