摘要
目的对鸡冠来源的透明质酸钠病毒灭活/去除工艺进行验证。方法根据生产所用鸡冠确定其可能携带的病毒种类,选择呼肠孤病毒Ⅲ型、伪狂犬病毒、水泡性口炎病毒和猴空泡病毒40作为相关的指示病毒。对透明质酸钠原料的制备工艺进行分析,确定透明质酸钠原料制备工艺中加热灭活工艺作为可能灭活/去除病毒的工艺,并进行病毒灭活/去除效果的验证。结果呼肠孤病毒Ⅲ型、伪狂犬病毒、水泡性口炎病毒和猴空泡病毒40经加热灭活处理的平均灭活对数值分别为≥5.688,≥5.375,≥6.542,≥7.125。透明质酸钠加热灭活工艺可有效灭活病毒。结论透明质酸钠加热灭活工艺可作为透明质酸钠制备过程中灭活病毒工艺,能有效保证产品的安全性。
Aim To verify the inactivation/ removal procedure of viruses in hyaluronate sodium derived from cockscomb.Methods Re-oviridae-3（Reo-3）,pseudo-rabies virus（PRV）,vesicular stomatitis virus（VSV） and simian virus 40（SV40） were chosen as indica-tors for analyzing the preparation procedure of hyaluronate sodium.It is concluded that heat-inactivation is an effective method.The effi-ciency of viruses inactivation/removal was verified as well.Results Heat-inactivation is effective.The average logarithm inactivation value（LIV） of Reo-3,VSV,PRV and SV40 are above 5.688,5.375,6.542,7.125,respectively.Conclusion rerpectiody Heat-inacti-vation can be used as an effective way to inactivate/ remove viruses during the procedure of hyaluronate sodium production from cocks-comb,in which the product safety can be ensured.
出处
《安徽医药》
CAS
2010年第10期1126-1128,共3页
Anhui Medical and Pharmaceutical Journal
关键词
透明质酸钠原料
病毒灭活/去除
验证
hyaluronate sodium
heat inactivation/removal virus
verification
