Comparative analysis of the requirements for the quality of excipients in Russia and abroad. Problems of biological, medical and pharmaceutical chemistry
- 作者: Sakanyan K.M.1, Kedik S.A.1, Panov A.V.1
-
隶属关系:
- Federal State Budgetary Educational Institution of Higher Education "MIREA – Russian Technological University"
- 期: 卷 28, 编号 1 (2025)
- 页面: 3-11
- 栏目: Pharmaceutical chemistry
- URL: https://journals.eco-vector.com/1560-9596/article/view/646626
- DOI: https://doi.org/10.29296/25877313-2025-01-01
- ID: 646626
如何引用文章
详细
The article presents the main classification of auxiliary substances used in the composition of medicines according to their functional purpose, a comparative analysis of regulatory documents regulating the quality of auxiliary substances included in the composition of medicines, starting from the stage of pharmaceutical development. Special attention is paid to the list of quality indicators, the inclusion of which in pharmacopoeia articles or specifications is mandatory.
全文:

作者简介
K. Sakanyan
Federal State Budgetary Educational Institution of Higher Education "MIREA – Russian Technological University"
编辑信件的主要联系方式.
Email: sakanyan@karen.ru
ORCID iD: 0000-0002-2028-2776
Ph.D. (Pharm.), Leading Research Scientist, Department of Biotechnology and Industrial Pharmacy
俄罗斯联邦, 78 Vernadsky Avenue, Moscow, 119454S. Kedik
Federal State Budgetary Educational Institution of Higher Education "MIREA – Russian Technological University"
Email: kedik@mirea.ru
ORCID iD: 0000-0003-2610-8493
Dr.Sc. (Tech.), Professor, Head of Department of Biotechnology and Industrial Pharmacy
俄罗斯联邦, 78 Vernadsky Avenue, Moscow, 119454A. Panov
Federal State Budgetary Educational Institution of Higher Education "MIREA – Russian Technological University"
Email: alpa602@mail.ru
ORCID iD: 0000-0002-1603-143X
Ph.D. (Chem.), Associate Professor of the Department of Biotechnology and Industrial Pharmacy
韩国, 78 Vernadsky Avenue, Moscow, 119454参考
- Ob obrashhenii lekarstvennyh sredstv: Federal'nyj zakon № 61–FZ ot 12.04.2010 (v poslednej redakcii otred. ot 30.01.2024). [Jelektronnyj resurs]; http://base.ga-rant.ru/12174909/. (In Russ.).
- Gosudarstvennaja farmakopeja Rossijskoj Federacii XIV izdanija. [Jelektronnyj resurs]; https://femb.ru/record/phar-macopea14. (In Russ.).
- Gosudarstvennaja farmakopeja Rossijskoj Federacii XV izdanija. [Jelektronnyj resurs]; https://pharmacopo-eia.regmed.ru/pharmacopoeia/izdanie-15/.
- Informacija o bezopasnosti vspomogatel'nyh veshhestv, vhodjashhih v lekarstvennye preparaty [Tekst]. Farmacija. 2007; 6: 6–9. (In Russ.).
- Rukovodstvo VOZ po GMP. Prilozhenie 2: Nadlezhashhaja proizvodstvennaja praktika VOZ v otnoshenii vspomogatel'nyh veshhestv, ispol'zuemyh v farmacevticheskoj produkcii (TRS 1052). (In Russ.).
- Rukovodstvo ES po formalizovannoj ocenke riskov pri vnedrenii pravil GMP dlja vspomogatel'nyh veshhestv, ispol'zuemyh v proizvodstve lekarstvennyh sredstv (2015 /s 95/02). (In Russ.).
- Reshenie Soveta EJeK ot 03.11.2016 № 78 «O pravilah registracii i jekspertizy lekarstvennyh sredstv dlja medicinskogo primenenija». (In Russ.).
- Tehnicheskij reglament Tamozhennogo sojuza «Trebovanija bezopasnosti pishhevyh dobavok, aromatizatorov i tehnologicheskih vspomogatel'nyh sredstv» (TR TS 029/2012). (In Russ.).
- Promyshlennaja farmacija. Put' sozdanija produkta. Pod red. Hohlova A.L., Pjatigorskoj N.V. M.: 2019. 394 s. (In Russ.).
- Postanovlenie Pravitel'stva RF ot 23.03.2022 № 440 «Ob utverzhdenii osobennostej vnesenija izmenenij v dokumenty, soderzhashhiesja v registracionnom dos'e na zaregistrirovannyj lekarstvennyj preparat dlja medicinskogo primenenija, v sluchae defektury ili riska vozniknovenija defektury lekarstvennyh preparatov v svjazi s vvedeniem v otnoshenii Rossijskoj Federacii ogranichitel'nyh mer jekonomicheskogo haraktera». (In Russ.).
- Reshenie ot 3 nojabrja 2016 g. № 77 «Ob utverzhdenii pravil nadlezhashhej proizvodstvennoj praktiki evrazijskogo jekonomicheskogo sojuza». (In Russ.).
- Rekomendacija ot 21 dekabrja 2021 g. № 30 «O rukovodstve po farmacevticheskoj razrabotke lekarstvennyh sredstv dlja primenenija v pediatricheskoj praktike». (In Russ.).
- US Pharmacopoeia, national Formulary, USP 46 NF 41.
- European Pharmacopoeia, 10th edition.
- Rowe R.C., Sheskey P.J., Quinn M.E. Handbook of Pharmaceutical Excipients, Sixth edition. 2009; 855: 422–424.
- Reshenie Kollegii EJeK ot 22.09.2015 № 119 «O Koncepcii garmonizacii farmakopej gosudarstv – chlenov Evrazijskogo jekonomicheskogo sojuza». (In Russ.).
