54928844 Ch 1 Pharma Cog Nosy Intro

5/21/2018 54928844 Ch 1 Pharma Cog Nosy Intro

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Chapter No. 1 - General Introduction

Sem. 1 Second Professional

Abdul Aleem Awan

Lecturer

Pharmacy Department

Hazara University.


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Pharmacognosy

Pharmacognosy is a branch of pharmacy which deals with

the basic resources of medicines from nature (plant &

animal) and their uses as medicaments from ancient time

to present day.

Pharmacognosy is derived from two Greek words,

Pharmakon&Gnosis Pharmakon meansdrug.

Gnosis meansknowledge.

In brief, Pharmacognosy meansknowledge of drugs.

It is a study of drugs that originate in theplant & animal

kingdoms.

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At present pharmacognosy involves not only the crude

drugs but also their natural derivatives (pure compounds

or constituents).

Digitalis leafand its isolated glycoside,digitoxin;Rauwolfia

rootand its purified alkaloid,reserpine; andthyroid gland

with its extracted hormone,thyroxine, are all part of the

subject matter of pharmacognosy.

Pharmacognosy

Pharmacognosymay be defined as an important branch

of Pharmacy which deals with the study of structural,

physical, chemical, biochemical and sensory characters ofnatural drugs of plant and animal origin. It also includes

a study of their history, distribution, cultivation,

collection, identification, preparation, evaluation,

preservation, use and commerce.

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Pharmacognosy -History

The first or beginning of pre-history on use of

medicinal plants or herbs or animals, and the placewhere and how used were not well known, and those

information were unwritten for a long time. As a

result, the pre-history on herbs was almost lost.

However, some information was recorded by oral

transmission from generation to generation.

Pre-history:

History of pharmacognosy is actually the history of

medicine that is medicinal plants.

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The written history has originated which was based on

region, religion and culture etc.

The written history was divided into the following:

1. The western medicine

2. The Unani (Islam)

3. The Ayurveda (Indian)4. The orient

5. The Greek History

6. The African System

Written History:

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This is originated inMesopotamia and Egypt.Mesopotamiaisconsidered as the first origin of human civilization. The

Sumerians (peoples of ancient Mesopotamia) developed

cuneiform tablet of herbal medicines. Those tablets are

preserved in British museum.

In Egypt,information had been written on paper Papyrus

ebers(1600BC). It consisted of 800 prescriptions, mentioning

700 drugs.

The first pharmacopoeia named London Pharmacopoeia was

published in 1618 and then British Pharmacopoeia was

published in 1864.

1. The western medicine:

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This herbal system was developed byArabian Muslim

Ibn Sina(980 1037 AD). He was a prince and ruler.

He was a very brilliant pharmacist and physician who

wrote a book Kitab-Al-Shifa, means Book of

Healing.

The book was written on Arabic language. This is a

great contribution of Ibn Sina towards medical and

pharmaceutical sciences.


2. The Unani (Islam)

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Ayurveda is the term for traditional medicine of ancient

India.

The word Ayur means Life and veda means The

study of that isStudy of Life.

The Ayurvedic writings were divided into three systems:

1) Charaka Samhita, 2) Sushruta Samhita and 3)

Astanga samhita.

The oldest writing was Charaka Samhita (six to seven

century before Christ).

The book describes uses of many metallic drugs eg.,

iron, mercury, sulphur, copper etc with herbs.


3. The Ayurveda (Indian, 2500-600 BC):

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This is originated from Chinese, Japanese and

Tibetiansetc. The orient herbalism was very old

(142 220 BC) and called Kampo. The writtendocuments were made by the King Shen Nung

(2700 BC) and Shang (1766 1122 BC) etc.

Shen Nunginvestigated medicinal value of severalherbs and written a book Pen T-Saoor native

herbal.


4. The orient (2700 BC):

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Hippocrates (Father of Medicine, 460-370 BC):

He was the first natural doctor who utilized simple remedies such as

vinegar, honey, herbs etc in healing. He is also known to have collected

and identified a number of medicinal plants.

Aristotle (384-322 BC):

He gave the philosophy of medicine. He listed more than 500 plants of

medicinal importance.

Theophrastus (371-287 BC):

gave scientific basis of use of plants as medicine.

Galen (131-200 AD):

a Greek pharmacist-physician. He developed the methods of preparing

and compounding medicines by mechanical means. He was the

originator of the formulae for a cold cream.

Pharmacognosy -History5. The Greek History:

Some of the early naturalists, scientists and physicians who contributed enormously tothe development of human knowledge about medicinal plants include following:

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They keep information in their groups or tribes.

The information transmitted from one generation

to another.

These regions are richest sources of medicinal

plants and needs to explore for new drug

discovery.


6. The African System (Tropical Africa, North

and South America):

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Scope of Pharmacognosy

1. Primary source of medicines(from ancient time to

present day), for example hyoscine, morphine,

ergotamine, ouabain etc.

2. Providing Template/guide for the discovery of new

drugs, for example Pathidine (analgesic drug)

designed from morphine.

Pharmacognosy deals primarily with information on

thesourcesandconstituentsof natural drugs.

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Terms & Phrase

used inPharmacognosy

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Standard dictionaries definedrug as an original, simple

medicinal substance, organic or inorganic, used by itself

or as an ingredient in medicine.

According to WHOs definition any substance used in

a pharmaceutical product that is intended to modify or

explore physiological systems or pathological states for

the benefit of the recipient.

DrugTerminology

Pharmaceutical product/Medicine means a dosage form

(tablet/capsule/syrup/Inj - IV/IM) containing one or more

drugs along with other substances included during the

manufacturing process. 14


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Application of Drug

Prevention of a disease :for example,vaccine.

Fight against an infection:for example,antibiotics.

Temporary blocking of a normal function:for example,

general & local anesthetics

Detoxification of the body:for example,antidotes.

Diagnostic agents:for example,radioisotopes.

Correction of dysfunction:for example,cardiotonics (eg,

digoxin)for the treatment of congestive heart failure. Correction of hyperfuntion:for example,Rauwolfia root

(eg., reserpine)for the treatment of hypertension.

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Crude Drug:

The term Crude, as used in relation to natural products.

A crude drug is a natural drug of plant or animal origin

which has undergone no treatment other than collection

and drying,that is, the quality or appearance of the drug

has not been advanced in value or improved in condition

by any physical or chemical treatment.

For example:Digitalis leaf, Rauwolfia root etc.

Terminology

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Indigenous vs Naturalized

Indigenous :

Plants growing in theirnative countriesare said to be indigenous to

those regions.

For example:Aconite (Aconitum napellus)in the mountainous region

of Europe. It is highly poisonous used as diuretic in Homeopathypreparation

Terminology

Naturalized:

Plants are said to be naturalized when they grow in aforeign land or

in a localityother than their native homes.

For example:Datura (Datura stramonium)which was introduced into

the USA from Europe.

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Official Books

It provides guideline for the manufacturing, quality control,

packaging, storage, dose regimen, indication, contraindicationetc

of different pharmaceutical products/medicine for the treatmentof diseases.

USP United States Pharmacopoeia

BP British Pharmacopoeia

NF National Formulary BNF British National Formulary

BDNF Bangladesh National Formulary

BPC British Pharmaceutical Codex

Martin Dale Extra Pharmacopoeia

Materia Medica

Physicians Index

Goodmans & Gilmanns:The Pharmacological Basis of

Therapeutics. 18

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Official vs Unofficial vs Nonofficial drug

Official drug:

Any drug (crude or prepared) which is included inpharmacopoea or in national formulary or in recognized books

is called an official drug.

For example: quinine, morphine, codeine, paracetamol are

included in BP, USP, NF and so on.

Terminology

Unofficial drug:

A drug which has been recognized earlier in the pharmacopoeia

or in national formulary or in recognized books but not found

in the current issue is designated as an unofficial drug. Those

substances were excluded from the recognized books due to

their severe toxic effects on humans. For example:Sucralfate

(hyperacidity), mercurial compounds (diuretics), benzoic acid

(preservative) etc. 19

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Official vs Unofficial vs Nonofficial drug

Nonofficial drug

Substance that has never been appeared in either of

the official books may be called nonoffical. Suchtypes of compounds may be published in current

journals having proven clinical value, but we do not

know about their side effects.

For example - Curcumine (sinusitis), etc.

Terminology

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Terminology

Extractive

Thecrude mixtures of chemical constituentsthat are removed

from plants or animals by various extraction processes are

called extractives or derivatives.

Secondary metabolites

These are substances synthesized or produced asby-products

by plants during theirmetabolic activities. Apparently they

are of no primary use to plants.

They are therefore also regarded as waste products of

metabolism, which are usually accumulated in some parts of

the plant and are physiologically active on living organisms. 21

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Monograph

The descriptive material pertaining to any drug,

therapeutic agent included in the pharmacopoeia is

known as the monograph.

The monograph of a drug includes the following

information on the drug:

official title, synonyms, definition, description,

collection or preparation, identity tests, tests for

adulterants, method of assay, storage, uses and doses.

Terminology

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Monograph of

Trigonella foenum-graecum (Family: Papilionacacae)

Common name:Fenugreek (Eng.), Methi (Bengali)

Cultivation:It is cultivated in different area of Bangladesh, India, Pakistan, MiddleEast, Africa.

Description:The Latin species namefoenum-graecummeans Greek hay, which

is a dried plant's (leaves or seeds) and has a strong hay-like scent. It has a

strong, pleasant and a peculiar odor and grows best in well-drained soils witha low rainfall into brownish- yellow rhombic shape seeds.

Parts used: Ripe, dried seeds

Chemical constituents: Seeds are rich in mucilage (maily galactomannans),

fixed oil, fatty acids and protein. They also contain alkaloids, saponine,

glycosides etc.

Uses:Seeds are diuretics, astringent. They are popularly used in the treatment

of loss of appetite, weight loss, menstrual disorder. Also used in

hypertension, diabetes, etc. It lowers TG, cholesterol, LDL.

Dose:Daily dose, 18 g. 23


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Fenugreek (Kasuri Methi)

Fenugreek seeds Fenugreek with flowers

Dried Fenugreek Fenugreek Powder

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Pharmacognosy & Modern Medicine

Simultaneous advancement in the field of

chemistry, biochemistry, biosynthesis and

pharmacologyhas developed pharmacognosy.

Various active compounds have been isolated fromplants which are used in modern medicine.

With the advancement of synthetic organic

chemistrymost of the active constituents of plantshave been synthesized.

100s of plants are used in modern medicine in

various parts of the world. 25 25

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Important active constituents of plants used in medicine

Active constituents Plants Pharmacological activity

Morphine, Codeine,

Papaverine

Papaver somniferumL. Sedative, smooth muscle

relaxant

Quinine, Quinidine Cinchona sp. Antimalarial,

antiarrthythmic

Hyoscine, Atropine Daturasp., Parasympatholytic

Digitoxin, Digoxin Digitalis lanata Cardiotonic

Reserpine, Rescinamine Rauwolfiasp. Hypotensive,

vasodialator

Vincristine, Vinblastin Catharanthus roseus Anticancer

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Caffeine Camellia sinenssis CNS stimulant

Cocaine Erythroxylum coca Anaesthetic

Ephedrine Ephedrasp. Sympathomimetic

Pilocarpine Pilocarpus jaborandi Parasympathomimetic

ErgometrineErgotamine

Ergotoxine

Claviceps purpurea OxytocicVasoconstrictor

Vasodialator

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Psyllium mucilage Plantago ovata Laxative

Sennosides Cassia

angustifolia

Laxative

Theophylline Caffea arabica CNS stimulant

Diuretic

Steroid hormones Solanumsp. Anti-inflammatory,

antiarthriytic

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Plants always provide novel molecular structure,

which played important role for the molecular designand development of novel potent, less toxic or

nontoxic drugs e.g. natural morphine has got

analgesic & narcotic effect but meperidine a syntheticdrug originates from morphine basic skeleton is non-

narcotic.

Plant & animal products give potential biologicaleffect without any undesirable effects.

Plant & animal products can be taken with very ease.

Application of Pharmacognosy

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Drugs obtained from natural sources have a variety of

limitations. The majors are;

A natural compound may be highly active but usually this is

associated with high toxicity problem, ex- the toxic and

therapeutic dose of digitalis are very close which create

serious problem to use this medicine by the patient alone.

Some compounds are found in nature that give beneficial

pharmacological actions but their potencies are too low to be

employed therapeutically.

The yield of active natural products may be very low andthus the production cost of those drugs will be very high

The source of a natural drug may be very limited with

respect to geography, season and climate etc.

Limitation of Pharmacognosy

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Sources of Medicaments


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At present the prime source of modern or allopathic

medicines issynthesisin the laboratory by organic chemist. Only a few of compounds are isolated from plants, which

cannot be replaced by synthetic method.

For example:morphineisolated fromPapaver somniferum;

vincristin & vinblastin(anticancer drug) fromVinca rosea,

the most potent anticancer drug taxol from Texus

brevifolia;

the constituents ofdigitaliscannot be properly replaced byany synthetic drug likequinidine which is used for the

treatment of arrhythmia.

Sources of Medicaments

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In pharmacognosy, drugs may be classified according to -

1. Their morphology

2. The taxonomy of the plants and animals from

which they are obtained3. Their therapeutic/ pharmacological application

4. Their chemical constituents or active principles.

Each of these methods of classification has

advantages and disadvantages.

Classification of Drugs

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Classification of Drugs1 M h l i l l ifi ti


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In this system, the drugs are grouped according to the part of the

plants, such as roots, leaves, stems, barks, flowers, seeds etc.

The drugs obtained from the direct parts of the plants are called as

organized drugs. They are made up of whole plants or any parts

derived from them.

eg.,Root Rauwolfia, aconite, ginger;Bark Cinnamon, CinchonaFruit Amla, Bahera, Capsicum,Leaf Digitalis, Senna, Tulsi, coca;

Wood Sandal wood.

The drugs which are prepared from plants by some intermediate

physical process such as incision, drying or extraction with a solventare called unorganized drugs, eg., Dried juice (Aloe juice), Dried

extract (agar), Dried latex (Opium latex), Honey, Beewax etc.

Classification of Drugs1. Morphological classification

The main drawback of morphological classification is that there is no co-

relation of chemical constituents with the therapeutic actions. 33



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In this system crude drugs are arranged according to the

natural groups (e.g. Families) of their source.

For example: all the drugs obtained from Solanaceae are

grouped together as Solanaceous drugs.

Tropane alkaloids are the main constituents of

Solanaceous drugs.


2. Taxonomical classification

Family Drugs

Solanaceae Solanaceous drugs.

eg. Tropane alkaloids

Umbelliferae Umbelliferous drugs. eg.,

volatile oils 34 34



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In pharmacological classification the drugs are grouped

according to their therapeutic use.

For examplecardiotonic drug include digitalis, purgative

drugs include castrol oil.


3. Pharmacological classification

Pharmacological action Drugs

Anticancer VincaAnalgesic Opium, cannabis

Purgatives Senna, Aloe, Castrol oil, Plantago

husk

Cardiotonic Digitalis, strophanthus

Tranquillizer Rauwolfia root

Anti-inflammatory Tumeric, colchicum

The main drawback of this classification is that a drug can be placed in

various classes according to its therapeutic use. For example: Cinchona(quinine)can be grouped inantimalarial and antiarrhythmic catagories. 35



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The biological activity of a drug is due to the

presence of certain chemical constituents in the

drug.

Plants and animals synthesize chemical

compounds such as carbohydrates, protein, fat,

volatile oils, alkaloids, resin etc.

The chemical classification of drugs is dependent

upon the grouping of drugs with identical

chemical constituents.


4. Chemical classification

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g

Chemical classification of drugsChemical constituents Drugs

1. Carbohydrates

a) Monosaccharidaseb) Disaccharide

c) Polysaccharide

Gum

Mucilages

Cellulose

- Dextrose, fructose, galactose-Sucrose, Lactose, Maltose

-Starch

- Acacia, Tragacanth

-Plantago seed

-Cotton

2. Glycosides

a) Cardiac

b) Anthraquinone

c) Saponins

d) Cyanophore

-Digitalis, strophanthus

- Aloe, Cascara, senna

- Arjuna

-Wild cherry bark

3. Tanins Amla, Bohera, Ashoka bark

4. Volatile oil Clove oil, rose oil, peppermint oil, tulsi etc

5. Lipids

a) Fixed oils & fats

b) Waxes

-Olive oil, castor oil, coconut oil etc

-Bees wax

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g

Chemical classification of drugsChemical constituents Drugs

6. Resins ginger, capsicum etc.

7. Alkaloids

a) Pyridine & piperidine

b) Tropane

c) Quinoline

d) Isoquinoline

e) Indole

f) Steroidal

g) Purine

a) Nicotiana, areca nut

b) Coca, Belladonna, Datura

c) Cinchona

d) Opium, Ipecac

e) Ergot, Nuxvomica, Rauwolfia, catharanthus, Physostigma

f) Kurchi

g) Tea, Coffee

8. Protein Gelatin, gluten etc

9. Vitamins Thiamine (B1), Riboflavin (B2), Ascorbic acid etc

10. Antibiotics Penicillin, streptomycin, tetracycline etc

11. Hormones Adrenaline, thyroxine etc

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A natural substance is considered as food if it fills stomach

in every day life without any harmful effect. A substance becomes a drug if it changes a pathological or

disease state of human/ animal to normal physiological

condition having no undesirable effect in specific dose.

A long-term studies (chemical, biological and physical etc)

are required to establish whether a substance will be

considered as drug or food or eliminate for consumption.

Those studies are referred to asevaluation.

Evaluation of drug means

Identification

Determination of quality

Determination of purity

Evaluation of Drugs

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Cultivation

The identification can be established bycareful observational studyof the collected drug, and thencompared with authentic specimen

by the collector.

Therefore, for proper identification of a drug from plant or animal

sources, a collector must be educated about plant taxonomy and

very much experienced with his/her job.

Therefore, drugs from plants/animals are identified by

o A qualified, specialized & experienced person

o Comparison with the authentic sample specimen.

In every country, there is anational herbariumwhere most of plants

specimen are preserved. A number of specialists are working on

plant identification there.

Identification

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Quality


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Quality

The word quality refers tothe intrinsic value of the drug,i.e.,

the amount of medicinal principles or active constituents

present. These principles are classified as carbohydrate,alkaloid, glycoside, volatile oil, lipid, antibiotics and steroids etc.

A high grade of quality in a drug is of primary importance. An

effort should be made to obtain and maintain high quality.

To maintain high quality products one should do the following:

1. Select proper source (wild or cultivated)

2. Appropriate time of collection

3. Collection of required parts of plants (bark, leaf, stem, rhizome,

root)

4. Preparation of the collected drug by proper cleaning, drying.

5. Proper preservation to avoid contamination by microorganisms

and moisture, heat, air and light.41


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Purity

The purity of drug can be achieved by

1. Proper identification

2. Quality assurance.

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Evaluation Method

The evaluation of a drug involves a number ofmethods, which may be classified as follows:

1. Organoleptic

2. Microscopic

3. Biological

4. Chemical

5. Physical

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1. Organoleptic evaluation of drug

Organoleptic evaluation means the study of a drug with

the help oforgans of sense. It includes any drugs macroscopic or external

appearance, color, odor, taste & sounds of its fracture

etc.

The macroscopic or external characteristic of a drug may

be divided into 7 headings -

1. Shape

2. Size3. Color

4. Internal color

5. Fracture

6. Odor

7. Taste 44


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2. Microscopic evaluation of drug

Microscopic evaluation of drug can be done in the

laboratory by the use of microscopes and utilizes

variousmicroscopic characters of the drugs,

such astypes and arrangement of variouscells and

tissues.

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3. Chemical evaluation of drug

Chemical evaluation of drugs involves both

qualitative and quantitative determination of their

active principles.

In this method characteristicqualitative chemical

testsare employed to identify crude drugs and their

constituents.

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4. Biological evaluation of drug

The biological evaluation of crude drugs is very useful

in determining thepharmacological activityof the drug.

Sinceliving organism or their isolated living tissuesare

used, this method is also called the biological method or

bioassay.

Many drugs, particularly the antibiotics, toxins and

toxoids and also vitaminsare assayed by this method.

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5. Physical evaluation of drug

The physical evaluation of crude drugs is

accomplished by the determination of variousphysical

characteristics using various physico-chemical

techniques, for example, specific gravity(of fats and

volatile oils), melting points (of alkaloids), optical

rotation(of alkaloid and volatile oils), etc.

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Preparation of Drugs for Commercial Market


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Following are different steps performed for preparation of

drugs for market.

Collection

Harvesting

Drying

Garbling

Packaging, storage, and preservation

Preparation of Drugs for Commercial Market

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1. Collection

Collection of drugs from cultivated plants always insures a

true natural source and a reliable product. This may, or may

not, be the case when drugs are collected from wild plants.Carelessness or ignorance on the part of the collector can

result in complete or partial substitution. This is especially

true when drugs arc difficult to collect or the natural source is

scarce.

Many drugs are collected from wild plants sometimes on a

fairly extensive scale (tragacanth, senna) when collection is the

vocation of the gatherer, and sometimes on a limited scale

when collection is an avocation (podophyllum, hydrastis).

Because drugs come from all over the world, collection areasare almost universal, and collectors may vary from

uneducated natives to highly skilled botanists.

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1. Collection contd..

Time of collecting:

The proper time of collecting is particularly important

because the nature and quantity of constituents vary greatly

in some species according to the season.

The most advantageous collection time is when the part of the

plant that constitutes the drug is highest in its content of

active principles and when the material will dry to give the

maximum quality and appearance.

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2 Har esting


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2. Harvesting

The mode of harvesting varies with each drug produced andwith the pharmaceutical requirements of each drug. Some

drugs may be collected by hand labor; however, when the cost

of labor is an important factor, the use of mechanical devices

is often more successful in economic production of the drug.

With some drugs, where the skillful selection of plant parts is

an important factor (digitalis), mechanical devices cannot

replace hand labor.

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3 Drying


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3. Drying

By drying the plant material, one removes sufficient moistureto ensure good keeping qualities and to prevent molding, the

action of enzymes, the action of bacteria, and chemicals or

other possible changes.

Drying fixes the constituents, facilitates grinding and milling,

and converts the drug into a more convenient form for

commercial handling.

Proper and successful drying involves two main principles:

Control of temperatureand

Regulation of air flow.

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3 Drying contd


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3. Drying contd..

Control of the drying operation is determined by the nature of

the material to be dried and by the desired appearance of thefinished product. The plant material can be dried either by the

sun or by the use of artificial heat.

With some natural products, such as vanilla, processes of

fermentation or sweating are necessary to bring about

changes in the constituents. Such drugs require special drying

processes, usually called"curing."

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4 Garbling


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4. Garbling

Garbling is the final step in the preparation of a crude drug.

Garbling consists of the removal of extraneous matter, such asother parts of the plant, dirt, and added adulterants.

This step is done to some extent during collection, but should

be carried out after the drug is dried and before the drug is

baled or packaged. Although garbling may be done by

mechanical means in some cases, it is usually a semiskilled

operation.

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5: Packaging storage and preservation


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5: Packaging, storage, and preservation

The packaging of drugs depends on their final disposition.

In commerce, if transportation, storage, and ultimate use for

manufacturing purposes are involved, it is customary tochoose the type of packaging that provides ample protection

to the drug and gives economy of space.

Leaf and herb material is usually baled with power balers into

a solid compact mass that is then sewn into a burlap cover.

Senna leaves from India come in bales of 400 lb; stramonium

from Argentina in bales of 700 lb.

Drugs that are likely to deteriorate from absorbed moisture

(digitalis, ergot) are packed in moisture-proof cans. Gums,

resins, and extracts are shipped in barrels, boxes, or casks.

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5: Packaging storage and preservation contd


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5: Packaging, storage, and preservation contd

Proper storage and preservation are important factors in

maintaining a high degree of quality of the drug. Hard-packed

bales, barks and resinous drugs usually reabsorb little

moisture. But leaf, herb and root drugs that are not well

packed tend to absorb amounts of moisture that reach 10, 15,

or even 30% of the weight of the drug. Excessive moisturenot

onlyincreases the weight of the drug, thus reducing the %ageof active constituents, but also favors enzymatic activity and

facilitates fungal growth.

Light adversely affects drugs that are highly colored,

rendering them unattractive and possibly causing undesirablechanges in constituents.

The oxygenof the air increases oxidation of the constituents of

drugs, especially when oxidases are present. Therefore, the

warehouse should becool,dark, andwell ventilatedwith dry

air. 57



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The protection of drugs againstattacks by insectsmust not be

overlooked. The insects that infest vegetable drugs belongchiefly to the ordersLepidoptera,Coleoptera,andDiptera.

For destruction of insects and prevention of their attacks, a

number of methods have been employed.

The simplest & the most efficient method is to expose the

drug to a temperature of 65C which not only prevents insect

attacks, but also many other forms of deterioration.

For the fumigation of large lots of crude drugs, such as those

stored in warehouses and manufacturing plants, the use of

methyl bromide has met with considerable success.Small lots of drugs may readily be stored in tight, light-

resistant containers e.g. tin cans, covered metal bins, or amber

glass containers.

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Drugs should not be stored in wooden boxes or in drawers and

never in paper bags. Not only is deterioration hastened, butodors are communicated from one drug to another, attacks by

insects are facilitated, and destruction by mice and rats may

occur.

If drugs in small quantities are stored in tight containers,

insect attack can he controlled by adding to the container a

few drops of chloroform or CCl4from time to time.

In the case of digitalis and ergot, whose low moisture contentmust be maintained at all times, the insertion of a suitable

cartridge or device containing a non-liquefying, inert,

dehydrating substance may be introduced into the tight

container. 59



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Because high temperatures accelerate all chemical reactions,

including those involved in deterioration, drugs must alwaysbe stored at as low temperature as possible.

The ideal temperature is just above freezing, but since this is

impractical in most cases, the warehouse or other storage

place should be as cool as possible.

Certain drugs such as the biologics, must be stored at a

temperature between 2 and8.

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Animal Drugs


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Animal Drugs

Animal drugs are produced from wild or domesticated

animals. Wild animals must be hunted (whale, musk deer) orfished for (cod and halibut), and thus, in a sense, their

collection parallels the collection of vegetable drugs.

Many animal drugs, however, are produced from

domesticated animals &, therefore, correspond to the

cultivated vegetable drugs. When drugs consist of insects, the

drugs are either collected from wild insects (cantharides) or

definite attempts are made to cultivate them, i.e., to furnish

the insects with food and shelter and to maintain optimumconditions for their propagation (honeybee).

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Animal Drugs contd


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Animal Drugs contd..

Drugs such as lanolin and milk products, as well as hormones,

endocrine products, and some enzymes, are obtained fromdomesticated pigs, sheep, or cattle.

The slaughterhouse is the usual source of glandular products

and enzymes, and the larger packing establishments have

departments for the recovery and refinement of these

therapeutic agents and pharmaceuticals.

Processing and purification of the animal drugs vary with the

individual drug.

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Adulteration of Crude Drug


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The term'adulteration'or debasement of an article covers a

number of conditions, which may be deliberate oraccidental. Usually in crude drugs, this practice includes

substitution of the original crude drugs partially or fully

with other substances which is either free from or inferior in

therapeutic and chemical properties.

1) Inferiorityis a natural substandard condition (e.g. where a

crop is taken whose natural constituent is below the

minimum standard for that particular drug) which can beavoided by more careful selection of the plant material.

Adulteration of Crude Drug

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Adulteration of Crude Drug contd


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2) Spoilageis a substandard condition produced by microbial

or other pest infestation, which makes a product unfit for

consumption, which can be avoided by careful attention to

the drying, and storage conditions.

3) Deteriorationis an impairment of the quality or value of an

article due to destruction or abstraction of valuable

constituents by bad treatment or aging or to the deliberate

extraction of the constituents and the sale of the residue as

the original drugs.

4) Admixtureis the addition of one article to another through

accident, ignorance or carelessness e.g. inclusion of soil on

an underground organ or the co-collection of two similar

species.

Adulteration of Crude Drug contd..

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5) Sophistication is the deliberate addition of spurious or

inferior material with intent to defraud; such materials arecarefully produced and may appear at first sight to be

genuine e.g. powder ginger may be diluted with starch with

addition of little coloring material to give the correct shade

of yellow color.

6) Substitutionis the addition of an entirely different article in

place of that which is required e.g. supply of cheap

cottonseed oil in place of olive oil.


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Types of Adulteration Of Crude Drugs


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Different methods used for adulteration may be grouped as follows:

1) Substitution with inferior commercial varieties.

2) Adulteration by artificially manufactured substitutes.

3) Substitution by exhausted drugs.

4) Substitution by superficially similar but cheaper natural substances.

5) Adulteration by addition of worthless heavy materials.

6) Addition of synthetic principles.

7) Usage of vegetative matter from the same plant.

Types of Adulteration Of Crude Drugs

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Types of Adulteration Of Crude Drugs contd..


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1. Substitution with Inferior Commercial Varieties

Due to morphological resemblance to the authentic drugs,

different inferior commercial varieties are used as

adulterant which may or may not have any chemical or

therapeutic potential as that original natural drug e.g.

Arabian Senna (Cassia angustifolia), dog Senna (Cassia

obovata) and avaram (Cassia auriculata)have been used to

adulterate Senna (Cassia senna); Japanese ginger (Zingiber

mioga) to adulterate medicinal ginger (Zingiber officinale).

2. Adulteration by Artificially Manufactured Substitutes

To provide the general form and appearance of various

drugs, some materials are artificially manufactured and are

used as substitute of the original one, e.g. artificial invert

sugar for honey; paraffin wax after yellow coloration

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3. Substitution by Exhausted Drugs

Here the same plant material is mixed which is having no

active medicinal components as they have already been

extracted out. This practice is most common in case of

volatile oil containing materials like clove, fennel etc., where

the dried exhausted material resembles the same like

original drug (similarly with drugs likeCascara sagradaandginger). Sometimes when coloring matters have been

extracted or removed during exhaustion, the residue is re-

colored with artificial dyes as is done with saffron and red

rose petals.

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4. Substitution by Superficially Similar but Cheaper Natural

Substances

Usually here the adulterated product has no relation with

the genuine article, may or may not have any therapeutic

or chemical component desired, e.g. leaves of species -

Ailanthusare substituted for belladonna, senna, mint etc.;

Leaves ofPhytolaccaandScopoliafor belladona; Leaves ofXanthium for stramonium and dandelion for henbane;

Indian dill with European dill or caraway etc.

5. Adulteration by Addition of Worthless Heavy Materials

A large mass of stone mixed with Liquorice root, pieces oflimestone are found in asafoetida and lead shot has

occurred in pieces of opium etc.

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6. Addition of Synthetic Principles

Sometimes to fortify inferior natural products, synthetic

principles are added e.g. adding citral to oil of lemon;

benzyl benzoate to balsam of Peru etc.

7. Usage of Vegetative Matter from the Same Plant

This is done by mixing adventitious matters or naturallyoccurring with the drug in excessive amount or parts of

plant other than that which constitutes the drugs. For

example liver warts and epiphytes growing in bark portion

are mixed with Cascara or Cinchona;stems of buchu aresometimes cut into short lengths and added to the drug.

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Deterioration of Crude Drugs


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Besides being adulterated by different means as discussed earlier, the

crude drugs are prone to deterioration on storage. The shelf-life of crude

drugs are influenced by many factors which include not only the quality

of storage conditions but also the stability of the secondary (2)

metabolites present therein. Several factors are to be considered for the

detrimental effects on the stored products.

Several primary environmental factors relating to storage can produce

detrimental effects on stored products e.g.

1) Light,

2) Moisture / humidity,

3) Temperature &

4) Oxygen etc.

But more deterioration usually results from a combination of these

factors, which leads to the development of living organism including

molds, mites, bacteria etc. 71

ete o at o o C ude ugs

Primary Factors for Deterioration


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1. Light

Photo-decomposition occurs with santonin, the principal constituents of

wormseed, which on exposure to light darkens and eventually becomes

black. In general, drugs should be protected by suitable light-proof

wrapping or by the use of amber colour containers. Powdered rhubarb

stored in clear glass jars rapidly changes as the exposed surfaces

turning from yellow to more reddish colour.

For these detrimental effects, WHO has specified that medicinal plant

materials requiring protection from light should be maintained in a

light resistant container that shields the contents from the effects of

light. Alternatively, the container maybe placed inside a suitable light

resistant (opaque) covering and/or stored in a dark place.

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Primary Factors for Deterioration contd..


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2. Moisture/Humidity

Moisture present in drugs depends largely upon the amount of moisturein the atmosphere, which is usually expressed in the terms of humidity.

When the atmosphere is completely saturated, the humidity is 100%,when half saturated it is 50% and so on. Drugs stored in non-airtightcontainers are termed air-dry and contain about 10-12% of waterdepending on the humidity of the atmosphere. This amount of water issufficient to activate the enzymes present in some dried plant materials,such as Digitalis and bring about the decomposition of the active

glycosides. Such drug should therefore be stored with a dehydratingagent or in sealed containers immediately after drying.

Squill contains a hygroscopic mucilage and the powder there from, ifexposed to the atmosphere, will pickup moisture and become a stickymass.

Therefore strict humidity control is necessary while storing; lowmoisture may be maintained, if necessary by the use of desiccant in thecontainer provided that direct contact with the product is avoided.

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3. Temperature

It has a marked effect which is sometime unsuspected. Many enzymatic

changes in the plant secondary metabolites proceed more rapidly at theslightly raised temperature up to about 45C. Obviously those drugs

containing volatile constituents in unprotected structures, e.g. plants

belonging to Labiatae family and the petals of rose and chamomile all

loose oil with an increase in temperature. Absorbent cotton wool

contains a small amount of fatty material which is the residualcomponent from the natural fiber. At a raised temperature these

molecules become re-oriented, spreading themselves over the surface of

the fiber to form an impervious layer. Thus cotton wool, once fully

absorbent will gradually become completely non-absorbent because of

the effect of temperature.

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4. Air Oxidation

Direct oxidation of the constituents of crude drug is sometime brought

about by the oxygen of the air, e.g. Linseed oil rapidly becomeresinified as like the oil of Turpentine and oil of Lemon. Usually this

conversion is applied to the essential oil with terpenoid derivatives and

we can find the resinous deposit build-up around the stoppers used in

dispensing bottle containing this oil. Beside this, the rancidification of

fixed oils e.g. cod-liver oil, which involves the formation of unstable

peroxides, is also an oxidative process. Thus, these types of materials

require storage in a well-filled, airtight container.

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Secondary Factors for Deterioration


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Living organisms usually develop in stored drugs where the conditions

are satisfactory for them. From a hygienic point of view, such

contaminated material should be destroyed irrespective of whether or

not the active principles of drug have been effected. The more common

of such organisms belongs to the groups of bacteria, moulds, mites,

nematodes, worms, insects etc.

1) Bacteria and Moulds

2) Mites and Nematode Worms

3) Insects/Moths

4) Coleoptera or Beetles

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Secondary Factors for Deterioration contd..


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1. Bacteria and Moulds

Dried herbs are particularly liable to be contaminated with the spores

of the bacteria and moulds, which are always present in the air. Under

satisfactory storage conditions their presence causes no problem, but it

is generally accepted thatthe viable count permissible for crude drugs

should be the same as that for the food stuff. The effect produced by

bacteria are not always very visible with the exception of some

chromogenic species of bacteria, e.g. Bacillus prodigious, which

produces red patches in starchy materials. However, bacterial growthis usually accompanied by the crude drug by growth of moulds whose

presence is quickly evident by the characteristic smell and by the mass

of clinging particles entrapped in the mycelial hyphae.

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Dusty cotton wool, which is formed by bacterial attack causing the

trichomes to break into short length, rendered it to be very brittle. In

order to identify a particular mould or bacteria, which is proliferating

in a stored product, it is necessary to culture it on a suitable mediumwith a view to obtain fruiting bodies for examination. However, if the

drug to be examined is infested rapidly, then it may be possible to make

microscopic preparation directly from the sample. Usually the moulds

encountered with poorly stored drugs include the genera Mucor(e.g.

grey mould, M. mused), Rhizopus (e.g. black mould, R. nigricans),Penicillium(e.g. blue mould,P. glaucum),Aspergillus(e.g. green mould,

A. repens)andSaccharomyces.

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2. Mites and Nematode Worms

If found in stored drugs, mites are usually present in countless numbers

upto 1.0 mm in length. Different mites found usually include

Tyroglyphces siro (Cheese mite); Aleurobius farinae (Flour mite) and

Glycyphagus spinipes (Cantharides mite). All these mites can be

examined microscopically by clearing the sample of powder containing

them with chloral hydrate reagent. The best known examples of

nematode worms are "Vinegar eel" Turbatrix aceti, Anguillula aceti,

Anguina tritici which are found in wheat flour or in the crude drugcontaining starchy materials. These worms are visible to the unaided

eye as minute threads continually curling and twisting in the medium

they inhabit.

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3 Insects/Moths



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3. Insects/Moths

A few species of the Lepidiptera attack the stored crude drugs and

cause damage at the larval stage, where the infestation can spread

rapidly due to the mobility of the adults. The moths involved are

unspectacular in appearance, 22-30 mm in length with off-white wings

e.g. Ephestia kuehniella (Flour moth); E. ellutella (Cocoa moth).

Besides this some other insects, cockroaches, ants and others are

sometimes found to cause deterioration to the stored products.4. Coleoptera or Beetles

These are the insects that constitute the largest order of the animal

kingdom comprising about 2,50,000, species of which about 600 have

been found to be associated with stored food product or drugs.Stegobium paniceum is one beetle, which is found in many drugs

including gentian, liquorice and rhubarb as well as leafy drugs and

seeds. Belonging to the same family isLasioderma serricorne(tobacco

or cigar beetle) which is reddish brown in colour, 2 to 2.5 mm in length

and found in many stored crude drugs including ginger and liquorice. 80

Control Measures for Deterioration


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The container used for storage and its closure must not interact

physically or chemically with the material within in any way which

would alter its composition. A well closed container must protect the

contents from extraneous matter or from loss of the material while

handling and a tightly closed container must protect the material from

efflorescence, deliquescence or evaporation under normal condition of

handling or storage. Storage area should be kept clean and spillages not

allowed to enter cracks or in accessible crevices. Periodic spraying of thepremises with insecticides will help to prevent the spread of infestation.

The principles, which apply to the control of infestation in warehouses,

are equally applicable to small-scale storage. Good house keeping is

utmost essential. Each stock should be inspected regularly and thematerial found to be contaminated is best to be destroyed by burning. In

this respect a quick turn over to eliminate the effects of deterioration due

to both the primary and secondary factors as mentioned above are

desirable.

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Control Measures for Deterioration contd..


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Cool, dry condition is the most suitable for the retardation of living

organisms. As all leaves organisms require water for the development,

perfectly dry drugs should be immune from secondary deterioration.Sometimes the crude drugs purchased by the herbalist may already have

been sterilized, which is most commonly achieved by treatment of the

bulk consignment with ethylene oxide or methyl bromide under

controlled conditions.

Drugs so treated, should comply with an acceptable limit for toxic

residues e.g. for Senna pods 50 ppm of ethylene oxide is the limit.

54928844 Ch 1 Pharma Cog Nosy Intro

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Transcript of 54928844 Ch 1 Pharma Cog Nosy Intro