Extractives

Tinctures（酊劑）Fluidextracts（流浸膏劑）
Extracts （浸膏劑）

Reference:
Remington: The Science and Practice of
Pharmacy, 2013, Chap. 39

1
  Extraction
 Extraction involves the separation of
medicinally active portions of plant or animal
tissues from the inactive or inert components
by using selective solvents in standard
extraction procedures.
 The products obtained from plants are relatively
impure liquids, semisolids, or powders intended
only for oral or external use.
 These include classes of preparation known as
decoctions, infusions, fluidextracts, tinctures,
pilular (semisolid) extracts, and powdered
extracts. Such preparations popularly have
been called galenicals (草藥、植物製劑), after
Galen, the second century Greek physician.
2
  Menstruum - Selective solvent or solvent
mixture to extract desired therapeutical portion
from crude drugs.
 Principle methods of extraction include:
maceration（浸漬）; percolation（滲漉）;
digestion; infusion; and decoction（煎煮）.

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 Maceration （浸漬法）
 Maceration is a process of extraction by soaking
properly comminuted drug or substance in the
menstruum until the cellular structure is thoroughly
penetrated and the soluble portions are softened
and dissolved.
 In this process the solid ingredients are placed in a
stoppered container with 750 mL of the prescribed
solvent and allowed to stand for a period of at least
3 days in a warm place with frequent agitation,
until soluble matter is dissolved. The mixture is
filtered and the residue on the filter is washed with
sufficient quantity of the prescribed solvent or
solvent mixture; the filtrates are combined to
produce 1000 mL.
4
 The menstruum may consist of alcohol of
various strengths, ether, ether and alcohol, or
other specified solvent
 Maceration must be used in the extraction for
some drugs especially for those containing little
or no cellular structure such as benzoin（安息
香）, aloe（蘆薈）, Styrax （安息香屬）之 storax
（蘇合香脂、安息香脂）, tolu（妥魯香膠）, etc.
Maceration is usually conducted at a
temperature of 15~20 C.
Due to the difficulty of extracting completely,
the maceration process is repeated with the
same or different solvent.  Double
maceration; Triple maceration; Repeated
5 maceration
 Percolation（滲漉法，Lixiviation）
Per, meaning “through” and colare,
meaning “to strain”

 Ground solids are mixed solvent to make it

evenly and uniformly damp and allowed to stand
for 15 minutes, then transferred to a percolator
and packed. Add sufficient solvent to saturate
the solids.
 The top is placed on the percolator, and, when
the liquid is about to drip from the apparatus, the
lower opening is closed.
 The solids are allowed to macerate for 24 hours
or for the specified time.

6
 Percolation（滲漉法，Lixiviation）
 The percolation is allowed to proceed slowly or
at the specified rate, gradually adding sufficient
solvent to produce 1000 mL of solution.
 If an assay is required, only 950 mL of percolate
are collected and mixed and a portion assayed
as directed. The rest of the percolate is diluted
with the solvent to produce a solution that
conforms to the required standard and then
mixed.
 The major physical forces involved in
percolation are: Gravitation; Viscosity;
Adhesion; Friction; Osmosis; Capillarity;
Surface tension; etc.
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 Four major components in percolation:
Percolator – the apparatus used to hold the
powder
Menstruum – liquid poured on top of the
powder
Percolate – the liquid coming from the
percolator impregnated with the soluble
principles; the extractive collected
Marc – the residual drug remaining in the
percolator after the extraction

8
Points Concern in Percolation (Small-
Scale Percolation)
Shape of the Percolator
(A)Official - first definitely fixed by USP of 1880
(B)Glass cylindrical percolator
(C)Oldberg percolator
(D)Conical percolator – a glass funnel

9
 Selecting a percolator:
Fluidextracts – a comparatively narrow percolator
should be chosen, (due to that the menstruum
should traverse a high column of powder) ---A
If place a powder, which contains a large quantity
of soluble materials, in a narrow percolator  the
percolate may become so dense that it would
cease to descend  need a wider percolator for
such powder ---B
Tincture and weaker preparation require wider
percolator ---C

Fluidextract: A;
Strong Tincture: B;
10
Weak Tincture: C
 The size of percolator selected should be in
proportion to the quantity of drug extracted.
When properly packed, the drug should not
occupy more than 2/3 of the height of the
percolator.

Comminution
Degree of comminution for each substance
depends on:
 the physical structure of the drug,
 the ease with which the menstruum dissolves
the desirable constituents,
 the length of time required to exhaust the
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powder
 Example: Assume there are two preparation
conditions of different relative proportion of
menstruum to drug :
 preparation : 100 volumes is used to exhaust
100 parts by weight of the drug, and
 preparation : 100 volumes is used to exhaust
10 parts by weight of the drug

The powder of preparation  should be finer

than that of preparation .

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 Moistening the Powder
 It is the step almost required before packing the
powder in percolation.
e.g.: dry sponge and wet sponge
 Vegetable drugs are naturally containing moisture,
however, the tissues have been hardened and
dried after desiccation.  They absorb moisture
very slowly, even under compression (i.e., packing
in percolator).
 The passage of water (or solvent) may be prevented
by the swollen effect of drugs after immediately
contacted with water.  Drugs swelled to a degree
that they pass tightly against the sides of percolator
and thus entirely overcome the force of gravity and
the penetration power of water.
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  Pre-moisten the drug powder with sufficient
water, and then pack the powder into percolator,
water would be allowed to pass through by slow
percolation with stoppage.

 In some conditions moistening is not allowed,

i.e.,
 addition of menstruum may cause
adhesiveness and cause the powder to form
lumps;
 moistened powder is too little resistance to
the passage of menstruum;
 the menstruum is too volatile or too
flammable, etc.

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 Packing the Powder
No special directions -
“Pack it moderately”
“Pack firmly”
It is suggested that does not
moisten the cotton or cork
with water unless the
menstruum is aqueous.
The moistened powder should be
deposited carefully in the
percolator in layers.

15
 Notched cork
Scored filtering paper
(must be slightly larger
than the cork and the
edges are deflected up
the sides)
Packer

16
 Pretreatment of the Ground Drug
 In some cases, it is necessary to remove the waxes
and fixed oils from the ground drug.
 A preliminary extraction with petroleum benzin is
performed on ergot, digitalis, and certain other
drugs.

Adding the Menstruum

 A sheet of filtering paper, scored at the edges
and slightly larger than the surface of the
powder is laid on the top of the powder in
percolator.
 A weight of some kind is usually placed on the
paper to keep it from floating.  Clean pebble
(卵石); bottle stopper; small glass funnel; glass
17 percolator weight
18
 Previous Maceration
It is recommended to carry out a previous
maceration before percolation for the drugs
those have a tough structure, the soluble
principle are not easily extracted by menstruum,
or a comparatively large quantity of powder is to
be exhausted by a small quantity of menstruum.

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 Finishing the Process
“percolate to exhaustion” – have to know the
active principles of the drug beforehand.
How to determine?
A few examples:
 The absence of bitterness in the percolate
 The absence of color in the percolate
 The absence of astringency in the percolate,
(for the drugs that tannin is the principle
component)
 A quantitative test – residual alkaloid content
determination; color determination; a test for
tannins.
 The absence of precipitation when the percolate

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is dropped into water – The exhaustion of resins
in drugs.
 The Menstruum
Proper solvent or solvent combination
aids to attain a maximum of active constituents
and a minimum of undesired constituents in the
finished extract.
Choice of Solvent
Alcohol – solvent of choice; low toxicity internally;
low latent heat of evaporation
Water
Glycerin
Alkalis and acids – adjust the pH of the solvent of
finished product
Absorbed Menstruum
The amount of menstruum absorbed and retained
after percolation.
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 Controlling the Flow of the Percolate

Rate of Flow
For official preparations definite
rate of flow is prescribed.
For preparations made by
percolation, using 1000 g of
powder, the rate of flow should
not exceed of 5 mL/min.
The terms used to describe rate of flow have the
official meanings:
slowly – 1 mL/min
at a moderate rate – 1-3 mL/min
rapidly – 3-5 mL/min
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 酊 劑
酊劑為生藥或化學藥品，經滲漉法、浸漬法或溶
液法製成之一種乙醇溶液，或含水乙醇溶液。
其所含藥品成分，除另有規定外，依照下列規定
標準：
(1)劇藥之酊劑，每100 mL代表藥品10 g之效能。
(2)普通藥品之酊劑，每l00 mL代表藥品20 g之
效能。
(3)由新鮮生藥製成之酊劑，每100 mL代表生藥
50 g之效能。
(4)複方酊劑多係根據規定成分製備，無一定濃
度規定。

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 酊劑之製法，除正文另有規定外，通常有下列三種：

(1)滲漉法－取供製造酊劑之藥品粉末，小心混和，
以規定之浸溶劑適量充分濕潤之，放置十五分鐘，
然後移置於適當之滲漉器內，均勻壓平，覆以濾
紙，加入足量之浸溶劑，使藥粉充分飽和，將滲
漉器上口加蓋，開放下出口，俟滲出液開始滴出
時，關閉下出口，靜置浸漬廿四小時(或特別指定
之時間)。如毋須測定含量者，即徐徐滲漉或按規
定之滲漉速率滲漉之，並不斷補充浸溶劑，至滲
出液全量達1,000 mL為止，混合均勻，即得，如
須測定含量者，則收集滲出液達950 mL時，混合
均勻，取其中小部分，依照含量測定法測定其含
量，然後按照測定之結果，以適量之規定浸溶劑
稀釋，調整其含量，使符合規定標準，混和均勻，
24 即得。
 (2)浸漬法－取供製造酊劑之藥品粉末，置適當之有蓋容器
內，加規定之浸溶劑750mL，在溫暖處，密蓋容器，時
時予以振搖，浸漬三日，或至有效成分完全浸出為止，
然後過濾，至大部分濾液濾出後，由濾器添加適量之浸
溶劑，以洗滌濾渣，合併濾液，使全量達1,000 mL，混
合均勻，即得。
(3)溶液法－取供製造酊劑之藥品粉末，加適量之規定浸溶
劑溶解，使全量達1,000 mL，必要時過濾，混合均勻，
即得。如須測定含量者，先製成溶液950 mL，混合均
勻，取其中小部分，依照含量測定法測定其含量，然後
按照測定之結果，以適量之規定浸溶劑稀釋，調整其含
量，使符合規定標準，混合均勻，即得。
貯藏法－酊劑應置緊密阻光容器內，於冷暗處貯之。
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 流浸膏劑
流浸膏為生藥以適當浸溶劑抽提，所製得之一種含乙
醇液體製劑。每mL所含之有效成分，相當於標準生藥1g。
法定之流浸膏，均係以滲漉法製備之，其使用之浸溶
劑，則照正文之個別規定。製備所得之稀滲出液，須用
低溫蒸發濃縮，濃縮時之溫度應保持在60°以下。
為求有效成分之提取完全，並使無效成分減至最小限
度，各種不同生藥所需浸漬時間及滲漉速率均不相同，
故必須個別規定之，且生藥之量如有增減。應將規定之
浸漬時間及滲漉速率酌予改變。

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 流浸膏劑
製備流浸膏之滲漉器，通常以使用圓筒形滲漉器為最
適宜，但所用藥品遇浸溶劑過於膨脹者，則以使用廣口
式滲漉器為宜。
滲漉速率可分為：(1)慢速率，(2)中速率，(3)快速
率三種，其規定如下：凡抽提生藥1,000 g，所稱「慢
速率」，係指每分鐘流出之滲出液不超過l mL而言；所
稱「中速率」係指每分鐘流出之滲出液為1~3 mL而言；
所稱「快速率」，係指每分鐘流出之滲出液為3~5 mL而
言。
流浸膏貯置相當時間後，常有沈澱發生，可予過濾，
或將澄明部分傾出，再調整其濃度使符合規定標準。
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 流浸膏之製法有下列四種：
(1)本法係以乙醇與水之混液為浸溶劑，用普通滲漉法
製備之：取適當細度之生藥粉末1,000g，加規定之
浸溶劑適量，使完全均勻濕潤(通常需用浸溶劑
600~800 mL)，放置十五分鐘，然後移置適當滲漉器
中，均勻壓平，覆以濾紙，再加適量之浸溶劑，使
藥品充分濕潤飽和，並使藥品表面淹有一層浸溶劑。
當滲漉器下出口開始流出滲出液時，即將其下出口
關閉，同時將滲漉器加蓋，使之浸漬一規定時間。
然後依規定速率滲漉之。時時補充新鮮浸溶劑，直
至生藥中有效成分抽提完全為止。將最先之滲出液
850 mL，用另一容器保存。收集其後所得之滲出液，
經蒸餾收回其中所含之乙醇，將剩留液用60°以下之
溫度濃縮成膏狀，然後將其溶於最初保存之滲出液
850 mL中。若所製之流浸膏毋須測定含量者，即加
適量之乙醇與水溶液，使全量成1,000 mL，並使其
28
含乙醇量合於規定，混合均勻，即得。
 若須測定其含量時，則將濃縮之膏狀物溶於最初保
存之滲出液850mL後，取其一部分作含量測定，依照
測定之結果，加適量乙醇與水之溶液，使其有效成
分之含量及含乙醇量均符合規定，混合均勻，即得。
(2)本法需用二種浸溶劑，第一種浸溶劑為乙醇與水之
混液，其中並含有一定量之酸或甘油，第二種浸溶
劑為乙醇與水之混液。取適當細度之生藥粉末
1,000g，加第一種浸溶劑適量，使完全均勻濕潤
(通常須用浸溶劑600~800mL)。放置約十五分鐘，
然後移置適當滲漉器中，均勻壓平，覆以濾紙，將
所餘之第一種浸溶劑完全加入。當滲漉器之下出口
開始流出滲出液時，即將其下出口關閉，同時將滲
漉器加蓋，使之浸漬一規定時間，然後以規定之速
29 率滲漉之。
 當藥品面上之第一種浸溶劑滲完後，則以第二種浸溶
劑補充之，直至生藥中有效成分抽提完全為止。將最
先之滲出液850 mL，用另一容器保存，其後所得之滲
出液，經蒸餾收回其中所含之乙醇。將剩留液用60°
下之溫度蒸發至軟膏狀，將其溶於最初保存之滲出液
850 mL中。若所製之流浸膏毋須測定含量者，即加適
量乙醇與水之混液,使全量成1,000 mL，並使其含乙
醇量符合規定，混合均勻，即得。若須測定其含量時，
則將濃縮之膏狀物溶於前存留之滲出液850 mL後，取
其一部分作含量測定，依照測定之結果，加適量乙醇
與水之混液，使其有效成分之含量及含乙醇量均符合
規定，混合均勻即得。
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 (3)凡生藥中有效成分遇熱易受損者，或由於其他原因
不便使用前二法製備流浸膏時，可用本法製備之。
本法所用之浸溶劑與第(2)法中之第一種浸溶劑相
同，即乙醇或乙醇與水之混液，其中並含有一定量
之酸或甘油。
取適當細度之生藥粉末1,000 g，分為 500 g、
300 g 及 200 g 三份，取第一份(500 g)生藥，加
規定之浸溶劑適量，使其完全均勻濕潤，靜置十五
分鐘,然後移置適當滲漉器中，均勻壓平，覆以濾
紙，再加入浸溶劑使之飽和，浸漬一規定時間後，
開始滲漉。收集最初滲出液200 mL，用另一容器保
存。然後再分別收取滲出液五份，每份300 mL，並
依其滲出次序編列號碼，自第一號至第五號。
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 取第二份(300 g)生藥，用前節收取之五份滲出液為
浸溶，先以第一號滲出液300 mL濕潤後，依次使用其餘
四份為浸溶劑如上法滲漉之。倘該五份滲出液不足使用
時，可用適量之新鮮浸溶劑補充之。收集最初之滲出液
300 mL，用另一容器保存，然後再分別收集滲出液五份，
每份200 mL，依其滲出次序編列號碼。
取第三份(200 g)生藥，依次序用第二份生藥所收集
之五份滲出液(每份200 mL)為浸溶劑，依同法滲漉之。
若無測定其含量之規定，收集滲出液500 mL｀與前保存
之二份滲出液混合，共成1,000 mL，即得。若須測定其
含量，則於滲漉第三份生藥時，僅收集滲出液420mL，
與前保存之二份滲出液混合，取其一部分作含量測定，
依照測定之結果，加適量乙醇與水之混液，使其有效成
32 分之含量及含乙醇量，均符合規定，混合均勻，即得。
 (4)本法係以沸水為浸溶劑，於濃縮滲出液中加乙醇為
防腐劑。
取生藥粗粉1,000 g，加沸水3,000 mL，混合均
勻後，移置適當有蓋之金屬滲漉器中，浸漬二小時。
然後依照規定速率滲漉之，並不斷補充沸水，直至
生藥中有效成分抽提完全為止。將滲出液置水鍋上
蒸發至規定容積，冷卻，加適量之乙醇，然後置有
蓋之容器內，靜置數日。傾取上層澄明溶液，將其
餘部分濾入澄明液中，再於漏斗上用適量乙醇與水
之混液洗滌，使全量達1,000 mL，並使含乙醇量符
合規定，混合均勻，即得。
貯藏法－流浸膏劑應置緊密阻光容器內，於低溫處
避光貯之。
33
 浸膏劑
浸膏劑為生藥以適當之浸溶劑抽提所製得之一種濃縮製
劑。依其外形可分為三種：(1)半流體或糖漿狀浸膏；(2)
軟塊狀或固體浸膏；(3)粉狀浸膏。
浸膏劑通常之製備法係將生藥用滲漉法抽提之，其滲灑
速率可照流浸膏劑(附錄第65頁)項下所述之規定，將所得
之滲出液減壓蒸發濃縮，並用稀釋劑調整其有效成分之含
量，使符合規定標準。
調整含量所用之稀釋液，軟塊狀浸膏劑通常用液體葡萄
糖、麥芽浸膏或甘油等；粉狀浸膏劑通用100°乾燥之澱粉、
蔗糖、乳糖、甘草粉、碳酸鎂、氧化鎂、磷酸鈣及經抽提
後所餘留之生藥殘渣細粉等；但碳酸鎂及氧化鎂不能用作
顛茄粉狀浸膏及曼陀羅粉狀浸膏之稀釋劑。
粉狀浸膏所用之稀釋劑可用葉綠素或焦糖染色，使與浸
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膏原有之顏色一致。
 浸膏之脫脂－粉狀浸膏中含有無效之油類或脂肪類物質必
須除去，始可製成安定之浸膏。浸膏之脫脂可依下述方
法行之。
將須要脫脂之浸膏於調整其含量前，酌加一部分澱粉
乾燥之。於此乾粉中加石油本清(每100 g之浸膏約300
mL)於二小時內均勻攪拌數次，靜置後傾出過量之石油
本清液層，並儘可能滴乾之。第一次脫脂後之浸膏，再
與另一部分(較少量)石油本清混合均勻攪拌，待分出石
油本清後，再依同法用第三份石油本清反覆洗滌，儘量
將石油本法滴乾，於70°以下乾燥之。然後將此乾燥粉末
稱定，並調整使達規定之重量或濃度。
貯藏法－浸膏劑應置緊密阻光容器內，於不超過30°貯之。

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 浸劑
浸劑為生藥用沸水浸漬所得之一種浸出液，應於臨用
時新製之。除另有規定外，含生藥之濃度，通常依照下列
數量製備之：
生藥〈粗粉〉 50g
蒸餾水 適量
共製 1000mL
取生藥粉末，置適當有蓋之容器中，加冷蒸餾水50mL，
使其濕潤後放置十五分鐘。然後加沸蒸餾水900mL，密蓋，
於溫暖處浸漬三十分鐘，用細密棉布或精製棉過濾，並由
濾器上添加足量之蒸餾水，使全量成1,000mL，混合均勻，
即得。
如生藥遇熱即起變化，或其有效成分於沸水中易分解
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者，則宜改用冷蒸餾水浸漬。