QUALITY ASSESSMENT OF A NEW TISSUE PREPARATION «NIKA-EM»

Abstract

The objective characteristics of the tissue preparation based of fetal tissues requires the evaluation of their quality, both with regard to the general mandatory requirements laid down in regulatory documents to verify the preparations based on animal origin raw materials, as well as indicators taking into account the biochemical features of embryonic materials and specificity of technological manipulation. An assessment of the new tissue preparation «NIKA-EM», obtained on the basis of embryonic tissues of birds. We used common criteria and modern innovative methods of assessing the quality of drugs. The fundamental point of the study was evaluation of the physicochemical properties of the preparation, the degree of homogenization and dispersion of substances, as well as an integrative approach to the determination of the biological activity of the preparation in the body, through the calculation of adaptive capacity of the liver, both test systems. Studied a number of characteristics that allow the preparation «NIKA-EM» qualify for standardization as an effective biologically active tissue preparation.