Vol 68, No 7 (2019)

Introduction. To assess the quality and safety of drugs entering the consumer market of the Russian Federation is one of the main tasks of the pharmaceutical industry. Microbial contaminants contained in the drugs and their metabolic products can infect the patient's body and cause severe pyrogenic reactions. In addition, they are able to influence the ingredients of the drug, causing their decomposition. Objective: to study the effects of microbial contaminants contained in drugs on the identity and content of active ingredients. Material and methods. The investigation objects were four drugs contaminated with various bacteria and fungi; these included sodium picosulfate, darunavir, iohexol, and lidocaine. Isolated microbial contaminants were identified using appropriate selective and differential diagnostic culture media, as well as a Vitek 2 Compact bacterial analyzer. The content of active ingredients in the drugs was determined by high performance liquid chromatography and UV spectrophotometry. Results. The analyzed drugs were contaminated with mold fungi, Bacillus circulans, and Burkholderia cepacia. After 24-month storage in sodium picosulfate and lidocaine, the content of the microorganisms did not change; the quantity of molds contained in darunavir tablets decreased by 4 times and that of Burkholderia cepacia in injectable Yogexol solution increased by 900 times. The microorganisms present in the drugs did not affect the identity and content of active ingredients. Conclusion. Preservation of the viability of the microorganisms identified in the test drugs for 24 months of storage was studied. The effects of microorganisms on the quality indicators of these drugs were not established.

Introduction. Zidovudine is the first antiviral agent to treat HIV infection and viral hepatitis. The compound belongs to a group of nucleoside reverse transcriptase inhibitors. It is used as part of combination therapy that may include drugs of different pharmacological groups. There may be cases of toxic reactions due to the rather complex and long-term treatment of HIV infection. The pharmaceutical analysis of zidovudine in drug substance and dosage forms is based on the use of high performance liquid chromatography (HPLC); the analyzed literature lacks data from the chemical toxicological analysis of zidovudine and its combinations with other drugs. Objective: to develop a procedure for isolating, identifying, and quantifying zidovudine in biological objects. Material and methods. The investigation objects were aqueous zidovudine solutions and zidovudine-containing model mixtures of urine, saliva, and liver. Zidovudine was isolated using liquid-liquid and solid-phase extraction methods. Thin layer chromatography (TLC), UV spectrophotometry, and HPLC were used to identify and quantify the drug. Results. Conditions for extracting zidovudine from aqueous solutions were selected and procedures for isolating zidovudine from biological objects by liquid-liquid and solid-phase extraction methods were developed. Zidovudine in the extracts was identified and quantified by TLC, UV spectrophotometry, and HPLC. Conclusion. The procedures for isolating, identifying, and quantifying zidovudine in the biological objects have been developed and validated. There is evidence that the procedures are suitable to carry out a chemical toxicological analysis of zidovudine.

Introduction. Biofilms are a form of microbial communities fixed onto various abiotic and biotic surfaces. This way in which the microorganisms exist creates major problems in pharmaceutical, medical, and veterinary practice. The creation of biofilms by microorganisms makes them inaccessible to the vast majority of antimicrobial agents. The existence of biofilms in chronic infections requires entirely new treatment approaches. Some mechanisms for the formation and maintenance of certain types of biofilms are not yet completely clear. Objective: to comparatively assess and select effective methods for studying the structural and functional features of the formation of biofilms by microscopic fungi and bacteria for the further design of effective pharmacological preparations. Results. The investigators studied the structural and functional features of non-pathogenic strains of microscopic fungi of the genus Candida and bacteria Escherichia coli on the ability to form biofilms by a new modified method. A simple and economical method for producing biofilms was developed, which allows one to study the role of the tube formation process in Candida-Escherichia communities. Conclusion. The proposed model can be used to study the therapeutic effect of various drugs on biofilms and the mechanisms of their initial adhesion.

Introduction. The reduction in the production activities of pharmacies due to the ban on the manufacturing of medicines registered in the Russian Federation and produced by the pharmaceutical industry has resulted in increasing the burden on the budget of healthcare facilities that purchase these drugs on the market. The hypothesis for that the manufacture of infused drugs by the pharmacies of healthcare facilities for their own needs may be now economically feasible compared with the costs of their procurement has been made. Objective: to calculate the economic expenditures that form the cost price of infusion solutions during pharmacy manufacturing, to compare the cost price with the purchasing one of similar drugs manufactured by the industry, and to identify reserves for enhancing the efficiency of production activities of pharmacies. Material and methods. Methods for documentary observation, analysis of the chemical-technological system of production processes, and timing observations were used. Results. The values of material, utility, and labor costs were determined, the total value of which amounted to the cost of 7 names of infusion solutions selected as investigation objects. Comparison of the cost price of manufactured drugs and the purchasing prices of their analogues produced by the industry revealed that the pharmacy manufacturing was not really economically profitable for the entire range of test infused drugs under the existing conditions. Conclusion. To enhance the economic efficiency of the pharmacy manufacturing of infusion solutions, it is necessary to reduce material costs, by coming to the use of a polymer consumer container and by equipping the pharmacies of multidisciplinary healthcare facilities with modern technological complexes for the manufacture of infused drugs.

Introduction. Cystic fibrosis is a common inherited disease that affects many organs and often leads to death. The treatment complexity is the resistance of its pathogenic strains to currently available drugs. The problem can be solved by the use of antibacterial herbal drugs. One of the sources of biologically active substances for antimicrobial herbal remedies can be common horse chestnut (Aesculus hippocastanum). Objective: to conduct a screening study of the antibacterial activity of aqueous alcohol extracts from common horse chestnut flowers and buds, as well as chloroform extract and fraction of an individual substance of flavonoid nature, which are obtained from the plant buds. Material and methods. The investigation objects were aqueous alcohol extracts from horse chestnut buds and flowers in 40, 70 and 96% ethanol, as well as alcohol solutions of chloroform extracts of the flavonoid fraction from the plant buds. The minimum inhibitory concentration (MIC) was estimated by the double serial broth dilution method. The clinical strains Burkholderia cenocepacia ST 208, Burkholderia multivorans, and Pseudomonas aeruginosa from patients with cystic fibrosis were used as test cultures. Results. The extracts from horse chestnut flowers were found to have a broad-spectrum antimicrobial activity and a pronounced bactericidal effect. The chloroform extract from the buds and the flavonoid fraction had lower activity. The extracts from horse chestnut buds showed a narrow-spectrum activity with sustained activity as antibacterial agents against Burkholderia cenocepacia ST 208 and Pseudomonas aeruginosa. Conclusion. The results of the investigation can be used as a rationale for including novel types of medicinal plant materials, as well as their based preparations in the State Pharmacopoeia of the Russian Federation.