Pharmaceutical Development of «Sedoflav» Capsules, Standardization and Validation of Flavonoids Assay Methods

Джавахян, М А; Токарева, Мария Григорьевна; Прожогина, Ю. Э.; Kalenikova, E. I.

doi:10.33380/2305-2066-2020-9-3-118-127

Razrabotka i registraciâ lekarstvennyh sredstv

2020

DOI: 10.33380/2305-2066-2020-9-3-118-127

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Pharmaceutical Development of «Sedoflav» Capsules, Standardization and Validation of Flavonoids Assay Methods

М А Джавахян

Мария Григорьевна Токарева

Ю. Э. Прожогина

et al.

Abstract: Введение. Создание нового седативного препарата растительного происхождения, обладающего минимальным количеством побочного действия, является актуальной задачей современной фармакологии и фармацевтической технологии. Лекарственная форма инновационного лекарственного средства должна учитывать его свойства, обеспечивать эффективность препарата и удобство приема. Цель. Создание твердых желатиновых капсул с растительной композицией -экстрактом сухим -и валидация методик количественного определения суммы флавоноидо… Show more

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Cited by 4 publications

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Development and validation of a procedure for the quantitative determination of polysaccharides in linden flowers

Rodin,

Bokov,

Kahramanova

et al. 2024

Farmaciya

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Introduction. Linden flowers are pharmacopeial medicinal plant raw material (MPRM), containing polysaccharides. Nowadays, according to the current regulatory documentation, the assessment of the content of biologically active substances (BAS) is carried out only for flavonoids. To improve the standardization of linden flowers, the development and validation of the spectrophotometric procedure of polysaccharides determination with anthrone reagent is proposed to be relevant. Objective: To develop and validate a procedure for the quantitative determination of polysaccharides in linden flowers. Material and methods. In the development and validation of the procedure we used the method of differential spectrophotometry based on the complexation reaction of linden hydrolysate sugars with an anthrone reagent. The resulting complex has an absorption maximum of 625±2 nm, the reference standard (RS) of glucose was used as a comparison solution. The influence of extraction conditions on the yield of polysaccharides from raw materials was studied: the size of raw material particles, the ratio of raw material and extractant, the duration of extraction, as well as the selection of optimal conditions for the complexation reaction. Validation of the procedure was carried out according to the indicators: specificity, linearity and representativeness, trueness, repeatability, intermediate precision (reproducibility). Results. The optimal parameters of polysaccharides extraction from raw material were determined (three-stage extraction with distilled water on a water bath, the ratio “raw material – extractant” – 1:30 for 30 minutes, the size of raw material particles – 2,0 mm). The conditions of complex formation reaction were selected (ratio “extract – complexing agent” – 1:2, complexing agent is anthrone reagent, appearance of stable coloring of the solution in 25 minutes). During the validation of the developed procedure, it was found that the validation characteristics are within the criteria of acceptability. In the analysis of linden flowers, it was found that the content of reducing sugars in the polysaccharide composition was 1,9–3,1%. Conclusion. Optimal parameters of polysaccharide extraction from raw materials were determined, conditions of complex formation reaction were selected, and the procedure validation was carried out. The total content of reducing sugars in the polysaccharide composition in terms of absolutely dry raw material in linden flowers using differential spectrophotometry was determined.

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Development and validation of a procedure for the quantitative determination of polysaccharides in linden flowers

Rodin,

Bokov,

Kahramanova

et al. 2024

Farmaciya

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Experimental substantiation of the composition of gelatin mass for obtaining capsules with essential oils

Molokhova

Пономарева

Sorokina

et al. 2021

Razrabotka i registraciâ lekarstvennyh sredstv

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Introduction. Soft gelatin capsules are a promising dosage form comprising essential oils as active agents. Joint research of the staff of the Perm State Pharmaceutical Academy, the Research Institute of Nutrition of the Ministry of Energy and Industry of the Republic of Tajikistan have proposed the composition of gelatin mass for encapsulation by the rotary matrix method. The mechanical and physical-technological parameters required to preserve the strength and elasticity of the capsule shell during the production process and storage are determined.Aim. Study of the rheological properties of gelatin masses based on gelatin of different grades, as well as the migration of essential oils through capsule shells.Materials and methods. Pharmaceutical active substances "Lipovitol" and "Limoneol" obtained in the Republic of Tajikistan were used as active substances introduced into the composition of soft gelatin capsules. Sunflower oil was used as the solvent. Gelatin samples were used to obtain gelatin masses: 1 – Foodchem (China), 2 – Brodnickie Zaklady Zelatyny Sp. zo.o. (Poland), 3 - Italgelatine s.p.a. (Italy), 4 – Ewald-Gelatine GmbH (Germany), 5 – Weishardt International (France); glycerol; sunflower oil. Gelatin mass for manufacturing soft capsules was prepared in a closed reactor. Capsules were prepared on an automatic encapsulation line RJWJ – 115 Soft Gelatin Encapsulator Machine (China). The structural and mechanical properties of soft gelatin masses were determined on a rotary viscometer RV type "Reotest 2" (Germany). The dynamics of the process of migration of essential oils and its components were studied by changing their amount in a capsule by chromato-mass spectrometry method on a chromatograph Varian CP 3800 with a quadrupole mass spectrometer 4000 MS as a detector (USA).Results and discussion. When studying the rheological properties of model compositions, it was found that for all samples of gelatin masses there is a decrease in values of effective viscosity when the shear rate increases, which characterizes the tested samples as a structured dispersion system. Additional studies have shown that the gelatin masses have thixotropic properties. Samples of gelatin masses 3–5 had narrower hysteresis loops, while sample 5 the narrowest, restoration of the structure took place quite quickly. Capsules obtained from gelatin mass 3 and 4 samples had a strong seam and were well cut out of the tape. From the mass of sample 5, high strength ribbons were obtained, a high temperature was required to seal the capsules, in some capsules the seam was not glued on one side, as a result, the capsules were rigid and brittle. As a result of the study, the rheological optimum of the gelatin mass suitable for preparing capsules by a rotary matrix method was determined, which has boundaries in the ranges of shear rates of 0.556–243 s-1 and viscosity ranges of 11.46-5028.76 Pa ⋅ s and shear stress of 2788–2808 Pa developing at these rates. When studying the migration of active substances through the capsule shell, it was found that over three years of storage of capsules in a closed polymer can, the content of essential oil in Lipovitol capsules decreased by 4.88 %, in Limoneol capsules by 5 %, which indicates partial migration of oil through the gelatin shell. The content remained within the permissible deviations (±10 %). The content of essential essential oil components also remained within acceptable deviations throughout the shelf life.Conclusion. The optimal composition of the shell for producing soft capsules by a rotary matrix method is justified. It was found that the rheological optimum of gelatin mass is characterized by viscosity ranges of 11.46-5028.76 Pa ⋅ s and shear stress of 2788–2808 Pa. According to the results of the study of the migration of essential oils through the shell, has been established the shelf life of soft gelatin capsules in glass jars made of dark glass and a temperature of 15 to 25 °C – 3 years.

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Development of the Composition and Technology of Capsules Containing Peony Evadiant Rhizomes and Roots Dry extract and Glycine

Zamakhaeva,

Smirnova,

Oleshko

et al. 2023

Razrabotka i registraciâ lekarstvennyh sredstv

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Introduction. The development of dosage forms of sedative action is an urgent task of pharmaceutical technology in view of the prevalence of diseases of the nervous system. Peony rhizomes and roots dry extract in combination with glycine have a sedative and anxiolytic effect, which is associated with an improvement in the psycho-emotional state. Taking into account the physicochemical characteristics and composition of biologically active substances of peony rhizomes and dry extract roots, it is necessary to select auxiliary substances that improve its technological properties.Aim. Development of the composition and technology of hard gelatin capsules containing dry peony rhizomes and roots, dry extract and glycine.Materials and methods. Objects of research – dry peony rhizomes and roots (LLC "Kazan Extract Plant", Russia), glycine (JSC "Biokhimik", Russia). Excipients: apple pectin (LLC TD "HIMMED", Russia), starch (LLC TD "HIMMED", Russia), aerosil (LLC TD "HIMMED", Russia), lactose (LLC TD "HIMMED", Russia), microcrystalline cellulose (LLC TD "HIMMED", Russia), basic magnesium carbonate (LLC TD "HIMMED", Russia), magnesium oxide (LLC TD "HIMMED", Russia).Results and discussion. The composition and technology for obtaining capsules containing dry peony rhizomes and roots, dry extract and glycine, have been substantiated. The quality indicators of peony rhizomes and roots of dry extract in combination with glycine and developed capsules were determined.Conclusion. The composition of capsules of peony rhizomes and roots of dry extract and glycine has been developed, auxiliary substances have been selected to ensure satisfactory technological properties of the mass for filling the capsules.

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Pharmaceutical Development of «Sedoflav» Capsules, Standardization and Validation of Flavonoids Assay Methods

Cited by 4 publications

References 5 publications

Development and validation of a procedure for the quantitative determination of polysaccharides in linden flowers

Development and validation of a procedure for the quantitative determination of polysaccharides in linden flowers

Experimental substantiation of the composition of gelatin mass for obtaining capsules with essential oils

Development of the Composition and Technology of Capsules Containing Peony Evadiant Rhizomes and Roots Dry extract and Glycine

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