2,4 - dibrom - 6 - [cikloheksil(metil)amino]metilanilīna sīrupa 8 mg/5mL ražošanas tehnoloģijas un analītisko metožu izstrāde un validācija
Date
2016
Authors
Kuprevičs, Kaspars
Journal Title
Journal ISSN
Volume Title
Publisher
Latvijas Universitāte
Abstract
Klepus ir viens no labākajiem organisma aizsargmehānismiem. Tas ir dabisks veids, kā organisms rūpējas par kakla un elpceļu tīrību. Kad elpceļi tiek kairināti, signāls nonāk klepus centrā, kas atrodas galvas smadzenēs. Viens no pazīstamākajiem pretklepus līdzekļiem ir 2, 4 – dibrom – 6 – [cikloheksil(metil)amino]metil anilīns jeb bromheksīna, kurš pieejams gan sīrupu veidā, gan tablešu formā. Bromheksīna pieskaitīts pie terapeitiskās grupas, kuras ārstē elpceļu slimības, kurām raksturīgas produktīvs, klepus ar viskozām krēpām. Latvijas farmaceitiskie uzņēmumi ražo šādas zāļu formas, taču lai produkcija būtu piemērota gan bērniem un pieaugušajiem ir jāizstrādā atšķirīgas koncentrācijas. Pašreiz Latvijā ir pieejama AS “Grindeks” produkcija tabletēs ar bromheksīna hidrohlorīdu koncentrācijā 4 mg un 8 mg, taču sīrups pieejams tikai 4 mg/5 mL koncentrācijā. Lai AS “Grindeks” produktu portfelis būtu pievilcīgs citiem Pasaules reģioniem ir nolemts paplašināt sīrupu ražošanas līniju ar 8 mg/5 mL. Darba mērķis bija izstrādāt izstrādāt 2, 4 – dibrom – 6 – [cikloheksil(metil)amino]metil anilīna jeb bromheksīna sīrupa ražošanas tehnoloģiju, veikt izstrādātai tehnoloģijai ražošanas validāciju un izstrādāt analītiskās metodes produkta kvalitātes novērtēšanai.
Cough is one of the best body's protective reactions. It is natural way of body's care about cleanness of throat and respiratory pathways. When the airways get irritated, signal reaches cough centre, situated in brain. One of the most widely known antitussive agents is 2,4-dibromo-6-[cyclohexil(methyl)amino]methylaniline, as known as bromhexine, available as syrups, as well as tablets. Bromhexine is one of agents for treatment of respiratory disorders associated with productive cough with viscous sputum. Pharmaceutical facilities of Latvia produce the necessary formulations, but, to make the product suitable for children as well as adults, it is necessary to design various concentrations. Now in Latvia are available tablets manufactured by JSC "Grindeks" containing 4 mg or 8 mg of bromhexine hydrochloride, but the solely syrup's concentration is 4 mg/5 mL. To make product portfolio of JSC "Grindeks" more attractive to other regions of world it was decided to broaden production line of syrups, adding 8 mg/5 mL. The aim of this work was to develop production technology of syrup of 2,4-dibromo-6-[cyclohexil(methyl)amino]methylaniline, as known as bromhexine, perform production validation of designed technology and develop analytical methods for evaluation of product's quality.
Cough is one of the best body's protective reactions. It is natural way of body's care about cleanness of throat and respiratory pathways. When the airways get irritated, signal reaches cough centre, situated in brain. One of the most widely known antitussive agents is 2,4-dibromo-6-[cyclohexil(methyl)amino]methylaniline, as known as bromhexine, available as syrups, as well as tablets. Bromhexine is one of agents for treatment of respiratory disorders associated with productive cough with viscous sputum. Pharmaceutical facilities of Latvia produce the necessary formulations, but, to make the product suitable for children as well as adults, it is necessary to design various concentrations. Now in Latvia are available tablets manufactured by JSC "Grindeks" containing 4 mg or 8 mg of bromhexine hydrochloride, but the solely syrup's concentration is 4 mg/5 mL. To make product portfolio of JSC "Grindeks" more attractive to other regions of world it was decided to broaden production line of syrups, adding 8 mg/5 mL. The aim of this work was to develop production technology of syrup of 2,4-dibromo-6-[cyclohexil(methyl)amino]methylaniline, as known as bromhexine, perform production validation of designed technology and develop analytical methods for evaluation of product's quality.
Description
Keywords
Farmācija , 2, 4 – DIBROM – 6 – [CIKLOHEKSIL(METIL)AMINO]METIL ANILĪNS , SĪRUPS , ANALĪTISKĀ METODE , FORMULĀCIJA , STABILITĀTE