Standardization of herbal drug Ppt

PHYSICAL, CHEMICAL AND BIOLOGICAL/TOXICOLOGICAL STANDARDIZATION OF HERBAL DRUGSINDER MAKHIJAMCOPS , MANIPAL UNIVERSITYEMAIL: indermakhija5@gmail.com

STANDARDIZATIONStandardization of drug means confirmation of its identity and determination of its quality and purity and detection of nature of adulterant by various parameters like morphological, microscopical, physical, chemical and biological observations.

Different techniques involved in standardization of crude drugs Macroscopic methodsMicroscopic methodsPhysical methodsChemical methodsBiological methods

PHYSICAL STANDARDIZATIONOF HERBAL DRUGS:ViscosityMelting pointSolubilityMoisture content and volatile matterSpecific gravityDensityOptical rotationRefractive indexBitterness valueHemolytic activitySwelling indexFoaming indexAsh valueAstringency

VISCOSITYViscosity of a liquid is constant at a given temperature and is an index of its composition. Hence, it can be used as a means of standardizing liquid drugs.MELTING POINTIn case of pure photochemical, melting points are very sharp and constant.The crude drugs from plant or animal origin, containing the mixed chemicals, are described with certain range of melting point.Their purity can be ascertained by determining their melting points in that rangefor E.g. Colophony- 75-80˚c Cocoa butter- 30-33˚c

SOLUBILTYThe presence of adulterant could be indicated by solubility studiesE.g.pureAsafoetida is soluble in carbon disulphideMOISTURE CONTENT AND VOLATILE MATTERThe moisture content of the drug should be minimized in order to prevent decomposition of crude drug either due to chemical change or microbial contamination.The moisture content is determined by heating a drug at 105˚c in an oven to a constant weight.For the drugs containing volatile constituents, toulene distillation method is used E.g. – Aloe should have moisture content not more than 10% w/w

OPTICAL ROTATIONOptically active compounds have the property of rotating the plane of polarized light.Thisproperty is known as optical rotation.Normally, the optical rotation is determined at 25˚c using sodium lamp as the source of light. E.g. castor oil has optical rotation from +3.5˚to +6˚REFRACTIVE INDEXWhen a ray of light passes from one medium to another of different density, then the ratio of velocity of light in vaccum to its velocity in substance is termed as refractive index of second medium.It is constant for a pure drug and varied with wavelength of incident light, temperature and pressureE.g. Castor oil has refractive index 1.4758-1.527

ASH VALUES AND EXTRACTIVESThe residue remaining after incineration is the ash content of drugTotal ash method is used to measure the total amount of material remaining after incinerationAcid insoluble ash is the residue obtained after boiling the total ash with dil. HCl and igniting the remaining insoluble matter.Water soluble ash is the difference in weight between total ash and residue after treatment of total ash with water.

DETERMINATION OF EXTRACTABLE MATTER:HOT EXTRACTION:place 4 gms powdered material in a conical flask. Add water and weigh to obtain total weight. Shake and allowed to stand for 1hr. attach the reflux condenser and boil for 1hr. Readjust to the original weight with solvent. Shake and filter.Transfer the filter to a flat bottomed disk and evaporate to dryness on a water bath. Dry at 105˚ c for 6hrs, cool and weigh immediately. Calculate the content of extractable matter in mg per g of air dried material.

COLD MARCERATIONPlace the powdered material in a conical flask. Macerate with 100ml of solvent specified for 6hrs, shake then allowed to stand for 18hrs. Filter and transfer the filtrate to flat bottomed disk and evaporate to dryness on a water bath. Dry at 105̊ c for 6hrs, cool and weigh immediately. Calculated the content of extractable matter in mg per g of air dried material.

BITTERNESS VALUEMedicinal plants having strong bitter taste are therapeutically used as appetizing agentsThe bitterness is determined by comparing the threshold bitter concentration of an extract material with that of quinine hydrochlorideThe bitterness value is expressed as units equivalent to the bitterness of a solution containing 1gm of quinine hydrochloride in 2000ml.0.1gm of quinine hydrochloride is dissolved in 100ml drinking water and the stock solution is prepared. Then it is diluted and tested and compared with drug.Bitterness value in unit per gm = 2000*c A*BWhere, A = concentration of stock solution B = volume of test solution in tube with threshold bitter concentration C = quantity of quinine hydrochloride in the tube with threshold bitter concentration

HAEMOLYTIC ACTIVITYHaemolyticactivity of plant material is determined by comparison with that of reference material, Saponin R, having haemolytic activity of 1000units/g. Method of preparation of standard:Fill a glass stopper flask to 1/10 of its volume with sodium citrate. Ass sufficient volume of blood freshly collected from healthy ox and shake, this can be stored for about 8 days at 2-4̊ c. place 1ml of citrated blood in a volumetric flask with phosphate buffer pH 7.4.Haemolytic activity = 1000* a/bWhere, 1000 = defined haemolytic activity of Saponinstandarda = quantityofsaponin standard that produce total haemolysis(g) b = quantity of plant material that produce total haemolysis (g)

SWELLING INDEX The swelling index is the volume in ml taken up by the swelling of 1gm of plant material under specified conditions.Its determination is based on addition of water or a swelling agent as described in test procedure. FOAMING INDEX:The foaming ability of an aqueous decoction of plant material and their extracts is measured in terms of foaming index. WATER AND VOLATILE MATTER:Azeotropic method is used to directly measure the water present in a material.Loss on dryingIn order to measure volatile matter, plant is diluted with water and distillate is collected in a graduated tube. The aqueous portion separates and returns to distillation flask. A solvent of low mass density with a suitable boiling point may be added to measuring tube to easily separate the volatile oil.

CHEMICAL METHODS OF STANDARDIZATION OF HERBAL DRUGS:It comprises of different chemical tests and assays. The isolation, purification and identification of active constituents are chemical methods of evaluation.Quantitative chemical tests shuch as acid vale, saponification value etc., are also coveredunder this technique. Qualitative chemical tests are used in detection of adulteration.The chemical evaluation also covers phytochemical screening carried out for establishing chemical profile of a drug.

CHEMICAL EXAMINATIONDetection of alkaloidsDetection of carbohydrates and glycosidesDetection of phytosterolsDetection of fixed oils and fats Detection of saponinsDetection of phenolic compounds and tanninsDetection of protein and free amino acidsDetection of gums and mucilageDetection of volatile oils

BIOLOGIAL/ TOXICOLOGIAL STANDARDIZATIONDrugs which cannot be assayed by chemical, or physical means are evaluated by biological methodsINDICATION FOR BIOLOGICAL EVALUATIONThis is true for the substances having anInterfering obstaclesWhen quantity is too small.No specific chemical test is available When the action of drug is due to a mixture of substancePurification of drug is not possible

BIOASSAYWhen the estimation of crude drug or its preparation is done by means of its effect on living organism like bacteria, fungi, or animal tissue or entire animal it is known as BIOASSAY.TYPES OF BIOASSAYQUANTAL:-It is all or none phenomenon GRADED:-Based on observation that there is a proportionate increase in the observed response with increase in concentration or dose.

Graded bioassay can be performed by using any of the following techniquesMatching bioassayInterpolation MethodBracketing MethodMultiple point bioassay

TOXICOLOGICAL STANDARDIZATIONDetermination of pesticides.Determination of arsenic and heavy metalsDetermination radioactive contaminationDetermination of aflatoxins.

PESTICIDESFUNGICIDESHERBICIDESINSECTICIDESACARCICIDESNEMATOCIDESRODENTICIDESBACTERICIDES

ACCEPTABLE RESIDUE LEVEL(ARL) ARL = ADI*E*60 MUI*100ADI=maximum acceptable daily intake of pesticides (mg/kg of body weight)E= extraction factor, which determines the transition rate of the pesticides from the plant material into the dosage formMDI=Mean Daily Intake of medicinal palnt products60 in numerator=adult body weight100 in denominator=consumption factor

Determination of arsenic and heavy metalsArsenic and heavy metals are even in trace amounts but they are dangerous removed from herbal drugs.Amount is estimated by matching the depth of colour with of standard stain

Coarsely ground material in kjeldahl flaskAdd water nitric acid and then sulphuric acidMaterial is destroyedNo further darkening with heatingClear solution with sulphur trioxide vapors, cool and add ammonium oxalateHeat with sulphur trioxide vaporsCoolAdd potassium iodide and granulated zinc; keep for 40 minutesCompare the stains with standard solution on mercuric bromide paper

StandardStandard chloride + dilute arsenic + water Gives stain on mercuric bromide paper

Limit test for cadmium and leadMaterial weighedAdd digestion mixtureHeatDissolve in nitric acidDetermination of the metal concentrationMaximum amount should not exceed than 10 mg/kg; cadmium 0.3 mg/kg

Radioactive contaminationThe exposure cannot be avoided because of many naturally occurring sources including radionucleotides occurring in ground and atmosphereHealth risk depend onSpecific radionucleotidesLevel of contaminationQuantity of food

AflatoxinsAflatoxins are the poisonous substance in the spores of the fungus Aspergillus flavusThe toxin is known to produce cancer in human beings living in warm and humid region of the worldStored nuts and cereals are contaminated by the fungusThey should therefore be determined after using a suitable clean up procedure.

TEST FOR SPECIFIC MICROORGANISMSTests are designed to minimize the accidental contamination of micro organisms.

Standardization of herbal drug Ppt

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Standardization of herbal drug Ppt