替曲朵辛注射液稳定性的初步考察

Preliminary study on the stability of tetrodotoxin injection

目的 考察不同温度和光照对替曲朵辛 (tetrodotoxin)注射液稳定性的影响。方法 替曲朵辛注射液在不同温度或光照下存放一定时间后 ,用小鼠生物测定法检测注射液的毒性 ,由标准曲线计算替曲朵辛的含量 ,并运用初均速法和Q10 法预测其有效期。结果 替曲朵辛注射液的稳定性受温度影响 ,预测在 2 5℃和 4℃的有效期分别为 2～ 6个月和 2年 ;在 35 0 0lx强光照射下 ,替曲朵辛注射液的外观和含量没有明显变化。结论 替曲朵辛注射液对热不稳定 ,但对光照稳定性较好 ,宜存放在阴凉处。

OBJECTIVE To study the effect of temperature and light on the stability of tetrodotoxin(TTX) injection. METHOD TTX injection samples were incubated at different temperatures and light for various times. The toxicity was determined using mouse bioassay. TTX content was calculated by the standard curve prepared at the same time. The expiration date was predicted using the initial velocity and the Q 10 method. RESULTS The studies showed that the shell life of TTX injection was 2～6 and 24 months when stored at 25℃and 4℃ respectively. The studies also indicated that strong lighting at 3500lx had no significant effect on the physical appearance of TTX injection as well as TTX content.CONCLUSION TTX is sensitive to heat but stable under light. The expiration date of TTX injection is 2 years when stored at 4℃.