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SKRINING Farmakologi

SKRINING Farmakologi. Oleh Heny Ekowati Bagian Farma si Klinik Jurusan Farmasi FKIK UNSOED 2013. Drug Development. Preclinical study pharmacological study toxicological study pharmaceutical study Clinical study phase 1, 2 and 3 Postmarketing surveilance (phase 4 clinical study).

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SKRINING Farmakologi

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  1. SKRINING Farmakologi Oleh Heny Ekowati BagianFarmasi Klinik Jurusan Farmasi FKIK UNSOED 2013

  2. Drug Development • Preclinical study • pharmacological study • toxicological study • pharmaceutical study • Clinical study • phase 1, 2 and 3 • Postmarketing surveilance • (phase 4 clinical study)

  3. Uji farmakdinamik- uji farmakodinamik tahap awal- uji farmakodinamik tahap lanjut

  4. Uji Farmakodinamik tahap awal • Pada hewan uji invivo atau invitro • Mengamati ada tidaknya efek yang diharapkan Pengamatan kritis

  5. Uji Farmakodinamik tahap awal Model invivo - analgesik - antipiretik - antiinflamasi - sedatif / hipnotik - antihipertensi - diuretika - hipoglikemik - anti ulkus peptik

  6. Testing for analgesic effect - Exp. Animal . Radiant heat or pressure pain (skin) . Electric shock (skin or tooth pulp) . Intraperitoneal injection of BK(peritoneal)

  7. Test for ANALGESICS Using experimental animals it is necessary to inflict a certain amount of pain follow the law and ethical guidelines (to minimize the suffering of experimental animals)

  8. Test for Analgesics Produce the relevant stimuli Observe the reaction of exp. animals . Monosynaptic reflexes - tail flick . Polysynaptic reflexes - licking, jumping, vocalization, local contacture of abdominal musculature need high degree of sensory motor coordinations

  9. Hot plate procedure Heat stimulus does not affect the mechanoreceptors easy to be controled easy to be applied to the moving subject (animal) • * mobile subject  hot plate procedure • immobile subjects  immersion radiant heat • procedure

  10. Hot plate procedure Thermostaticaaly controlled electrically heated surface (50o – 55o, 55o – 60o C) glass restraining cylinders (diam. 13 cm - h. 17 cm for mice; 26 cm - 25 cm for rat) stopwatch objectives : analgesic potency, peak time and duration of analgesic activity

  11. Hot plate procedure Observations 30 minutes after injection (of testing substance) place the animals on the hot place (constant temperature, 50o – 60o C) to observe licking latency or jumping latency tR (disregard kicking and dancing) remove animal from hot plate (as soon as they exhibit licking and jumping)

  12. Hot plate procedure Calculate mean and SD(of the jump latency for control group and treatment groups) % of animal showing an analgesic response (for each group) plot the dose – response curve  ED-50 (% animal showing the analgesic activity) - calculete the ED-50

  13. Hot plate procedure X 100 or calculate the % MPE(maximal possible effect) for each animal in the control or treatment group (jump latency) – ( mean of vehical group jump latency) % MPE = (cutoff time ; 60’) - (predrug latency) plot the dose – response curve compare the AUC

  14. Tail immersion procedure The tip of tail is immersed in hot water 50o + 0.2oC (thermostatic water bath) tail withdrawal (flick) may use the animal again (15 immersion) measure : basal latency and analgesic (treatment) latency

  15. Tail flick procedure Radiant heat prosedure 50 – 100 W bulb (infrared bulb) foccusing apparatus (reflector and photocell) may use the animal again (7 - 15 heating) observe : tail flick (jentikan) after latency period of pain (cause by infrared beam)

  16. Tail or paw clip Observations clip tail or paw (by mean of weight) animals attempt to dislodge the clip (by bitting the clip or the area where the clip is placed) the bitting reflex is more complex response (involves high centres) animal may be used again (15 – 20)

  17. analgesimeter

  18. Tourniquete procedure Upper arm (human) pump spygmomanometer (until 180 mm Hg) observe the response (vocalisation) of probandus (pain is come) is a complex response (subjective, individual) may be used again (few times)

  19. Testing for analgesic effect - Experimental probandus . Tourniquete procedure (skin – muscle) . Cold immersion procedure (skin)

  20. Analgesic tests in human beeing Healthy probandus it is necessary to inflict a certain amount of pain follow the law and ethical guidelines (to minimize the suffering of experimental individuals)

  21. Tourniquete procedure Calculations pain latency (mean and SD of time 180 mm Hg – pain response) control group and treatment group (calculate % probandus showing an analgesic response) plot dose – response curve --- ED-50 calculate the % MPE (maximul posible effect) (for each probandus in control and treatment group) - compare between them

  22. Cold immersion procedure Hand (human) immersion into icy water (approx 0oC) observe vocalisation of probandus (pain is come) is a complex response (subjective, individual) may be used again (few times)

  23. Cold immersion procedure Calculations pain latency (mean and SD of time immersion – pain response) control group and treatment group (calculate % probandus showing an analgesic response) plot dose – response curve calculate the % MPE (maximul posible effect) (for each probandus in control and treatment group) - compare between them

  24. Testing for AntiinflamatoryActivity

  25. Testing for Sedative – hypnotics

  26. Testing for hypotensive activity

  27. Testing formetabolism activity

  28. Metabolite cage

  29. Uji Farmakodinamik tahap awal Model invitro - antispasmodik - bronkodilator - antiaritmia - spasmolitik - antiskresi asam lambung - dsbg.

  30. Efek ekstrak pace pada jantung kelinci terpisah

  31. Efek ekstrak pace pada jantung kelinci terpisah

  32. Efek ekstrak rumput wijen pada jantung kelinci terpisah

  33. Efek ekstrak rumput wijen pada jantung kelinci terpisah

  34. Efek ekstrak rumput wijen pada jantung kelinci terpisah

  35. tikus dikelompokkan (amilum, simetidin EAPK) aklimatisasi 7 hari diberi bahan uji (pretreatment) hari ke 8 dipuasakan dan diberi asetosal 150 mg/kgBB biarkan 5 jam, hewan uji dibunuh lambung diangkat, amati ulkus dan dibuat skor

  36. Musa balbisiana Colla

  37. Musa balbisiana Colla

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