Vol 69, No 2 (2020)

Standard samples (SSs) for drug quality control procedures require a special approach, which is marked by biological agent (BA) control methods in general and biological control ones in particular. The list of SSs of the Research Center for Examination of Medical Products (RCEMP) currently includes 61 names for SSs. By analyzing international guidelines and recommendations and by generalizing the experience of the RCEMP in developing, certifying, and using SSs to control BA quality and to consider the Russian normal legal base of state SSs and the documents of the Eurasian Economic Union, the authors have proposed the main study areas to improve SSs, which include the elaboration of approaches to validating similar (same type) biological, methods for certifying SSs; the development of the order in which alternative approaches are applied to statistically processing test results when certifying SSs of medicines in the absence of a normal distribution of results; the formation of Russia's requirements for the development, quality assessment, and procedure for certification of both primary and secondary SSs of a manufacturer; the development of SS requirements for qualitative (not quantitative) procedures.

Currently, there is a steady increase in the incidence of diseases, the basis for which is associated carbohydrate and fat metabolism disorders (metabolic syndrome, type 2 diabetes mellitus, obesity, dyslipidemia, and non-alcoholic fatty liver disease). Despite the drugs available in clinical practice for the correction of fat and carbohydrate metabolism disorders, there is a high demand for new effective medicines that would expand the existing arsenal of drugs with this kind of a therapeutic effect. Among the traditional sources of biologically active substances, such as chemical synthesis, biotechnological synthesis, and design of plant-based drugs, the latter area is of great interest due to the variety of active ingredients that are constituents of medicinal plants. The final product of extracts from medicinal plants can be phytopreparations, phytoadjuvants (plant extracts that are able to change the pharmacokinetic and/or pharmacodynamic properties of phytopreparations), and phytonutrients, the components of medicinal and food plants, which ensure optimal functioning of various body systems.

Introduction. Prickly lettuce (Lactucaserriola L.) is widespread in the European part of Russia. Its chemical composition has not been sufficiently studied; there are some publications by foreign scientists. The plant contains triterpene compounds, sesquiterpene lactones, steroids, and flavonoids; fatty seed oil has been investigated. Lettuce is widely used in folk medicine. For raw material identity, there is a need for morphological and anatomical data that are unavailable in the literature. Objective: to develop the characteristics of the identity of prickly lettuce, as well as to identify the morphological and anatomical signs of its raw materials. Material and methods. The investigation object was the fresh and dried prickly lettuce herb harvested in the Kursk Region in 20182019. The morphological features were studied using a binocular magnifier. The anatomical structure of various prickly lettuce organs was investigated on temporary micropreparations made according to the pharmacopoeia test procedures using a Micromed C1LED microscope with a digital adjutage. Results. The diagnostic morphological and anatomical signs of prickly lettuce herb were established. The main diagnostic microscopic signs are simple hairs of various structures and articulated lacticifers. Conclusion. New data on the morphological and anatomical structure of prickly lettuce herb were obtained.

Introduction. Plant hepatoprotectors are actively used in the therapy of liver diseases. However, the range of medicines of this group, which are made in Russia, is small. Dry corn silk style and stigma extract is a promising hepatoprotective drug. Objective: to develop the composition of dry corn silk style and stigma extract-based capsules and their technology. Material and methods. The investigation object was dry corn silk style and stigma extract. The investigators determined the technological and physicochemical properties of the test extract: fractional composition, flowability, bulk weight, weight loss on drying, damping capacity, and hygroscopicity. Aerosil, lactose, ludipress, and magnesium oxide were used as excipients for capsulation. The experimental capsular masses were assessed by the degree of flowability and hygroscopicity, and the capsules were by the indicators «Disintegration» and «Dissolution». Results. The dry corn silk style and stigma extract has satisfactory flowability, but high hygroscopicity. Improvement in these parameters is favored by the addition of ludipress to the test extract in a ratio of 1:5. The resulting capsules disintegrate within 10 minutes; the dissolution of active ingredients exceeds 95%. Conclusion. Capsules with dry corn silk style and stigma extract can be prepared without prior granulation according to the recipe: dry extract 0.4; ludipress 0.08; size 0 gelatin capsules.

Introduction. Pyridostigmine bromide is an anticholinesterase drug used to treat myasthenia gravis and as an antidote for organophosphate poisoning. This substance is toxic to warm-blooded animals and can cause poisoning in humans or death. Objective: to study of the body distribution of pyridostigmine bromide in warm-blooded animals (rats) after intragastric administration of a triple LD50 of this substance. Material and methods. Pyridostigmine bromide was the object of the investigation. The latter used analytical methods, such as thin layer chromatography (TLC), high performance liquid chromatography (HPLC), and UV spectrophotometry. Male Wistar rats were intragastrically injected with a triple LD50 of pyridostigmine bromide as an aqueous suspension. The compound analyzed was isolated with acetone from the tissues of the organs and blood of dead animals, purified by replacing the solvent and by subsequent TLC using a model of the grafted stationary phase C14-C15 and the mobile phase buffer solution (pH 1.98)/ acetone = 8/2 (v/v). Results. Pyridostigmine bromide in biological objects was identified by the value of absolute chromatographic mobility (TLC), retention time in a sorbent column (HPLC), and absorption characteristics in the UV region of the spectrum. The content of pyridostigmine in the biological objects was estimated by UV spectrophotometry. The developed methods for determining the analyte in the biological objects were validated by linearity, selectivity, accuracy, precision, detection limits, and quantitative indicators. Conclusion. Pyridostigmine (pg/g of biomaterial) was found to be predominantly present in the spleen (340.8±18.51), gastric wall (240.6±21.79), gastric contents (209.8±13.35), and heart (191.2±15.49) of experimental animals.