standerdization of ayurvedic drugs by gurmeet singh

7/29/2019 Standerdization of Ayurvedic Drugs by Gurmeet Singh

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Concept and importance of

standardization in ASU Drugs

Gurmeet Singh MPharm Ayurveda

lovely school of applied medical [email protected]
mailto:[email protected]:[email protected]


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INTRODUCTION

A system to ensure that every packet ofmedicine that is

being sold has the correct substances in thecorrect

amount and will induce its therapeutic effectthis is

known as standardization.


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Ayurveda

Ayurveda is widely

practised in India and is well knit into social fabric, as it is culturallylinked

with lifestyle of the local communities. The sources of Ayurveda are the

Vedas, the oldest available classics. Around 1000 B.C. the knowledge of Ayurveda was comprehensively

documented in Charak Samhita and Sushruta Samhita. The basicpremise

of the system is that every individual is unique rather than being just

another case of a particular disease. Ayurveda deals not only with the

treatment of diseases but is in fact a complete way of life


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Siddha System of Medicine

Practiced in southern parts of India

Similarity with Ayurveda

Herbo-mineral formulations

Time tested.


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Unani System of Medicine

Originated in Greece and accepted in

India since 13th century

Similarity with Ayurveda

Mainly Herbal formulations

Siddha system gained popularity in South

India


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Standardization parameters

for plant drugs Foreign matter

Extractive value

Microscopic examination Microbial count

Pesticide residue

Density

Specific gravity

Viscosity

Heavy metal count


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Standardization parameters

for plant drugs Total ash value

Melting point

Authenticity quality

Refractive index


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Raw drug standardization

(Example)

Maramanjal consists of the dried root andstem ofCoscinium fenestratum(Gaertn)

Colebr. (Fam. Menispermaceae); a largewoody climber with stout stem andbranches, occuring in the hills of Malabarregion, particularly Western Ghats


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a) Macroscopic : Root - 5 to 30 cm or more in length, 2 to 5 cm. in diameter,

somewhat longitudinally grooved, transversely cut surfacesmooth, yellow; texture rough and fibrous; acrid in taste; noparticular odour.

Stem -15 to 30 cm. or more in length, 2 to 8 cm. in diameter,straight or occasionally slightly twisted, pale grey or greyishyellow with a fairly smooth surface, marked with longitudinalstriations spaced about a mm apart, cut surface yellowish-green to yellow in colour showing wedge shaped areas,fissured with shallow vertical slits of varying length; texturehard, acrid in taste.


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b) Microscopic : Root -Transection almost circular in outline; cork cream coloured, 20 to 30 or more rows of

uniform rectangular cells with 1 to 2 stone cells; outer cortical tissue characterized by thepresence of very prominent yellowish band almost in the form of ring of thick walled, pittedstone cells; prismatic crystals of calcium oxalate found in the thick walled cells; phloem ingroups, sieve tubes with oblique pore and simple perforation plate; narrow radiatingwedge shaped xylem strips; medullary rays multiseriate with thick walled cells and wedgeshaped, extending to the centre, cells filled with rod shaped crystals of calcium oxalate andstarch grains which are circular, appearing lenticular on edge view, simple, 30-45 m in

diameter hilum indistinct or dot-like centrally placed if present, lamellae indistinct; vesselsfilled with tyloses and in mature root these tyloses become thick walled giving theappearance of stone cells; fibres long, lignified.

Stem- The transverse section circular in outline, shallowly crenate; cork 20 to 40 cells thick;cortex 5 to 8 layers of tangentially elongated parenchymatous cells having veryconspicuous yellowish crenate bands of hard tissue or stone cells with radiating canals andfilled with dark yellow content and almost capping the wedge shaped medullary rays andphloem; sclerotic elements cubical to oval with very thick pitted walls filled with prismaticcrystals of calcium oxalate; phloem distinct; xylem narrow, radiating, wedge shaped as inroot, vessels 70 to160 m in diameter, solitary, transversely elongated, pitting reticulatedwith small lenticular orifices, occluded with thick walled tyloses; fibres septate tononseptate, septate fibres having 2 to5 septa, 270 to 400 m long and 12 m in diameter;medullary rays extend from pith to periphery, broad, multiseriate, interfasicular,15 to manycells high and 2 to many cells wide; pith consist of two regins (i) parenchymatous cellscircular to polyhedral in shape with intercelular spaces, cells larger towards the centre (ii) 4to 6 layers of smaller collenchymatous cells towards periphery


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Powder

Powder of both root and stem yellow withgreenish tinge, bitter and odourless. Microscopicalexamination shows the presence of fibres, tyloses,stone cells, prismatic crystals of calcium oxalate,starch grains circular appearing lenticular shapedon edge view, simple, 30-45 m in diameter hilumindistinct or dot like centrally placed if present,lamellae indistinct and fragments of vessels,tracheids and parenchymatous cells; when treatedwith 1N NaOH aqueous and mounted innitrocellulose in amylacetate emits verycharacteristic canary yellow colour under UV-365nm.


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Powder characters

Starch grain


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IDENTITY, PURITY AND STRENGTH

Root Foreign matter : Not more than 1% Moisture content : Not more than 7% Total ash :Not more than 2% Acid insoluble ash : Not more than 0.4% Alcohol soluble extractive :Not less than 11% Water soluble extractive : Not less than 10 % Total alkaloid as berberine chloride :Not less than 2%

Stem Foreign matter : Not more than 1% Moisture content : Not more than 6% Total ash : Not more than 3%

Acid insoluble ash : Not more than 2% Alcohol soluble extractive : Not less than 3% Water solubleextractive :Not less than 8% Total alkaloid as berberine chloride :Not less then 1%

CONSTITUENTS Alkaloids - Berberine, Palmitine, Jatrorrhizine, Proto-berberine,

Barbarrubin, N, N-di-lindacarpine, Thalifendine and Columbamine.


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PROPERTIES AND ACTION

Rasa : Kasaya, Tikta Guna : Laghu, Ruksa Virya : Usna Vipaka : Katu Karma : Shothara, Vednasthapana, Vernsodhan,

Chakshoya IMPORTANT FORMULATIONS Rasaut or ras,

Syrups Coscinii fenestrati, Radicis Liquidum.

THERAPEUTIC USES Tikta-Usna, Dipan, Pachan,Anuloman, Pitsarak and Krimighna, Raktavardhak,Rakta shodak, Javarghan and Katupostic.

DOSE - 1 3 g in powdered from; Infusion 4-12 drams;Tincture - 1 drachm; Decoction -1ounce.


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ASU Drug Development, Standardization &

Quality Parameters

Standardization of Raw Drugs (with chemical profile)

(Protocol enclosed- I)

SOP of Extract (Protocol enclosed- II)

(If used)

Standardization of Extracts (Protocol enclosed- III)

SOP of Formulation (Protocol enclosed- IV)

Standardization of Formulation/ Finished product

(Protocol enclosed- V)

Biological Screening (Targeted Biological activity)

Safety and Toxicity Studies

Preservation, Packing and Storage


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STANDARDIZATION OF SINGLE PLANT MATERIAL

(RAW DRUG)

S.No. Test

Botanical Description

Sanskrit Synonyms/Regional name

Part Used

Botanical Origin

Distribution

Adulteration

substitution

Season of Collection

Site of collection

Stage of plant

1.

Substitution of exhausted products/Foreign matter

Description Colour

Odour

Taste

2.

Fracture/ texture


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Identification

Macroscopy

Microscopy

Colour test

Chemical test

3. TLC/HPTLC etc.

Physico-chemical Parameters

Loss on drying at 105 oC

Total- ash

Acid insoluble ash

Total solid Alcohol soluble extractive

Water soluble extractive

pH

4.

Volatile oil


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5. Assay for Constituents (Marker % , Major compounds

like Alkaloids,flavonoids/saponin compounds

Particle size

Bulk density

6. Tap density

Test for heavy/toxic metals As per WHO / FDA

(Permissible limit)

Lead 10.0 ppm

Cadmium 0.30 ppm

Mercury 1.00 ppm

7.

Arsenic 10.0 ppm


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Microbial contamination

Total viable aerobic count

Total Enterobacteriaceae

8.

Total fungal count

Test for specific pathogen

E. coli

Salmonella spp.

S. aureus

9.

Pseudomonas aeruginosa

Pesticide residue

Organochlorinepesticides

1. DDT( all derivatives)

2. HCH( all their Isomers)

3. Endosufan

4. Alderin used as standard

Organophosphorus pesticides

1. Malathion

2. Parathion


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11. Test for aflatoxine (B1,B2,G1,G2)

12. Safety Profile

13. Shelf life

Other Requirements

Packing and labeling

ASU Formulation in which used

14.

Therapeutic Applications

15. Dose and manner of Administration


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SOP OF PREPARATION OF EXTRACTS RAW MATERIAL (PART USED-ROOT, LEAVES, STEM, SEEDS,

BARK, WHOLE PLANT, FLOWER)

LEVEL OF GRINDING (MESH SIZE)

SOLVENT USED (WATER, ALCOHOL,

SUPERCRITICAL CO2 OR MIXTURE)

HERB: SOLVENT

METHOD OF EXTRACTION

CONCENTRATION UNDER VACUUM

DRYING UNDER VACUUM

QUANTITY OF EXTRACT OBTAINED

CONSISTENCY OF EXTRACT (POWDER, STICKY ETC.)

NAME AND QUANTITY OF EXCIPIENT USED FOR DRYING

RATIO OF HERB AND EXTRACT OBTAINED

REQUIREMENT OF PACKING AND STORAGE


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QUALITY EVALUATION OF

HERBAL DRUGS

Standardization & Quality Evaluation of Herbal drugs


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THANK YOU

standerdization of ayurvedic drugs by gurmeet singh

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