低硼硅玻璃安瓿在维生素B_6注射液和碳酸氢钠注射液中的迁移性  

Mobility Between Low Borosilicate Glass Ampoule and Vitamin B_6 Injection/Sodium Bicarbonate Injection

作　　者：张涛 杨鹏波 曲璐 ZHANG Tao;YANG Pengbo;QU Lu(Center for Food and Drug Control Anyang Ciy,Henan Province,Anyang 455000,Chin)

机构地区：[1]河南省安阳市食品药品检验检测中心,安阳455000

出　　处：《医药导报》2018年第8期996-999,共4页Herald of Medicine

摘　　要：目的对维生素B_6注射液和碳酸氢钠注射液与低硼硅玻璃安瓿的迁移性进行研究。方法采用电感耦合等离子体质谱法(ICP-MS),检测低硼硅玻璃安瓿所含的硼(B)、铝(Al)、砷(As)、镉(Cd)、锑(Sb)、钡(Ba)、铅(Pb)元素在6和30个月向维生素B_6注射液和碳酸氢钠注射液中迁移的情况。结果 B、Al、As、Cd、Sb、Ba、Pb检测质量浓度线性范围分别为2~1 000 ng·mL^(-1)(r=0.998 8)、25~1 000 ng·mL^(-1)(r=0.998 2)、0.2~1 000 ng·mL^(-1)(r=1.000 0)、0.04~1 000 ng·mL^(-1)(r=0.999 8)、0.02~1 000 ng·mL^(-1)(r=0.999 9)、0.2~1 000 ng·mL^(-1)(r=0.999 8)、0.1~1 000 ng·mL^(-1)(r=0.999 9);检测限分别为0.391,7.482,0.0351,0.006 24,0.004 94,0.030 5,0.025 4 ng·mL^(-1)。结论酸性药物和碱性药物对低硼硅玻璃安瓿有影响,且影响不同,并且随着放置时间增加,影响会增加。Objective To study the mobility between vitamin B_6/sodium bicarbonate injection and low borosilicate glass ampoule Methods The translocation of element boron（ B）,aluminum（ Al）,arsenic（ As）,cadmium（ Cd）,antimony（ Sb）,barium（ Ba） and lead（ Pb）,migrated from the glass ampoule to B_6/sodium bicarbonate injection was respectively measured in 6 and 30 months using inductively coupled plasma mass spectrometry（ ICP-MS）. Results The linear ranges of B,Al,As,Cd,Sb,Ba,Pb were 2-1 000 ng·mL^-1（ r= 0.998 8）,25-1 000 ng·mL^-1（ r= 0.998 2）,0.2-1 000 ng·mL^-1（ r= 1.000 0）,0.04-1 000 ng·mL^-1（ r = 0.999 8）,0.02-10 000 ng·mL^-1（ r = 0.999 8）,and 0.1-1 000 ng·mL^-1（ r =0.999 9）,respectively. Additionally, their respective detection limit were 0. 391 ng · mL^-1（ B）,7. 482 ng · mL^-1,0.035 1 ng·mL^-1（ Al）,0.006 24 ng·mL^-1（ As）,0.004 94 ng·mL^-1（ Cd）,0.030 5 ng·mL^-1（ Ba） and 0.025 4 ng·mL^-1（ Pb）. Conclusion The influence of acidic injection and basic injection on low-borosilicate glass ampoules is different and the influence increases in a time-dependent manner.

关 键 词：维生素B6注射液 碳酸氢钠注射液 低硼硅玻璃安瓿 电感耦合等离子体质谱 迁移性 

分 类 号：R927.2[医药卫生—药学] R969.3