Elements of standardization and quality control of laboratory batches of peritoneal dialysis solutions containing dextrose and sodium lactate

Authors

  • Nataliia Hudz Danylo Halytsky Lviv National Medical University Pekarska str., 69, Lviv, Ukraine, 79010, Ukraine https://orcid.org/0000-0002-2240-0852
  • Anna Filipska Danylo Halytsky Lviv National Medical University Pekarska str., 69, Lviv, Ukraine, 79010, Ukraine

DOI:

https://doi.org/10.15587/2519-4852.2017.91870

Keywords:

розчини для перитонеального діалізу, фармацевтична розробка, стандартизація, аргентометричний метод, потенціометричний метод, комплексонометричне титруванння, осмолярність, осмоляльність, іони кальцію, іони магнію

Abstract

Aim. The aim of our work was to develop the analytical support for pharmaceutical development for laboratory batches of solutions for peritoneal dialysis containing dextrose and sodium lactate.

Methods. We used the following research methods: direct argentometric (determination of chloride ions), complexonometric (determination of the amount of calcium and magnesium ions), criometric (determination of osmolality and osmolarity), potentiometric methods, weighting, statistical methods and data processing of chemical experiments.

Results. Firstly in Ukraine the results of standardization and the analytical support for pharmaceutical development for laboratory batches of solutions for peritoneal dialysis are presented in the article.

Conclusions. Two procedures of quantitative determination of chloride-ions and complexonometric method of assay of the amount of calcium and magnesium ions are developed. These procedures are the basis for the quantitative determination of sodium chloride by calculation method and quantitative determination of magnesium ions by calculation method provided quantitative determination of calcium ions. The procedure of determination of the actual osmolality and osmolarity is established, acceptability criteria for osmolality and osmolarity for the solutions, which are investigated, are developed, the dependence between osmolality and osmolarity is established. The procedures of rapid quantitative determination of chlorides make it possible to assess the contribution of the stabilizer in total chloride content of solutions for peritoneal dialysis.

Author Biographies

Nataliia Hudz, Danylo Halytsky Lviv National Medical University Pekarska str., 69, Lviv, Ukraine, 79010

PhD, associate professor

Anna Filipska, Danylo Halytsky Lviv National Medical University Pekarska str., 69, Lviv, Ukraine, 79010

Assistant 

References

  1. Zvіt pro rezultaty audytu efektyvnostі vykorystannya koshtіv derzhavnogo biudzhetu, vydіlenykh dlia nadannia medychnoi dopomogy hvorym nefrologіchnogo profіlyu іz zastosuvanniam zamіsnoi nyrkovoi terapіi [Report on the results of efficiency audit of the usage of funds of the state budget allocated for the provision of medical care to patients of nephrology profile with using renal replacement therapy] (2015). Rahunkova palata. Kyіv, 43. Available at: http://www.ac-rada.gov.ua/doccatalog/document/16746643/Zvit_13_2.pdf
  2. Dudar, І. O., Palamar, B. І., Krasiuk, E. K., Petrova, A. S. (2015). Poshyrenіst' hronіchnoi hvoroby nyrok VD stadіi u svіtі ta v Ukrainі [The prevalence of chronic kidney disease VD stage in the world and in Ukraine]. Zdorov’ya Ukrainy. Available at: http://health-ua.com/stati/nephrology/poshirenist-hronichnoyi-hvorobi-nirok-vd-stadiyi-u-sviti-ta-v-ukrayini.html
  3. Thomas, B., Wulf, S., Bikbov, B., Perico, N., Cortinovis, M., Courville de Vaccaro, K. et. al. (2015). Maintenance Dialysis throughout the World in Years 1990 and 2010. Journal of the American Society of Nephrology, 26 (11), 2621–2633. doi: 10.1681/asn.2014101017
  4. Saidakova, N. O., Kozliuk, N. І., Nіkolaienko, S. S., Stepanova, N. M. (2014). Peritonealnyi dіalіz v Ukrainі: 2009–2013 [Peritoneal dialysis in Ukraine: 2009–2013]. Ukrainian Journal of Nephrology and Dialysis, 4, 1–20.
  5. Hudz, N. І., Korytniuk, R. S. (2015). Dynamіka poshyrennya hronіchnoi hvoroby nyrok v Ukrainі ta analіz asortymentu rozchynіv dlya lіkuvannya metodom perytonealnogo dіalіzu [Dynamics of chronic kidney disease prevalence in Ukraine and analysis of the assortment of solutions for peritoneal dialysis]. Coliection of scientific works of staff member of P. L. Shupyk NMAPE, 24 (4), 255–364.
  6. Kjellstrand, P., Erixon, M., Wieslander, A., Linden, T., Martinson, E. (2004). Temperature: the single most important factor for degradation of glucose fluids during storage. Peritoneal Dialysis International, 24 (4), 385–391. Available at: http://www.pdiconnect.com/content/24/4/385.long
  7. Duan, S., Yu, J., Liu, Q. et. al. (2011). Epithelial-to-mesenchymal transdifferentiation of peritoneal mesothelial cells mediated by oxidative stress in peritoneal fibrosis rats. Journal of Central South University. Medical sciences, 1, 34–43.
  8. Fernandez-Perpen, A., Perez-Lozano, M. L., Bajo, M.-A., Albar-Vizcaino, P., Correa, P. S., del Peso, G. et. al. (2012). Influence of Bicarbonate/Low-GDP Peritoneal Dialysis Fluid (Bicavera) on In Vitro and Ex Vivo Epithelial-to-Mesenchymal Transition of Mesothelial Cells. Peritoneal Dialysis International, 32 (3), 292–304. doi: 10.3747/pdi.2010.00315
  9. Nastanova ST-N MOZU 42-4.2:2011. Lіkarskі zasoby. Upravlіnnya ryzykamy dlya yakostі (ICH Q9) (2011). Kyiv: Mіnіsterstvo ohorony zdorov’ya Ukrainy, 26.
  10. Nastanova ST-N MOZU 42-4.3:2011. Lіkarskі zasoby. Farmacevtychna systema yakostі (ICH Q10) (2011). Kyiv: Mіnіsterstvo ohorony zdorov’ya Ukrainy, 22.
  11. Hudz, N. I., Korytniuk, R. S. (2016). Osobennosti razrabotki tehnologii laboratornyh serij glyukozolaktatnyh rastvorov dlya peritonealnogo dializa [Features of the development of laboratory batches technology of solutions for peritoneal dialysis containing dextrose and sodium lactate]. Recipe, 1, 14–25.
  12. European Pharmacopoeia 8.0 (2014). European Directorate for the Quality of Medicines and Health Care (EDQM). Strasbourg: Council of Europe, 3656.
  13. Hudz, N. І. (2008). Doslіdzhennya zalezhnostі fіzyko-hіmіchnyh vlastyvostej gliukozolaktatno-hіdrokarbonatnyh perytonealnyh dіalіznyh rozchynіv vіd koncentracіi natrіiu laktatu ta natrіiu hіdrokarbonatu [Investigation of the dependence of physicochemical properties of peritoneal dialysis solutions containing dextrose, sodium lactate, and sodium hydrocarbonate on concentration of sodium lactate and sodium bicarbonate]. Pharmaceutical Journal, 5, 71–76.
  14. Hudz, N. I. (2015). Rozrobka metodyk kontrolyu dlia laboratornoi tehnologіi hliukozovmіsnyh perytonealnyh dіalіznyh rozchynіv [Development of analytical procedures of quality control for laboratory batches of dextrose containing solutions for peritoneal dialysis]. Pharmaceutical Rewiev, 2, 49–54.
  15. Hudz, N. I. (2015). Obosnovaniie sostava peritonealnyh dializnyh hlyukozosoderzhashhih rastvorov [Justification of the composition of peritoneal dialysis solutions containing dextrose]. Vestnik farmacii, 2, 33–40.
  16. Hudz, N. I. (2015). Spektrofotometricheskii analiz v razrabotke peritonealnyh dializnyh rastvorov [Spectrophotometric analysis in the development of peritoneal dialysis solutions]. Vestnik Farmatsii, 4, 63–70.
  17. Derzhavna Farmakopeya Ukrainy. Vol. 1. Vol. 2. Vol. 3 (2014). Kharkіv: Derzhavne pіdpryiemstvo «Ukrains'kyj naukovyi farmakopejnyj centr yakostі lіkars'kyh zasobіv», 1130, 724, 732.
  18. Nastanova ST-N MOZU 42-3.2:2004. Lіkars'kі zasobi. Nastanova z yakostі. Specifіkacіya і kontrol'nі vyprobuvannya gotovoi produkcіi (2004). Kyiv: Mіnіsterstvo ohorony zdorov’ya Ukrainy, 42.
  19. Orlovec'ka, N. F. Izotonichnyj koeficijent. Farmacevtychna encyklopedіia. Available at: http://www.pharmencyclopedia.com.ua/article/3294/izotonichnij-koeficiyent

Downloads

Published

2017-02-28

How to Cite

Hudz, N., & Filipska, A. (2017). Elements of standardization and quality control of laboratory batches of peritoneal dialysis solutions containing dextrose and sodium lactate. ScienceRise: Pharmaceutical Science, (1 (5), 4–12. https://doi.org/10.15587/2519-4852.2017.91870

Issue

No. 1 (5) (2017)

Section

Pharmaceutical Science

License

Copyright (c) 2017 Наталія Іванівна Гудзь, Анна Михайлівна Філіпська

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Our journal abides by the Creative Commons CC BY copyright rights and permissions for open access journals.