DEVELOPMENT AND STUDY OF VACCINE THIOMERSAL-FREE DRUGS

Abstract

Aim. To produce and control the experimental series of exhausted diphtheritic and tetanic anatoxins, not containing thiomersal, to study the vaccine storage stability, to conduct the comparative analysis of the obtained results and assess the comparability of drug containing thiomersal and free of it. Materials and methods. Experimental series of the drugs “ADS-M-anatoxin”, “AD-M-anatoxin” and “AS-anatoxin” free of thiomersal and commercial series of these preparations with thiomersal added were used as the object of studying. Safety, efficiency of vaccines and their physical-chemical properties were studied with generally accepted methods. Results. The data on control of experimental series (thiomersal-free) prove that the drugs ADS-M-anatoxin, AD-M-anatoxin and AS-anatoxin correspond to the requirements of normative documentation by all the parameters and do not differ from the series with preservative added. In conditions of storage at the temperature of 2 to 8°C, thiomesal-free drugs by their physical-chemical properties and safety are stable during all the period of shelf life established for drugs containing thiomersal. Specific activity of experimental series of the drug on completion of its shelf life corresponds to normative documentation requirements. On the basis of the obtained data, documents for making changes in registration dossier regarding the drugs “ADS-M-anatoxin”, “AD-M-anatoxin” and “AS-anatoxin” were prepared. Conclusion. The technology developed at Perm Branch of “SPA Microgen” of Ministry of Hhealth of Russia permits to produce thiomersal-free vaccines which by their physical-chemical parameters, safety and efficiency are identical to thiomersal-containing vaccines.

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Copyright (c) 2014 Nikolaeva A.M., Gryaznova D.V., Semenova V.D., Pushkareva E.V., Perevozchikov A.B., Sosnina O.Y.

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