Comparison of Analytical Methods for DEHP Migration from PVC Bags for Blood Storage and Infusion; By Gas Chromatography and UV-vis Spectrophotometry

혈액·수액용 PVC 백에서 용출된 DEHP의 검출 분석 방법 비교; 기체 크로마토그래프와 분광 광도계

  • Kim, Jung Hwan (Department of Fiber & Polymer Engineering, Center for Advanced Functional Polymers, Hanyang University) ;
  • Kim, Seong Hun (Department of Fiber & Polymer Engineering, Center for Advanced Functional Polymers, Hanyang University) ;
  • Choi, Hyeong Ki (Biotechnology & Environmental Engineering Division, Agency for Technology and Standards) ;
  • Lee, Chang Hyung (Department of Medical Devices & Radiation Health, Korea Food & Drug Administration)
  • 김정환 (한양대학교 섬유고분자공학과) ;
  • 김성훈 (한양대학교 섬유고분자공학과) ;
  • 최형기 (기술표준원 생물화학기술표준부) ;
  • 이창형 (식품의약품안전청 의료기기평가부)
  • Received : 2001.10.22
  • Published : 2002.02.25

Abstract

Di-(2-ethylhexyl)phthalate (DEHP) may be released from plasticized poly(vinyl chloride) (PVC) articles. In the cases of various methods for the quantitative analysis of migrating DEHP, there are much differences in migrating quantity according to the experimental methods. It is therefore important to make the comparison and analysis between these two results. A study of DEHP migration from blood and infusion bags has been carried out in different methods to evaluate the amount of DEHP migration using gas chromatograph and UV-vis spectrophotometry. Five PVC bags were cut into plane sheets in size of $40{\times}10{\times}0.4mm$, then were immersed in extraction solvent for an hour to release DEHP. It was determined by a gas chromatograph that $23.2{\sim}70.9{\mu}g/mL$ of DEHP was extracted. While extraction solvent was injected into PVC bags which were then placed for an hour to leach DEHP out. It was checked by a UV-vis spectrophotometer that the concentration of DEHP in extraction solvent was $24.8{\sim}41.3{\mu}g/mL$. Two results show different values according to the extraction conditions and experimental methods and the gas chromatographic results were converted into UV-vis spectroscopic results on condition that DEHP would be extracted equally per unit time and unit contact area. It was concluded that DEHP migrating amounts are approximately equal in two analytical methods.

Di-(2-ethylhexyl)phthalate (DEHP) 가 가소제로 첨가되 있는 poly(vinylchloride) (PVC) 제품의 사용중에는 DEHP가 방출되어 나올 가능성이 있다. 이때 추출되는 DEHP의 정량적인 측정법에는 여러가지가 있으나 그 방법에 따라 용출량에 많은 차이가 발생하기 때문에 측정방법과 결과에 대한 비교분석은 시급한 과제라 할 수 있다. 이를 평가하기 위하여 PVC를 주원료로 하는 혈액백과 수액백에서의 DEHP 용출에 관한 연구를 기체 크로마토그래프와 분광광도계를 이용한 두 가지 방법으로 수행하였다. 5종류의 PVC 백을 실험 재료로 선택하여 $40{\times}10{\times}0.4mm$ 크기의 시편을 제조하고 이를 용출액에 담가 1시간동안 DEHP를 용출하였다. 기체 크로마토그래프로 DEHP 를 검출한 결과 시료에 따라 $23.2{\sim}70.9{\mu}g/mL$ 의 DEHP가 용출되는 것을 알 수 있었다. 반면 PVC백 안에 용출액을 주입하여 1시간 동안 DEHP를 용출시키고 분광 광도계를 이용하여 DEHP를 검출한 결과 $24.8{\sim}41.3{\mu}g/mL$의 DEHP가 용출되었다. 용출 조건과 실험방법에 따라 서로 다른 수치를 보임을 알 수 있었고 단위 시간 단위 면적 당 용출되는 DEHP의 양은 일정하다는 전제 하에 두 실험의 결과를 비교하고 환산하는 식을 구하여 적용한 결과 두 측정방법에서 얻어진 용출량이 거의 일치하였다.

Keywords

References

  1. Transfusion v.20 no.4 An in vitro evaluation of a new plasticizer for polyvinylchloride medical devices. M. S. Jacobson;S. V. Kevy;R. Parkman;J. S. Wesolowski https://doi.org/10.1046/j.1537-2995.1980.20480260277.x
  2. 고분자 과학과 기술 v.4 no.4 원호연;김일원
  3. Polymer v.37 no.23 Phase transfer catalysed surface modification of plasticized poly(vinyl chloride) in aqueous media to retard plasticizer migration A. Jayakrishnan;M. C. Sunny https://doi.org/10.1016/0032-3861(96)00501-0
  4. Artificial Organs v.8 no.1 Plasticizer migration from blood lines in hemodialysis. L. Ljunggren https://doi.org/10.1111/j.1525-1594.1984.tb04251.x
  5. Med. Clin. N. Am. v.74 no.2 D. R. Mattison;D. R. Plowchalk;M. J. Meadows;A. Z. Al-Juburi;J. Gandy;A. Malek https://doi.org/10.1016/S0025-7125(16)30569-7
  6. Food Addit. Contam. v.11 no.3 M. Sharman;W. A. Read;L. Castle;J. Gilbert https://doi.org/10.1080/02652039409374236
  7. Environmental Health Perspectives v.45 I. Tomita;Y. Nakamura;Y. Yagi;K. Tuikawa https://doi.org/10.2307/3429386
  8. Toxicology and Applied Pharmacology v.153 no.2 Effects of Relatively Low Levels of Mono-(2-Ethylhexyl) Phthalate on Cocultured Sertoli Cells and Gonocytes from Neonatal Rats L. H. Li;W. F. Jester;J. M. Orth https://doi.org/10.1006/taap.1998.8550
  9. General and Comparative Endocrinology v.101 no.1 Reduction in Penis Size and Plasma Testosterone Concentrations in Juvenile Alligators Living in a Contaminated Environment L. J. Guillette;D. B. Pickford;D. A. Crain;A. A. Rooney;H. F. Percival https://doi.org/10.1006/gcen.1996.0005
  10. Polymer v.39 no.1 Photocross-linking of dithiocarbamate-substituted PVC reduces plasticizer migration S. Lakshim;A. Jayakrishnan https://doi.org/10.1016/S0032-3861(97)00244-9
  11. Food Addit. Contam v.15 no.7 I. Steiner;L. Scharf;F. Fiala;J, Washuttl https://doi.org/10.1080/02652039809374715
  12. Transfusion v.26 no.4 Platelet storage. Effects of leachable materials on morphology and function. R. S. Labow;M. Tocchi;G. Rock https://doi.org/10.1046/j.1537-2995.1986.26486262743.x
  13. Food Addit. Contam. v.15 no.6 C.D. Papaspyrides;S. G. Tingas https://doi.org/10.1080/02652039809374698
  14. Chromatographia v.47 no.11 Gas Chromatographic Analysis of Phthalate Esters in Plastic Toys S. C. Rastogi https://doi.org/10.1007/BF02467461
  15. Biomedical Chromatography v.5 no.2 Rapid determination by high performance liquid chromatography of di-2-ethylhexyl phthalate in plasma stored in plastic bags. T. Dine;M. Luyckx;M. Cazin;CI. Brunet;J. C. Cazin;F. Goudaliez. https://doi.org/10.1002/bmc.1130050211
  16. J. Pharm. Pharmac. v.29 S. Fayz;R. Herbert;A. A. Martin https://doi.org/10.1111/j.2042-7158.1977.tb11354.x
  17. ISO 3826 Plastic Collapsible Containers for Human Blood and Blood Components
  18. J. Appl. Polym. Sci. v.26 D. Messadi;J. M. Vergnaud
  19. Polymer v.27 no.12 Flexible poly(vinyl chloride) sheets: 1. Interrelations between ultra-violet irradiation and plasticizer migration into alcohols C. D. Papaspyrides https://doi.org/10.1016/0032-3861(86)90191-6
  20. Polymer v.27 C. D. Papaspyrides
  21. Quantitative Analysis by Gas Chromatography J. Novak
  22. Physical Chemistry(6th Ed.) P. W. Atkins