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RESEARCH ON ACUTE TOXICITY "CHONDROSUT" DRUGV. L. Karbovsky1, I. A. Shevchuk1, T. Ye. Makovska2, O. A. Makovskyi1LLC «Biofarma», Bila Tserkva1,Main Military Medical Hospital, Kyiv2Introduction. One of the most common locomotor system disease that is suffered, according to WHO data, by up to 80% of population aged 50-60 years, is osteoarthritis – a chronic degenerative-dystrophic arthropathy, which is characterized by a progressing articular cartilage degradation, epiphyse remodeling, osteophyte development and fixed joint deformity at the advanced stages of the disease. A characteristic feature of the cartilaginous destruction in osteoarthritis is the loss by the matrix of the superficial, intermediate and deep zones of glucosaminoglycans – chondroitin sulphate (CS), keratin sulphate, hyaluronic acid. Among the chondroprotective agents, glucosamine and CS have the highest degree of provability and reliability of results, and therefore it is timely to put into practice new chondroprotectors ofUkraine's production, containing glucosaminglycans. A successful development and introduction of the new drugs into medical practice require a thorough preclinical research. That is why the purpose of our study was to elucidate the safety of using solution for injections "Chondrosut" by LLC "Pharmaceutical plant "Biofarma" in experiments on animals.Study methods. Toxicological characteristics of drug "Chondrosut" under the condition of its single intraperitoneal administration in a dose of 1000mg/kg were studied on the white non-pedigree rats of both sexes, weighing 180-200g. Following the use of the substances, the animals were observed for 14 days. The effect of "Chondrosut" single administration was evaluated by the indicators as follows: general condition and behavior of the rats, lethality and dynamics of the body weight changes (days 0, 3, 7 and 14). Upon completion of the experiment, after the animals have been withdrawn from the experiment by euthanasia, a macroscopic inspection of the their internals was performed and their mass coefficients were calculated.Results and discussion. Following the intraperitoneal administration of drug "Chondrosut" no symptoms of intoxication in rats of both sexes were revealed: the animals were tidy, active, reacted to the photic and sound stimuli, the processes of uropoiesis and defecation were in the norm, respiratory impairments and convulsions were not observed, reflectory excitability was preserved. Water and food consumption in the experimental group did not differ from that in the control group. Throughout the whole observation period no deaths of the animals were registered. Both in the control and experimental rats the body weight increased relative to the baseline level and was within the limits of physiologic norm, i.e. the drug "Chondrosut" possesses no toxic properties capable of exerting a strong effect on the general trophic processes in the body. When inspecting the condition of indumentums, skin, mucous membranes of physiologic ostia, as well as microscopically evaluating the condition of internals during autopsy in rats receiving "Chondrosut", no signs of irritation, inflammation or other manifestation of pathologic processes were revealed. The experimental group of rats did not differ from the control one in the size, color, consistence and location of the internals. Mass coefficients of internals of the animals injected with "Chondrosut" did not have significant changes relative to those in the control animals.ConclusionsThe results of the studies point to the fact that LD50 for drug "Chondrosut" when administered intraperiotoneally to rats is beyond the limits of 1000mg/kg. According to toxicological classification of substances, drug "Chondrosut" belong to V class of toxicity – practically nontoxic substance.ReferencesVnutrishni hvoroby / Za red. I. M. Gandzhi, V. M. Kovalenka. – Kyi'v, Zdorov'ja, 2002. – 988 s.Doklinichni doslidzhennja likars'kyh zasobiv: metodychni rekomendacii' / Za red. O. V. Stefanova. – K.: Avicena, 2001. – 528 s.Kovalenko V. N. Osteoartroz: praktycheskoe rukovodstvo / V. N. Kovalenko, O. P. Bortkevych. – K.: Moryon, 2003. – 448 s.Kovalenko V. N. Osteoartroz. Praktychna nastanova / V. N. Kovalenko, O. P. Bortkevych. – 3-tje vyd., dopov., zi zminamy – K.: MORION., 2010. – 608 s.Nejko Je. M. Suchasni ujavlennja pro patogenez deformujuchogo osteoartrozu / Je. M. Nejko, I. Ju. Golovach // Ukr. revmatol. zhurnal. – 2000. – № 1. – S. 9-12.Nomenklatura, klasyfikacija, kryterii' diagnostyky ta programy likuvannja revmatychnyh hvorob /Za red. V. M. Kovalenka, N. V. Shuby. – Kyi'v, 2004. – 156 s.Rebrova O. Ju. Statystycheskyj analyz medycynskyh dannыh. Prymenenye paketa prykladnыh programm STATISTICA / O.Ju.Rebrova – 3-e yzd. – M.: MedyaSfera, 2006. – 312 s.Bruyere O. Glucosamine and chondroitin sulfate as therapeutic agents for knee and hip osteoarthritis / O. Bruyere, J. Y. Reginster // Drugs. Aging. – 2007. – V. 24(7). – P. 573-80.Kelly G. S. The role glucosamine sulfate and chondroitin sulfate in the treatment of degenerative joint disease / G. S. Kelly // Alt. Med. Rev. – 1998. – V.3 (1). - P. 27-39.EULAR evidence based recommendations for the diagnosis of knee osteoarthritis / W. Zhang, M. Doherty, G. Peat [et al.] // Ann. Rheum. Dis. – 2009. – Vol. 68, №13. – Р. 141.Uebelhart D. Clinical review of chondroitin sulfate in osteoarthritis / D. Uebelhart // Osteoarthritis Cartilage. – 2008. – V. 16, Suppl 3. – P. S19-21.

RESEARCH ON ACUTE TOXICITY "CHONDROSUT" DRUGV. L. Karbovsky1, I. A. Shevchuk1, T. Ye. Makovska2, O. A. Makovskyi1LLC «Biofarma», Bila Tserkva1,Main Military Medical Hospital, Kyiv2Introduction. One of the most common locomotor system disease that is suffered, according to WHO data, by up to 80% of population aged 50-60 years, is osteoarthritis – a chronic degenerative-dystrophic arthropathy, which is characterized by a progressing articular cartilage degradation, epiphyse remodeling, osteophyte development and fixed joint deformity at the advanced stages of the disease. A characteristic feature of the cartilaginous destruction in osteoarthritis is the loss by the matrix of the superficial, intermediate and deep zones of glucosaminoglycans – chondroitin sulphate (CS), keratin sulphate, hyaluronic acid. Among the chondroprotective agents, glucosamine and CS have the highest degree of provability and reliability of results, and therefore it is timely to put into practice new chondroprotectors ofUkraine's production, containing glucosaminglycans. A successful development and introduction of the new drugs into medical practice require a thorough preclinical research. That is why the purpose of our study was to elucidate the safety of using solution for injections "Chondrosut" by LLC "Pharmaceutical plant "Biofarma" in experiments on animals.Study methods. Toxicological characteristics of drug "Chondrosut" under the condition of its single intraperitoneal administration in a dose of 1000mg/kg were studied on the white non-pedigree rats of both sexes, weighing 180-200g. Following the use of the substances, the animals were observed for 14 days. The effect of "Chondrosut" single administration was evaluated by the indicators as follows: general condition and behavior of the rats, lethality and dynamics of the body weight changes (days 0, 3, 7 and 14). Upon completion of the experiment, after the animals have been withdrawn from the experiment by euthanasia, a macroscopic inspection of the their internals was performed and their mass coefficients were calculated.Results and discussion. Following the intraperitoneal administration of drug "Chondrosut" no symptoms of intoxication in rats of both sexes were revealed: the animals were tidy, active, reacted to the photic and sound stimuli, the processes of uropoiesis and defecation were in the norm, respiratory impairments and convulsions were not observed, reflectory excitability was preserved. Water and food consumption in the experimental group did not differ from that in the control group. Throughout the whole observation period no deaths of the animals were registered. Both in the control and experimental rats the body weight increased relative to the baseline level and was within the limits of physiologic norm, i.e. the drug "Chondrosut" possesses no toxic properties capable of exerting a strong effect on the general trophic processes in the body. When inspecting the condition of indumentums, skin, mucous membranes of physiologic ostia, as well as microscopically evaluating the condition of internals during autopsy in rats receiving "Chondrosut", no signs of irritation, inflammation or other manifestation of pathologic processes were revealed. The experimental group of rats did not differ from the control one in the size, color, consistence and location of the internals. Mass coefficients of internals of the animals injected with "Chondrosut" did not have significant changes relative to those in the control animals.ConclusionsThe results of the studies point to the fact that LD50 for drug "Chondrosut" when administered intraperiotoneally to rats is beyond the limits of 1000mg/kg. According to toxicological classification of substances, drug "Chondrosut" belong to V class of toxicity – practically nontoxic substance.ReferencesVnutrishni hvoroby / Za red. I. M. Gandzhi, V. M. Kovalenka. – Kyi'v, Zdorov'ja, 2002. – 988 s.Doklinichni doslidzhennja likars'kyh zasobiv: metodychni rekomendacii' / Za red. O. V. Stefanova. – K.: Avicena, 2001. – 528 s.Kovalenko V. N. Osteoartroz: praktycheskoe rukovodstvo / V. N. Kovalenko, O. P. Bortkevych. – K.: Moryon, 2003. – 448 s.Kovalenko V. N. Osteoartroz. Praktychna nastanova / V. N. Kovalenko, O. P. Bortkevych. – 3-tje vyd., dopov., zi zminamy – K.: MORION., 2010. – 608 s.Nejko Je. M. Suchasni ujavlennja pro patogenez deformujuchogo osteoartrozu / Je. M. Nejko, I. Ju. Golovach // Ukr. revmatol. zhurnal. – 2000. – № 1. – S. 9-12.Nomenklatura, klasyfikacija, kryterii' diagnostyky ta programy likuvannja revmatychnyh hvorob /Za red. V. M. Kovalenka, N. V. Shuby. – Kyi'v, 2004. – 156 s.Rebrova O. Ju. Statystycheskyj analyz medycynskyh dannыh. Prymenenye paketa prykladnыh programm STATISTICA / O.Ju.Rebrova – 3-e yzd. – M.: MedyaSfera, 2006. – 312 s.Bruyere O. Glucosamine and chondroitin sulfate as therapeutic agents for knee and hip osteoarthritis / O. Bruyere, J. Y. Reginster // Drugs. Aging. – 2007. – V. 24(7). – P. 573-80.Kelly G. S. The role glucosamine sulfate and chondroitin sulfate in the treatment of degenerative joint disease / G. S. Kelly // Alt. Med. Rev. – 1998. – V.3 (1). - P. 27-39.EULAR evidence based recommendations for the diagnosis of knee osteoarthritis / W. Zhang, M. Doherty, G. Peat [et al.] // Ann. Rheum. Dis. – 2009. – Vol. 68, №13. – Р. 141.Uebelhart D. Clinical review of chondroitin sulfate in osteoarthritis / D. Uebelhart // Osteoarthritis Cartilage. – 2008. – V. 16, Suppl 3. – P. S19-21.