Transcript Slide 1

Innovative methods of Ayurvedic
preparations
Dr. Manoj Kumar Samantaray
•Medicine
•Important instrumental aid
•Physician
•Success in treatment
•Ayurvedic Pharmaceutics
•Rasashastra & Bhaishajya Kalpana
Dravyaguna
MATERIA MEDICA
JANGAM
(Animal origin)
PARTHIV
(Metals & minerals)
AUDBHID
(Plant origin)
Food
Drug
Poison
Ayurvedic Medicines
Herbal, HM, Medicines
Holistic Medicines
Modern Medicines
(Disease Management)
(Health Restoration)
Green Pharmacy
Red Pharmacy
The therapy which pacifies diseases
and gives rise to other diseases is
not pure therapy. The pure is one
which pacifies without erupting
other problems.
CATEGORIES OF FORMULATIONS
Charaka Samhita (12th BC) 128 dosage forms
Sushruta Samhita (10th BC) 129 dosage forms
Ashtanga Hridaya (6th AD) 90 dosage forms
Chakradutta (9th AD) 90 dosage forms
Sharangadhara (14 AD) 75 dosage forms
th
Bhaishajya Ratnavali (18th AD)98dosageforms
AYURVEDIC DOSAGE FORMS
BASIC
(5)
Swarasa
OTHERS
(>120)
Kalka
Shrita
Bolus
Expressed Juice
Hima
Phanta
Cold Infusion
Hot Infusion
Decoction
DOSAGE FORMS
Solid
Semi-Solid
Anjana
Churna
Lepa
Upnaha (Poultice)
Kshara
Gutika
Guda
Dhumravarti
Puplika
Prithuka
Mandura
Modaka
Rasakriya
Vati
Varti
Shashkuli
Saktu
Ksharasutra
Kalka
Krishara
tilapishta
Patrasveda
Madhucchishta
(Bees wax)
Avaleha
Liquids
Fumes
Taila
Ghrita
Dhumrapana
Asava/Arishta Dhupana
Arka
Kwatha
Ashchyotana
Karna purana
Kshirapaka
Phanta
Takra
Hima
Swarasa
Peya
Phanita
Manda
Madhu (Honey)
Mansa
Yusha rasa
Vesavara
Vilepi
Madya
3
MAJOR DOSAGE FORMS
• Vati (Tablet)
• Avaleha (Medicated confection)
• Asava (Fermented Syrup)
• Arishta (Fermented syrup)
• Gutika (Tablet)
• Modaka (Round tablet)
• Ghritapaka (Processed clarified butter)
• Tailapka (Oil processed with herbs)
• Churna (Powder)
• Kshirapaka (Milk processed with herbs)
• Guda (Herbs mixed with jaggery)
• Peya (A drink made of rice & herbs)
• Ghana satva (Decoction of herbs evaporated to make
tablets) etc.
Is it new ?
•Innovation & Ayurveda
•Always there is a continuous
evolution of new ideas = aimed
at better service.
•Sufficient evidence available.
Old wine in new bottle…….
•The basic principles of ayurveda is the
same as devised by our Acharyas.
•We have not added anything new
•Only changed the way of presentation
•By using modern technology.
•We must ensure that the quality must be
as original as possible.
•The faulty presentation of the original
products in the name of modernization is
very much responsible.
•So
we must
introducing
techniques
be very
modern
careful while
innovative
Innovative techniques are necessary ?
•Definitely it is required
• To
prove the authenticity
medicines scientifically
• For large scale production
•For globalization
of
our
•In the process of evolution we have
started making many new ways of
presentation such as
• Different dosage form
•By using modern machineries
•Packaging
•Preservatives etc.
Is the final product is genuine &
effective?
• it always remains doubtful about
the efficacy ?????
•The answer is = QUALITY CONTROL
& STANDARDIZATION
•I will present two preparation one each
from Rasashastra (mineral) &
bhaishjyakalpana (herbal) through
innovative techniques.
•However emphasis should given on
regular quality control & Standardization
for each & every step to ensure the
effectiveness.
CONCEPT OF BHASMA ALONG WITH
RECENT ADVANCEMENT
 Herbs were widely used for medicinal purposes from
the ancient past.
 Gradually
minerals were also identified and
incorporated for medicinal purposes.
For making fine powder heating, quenching in various
liquids, grinding and filtering through cloth were
adopted.
 Later along with these techniques, many other
specialized processing techniques like Shodhana
(purification), Marana (incineration / calcinations),
Samskara
(specialized
processing
techniques specially used for mercury) etc were also
developed.
 With the advent of processing techniques of Rasa
Shastra, use of metals and minerals came frequent in
therapeutics.
1. Rasa: Parada (Mercury)
2. Maharasa: Abhraka (Biotite), Makshika ( chalcopyrite),
Vaikranta (blackturmaline) etc
3. Uparasa: Gandhaka (S), Gairika (Red heamatite),
Manahshila (As2 S2),
Haratal (As2 S3) etc.
4. Sadharanarasa: Gauripashana (Arsenic oxide),
Hingula (HgS),
5. Dhatu: Gold, Silver, Copper, Iron, Lead, Tin, Zinc etc
6. Ratna: Ruby, Diamond, Emerald, Topaz etc gems.
7. Marine products: Pearl, Coral, Shankha, Shukti, Varatika etc.
 Small dosage,
 Tastelessness,
 Quick absorption and effectiveness,
 Long self-life,
 Wide range of therapeutic efficacy,
 Effective on dreadful chronic and incurable diseases.
 Easy storage and
 Easy transportation.
Above such qualities of mineral preparations made them popular
and superior over the herbal medicine.
In general practice simple diseases are treated with herbs or herbal
formulations where as chronic and dreadful are through
Rasoushadhi
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Heating,
Heating and quenching,
Boiling with various liquids (swedana),
Grinding (mardana),
Roasting (bharjana),
Filtering (galana),
Distillation (patana),
Sublimation (urdhwapatana),
Wet trituration (bhavana),
Heating through puta or kupi paka system.
Above are the important procedures applied
during Shodhana and Marana.
1.
2.
3.
4.
5.
6.
7.
8.
9.
Shuddha dravya,
Bhasmas,
Sindura,
Pottali,
Parpati,
Druti,
Drava,
Satwa bhasma,
Kharaliya Rasayanas
Above are the products of mineral material. With the
combination of these above innumerous formulations
are derived.
1.
2.
3.
Pre treatment:
Shodhan (Purification)
Main / chief treatment: Marana
(incineration /calcinations),
Postoperative treatment:
Lohitikarana, Nirutthikarana and Amritikarana.
For the production of Bhasmas, Shodhan (Purification /
Pretreatment) and Marana (incineration /calcinations), these two fold procedures are the important steps (including some
intermediary procedures in respect of particular materials like
Dhanyabhraka for Abhraka and jarana for lead, tin and zinc).
Shodhana is an addition and separation process, it is a
pre process for marana.
Following effects are observed during Shodhana,
1.
2.
3.
4.
5.
6.
Material becomes free from visible and invisible impurities.
Undesirable volatile and inflammable material escapes out.
Masses of minerals converted into fine and brittle.
Development of fineness and brittleness facilitates the
bhavana process.
Partial oxidation and reduction takes place.
Induction of organic therapeutic property in the inorganic
material
It is a wet trituration process; Advantages of Bhavana are
following,
1.
2.
3.
Materials are mixed uniformly
Materials divided into fine.
Surface area of material exposed and
expended which facilitates reaction
during firing (Marana)
4. Develops softness, smoothness and
stickiness in the material facilitates
better binding of material.
5. Enhances the therapeutic property of
minerals
and metals.
1. Small disk of Bhavita material should be made.
2. Its diameter should be of 3’ CM and thickness of ½ CM.
3. Dry in sun or in dryer
Drying of pellets:
1. Before putting it in Sarava (casseroles) for sealing it should be dried
completely.
2. Wet pellets should not be allowed.
3. Wet pellets if subjected for firing (puta) desired colour will not appears.
4. Desired smoothness will not develop.
1.
Arrange it 1- 3 layer in a earthen casserole
2.
Covered it with another casserole
3.
Joints of earthen lids should be sealed 3 to
7 layers with cloth and mud
4. Again dry it in sun or in dryer.
5.
Properly sealed prevents the escape of volatile material.
6. It prevents interference of out side gases and dirt.
Finally sealed casseroles subjected to puta system of repeated
heating till the material completely converted into bhasma with
desired characteristics.
1. Marana term denotes the meaning of incineration or calcinations.
When minerals (compounds) and metals (elements) are subjected
for heating on moderate to intense temperature, compound material converted
to certain other compounds where as elements get reduced to certain
compounds.
2. Nature of compound depends upon the material added in to
the main material and exposure of environment.
3. Various system of heating is applied for this purpose but the puta
system of heating is common for marana.
4. Marana is an Association and dissociation process.
5. Elements are converted into certain compounds
6. Metals are reduce to ash (forms compound)
7. Compounds are converted into certain other compounds.
8. Nature of compound formed depends upon the material used
for marana.
9. It may be sulphide, oxide, chloride, sulphates etc.
10.Macro forms of material converted into micro form,
11.Heavy and solid material converted into light and soft.
1.
Puta is a specific system of heating for the incineration
metals and minerals.
2.
For the hard, soft, organic, inorganic, volatile, inflammable and
according to heat resistance various puta have been described.
3.
According to the quantity of fuel Mahaputa, Gajaputa,
Varahaputa, Kukkutaputa, kapotputa, Gorbarputa, Bhanda and Tusha
etc puta
are mentioned.
4.
Each and every puta have different diameters.
5.
Intensity of heat, Mode of Temperature and Time duration
depends upon the puta.
6.
According to the heat resistance of the material puta are selected
and applied for the marana purpose. Such as,
for Gold & Silver Laghu or Kapot puta,
Vanga, Naga, Yashada Kukkutaputa or Ardha gajaput,
Tamra in Varaha or kukkutaputa and for
Abhraka and Loha in Varaha or Gajaputa are applied.
Effects of puta,
1.
2.
3.
4.
5.
6.
7.
Puta is an unit of quantum of heat (to be applied for
the marana of material).
Puta removes the blemishes (dosha vinash) and
Exposes the therapeutic quality (gunodaya) of the\
material.
Metals (elements) are reduced to ash (converted into
compounds)
Compounds are converted into some other suitable
compounds.
Material becomes light, fine, smooth and non
reversible.
Materials are converted into Bhasma
(suitable therapeutic forms).
Each and every puta have different diameters.
According to size of pit quantity of fuel accommodated in it.
Quality and Quantity of fuel is responsible for the production
different intensity of heat for particular duration.
Selection of puta is based on the chemical nature of the material
to be taken.
Intensity and duration of temperature depends upon the size of
puta.
Selection of putas depends upon the chemical nature
(volatile, inflammable etc) of material. and heat applied.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Mahaputa
Gajaputa
Varahaputa
Kukkutaputa
Kapotaputa / Laghuputa /
Lavakaputa / Gorbaraputa
Bhudharaputa
Bhandaputa / Balukaputa
Vastraputa
Sutraputa,
Suryaputa
Chandraputa
(Post operative Specific treatment):
1.
2.
3.
Lohitikarana,
Nirutthikarana and
Amritikarana
In some cases post operative procedures are also followed
to achieve safe, effective and desired Bhasma.
Amritikarana:
1.
2.
It removes the remaining blemishes of the
bhasma and
It enhances the therapeutic properties of the bhasma.
Lohitikarana:
1.
It develops desired red colour in case of loha and Abhraka bhasma.
Nirutthikarana:
1.
2.
It reduces remaining free metals of the bhasma.
It convert the metals into complete bhasma.
Rasaushadhies are mainly based on minerals (compound state) and
metals (elemental state). The basic material when treated frequently
with plant extractives and heated on fire the following reactions are
observed.
1. Marana is a compounding / reduction and dissociation process.
2. Plant extractives are converted into ash or solid organic / inorganic
forms depend upon the intensity of heat applied.
3. Compounds are reduced and converted into another compounds.
4. Elemental metals gradually reduced and converted into compounds.
5. Nature of compound depends upon the media as catalyst added.
6. Herbal residue participates in formation of compound or it may
present with the mineral compounds.
7. Wet grinding after each firing exposes the surface of metallic
particles.
8. Exposed surface coated with the media of catalysts for further
reaction.
There are many testing parameters, through which
product can be judged,
1.
Physical –
a. Rekha purnatwa (indicative of fineness),
Varitaratwa (lightness),
Nishchandratwa (free from metallic luster),
2.
Chemical –
b. Apunarbhavatwa and Nirutthatwa
(complete conversion into non reversible compound /
absence of free metal in bhasmas)
c. (tastelessness),
Dadhi / Amla parikshaas for Tamra or Tamra
containing metals (indicative of absence of free
metallic radicals in the bhasmas),
Colour of various Bhasmas i.e.
Swarna - Champaka varna (reddish yellow colour) ,
Rajata and Tamra - Krishna varna (black),
Vanga – Sweta varna (white) etc.
Kamsya – Dhusara.
Naga – Kapot varna.
Teekshna loha – Pakwa Jambu phala varna.
Abhraka – Istika varna (brick red colour).
These testing parameters are essentially followed for the
determination of Bhasmas on process as well as on product level.
1.
2.
3.
4.
5.
These tests are time tested and perfect but these essentially
based only on naked eye observation and experience.
They have limited sensitivity and can be applied only after long
experience
and
practice.
With the advent of modern science and technology many other
sophisticated and sensitive tests are being employed for
ascertaining
the
standards
of
the
Bhasma
prepared.
These include Metallographic study, Spectrophotometer, Scanning
electron
microscopy
(SEM),
XRD,
Atomic
Absorption
Spectrophotometer,
Particle
size
analysis
etc.
The analytical study of metallic bhasmas reveals that physical
and chemical changes take place after each and every process.
Hence chemical analysis on the level of ash content, acid
soluble / insoluble content, moisture content, specific gravity,
loss on ignition, loss on drying etc. should be determined.
For the grinding, powdering, filtering, heating, drying various new
machines are presently utilized, such as
1.
2.
3.
4.
5.
6.
Grinder (mortar & pestle)
End runner / Edge runner
Disintegrator / Pulverizer
Sheave shaker / shifter
Dryer / drying ovens
Electrically/ petroleum oil and gas heated muffle furnaces
To save the manual labor, prevention of pollution, bulk production and
ultimately for the better result these devises are the need of the time.
Details their working performance and output should be established,
drying, heating are the important steps hence before shifting on them
temperature pattern should be understand and then these can be
utilized.
1. Selection and authentication of raw material,
2. Application of standard procedural methods
(various procedural steps)
3. Use of essential equipments and utensils,
4. Uses of various heating devices (various putas / electric
muffle furnaces) or system are applicable for particular
material,
5. Intensity of temperature required / to be applied,
6. Application of testing parameters to achieve desired
characteristics in the Bhasmas,
7. Application of post operative Samskaras to the Bhasmas
wherever needed.
1.
2.
3.
4.
5.
Earlier medicines were prepared by the
physician themselves for their patients.
The physicians were well qualified to identify
the materials.
They were trained in various processing.
They were following guidelines of Shastra
and experienced teachers.
According to the immediate need of the
patients they were modifying the formulations
as per their occupied understanding.
1.
2.
3.
Physicians today are more involved with diagnosis and treatment.
The drug manufacturing has gone into the hands of businessmen.
The crude drugs are mostly in the hands of shopkeepers who supply
them to the pharmaceutical industries.
4. They are using their own methods.
5. In large-scale production they compromised with quality and
quantity of material.
6.
Compromised with longer and lengthy procedures.
7.
The drugs added during procedure are not mentioned on the label.
8.
Equivalent substitutes are added in the compounds are not
validated.
9. The exact important procedures either altered or made shortcut
10. This led to the decline in the quality of Ayurvedic drugs.
11. The standardization of Ayurvedic drugs is thus felt necessary
Vanga Bhasma
1. Bhasmas & kupipakwas of minerals, metals and mercurials were
prepared earlier through the manual trituration and conventional heating.
2. These two, trituration and heating are important factor with respect to
safe and effective products.
3. Trituration makes material fine and heating converts them into suitable
compound form.
4. During trituration greater surface of particle is exposed, resulting in better
contact of other material added during process which reacts with the
exposed surface and convert them into suitable compounds. Continuous
trituration is not possible manually since it is difficult, laborious and time
consuming. It can be made easy by mechanical process. Hence, trituration
and grinding for bhavana should be shifted to machines. It is beneficial as
well as easy to achieve the desired particle. It can be determined with the
help of particle size analyzer. Fine particle can be absorbed easily by the
system.
For the preparation of bhasma and kupipakwa, application of desired
temperature and time is essential.
For Bhasma, Puta method and for KupiPakwa, Valuka Yantra method is
in practice.
In puta method, cow dung cakes are mostly used as fuel material. In
some cases, firewood, goat dung is also used. The temperature value
and duration depends upon the quality and quantity of fuel. For
applying Puta with the fuel, various sizes of pits by the name
MahaPuta, GajaPuta, VarahPuta etc have been mentioned in the text
and is in practice. After long observation and detail studies, the Puta
system is shifted to Electric Muffle Furnace. With respect of land,
labor, capital and quality of yield, this system has proven to be
advantageous. Various commercial houses have adopted this system
due to its easy control system too. Temperature patterns applied in
different puta’s are shown in the graph.
Temperature (in C)
1200
1000
800
600
400
200
0
0
2
4
6
8
10
Time (in hours)
MahaPut
GajPut
KukkutPut
VarahPut
LaghuPut
BhudharPut
12
Temperature (in C)
500
400
300
200
100
0
0
5
10
15
20
25
Time (in hours)
GorbarPut
BhandPut
BalukaPut
30
Most of the products, including their intermediary samples have been
studied chemically, as well as physically i.e. Metallographically & XRD
levels. Metallographic technique was found advantageous in
determining the presence of free metal in bhasmas. This technique is
considered as an advancement of Nirutha Pariksha of metallic
bhasmas.
Toxicity evaluation of all the materials along with their final products
have been done to rule out their toxic effects on various vital organs at
acute, sub acute, and chronic levels in variable doses and found to be
nontoxic in therapeutic doses.
Drug manufacturing is a skill full art. Neither less nor excess
processing / cooking is beneficial. Only supakwa (properly cooked) is
beneficial and desirable.
In fact the minerals and metals of industrial importance are identified
on global level. Their data and values are available. But the Ayurvedic
compounds based on minerals and metals and prepared by ancient
classical methods are yet unidentified. It is due to their nation wide
limited use
Bhasmas and sinduras are safe when prepared and used properly. Use
of bhasmas and sinduras when prepared in Improper and short cut
ways, can prove injurious to health
Ayurveda and its medicines are serving the needs of ailing humanity
since many centuries. Particularly bhasmas and sinduras have good
preventive, curative and rejuvenating potential. There is a need of
systematic and well-organized coordination of allied sciences along
with adequate infrastructure and facilities to solve various problems
related to the standardization of Ayurvedic drug / Rasaushadhies /
Metallic bhasmas. This may facilitate the development this discipline
and lead to its global recognition.
Discovering new knowledge about products, processes,
and services, and then applying that knowledge to create new
and improved standard products, processes, and services that
fill market needs.
•Level of research in Ayurveda in India and at International level is
not up to the mark.
•Format and Protocol of Ayurvedic researches are not adequate.
•Financial support for Ayurvedic researches from different sources
is very meagre.
•Moreover the standardization of the ingredients in Ayurvedic
formulations itself is a biggest challenge.
Available Research initiatives in India for Ayurveda
• Ayurvedic Post Graduate teaching institutions private, Govt.
aided and Government.
• Central Council for Research in Ayurveda & Siddha.
• Modern Research Institutions of Govt. of India like CSIR, ICMR,
ICAR, CDRI, ITRC, NBRI, CIMAP etc.
• University Faculties – Dept. of Botany, Biology, Pharmacology,
Medicinal Chemistry etc.
• Pharmaceutical companies as a part of their R & D
• NGOs like FRLHT (Bangalore)
 CCRAS-Central Council for Research in Ayurveda & Siddha
 ICMR-Indian Council for Medical Research
 CSIR-Council for Scientific & Industrial Research
 DST –Department of Science & Technology
 DBT –Department of Bio-technology
 BHU, AIIMS, NIMHANS
 Golden Triangle Initiative (GTP) of AYUSH, CSIR & ICMR
International Research Establishments
Following organizations in foreign countries are engaged in researches
•on therapeutic aspects of herbs and their extracts used in Ayurveda
are being published in Western Journals occasionally.
•World Health Organization (W.H.O.)
•National Center for Complimentary and Alternative Medicine
(NCCAM)
•University of Texas Center for Alternative Medicine Research.
•American Botanical Council
At International level especially in US & UK various
Universities and medical schools few scientist are
conducting researches on herbs used by Ayurveda as CAM /
Alternative medicine
What we can do for better establishment of R&D and QC Department.
Construction of a board of experts in
•Dravyaguna
•Rasashastra & Bhaishajyakalpana
•Kayachikitsha
•Modern Pharmacology
•Clinical Research Associate (CRA)
•Botanist
•Chemist
•Microbiologist
Management personnel.
This board will help in the following stages
•Raw material Standardization
•In process Standardization
•Finish product Standardization
•Pre Clinical & Clinical Trials with Clinical
Data Management
•Market survey
Proposed methods for Raw material
Standardization
•The required samples are to be collected from ear marked vendors
with the help of the Dravya guna Experts.
•The Botanist, Chemist & microbiologist will ensure the
pharmacological contents of the Raw materials & ensure absence of
contamination. (As per API GUIDELINES/ IN HOUSE
STANDARDS).
•The pharmacologist will certify the action of the active principles in
the Raw material.
•Preservation of Raw materials along with the shelf life is to be
certified by the Botanist & Dravya guna Expert.
•The required amount of Raw material should be procured from the store taking
into account the possible loss in weight during preparation. (Raw material
processing)
•The formulation should be prepared as per the AFI (for classical) or In house
(for proprietary) guidelines.
•Manufacturing procedures are to be supervised by a qualified Ayurvedic
Doctor (RS& BK Expert) at each and every stage.
•In process quality check is a must.
• Maintenance of existing standards is to be reevaluated by following the
textbook directions and cross checking with the same standards as described in
the books. If at all any vague descriptions they can be clarified.
• If there is any additional standard after fulfilling all as in the text books this
can be considered.
•End product quality analysis is must as per the AFI Guidelines.
•The components of each finished product should be tested &
conformed.
•To keep an authentic standard sample of every traditional
preparation in central office wherein, all the other ayurvedic
manufacturers can crosscheck their preparation with this official
standard.
•Cross checking with standards from the authentic samples from
recognized and reputed institutes like BHU, Kottakkal Institute,
Jamnagar Ayurvedic Universities etc.
•Shelf life & stability study should be made meticulously.
•Each product should be analyzed as to its expected
pharmacological action devoid of toxic effects.
•Disease wise CRF (Clinical research format) to be prepared
by Kayachikitsha Expert, Pharmacologist & Clinical research
Associate.
•Pre clinical (experimental) trial to be carried out on
laboratory animals.
•Clinical trial on volunteers & Data management are to be
taken up as per GCP (Good clinical practice) guidelines.
•Field studies to be taken up by expert personnel.
Efficacy without safety is useless. Hence,
efficacy and safety has to go hand in hand at all
levels.

Safety evaluation should be based on
internationally
accepted
guidelines.
Safety of drug should be evaluated on different
species of experimental animals in variable
doses
and
time
duration.
Acute, sub-acute, and chronic physicopathological variations should be estimated
biochemically and histo-pathologically.

Efficacy should be evaluated on various
pharmacological, as well as clinical parameters.

 Prof. Siddhinandana Mishra
 Prof. C.B Jha
 Prof. Kamadev Das
 Dr. Sathyanarayana Bhat
 Dr. Prabhakar Ranjal
 Dr. Ravindra Angadi
It was observed in the studies that the difference in temperature
between, out side and inside the Samputa is about 100 degree C.
In
Kupipakwa
method,
many
compounds
are
derived.
Each material and their products have different nature; hence
temperature pattern varies according to product, as shown in the graph.
In Kupipkwa preparations, temperature and time both are important
and
it
can
not
be
overlooked.
In case of Sagandh Kupipakwa, contact of mercury and sulphur for
longer duration is belived beneficial with regards to efficacy.
But for the formation of Rasasindura (Red Sulphide compound) 6 to 8
hour’s duration is sufficient (Rasa Sindur Pak Kalagni Vinischaya, Dr
H.S.
Sharma
.et
al
in
1976).
Time may vary according to the quantity of sulphur taken.
In case of Rasa Karpur and Swarna Vanga temperature pattern will be
changed, as shown in the chart.