辐照对重酒石酸间羟胺注射液含量的影响考察

Effects of Irradiance on the Content of Metaraminol Bitartrate Injection

目的:建立测定重酒石酸间羟胺注射液(MBI)含量的方法,并考察其辐照不同强度的γ射线后含量的变化。方法:采用高效液相色谱法测定含量,色谱柱为Diamonsil Technology C18,流动相为甲醇-0.03%庚烷磺酸钠溶液(pH3.0)(35∶65),流速为1.0mL·min-1,检测波长为272nm。将同一批MBI放置于60Co-γ射线放射源中,一次性辐照1、2、4、8、16、25kGy的强度后检测药物含量,并与辐照前比较。结果:重酒石酸间羟胺检测浓度线性范围为8～24μg·mL-(1r=0.99996);低、中、高浓度的平均回收率为99.87%、100.15%、99.92%;日间及日内RSD均小于2%。辐照前与辐照1、2、4、8、16、25kGy强度后的含量分别约为20.03、19.73、19.59、19.53、19.48、19.32、18.86μg·mL-(1辐照前后比较:P<0.01)。结论:所建立的方法可用于MBI的含量测定;辐照下MBI液具有不稳定性,随着辐照强度的增加其含量下降显著。

OBJECTIVE： To develop a method for the content determination of Metaraminol bitartrate injection （MBI）, and to study the content changes of MBI after absorption of γ-ray irradianee in different intensity levels. METHODS： HPLC method was adopted. The determination was performed on Diamonsil Technology C18 column with methanol-0.03% sodium heptanesulfonate so- lution （pH adjusted to 3.0） （35：65） at the flow rate of 1.0 mL.min-11 with detection wavelength at 272 nm. Same batch of MBI were put in the ^60Co-7 ray with absorbing the irradianee dose of 1, 2, 4, 8, 16, 25 kGy by one-time, and then the content of MBI was determined and compared with before irradiance. RESULTS： The linear range of metaraminol bitartrate （MB） was 8-24μg- mL-1 （r=0.999 96）, and the average recoveries were 99.87%, 100.15% and 99.92% at low, medium and high concentrations. The RSDs of inter-day and intra-day were less than 2 %. The contents of metaraminol bitartrate before irradiance and after irradi- ance with dose of 1, 2, 4, 8, 16, 25 kGy were 20.03, 19.73, 19.59, 19.53, 19.48, 19.32 and 18.86 ~tg.mL-1 （before vs. after ir- radiation： P〈0.01）. CONCLUSION： The developed method can be used for the content determination of MBI, and MBI is not sta- ble under the irradiance and the content of it decreases significantly as the increase of irradiance density.