Current problems with the standard samples of medicines in the Russian Federation

Волкова, Р. А.; Fadeikina, O.V.; Ustinnikova, O. B.; Sakanyan, E. I.; Меркулов, В. А.; Movsesyants, A. A.; Бондарев, В. П.; Olefir, Yu. V.

doi:10.29296/25419218-2020-02-01

Cited by 8 publications

(1 citation statement)

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“…Основополагающий принцип лабораторного тестирования -обеспечение точности и метрологической прослеживаемости получаемых данных. С целью повышения достоверности и воспроизводимости результатов контроля качества лекарственных средств ВОЗ, Международным советом по гармонизации технических требований к фармацевтическим препаратам для медицинского применения ( [22,[29][30][31][32][33].…”

Section: Introductionunclassified

Determination of quality criteria for candidate standard for anti-D immunoglobulin

Kalinina,

Vildanova,

Kormshchikova

et al. 2024

Sibirskij nauchnyj medicinskij zhurnal

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Quality control of medicines is an integral part of the technological cycle, obligatory for the release of products into public distribution. Both in Russia and abroad, when carrying out of laboratory testing of the preparations, it is prescribed to use the reference materials – the certified standard samples. Currently, it is important for the Russian pharmaceutical industry to provide the methods for evaluating the specific activity of human anti-D immunoglobulin with a national standard sample. Its production is impossible without the production of stabilized concentrate of anti-D antibodies and verifying the suitability of each batch for sale. This requires the establishment of specification requirements and the development of regulatory documentation.Aim is to define the quality criteria for candidate standard for anti-D immunoglobulin.Material and methods. The national and foreign normative bases in the field of quality control of blood products, manufacturing and application of biological standards of medicines were analyzed. Three series of lyophilized concentrate of anti-D antibodies were obtained and a laboratory-experimental study of their properties was carried out.Results and discussion. As a result of the work done, technical specifications were approved, including a list of consumer characteristics, a description of the methods for their assessment and relevant norms.Conclusions. The established requirements can become the basis for the releasing quality control of the candidate standard for anti-D immunoglobulin during its serial production.

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Section: Introductionunclassified

Determination of quality criteria for candidate standard for anti-D immunoglobulin

Kalinina,

Vildanova,

Kormshchikova

et al. 2024

Sibirskij nauchnyj medicinskij zhurnal

View full text Add to dashboard Cite

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Application of Reference Materials in the Analysis of Medicinal Plant Raw Materials and Herbal Medicinal Products

Ryazanova,

Kurkin

2024

Reference Materials in Measurement and Technology

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The Use of Reference Materials In the Analysis of Medicinal Plant Raw Materials and Herbal Medicinal Products

Ryazanova

Куркин

2023

Stand. obraz.

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The need to improve pharmacopoeial approaches to the standardization of medicinal plant raw materials (MPRMs) and herbal medicinal products (HMPs), and the need to ensure the implementation of the principle of «cross-cutting» standardization in the series «medicinal plant raw material – phyto-substance – herbal medicinal product» determine the relevance of developing new, more rational approaches to the analysis of objects of plant origin.The purpose of the research was the theoretical and experimental substantiation of the use of reference materials in the development of assay procedures on the example of certain types of plant raw materials and products based on it from the standpoint of the chemical composition, stability and physicochemical properties of the biologically active compounds contained in them.Assay of active substances was carried out by high performance liquid chromatography (HPLC) using a Milichrome-6 chromatograph with a spectrophotometric detector in the ultraviolet (UV-) region. The UV spectra were recorded using a Specord 40 spectrophotometer. The measurement results were processed using the WinASPECT and Microsoft Excel 2016 programs.As a result of research, procedures for assay of syringin in the bark of Syringa vulgaris, and in the rhizomes and roots of Eleutherococcus senticosus, rosavin and salidroside in the rhizomes and roots of Rhodiola rosea, arbutin in the leaves of Arctostaphylos uva-ursi and Vaccinium vitis-idaea, isosalipurposide in the flowers of Helichrysum arenarium, the amount of anthracene derivatives in fresh leaves of Aloe arborescens were developed and validated. Spectrophotometric methods for determining the amount of biologically active phenylpropanoids in terms of eleutheroside B (syringin) in MPRMs and HMPs of Eleutherococcus senticosus and the amount of aralosides in the roots of Aralia Manchurian were introduced. Based on the data obtained, the scientific rationale for the use of reference materials of syringin (Syringa vulgaris bark, Eleutherococcus senticosus rhizomes and roots), rosavin and salidroside (Rhodiola rosea rhizomes and roots), the sum of ammonium salts of aralosides (Manchurian aralia root), arbutin (Arctostaphylos uva-ursi and Vaccinium vitis-idaea leaves), mixtures of aloins A and B (Aloe arborescens fresh leaves) in the analysis procedures was provided. The concept of a systematic approach to the analysis of medicinal plant raw materials and products based on it was formulated.

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Current problems with the standard samples of medicines in the Russian Federation

Cited by 8 publications

References 0 publications

Determination of quality criteria for candidate standard for anti-D immunoglobulin

Determination of quality criteria for candidate standard for anti-D immunoglobulin

Application of Reference Materials in the Analysis of Medicinal Plant Raw Materials and Herbal Medicinal Products

The Use of Reference Materials In the Analysis of Medicinal Plant Raw Materials and Herbal Medicinal Products

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