Journal of Society of Preventive Korean Medicine (대한예방한의학회지)

Society of Preventive Korean Medicine (대한예방한의학회)
권호 표지

Effect of Gongjindon a Traditional Korean Polyherbal Formula, on the Pharmacokinetics Profiles of Donepezil in Male SDRats (1) -Single Oral Combination Treatment of Donepezil 10mg/kg with Gongjindan 100mg/kg within 5 min-

  • Chung, Dae-Kyoo (Department of Neuropsychiatry, College of Korean Medicine, DaeguHaany University) ;
  • Kwon, Oh-Dae (Department of Neurology, Catholic University of Daegu School of Medicine) ;
  • Park, Soo-Jin (Department of Anatomy and Histology, College of Korean Medicine, DaeguHaany University) ;
  • Lee, Young-Joon (Department of Preventive Medicine, College of Korean Medicine, DaeguHaany University) ;
  • Ku, Sae-Kwang (Department of Anatomy and Histology, College of Korean Medicine, DaeguHaany University)
  • Received : 2013.03.15
  • Accepted : 2013.04.17
  • Published : 2013.04.30
Download PDF
⟨ Previous Next ⟩

Abstract

Objectives : This study was aim to evaluate effects of pharmacodynamics and toxicity in combination therapy of donepezil with Gongjindan. Methods : After 10mg/kg of donepezil treatment, Gongjindan 100mg/kg was administered within 5 min. The plasma were collected at 30min before administration, 30min, 1, 2, 3, 4, 6, 8 and 24hrs after end of Gongjindan treatment, and plasma concentrations of donepezil were analyzed using LC-MS/MS methods. PK parameters of donepezil were analysis as compared with donepezil single administered rats. Results : Gongjindan markedly inhibited the absorption of donepezil regardless of sample time, from 30min to 8hrs after end of co-administration comparing with donepezil single treated rats. Especially the absorption of donepezil was significantly decreased at 2hrs after co-administration as compared with donepezil single treated rats, in the present study. Accordingly, the Cmax(-27.76%), $AUC_{0-t}$(-27.22%) and $AUC_{0-inf}$(-26.54%) of donepezil in co-administered rats were significantly decreased as compared with donepezil single treated rats, respectively. Conclusions : Based on the results of the present study, co-administration of Gongjindan decreases the oral bioavailability of donepezil by inhibiting the absorption. It is considered that the more detail pharmacokinetic studies should betested to conclude the effects of Gongjindan on the pharmacokinetics of donepezil, when they were co-administered, like the effects after co-administration with reasonable intervals considering the Tmax of donepezil and after repeated co-administrations.

Keywords

References

  1. Birks J, Harvey RJ. Donepezil for dementia due to Alzheimer's disease. Cochrane database of systematic reviews (Online). 2006(1): CD001190
  2. Rogers SL. Perspectives in the management of Alzheimer's disease: clinical profile of donepezil. Dementia and geriatric cognitive disorders. 1998;9 Suppl 3:29-42
  3. Roman GC, Rogers SJ. Donepezil: a clinical review of current and emerging indications. Expert opinion on pharmacotherapy. 2004;5 (1):161-180 https://doi.org/10.1517/14656566.5.1.161
  4. Rojas-Fernandez CH. Successful use of donepezil for the treatment of dementia with Lewy bodies. The Annals of pharmacotherapy. 2001;35(2):202-205 https://doi.org/10.1345/aph.10192
  5. Malouf R, Birks J. Donepezil for vascular cognitive impairment. Cochrane database of systematic reviews (Online). 2004(1):CD00 4395
  6. Moraes W, Poyares D, Sukys-Claudino L, Guilleminault C, Tufik S. Donepezil improves obstructive sleep apnea in Alzheimer disease: a double-blind, placebo-controlled study. Chest. 2008;133(3):677-683 https://doi.org/10.1378/chest.07-1446
  7. Riedel G, Kang SH, Choi DY, Platt B. Scopolamine-induced deficits in social memory in mice: reversal by donepezil. Behavioural brain research. 2009;204(1):217-225 https://doi.org/10.1016/j.bbr.2009.06.012
  8. Handen BL, Johnson CR, McAuliffe-Bellin S, Murray PJ, Hardan AY. Safety and efficacy of donepezil in children and adolescents with autism: neuropsychological measures. Journal of child and adolescent psychopharmacology. 2011;21(1):43-50 https://doi.org/10.1089/cap.2010.0024
  9. PfizerCanada Inc.. PRODUCT MONOGRAPH $PrARICEPT^{(R)}$ (donepezil hydrochloride) Tablets 5 and 10 mg PrARICEPT RDTTM (donepezil hydrochloride) Rapidly Disintegrating Tablets 5 and 10 mg Cholinesterase Inhibitor. FDA Submission Control No: 107207. 2007
  10. Dunn NR, Pearce GL, Shakir SA. Adverse effects associated with the use of donepezil in general practice in England. Journal of psychopharmacology (Oxford, England). 2000; 14(4):406-408 https://doi.org/10.1177/026988110001400410
  11. Benazzi F. Mania associated with donepezil. Journal of psychiatry & neuroscience : JPN. 1999;24(5):468-469
  12. Umegaki H, Itoh A, Suzuki Y, Nabeshima T. Discontinuation of donepezil for the treatment of Alzheimer's disease in geriatric practice. International psychogeriatrics / IPA. 2008;20(4):800-806
  13. Lockhart IA, Mitchell SA, Kelly S. Safety and tolerability of donepezil, rivastigmine and galantamine for patients with Alzheimer's disease: systematic review of the 'real-world' evidence. Dementia and geriatric cognitive disorders. 2009;28(5):389-403 https://doi.org/10.1159/000255578
  14. Tiseo PJ, Perdomo CA, Friedhoff LT. Concurrent administration of donepezil HCl and cimetidine: assessment of pharmacokinetic changes following single and multiple doses. British journal of clinical pharmacology. 1998;46 Suppl 1:25-29
  15. Tiseo PJ, Perdomo CA, Friedhoff LT. Concurrent administration of donepezil HCl and ketoconazole: assessment of pharmacokinetic changes following single and multiple doses. British journal of clinical pharmacology. 1998;46 Suppl 1:30-34
  16. Yasui-Furukori N, Furukori H, Kaneda A, Kaneko S, Tateishi T. The effects of Ginkgo biloba extracts on the pharmacokinetics and pharmacodynamics of donepezil. Journal of clinical pharmacology. 2004;44(5) :538-542 https://doi.org/10.1177/0091270004264161
  17. Tiseo PJ, Perdomo CA, Friedhoff LT. Concurrent administration of donepezil HCl and digoxin: assessment of pharmacokinetic changes. British journal of clinical pharmacology. 1998;46 Suppl 1:40-44
  18. Tiseo PJ, Foley K, Friedhoff LT. Concurrent administration of donepezil HCl and theophylline: assessment of pharmacokinetic changes following multiple-dose administration in healthy volunteers. British journal of clinical pharmacology. 1998;46 Suppl 1:35-39
  19. Tiseo PJ, Foley K, Friedhoff LT. The effect of multiple doses of donepezil HCl on the pharmacokinetic and pharmacodynamic profile of warfarin. British journal of clinical pharmacology. 1998;46 Suppl 1:45-50
  20. Kim YH, Bae MJ. The effect of Kong Jin Dan on the lipid metabolism in rats fed high fat-diet. J East-West Med. 2001;14 :61-78
  21. Kim YS, Lee JD, Kim CH, Choi DY, Park DS, Nam SS, Kang SK. The Effect of Gongjindan Aqua-acupuncture on the CD4+ T cell count at al. in rats were administered with MTX. J Korean Acup Moxi Soc. 1999;16:179-202
  22. Choi KH, Park CS. An analysis of the Gongjindan's ingredients and its efficacy on anti-oxidation. Korea J Herbology. 2007 ;22(2):51-63
  23. Seong KM, Hae RK, Song BK. The effect of Gongjin-dan on gliosis in middle cerebral artery occlusion (MCAO) rats. J Korea Oriental Int Med. 2009;30:674-684
  24. Hwang SM, Chung DK. The Effects of KongJin-Dan (KJD) on the Alzheimer's disease model induced by CT105. J Oriental Neuropsychiatry. 2004;15(2):103-118
  25. Jung HC, Jang HJ, Sung WY, Lee SH, Son JH, Han SH. A study of Gongjin-dan in patients with mild dementia of Alzheimer type. J Oriental Neuropsychiatry. 2004;15 (2):141-148
  26. Park MY, Kim JD, Ku SK. Single Oral Dose Toxicity Test of Kong-Jin-Dan, a Polyherbal Formula in ICR Mice. Biomolecules & Therapeutics. 2007;15(4):245-251
  27. Ku S-K. Micronucleus Test of Kong- Jin-Dan, a Polyherbal Formula, in Bone Marrow Cells of Male ICR Mice. Toxicological Research. 2008;24(3):213-218 https://doi.org/10.5487/TR.2008.24.3.213
  28. Gibaldi M, Perrier D. Pharmacokinetics. 2nd ed. New York: Marcel-Dekker; 1982.
  29. Bailer AJ. Testing for the equality of area under the curves when using destructive measurement techniques. Journal of pharmacokinetics and biopharmaceutics. 1988;16(3) :303-309
  30. Chiou WL. Critical evaluation of the potential error in pharmacokinetic studies of using the linear trapezoidal rule method for the calculation of the area under the plasma level-time curve. Journal of pharmacokinetics and biopharmaceutics. 1978;6(6):539-546
  31. Dickinson BD. UHC drug monograph: Donepezil. UHC (University Health System Consortium) Services Corporation. 1996:1-14
  32. Mihara M, Ohnishi A, Tomono Y, Hasegawa J, Shimamura Y, Yamazaki K, Morishita N. Pharmacokinetics of E2020, a new compound for Alzheimer's disease, in healthy male volunteers. International journal of clinical pharmacology, therapy, and toxicology. 1993;31(5):223-229
  33. Tiseo PJ, Rogers SL, Friedhoff LT. Pharmacokinetic and pharmacodynamic profile of donepezil HCl following evening administration. British journal of clinical pharmacology. 1998;46 Suppl 1:13-18
  34. Tiseo PJ, Perdomo CA, Friedhoff LT. Metabolism and elimination of 14C-donepezil in healthy volunteers: a single-dose study. British journal of clinical pharmacology. 1998;46 Suppl 1:19-24
  35. Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Donepezil Study Group. Neurology. 1998;50(1):136-145 https://doi.org/10.1212/WNL.50.1.136
  36. Rogers SL, Friedhoff LT. Long-term efficacy and safety of donepezil in the treatment of Alzheimer's disease: an interim analysis of the results of a US multicentre open label extension study. European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology. 1998 ;8(1):67-75 https://doi.org/10.1016/S0924-977X(97)00079-5
  37. Matsui K, Mishima M, Nagai Y, Yuzuriha T, Yoshimura T. Absorption, distribution, metabolism, and excretion of donepezil (Aricept) after a single oral administration to Rat. Drug metabolism and disposition: the biological fate of chemicals. 1999;27(12) :1406-1414
  38. Tiseo PJ, Vargas R, Perdomo CA, Friedhoff LT. An evaluation of the pharmacokinetics of donepezil HCl in patients with impaired hepatic function. British journal of clinical pharmacology. 1998;46 Suppl 1:51-55