Potassium Alum Vaginal Suppository: Irritation Assessment in Rabbit

Authors

1 Pounak Traditional Medicine Clinic, Tehran, Iran.

2 Traditional Medicine and Materia Medica Research Center and Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

3 Traditional Medicine and Materia Medica Research Center and Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

4 Traditional Medicine and Materia Medica Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Abstract

Background and objective: Potassium alum, called “Zaj-e-abyaz” in Iranian traditional medicine, is used vaginally in traditional clinics as an astringent agent for uterine fibroids. Before evaluating its efficacy, it is necessary to prepare a suitable dosage form and assess the possible irritation in animal model which was the aim of the current research. Methods: Vaginal suppositories were prepared using 400 mg potassium alum, 200 mg honey and different proportions of poly ethylene glycol (PEG) 600, 1000 and 4000 in each suppository. The best formulation was used for evaluation of possible irritation in rabbit. The suppositories were used in rabbit’s perineum daily for 5 consecutive days in 3 albino rabbits and the appearance of the vaginal opening and perineum for signs of erythema and edema were recorded every day. The final results were calculated as a primary irritation index (PII). Results: The best formulation contained potassium alum 20%, honey 10%, PEG 600 18%, PEG 1000 12%, PEG 4000 30% and water 10%. According to the animal test, the irritation of the vaginal mucus membrane was considered moderate in rabbits. Conclusion: Regarding the results, potassium alum could not be used in form of suppository in PEG vehicle and other formulations should be prepared for acquiring the least irritation.

Keywords

References

  • Nivethithai P, Nikhat SR, Rajesh BV. Uterine fibroids: a review. Indian J Pharm Pract. 2010; 3(1): 6–11.
  • Wallach EE, Vlahos NF. Uterine myomas: an overview of development, clinical features, and management. Obstet Gynecol. 2004; 104(2): 393–406.
  • Fu Y, Fan Y, Fan W, Lv Y, Ai S, Yu Efficacy and safety of traditional Chinese herbal formula combined with western medicine for uterine fibroid. Medicine. 2020; 99(36): 1–5.
  • Tansaz M, Tajadini H. Comparison of leiomyoma of modern medicine and traditional persian medicine. J Evid Based Complement Altern Med. 2016; 21(2): 160–163.
  • Ghassab-Abdollahi N, Sadeghzade Oskouei B, Asgharian P, Jahanshahi A, Farshbaf-Khalili A. The effect of mullein capsule on uterine leiomyomas volume and the amount of menstrual bleeding: a randomized controlled trial. J Herb Med. 2020; Article ID 100317.
  • Ali A, Hamiduddin, Zaigham M. Shibb-e-Yamani (alum) a unique drug and its utilization in Unani medicine: a physicochemical and pharmacological review. Int J Res Ayurveda Pharm. 2017; 8(2): 17–22.
  • Mbow ML, De Gregorio E, Ulmer JB. Alum’s adjuvant action: grease is the word. Nat Med. 2011; 17(4): 415–416.
  • Dubasi N, Varala R, Bollikolla HB, Kotra V. Applications of Alum (KAl (SO4)2.12H2O) in organic synthesis and as catalysis: a quinquennial update (2017-2022). J Chem Rev. 2023; 5(3): 263–280.
  • Chisholm H. “Alum”, encyclopedia Britannica. London: Cambridge university press, 1911.
  • Aghili Khorasani Shirazi SMH. Makhzan al-adviyeh. Tehran: Iranian Teb, 1396.
  • ISO 10993-10:2010, biological evaluation of medical devices, part 10: tests for irritation and skin sensitization. [Accessed 2023] of  available from: https://www.iso.org/standard/40884.html
  • Wassberg TN, Blaug Prof SM, Zopf LC. A study of the antibacterial activity of some complex aluminum salts. J Am Pharm Assoc. 1956; 45(7): 498–500.
  • Dutta S, De S, Bhattacharya SK. In vitro antimicrobial activity of potash alum. Indian J Med Res. 1996; 104: 157–159.
  • Al-Abbasi AM. The benefit of alum in tonsillectomy. Gomal J Med Sci. 2009; 7(2): 124–127.
  • Takashi M, Kondo A, Kato K, Murase T, Miyake K. Evaluation of intravesical alum irrigation for massive bladder hemorrhage. Urol Int. 1988; 43(5): 286–288.
  • Goel AK, Rao MS, Bhagwat AG, Vaidyanathan S, Goswami AK, Sen TK. Intravesical irrigation with alum for the control of massive bladder hemorrhage. J Urol. 1985; 133(6): 956–957.
  • Gattegno B, Guillemenot F, Fiatte P, Cohen L, Becker A, Gluckman E, Thibault Treatment of hemorrhagic cystitis caused by cyclophosphamide using intravesical instillation of potassium alum. Apropos of 5 cases. Ann Urol (Paris). 1989; 24(3): 190–192.
  • Altaei TS, Al-Jubouri RH. Evaluation of the efficacy of alum suspension in treatment of recurrent ulcerative ulceration. J College Dentistry. 2005; 17(2): 45–48.
  • Perl DP, Brody AR. Alzheimer's disease: X-ray spectrometric evidence of aluminum accumulation in neurofibrillary tangle-bearing neurons. 1980; 208(4441): 297–299.
  • Perazella M, Brown E. Acute aluminum toxicity and alum bladder irrigation in patients with renal failure. Am J Kidney Dis. 1993; 21(1): 44–46.
  • Kanwar VS, Jenkins 3rd JJ, Mandrell BN, Furman Aluminum toxicity following intravesical alum irrigation for hemorrhagic cystitis. Med Pediatr Oncol. 1996; 27(1): 64–67.
  • Banks WA, Kastin AJ. Aluminum-induced neurotoxicity: alterations in membrane function at the blood-brain barrier. Neurosci Biobehav Rev. 1989; 13(1): 47–53.
Research Journal of Pharmacognosy
Volume 11, Issue 1
January 2024
Pages 65-69

Files

Share

How to cite

Statistics