Acute toxicity study of Dermabin

Authors

  • V. L. Karbovskyy LLC «PP «Biofarma»,
  • I. A. Shevchuk LLC «PP «Biofarma»,
  • O. V. Kurkina LLC «PP «Biofarma»,
  • T. Ye. Makovska Main Military Medical Hospital, Kyiv,

DOI:

https://doi.org/10.14739/2409-2932.2017.1.93456

Keywords:

psoriasis, dermatosis, Dermabin, acute toxicity

Abstract

The problem of improving the therapy of patients with psoriasis and psoriatic arthritis still remains to be one of the most pressing in the up-to-date dermatology, despite a considerable number of the available and newly appeared medications.


The aim of research. The purpose of our study was to explore the safety of Dermabin use in experiments on animals.

Materials and methods. The studies of drug Dermabin acute toxicity under the conditions of its single epicutaneous application at a dose of 3300mg/kg (betamethasone – 1.65 mg/kg, salicylic acid – 100 mg/kg) or single intragastric administration at a dose of 20000 mg/kg (betamethasone – 10 mg/kg, salicylic acid – 600 mg/kg) were carried out on 40 sexually mature rats of both sexes and 40 sexually mature mice of both sexes. The effect of drug Dermabin was evaluated by the following indicators: a) lethality (term animal deaths in each groups, daily); b) toxicity (daily), including irritation, edema and hyperemia in the area of application; c) body weight changes (days 0, 4, 7 and 14); d) macroscopic examination of innards and calculation of their mass coefficients (14 days).


Results. The study results showed that both during the epicutaneous application and intragastric administration of drug Dermabin, signs of intoxication in rats and mice were not revealed. The application of drug Dermabin has no effect on body weight dynamics, integrative indicators of functional status of the animals and a relative mass of their innards.

Conclusions. The study shows that LD50 for Dermabin drug while epicutaneously application and intragastrically administration to rats and mice is beyond the limits of 15000 mg/kg. According to toxicological classification of substances, drug Dermabin belongs to V class of toxicity – practically nontoxic substances.

References

Raychaudhuri, S. P., & Farber, E. M. (2001) The prevalence of psoriasis in the world. J. Eur. Acad. Dermatol. Venereol, 15(1), 16–17. doi: 10.1046/j.1468-3083.2001.00192.x.

Eberle, F. C., Brück, J., Holstein, J., Hirahara, K., & Ghoreschi, K. (2016) Recent advances in understanding psoriasis. F1000Res., 5. doi: 10.12688/f1000research.7927.1.

Schön, M. P., Zollner, T. M., & Boehncke, W. H. (2003) The molecular basis of lymphocyte recruitment to the skin: clues for pathogenesis and selective therapies of inflammatory disorders. J. Invest. Dermatol, 121, 951–962. doi: 10.1046/j.1523-1747.2003.12563.x.

Murphy, J. E., Robert, C., & Kupper, T. S. (2000) Interleukin-1 and cutaneous inflammation: a crucial link between innate and acquired immunity. J. Invest. Dermatol., 114, 602–8. doi: 10.1046/j.1523-1747.2000.00917.x

Leonardi, C. L., Powers, J. L., Matheson, R. T., Goffe, B. S., Zitnik, R., Wang, A., & Gottlieb, A. B. (2003) Etanercept as monotherapy in patients with psoriasis. N. Engl. J. Med., 349, 2014–22. doi: 10.1056/NEJMoa030409.

Raychaudhuri, S. P., & Raychaudhuri, S. K. (2004) Role of NGF and neurogenic inflammation in the pathogenesis of psoriasis. Prog. Brain. Res., 146, 433–7. doi: 10.1016/S0079-6123(03)46027-5.

Rhen, T., & Cidlowski, J. A. (2005) Antiinflammatory Action of Glucocorticoids – New Mechanisms for Old Drugs. N. Engl. J. Med., 353, 1711–23. doi: 10.1056/NEJMra050541.

Koo, J., Cuffie, C. A., Tanner, D. J., Bressinck, R., Cornell, R. C., DeVillez, R. L., et al. (1998) Mometasone furoate 0.1%-salicylic acid 5% ointment versus mometasone furoate 0.1% ointment in the treatment of moderate-to-severe psoriasis: a multicenter study. Clin. Ther., 20, 283–91. doi: 10.1016/S0149-2918(98)80091-X.

Nakaz MOZ Ukrainy «Poriadok provedennia doklinichnoho vyvchennia likarskykh zasobiv ta ekspertyzy materialiv doklinichnoho vyvchennia likarskykh zasobiv» vid 14.12.2009 r. №944. [Order of the Ministry of Health of Ukraine “Realization of medicines’ preclinical study and expertise of medicines’ preclinical study” 14.12.2009.№944]. Retreved from: http://zakon5.rada.gov.ua/laws/show/z0053-10.

Stefanov, О. V. (Ed) (2001) Doklinichni doslidzhennia likarskykh zasobiv: metodychni rekomendatsii [Preclinical studies of drugs]. Kyiv: Avitsena. [in Ukrainian].

(2011) Product Monograph. DIPROSALIC® Lotion and Ointment (Betamethasone Dipropionate and Salicylic Acid). Topical Corticosteroid and Keratolytic. – Merck Canada Inc.

Rebrova, O. Yu. (2006) Statisticheskij analiz medicinskikh dannykh. Primenenie paketa prikladnykh program STATISTICA [Statistical analysis of medical data. The use of the application package STATISTICA]. Moscow: Media-Sphera. [in Russian].

How to Cite

1.
Karbovskyy VL, Shevchuk IA, Kurkina OV, Makovska TY. Acute toxicity study of Dermabin. Current issues in pharmacy and medicine: science and practice [Internet]. 2017Feb.20 [cited 2024Jun.21];(1). Available from: http://pharmed.zsmu.edu.ua/article/view/93456

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