Vol 71, No 8 (2022)

Introduction. Crescent alfalfa (Medicago falcata L.) is widespread in the regions of central Russia, it is a fodder and honey plant. The plant contains various classes of biologically active substances, among which flavonoids, isoflavonoids are more valuable, because. have different pharmacological efficacy, such as anti-inflammatory, anticarcinogenic, antimicrobial, antioxidant.

In this regard, the identification and qualitative determination of individual flavonoids of the herb sickle alfalfa by various methods is relevant.

Objective: study of the flavonoid compounds of the alfalfa herb by known qualitative reactions, paper chromatography and ultra performance liquid chromatography/MS.

Material and methods. The flavonoid composition of sickle alfalfa was studied using qualitative reactions, paper chromatography, ultra performance liquid chromatography/MS on a Waters Acquility chromatograph with a UV diode array detector and a TQD tandem quadrupole MS detector (Waters) in the gradient elution mode. Flavonoid compounds were extracted with 70% ethyl alcohol.

Results. The flavonoid composition of the crescent alfalfa herb is represented by derivatives of quercetin, myricetin, apigenin, mainly their methoxylated forms. A total of 10 compounds were identified, including 8 flavonols, which were divided into quercetin derivatives (rutin, 4',7-O-Dimethylquercetin-3-O-di-methylglucoside, 4',7-O-dimethylquercetin-3-O-methylglucoside) , the rest are classified as myricetin derivatives. Two compounds are classified as flavones (apigenin-7-O-methylglucoside, apigenin-7-O-acetylglucosyl, glucosylglucoside).

Conclusion. 10 flavonoid compounds, represented mainly by methoxylated compounds, were identified in the herb alfalfa sickle, and therefore it can serve as a potential source of these compounds.

Introduction. Lapatinib is used for targeted therapy of breast cancer caused by overexpression or activation of tyrosine kinase receptors of epidermal growth factor (Human epidermal growth factor receptors, HER/ErbB). For the determination of lapatinib in tablets, chromatographic methods are mainly used. However, spectrophotometry in the visible and ultraviolet regions of the spectrum can be considered as a more accessible and simple method of quantitative determination. To prove the suitability of the method for quantitative determination of lapatinib in tablets by UV spectrophotometry in the dissolution test, it is necessary to validate it.

The objective of the study was to validate the method for the quantitative determination of lapatinib during the dissolution test.

Material and methods. As an investigational drug, lapatinib tablets (film-coated tablets, 250 mg) obtained in the laboratory for the development of dosage forms of the FSBI " N.N. Blokhin National Medical Research Center of Oncology" was chosen. The "Dissolution" test was carried out in accordance with GPM.1.4.2.0014.15 "Dissolution for solid dosage forms", the quantitative determination of the released substance was carried out by UV spectrophotometry, the statistical processing of the results was carried out in accordance with GPM.1.1.0013.15 "Statistical processing of the results of a chemical experiment" and the recommendations of the Guidelines for pharmaceutical industry enterprises.

Results. When determining specificity, placebo interference was found to be less than 0,1%. A linear relationship between the concentration of lapatinib and the optical density of the solution has been proven. The values taken as true lay within the confidence intervals of the corresponding average results of analyzes obtained experimentally using validated method. When determining the repeatability, the value of the relative standard deviation (RSD, %) for the degree of dissolution of lapatinib did not exceed 2%. For the validated method, acceptable specificity, linearity, accuracy, and precision were proven in the concentration range from 0.025 mg/ml to 0.061 mg/ml, which corresponds to the range from 55% to 135%.

Conclusion. Validation of the method for lapatinib quantitative determination during the “Dissolution” test for the dosage form of film-coated tablets, 250 mg has shown the possibility of its use for quality control of the medicinal product.

Introduction. A comprehensive study of medicinal plants widely used in traditional medicine, in order to scientifically substantiate their use in practical medicine, is one of the urgent tasks of modern pharmacy. One of these plants is the Samarkand immortelle (Helichrysum maracandicum Popov ex Kirp.), widely distributed in Central Asia.

Objectives. Study of the amino acid and elemental composition of the dry extract of Samarkand immortelle flowers.

Material and methods. The elemental composition of the dry extract was determined by inductively coupled plasma mass spectrometry (ICP-MS), and the quantitative determination of interchangeable and essential amino acids was carried out by high-performance liquid chromatography.

Results. In the dry extract of the Samarkand immortelle, the presence of 38 micro- and macroelements has been established, of which eight are vital (essential) and five are conditionally essential. Elements such as potassium, calcium, phosphorus, magnesium, sodium, aluminum, etc. are represented in the largest amount. According to the classification of Polyanskaya (2005), the detected elements by quantitative content can be divided into the following categories:

• 2 macroelements (K, Ca);
• 9 millielements (P, Mg, Na, Al, Fe, B, Mn, Zn, Cu);
• 25 microelements (Ba, Cr, Ni, Ga, V, Li, Mo, Sr, Pb, Sc, Zr, Ag, Co, As, Ti, Tl, Se, Rb, Y, Sn, Sb, Cs, Be, Pt, Au);
• 2 nanoelements (In, Cd).

At the same time, the quantitative content of heavy metals and arsenic does not exceed the limits specified in regulatory documentation. Free amino acid analysis showed the presence of 20 amino acids in the dry extract, 10 of which are essential. The total free amino acid content is 6753.134 mcg/g, of which 29.19% are essential amino acids.

Conclusion. The research results confirm the high value of the dry extract of the Samarkand immortelle in terms of the content of amino acids, macro- and microelements. This fact testifies to its supposed pharmacotherapeutic activity, possible breadth of application in medicine and the expediency of creating drugs based on it.

The balance of the drug portfolio of healthcare facilities contributes to the prolongation of the provision of medical care at the proper level, ensuring interaction and continuity between the inpatient and outpatient stages of care, which is especially important in organizing and conducting pain syndrome therapy. Currently, the patient's need for pain therapy already at the time of discharge from the hospital before an appointment with an outpatient doctor is expressed by the legislative possibility of handing over potent drugs to the patient for a period of up to 5 days.

Objectives: justification of medicine provision with a fixed-dose combination (FDC) of Paracetamol and Tramadol to patients with pain syndrome during their transition from inpatient to outpatient care based on a pharmacoeconomic approach and to evaluate the costs of such pharmacotherapy.

Material and methods. The results of previous studies on the evaluation of the effectiveness of the analgesic action of the Paracetamol and Tramadol FDC in comparison with the injectable monodrug Tramadol product and the cost of obtaining 1 unit of effectiveness in the conditions of emergency surgical and trauma departments of a hospital, content analysis of legislation and internal regulations on the circulation of drugs of controlled groups, statistics of the bed capacity of the emergency surgery department for the period of 2021–2022.

Results and discussion. The use of Paracetamol and Tramadol FDC for pain therapy, taking into account the comparison and grouping of patients, made it possible to reduce the cost of pain syndrome therapy by 23,472.68 rubles within 4 months. Extrapolation of the obtained data for 4 months for an annual period showed the possibility of reducing the cost of treating pain syndrome by 70,418.04 rubles while ensuring a comfortable transition of patients to outpatient care.

Conclusion. The studies show the clinical and economic feasibility of using a Paracetamol and Tramadol FDC both in hospital care and when moving from a hospital to an outpatient clinic.