辐照对盐酸肾上腺素注射液含量的影响

目的建立测定盐酸肾上腺素注射液中盐酸肾上腺素含量的高效液相色谱法,考察盐酸肾上腺素注射液吸收不同强度的γ射线辐照后的含量变化。方法将同一批盐酸肾上腺素注射液放置于60Co-γ射线放射源中,一次性吸收1,2,4,8,16,25 kGy的辐照剂量。以0.14%庚烷磺酸钠溶液(磷酸调节pH=3.0)-甲醇(65∶35)为流动相,流速1.0 mL/min,检测波长280 nm,进样量20μL,测定盐酸肾上腺素注射液含量。结果含量测定方法质量浓度线性范围是2.5～12.5μg/mL(r=0.999 8),高、中、低3个质量浓度的平均回收率为96.11%,96.05%,98.46%,日间(n=5)及日内(n=3)精密度RSD均小于1%。盐酸肾上腺素注射液吸收1,2,4,8,16,25 kGy的辐照剂量后,外观及澄明度没有明显变化,含量随着辐照强度的增加呈下降趋势,且吸收16 kGy辐照剂量以上含量下降超出质量合格范围。结论所建立的方法可用于盐酸肾上腺素注射液的含量测定。超过一定辐照剂量对盐酸肾上腺素注射液的稳定性有影响。

Study on Influence of Irradiation on Content of Epinephrine Hydrochloride Injection

Objective To establish an HPLC method for determining the content of epinephrine hydrochloride in Epinephrine Hydrochloride Injection,and to investigate the content change of epinephrine hydrochloride after absorption of γ-ray irradiation with different intensity levels.Methods The same batch of Epinephrine Hydrochloride Injection was put in the radioactive source of 60Co-γray and absorbed the radiation dose of 1,2,4,8,16,25 kGy by one-time.The mobile phase consisted of 0.14%heptanesulfonic acid sodium solution（adjusting pH to 3.0 by phosphoric acid）：methanol（65 ∶35）with the flow rate of 1.0 mL/min,the detection wavelength of 280 nm and the injection volume of 20 μL.The content of Epinephrine Hydrochloride Injection was determined.Results The linear range of epinephrine hydrochloride was 2.5-12.5 μg/mL（r=0.999 8）;the average recovery rates of high,medium and low concentrations were 96.11%,96.05%and 98.46%respectively.The inter-day（n=5）and intra-day precision（n=3）were less than 1%.After absorption dose of 1,2,4,8,16,25 kGy by one-time,the injection appearance and clarity had no significant change,the content showed the decreasing trend with the irradiation intensity increases,and the content decrease exceeded the range of acceptable quality by absorption of the radiation dose above 16 kGy.Conclusion The established method can be used for the content determination of Epinephrine Hydrochloride Injection.Exceeding certain irradiation dosage has impact on the stabilization of Epinephrine Hydrochloride Injection.