For B-Pharm 6th semester students

1. PREPARATION AND STANDARDIZATION OF HERBAL
FORMULATIONS
BY
DR. PRINCE AHAD MIR
ASSISTANT PROFESSOR
KHALSA COLLEGE OF PHARMACY
GT ROAD AMRITSAR

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

3. 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
• Understanding why addition of harmful additives works evaluating “drug”
interactions
• Constraints with clinical trials and people available
• Standardization
• Safety, and efficacy assessment

4. 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.

5. 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.
• 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

6. FACTORS AFFECTING HERBAL FORMULATION
• Drug adulteration
• Faulty collection
• Imperfect preparation
• Incorrect storage
• Gross substitution with plant material
• Substitution with exhausted drugs

7. 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.

8. TYPE OF AYURVEDIC FORMULATIONS
• 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.
• 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.

9. TYPES AND FORMS OF AYUVEDIC FORMULATIONS
• Solid dosage forms: Gutika, Chruna, Vatika, Bhasma,
• Semi solid forms: Avaleha, Ghrita, Lepa, Matras, Kalka,
Lehyam
• Liquid dosage forms: Asava , Arista, Arka, Kwaha, Dravaka
& Taila

10. GUTIKA
• GUTIKA: 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 upto 2 years. Pills with minerals can be used
indefinitely.
• These formulations should not loose their original colour, odour, taste and form
on standing.
• They should be kept away from moisture, if they contain salt, Ksara or sugar.
• Examples: Lasunadi gutika, Pranda gutika, Khadiradi gutika.

12. STANDARDIZATION PARAMETERS OF GUTIKA
v Uniformity of weight
v Hardness of pill/tab
v Disintegration time
v Water soluble extract
v Alcohol soluble extract
v Ash value
v Loss on drying

13. CHURNA
• It is a fine powder of drug or drugs. The churna is free flowing and retains
potency for one year, if preserved in air tight containers. E.g. Triphala churna,
Sudarshan churna, Trikatu churna, Drakshadi churna, Sitopatadi churna.
• Preparation

14. STANDARDIZATION PARAMETERS OF CHURNA
• Standardization of churna involves the physical, chemical and
microbiological method.
• Determination of pH
• Determination of moisture content.
• Determination of Ash value
• Churna should be free from flowing powders and not adhere or become
moist.
• Churna are stable upto one year if they are stored properly.
• Finer the powder, better is its potency and therapeutic value.

15. BHASMA
• These are the preparations containing ash which are obtained through the process of
incineration of crude drug treated with metallic or non metallic minerals (gold, silver,
zinc, copper) reagents or extract or plant juice or animal derived substances like shells
and horns in closed crucibles or in pits with cow dung cakes
• Preparation of bhasma: it include two methods such as
– Shodhna
– Marana
• Shodhna: it involves two methods
• Samanya Shodhna (General Purification): it is done in case of metals or minerals.
This is performed by only heating the thin sheets of the metals and immersing them in
any specified liquid like oil, butter milk and cow urine
• Vishistha shodhna (Special purification): it is done only in case of certain drugs
and in certain preparations

16. MARANA
• This is second stage of preparing bhasma in which the purified drug
obtained from sodhna process are mixed with plants/extracts as
specified.
• After specified time small cakes are made and dried in sunlight
• The dried cakes are kept in earthen vessels, sealed with clay
smeared cloth and kept in pit covered with cow dung and the fire is
put on all the sides.
• After heating for a specified period the contents are removed and
convert into fine powder and stored it.

17. STANDARDIZATION
• Bhasma are grey, whitish, yellowish or black colored powders.
They should not change in color during storage. They are
highly stable for long periods and should not loss their potency
• E.g. suvarna bhasma

18. LEHYA
• PRINCIPLE OF PREPARATION
• Lehya is a semisolid or thickened extract prepared in a medium of sugar or jaggery .
• It is prepared by using powdered drugs and pulp of fruits in the sugar medium of jaggery, sugar,
sugar candy in an aqueous medium.
• It is boiled with the prescribed liquid till the correct constituency is obtained.
• Then spices and ghee are added and stirred well.
• After cooling honey is also added.
• Generally all type of lehya preparation, have following ingredients-
• Kashaya
• Sharkara/gud (sugar, sugar candy or jagerry)
• Churna (powder or pulps of certain drugs)
• Ghee or oil 5.Madhu(honey)
• PRESERVATION: It should be kept in glass or porcelain jars. It can also be kept in a
metal container which do not react with it

19. STANDARDIZATION PARAMETERS LEHYA
Organoleptic parameter Physical parameter
Color Determination of foreign organic matter
Odor Determination of Ash value
Taste Determination of extractive value
pH Alcohol content
Moisture content
Specific gravity
Solid content
Loss on drying
Solid content

20. ARISTA AND ASAVA
• They are also known as preparations containing self-generated
alcohol (Alcoholic preparations). Both the preparations are prepared
separately and the methods for their preparation are also different.
• Arista are prepared by extracting the powdered drug in the form of
decoction while as Asava are prepared by directly adding the
powdered drug into the solution of sugar or jiggery (gud shaker).

21. STEPS INVOLVED IN ARISTA PREPARATION
Ø Herbs or drugs are coarsely powdered (Yavakuta churna)
Ø Decoction is prepared from them by boiling the powdered drug in water (Kashya/Kwatha)
Ø The prepared decoction (Kashya) is then strained and kept in a safe place in the fermentation vessel/pot or
barrel
Ø Jaggery, sugar or honey according to the formula is separately dissolved, boiled filtered and added in the
fermentation vessel where decoction is kept.
Ø The mouth of vessel is completely covered with an earthen lid
Ø Container is kept in heap of paddy. Use of paddy is to maintain the constant temperature during fermentation
Ø After specified period the earthen lid is removed carefully and the content of the vessel are examined for
ascertain the process of fermentation has been completed or not
Ø The content or fluid is then decanted and strained and kept as it is for two to three days. It is again strained to
mix sediments properly and packed in a glass or pet bottle.

22. STEPS INVOLVED IN ASAVA PREPARATION
• Jaggery or sugar is dissolved in the required quantity of water, boiled and
cooled.
• This is poured into fermentation vessel
• Fine powder of drug is added in the container covered with lid and edges
are sealed with clay smeared cloth.
• Constant temperature maintained by keeping container in special room or
heap of paddy.
• After specified period the lid is removed and content checked whether
fermentation has been completed.
• Finely fluid is first decanted and then strained after two or three days
when the fine suspended particles settle down it is strained and bottled

23. STANDARDIZATION OF ARISTA AND ASAVA
Organoleptic
characters
Physical parameter Chemical parameter Toxicological
parameter
color Determination of Foreign organic
matter
Alkaloids: Mayer, Hager, Dragendroff ,
wagner’s test
Pesticide residue
Odor Determination of Ash Value Glycosides: Brontrager test, Modified
Brontrager test, Killer kallani test
Heavy metal
Taste Determination of Extractive value Flavanoid: Shinoda Microbial contamination
pH Alcohol content Phenolic lead acetate
Moisture content Tannin- Ferric chloride
Specific gravity Steroid- Salkowski reaction
Solid content Amino acid- Ninhydrin
Physical constant like MP, BP,
refractive index and optical
rotation
Carbohydrates: Fehling's test, Benedict
test, Molish test

24. THANK YOU