Objective: to develop a method for verifying ceftriaxone and determining its concentration in blood serum by means of capillary electrophoresis. Materials and methods. The study used ceftriaxone sodium salt (CJSC Pharmaceutical Company "Lekko"), model mixtures of biological fluids (whole blood, serum and blood plasma) with different concentrations of ceftriaxone; clinical biological blood samples taken during breast surgery against the background of perioperative antibiotic prophylaxis. The concentration of ceftriaxone was determined by using a Capel-105M capillary electrophoresis system (CJSC Lumex, St. Petersburg, Russia). Results. An express method has been developed for the determination of ceftriaxone in blood serum (sample volume - 0.1 ml), which involves the use of a precipitant of protein substances - crystalline ammonium sulfate, extraction of the organic system chloroform - isobutanol in a ratio of 3: 1, re-extraction of the substance into a working electrolyte diluted with water, and subsequent electrophoresis on the device "Capel-105M". Method validation indicates its linearity, correctness, precision and specificity; the lower limit of quantitation is 0.1 µg/0.1 ml biological medium. The effectiveness of the technique was confirmed in a clinical trial by determining the concentration of ceftriaxone in the blood serum 30 minutes after intravenous administration of 1 g of the drug for the purpose of perioperative antibiotic prophylaxis. Conclusion. The method for the quantitative determination of ceftriaxone in blood serum, performed by using a capillary electrophoresis system (“Kapel-105M”), meets the established validation criteria. At the same time, the identification of the antibiotic is carried out under selective conditions and requires a minimum amount of the object, thereby reducing the amount of co-extractive substances in the samples, which, in combination with the method of stacking during electrophoresis, provides a high sensitivity of the technique. It can be recommended for analysis in clinical diagnostic laboratories.
Purpose. To evaluate clinical trials data since January 2021 till March 2021. Materials and methods. The information about clinical trial’s approvals from the state register of medicines of Russian Federation ministry of health website was used as the main source of the original data concerning clinical trials. The register contains all the information relating to clinical trials in Russian Federation. Results. Clinical trials data was analyzed by its type (international, local, bioequivalence), sponsorship (foreign, local), phases and disease areas. Separately COVID-19 clinical trials were considered. Conclusion. During the 2021 Q1 we can mark a clinical trail’s quantity growth (started ones) both in Russia and in Moscow in comparison with 2018-2020 similar periods, that is definitely a positive trend especially in COVID-19 pandemic circumstances. There is a significant growth of bioequivalence share in 2021 versus 2019-2020 in Moscow. Due to SARS-CoV-2 ongoing pandemic lots of related to SARS-СоV-2 treatment clinical trials started, which considerably increased the contagious diseases pool in clinical trials market structure. Totally 14 related to SARS-СоV-2 treatment trials started in Russia, including 5 ones held in Moscow Healthcare Department medical organizations.
The article is a comparative analysis of the quality of life indicators of patients with rheumatoid arthritis with similar indicators in the Moscow population. We conducted a survey of patients in the register of rheumatoid patients in Moscow using the EQ-5D-5L questionnaire and the EQ-VAS visual analog scale. The population of patients with rheumatoid arthritis, in accordance with the recommendations of EuroQoL, was divided into 6 age and sex groups. The responses of patients from each age and sex group were compared with similar groups of respondents in the Moscow population. Key differences in the quality of life of rheumatoid patients were identified in comparison with both the population norm in Moscow and similar foreign registries.
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