OSON OKSIDLANADIGAN, TERMOLABIL VA TURG'UN BO'LMAGAN MODDALAR SAQLAGAN INYEKSION ERITMALARNING XUSUSIY TEXNOLOGIYALARI
;
https://doi.org/10.5281/zenodo.20610533;
inyeksion eritmalar, oksidlanish, termolabillik, turg'unsizlik, antioksidantlar, lyofilizatsiya, inertsiyali atmosfera, ICH Q1A(R2), barqarorlik sinovi, farmatsevtik texnologiyaAbstrak
Ushbu tadqiqotda oson oksidlanadigan (askorbik kislota, epinefrin, dopamin), termolabil (insulin, biologik preparatlar) va kimyoviy jihatdan turg'un bo'lmagan faol moddalar (beta-laktam antibiotiklari, nitroglitserin) saqlagan inyeksion dori shakllarini ishlab chiqishning xususiy farmatsevtik texnologiyalari tizimli tahlil qilindi. Antioksidant qo'shimchalarining (natriy metabisulfit, EDTA, tiosistein) optimal konsentratsiyalari, pH bufer tizimlari (pH 3.0–8.0), inertsiyali atmosfera (N₂, Ar) sharoitlarida ishlab chiqarish parametrlari va lyofilizatsiya rejimlarining ta'siri o'rganildi. Akseleratsiyalangan barqarorlik sinovlari (40°C/75% nisbiy namlik, 6 oy; ICH Q1A(R2) talablari) va real saqlash sharoitlari (2–8°C, 12 oy) bo'yicha olingan ma'lumotlar solishtirma tahlil qilindi. N₂ atmosferasida (O₂ < 5 ppm) qadoqlangan va 2–8°C da saqlangan namunalarda faol modda miqdorining saqlash davomida 98.6 ± 0.4% (12 oy) bo'lganligi aniqlandi, bu xona haroratida havoli sharoitda saqlangan namunadagi 91.3 ± 0.9% ko'rsatkichidan statistik jihatdan ahamiyatli darajada yuqori ekanligi ko'rsatildi (p < 0.001). Lyofilizatsiya usuli qo'llanilganda sof moddaning 12 oylik saqlash davomida 99.6 ± 0.2% gacha saqlanishi ta'minlandi. Olingan natijalar turg'unsiz moddalar uchun ishlab chiqarish texnologiyasini tanlashda ilmiy asoslangan mezonlarni belgilash imkonini beradi.Iqtiboslar
ICH Harmonised Tripartite Guideline. Impurities in New Drug Products Q3B(R2). Geneva: ICH; 2006.
Li J, Nation RL, Milne RW, Turnidge JD, Coulthard K. Evaluation of colistin as an agent against multi-resistant Gram-negative bacteria. Int J Antimicrob Agents. 2006;25(1):11–25.
Trissel LA. Handbook on Injectable Drugs. 17th ed. Bethesda: American Society of Health-System Pharmacists; 2013.
Wang W. Instability, stabilization, and formulation of liquid protein pharmaceuticals. Int J Pharm. 1999;185(2):129–188.
Walsh G. Biopharmaceuticals: Biochemistry and Biotechnology. 3rd ed. Oxford: Wiley-Blackwell; 2018.
Mach H, Middaugh CR, Lewis RV. Statistical determination of the average values of the extinction coefficients of tryptophan and tyrosine in native proteins. Anal Biochem. 1992;200(1):74–80.
USP 43-NF 38. General Chapter <1> Injections and Implanted Drug Products. Rockville, MD: USP Convention; 2020.
British Pharmacopoeia 2024. Parenteral Preparations. London: The Stationery Office; 2024.
Strickley RG. Solubilizing excipients in oral and injectable formulations. Pharm Res. 2004;21(2):201–230.
Khabibullaev, S., Yuldashev, N., & Mamazulunov, N. (2023). Metabolic changes in the body as the result of long-term use of artificial sweetener-sodium cyclamate. Science and innovation, 2(D10), 64-70.
Қодиров, Р. Ш., Мамазулунов, Н. Х., Ботиров, Э. Х., & Юсупов, М. М. (2020). ФЛАВОНОИДЫ RUSSOWIA SOGDIANA (BGE). FEDSCH. Экономика и социум, (12-1), 628-631.
Mamazulunov, N. (2021). INORGANIC PHOSPHATE AND PRINCIPLES OF FLUORESCENCE. Экономика и социум, (3-1 (82)), 167-169.
Икрамова, М. М., Таджибоев, К. Т., & Мамазулунов, Н. Х. (2013). ОПРЕДЕЛЕНИЕ АКТИВНОСТИ АМИНОТРАНСФЕРАЗА В ПЕРФУЗАТЕ ПЕЧЕНИ ПРИ ЭКСПЕРИМЕНТАЛЬНОМ ТОКСИЧЕСКОМ ГЕПАТИТЕ. SCIENCE AND WORLD, 42.
Bokiyev, M. (2021). Bokiyev M. Mamazulunov N. SOME BIOLOGICAL ACTIVE PRODUCTS OF METALLOCENES: ferrocene, cyclopentadiene, ferrostimulants, siacrine, bioglue, ferrocerone. Архив исследований.
Қодиров, Р. Ш., Мамазулунов, Н. Х., Ботиров, Э. Х., & Юсупов, М. М. (2020). ФЛАВОНОИДЫ RUSSOWIA SOGDIANA (BGE). FEDSCH. Экономика и социум, (12-1), 628-631.
##submission.downloads##
Nashr qilingan
Nashr
Bo'lim
Litsenziya
##submission.copyrightStatement##
##submission.license.cc.by4.footer##Iqtibos keltirish tartibi
