350 rub
Journal №8 for 2012 г.
Article in number:
Equivalence of the Preparation «Protub-4®» to Analogue «Kombitub®»
Authors:
K.I. Usov, G.G. Yushkov, M.M. Rasulov, A.S. Gushchin
Abstract:
Defined identity of pharmacological properties of a preparation « Protub-4®», to the registered analogue corresponding on structure to a preparation «Kombitub®» manufactures Cimpex Pharma PVT. LTD. (India). Bioequivalence researches are executed on nonlinear white rats. Defined the maintenance in blood of the basic components - rifampicin, isoniazid, pyrazinamid and etambutol hydrochloride. Bioequivalence, i.e. a parity of the total areas concluded under curves of dependences of concentration of components of compared preparations and expressed in percentage has appeared: for rifampicin - 3%, for isoniazid - 6%, for pyrazinamid - 1% and for etambutol - 9%. It means, that tablets «Protubas-4», covered with a cover, Open Society «Pharmasyntes» manufactures bioequivalences to tablets «Kombitub», covered with a cover, manufactures Cimpex Pharma PVT. LTD (India).
Pages: 43-47
References
- Каркищенко Н.Н., Хоронько В.В., Сергеева С.А. и др. Фармакокинетика. Ростов н/Д. Феникс. 2001. 384 с.
- Карлина М.В., Пожарицкая О.Н., Косман В.М. Исследование фармакокинетики гопантеновой кислоты при введении внутрь // Журнал экспериментальная и клиническая фармакология. 2010. № 73 (8). C. 46-48.
- Усов К.И., Юшков Г.Г., Гущина А.А. К оценке биохимических изменений при однократном воздействии противотуберкулезным препаратом «Протуб-4 плюс» в условиях эксперимента // Медицинский академический журнал. 2010. № 10 (5). 175 с.
- Михайлов И.Б. Клиническая фармакология. СПб.: Фолиант. 2000. 496 с.
- Lienhardt C., Cook S.V., Burgos M., Yorke-Edwards V., Rigouts L., Anyo G., Kim S.J., Jindani A. Efficacy and safety of a 4-drug fixed-dose combination regimen compared with separate drugs for treatment of pulmonary tuberculosis: the Study C randomized controlled trial // Jama. 2011. V. 305(14). P. 1415-1423.
- Ramachandran G., Kumar A.K., Swaminathan S. Pharmacokinetics of Anti-tuberculosis Drugs in Children // Indian J. Pediatr. 2011. V. 78 (4). P. 435-442.