摘要
目的根据胸腺肽注射液存放过程中易出现沉淀、胸腺肽原料提取率低、E-玫瑰花结法测定产品活力低的产品特性,为提高胸腺肽单位产量,提高胸腺肽制剂的稳定性,对其生产工艺进行改进,以提高胸腺肽原料的利用率、制剂稳定性和产品活性。方法比较常规冻融提取法与酸碱结合提取法制备胸腺肽溶液生产工艺的收率及制剂稳定性。结果常规冻融提取法工艺生产的胸腺肽收率为3mg/g左右,酸碱结合提取法收率为7mg/g,酸碱结合提取法收率及制剂稳定性优于常规工艺。结论酸碱结合提取法制备的胸腺肽工艺产量高,E-玫瑰花结法测定产品活力高,制剂稳定性好,损失小,适合大规模生产。
Objective： As precipitated easily in the stored process of thymosin injection, low rate of extraction of raw materials and low energy of product determination by E-rosette method, for improving thymosin units production and the stability of thymosin preparations, production process was improved. Methods： The yield of production and preparations stability of thymosin solution was compared with the methods of conventional freeze-thaw extraction and acid-base combination extraction. Results： Thymosin yield was 3 mg/g around by the method of conventional freeze-thaw extraction, which was 7 mg/g by the method of acid-base combination of extraction, and the extraction yield and preparation stability of acid-base combination method is better than conventional method. Conclusion The yield of thymosin were high prepared with acid-base combination method, high energy of product determination by E-rosette method, and good stability, small losses, the method would be suitable for mass production.
出处
《岳阳职业技术学院学报》
2008年第5期90-94,共5页
Journal of Yueyang Vocational and Technical College
关键词
胸腺肽
生产工艺
Thymosin
production process
