甲砜霉素注射液的研制及稳定性实验

PREPARATION AND STABILITY TEST OF THIAMPHENICOL INJECTION

为了开发甲砜霉素注射液新剂型 ,设计出合理的处方及制备工艺。用紫外分光光度法在2 65nm处测定其含量变化 ,以经典恒温加速法测试该注射液的稳定性 ,并预测其有效期。甲砜霉素注射液的热降解属一级动力学过程 ,在 50℃、70℃、90℃、10 0℃的降解速度常数分别为 5.37×10 - 5、6.88× 10 - 4、1.80× 10 - 3、1.0 3× 10 - 2 ,根据Arrhenius的指数定律k =Ae-E/RT推算出室温 ( 2 5℃ )条件下的速度常数k2 5℃ 为 2 .878× 10 - 6/h ,室温贮存有效期为 4 .18年。该处方及工艺是合理可行的 。

To work out rational prescription and manufacturing technology for the preparation of thiamphenicol injection,the content change was measured with ultraviolet spectrophotometry at 265nm. Its stability was tested with classical constant temperature acceleration method, and its shelf-life was predicated. The heat degradation reaction of thiamphenicol injection accords with first-order kinetics. Degradation velocity constant Ks were 5.37×10 -5 h -1 ,6.88×10 -4 h -1 ,1.80×10 -3 h -1 ,and 1.03×10 -2 h -1 ,respectively, at 50 ℃,70 ℃,90 ℃, and 100 ℃. According to the Arrhenius equation k=Ae -E/RT ,K 25℃ was calculated to be 2.878×10 -6 h -1 , t 25℃,0.9 was 4.18 years. The pH, color, and clarity of the injection had no obvious changes after storage at 50 ℃ for 120 hr or 100 ℃ for 5 hr. This prescription and manufacturing technology were rational and feasible, and the injection was stable.