TRADITIONAL DRUGS AND HERBAL MEDICINE

TRADITIONAL DRUGS AND HERBAL MEDICINES(PHYTOTHERAPY)Department of Pharmacology & TherapyMedical Faculty, Lampung UniversityINTRODUCTIONDEFINITION :Traditional Drugs :Material (plants, animals, mineral), empiricalTOGAHerbal MedicinePhytopharmacaSimplicia Herbal preparations Infusion, decoct, etc.

TOGAGarden plantsSimple preparations JAMU / HERBAL MEDICINE :EmpiricalSimple preparations Traditional terminology : tolak angin, pegel linu, galian singsetPHYTOPHARMACAEfficacy and safety (+)Pharmacological terminology : analgetic, diuretic, antipiretic, etc= modern drugs / orthodox medicinePreparations : capsule, tablets, etcModern packaging HERBAL MEDICINES (PHYTOTHERAPY)May have pharmacological actions which affect the patientNot all herbal medicines are free from adverse effectsMay interact with orthodox medicines if they are taken concurrentlyAman + Aman + Aman - Aman-Khasiat + khasiat - khasiat + khasiat-

Terus beredar Terus beredar Tdk dipakai dilarang+ label klaim tanpa klaim ind. sp pen. lanjut edar

Standarisasi Tek. Farmasi IsolatSederhanaUji klinik OT Uji klinik OT Uji klinik OT

Bermanfaat bermanfaat bermanfaat Pelayanan kesehatan Obat jadi

Inventarisasiobservasiseleksi

Uji praklinik obat tradisionalADVERSE EFFECTS & EFFICACY OF T.DAdverse effects : rarelySEES (Side effects Eliminating Substances)Secondary Efficacy Enhancing Substances

PREPARATION OF AN ORAL DOSAGE FORMLIQUIDMedicinal teaInfusionDecoctionSOLIDTabletsPillsHERBAL MEDICINE ORTHODOX MEDICINE/MODERN DRUG ALKALOIDS

Rauwolfia serpentina Reserpine Ephedra sp EphedrineAtropa belladonna Atropine, scopolamine Pilocarpus jaborandi Pilocarpine Vinca rosea Vincristine, vinblastine

ADVERSE EFFECTS OF HERBAL DRUGSReport :Liver cell necrosis : herbal tea from comfrey leaves (Symphytum officinale)General rule :tested for microbiological quality and for residues of pesticides and fumigation agents, toxic metals, likely contaminant and adulterants, etc

POTENTIAL CONTAMINANTSType of contaminantsExamples______________________________________________________BotanicalsAtropa belladonna, digitalis, Rauwolfia serpentinaMicro-organismStaph. Aureus, E. coli,Salmonella, Shigella,Psudomonas aeroginosaMicrobial toxinsBacterial endotoxins, aflatoxinsPesticides & fumigants agentsMetalsLead, Cadmium, mercury, arsenicSynthetic drugsAnalgesic and antiinflammatory agents(aminophenazone, phenylbutazone, indomethacin ), corticosteroids, HCT, diazepamAnimals drugsThyroid hormonesQuality specifications of plant materials and preparationsInformation for fresh, dried and processed plant materials Name and characteristicsLatin, native languages, EnglishPart of the plant used and its conditionA brief description of the distribution and habitat Quality specificationsAuthenticityPurityAssay Packaging, labeling and storageInformation for medicinal preparations of plant materials

Powdered plants materials traditional powders and pills Extracts tablets, granules, ointments and newer types of pills Purified extracts/pure active constituents isolated from the plants material injections

PHARMACODYNAMIC AND GENERAL PHARMACOLOGICAL STUDIES OF HERBAL MEDICINESVarious pharmacological effectsAnimalsSpecies : mice, rats, guinea pigs, rabbits, dogs, etc Characteristics of the animals : strain, sex, age, holding conditionsDisease models : chemicals & other modalitiesTest assays can use : whole animals, isolated organs/tissue, etcAdministrationRoute adm. : PO (clinic)Frequency of adm. Control group : Negative (vehicle only)Positive ( modern drugs )

Toxicity investigation of herbal medicinesAcute toxicity testAnimals species : at least two species (rodents & non rodents) Sex : males & femalesNumber of animals : rodents 5 animals/sex non rodents 2 animals/sexRoute of adm.= PODose levels : rodents LD ; non rodents toxic signsFrequency of adm : one or more doses /24 hour periodObservation : toxic signs & severity, onset, progression, reversibility of the signs ; at least 7-14 dayLong term toxicity testAnimal speciesAt least two species (rodent & non rodent)SexThe same number of male and femaleNumber of animalsRodents : at least ten/sexNon rodents : at least three/sexRoute of admThe expected clinical route of admAdm. PeriodThe expected period of clinical useDose levelsAt least three different dose levelsObservations and examinationGeneral signs, body weight , food & water intakeHaematological examinationRenal & hepatic function testsRecovery from toxicity Expected period of clinical use Adm. period for the toxicity study--------------------------------------------------------------------------Single adm. or repeated adm. for less 2 weeks to 1 monththan one week

Repeated adm., between one week to 4 weeks to 3 monthsfour weeks

Repeated adm, between one to 3 to 6 monthssix months

Long-term repeated adm. for more 9 to 12 monthsthan six monthsLocal toxicity test & special toxicity testsLocal toxicity testsSkin sensitization testSpecial toxicity testsMutagenicity testCarcinogenicity testReproductive and development toxicity testADULTERATION OF COMMERCIAL PRODUCTSReplaced by an equivalent related speciesCareless gathering, storage, or distribution of medical plant materialTo add modern drugs in the herbal medicine

ADULTERATION OF ASIAN HERBAL MEDICINES WITH SYNTHETIC DRUG SUBSTANCESReferencePreparations Chemical and clinical details-------------------------------------------------------------------Itdehaag et al-Chuifong ToukuwanOne patient developed(1979) (Hongkong) Cushings syndrome from 12 pills/dayThe pills contained dexa-methasone, indomethacin,HCT, diazepamTay and Johns--Dr.Tong Shap YeesTheophylline12 mgton (1989) asthma pillsBury et al-Powder : colds andOne patient gained weight flu and became moonfacedContained prednisolone +paracetamol

INTERACTIONS BETWEEN HERBAL MEDICINES AND DRUGS USED IN ORTHODOX MEDICINEHerbal preparation Orthodox medicine Interaction---------------------------------------------------------------------------------------Sedatives :Sedative prep. Alcohol/antihistamines,hypnotics PotentiationTropane alkaloids Alcohol/antihistamines,hypnotics Potentiation Endocrine :Antidiabetic prep. Antidiabetic agents, insulin Loss of diabetic contr.Guar gum Penicillin Reduced bioav.of abRauwolfia,ginseng Drugs causing gynaecomastia, Potentiation of gynae. phenothiazine comastia, galactorrhoeaAntidepressant :Ginseng Phenelzine Headaches,insomnia, visual hallucinations