[Experimental study of human recombinant insulin].

Area of Science:

• Biotechnology
• Pharmacology
• Endocrinology

Background:

• Recombinant human insulin is a critical therapeutic for diabetes management.
• Ensuring the quality and efficacy of domestically produced biologics is essential.

Purpose of the Study:

• To evaluate the specific activity and pharmacokinetic profile of novel recombinant human insulin.
• To compare the therapeutic effects and safety of a new insulin formulation against a global standard.
• To assess the pharmacological safety of the developed insulin dosage forms.

Main Methods:

• Experimental study of recombinant human insulin.
• Kinetic analysis of hypoglycemic effects.
• Pharmacological investigation of dosage forms.

Main Results:

• The recombinant human insulin exhibited high specific activity.
• Similar hypoglycemic effect kinetics were observed between the developed and Eli Lilly's insulin formulations.
• Pharmacological studies indicated no adverse effects on vital organs and systems.

Conclusions:

• The gene-engineered human insulin developed at the National Research Centre of Antibiotics is comparable to international standards.
• The new insulin dosage forms possess favorable efficacy and safety profiles.
• This research supports the availability of high-quality, domestically produced insulin analogs.