Ayurvedic Formulation: Asava, Arishta, Avaleha, Ghrita, Taila, Gutika Concept of Detoxification: Panchkarma Final Year B.Pharm (Sem-VIII) Pharmacognosy-III (Mumbai University Syllabus

1. Herbal formulations

2. Content
• Herbal formulation
• Challenges in herbal formulation
• Constrain in herbal formulation
• Ayurvedic formulations
• Concept of detoxification

3. Herbal formulation
• Herbal formulation shall mean a dosage form
consisting of one or more herbs or processed herb(s)
in specified quantities to provide specific nutritional,
cosmetic benefits, and/or other benefits meant for
use to diagnose treat, mitigate diseases of human
beings or animals and/or to alter the structure or
physiology of human beings or animals.

4. Herbal formulation
• Herbal preparations are obtained by subjecting herbal
substances to treatments such as extraction,
distillation, expression, fractionation, purification,
concentration or fermentation.
• These include comminuted or powdered herbal
substances, tinctures, extracts, essential oils,
expressed juices and processed exudates.

5. Challenges in Herbal formulation
• A key challenge is to objectively assess conflicting
toxicological, epidemiological, and other data and the
verification of herbal materials used.
• Management within ranges of risk
• Communication of uncertainty
• Pharmacological, toxicological, and clinical
documentation
• Pharmacovigilance

6. Challenges in Herbal formulation
• Understanding why addition of harmful additives
works evaluating “drug” interactions
• Constraints with clinical trials and people available
• Standardization
• Safety, and efficacy assessment

7. Factors affecting safety and Quality
• Quality of starting materials
• Complexity of nomenclature of herbal ingredients
• Chemical contamination by Heavy metals
• Choice of chemical markers
• Adulteration with synthetic chemical drugs

8. Constrains of herbal formulation
• Indiscriminate harvesting and poor post-harvest
treatment practices.
• Lack of research on the development of high-
yielding varieties, domestication etc.
• Poor agriculture and propagation methods.
• Inefficient processing techniques leading to low
yields and poor quality products.
• Poor quality control procedures.

9. Constrains of herbal formulation
• Lack of current good manufacturing practices.
• Lack of R & D on product and process
development.
• Difficulties in marketing.
• Lack of trained personnel and equipment.
• Lack of facilities to fabricate equipment locally.
• Lack of access to latest technological and market
information

10. Factors affecting herbal formulation
• Drug adulteration
• Faulty collection
• Imperfect preparation
• Incorrect storage
• Gross substitution with plant material
• Substitution with exhausted drugs

11. Ayurvedic formulations
• Ayurvedic medicine originated in the early evolution
of India about 3,000-5,000 years ago.
• These formulations are taken from the ancient Vedic
text or Vedas (books of Ayurveda), the ancient
religious and philosophical texts that are the oldest
surviving literature in the world, which makes
Ayurvedic medicine the oldest surviving healing
system.

12. Type of Ayurvedic formulations
1. CLASSICAL AYURVEDIC MEDICINES
• These medicines are present in traditional Ayurvedic
text books such as Charaka Samhita, Sushruta
Samhita etc. The manufacturing company follows the
same formula and prepares medicines. For e.g
bhasmas, asavas, arishtas, taila etc.

13. Type of Ayurvedic formulations
2. PROPRIETARY MEDICINES
• These are also known as patent medicines or modern
Ayurvedic medicines. Their formula, dosage form are
decided by the manufacturing company and
ingredients used in these preparation are not found
in traditional Ayurvedic text books. Every company
has its own formula and conducts clinical trial,
research on the medicine about its efficacy. For e.g.
capsules, syrups etc.

14. Types and Forms
of Ayuvedic formulations
• Solid dosage forms:
• Gutika & Chruna
• Semi solid forms:
• Avaleha & Ghrita
• Liquid dosage forms:
• Asava , Arista & Tai;la

15. Asava & Arishta
Natural fermented liquid medicines
• Medicinal preparations processed by soaking drugs in
the powdered forms or in the form of their
decoction (known as kasaya in Ayurveda), in a
solution of sugar or jiggery (gur), for a specified
period of time.
• During soaking, it undergoes fermentation
generating alcohol and in process facilitating
extraction of active constituents contained in the
drugs.

16. Asava & Arishta
• Alcohol so generated also serves as preservative in
the product.
• Absolute cleanliness is maintained during the
preparation of arishta and asava.
• The wooden pots (vessels) are fumigated with pippali
(long pepper) churna and also smeared with ghee
before the fermentation liquids are poured into them.
• They can be kept indefinitely, should be stored in
well stoppered bottles or jars.

17. Dhoopana
Why fumigation?
• The fermentation vessels are subjected to dhoopana, a process
of fumigation to prevent the growth of naturally occurring
microorganisms that may contaminate or hamper the process
of fermentation. Molasses or powders of crude drugs like
Indian valerian, agaru (Aquilaria agallocha), chandan (Santalum
album), marich (Piper negrum, Black pepper) and such are
sprinkled on hot embers and burnt to fumigate.
• These crude drugs may contain volatile oils that have
antibacterial, antiseptic action thereby providing a specific eco-
system similar to present day sterilization procedures.

18. Lepana –
Why Smearing and Coating Process?
• The fermentation vessels are porous to outside air that may
affect fermentation process.
• Process to smear and coat the inner surface of the fermentation
vessel is prescribed to edge out such adverse effects.
• Ghee, honey or cow‟s urine are used as base with herbs like
Pippali (long pepper) Chavya (Piper retrofractum), Priyangu
(Callicarpa macrophylla) made into the form of paste that is
smeared evenly to provide a coat on the inner surface of the
fermentation vessel.
• Such a coat forms protective layer to prevent any unwarranted
interaction between the fermentation material and outside air.
Most ingredients used for smear have pungent or sharp
attributes.

19. Asava (Definition by Sushruta)
• The medication which is prepared by mixing together
different kinds of medicinal juices, decoction, jaggery
(molasses) and flowers of dhataki (Woodfordia fruticosa)
in an earthen vessel buried deep into a heap of grains
for flavoring and to initiate fermentation.

20. Asava
(Fermented infusion)
• Required quantity of water and jiggery or sugar is
taken, boiled, cooled and transferred to fermentation
vessel or barrel.
• Finely powdered crude drugs and other ingredients
as mentioned in the formula are then added to it
• The container is covered with the lid and edges are
sealed with clay smeared cloth, wrapped in seven
consecutive layers. Normally the vessels used for
processing of asava are placed in cellar(basement) of
a specific period in order to facilitate sadhana
(fermentation) process.

21. Asava
(Fermented infusion)
• The contents are examined for completion of
sadhana process and asava is filtered and bottled.
• Filtered asava should be clear and without any froth
(foam) at the top.
• It should not become sour on standing.
• It has characteristic, aromatic and alcoholic odour.
• Examples: Kumariasava, Punarnavasava,
Chandanasava, Arvindasava, Kanakasava,
Madhukasava

22. Arishta
(definition by Bhavprakash samhita)
• The formulations which are prepared with the use of
pakvaushadha siddha; earlier prepared (cooked)
medications like herbal infusions or decoctions

23. Arishta
(Fermented decoction)
• The crude drugs mentioned in the formula (patha),
are coarsely powdered and decoction (Kashaya) is
prepared, filtered and transferred to wooden vats.
• Sugar, honey or jiggery is added to it, dissolved and
boiled.
• Dravyas, other finely powdered ingredients and
Dhataki pushpa (Woodfordica fruticose) are added to it
to trigger the fermentation process.

24. Arishta
(Fermented decoction)
• The container is covered with the lid and edges are
sealed with clay smeared cloth, wrapped in seven
consecutive layers. Normally the vessels used for
processing of arishta are placed in cellar(basement)
of a specific period in order to facilitate sadhana
(fermentation) process.
• The contents are examined for completion of
sadhana process and arishta is filtered and bottled.

25. Arishta
(Fermented decoction)
• Filtered arishta should be clear and without any froth
(foam) at the top.
• It should not become sour on standing.
• It has characteristic, aromatic and alcoholic odour.
• Examples: Ashokarishta, Kutarishta, Dashmularishta,
Vidangarista, Arjunarishta, Ashwagandharishta

26. Avaleha
(Jam/Paste like products)
• Avaleha or leha is a semi solid preparation of drugs
prepared by addition of sugar, jiggery(gur) or sugar
candy and boiled with prescribed drug juice or
decoction.
• Jaggery-gur or sugar candy is dissolved in liquid,
boiled and strained.
• The powdered drugs in small quantities are added
and stirred continuously to form homogenous mass.

27. Avaleha
• Ghee or oil is added when preparation is hot.
• Examples:
• Chyawanprash, Kutakabaleha, Drakshavaleha,
Vasavaleha, Bilvadileha, Surnava leha

28. Ghrita
(Medicated clarified butters)
• The preparation in which ghee is boiled with the
prescribed quantity of the decoction (kasaya) and
fine paste (kalka) of the drug as specified in the
formula.
• The process of preparation of ghrita ensures the
absorption of the therapeutically active constituents
of the drugs used in the preparation.
• Ghrita solifies when cooled. It has colour, odour and
taste of the ingredients used in the preparation.

29. Ghrita
(Medicated clarified butters)
• Ghrita are preparation for internal consumption and
are stable for about 16 months.
• Normally they are taken along with warm vehicle
(water or milk).
• Examples: Asokaghrita, Nirgundi ghrita, Brahmi
ghrita, Sukumara ghrita, Pippalyadi ghrita
• It can be preserved in glass, polythene or aluminium
containers.

30. Churna (Powders)
• Fine powder of drug or drugs is known as churna.
• Drugs mentioned in patha, are cleaned properly,
dried thoroughly, pulverised and the sieved.
• The churna is free flowing and retains potency for
one year, if preserved in air-tight containers.
• Examples: Triphala churna, Sudarshan churna,
Trikatu churna, Drakshadi churna, Sitopatadi churna

31. Taila (Medicated Oils)
• They are called sneha kalpa/paka and prepared by
cooking oil with the juice or the decoction and paste
of drugs.
• Unless otherwise specified, paste of drug should be
1/4th part of the oil and the liquid (drava) should be
4 times of oil.
• If no liquid is specified in recipe, water should be
used.

32. Taila (Medicated Oils)
• For preparing medicated oil, the fine paste of drug,
liquid and oil together, cooked, stirred constantly to
the paste at the bottom and prevented from getting
charred.
• When medicated taila gets properly cooked, large
amount of foam appears at the surface of the oil.
• Therefore the formulation should be strained prior
to packing.

33. Taila (Medicated Oils)
• If salt or any alkali preparation is added to the recipe, it
should be after the oil is strained and mixed thoroughly.
• Tailas can be used internally and topically.
• They retain potency for about 16 months.
• They are taken internally with warm water or warm milk.
• Examples: Bhrinraj taila, Mahanarayan Taila, Anu taila,
Jyotismati taila

34. Gutika (Pills)
• It is in the form of pills. They are made by using
single or combinations of vegetable, mineral or
animal drugs.
• These preparations can be used up to 2 years. Pills
with minerals can be used indefinitely.
• These formulations should not loose their original
colour, odour, taste and form on standing.

35. Gutika (Pills)
• They should be kept away from moisture, if they
contain salt, ksara or sugar.
• Examples: Lasunadi gutika, Pranda gutika, Khadiradi
gutika

36. Detoxification of Formulation
• Ayurveda involves the use of drugs obtained from
plants, animals, and mineral origin.
• All the three sources of drugs can be divided under
poisonous and nonpoisonous category.
• There are various crude drugs, which generally
possess unwanted impurities and toxic substances,
which can lead to harmful health problems.
• These poisonous/toxic plants are categorized as viṣa
(poison) and upaviṣa (toxic but not lethal for human
health) in Ayurvedic texts and also listed in the
schedule-E of Drugs and Cosmetics Act 1940.

37. Detoxification of Formulation
• The detoxification or purification process of any
toxic material used for medicinal purposes is termed
as “Śodhana”.
• Śodhana (detoxification/purification) involves the
conversion of any poisonous drug into beneficial,
nonpoisonous/nontoxic ones.
• It is cited in the treatises of Ayurveda that by proper
processing, viṣa can be converted into amṛta (nectar)
and on other hand on adoption of inappropriate
methods, nontoxic materials become a toxic.

38. Detoxification of Formulation
• Aconitum species, Strychnos nux-vomica, Acorus
calamus, Abrus precatorius etc., are some of the
interesting examples of toxic plants, which are still
used in the Indian system of medicine.
• Aconitine, strychnine, β–asarone, abrin are some of
the toxic components present in these plants and are
relatively toxic in nature.
• Śodhana process involves the purification as well as
reduction in the levels of toxic principles which
sometimes results in an enhanced therapeutic
efficacy.

39. Detoxification of Formulation
• Various sodhana process includes
1. Simple boiling with water or lemon juice
2. Triturating with borax
3. Swedana (heat treatment with liquids)
4. Treating with cows urine
5. Treating with cow milk
6. Frying with cow ghee or castor oil

40. Detoxification of Formulation
Objectives of Sodhana
1. To prepare herbomineral preparations
2. To enhance safety
3. To enhance Potency
4. To decrease the toxicity
5. To produce synergistic effects with other plant
materials.

41. Shodhana-Abrus
• Guñjā (Abrus precatorius Linn., Family: Fabaceae)
roots, seeds, and leaves have been used traditionally
for their purgative, emetic, tonic, aphrodisiac, and
hair growth promoting properties after being
processed through Śodhana.
• Since ancient times, it has been used as fish poison,
arrow poison and also for criminal purposes of
poisoning both humans and cattle.

42. Shodhana-Abrus
• Abrus seeds contain a toxic lectin, abrin (an
albumotoxin), a fat-splitting enzyme, a glucoside
(abrussic acid), urease, abarnin, trigonelline, choline,
hypaphorine, and steroidal oil that have abortive
effects.
• Abrin has a fatal dose of 0.1–1 μg/kg in humans and
it is reported that boiling renders the seed harmless.
• In Śodhana of Guñjā seeds, they are subjected to the
svedana in dolā yantra with Godugdha or Kāñji for
3–6 h.

43. • It consists of a pot half filled
with specified liquid with a
horizontal rod placed on the rim
from which the bundle of
material to be treated will be
immersed and heated.
• Swedana is a steam treatment
• Godugdha: Cow milk
• Gomutra: Cow urine
• Goghrita: Cow ghee
• Kanji: Sour gruel

45. Shodhana-Abrus
• The Śodhita material is then subjected to washing
with hot water and drying under shade.
• During the Śodhana process, color of the media
changes due to the removal of colored materials
from the endosperm of the seeds and subsequently
there is loss in weight.
• According to Singh et al. High performance liquid
chromatography (HPLC) study of the Guñjā extract
before and after the Śodhana process showed that
the level of toxic hypaphorine decreases, whereas the
less toxic alkaloid abrine increases.

46. Shodhana-Abrus
• Perhaps during Śodhana process, a major part of
hypaphorine might have undergone transformation
into abrine by reduction of its tertiary amino group
into the primary amino group.
• Percentage of protein present in Guñjā also reduces
after Śodhana.

47. Shodhana-Abrus
• In another study, chromatographic evaluation
confirms the absence of the steroidal oil in Śodhita
Guñjā seed, which is responsible for the abortifacient
effect. The LD50 dose of Guñjā was reported to
increase from 2 to 5 g/kg (aśodhita) to ≥5 g/kg
(Śodhita).
• The efficacy studies on hair growth and antibacterial
effect of the Śodhita Guñjā show significant result.

48. Shodhana-Aconite
• Many species of the genus Aconitum viz., Aconitum
ferox Wall., Aconitum napellus Linn., and Aconitum
chasmanthum Holmes ex. Stapf. are known under
the common name “Vatsanābha” in Sanskrit and
“Aconite” in English.
• The roots of all the three plants are extremely
poisonous but useful in the treatment of various
diseases such as fever, rheumatoid arthritis, sciatica,
hypertension, and acts as “rasāyana”
(immunomodulators) after their detoxification.

49. Shodhana-Aconite
• Most of the alkaloids present in the root of
Aconitum species at higher doses are reported to
have cardiotoxic and neurotoxic effects. Severe
Aconite poisoning results mainly due to the
accidental ingestion of wild plant or excess
consumption of herbal decoction made from the
Aconite roots.
• Isolated compound (Aconite) from Vatsanābha at a
dose of 2 mg can cause death, while 1 g of
Vatsanābha is fatal for human being.

50. Shodhana-Aconite
• The root of Vatsanābha was used as poison for
hunting animals in ancient times by tribals.
• Overdosing of traditional Ayurvedic formulations of
Vatsanābha may cause hypotension, bradycardia or
bidirectional tachycardia.
• Due to such reasons, the therapeutic dose of
Vatsanābha mentioned in Ayurvedic system of
medicine is 8 mg to 16 mg/day.

51. Shodhana-Aconite
• Its purification process includes svedana (boiling) in
dola yantra using Godugdha (cow milk) for 3 h daily
for three continuous days, followed by washing with
water thrice and drying under sun light.
• After Śodhana process, the total alkaloid content
decreases, but the contents of less toxic substances
such as aconine, hypoaconine, and
benzylhypoaconine increases possibly due to
conversion of the toxic aconitine into aconine or
hydrolysis of the alkaloids to their respective amino
alcohols after Śodhana process.

52. Shodhana-Aconite
• In another study, it has been reported that the
purified form of A. carmichaeli produces cholinergic
stimulation which prevents the cold-stress-induced
hypothermia and immuno–suppression.
• Moreover, the unpurified root of A. napellus has
been reported to cause a significant rise in heart rate
and changes in electrocardiogram as compared to
purified Aconite. It has been reported that Gomūtra
(cow urine) converts Aconite to a compound with
cardiac stimulant property, whereas, raw Aconite
showed cardiac depressant properties.

53. Shodhana-Aconite
• Śodhana by both Gomūtra and Godugdha makes
Aconite devoid of cardiac and neuro–muscular toxic
effects without affecting its antipyretic activity.
• A. chasmanthum is another species which is well
known for its cardiac and neuro-toxicity.

54. Shodhana-Aconite
• A. chasmanthum showed toxic effects, which leads to
the impairment in kidney and liver functions.
Śodhana with Gomūtra reduces the toxic effects of
Aconite significantly.
• In vivo and in vitro studies on frog heart showed that
A. ferox has potential effect to depress the heart rate
by its positive inotropic and negative chronotropic
effects and these effects may be mediated through
cholinergic stimulation or by direct action on the
heart muscle.

55. Shodhana- Nuxvomica
• Kupīlu (Strychnos nux-vomica Linn., Family:
Loganiaceae) is extensively used in various conditions
such as nervous debility, paralysis, and weakness of
limbs, sexual weakness, dyspepsia, dysentery, and
rheumatism after proper Śodhana.
• Kupīlu has been reported to contain active alkaloids
(strychnine and brucine), which are highly poisonous.
• There are several specific Śodhana procedures, which
have been adopted to purify the toxic materials from
the seeds of Kupīlu.

56. Shodhana- Nuxvomica
• Classical method of purification includes soaking of
Kupīlu seeds in liquid media (one after another) for
3–20 days. The liquid media include kāñji (soaking
for 3 days), Godugdha (boiling for 3 h), Gomūtra (7
days soaking) and Goghrita (cow ghee) (fried till
brownish red in color and swollen) After Śodhana
process, the seeds are washed with lukewarm water
where the outer seed coat and embryo are removed
from the cotyledons.
• Similarly in Chinese system of medicine, nux-vomica
is fried with sesame oil for detoxification.

57. Shodhana- Nuxvomica
• Kupīlu after Śodhana exhibits low percentage of
total alkaloid content (strychnine and brucine); and
the toxic loganin glycoside is eliminated.
Detoxification of Kupīlu might be due to the
chemical changes that causes the enhance N–
oxidation and conversion of strychnine and brucine
into less toxic derivatives such as isostrychnine,
isobrucine, strychnine N–oxide, brucine N–oxide,
and reduced level of loganic acid content of the
seed.

58. Shodhana- Nuxvomica
• Being acidic in nature, kāñji is a better extraction
medium because it may facilitate the extraction of
alkaloids and other phytochemicals.
• Though larger doses of strychnine are known to be
lethal, in lower doses it is known to be a stimulator.
• Gomūtra Śodhita Kupīlu shows better
pharmacological potency than the raw seeds.
Śodhana enhances its hepatoprotective potency.

59. Shodhana process-Datura
• Dhattūra (Datura metel Linn., Family: Solanaceae)
seeds are highly toxic and may be fatal, due to the
presence of alkaloids in them.
• Most of the side-effects (dryness of the mouth,
excessive thirst, cramps, unconsciousness, and
giddiness) are due to anticholinergic property of the
alkaloids present in this plant.
• In the purification process of Dhattūra, seeds are
soaked in freshly collected Gomūtra and kept aside
for 12 h.

60. Shodhana process-Datura
• After washing, the seeds are transferred to the dolā
yantra for svedana process for 3 h.
• The seeds are again washed with lukewarm water,
allowed to dry and the seeds testa are removed.
• Reduction in total alkaloid content and increase in
total protein content of seed were observed after
Śodhana.
• Complete removal of scopolamine and partial
removal of hyosciamine reflects the importance of
Śodhana of Dhattūra by means of which the toxic
effects are removed

61. Shodhana-Cannabis
• Leaves of Cannabis seativa Linn. are bitter,
astringent, tonic, aphrodisiac, alterative, intoxicating,
stomachic, analgesic, and abortifacient.
• It is used for the treatment of convulsions, otalgia,
abdominal disorders, malarial fever, dysentery,
diarrhea, skin diseases, hysteria, insomnia, gonorrhea,
colic, tetanus, and hydrophobia.
• Its excessive use causes dyspepsia, cough, impotence,
melancholy, dropsy, restlessness, and insanity.

62. Shodhana-Cannabis
• In order to reduce these toxic effects, Bhangā is
boiled with Babbula Tvak kvātha for 3 h and the
powder obtained is triturated with Godugdha.
• Toxic effects of Bhangā can also be reduced by
triturating with Babbula Tvak kvātha and frying the
powder obtained in Cow Ghee.

63. Sodhana-Papaver
• The opium obtained from the fruits of Papaver
somniferum Linn. is bitter, astringent, sweet,
constipating, aphrodisiac, sedative, somniferous,
narcotic, myotic, and antispasmodic.
• It is used for the treatment of cough, fever,
inflammatory affections of eye, proctalgia and low
back pain due to diarrhea and dysentery, migraine,
malaria, dysmenorrhea, cystitis, menorrhagia, and
other painful conditions.
• Major constituents of opium are morphine and
papavarine.

64. Sodhana-Papaver
• Large dose of opium exhibited toxic effects of
central nervous system, induces sleep, relieves pain
and develops euphoria.
• Toxic effects of opium can be reduced by steeping in
cold water for 5–6 h. After this process, the insoluble
brown latex obtained is used in the Ayurvedic
medicine.
• Severe toxicity of opium can also be reduced by
triturating with ginger juice. This process is repeated
21 times.