γ辐射对沙丁胺醇降解的影响。

The effect of gamma radiation on the degradation of salbutamol.

作者信息

Basly J P, Duroux J L, Bernard M

机构信息

Laboratoire de Chimie Analytique et Bromatologie, Faculté de Pharmacie, Limoges, France.

出版信息

J Pharm Biomed Anal. 1997 May;15(8):1137-41. doi: 10.1016/s0731-7085(96)01947-4.

DOI:10.1016/s0731-7085(96)01947-4

PMID:9215966

Abstract

The use of ionizing radiation for sterilization of pharmaceuticals is now a well established technology. Degradation of salbutamol was investigated after gamma irradiation using HPLC and ESR spectroscopy. HPLC evidenced the formation of radiolytic products after gamma irradiation. Salbutamol showed a degradation of nearly 2% at 25 kGy. Sterilization of salbutamol in the liquid state appeared not technically feasible. Simulation of the increase of free radicals versus dose was performed using linear and polynomial regression. These radicals could be detected even after a storage period of more than 12 months.

摘要

利用电离辐射对药品进行灭菌现在已是一项成熟的技术。使用高效液相色谱法（HPLC）和电子自旋共振光谱法（ESR）研究了γ射线辐照后沙丁胺醇的降解情况。HPLC证明γ射线辐照后形成了辐射分解产物。在25千戈瑞的剂量下，沙丁胺醇的降解率接近2%。液态沙丁胺醇的灭菌在技术上似乎不可行。使用线性和多项式回归对自由基随剂量增加的情况进行了模拟。即使在储存超过12个月后仍能检测到这些自由基。