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作 者:闫肃[1] 杨琳[1] 申镇维[1] 闫素志[1] 夏天瑶[1] 孟祥文[1] 耿星海[1] 陈菲[1] 徐志宝[1]
出 处:《中国卫生工程学》2007年第6期355-356,共2页Chinese Journal of Public Health Engineering
摘 要:目的研究以猪脾为材料制备转移因子口服液的方法。方法将猪脾去脂肪细胞破碎,离心澄清、超滤、除菌,按国家药品监督管理局国家药品标准用Folin酚法进行全面检定。结果用上述工艺提取的转移因子口服液,多肽8.04 mg/ml,核糖459.2μg/ml,E玫瑰花15.8%;经检验质量稳定,3批试制品其理化性质和生物学活性均符合转移因子的制备要求;无菌试验,免疫活性测定均达到国家的药品标准。结论使用该生产工艺制备的转移因子口服液,具有周期短、质量稳定、产量高、含量高、生产成本低等优点,可大规模生产。Objective To explore a method for preparing transfer factor oral solution (TFOS). Methods Pig spleens were chosen as a meterial, the cells were broken after getting rid of fat, and then, the semifinished product was purified by centrifugal method and superfiher methods of Folin was used to detected. Results Polypeptide was 8.04 mg/ml, rilose was 459.2 μg/ml ,activing of E - rose was 15.8%. The TFOS extraced by that technique had stable quality after detection. The physical and chemical characters and biological activity all met the requirements of TF. The sterihty test and immunological activity accorded with the requirements of national drug. Conclusion This method for preparing TFOS has the advantages of short cycle, stable quality,high output and content, low cost. It is suitable for a large scale production.
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