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PREPARATION AND EVALUATION OF HERBAL GEL …

Mohsin of PharmaceuticalResearch &Education,2017, 1( 2), 201-224201 Research ArticleJournal of Pharmaceutical Research & EducationJournal homepage: AND EVALUATION OF HERBAL GEL FORMULATIONM ohsin J. Jamadar*,Rajmahammad Husen ShaikhDepartment of Quality Assurance,Pharmaceutics,Appasaheb Birnale College of pharmacy,Sangli. Maharashtra, India. :-Herbalmedicinesisstillthemainstayofabo ut75-80%oftheworld spopulation, mainlyindevelopingcountries,forprimaryhe althcarebecauseofbetterculturalacceptabi lity,better compatibilitywith human bodyand lesser side effects. Herbalmedicinesconsistofplantoritspartto treatinjuries,diseaseorillnessesandare the oldest form of healthcareknown to ,HPMCK100 MandXanthangumshowedgoodhomogeneity,nosk inirritation,goodstabilityandanti-inflam matoryactivity. However,theXanthangumbasedgelprovedtothe formulaofchoice,sinceitshowedthe highest percentage ofextrudability, good spreadabilityandrheological properties. FormulationF5with1%leavesextractandF11wi th1% F11shows approximatelyequal anti-inflammatoryactivity.

Formulation F5 with 1 % leaves extract and F11 with 1% root extract of Clerodendrum serratum showed the best formulation with significant anti-inflammatory activity. Formulation 5 and F11 shows approximately equal anti-inflammatory activity. Hence, there is no need to used roots for the preparation of medicines for anti-inflammatory action ...

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Transcription of PREPARATION AND EVALUATION OF HERBAL GEL …

1 Mohsin of PharmaceuticalResearch &Education,2017, 1( 2), 201-224201 Research ArticleJournal of Pharmaceutical Research & EducationJournal homepage: AND EVALUATION OF HERBAL GEL FORMULATIONM ohsin J. Jamadar*,Rajmahammad Husen ShaikhDepartment of Quality Assurance,Pharmaceutics,Appasaheb Birnale College of pharmacy,Sangli. Maharashtra, India. :-Herbalmedicinesisstillthemainstayofabo ut75-80%oftheworld spopulation, mainlyindevelopingcountries,forprimaryhe althcarebecauseofbetterculturalacceptabi lity,better compatibilitywith human bodyand lesser side effects. Herbalmedicinesconsistofplantoritspartto treatinjuries,diseaseorillnessesandare the oldest form of healthcareknown to ,HPMCK100 MandXanthangumshowedgoodhomogeneity,nosk inirritation,goodstabilityandanti-inflam matoryactivity. However,theXanthangumbasedgelprovedtothe formulaofchoice,sinceitshowedthe highest percentage ofextrudability, good spreadabilityandrheological properties. FormulationF5with1%leavesextractandF11wi th1% F11shows approximatelyequal anti-inflammatoryactivity.

2 Hence,there isnoneedtoused roots forthe preparationof medicines for :-Inflammation:Inflammationisacomplexpro cess,whichisfrequentlyassociatedwithpain andinvolves occurrencessuchas:theincreaseofvascularp ermeability, ,physicalagentsor chemicalagents, ,pain,heat,andswellingandloss snonspecificinternalsystemsof defense,theresponseofatissuetoanaccident alcutissimilartoresponsethatresultsfromo thertype of tissue damage, caused byburns due to heat, radiation,bacterial or viral invasion.[1]Inflammationdilutes,destroys , are infections, burns and trauma, andmanytypes of immune of PharmaceuticalResearch &Education,2017, 1( 2), 201-224202 Classification of inflammation:Inflammation maybroadly classifyinto three categories; inflammation; inflammation; ;Topical Drug Delivery System:The goal of anydrug deliverysystemistoprovideatherapeuticamo untofdrugtotheproper oneofthemostreadilyaccessibleorgansonhum anbodyfortopicaladministrationandismainr oute oftopical drug deliverysystem.

3 Topical deliverycan bedefinedastheapplication ofadrugcontainingformulationtotheskintod irectlytreatcutaneousdisorders( )orthecutaneousmanifestationsofagenerald isease( ) ,butfoams,spray,medicatedpowders,solutio ns,aswellasmedicatedadhesivesystemsareal so in use.[3] Externaltopicalthatarespread,sprayed,oro therwisedispersedontocutaneoustissuesto cover the affectedarea. Internaltopicalthatareappliedtothemucous membraneorally,vaginallyoronanorectal tissues for local of TopicalDrug Delivery System:[5] Avoidance of first pass metabolism. Convenient and easyto apply. Avoidanceoftherisksandinconveniencesofin travenoustherapyandofthevariedconditions ofabsorption,likepHchanges,presenceofenz ymes, Achievementof efficacywith lower total dailydosage of drug bycontinuous drug input. Avoids fluctuation in druglevels, inter-and intrapatient variations. Abilityto easilyterminate the medications, when needed. Arelatively large area of application in comparison with buccal or nasal cavity Abilityto deliver drug more selectively to a specific site.

4 Providing utilization of drugs with short biological half-life, Improving physiological and pharmacological response. Improve patient compliance. Provide suitabilityfor of TopicalDrug Delivery System:[5] Skin irritation of contact dermatitis mayoccur due to the drug and/or excipients. Poor permeabilityof some drugs through the skin. Possibilityof allergenicreactions. Can be used only for drugs which require verysmall plasma concentration for action Enzyme in epidermis may denature the drugs Drugs of larger particle size not easy to absorb through the skinClassification of Topical Drug Delivery System:Mohsin of PharmaceuticalResearch &Education,2017, 1( 2), 201-224203 Classification of Topical Drug Delivery System based on physical state-Introduction to HerbalMedicines:[6-8]Ever since the birth of mankind of there has beena relationship between life, thing theycould find was there in environment the plants (WHO)hasdefinedherbalmedicinesarefinishe d,labeledmedicinalproductsthatcontainact iveingredients,aerialorundergroundpartso ftheplantsor other plant material or anti-microbial,anti-diabetic,anti-ageing ,anti-arthritic,anti-depressant,anti-anx iety,anti-inflammatory,anti-HIV,treatmen tofcirrhosis,asthma,migraine,Alzheimer sdiseaseand memoryenhancing ,about16% otherorganisms.

5 [9,10]Anatomy-Physiology ofskin:-[9,11] ;thelayerbelowepidermis iscalled the dermis are subcutaneous fatty :A gel is asolid orsemisolidsystemofatleasttwoconstituent s,consistingofaMohsin of PharmaceuticalResearch &Education,2017, 1( 2), 201-224204condensedmass enclosingandinterpenetratedby a and jelliesarecomposedofsmallamountofsolidsd ispersedinrelativelylargeamountofliquid, yettheypossesmoresolid-likethan cutaneous structure, which provides AND POLYMER PROFILEP lantProfile:Clerodendrum serratum[1-4] genus of flowering plants in Propertiesand Actions:Rasa:Katu, Tikta, KasayaGuna:Laghu, RuksaVirya:UsnaVipaka:KatuKarma:Dipana, Kaphahara, Pacana, Vatahara, Swasahara Habit:[5]Clerodendrum serratumis a perennial shrub m , , ,sometimes reaching upto 28cm long,narrowlyobovate-oblongorsub-ellipti c, acute base, acuminate tip, coarsely and sharply serrate areverystout and 6 cm :-Numerous,inlaxpubescentdichotomouscyme swithapairofacutebractsateachbranchingan daflowerinthefork,eachintheaxialofalarge leafingbractandcollectively formingalonglaxterminalusuallypyramidale rectpenicle15-25cmlong;pedicelsoftentwis ted so as to make the cm long, from obovate to lanceolate, pubescent, and often ,somewhatsucculent,broadlyobovoid, of PharmaceuticalResearch &Education,2017, 1( 2), 201-224205 EXPERIMENTAL:Methods:Preformulation various of Preformulation study: To determine the necessaryphysicochemical parameter of a new drugsubstance.

6 To establish its incompatibilitywith excipients of and Authentication:Collection ofClerodendrum serratum(Linn) (Linn)moon(Verbenaceae)Werecollectedatth efloweringstageinAugustfromsideofKoyana Ricer, K o y a n aTal-Patan(Dist-Satara),MaharashtraState , Characterization:Colour, odour, shape, test and size of the rhizomes and bark were Characters:Afterbotanicalevaluation,thes hade-driedplantmaterialweresubjectedtosi zereductiontoget ,theuniform powder was subjected to standardization with different parameters as values:[1,2]a)Alcohol soluble extractivevalue:Macerated5gmoftheairdrie ddrugcoarselypowdereddrug(leavesandroots ),with100mlof alcoholthespecifiedstrengthinaclosedflas kfortwenty-fourhoursshakingfrequentlydur ingsix hours and followed to stand for eighteen hours. Filteredrapidly,takingprecautionsagainst lossofsolvents,evaporate25mlofthefiltrat etodryness inatared flatbottomedshallow dish, )Water Solubleextractivevalue:Macerated5gmofthe airdrieddrug,coarselypowdered(leavesandr oots), with100mlofChloroform-waterthespecifieds trengthinaclosedflaskfortwenty-fourhours ,shaking frequentlyduring six hours and followed to stand for eighteen ,takingprecautionsagainstlossofsolvents, evaporate25mlofthefiltratetodrynessinata redflatbottomedshallowdish,anddriedat105 0C, the % of water-soluble extractive with reference to the air dried of PharmaceuticalResearch &Education,2017, 1( 2), 201-224206 Determination of Ash value:a)Determination of total ash.

7 Incineratedabout2-3gmaccuratelyweighed,o fthegrounddruginataredsilicadishata temperaturenotexceeding4500 Cuntilfreefromcarbon, cannot be obtained in this way,exhaustthecharvedmass withhotwater,collectedtheresidueonanashl essfilterpaper,incineratedtheresidueandf ilterpaper, the % of ash with reference to the airdried )Determination of Acid-Insoluble ash:Tothecruciblecontainingtotalash, (Whatman41)andwashedwithhotwateruntilthe crucible, ash with referenceto theair-dried ofForeign Matter:Thesampleshallbefreefromvisiblesi gnsofmoldgrowth,sliminess,stones,rodente xcreta, representativeportionfromalargecontainer ,orremovedtheentirecontentsofthepackingi f 100gorless, ,ifany,toapetridish, : PREPARATION of EthanolicExtract of Clerodendrum serratum , method using Soxhletapparatus. The extractionwas continued untilthesolventinthe thimblebecameclearthenfewdropsofsolventw erecollectedinthetesttubeduringthe completion of the cycle and chemical test of the solvent was , , procedureswereadoptedtotestforthepresenc eofvariousphytochemicalconstituentsinthe Mohsin of PharmaceuticalResearch &Education,2017, 1( 2), ,terpenoids,carotenoids,flavanoids,alkal oids,tannins, for lead optimization programs, which are intended tomake safe and effective drugs.

8 Thefollowingprocedureswereadoptedtotestf orthepresenceofvariouschemicalconstituen ts in FOR of foam persistingfor 10 minutes indicates presenceof ' 'sreagent(PotassiumBismuthIodide).Appear anceoforangeredprecipitateindicatesprese nceof s test:2-3 ml of filtrate with few drops of Mayer s reagent gives stest:2-3mloffiltratewithfewdropsofWagne r ' sBsolutionsboilforoneminute. of orange red precipitate indicates presence of stest:MixequalvolumeofBenedict ,yelloworreddependingonamount of reducingsugar present in test ofgreen colour indicates presence of :Todryextract, , magnesium acid-reductiontest: Test solutionwithzincdustandfewdropsofHCLshow s magneta red :Testsolutionwhentreatedwithsodiumhydrox idesolutionshows increaseintheintensityofyellowcolourwhic hbecomescolourlessonadditionoffewdrops of :Testsolutionwithfewdropsofleadacetateso lution(10%) givesyellow of PharmaceuticalResearch &Education,2017, 1( 2), 201-2242085. :a) of red or violet colour indicates presence of ) stest:Testsolutiontreatedwithmillion sreagentandheatedonawaterbath, test:Testsolution treated with Ninhydrine reagentgives blue colour indicates presence of glycoside with lactone :Thetestsolutionwithfewdropsofglacialace ticacidin2mlof ferric chloride solution and acid is added from the sides oftest tube whichshowstheseparationbetweentwolayers, lowerlayershowsreddishbrownandupperlayer turns bluish watertest:Test solution dissolved in Bromine water givesyellow stest:Testsolutionwhentreatedwithpyridin e(madealkalinebyaddingsodium nitroprusside solution)gives pink to AMINO :Heat3mlextractand3dropsof5%Ninhydrineso lutioninboilingwaterbath 10 or bluish color :Heat3mlextractand3dropsofMillion dark :To5mlofextractaddfewdropsof40%NaOHand10 % ppt.

9 Of lead FOR :To2mlofextract, few drops anti inflammatory study ofextract Inhibition of albumin , then heatedto 510C for20min,aftercoolingthesamplestheturbid itywasmeasuredMohsin of PharmaceuticalResearch &Education,2017, 1( 2), experiment was performed in triplicate. The Percentage inhibition of proteindenaturation was calculatedas follows:Percentage inhibition= (abs Control-Abs Sample) 100/ Abs study:-Study of interaction of the drug with excipients by physical compatibility study:-Eachexcipientsusedintheformulatio nswasblendedwiththedruglevelsthatare realistic was thoroughlyblendedwithdrug extracttoincreasedrug-excipientsmolecula rcontactsandalsotoacceleratethereactioni f monthstudyat400cand at75% ,sampleswereobservedforphysicalchangesbu ttherewerenophysicalchangesobservedinthe mixtureofClerodendrum Serratum extract and polymer Experimental design:Duringformulationthreegellingagen tsusedattwodifferentconcentrations,resul tingin sixdifferentbatchesofgelsforleavesextrac tandsixbatchesforrootextract, ,HPMCK100 MandXanthangum,thesethree types of gelling agents were taken.

10 Three gellingagents were used asfollows:a. Carbopol 934 (at concentration 1% and ) K 100 M (at concentration 1%and ) (at concentration 1% and ) accordingto the experimental ofGel:[9]a) PREPARATION of gel withCarbopol 934:AccuratelyweighedCarbopol934wastaken inabeakeranddispersedin50mlof Carbopoldispersed, added dropwise to theformulationsforadjustmentofrequiredsk inpH( )andtoobtainthegel at required ) PREPARATION of gel with HPMC K 100 M:Accurately weighed 1gmof extractwastransferredtoabeakeranddissolv edin10mlof propylene glycol into which preservativesMohsin of PharmaceuticalResearch &Education,2017, 1( 2), 201-224210were K 100 M was made to preparationandstirredvigorouslytomixinco ldconditionandwaterwasaddedtomakeupthe volume up to 100 ml and stirred in mechanical stirred well toget a ) PREPARATION of gel with Xanthan gum:AccuratelyweighedXanthangumwastakeni nabeakeranddispersedin50mlof beakerandaddweighedquantityofpropylparab enandmethylparabentoitandstirred ,Extractandpreservativessolutionswereadd edwith :[10-13]Physical appearance:Thepreparedgelformulationscon tainingClerodendrumSerratumwereinspected visually for their color, homogeneity, consistencyand phase of pH of each formulation was done in triplicate and average values :Spreadabilitywasdeterminedbytheapparatu swhichconsistsofawoodenblock, (about2gm) (insec.


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