声振50%葡萄糖微气泡造影剂安全性的体外实验研究

The safety study of sonicated 50% dextrose in vitro experimental

目的:探讨声振50%葡萄糖(sonicated 50%dextrose)微气泡造影剂的生物理化性能,为其临床应用的安全性提供更充分可靠的实验依据。方法:选择不同的声振强度对50%葡萄糖溶液进行声振处理,声振时间依次为10s、20s、30s、60s及2min。按照中华药典内葡萄糖注射液的药品标准,观察并检测不同时间点造影剂的各项理化指标变化情况。结果:经声振处理后葡萄糖溶液的性状稳定,其外观与鉴别试验均符合药品标准要求,与声振处理前无显著差别;声振处理后,葡萄糖溶液随声振强度增大及时间延长温度相应升高,相同条件声振处理,50%葡萄糖较生理盐水温度升高更明显;经声振处理后的葡萄糖溶液pH值为3.2～5.5;5-羟甲基糠醛按分光光度法检测吸收度均<0.32;葡萄糖(C6H12O6.H2O)含量按旋光度法检测为标示量的95.0%～105.0%。结论:50%葡萄糖溶液经声振处理后,各项理化指标变化均符合药品标准要求,与声振处理前并无显著差别。声振葡萄糖作为超声造影剂或在临床应用安全、有效。

Objective：To explore the ultrasonic characteristics of sonicated 50% dextrose as an ultrasound contrast agent and its safety in clinical applications. Method：50% glucose solution was sonicated with different ultrasonic intensities.The exposure durations were set to 10 sec,20 sec,30 sec,60 sec,and 120 sec,respectively.The physical and chemical characteristics of the sonicated solutions were examined according to the Glucose Injection’s Drug’s standard of Chinese pharmacopoeia（2005）. Result：After sonication,the solutions were stable.The appearances and results of distinction tests were of no significant differences from those before the sonication,and were conformed to the Glucose Injection’s Drug’s standard.The temperature of the sonicated solutions increased along with the increased ultrasonic intensity and exposure duration.With the same condition,the temperature increment of 50% glucose solution was more obvious than 0.9% sodium chloride solution.The pH values of 50% glucose solutions were 3.2-5.5.And the absorbencies of 5-hydromethylfurfural were less than or equal to 0.32 byspectrophotometry.The contents of glucose（C6H12O6·H2O） were 95.0%~105.0% of the indicated quantity by measuring the optical rotation. Conclusion：All characteristics of sonicated 50% glucose conformed to the Glucose Injection’s Drug’s Standard,with no significant differences from those before the sonication.Sonicated 50% glucose as an ultrasound contrast agent is safe in clinical application.