肌氨肽苷制备工艺及其病毒去除方法的验证  

Study on the processing technique of musclar amino acids and nucleosides and validation of the virus removal by ultrafiltration

作　　者：孙妙囡[1] 孙德军[2] 王智鼎[2] 

机构地区：[1]吉林大学白求恩医学院,吉林长春130021 [2]吉林大学再生医学科学研究所生物技术药物教研室,吉林长春130021

出　　处：《中国生化药物杂志》2008年第6期395-397,共3页Chinese Journal of Biochemical Pharmaceutics

摘　　要：目的研究肌氨肽苷制备工艺并对超滤法去除病毒工艺进行验证。方法以家兔心脏和肌肉为原料,制得肌氨肽苷原液。并以猪细小病毒(PPV)为指示病毒,观察用截留相对分子质量为10 000的超滤器在进压0.12MPa、回流压0.05 MPa和进压0.20 MPa、回流压0.12 MPa条件下去除肌氨肽苷原液中病毒的效果,并以牛血清白蛋白为对照品,20%磺基水杨酸作为指示剂的条件下,对超滤膜的完整性进行验证。结果滤过液中未检测出PPV,经过盲传3代,也未发现特异性细胞病变;磺基水杨酸检测未变浑浊,表明膜完整性好,超滤设备可用。结论制备肌氨肽苷的方法可行,且所采用的超滤法去除PPV是1种有效去除病毒的方法。Purpose To study the processing technique of musclar amino acids and nucleosides and to vali- date the virus removal by ultrafiltration. Methods Muscular amino acids and nucleosides spiked with the porcine parvovirus（PPV）are uhrafihered with a 10000 molecular weight, cut-off memberane under different work pressures for 1 or 3 cycles. The bobine serum albulmin and 20% sulfosalicylic acid are used to examine the filter whether it can be used. Results The residual virus was undetectable in the ultrafihrate, whether the ultrafitration procedure was carded out under a feed pressure of 0.12 MPa and under a retentate pressure of 0.05 MPa, one or three cycles, or under a feed pressure of 0.20 MPa and under a retentate pressure of 0.12 MPa, one or three cycles. Cytopathic effects were not observed in three blind passages of the ultrafiltrate samples. It was showed that the memberance is integrated for the molecular weight of all components in the uhrafil-trate. Conclusion The craft to produce musclar amino acids and nucleosides can be used in practice. The method of PPV removal by uhrafiltration is effective.

关 键 词：肌氨肽苷 生产工艺 超滤法 病毒去除法 

分 类 号：TQ464.5[化学工程—制药化工]