Study the subchronic toxicity of the drug Dantinorm Baby
https://doi.org/10.37489/2587-7836-2020-3-52-60
Abstract
Presents results of a study of subchronic toxicity of homeopathic drug Dantinorm Baby in finished dosage form. The drug in the form of a ready solution was administered daily orally for one month to outbred rats Infanta and chinchilla rabbits at a dose of 0.3 ml/kg, corresponding to the therapeutic, and 3 ml/kg, exceeding the therapeutic dose 10 times. Clinical, laboratory and histopathological studies performed in accordance with the General Protocol, showed no toxic effects of homeopathic preparation of Dantinorm Baby. The totality of the obtained data of the subchronic experiment indicates that there are no obstacles to the clinical study of the drug Dantinorm Baby in the range of therapeutic dosages.
About the Authors
A. V. SorokinaRussian Federation
Sorokina Aleksandra V., PhD in Biology, Leading researcher of the laboratory of drug toxicology
S. V. Alekseeva
Russian Federation
Alekseeva Svetlana V., Leading researcher of laboratory of drug toxicolog
SPIN code: 8985-3418
I. A. Miroshkina
Russian Federation
Miroshkina Irina A., Research scientist of the laboratory of drug toxicology
SPIN code: 4697-7938
K. S. Kachalov
Russian Federation
Kachalov Kirill S., Engineer of the 1st category of the laboratory of
drug toxicology; student of the pharmaceutical faculty
SPIN code: 2992-6789
A. D. Zaharov
Russian Federation
Zakharov Aleksei D., Junior researcher of the laboratory of drug toxicolog
SPIN code: 9013-6228
I. V. Alekseev
Russian Federation
Alekseev Ivan V., Engineer of the 1st category of the Laboratory
of Pharmacology of mutagenesis; student of the faculty of pharmacy
SPIN code: 9757-6210
A. S. Lapizkaya
Russian Federation
SPIN code: 7966-8750
References
1. Kazyukova TV, Ilyenko LI, Kotlukov VK. Duration and effectiveness of exposure of various drugs for pathological teething symptoms in infants. Pediatria. Journal named after G.N. Speransky. 2019;98 (2):133-140. (In Russ).
2. Kazyukova TV, Radzig EYu, Pankratov IV, Aleev AS. Comparison of clinical efficacy and safety of the two drugs in the therapy of symptoms of eruption of infant teeth («Dantinorm Baby®» VS «Calgel®»). Pediatria. Journal named after G.N. Speransky. 2018;97(1):122-130. (In Russ).]
3. Kazyukova TV, Kotlukov VK, SHevchenko NN, Rusakova VD. Simptomy prorezyvaniya zubov u mladencev: sostoyanie ili bolezn? Pediatria. Journal named after G.N. Speransky. 2013;92(4):62-63. (In Russ).]
4. Guide for the Care and Use of Laboratory Animals. National Research Council (US) Committee for the Update of the Guide for the Care and Use of Laboratory Animals. 8th edition. Washington (DC): National Academies Press (US); 2011. DOI: 10.17226/12910
5. Guideline for Experimental (Preclinical) Studying of New Pharmacological Substances. Metodicheskie ukazaniya po izucheniyu obshchetoksicheskogo deistviya farmakologicheskikh veshchestv. Izuchenie «khronicheskoi» toksichnosti. Moscow: Medicine; 2005. P. 47-54 (In Russ).]
6. Guidance on Preclinical Evaluation of Medicines. Part 1. Metodicheskie rekomendacii po izucheniyu obshchetoksicheskogo dejstviya lekarstvennyh sredstv. Izuchenie hronicheskoj toksichnosti. Moscow: Grif i K; 2012, P. 17- 24. (In Russ).]
7. Rukovodstvo po ekspertize lekarstvennyh sredstv. Tom I. Moscow: Grif i K, 2013. (In Russ).
8. Diehl KH, Hull R, Morton D et al. A good practice guide to the administration of substances and removalof blood, including routes and volumes. J Appl Toxicol.Jan-Feb 2001;21(1):15-23. DOI: 10.1002/jat.727.
9. Issledovanie sistemy krovi v klinicheskoj praktike / [Kozinets GI, Arustamyan YuS, Ashurov GD et al.]; Ed by GI Kozinets, VA Makarov. Moscow: Triada-X; 1997. (In Russ).] ISBN 5-86021-006-X
10. Mikroskopicheskaya tekhnika. Rukovodstvo dlya vrachej i laborantov / Ed by DS Sarkisov and YuL Perov. Moscow: Medicine; 1996. (In Russ). ISBN: 5-225-02820-9
11. Histological and microscopical technique: Rukovodstvo / AG Sapozhnikov, AE Dorosevich. Smolensk: SAU; 2000. (In Russ).
12. Merkulov GA. Kurs patologogistologicheskoi tekhniki. Leningrad: Medicine; 1969. (In Russ).
13. Glanc S. Mediko-biologicheskaya statistika Moscow: Praktika; 1998. (In Russ).
14. Belenky MB. Elementy kolichestvennoj ocenki farmakologicheskogo effekta. Leningrad: Medgiz; 1963. (In Russ).]
15. Problemy normy v toksikologii / Ed by prof. IM Trahtenberga). Moscow: Medicina; 1991. (In Russ).
16. Spravochnik Fiziologicheskie, biohimicheskie i biometricheskie pokazateli normy eksperimental'nyh zhivotnyh / Ed by Makarova VG, Makarovoj MN. SBP: «LEMA»; 2013, (In Russ).] ISBN 978-5-98709-619-2
Review
For citations:
Sorokina A.V., Alekseeva S.V., Miroshkina I.A., Kachalov K.S., Zaharov A.D., Alekseev I.V., Lapizkaya A.S. Study the subchronic toxicity of the drug Dantinorm Baby. Pharmacokinetics and Pharmacodynamics. 2020;(3):52-60. (In Russ.) https://doi.org/10.37489/2587-7836-2020-3-52-60