论文部分内容阅读
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 study the method of preparing transfer factor oral liquid by using porcine spleen as material. Methods Porcine spleen was decellularized, clarified by centrifugation, ultrafiltered and sterilized. According to the national drug standard of the State Drug Administration, Folin’s phenol method was used to conduct a comprehensive test. Results The transfer factor oral solution, 8.04 mg / ml, 459.2μg / ml ribose and 15.8% E rose were extracted by the above process. The physical and chemical properties and biological activities of the three batches of products were all consistent with the transfer factor Preparation requirements; Sterility test, the determination of immunocompetence have reached the national drug standards. Conclusion The transfer factor oral solution prepared by using the production process has the advantages of short cycle, stable quality, high yield, high content and low production cost, and can be mass-produced.