Sadra Medical Journal

Current Issue

By Issue

By Author

By Subject

Author Index

Keyword Index

About Journal

Aims and Scope

Editorial Board

Publication Ethics

Indexing and Abstracting

Related Links

Peer Review Process

Design and Standardization of a Solid Oral Polyherbal Hypnotic Formulation Based on Traditional Persian Medicine

Articles in Press

Document Type : Original Article

Authors

1 Medicinal Plants Processing Research Center, Shiraz University of Medical Sciences, Shiraz, Iran

2 Department of Phytopharmaceuticals (Traditional Pharmacy), School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran

10.30476/smsj.2025.108006.1671

Abstract

Introduction: Insomnia is a prevalent global sleep disorder that adversely affects health, occupational performance, and emotional well-being. Conventional pharmacological treatments are often associated with limited efficacy, adverse effects, and risks of dependency. Consequently, there is growing interest in safer alternative approaches, particularly those derived from traditional medicine, for managing inadequate sleep quality and insomnia.
Methods: This study investigated traditional Persian medicinal approaches to insomnia by reviewing major classical texts, including Qarabadin-e Salehi, Qarabadin-e Azam, Qarabadin-e Ghaderi, Eksir-e Azam, the Canon of Avicenna, Mo’alajat-e Aghili, and Tibb-e Akbari. A commonly used traditional formulation known as “Monavvem” powder was selected for further development and analysis. Four medicinal plants, including Lavandula stoechas (lavender), Melissa officinalis (lemon balm), Echium amoenum (borage), and Valeriana officinalis (valerian), were processed into powder for use in herbal infusions (tea bags). Macroscopic and microscopic evaluations were conducted for botanical authentication. Gas Chromatography/Mass Spectrometry (GC/MS) and Gas Chromatography with Flame Ionization Detection (GC/FID) were employed to identify and quantify key essential oil components.
Results: Borneol (14.88%) and thymol (8.39%) were identified as the major essential oil components of Monavvem powder. The analytical methods were validated using standard analytical protocols. Additional fingerprinting was performed via Fourier-Transform Infrared Spectroscopy (FT/IR). Spectrophotometric analysis determined the total phenolic and flavonoid contents of the final product to be 6.91 mg/g and 1.5 mg/g, respectively. The formulation was assessed for microbial and heavy metal contamination, and all quality control parameters were met. 
Conclusion: The manufacturing procedures and quality control tests for the final tea bag product were successfully documented. This standardized product paves the way for a natural therapeutic aid in managing sleep disorders, pending future clinical evaluations.

Keywords

References
  1. Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6(2):97-111.
  2. Morphy H, Dunn KM, Lewis M, Boardman HF, Croft PR. Epidemiology of insomnia: a longitudinal study in a UK population. Sleep. 2007;30(3):274-80.
  3. Quan SF, Katz R, Olson J, Bonekat W, Enright PL, Young T, et al. Factors associated with incidence and persistence of symptoms of disturbed sleep in an elderly cohort: the Cardiovascular Health Study. Am J Med Sci. 2005;329(4):163-72.
  4. Saddichha S. Diagnosis and treatment of chronic insomnia. Ann Indian Acad Neurol. 2010;13(2):94-102.
  5. LeBlanc M, Merette C, Savard J, Ivers H, Baillargeon L, Morin CM. Incidence and risk factors of insomnia in a population-based sample. Sleep. 2009;32(8):1027-37.
  6. Scott GW, Scott HM, O’Keeffe KM, Gander PH. Insomnia - treatment pathways, costs and quality of life. Cost Eff Resour Alloc. 2011;9:10.
  7. Taylor DJ, Mallory LJ, Lichstein KL, Durrence HH, Riedel BW, Bush AJ. Comorbidity of chronic insomnia with medical problems. Sleep. 2007;30(2):213-8.
  8. Thorpy MJ. Classification of sleep disorders. J Clin Neurophysiol. 1990;7(1):67-81.
  9. Stoller MK. Economic effects of insomnia. Clinical therapeutics. 1994;16(5):873-97.
  10. Antoniades J, Jones K, Hassed C, Piterman L. Sleep… naturally: a review of the efficacy of herbal remedies for managing insomnia. Alternative and complementary therapies. 2012;18(3):136-40.
  11. Sarris J, Byrne GJ. A systematic review of insomnia and complementary medicine. Sleep Med Rev. 2011;15(2):99-106.
  12. Zlott DA, Byrne M. Mechanisms by which pharmacologic agents may contribute to fatigue. PM R. 2010;2(5):451-5.
  13. Blais D, Petit L. Benzodiazepines: dependence and a therapeutic approach to gradual withdrawal. Canadian Family Physician. 1990;36:1779.
  14. Morin CM, Benca R. Chronic insomnia. Lancet. 2012;379(9821):1129-41.
  15. Gooneratne NS. Complementary and alternative medicine for sleep disturbances in older adults. Clin Geriatr Med. 2008;24(1):121-38, viii.
  16. Smith RD. Avicenna and the Canon of Medicine: a millennial tribute. Western Journal of Medicine. 1980;133(4):367.
  17. Feyzabadi Z, Aliasl F, Qaraaty M, Aliasl J. Effective materia medica in treatment of insomnia in Iranian traditional medicine. J Res Hist Med. 2015;7(23):51-68. Persian.
  18. Abed A, Vaseghi G, Jafari E, Fattahian E, Babhadiashar N, Abed M. Echium Amoenum Fisch. Et Mey: A review on its pharmacological and medicinal properties. Asian J Med Pharm Res. 2014;4(1):21-3.
  19. Mehrabani M, Ghassemi N, Sajjadi E, Ghanadi A, Shams AM. Main phenolic compound of petals of Echium amoenum Fisch. and C.A. Mey., a famous medicinal plant of Iran. DARU J Pharm Sci. 2005;13(2):65-9.
  20. Ranjbar A, Khorami S, Safarabadi M, Shahmoradi A, Malekirad AA, Vakilian K, et al. Antioxidant Activity of Iranian Echium amoenum Fisch & C.A. Mey Flower Decoction in Humans: A cross-sectional Before/After Clinical Trial. Evid Based Complement Alternat Med. 2006;3(4):469-73.
  21. Abolhassani M. Antibacterial effect of borage (Echium amoenum) on Staphylococcus aureus. Braz J Infect Dis. 2004;8(5):382-5.
  22. Abolhassani M. Antiviral activity of borage (Echium amoenum). Archives of Medical Science. 2010;6(3):366-9.
  23. Andalib S, Vaseghi A, Vaseghi G, Naeini AM. Sedative and hypnotic effects of Iranian traditional medicinal herbs used for treatment of insomnia. EXCLI journal. 2011;10:192.
  24. Rabbani M, Vaseghi G, Sajjadi S, Amin B. Persian herbal medicines with anxiolytic properties. Journal of Medicinal Plants. 2011;10(39):7-11.
  25. Heidari MR, Azad EM, Mehrabani M. Evaluation of the analgesic effect of Echium amoenum Fisch & C.A. Mey. extract in mice: possible mechanism involved. J Ethnopharmacol. 2006;103(3):345-9.
  26. Góra J, Lis A, Gibka J, Wołoszyn A. Najcenniejsze olejki eteryczne: Wydawnictwo Uniwersytetu Mikołaja Kopernika; 2005.
  27. Akhondzadeh S, Kashani L, Fotouhi A, Jarvandi S, Mobaseri M, Moin M, et al. Comparison of Lavandula angustifolia Mill. tincture and imipramine in the treatment of mild to moderate depression: a double-blind, randomized trial. Prog Neuropsychopharmacol Biol Psychiatry. 2003;27(1):123-7.
  28. Soković M, Marin PD, Brkić D, Van Griensven L. Chemical composition and antibacterial activity of essential oils of ten aromatic plants against human pathogenic bacteria. Food. 2007;1(2):220-6.
  29. Sakamoto T, Mitani Y, Nakajima K. Psychotropic effects of Japanese valerian root extract. Chem Pharm Bull (Tokyo). 1992;40(3):758-61.
  30. Hikino H, Hikino Y, Takeshita Y, Kato H, Takemoto. [Constituents of wild Japanese valerian root. (1)]. Yakugaku Zasshi. 1965;85(2):179-80.
  31. Nathan M, Scholten R. The complete German Commission E monographs: therapeutic guide to herbal medicines. Ann Intern Med. 1999;130(5):459.
  32. Petkov V. Plants and hypotensive, antiatheromatous and coronarodilatating action. Am J Chin Med. 1979;7(3):197-236.
  33. Petkov V. Plants and hypotensive, antiatheromatous and coronarodilatating action. Am J Chin Med. 1979;7(3):197-236.
  34. Franck B, Petersen U, Huper F. Valerianie, a tertiary monoterpene alkaloid from valerian (1). Angew Chem Int Ed Engl. 1970;9(11):891.
  35. Janot M, Guilhem J, Contz O, Venera G, Cionga E. Contribution to the study of valerian alkaloids (Valeriana officinalis, L.): actinidine and naphthyridylmethylketone, a new alkaloid. Ann Pharm Fr. 1979;37(5):413-20.
  36. Tagashira M, Ohtake Y. A new antioxidative 1, 3-benzodioxole from Melissa officinalis. Planta medica. 1998;64(06):555-8.
  37. Tagashira M, Ohtake Y. A new antioxidative 1,3-benzodioxole from Melissa officinalis. Planta Med. 1998;64(6):555-8.
  38. Marongiu B, Porcedda S, Piras A, Rosa A, Deiana M, Dessi MA. Antioxidant activity of supercritical extract of Melissa officinalis subsp. officinalis and Melissa officinalis subsp. inodora. Phytother Res. 2004;18(10):789-92.
  39. Kuhn MA, Winston D. Herbal therapy and supplements: a scientific and traditional approach. Philadelphia: Lippincott Williams & Wilkins; 2000.
  40. Commission BP. British Pharmacopoeia. London: British Pharmacopoeia; 2015.
  41. Jahromi MAF, Etemadfard H, Zebarjad Z. Chemical Characterization and Antimicrobial Activity of Essential oil from the Leaves of Bienertia cycloptera. Chemistry of Natural Compounds. 2016;52(5):936-8.
  42. Farboodniay J, Moein M, Ahmadi S. In vitro free radical scavenging activity and total phenolic and flavonoid content of spathe extracts from 10 cultivar varieties of Phoenix dactylifera L. International Journal of Pharmacognosy and Phytochemical Research. 2016;8(9):1481-6.
  43. Derakhshan Z, Ferrante M, Tadi M, Ansari F, Heydari A, Hosseini MS, et al. Antioxidant activity and total phenolic content of ethanolic extract of pomegranate peels, juice and seeds. Food Chem Toxicol. 2018;114:108-11.
  44. Morteza-Semnani K, Saeedi M. Essential oil composition of Echium amoenum Fisch. & CA Mey. Journal of Essential Oil Bearing Plants. 2005;8(1):61-4.
  45. Pokajewicz K, Bialon M, Svydenko L, Fedin R, Hudz N. Chemical Composition of the Essential Oil of the New Cultivars of Lavandula angustifolia Mill. Bred in Ukraine. Molecules. 2021;26(18).
  46. Quality Control Methods for Medicinal Plant Materials. Geneva; World Health Organization: 1998.
  47. Karamipour Esfahani M, Abedi M. Standardization of medicinal plants and their herbal products and functional foods. Innovative Food Technologies. 2016;3(2):65-76.
  48. Aghajani S. Analysis and identification of volatile compounds and determination of the amount of two specific markers present in the traditional product of Javaresh Kamuni [PharmD thesis]. Shiraz: Shiraz University of Medical Sciences; 2023.
  49. Rozet E, Ceccato A, Hubert C, Ziemons E, Oprean R, Rudaz S, et al. Analysis of recent pharmaceutical regulatory documents on analytical method validation. J Chromatogr A. 2007;1158(1-2):111-25.
  50. Jia S, Kang YP, Park JH, Lee J, Kwon SW. Simultaneous determination of 23 amino acids and 7 biogenic amines in fermented food samples by liquid chromatography/quadrupole time-of-flight mass spectrometry. J Chromatogr A. 2011;1218(51):9174-82.
  51. Ekka NR, Namdeo KP, Samal PK. Standardization strategies for herbal drugs-An overview. Research Journal of Pharmacy and Technology. 2008;1(4):310-2.
  52. Isiri F. Feed-maximum Limit of Heavy Metals. The Institute of Standards and Industrial Research of Iran. 2010;12968:15.
Sadra Medical Journal

Articles in Press, Corrected Proof
Available Online from 23 September 2025
Files
Share
How to cite
Statistics