1) Maceration is an extraction process where solid ingredients are placed in a container with a solvent and allowed to stand for a period of time, usually 3-7 days. The soluble matter dissolves in the solvent. 2) There are different types of maceration including simple maceration, double maceration, and triple maceration which involve macerating the ingredients multiple times with portions of the total solvent volume. 3) Double and triple maceration are used to produce more concentrated preparations, with the maceration process repeated using separate portions of the total solvent volume each time.

1. 1
GALENICALS
BY
Jeeva P
Pharm D

2. Upon the completion of the lecture, the student should
be able to:
• Know the history of development of Galenicals
• Explain the different methods of Preparation of
Galenicals
• Know the development of pharmacopoeias
Outcomes
2

3. Galenicals
• Definition:
- Medicines prepared according to the formulae
of Galen.
- A medicinal preparation composed mainly of
herbal or vegetable matter.
- It is prepared by extraction of crude vegetable
drugs (active principles) with suitable solvent(s).
- The term is now used to denote standard
preparations containing one or more active
constituents of a plant and made by a process that
leaves the inert and other undesirable constituents
of the plant un-dissolved. 3

4. Galenicals
• Galen is a Greek anatomist
whose theories formed the
basis of European medicine
until the Renaissance
(between 4th and 17th)
• Pharmaceutical
preparations are divided
into:
1. Galenical preparation
2. Non-Galenical
preparations
4

5. Galenicals
Nomenclature:
• Galenicals : Owing to Galen who discovered it.
• Menstrum : Solvent used for extraction (ex.
water, alcohol, ether)
• Marc : The inert fibrous and other insoluble
materials remaining after extraction
• Types: Infusions- Decoctions- Fluid extracts
Semisolid extracts – Dry extracts- Tinctures
Medical oils…..
5

6. Galenicals
• General method of Preparation:
1- Comminution (reducing substances to small size).
2-Penetration of the crude drug by the menstrum.
3- Dissolution of the active principles by the menstrum.
4- Diffusion of the dissolved active principles through the
cell wall to the surrounding menstrum.
5- Separation of the dissolved active principles from the
marc by straining, filtration or expression
6

7. 1- Infusion
Drug
Crude drugs of light structure without dense tissues and
containing water-soluble constituents. The drug may be
freshly broken, thinly sliced, cut small, or coarsely
powdered in order to facilitate the solvent penetration.
Menstrum
– Always water (cold or boiling).
Time
– Determined according to the amount of drug constituents to
be extracted and the ease or difficulty with which the water
penetrate the drug.
Examples
– Teas- Senna infusion- Infusion of senega
7

8. Infusion Preparation
1.1- Fresh (Dilute) Infusion
• The simplest of all methods of extraction
• A definite weight of the crude drug in a certain state of
subdivision (cut small, powdered…) is prepared
• The calculated amount of hot or boiling menstrum (usually
water) is added to the crude drug
• Soak for a definite time
• During the period of infusion, the heat should be retained
in the container and the content should be stirred
• After the time of infusion, the liquid is poured off or
strained
• Do not press or squeeze the marc otherwise colloidal cell
contents may be forced out giving a cloudy infusion
• Such fresh infusion should be used within12 hours
8

9. Infusion
1.2- Concentrated (stock) infusion
• To avoid rapid decomposition to which the fresh
(dilute) infusions are subjected.
• These preparations are not made by the
concentration of the dilute infusion by
evaporation, since thermal treatment will result in
loss of the volatile principles.
• Concentrated infusions prepared with alcoholic
menstrum or contain alcohol as a preservative.
• Concentrated infusion are not intended to be
dispensed in the concentrated state, but upon use,
are diluted with at least seven times their 8
volume of water
9

10. Infusion
• Many medicines which were prescribed required
infusions of ingredients such as bitter orange,
cloves or senna.
• Originally the ingredients were left soaking in hot
water and then drained. Later, it was discovered
that it was more effective if the ingredients were
suspended near the surface of the water, as that
way more of the drugs were extracted, this
discovery led to the development of the infusion
pot.
10

11. Infusion Apparatus
• Consist of covered jar ( made
of earthenware, stainless-
steel, ceramic, glass,
porcelain…) to which is fitted
at certain height a perforated
tray upon which the crude
drug may be allowed to rest in
water being poured over it.
• The plant may be enclosed
loosely in a small muslin bag
and suspended in the jar at a
height where it will be just
covered by the liquid.
11

12. Infusion
• The perforated tray or muslin bag confers two
advantages:
• A - Placing the drug near the top of the liquid
rather than at its bottom gives complete extraction
because when the menstrum surrounding the drug
becomes saturated, it will sinks to the bottom due
to its increased density and another amount of
fresh menstrum displace it leading to circulatory
diffusion.
• B- At the end of infusion time, the drug can be
lifted out, leaving clear liquid which can be
strained quickly. 12

13. Examples of infusion
• Concentrated infusion of Quassia ( ( ‫خشب‬
‫المر‬
Rx.
Quassia, cut small………………..80 gm
Alcohol (90%)…………………….250 ml
Distilled water, cold Q.S to……...1000 ml
Prepared by triple maceration.
1- Macerate Quassia with 650 ml of cold water for one
hour, mix occasionally, strain and reserve the clear liquid.
2- Repeat maceration process twice, using 500 ml of cold
water for each maceration.
3- Combine second and third maceration and evaporate to
100 ml.
4- Mix liquid 3 with liquid 1, add alcohol and adjust the
volume to 1000 ml with cold distilled water
13

14. 14

15. Examples of infusion
Dose: 2 to 4 ml
N.B: alcohol is added to the final product as
a preservative
Use: Anti-malaria, Appetite stimulant (bitter
stomachic).
Dilute infusion of Quassia
Rx. Concentrated infusion of Quassia……… 125
ml Distilled water, cold Q.S
to………………..1000 ml
Preparation :
Just mix
Dose : 15 to 30 ml
15

16. Examples of infusion
• Dilute compound infusion of Gentian
Rx.
Gentian, thinly sliced …………………….12.5 gm
Dried bitter orange peel, cut small……12.5 gm
Dried Lemon peel, cut small…………….12.5 gm
boiling water Q.S to……………………….1000 gm
Preparation: Macerate the solid drugs with 1000 gm of
boiling water, then strain.
Dose: 15 to 30 ml
Use: Gentian is a bitter and is used to stimulate gastric
secretion, strengthen the digestive system and improve the
appetite.
It should be given from half to one hour before meals,
preferably with juice.
16

17. Infusion
General Notes
• The drug is usually coarsely ground. Very fine
powders should be avoided due to difficulty of
separation from the infusion.
• Where no specific directions are given, the
following general formula and procedure should
be used : 50 gm Drug in 1000 ml boiling distilled
water (moisten 50 gm drug with 50 ml of cold
water and allow to stand for 15 minutes. Then,
add boiling water to make 1000 ml infusion).
• Infusions of readily soluble active principles are
prepared by maceration in water cold.
17

18. General Notes
• Hot water extract the desired constituents more
quickly than cold but has the disadvantages of:
1- extracting inert materials that may
precipitate upon cooling. 2- causing
volatilization or destruction of certain
principles. 3- coagulation of albuminous
matters within the drug cell and thereby inhibit
the extraction.
18

19. 2- Decoction
• Definition:
- Solutions of the water soluble constituents of
plant drugs prepared by boiling the drug with
water.
• For extraction of drugs with water soluble and
non- volatile constituents, and drugs of hard and
woody nature.
• Should be freshly prepared.
19

20. Decoction Preparation
 Previously sliced drug barks or wood (5 parts) is
boiled with water (100 or 120 parts) in a vessel of
enameled iron or earthenware for a definite length of
time (15 min.) counting from when the liquid starts
to boil with occasional stirring.
 To obtain highly concentrated decoction, boiling
is continued until the liquid reduced to a certain
volume.
 Allow to cool to about 40ºC, press the marc and
mix the resulting liquid to the decoction.
 At the end of decoction time, decoction is
strained through fine muslin or flannel according to
the nature of marc. Then, sufficient water is passed
through the strainer to produce a definite volume.
20

21. Decoction
• Example : Cinchona bark
or wood (contains quinine)
• Uses: treatment of fever,
malaria and as an appetite
Stimulant.
• Also used in anemia,
indigestion, gastrointestinal
disorders, general fatigue.
21

22. Comparison between infusion and
decoction
Item Infusion Decoction
1- Plant Soft structure (ex. Senna
leaves)
Hard woody structure (ex.
Cinchona bark)
2- Menstrum Boiling or cold water Boiling water
3- Procedure Infusing the drug with cold
or hot water
Boiling the drug with water
4- Time Calculated as soon as water
is added to drug
Calculated as soon as the
water begins to boil
5- Adjustment of final
volume
No adjustment Adjustment is necessary
6- Apparatus Infusion earthenware pot Any covered apparatus
7- Storage Used fresh within 12 hours Used fresh and when stored
in refrigerator used within
few days
22

23. EXTRACTION
• Extraction term Pharmaceutically 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.
23

24. EXTRACTIONPROCESSES
INFUSION DECOCTION MACERATION/
DIGESTION
PERCOLATION
Fresh
Infusion
Concentrated
Infusion
Simple
Maceration
Macerationwith
adjustment
Multiple
Maceration
Double
Maceration
Triple
Maceration
Simple
Percolation
Continuous
HotPercolation
(Soxhlation)
Percolation
Process for
Conc.Preparation
Reserved
Percolation
Modified
Percolation
.
24

25. INFUSION
• An infusion is a dilute solution of the readily
soluble constituents of crude drugs
• Fresh infusions are prepared by macerating the
solids for a short period of time with either
cold or boiling water
25

26. Decoction
• Once this is a popular process for extracts of
water soluble and heat stable constituents from
crude drugs by boiling in water for
15min,cooling ,straining and passing sufficient
cold water through the drug to produce the
required volume
26

27. Digestion
• This is a form of maceration in which gentle
heat is used during the process of extraction.
• It is used when moderately elevated
temperatures is not objectionable and the
solvent efficiency of the menstrum in
increased thereby
27

28. Maceration
• This process the solid ingredients are placed in
a stoppered container with prescribed solvent
and allowed to stand for 3 days with frequent
agitation
• The soluble matter dissolved will be filtered
magma was washed with sufficient quantitiy of
prescribed solvent (mixtures) and the filterates
were combined
28

29. Percolation
• Ground solids were mixed with appropriate solvents
to make them damp
• Allowed to stand for 15min
• Transferred to a percolator and packed
• Sufficient prescribed solvent is added to saturate the
solids
• The solids are allowed to macerate for 24hrs or for a
prescribed time
• The percolate are collected
• If necessary percolate is diluted with the solvent to
produce a solution to meet the standards
29

30. INFUSION POT
PERCLATOR PACKED WITH
CRUDE DRUG
30

31. PERCOLATR WITH STEAM JACKET SIMPLE PERCOLATOR
31

32. PERCOLATOR FOR VOLATILE
MENSTRUUM
PERCOLATOR FOR OPERATION
UNDER REDUCED PRESSURE
32

33. BASKET PRESS HOT CONTINOUS PERCOLATION
33

34. 34

35. 35

36. MACERATION
• In this process solid ingredients are placed in a
stoppered container with the whole of the
solvent and allowed to stand for a period of at
least 3 days (3 - 7 days) with frequent
agitation, until soluble matter is dissolved.
• The mixture is then strained (through sieves /
nets), the marc pressed and the combined
liquids clarified (cleaned by filtration).
36

37. TYPES OF MACERATION
• Simple maceration: for organized and
unorganized Crude drug e.g.
i) Tincture of Orange
ii) Tincture of Lemon
• Double maceration :
Concentrated infusion of orange
• Triple maceration:
The maceration process may be carried out
with help of heat or stirring
37

38. • SIMPLE MACERATION: for organized drugs
e.g. roots, stems, leaves etc.
• Alcohol is used as a menstrum.
• In this process, the drug is placed with the
menstruum in a closed vessel for seven days.
• At this period shaking is done occasionally.
• After seven days, the liquid is strained & marc is
pressed.
• The expressed liquid is mixed with strained
liquid.
• Then again filter for obtaining the clear liquid.
• The final volume is not adjusted.
38

39. • MODIFIED MACERATION or MACERATION
WITH ADJUSTMENT : for Unorganized drugs
e.g. Gum, Resins, Gum-resins, Oleo gum-resins.
• In this process, the unorganized drug is placed
with 4/5th volume of menstruum in a closed
vessel for seven days.
• At this period shaking is done occasionally.
• After the stated period, the liquid is filtered & not
necessary to press the marc.
• After that, the final volume is adjusted with the
remaining quantity of 1/5th volume of menstruum
through the filter.
39

40. • DOUBLE MACERATION PROCESS: it is carried out in
the same way as simple maceration process, but
menstruum used in divided into two parts.
• In that process drug is macerated twice by using the
menstruum which is divided into two parts in a such
manner that the same volume is used for each maceration.
• The volume of menstruum required is calculated as
follows
• i. Volume of menstruum req. for first maceration Total
Vol.of menstruum - Vol.to be retained by the drug + Vol.to
be retained by the drug 2
• ii. Volume of menstruum req. for second maceration Total
vol.of menstrum – Vol. of menstruum used in first
maceration
40

41. • In that process the whole drug is macerated for
48 hrs with quty. of menstruum for first
maceration.
• Strain the liquid & press the marc after 48 hrs.
• Then again macerated for 24 hrs with remaining
quty. of menstruum for second maceration.
• Strain the liquid & press the marc after 24 hrs.
• Then mix the liquids obtained from the two
maceration & allows it to stand for 14 days &
then filter.
• e.g. Concentrated infusion of orange
Concentrated compound infusion of chirata
41

42. • TRIPLE MACERATION PROCESS: it is carried
out in the same way as simple maceration process,
but menstruum used in divided into three parts.
• In that process drug is macerated thrice by using the
menstruum which is divided into three parts in a
such manner that the same volume is used for each
maceration.
• The volume of menstruum required is calculated as
follows
i. Volume of menstruum req. for first maceration
Total Vol.of menstruum - Vol.to be retained by the
drug + Vol.to be retained by the drug 3
ii. Volume of menstruum req. for 2nd & 3rd
maceration Total vol.of menstrum – Vol. of
menstruum used in first maceration 2
42

43. • In that the drug is macerated for one hour with a part of
menstruum req. for first maceration & strained.
• Macerated again for one hour with a part of menstruum for
second maceration & strained.
• Macerated again for one hour with a part of menstruum for
third maceration & strained.
• After that, marc is pressed lightly.
• Then combine the liquids obtained from 2nd & 3rd
maceration & evaporated it to a specified extent.
• Then, mix it with the liquid obtained from 1st maceration
& add alcohol 90% equal to 1/4th of the volume of the
finished product.
• Then adjust the volume with water.
• Allow this solution for 14 days & then filter.
• e.g. Concentrated infusion of Quassia, Liquid extract of
senna
43

44. EXTRACTION METHODS Examples
A. MACERATION
i) Simple maceration
ii) Maceration of unorganized drug /
Maceration with adjustment
iii) Multiple Maceration
a) Double maceration
b) Triple maceration
Tincture of Orange
Tincture of Lemon
Tincture of Squill.
Tincture of Tolu Balsam
Compound Tincture of Benzoin
Concentrated infusion of orange.
Concentrated infusion of chirata
Concentrated infusion of gentian
Concentrated infusion of Quassia
Concentrated infusion of Senna
44

45. • PERCOLATION PROCESS
• 3 types of percolation process used for the
extraction of drugs are:
i. Simple percolation or percolation process for
tinctures.
ii. Percolation process for concentrated
preparations
a. Reverse percolation process
b. Modified percolation process
iii. Continuous hot percolation or soxhelation
45

46. SIMPLE PERCOLATION PROCESS
• In the percolator, arrange the powder on their size
i.e coarse powder to fine powder.
• Imbibition: at that first stage, the drug firstly
moisten or swelling of the tissues of the drug
before packing it into the percolator.
• Packing of the drug: before packing the drug
firstly pass through the sieves for prevention of
lumps & masses.
• Then, glass wool moistened with the solvent is
placed at the bottom of the percolator to prevent
the blockage of the outlet trap.
• Then add the moisten drug into the percolator &
pressed lightly after each addition & drug is
packed upto 2/3rd or 3/4th of the percolator.
46

47. Glass wool
47

48. • Then placed filter paper on the packed drug.
• Then placed washed sand on that for prevent
disturbance of the top layers of the drug.
• Finally add the menstruum to saturate the material.
When liquid starts coming out from the percolator
,outlet is closed.
• And again add menstruum in the percolator.
• Then allow it to macerate for 24 hrs. the percolator
is closed to prevent evaporation of the solvent.
• Maceration: after 24 hrs maceration, open the outlet
of the percolator & collect the percolate which
measures about 3/4th of the volume required for the
finish product.
• The rate of collection of percolate is generally 10-30
drops per minute.
48

49. • After collecting the required quty. of
percolator, the marc is taken out from the
percolator & it is pressed to recover the
solvent.
• Then adjust the final volume with
menstruum.
• Then, liquid is filtered in order to free it from
other material.
• e.g. Tincture of belladona, strong tincture of
ginger.
49

50. RESERVE PERCOLATION PROCESS:
• In this process, a part of the percolate, generally
3/4th the volume of the finished preparation, is
reserved.
• Then the percolation process is continued till the
drug is completely exhausted.
• Then the percolate is subjected evaporation or
distillation to convert it into a soft extract.
• This soft extract is dissolved in the reserve
portion of the percolate & then sufficient
menstruum is added to produce the required
volume. 50
PERCOLATION PROCESS FOR
CONCENTRATED PREPARATIONS

51. CONTINUOUS HOT PERCOLATION OR
SOXHELATION
• This process apply when, the drug are not
freely soluble in the solvent.
51

52. • The powdered plant material is packed in a
thimble.
• The solvent is boiled in a flask. The evaporated
solvent passes through the side tube of the
extractor and condensed in the condenser, fitted
at the top of the extractor.
• The condensed hot solvent runs into the thimble
and soaks the material & extracts the
constituents.
• When the chamber holding the thimble becomes
full the solvent siphons down to the flask and the
process is continuously repeated till extraction is
complete
52

53. EXTRACTION METHODS Examples
B. PERCOLATION
i) Simple percolation
ii) Reserved percolation
iii)Continuous hot percolation /
Soxhlation
C. INFUSION
i) Fresh infusion
ii) Concentrated infusion
D. DECOCTION
Tincture of Belladonna
Compound tincture of cardamom
Strong tincture of ginger etc.
Liquid extract of Liquorice
Cantharidin from cantharides
Alkaloids from seeds
Fresh infusion of Quassia
Concentrated compound infusion of
chirata
Concentrated compound infusion of
gentian
No official preparations in IP or BP.
53

54. Comparison between the methods of extraction
Extraction method Time for extraction Temperature Characteristics of
the active
constituents
Maceration 3-7 days Room temp Soluble in the
menstruum
Heat stable / unstable
Percolation 24 hours Room temp Soluble in the
menstruum
Heat stable / unstable
Digestion Few days Moderately high
Cold or boiling water
Heat stable
Infusion Short period Boiling water Readily soluble
Decoction 15 mins Boiling water Water soluble
Heat stable
54

55. EXTRACTIVE PREPARATIONS
55

56. • Defined as alcoholic or hydroalcoholic
solutions prepared from vegetable materials or
chemical substances(Iodine tincture)
• Potency can be adjusted following the assay
• 10gm drug/100ml tincture (Potent tincture)
TINCTURES
56

57. 57

58. Fluid extracts
• Defined as liquid preparations of vegetable
drugs containing alcohol as a solvent or as
preservative or both
• Each ml fluid extract = 1gm standard drug
58

59. 59

60. EXTRACTS – FORM WISE
Solid/Pilular extracts
• Have consistency to be used as pills
• Also suited for ointments and suppositories
preparation
• Ex: Pure Glycyrrhiza extract
60

61. EXTRACTS – FORM WISE
Powdered extracts
• Better suited to be incorporated as dry
formulations as in capsules
• Drugs that contain inactive oily or fatty matter
should be defatted inorder to avoid possible
loss of activity of the active constituents
• Ex:
• Belladona extract USP
61

62. 62

63. EXTRACTS – FORM WISE
Semi liquid extracts or extracts of syrupy
consistency
• They are used to prepare pharmaceutical
preparations
• Mostly they are medicinal agents with
therapeutic property as well as they are used as
vehicles
63

64. Applications
• Used to extract nutraceuticals from plants such as
essential oils and lipids dietary supplements. e.g. oils
from almond, apricot and rice bran
• Extraction of saponinfrom ginseng, the observed total
yield and saponin yield increased by 15 and 30%,
respectively extracts. It was found that rice bran oil
extraction can be efficiently performed in 30 min under
high-intensity ultrasound either using hexane or a basic
aqueous solution. Extraction rates of carvone and
limonene by ultrasound-assisted extraction with hexane
were 1.3–2 times more rapid than those by the
conventional extraction depending on temperature
64

65. Conclusion
• Extraction is essential for isolation of different
chemical constituent from crude drug material.
• Extraction depends on properties of material to
be extracted. Hence it is necessary to study
extraction methods in detail.
65

66. Reference :
1. Mukharji Pulok K. 2002, Quality Control of
Herbal Drugs,1st edition Published by Business
Horizon, p.p 380-421.
2. Mehta R.M. 2010, Introduction to Pharmaceutics,
5th edition Published by Vallabh Prakashan, p.p150-
167.
3. Rangari v.d. 2002 ,Pharmacognosy and
Phytochemistry ,1st edition ,volume 1st Published by
Career Publication, p.p.95-98
4. Cooper J.W, Gunn`s Colin 2010-2011, Register of
General Pharmacy p.p.308-393
66

67. 67