THE DEVELOPMENT OF NEW PHARMACEUTICAL SUBSTANCES - TRITICAINE-ALPHA
The article describes a method for producing a recombinant tritician-alpha protein, and also discusses the development of a tritician-alpha substance that meets the requirements of GP XIV. Scientists of the Institute of Molecular Medicine FSAE of the First Moscow State Medical University. THEM. Sechenov (Sechenov University) of the Ministry of Health of the Russian Federation developed a method for producing a truncated form of full-sized triticaine-alpha corresponding to its catalytic domain (i.e., without a leader peptide andgranulin-like domain) with a high yield and level of proteolytic activity containing a sequence of 6 His in N-terminal region of the recombinant protein (Patent RU 2 603 054 C2). However, the resulting recombinant protein did not meet the parameters set forth in GP XIV. In this regard, it was necessary to select the composition of cryoprotectants to obtain a stable lyophilis- ate in order to further create a new drug in the form of hard capsules, as well as the method of their administration. The quality assessment of the obtained samples of the substance with excipients was evaluated by the following indicators: appearance, ability to grind, moisture content and the formation of possible decomposition products of recombinant. Based on the study, the optimal composition of excipients was determined for the technology of obtaining the substance of the recombinant protein triticaine-alpha.