Abstract
Objective of the study is experimental substantiation of possibility to produce new presentation form of cholera diagnostic sera – lyophilizate in bottles. Materials and methods. Cholera diagnostic sera. Liophylization was performed in Martin Christ Epsilon 2-6D. Residual moisture of dry sera was determined using humidity meter Sartorius MA 150. Solubility of experimental samples was assessed visually. pH was evaluated by potentiometry with the help of PK SevenExcellence-475 Mettler Toledo device, measuring pH/ORP/Ion content/conductivity/concentration. Specific activity and specificity was analyzed through expanded agglutination reaction, using relevant control strains of cholera vibrio. Results and conclusions. Experimentally justified is the possibility to lyophilize cholera diagnostic sera in flasks. Specified are the optimum parameters of lyophilization. It is determined that lyophilization does not result in deterioration of properties, as judging by the quality indicators they meet the requirements of regulatory documentation. Using accelerated aging test, it is demonstrated that the new presentation form of cholera diagnostic sera – lyophilizate in flasks – maintains their specific activity within five years term (the set out shelf life), which fully conform to normative standards.
Highlights
Objective of the study is experimental substantiation of possibility to produce new presentation form of cholera diagnostic sera – lyophilizate in bottles
Solubility of experimental samples was assessed visually. pH was evaluated by potentiometry with the help of PK SevenExcellence-475 Mettler Toledo device, measuring pH/ ORP/Ion content/conductivity/concentration
Specific activity and specificity was analyzed through expanded agglutination reaction, using relevant control strains of cholera vibrio
Summary
Objective of the study is experimental substantiation of possibility to produce new presentation form of cholera diagnostic sera – lyophilizate in bottles. Justified is the possibility to lyophilize cholera diagnostic sera in flasks. It is demonstrated that the new presentation form of cholera diagnostic sera – lyophilizate in flasks – maintains their specific activity within five years term (the set out shelf life), which fully conform to normative standards. В РосНИПЧИ «Микроб» для идентификации Vibrio cholerae О1 серогруппы производятся пять наименований диагностических холерных сывороток для постановки реакции агглютинации: сыворотка диагностическая холерная О1 адсорбированная сухая, сыворотки диагностические холерные Огава и Инаба адсорбированные сухие, сыворотка диагностическая холерная RO адсорбированная сухая, сыворотка диагностическая холерная не О1 группы О139. Предотвратить появление подобных ситуаций представляется возможным разработкой технологии лиофилизации холерных диагностических сывороток во флаконах на сублимационном сушильном оборудовании, позволяющем производить операции замораживания препарата и герметизации первичной упаковки непосредственно в камере лиофилизатора. Все вышеперечисленное определило перспективность экспериментального обоснования новой формы выпуска холерных диагностических сывороток в лиофилизированной форме во флаконах
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