避光输液器中颜料橙64和DEHP的迁移溶出研究

目的：对一次性使用避光精密过滤输液器中颜料橙64和DEHP的溶出进行研究。 方法：采用RP-HPLC法对颜料橙64的迁移溶出进行研究，采用GC-MS法对DEHP的溶出进行分析。 结果：颜料橙64在65%乙醇溶液、0.1 mol·L^-1氢氧化钠溶液、0.2 mg mL^-1氨曲南溶液、0.2 mg·mL^-1维生素B₆溶液、4 mg·mL^-1替硝唑氯化钠注射液中未发生迁移溶出，在0.1 mol·L^-1盐酸溶液中微量溶出；平均每套避光输液器在46%乙醇溶液500 mL中溶出4.95 mg DEHP。 结论：本文建立的方法灵敏度高，重复性好，适合对避光输液器中颜料橙64和DEHP的迁移溶出进行检测。

Objective: To carry out the research on the dissolution of the pigment orange 64 and DEHP(di-phthalate-(2-ethyl hexyl)ester) from disposable photophobic precise filtering infusion sets (with needle). Methods: The reversed phase HPLC method was used to study the migration dissolution of pigment orange 64, and GC-MS was employed to analyze the dissolution of DEHP. Results: Migration diffusion of the pigment orange 64 was not observed in 65% ethanol, 0.1 mol·L^-1 sodium hydroxide, 0.2 mg·mL^-1 aztreonam, 0.2 mg·mL^-1 vitamin B₆ and 4 mg·mL^-1 tinidazole, while it was trace dissolved in 0.1 mol·L^-1 hydrochloric acid solution. 4.95 mg DEHP was leached from every disposable photophobic precise filtering infusion set in 500 mL ethanol solution on average. Conclusion: The method is sensitive and highly reproducible,which can be used for the study on the dissolution of the pigment orange 64 and DEHP in disposable photophobic infusion.

[1] ZHANG Jie(章杰).New type organic pigments used for colouring plastics(塑料着色用新型有机颜料) [J].Dyestuffs Ind(染料工业),1995,32(1):1
[2] SHEN Ji-jun(沈继军),HUANG Hai(黄海).Studies and applications of benzimidazolone series pigment(苯骈咪唑系列有机颜料的研究与应用)[J].Dyestuffs Ind(染料工业),1999,36(5):19
[3] Kaul BL. Coloration of plastics using organic pigments[J].Colorat Technol, 1993, 23(1): 19
[4] Woodisse SP, Whitaker A.X-ray powder data for some orange pigments[J].J Soc Dyers Colour, 1995, 111(1-2): 26
[5] WANG Yong-hua(王永华),YANG Lin-tao(杨林涛),ZHU Hong-wei(朱红卫),et al.Research and development of benzimidazolones pigments(苯并咪唑酮系列颜料的研究与发展概况)[J].Dyestuffs Colorat(染料与染色),2011,48(6):1
[6] Tickner JA, Schettler T, Guidotti T, et al.Health risks posed by use of di-2-ethylhexyl phthalate (DEHP) in PVC medical devices:a critical review[J].Am J Ind Med, 2001, 39(1): 100
[7] FU Bu-fang(付步芳).Determination of DEHP dissolving out of parenteral nutrient containers for single use(静脉营养输液袋中DEHP的溶出量研究)[J]. Chin J Pharm Anal(药物分析杂志), 2011,31(10):2005
[8] LI Na(李娜),JIA Jian-zhong(贾建忠),SUN Xiang-de(孙祥德).HPLC determination of di-2-ethylhexyl phthalate(DEHP) content in Niuhuang Shangqing pills and medicinal packaging materials(HPLC法测定牛黄上清丸及其药包材中DEHP的含量)[J]. Chin J Pharm Anal(药物分析杂志), 2013,33(7):1163
[9] DENG Liang(邓亮),YE Li-ming(叶利明),CHEN Cong(陈聪).Determination of DEHP in infusion packed with PVC bags by GC with 530μm capillary(大口径毛细管柱气相色谱法测定注射用聚氯乙烯袋中注射液的邻苯二甲酸二异辛酯含量)[J].Chin Pharm J(中国药学杂志),2011,46(5):66
[10] XUN Yan-bin(寻延滨),JIANG Lian-ge(姜连阁),BAI Zheng-zhong(白政忠).GC/MS determination of compound aluminium hydroxide tablets in the content of plasticizer (GC/MS测定复方氢氧化铝片中增塑剂含量)[J].Chin Pharm J(中国药学杂志),2012,47(5):384
[11] Mancuso AJ, Swern D.Activated dimethyl sulfoxide: useful reagents for synthesis[J].Synthesis, 1981, 1981(3): 165
[12] Brayton CF.Dimethyl sulfoxide (DMSO): a review.Cornell Vet, 1986, 76(1):61
[13] FDA Report Center for Devices and Radiological,US Health,Food and Drug Administration.Safety Assessment of Di(2-Ethylhexyl) Phthalate (DEHP) Released from PVC Medical Devices[R].2001