重组猪α-干扰素喷干粉剂的制备及其效果评价

Preparation and Effect Evaluation of Recombinant Porcine Interferon Alpha Spray Dried Powder

关键词:  重组猪α干扰素喷干粉剂  喷雾干燥技术  猪腹泻

Key words:  recombinant porcine interferon alpha spray powder  spray drying technology  diarrhea

摘要:

为制备一种高活性、低价格重组猪α-干扰素（PoIFN-α），采用喷雾干燥技术制备出重组猪α-干扰素（rPoIFN-α）喷干粉剂，并通过对rPoIFN-α喷干粉剂的稳定性，安全性，治疗效果等质量标准进行综合评价。结果显示，本试验制备的重组猪α-干扰素喷干粉剂质量稳定性，有效期暂定为两年；除10倍剂量rPoIFN-α喷干粉剂导致猪肝脏轻微脂肪样病变，其余各较低剂量rPoIFN-α喷干粉剂对猪无毒副作用；人工感染和临床应用试验表明rPoIFN-α喷干粉剂对猪腹泻具有显著的治疗效果。以上试验结果为PoIFN-α喷干粉剂的工程化生产及其在养猪业中的应用打下了基础。

Abstract:

To prepare high-activity and low-price recombinant porcine interferon alpha（PoIFN-α）, the recombinant porcine interferon alpha（rPoIFN-α）spray powder was prepared by spray drying technology, and its stability, safety and treatment effect were studied in detail, respectively. The results showed the rPoIFN-α spray powder had distinct quality advantages in stability, suggesting that expiration time of the spray-drying rPoIFN-α preparation was 24 months; 5-fold dose/only the following does did not produce any toxic effect on swine, whereas, 10-fold dose could lead to mild fatty degeneration in swines’ livers cells; The cure rate of artificially infected and clinical treatment showed rPoIFN-α spray powder had obvious curative effect against diarrhea. This study will pave the way for the production of the engineered porcine interferon in the large scale and their application in pig farming industry.