马免疫血浆的稳定性研究

目的了解不同温度条件对马免疫血浆外观和效价的稳定性影响,为马免疫血浆的采集、分离、贮存、运输及抗毒素生产提供数据支持。方法将破伤风类毒素及肉毒A、B、E、F型类毒素制备的马免疫血浆,分别放置于2~8℃、20℃、37℃3种温度下,并分别于0、1、3、6、12个月取样,依据《中国药典》三部(2010版)的检测方法和标准,对样品进行外观检查及效价检测。结果破伤风及肉毒A、B、E、F型马免疫血浆在2~8℃条件下,放置12个月稳定性良好,外观及效价均符合《中国药典》三部(2010版)规定要求。20℃与37℃下放置的马免疫血浆随着时间的延长,外观会发生不同程度的浑浊,效价也均有不同程度的降低,低效价组比中、高效价组的效价下降明显,且温度越高效价降低幅度越大。结论马免疫血浆在2~8℃条件下质量稳定。

Investigation of stabilities for immunized equine plasma

Objective To investigate the effects of different storage temperatures on immunized equine plasma, and provide basis for collection, separation, storage, and transportaion the immunized plasma used in production. Methods The teta- nus toxoids and botulinum serotype A, B, E, F toxoids immunized equine plasma were stored at 2-8 ℃, 20 ℃, 37 ℃ for 12 months, the stability for potency and appearance were tested at 0, 1, 3, 6 months and 12 months, respectively, based on the related requirements in 《Chinese Pharmacopoeia》. Results The biological activities and appearance were kept in stable after stored for 12 months at 2-8 ℃, which were met with the related requirements in 《Chinese Pharmacopoeia》. On the other hand, the plasma became turbid and formed floccule in different levels at 20 ℃ and 37 ℃, and the potencies were decreased significantly. Conclusion The immunized equine plasma could be preserved at 2-8℃ to maintain stable quality.